Friday, 29 February, 2008

Teva got final approval to market Irinotecan injection

Teva Pharma announced today that the USFDA has granted final approval for the Company's ANDA to market its generic version of Pfizer's chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection, 20 mg/mL. Shipment of this product, available in 40 mg/2 mL and 100 mg/5 mL single dose vials, will begin immediately.
The brand product had annual sales of approximately $556 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.

Pfizer to appeal against Atorvastatin enatiomer patent invalidation in Netherlands

Pfizer announced that it will seek to appeal a ruling of the Court of Appeal of The Hague in the Netherlands that Pfizer's Atorvastatin hemicalcium enantiomer patent is invalid. The patent (EP 409281) had been challenged by generics manufacturer Ranbaxy and expires in July 2010.
The decision has no commercial impact because Pfizer's basic patent covering Lipitor (EP 247,633) remains in force and expires in November 2011. Last week, the same court ruled that the basic patent would be infringed by Ranbaxy's proposed generic atorvastatin product. That decision, which is also subject to possible appeal, prevents Ranbaxy from launching a competitor drug before November 2011.
The company pointed out that today's ruling does not affect patent litigation involving Lipitor in other jurisdictions, including the United States. Pfizer said it will continue to vigorously defend its patents against infringement.

Thursday, 28 February, 2008

Pharma briefs

Sun Pharma got final approval for Torsemide tablets
Sun Pharma announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets.These generic torsemide tablets are therapeutic equivalents of Hoffman la Roche’s Demadex® Tablets and include four strengths: 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately USD 35 million in the US.Torsemide is a diuretic, indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.The Company expects to reach the market shortly with these products.Demadex® is a registered trademark of Roche Therapeutics, Inc.

Gabapentin litigation
As reported yesterday Apotex Corp. has settled all outstanding patent infringement and antitrust litigation with Pfizer Inc. regarding that company's former blockbuster anticonvulsant Neurontin.Though terms of the settlement are confidential, Apotex said that it is free to market and sell the generic version as it has done since April 2005.The agreement ends almost a decade of litigation between the two companies.Pfizer added Neurontin to its drug stable when it purchased Warner-Lambert in February 2000. The drug had received approval from the U.S. Food and Drug Administration in January 1994.In 2005, the federal district court in New Jersey ruled that Pfizer was unable to prove infringement of its Neurontin patents by generic drug makers including Alpharma, Apotex, Teva Pharma and Eon Labs.
In September, an appeals court overturned portions of the 2005 decision and sent the case to a new trial after ruling that the district court erred in granting summary judgment of non-infringement.Afterward, Pfizer said it planned to pursue full damages due to the so-called at-risk launch of generic versions of Neurontin, the patent for which doesn't expire until 2017.Such a move is called an at-risk launch because, under U.S. law, the generic maker can be liable for triple the damages incurred by the branded-drug company if it ends up losing the patent case.Pfizer says sales of Neurontin were more than $2 billion a year, prior to the generic versions' launching.Pfizer offers a generic version of Neurontin through its unit Greenstone Ltd.

Barr confirms Para IV filing on Dutasteride
Barr Pharma confirmed that it has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (Dutasteride) soft gelatin capsules, 0.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avodart. Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the U.S. Food & Drug Administration (FDA) in October 2007, and received notification of the application's acceptance for filing in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.On February 25, 2008, GlaxoSmithKline filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.Avodart (dutasteride) had annual sales of approximately $362 million in the U.S., based on IMS sales data for the twelve-month period ending December 2007.

Pfizer Pulls Lipitor Ads
Pfizer Inc. (PFE) will stop running advertisements for cholesterol drug Lipitor featuring a doctor who invented an artificial heart, following criticism that the ads were misleading because the doctor isn't licensed to practice.
The New York drug company said in a press release Monday it would withdraw the ads featuring Robert Jarvik, saying "the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions" from the goal of encouraging doctor-patient dialogue about heart disease. "We regret this," the company said.

Wednesday, 27 February, 2008

Patent issues

Genentech Antibody Patent Gets Rejected
Genentech announced that U.S. Patent and Trademark Office rejected a patent that protects ways the company makes some of its drugs. The company said it might appeal. The so-called '415 patent relates, in part, to certain ways Genentech makes antibodies by recombinant DNA technology.
Genentech said it uses this technology for many of its products and has confidential licensing agreements with a number of companies on the '415 patent. Genentech also receives royalties on products covered by one or more claims of the patent, also known as Cabilly.The patent issue goes back to last February, when the Patent Office rejected all 36 claims of the Cabilly patent. In May, Genentech requested continued reexamination and the Patent Office granted the request. On Monday, however, the company said it received notification from the Patent Office that its claims of the Cabilly patent were rejected. Genentech said it plans to file a response and, if necessary, appeal the rejection.
Appellate Court in the Netherlands Upholds Basic Lipitor Patent, Prevents Launch of Ranbaxy Product before November 2011
Pfizer Inc announced that the Court of Appeal of The Hague in the Netherlands has ruled that a competitor product from generics manufacturer Ranbaxy would infringe the basic patent covering atorvastatin -the active ingredient in Lipitor -. The decision prevents Ranbaxy from launching its drug before Lipitor's basic patent (EP 247,633) expires in November 2011.
Coughlin Stoia Geller Rudman & Robbins Files Class Action Suit Against Schering-Plough Corporation
Coughlin Stoia Geller Rudman & Robbins announced that a class action has been commenced in the United States District Court for the District of New Jersey on behalf of purchasers of Schering-Plough Corporation securities during the period between July 24, 2006 and January 14, 2008.

AstraZeneca Response to Ruling In Re: Alabama Medicaid Pharmaceutical AWP Litigation

AstraZeneca believes this lawsuit is legally and factually unfounded and we intend to appeal to the Alabama Supreme Court, if the trial court does not reject the jury's verdict. The case was based on the misleading premise that the Alabama State Medicaid Agency did not understand the basics on how drug prices are established and reported. We believe numerous errors occurred during the proceedings and that the verdict should not be upheld.
For example, the Court ruled that important information on the workings of the Alabama pharmacy system be withheld throughout the trial. The Court also permitted evidence of earlier, unrelated settlements and proceedings in clear violation of the rules of evidence. These and other reversible errors were compounded by negative public comments by the trial lawyers and state leaders prior to the jury selection process.
AstraZeneca has fully complied with the law, government guidelines and contracts that govern Medicaid pricing. We currently provide medicines to Medicaid programs at the lowest price that we offer to our best business clients, as federal law requires.
AstraZeneca and the State Medicaid program share a common goal of helping people access the medicines they need.
To help patients who have difficulty affording their medicines, we offer patient assistance programs side by side with our medicines. In the last two years alone, AstraZeneca helped more than 28,800 Alabama patients receive more than $25.5 million in savings through its prescription savings programs.
Apotex and Pfizer settle Gabapentin suit
Apotex Corp. and Pfizer Inc. have settled all outstanding patent infringement and antitrust litigation over Pfizer's blockbuster epilepsy drug, Neurontin, which had earned the company more than $2 billion a year.
Gabapentin is a medication originally developed for the treatment of epilepsy. Presently, gabapentin is widely used to relieve pain, especially neuropathic pain. Gabapentin is well tolerated in most patients, has a relatively mild side-effect profile, and passes through the body unmetabolized.Gabapentin was initially synthesized to mimic the chemical structure of the neurotransmitter gamma-aminobutyric acid (GABA), but is not believed to act on the same brain receptors. Its exact mechanism of action is unknown, but its therapeutic action on neuropathic pain is thought to involve voltage-gated N-type calcium ion channels. It is thought to bind to the α2δ subunit of the voltage-dependent calcium channel in the central nervous system.

Tuesday, 26 February, 2008

Teva invalidate patent covering method of use and Kit on Alendronate sodium in Netherlands and France

Teva Pharma announced (Feb 25, 2008) the following decisions by two European courts: On February 13, 2008, the Hague District Court in the Netherlands, decided to revoke the Dutch part of Merck 's European Patent no. EP1175904 which covers methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein. The compounds are bisphosphonates selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etridronate, ibandronate, risedronate, piridronate, pamidronate, zolendronate, optionally in combination with a histamine H2 antagonist. due to lack of inventive step, which relates to Fosamax(R) Once Weekly (Alendronate 70mg Once Weekly). This decision is the first European court decision on the merits of this patent, which is currently being litigated by Teva in Belgium, France, Italy, Sweden and Spain as well as in the European Patent Office. On February 15, the Tribunal de Grande Instance de Paris, decided that Merck's supplementary protection certificate SPC 96C0032 covering the use of Alendronate for the treatment of Urolithiase and Bone Resorption was invalid for lack of inventive step. Both decisions may be appealed. Teva's Alendronate products are a subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg. Teva is already marketing Alendronate 10mg and 70mg in various European countries.

Teva launches Oxcarbazepine
Teva Pharma announce the introduction and availability of Oxcarbazepine Tablets. This product is AB rated and bioequivalent to Trileptal®* Tablets. Oxcarbazepine Tablets are available in 150 mg, 300 mg, and 600 mg strengths, in bottle sizes of 100.“Generic pharmaceuticals are playing an increasingly important role in healthcare costcontainment,” states John Denman, V.P. Sales and Marketing.“Teva Pharmaceuticals continues tolead the way with timely new product launches.”Teva Pharmaceuticals, located in North Wales, Pennsylvania, is the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research andDevelopment effort and one of the best overall ANDA approval records in the industry
Ahead of the Bell: Pharmaceutical Suits
The pharmaceutical industry will be watching the Supreme Court Monday to see if the justices will give drug makers similar protection from lawsuits recently handed to medical-device makers.
The court ruled Wednesday in a case involving Medtronic Inc. that federal regulation of advanced medical devices preempts lawsuits in state courts against their manufacturers. Please read the complete article on following link
Abbott receives FDA approval for juvenile idiopathic arthritis drug
Abbott Friday said it had received marketing approval from the USFDA for its Humira drug, which treats juvenile idiopathic arthritis. The approval was based on the safety and efficacy results from a clinical trial, Abbott said.
Genetech wins U.S. approval to use Avastin to treat breast cancer
Genentech won U.S. approval to market its top-selling treatment Avastin for women with breast cancer, giving the company a chance to add more than $700 million in sales this year.
Avastin was cleared for marketing by the U.S. Food and Drug Administration, combined with paclitaxel chemotherapy, for women whose breast cancer had spread, the company said in a statement. Avastin, the first product to work by cutting off blood supply to tumors, was already approved for colorectal and lung malignancies.The FDA overruled one of its advisory panels, which recommended 5-4 in December against approving the medicine for breast cancer. The committee said Avastin's benefit of slowing the spread of tumors was not worth the risk of serious side effects, including high blood pressure and death. Avastin generated $2.3 billion in U.S. sales in 2007.

Thursday, 21 February, 2008

Pharma news in brief

Barr launches generic Fosamax 70 mg tabs
Barr Pharma has launched a generic version of Mercks Fosamax (Alendronate Sodium trihydrate) Tablets, 70 mg after receiving final approval from the USFDA. The FDA approved the company's application on February 6, 2008, following the expiration of paediatric exclusivity (PED) associated with the earliest to expire of the patents listed with the FDA for Fosamax, 70 mg tablets. Barr obtained favourable resolutions with regard to the other patents listed for this product. Barr is entitled to share 180 days of marketing exclusivity for its 70 mg Alendronate Sodium product. This exclusivity bars the entry of competition for this product against generic competitors, other than an authorized generic and another company with which Barr shares exclusivity.Barr's Alendronate Sodium product is indicated for the treatment and prevention of osteoporosis in postmenopausal women; for the treatment to increase bone mass in men with osteoporosis; for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density; and for the treatment of Paget's disease of bone in men and women.Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion in the United States, based on IMS sales data for the 12 months ending November 2007.
King launches Altace tablets
King Pharma launched its new Altace tablets (Ramipril). King has also received orders and initiated shipments of Altace tablets to many of its customers. The company will continue to make available Altace capsules.Altace is the leading branded ACE inhibitor with multiple indications. Altace is indicated for the treatment of hypertension. Altace has also been shown to reduce the risk of death in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction.
Orchid gets US FDA nod for cefuroxime tabs
The Chennai-based pharma company Orchid has received approval from the USFDA for its ANDA for cefuroxime axetil tablets. The product is available in three dosage strengths, 125 mg, 250 mg and 500 mg. This is the 25th ANDA approval that Orchid has received since it started its US generics journey in 2005. Ranbaxy has also approved ANDA on this product
Wockhardt consolidated net up by 23% in fourth quarter

Wockhardt has achieved good consolidated performance during the fourth quarter ended December 2007. The company's consolidated net profit for the quarter ended December 2007 increased by 22.7 per cent to Rs 106.90 crore from Rs 87.10 crore in the corresponding period of last year despite reduction in other income and significant growth in staff cost. The consolidated net sales increased by 44.8 per cent to Rs 762 crore from Rs 526.40 crore in the similar period of last year. For the full year ended December 2007, the company's consolidated net profit increased by 59.9 per cent to Rs 385.80 crore from Rs 241.30 crore in the previous year. Its consolidated net sales increased by 53.5 per cent to Rs 2653 crore from Rs 1729 crore. The staff cost went up by 75 per cent to Rs 443.30 crore from Rs 253.20 crore. Further its R&D expenditure reached at Rs 50.50 crore.

Patent Challenges: A favorable indication for Generics

Chron. com have published a good article entitled "Market Spotlight: Generic Drugs" Emboldened by favorable court rulings and the need to gain an early foothold in the market, generic drug developers are increasingly challenging lucrative drug patents.
In many cases those challenges have been coming in the form of at-risk launches, where a generic version of a patented drug is sold before the patent expires. Please read complete article on following link

Wednesday, 20 February, 2008

Pharma news

Wyeth Wins Thimerosal-Autism Case
Wyeth announced today that Circuit Court in Baltimore, Maryland, has granted Wyeth's motion for summary judgment in the case of Blackwell, et al. v. Sigma Aldrich, Inc., et al an alleged vaccine injury case claiming that Jamarr Blackwell's exposure to thimerosal-containing vaccines caused him to become autistic
Previously, the Court had granted Wyeth's motion to preclude all five of plaintiffs' expert witnesses from offering testimony at trial following extensive briefing and a 10-day evidentiary hearing held by the Court last August.
In his December 21, 2007 Memorandum and Order pertaining to Wyeth's evidentiary motion, Judge Berger found that "it is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism," also noting that "it is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy."
"This is a significant victory for good science generally," says Daniel J. Thomasch, a partner at Orrick, Herrington & Sutcliffe LLP, who served as lead counsel for Wyeth in this matter. "The Court appropriately found that plaintiffs' attempt to link autism to childhood vaccines is contrary to generally accepted science." (Pharmalive)
FDA Approves Xyzal (Levocetirizine dihydrochloride) Oral Solution
UCB and sanofi-aventis announced today that the USFDA approved a New Drug Application (NDA) for XYZAL® (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. XYZAL® tablets received FDA approval on May 25, 2007 and both formulations are now approved for use in adults and children 6 years and older.
"The oral solution of XYZAL® provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market XYZAL® in the U.S. UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms.
About Allergic Conditions Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies affect as many as 40 million people in the United States. (Pharmalive)

Endo and Penwest Receive Paragraph IV Certification Notice From Actavis for Oxymorphone hydrochloride ER tablets

Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that on February 14, 2008, they received a notice from Actavis South Atlantic LLC advising of the filing by Actavis of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII.
The Actavis Paragraph IV certification notice refers to Penwest's orange book listed patents
US5128143-Product patent
US5662933- Controlled release formulation
US5958456- Controlled release formulation
US7276250-Sustained release formulations
In addition to these patents, oxymorphone hydrochloride has a new dosage form (NDA) exclusivity that prevents final approval of any ANDA by the FDA until the exclusivity expires on June 22, 2009. Endo and Penwest are currently reviewing the details of this notice from Actavis. Endo and Penwest note that they intend to pursue all available legal and regulatory avenues in defense of oxymorphone hydrochloride ER, including enforcement of their intellectual property rights and approved labeling. As previously disclosed, Endo and Penwest also have been notified by IMPAX Laboratories Inc. of its filing of an ANDA containing Paragraph IV certifications for oxymorphone hydrochloride ER in late 2007. Patent infringement suits against IMPAX are pending in the U.S. District Court for the District of Delaware.

Barr Receives Final Approval for Generic Pramipexole Dihydrochloride Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex(R) Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.
Barr Receives Final Approval for Generic Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg
Following patents are listed in orange book for Pramipexole Dihydrochloride Tablets
US4886812 (Expiry: MAR 25,2011)- Product patent (specific)
US6001861 (Expiry:JAN 16,2018)- method of use for restless leg syndrome
US6194445 (Expiry:JAN 16,2018)- method of use for restless leg syndrome
The Company is currently challenging US4886812 (product patent) protecting Mirapex and a trial is scheduled to begin on March 10, 2008 in the District Court in Delaware. Under the terms of a Court Order, Barr has agreed not to launch its Pramipexole Dihydrochloride tablets product until the earliest of the following occurs: 90 days following the conclusion of the presentation of evidence in the District Court trial, the date a favorable judgment for Barr is entered by the District Court, or July 14, 2008.
Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing a paragraph IV certification with the FDA in May 2005 and in June 2005 amended its application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and 1.5mg. The Company received notification of the application's acceptance for filing in July 2005. Following receipt of the notice from the FDA, Barr notified Boehringer Ingelheim, the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.
Mylan has also filed ANDA and innovator has sued Mylan also for the infringement of US4886812. Barr's Pramipexole Dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

Pharma news in brief

Ranbaxy to demerge NDDR unit
Ranbaxy Laboratories Ltd has announced that the board of directors of the company has cleared a scheme of de-merger of the company's New Drug Discovery Research (NDDR) unit into a subsidiary, Ranbaxy Life Science Research Ltd. (RLSRL). This is subject to requisite approvals.Ranbaxy believes that this is a significant step in creating an independent pathway for NDDR with dedicated resources and an enhanced focus for long-term growth. Ranbaxy has state of the art Research infrastructure and a highly skilled scientific talent pool. These strengths can be more effectively leveraged through an independent vehicle that better aligns assets with priorities to accelerate the company's drug discovery programmes. The resulting operational freedom and flexibility will also help to open up new growth opportunities while providing a platform for increased collaboration.The demerger will result in cost savings of approx. US $25 million in the current year for Ranbaxy, a recurring expense, likely to increase significantly in the coming years. Speaking on the occasion, Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories Ltd, said, "The de-merger of our NDDR unit into a separate entity establishes a robust structure to carry out path breaking research at the cutting edge of modern medicine. It will also enable RLSRL to create intellectual property at a faster pace while positioning it for the future" (Pharmabiz)

Generex Biotechnology got approval for phase-III clinical trial
Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, said it has received an additional regulatory approval letter for the conduct of its phase III clinical trial protocol for Generex Oral-lyn at an additional 28 clinical sites located in Europe.The significance of this approval is that it represents initiation of additional clinical sites for the pivotal study and permits commencement of screening for suitable patients. More importantly, these additional sites allow for an enrolment of up to 340 study subjects in addition to the sites which have already received regulatory approval to initiate the phase III study. The Company will be conducting the phase III trial of Generex Oral-lyn in a total of seven countries.The protocol calls for a trial with a six month active treatment period and a six month follow up which is expected to include up to 750 patients with Type-1 diabetes mellitus worldwide. The company has already received a non-objection letter from Health Canada for the conduct of this pivotal study and the FDA objection period has lapsed. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the company's RapidMist Diabetes Management System with that of standard regular injectable human insulin therapy as measured by Hba1c in patients with Type-1 diabetes mellitus. (Pharmabiz)

Salveo Life Sciences to market Ostranil in regulated market
Salveo Life Sciences Limited, which is a dedicated herbal marketing company in the country, is looking at international market foray with its latest product Ostranil, a multi-pronged approach in arthritis management in capsule and gel form. The company is also looking at marketing tie-ups to increase its reach in India and abroad. In India, Ostranil capsule and ointment have been doing well. Since its launch six months ago, the product is already the fastest growing for the company in terms of sales. The key factor for success is its efficacious contents to manage osteoarthritis, rheumatoid arthritis, gout, spondylosis and Ankylosing spondylitis.
Each capsule contains documented herbs like Hemidesmus indicus, Moringa pterygosperma, Ricinus communis, Tinospora cordifolia and Boerrhavia diffusa. These ingredients not only help to control pain but also maintain the health of the joints. The company has also released Ostranil gel to strengthen the action of Ostranil capsule. (Pharmabiz)
Patent 'reform' legislation will raise patent costs & risks
Certain controversial elements of the patent 'reform' legislation pending before the Congress would sharply increase patent costs and risks, undermining innovation with potentially serious consequences for the US economy, according to a study conducted by Biotechnology Industry Organization (BIO).The study, entitled "The Economic Implications of Patent Reform: The Deficiencies and Costs of Proposals Regarding the Apportionment of Damages, Post-Grant Opposition and Inequitable Conduct," was conducted by Robert J. Shapiro, a renowned economist and senior government official in the Clinton Administration, and Aparna Mathur, a leading health care policy expert. "US intellectual property is estimated to be worth more than $5 trillion. This new analysis finds that elements of the patent reform legislation pending before the Congress would put this value at risk by raising both the costs and uncertainties of the patent system," stated Jim Greenwood, President and CEO, BIO. "This legislation, as currently written, would undermine one of the fundamental pillars of US economic growth and innovation - our strong patent system - putting the United States at an economic and technological leadership disadvantage. If enacted into law without substantial changes, this bill would serve as an unwelcome, and unnecessary, jolt to an economy already on the brink of recession, jeopardizing hundreds of thousands of high-wage American jobs in biotechnology and other patent-intensive industries."The Shapiro-Mathur study examined three controversial provisions contained in the legislation: apportionment of damages, a broad new post-grant opposition system, and codification of the inequitable conduct doctrine. Changing the rules for apportioning damages would increase the cost of patent litigation. The new rules will likely increase the costs of patent suits by requiring that judges and juries assess massive amounts of new data in a misguided attempt to "value" only certain elements of an infringed patent claim as compared to everything in the same area that came before it, the study says.A new post-grant opposition system would sharply increase the cost of adjudicating patents. The current patent re-examination procedures cost less than $15 million a year, compared to an estimated $1.6 billion a year for a post-grant opposition system modelled after the European Union (EU), with even greater costs if the US adopts an even broader system, as under consideration in the US Senate. And this excludes the direct costs to the PTO itself of operating such an expanded system, according to the report.The codification of harmful elements of the "inequitable conduct" doctrine imposed by some courts would increase litigation and patent transaction costs. Even though allegations of inequitable conduct rarely succeed, the doctrine's broad availability and use drive up the length and cost of patent suits, and increase the costs of patenting and technology transfer activities due to fears of inequitable conduct charges years after the fact. "This study confirms our long-held views about these provisions, which as currently drafted make it easier to challenge patents and harder to enforce them," stated Greenwood. "While a limited post-grant opposition system may make sense, the costs and risks of a broad new challenge system are too high for the Congress to ignore.""A wide range of industries, labour unions, and universities have joined us in expressing grave concerns about the Patent Reform Act of 2007 in its current form. At a time of increased economic anxiety, we encourage the Senate to take these concerns seriously and to make major changes to these provisions before bringing this bill to the Senate floor," Greenwood added. (Pharmabiz)

Bayer & Onyx halt phase III trial of Nexavar
Following a planned interim analysis, Bayer HealthCare Pharmaceuticals halted a phase III trial evaluating Nexavar (sorafenib) tablets, co-developed by Onyx Pharmaceuticals, Inc, in patients with non-small cell lung cancer (NSCLC). The trial stopped early when the independent Data Monitoring Committee (DMC) concluded that the study would not meet its primary endpoint of improved overall survival. The phase III ESCAPE (Evaluation of Sorafenib, Carboplatin and Paclitaxel Efficacy in NSCLC) trial evaluated Nexavar when administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with NSCLC. Safety events were generally consistent with those previously reported, the company said. However, higher mortality was observed in the subset of patients with squamous cell carcinoma of the lung treated with sorafenib and carboplatin and paclitaxel versus those treated with carboplatin and paclitaxel alone. (Pharmabiz)
Triphendiol gets additional orphan drug status
Marshall Edwards Inc (reuters) experimental cancer drug triphendiol was granted an orphan drug status by the USFDA for treatment of malignant melanoma.
Triphendiol also has an orphan drug status for the treatment of pancreatic cancer and for the treatment of cholangiocarcinoma, bile duct cancer.

Monday, 18 February, 2008

Matrix lab receive FDA Approval to market Generic Zidovudine Tablets

USFDA granted approval for a generic formulation of Zidovudine Tablets, 300 mg., manufactured by Matrix Laboratories, Inc. of Hyderabad, India. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR )
However, because patent protections for the reference product, Retrovir Tablets,300 mg, made by GlaxoSmithKline have expired, this generic product can be marketed in the United States, as well as being available for purchase under the PEPFAR program.
Zidovudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for the treatment of HIV in combination with other antiviral medications.

Novartis filed another Lotrel suit against Teva

Novartis now has two patent suits pending against generics maker Teva over the blockbuster hypertension drug Lotrel (Lotrel contains a combination of two active ingredients--amlodipine besylate and benazepril), lodging a new complaint after Teva submitted a bid to make its proposed generic in different dosage strengths (A mlodipine Besylate and Benazepril HCl) Capsules,2.5 mg base/10 mg,5 mg base/10 mg,5 mg base/20 mg,and 10 mg base/20 mg and new strengths 4/40 and 10/40mg
Novartis and Teva have been locked in litigation over Teva's ANDA for generic Lotrel since 2004. As the 30-month stay expired last year and, probably sensing that Teva was close to obtaining final approval (and fearing an at-risk launch), Novartis moved for a preliminary injunction in March.
On May 18, 2007, Teva received approval (after expiry of US4879303) and launched which was followed by a restraining order.
Teva is currently in patent litigation concerning this product in the U.S.District Court for the District of New Jersey. A suit was brought against Teva in September 2004 involving its paragraph IV certification to US6162802 (Expiry: 19-12-2017) which covers a method for the treatment of a variety of cardiovascular disorders and related conditions in a mammal having at least one such disorder or condition is disclosed comprising treating the mammal with cotherapy comprising benazepril and amlodipine or pharmaceutically acceptable salts of either or both. Combination formulations of benazepril and amlodipine for use in the method are also disclosed.
The following companies have also filed para IV against US6162802
Watson Laboratories
Dr. Reddy's Laboratories
Par Pharmaceuticals/Kali Labs
Lupin LtdMylan

Worldwide Patent Filings on the Rise - EPO

Statistics published by the World Intellectual Property Organization (WIPO) this week show that the number of patent applications filed worldwide has grown significantly in recent years, a press release by the European Patent Office (EPO) stated.
According to the WIPO Patent Report 2007, the number of worldwide patent filings increased by an average of 4.7 % per year between 1995 and 2005, reaching a total of more than 1.6 million patent applications in 2005.
Together major patent offices - China, Japan, the United States, Korea and the EPO - account for 77 % of all applications and 74 % of granted patents.
The report notes an increasing internationalization of the patent system, with the number of filings by non-residents increasing 7.6 % between 2004 and 2005.
Inventions in the field of electricity and electronics accounted for 35 % of patent applications between 2000 and 2005, with applications concentrated in Japan, the US, Korea, Europe and China.

Abbott received USFDA approval for Simcor (Niaspan/Simvastatin)

Abbott has received USFDA approval for Simcor, the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan (Abbott's proprietary niacin extended-release) and simvastatin. Simcor is a combination of two existing, approved treatments: simvastatin, a statin, and Abbott's Niaspan, an extended-release version of niacin, a B vitamin. Simcor's approval is the first for a cholesterol drug since questions cropped up about the effectiveness of another treatment, Merck and Shering plough Corp.'s Vytorin, and could augur well for FDA approval of Merck's Cordaptive cholesterol-lowering drug, which also is based on niacin. The FDA's approval was based on Simcor safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In the Seacoast clinical trial, patients receiving Simcor 1000/20mg achieved significant cholesterol improvements over and above what simvastatin 20 mg alone provided. Patients treated with Simcor 1000/20mg had additional lipid improvements beyond simvastatin 20-mg treated baseline, with additional LDL reductions of 12 per cent and an additional 21 percent HDL increase compared to a 7 per cent decrease in LDL and an 8 per cent increase in HDL with simvastatin 20mg alone. Furthermore, Simcor reduced triglycerides by an additional 27 per cent compared to 15 per cent with simvastatin 20 mg alone.
Abbott said it is performing a study investigating whether Simcor is better than simvastatin or Niaspan alone, but results won't be available until 2011.

Friday, 15 February, 2008

Drug approvals for Orchid and Sun

Granisetron hydrochloride tablets
Orchid Chemicals & Pharmaceuticals Ltd has received approval from the USFDA for its ANDA (Abbreviated New Drug Application) for Granisetron hydrochloride tablets. The product is available in 1 mg dosage strength. It is the first Indian company to be approved for this non-antibiotic product. An anti-emetic product, Granisetron is a new generation non-antibiotic product. With limited generic competition, Orchid hopes to garner a strong market share leading to a sizeable revenue contribution from this product.

Divalproex sodium delayed release tablets
The USFDA has granted tentative approval for Sun Pharmaceutical' Abbreviated New Drug Application (ANDA) for generic Depakote, divalproex sodium delayed release tablets. Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches.These generic versions of divalproex sodium delayed release 125 mg, 250 mg and 500 mg (valproic acid activity) tablets are bio-equivalent to Depakote delayed release tablets distributed by Abbott Laboratories. These strengths of Depakote delayed release tablets have annual sales of approximately USD 755 million in the US.

Thursday, 14 February, 2008

Wockhardt to launch Azithromycin in US

Wockhardt Ltd will be launching Azithromycin tablets in the US. The company has received approval from the United States Food & Drug Administration (US FDA) for marketing the tablets containing 250mg, 500mg and 600mg azithromycin, which is used for treating various kinds of infections. Azithromycin is the generic name for the brand Zithromax, sold in the US by Pfizer."Wockhardt is only one of the four companies to have received this approval," said Wockhardt chairman Habil Khorakiwala. "Development of azithromycin is a reflection of Wockhardt's strong R&D for bulk drugs and formulations. This again is proof of Wockhardt's commitment and dedication to developing innovative technologies, to capture opportunities in the USA".Wockhardt's azithromycin tablets will be launched in the US market immediately. According to IMS, the total market for azithromycin tablets in the US is $0.7 billon equivalent to nearly 250 million tablets. It is used in treating several kinds of infections and is one of the most potent, powerful and safe antibiotics.In the prescription generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. Wockhardt today markets over fifty products in the US.The azithromycin API is manufactured in the FDA approved API facility at Ankleshwar, Gujarat and the tablets are manufactured at the US FDA certified formulation plant at Aurangabad, Maharashtra. The API and the product were developed in-house.Wockhardt is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API's, the dose forms and marketing through the wholly-owned subsidiary in the US, enabling the company to capture maximum value.

Azithromycin History
Azithromycin is an azalide, a subclass of macrolide antibiotics. Azithromycin (brand names Zithromax® in Italy, The United Kingdom, The United States, Australia, Portugal and Belgium; ATM® in India, Vinzam® / Zitromax® in Spain; Zmax®; Sumamed®; Aztrin®, Zitrocin®, Azibiot®, Azifine®,AziCip®) is one of the world's best-selling antibiotics, team of Croatian pharmaceutical company Pliva researchers, Gabrijela Kobrehel, Gorjana Radobolja-Lazarevski and Zrinka Tamburašev led by Dr. Slobodan Đokić, discovered azithromycin in 1980. It was patented in 1981, and was later found by Pfizer's scientists while going through patent documents. In 1986 Pliva and Pfizer signed a licensing agreement which gave Pfizer exclusive rights for the sale of azithromycin in Western Europe and the United States. Pliva brought their azithromycin on the market in Central and Eastern Europe under the brand name of Sumamed in 1988, Pfizer Zithromax in 1991, and Zentiva Azitrox. After several years, the US FDA approved AzaSite®, an ophthalmic formulation of azithromycin, for the treatment of eye infections. AzaSite is currently marketed in the US by Inspire Pharmaceuticals. Azithromycin is commonly administered in tablet or oral suspension (a one-dose version was made available in 2005). It is also available for intravenous injection. Tablets come in 250 mg and 500 mg doses. Oral suspension comes in 100 mg/teaspoon and 200 mg/teaspoon strengths. The 250 mg tablets are often dispensed in packages of six and commonly referred to as a "Z-Pak," whereas the 500 mg tablets are commonly available commercially in a pack of three tablets, or "Tri-Pak," intended as a three-day treatment. A common dose of oral azithromycin therapy consists of a "double dose" of medication on the first day of treatment and subsequent treatment for four or five additional days. With the "Z-Pak," this means two 250 mg tablets (a total of 500 mg) on the first day and one 250 mg tablet once daily for the next four days.
Pfizer brand-name (e.g., Zithromax®) azithromycin tablets are mottled pink, unscored, film-coated, modified-oval-shaped tablets containing azithromycin monohydrate equivalent to 250 mg or 500 mg azithromycin and the following inactive ingredients: butylated hydroxytoluene, calcium phosphate, carmine, colloidal silicon dioxide, FD&C red # 40 lake, FD&C yellow # 6 lake, hypromellose (2910, 15cP), lactose monohydrate, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, talc, titanium dioxide and triacetin. The 250 mg tablets have the following appearance: They are mottled pink, of a modified-oval-shape, and have "Pfizer" engraved into one side with "306" engraved into the other. The 500 mg tablet is similar in appearance with the exception of its relative size and "ZTM500" engraved onto one side with "Pfizer" on the reverse. As with all medications, generic azithromycin tablets produced by companies other than Pfizer without the Zithromax brand name may have different appearances. For instance, the generic azithromycin sold under the Greenstone brand is pink, with the hexagonal "G" Greenstone, Ltd. logo engraved on one side and the numerals 3060 on the other.
Brand name Zithromax in Greece and Cyprus is sold in boxes containing a blister of six white 250mg capsules. On the capsules there is printed the "Pfizer" logo and the symbols "ZTM 250".
Azithromycin is now available with microcencapsulated in betacyclodextrin, in India with the brand name of VRENTROX-DS and VENTROX-250. It is also available in India under brand name Azivista-500 in a three dose pack of 500mg each and is manufactured and sold by Cadilla pharmaceuticals.

USFTC challenge generic settlement of Modafinil

The U.S. Federal Trade Commission (USFTC) filed a lawsuit against Cephalon on Wednesday, challenging deals that the company struck with generic drug makers to keep a cheaper generic version of the sleep disorder drug Provigil (Modafinil ) off the market.
Modafinil is a eugeroic drug generally prescribed to treat narcolepsy. It is not a typical stimulant and is often described as a "wakefulness promoting agent". The drug is sometimes prescribed off-label for Attention-Deficit Hyperactivity Disorder (ADHD). In mass-media advertisements and websites, Cephalon markets the drug for improving "alertness" and reducing excessive daytime sleepiness.
The FTC asked the U.S. District Court for the District of Columbia to void the agreements, essentially giving the generic drug makers the go-ahead to bring their versions to market.
The agreements, which the FTC said were worth $200 million, were designed to prevent Teva, Barr, Ranbaxy and Mylan all major generic manufacturers from selling a generic version of the sleep disorder drug Provigil until 2012, the agency said.
Provigil accounted for $800 million in the company's sales last year, or 46 percent, according to the FTC. Cephalon said in a statement it believed that the settlements were legal.
The agency said Cephalon made the $200 million in payments in "purportedly independent business transactions.""Cephalon prevented competition to Provigil by agreeing to share its future monopoly profits with generic drug makers poised to enter the market," FTC Bureau of Competition Director Jeffrey Schmidt said in statement. "Such conduct is at the core of what the antitrust laws proscribe."

Wednesday, 13 February, 2008

Stent infringement

Boston Scientific Corporation today announced that a U.S. District Court jury in Marshall, Texas has reached a verdict in a patent infringement suit brought against the Company by Dr. Bruce Saffran. The jury found that the Company's TAXUS(R) and Liberte(TM) drug-eluting stent products infringe Dr. Saffran's patent and that the patent is valid. No injunction was requested, but the jury awarded damages of $431 million. The Company believes the jury verdict is unsupported by both the evidence and the law. On these grounds, the Company plans to seek to overturn the verdict in post-trial motions before the District Court and, if unsuccessful, to appeal to the U.S. Court of Appeals for the Federal Circuit. The Company believes it will prevail on appeal

Pharma news in brief

FDA nod to review Silodosin NDA
Watson Pharma said USFDA accepted its application for a new drug to treat enlarged prostates.Watson said the Food and Drug Administration agreed to review its silodosin application, which was backed by data from two late-stage clinical trials.Silodosin is an α1-adrenoceptor antagonist with high uroselectivity. It appears to be more effective than tamsulosin in relieving urinary symptoms associated with benign prostatic hyperplasia (BPH).
The company expects regulators to review the application in the fourth quarter.
Edwards Lifesciences sues CoreValve for patent infringement
Edwards Life sciences Corp a maker of replacement heart valves, said it filed a patent infringement lawsuit against CoreValve Inc of Irvine, California, for infringement of three patents related to Tran catheter heart valve technology. The relevant U.S. patents, part of the Andersen patent portfolio, relate to a valve prosthesis for implantation by means of a catheter.The product named in the suit is the CoreValve ReValving System, the company said.
US FDA nod for APP Pharma's bleomycin sulfate injection
APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for bleomycin sulfate for injection, USP, the equivalent of Bristol-Myers Squibb's Blenoxane.APP's bleomycin sulfate is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. According to 2007 IMS data, sales of bleomycin sulfate exceeded $7.2 million.Bleomycin sulfate for injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: squamous cell carcinoma, lymphomas, testicular carcinoma and malignant pleural effusion.APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective and critical care markets. The company is one of the largest producers of injectables, with more than 100 generic products in more than 400 dosage formulations.
Biocon awaits registration of Insugen
Biocon has filed for registration of Insugen, the recombinant human insulin, in 40 countries. The company has gone in for registration of its product with the EMEA which is expected to take around 18 months, after which it will market the product in Germany. Insugen is already marketed in Middle East, Pakistan, South East Asia and Far East. In Germany alone the insulin market is valued at Euro 950 million and by 2015 it is expected to be around Euro 4-5 billion.As part of its innovative global business initiatives, the company has chalked out a plan to enter into exclusive marketing agreements (EMA) in several countries to grab a major share in the global market with formulations developed from innovative molecules. It signed an exclusive agreement with Bayer HealthCare to market Insugen in the Chinese market, which heralds its entry into the international branded formulations arena. The company launched Insugen in November 2004. It is recognized as the world's first recombinant human insulin developed by using Pichia expression. The company has managed to grab a substantial share in the Indian market. Insugen has been an important contributor to our top and bottom line growth. "We are gaining market share not only in India, but in other parts of the world. Going forward we see this as an important product for the company," Shaw said. The insulin market in India is valued at Rs 300 crore and growing at 20 per cent annually. The three insulin MNC majors in the country, Novo Nordisk, Eli Lily and Aventis, have captured 75 per cent market share. The remaining 25 per cent rests with Biocon, Wockhardt, Shreya, Ranbaxy and Dr Reddy's.

Astrazeneca ready to block Quetiapine generic

AstraZeneca has sought leave to file for summary judgment in a U.S. patent dispute with Teva Pharma as it tries to stem the threat of generic competition to antipsychotic drug Seroquel.
Quetiapine marketed by AstraZeneca with the brand name Seroquel, belongs to a series of neuroleptics known as "atypical antipsychotics", which have, over the last two decades, become increasingly popular alternatives to "typical antipsychotics", such as haloperidol.
Quetiapine is indicated for the treatment of schizophrenia as well as for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex. Quetiapine received its initial indication from the FDA for treatment of schizophrenia in 1997. In 2004, it received its second indication for the treatment of mania-associated bipolar disorder
Teva is challenging patents protecting Seroquel and may offer a less-expensive generic copy of the medicine in the U.S. as early as the end of March, once a 30-month stay on approval is lifted.

Monday, 11 February, 2008

Erlotinib hydrochloride and Section 3(d)

A Delhi high court judgment, expected soon, promises to become the second test case in less than a year on the way Indian judiciary balances public health issues and patents owned by large multinational drug makers.
Basel-headquartered F Hoffman-La Roche Ltd is seeking an injunction against a move by India’s Cipla Ltd, ranked among the top three in the country by sales, to introduce in the local market a generic version of the Swiss firm’s lung cancer drug, Erlotinib.
Erlotinib hydrochloride (trade name Tarceva, Genentech/OSIP, originally coded as OSI-774) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Cipla has asked the court for the Tarceva patent, granted in February 2007, to be revoked.

Cipla’s move, seen risky by some, hinges on the argument that the patented drug—costing Rs4,800 a tablet or nearly double an Indian’s per capita monthly income—is out of reach of most of this country’s citizens. Cipla sells its Erlotinib version at one-third of the Roche price.
The Roche-Cipla case follows a legal battle that Novartis AG is engaged in since early 2006 with the Indian authorities over the rejection of patent application for cancer drug Glivec (sold as Gleevac globally).
Imatinib is a drug used to treat certain types of cancer. It is currently marketed by Novartis as Gleevec (USA) or Glivec (Europe/Australia) as its mesylate salt, imatinib mesilate (INN). It was originally coded during development as CGP57148B or STI-571. It is used in treating chronic myelogenous leukemia (CML), gastrointestinal stromal tumors (GISTs) and a number of other malignancies.It is the first member of a new class of agents that act by inhibiting particular tyrosine kinase enzymes, instead of non-specifically inhibiting rapidly dividing cells.
Novartis’ challenge that a rule in the Indian Patents Act, 1970, is non-compliant with global trade laws has been rejected by the Madras high court and the company, also Swiss, is separately fighting the patent rejection at an appeal tribunal.
The New Delhi case, which has high profile lawyers fighting for Roche and Cipla, is keenly watched by the drugs industry, patient groups and patent attorneys.
“If Glivec was step one, then Tarceva will be step two. Glivec established the legitimacy of Section 3(D) (the patent rule that Novartis challenged), Tarceva will show what can the patent law do for public health and access to affordable drugs in the face of a patent protected drug,” said CPAA’s Sapru. Section 3(D) bars patenting of slight modifications on existing drugs without substantial increase in efficacy. Arguments in the Roche-Cipla case closed on 31 January.
In the court, Cipla, whose legal counsel is Arun Jaitley, also a politician representing the Bharatiya Janata Party in Parliament, contended that the Tarceva patent should be revoked under Section 3(D) as the drug is a mere derivative, or tweaked version, of an older drug. Cipla faces infringement charges and a claim of Rs1 crore in damages.
Tarceva, a new drug for Roche with revenues of about $1 billion (Rs3,960 crore), has the potential to be a moneyspinner. Indicated for non-small cell lung cancer and pancreatic cancer, it is approved in 87 countries for the second- and third-line treatment of patients with advanced lung cancer, says Roche website.
Mindful of the Glivec ruling, Roche’s legal counsel, Abhishek M. Singhvi, also a spokesperson for the Congress, stated in one of the hearings that they were not challenging Section 3(D), but just its application in erlotinib’s case. The managing director of the Swiss firm’s local unit, Roche Scientific Company (India) Pvt. Ltd, Girish Telang declined comment until the court verdict.
Roche has reported Rs13.91 crore of Tarceva sales since April 2006, when it first launched the drug in the country. The revenues of the Indian unit are not known as it is privately held and not mandated to publicly report financials.
Roche’s petition called Cipla’s actions as a brazen “infringement of the legal rights of the plaintiffs (Roche and OSI Pharmaceuticals Inc.)”. Its counsel Singhvi rebutted the Cipla claim that the drug is a derivative of quinazoline, a drug with a patent pre-dating 1995, the cut-off year for grant of patents in India.
Over the course of five hearings, Cipla’s counsel Jaitley argued the patent suffered from invalidity as it wasn’t new, obvious and didn’t involve an inventive step as it was a tweaked version of a pre-1995 drug, which is not eligible for a product patent in India. The specifications in the patent application didn’t sufficiently describe the invention or its claim to improved efficacy and didn’t disclose the drug was a mixture of two polymorphs, or drug derivatives, that qualifies it for rejection under Section 3(D), he contended.
Jaitley appealed for denial of the injunction, saying the patent was new and counterclaim serious. He also asked for a patient-friendly regime, where competition among drug makers could bring the price lower than even the Rs1,600 a tablet that Cipla charges and make affordable drugs available, especially when bulk of the medical costs are met not through insurance coverage.

Mylan Levothyroxine Sodium To Be Removed From Fla Negative Drug Formulary

Mylan said a Florida administrative law judge ordered that the company's Levothyroxine Sodium product be removed from the state's negative drug formulary.When a drug is included on Florida's negative formulary, pharmacists can't substitute a generic version for a prescribed brand version. Last August, Mylan filed a petition challenging the validity of Levothyroxine's inclusion on the list. Abbott Lab, which makes a brand version of Levothyroxine Sodium, intervened. In a Jan. 28 order, Mylan's subsequent motion for summary final order was granted.
The Pittsburgh generic-drug maker said Friday it will make its products available to pharmacies in Florida as soon as motions and procedural steps are satisfied.

Cadila sue Dabur for trdemark infringement

Cadila Health care, a market leader in sugar substitute business, has dragged Dabur India for use of its 'Sugar Free' trademark in a health supplement manufactured by the rival. In its suit filed Cadila has sought damages to the tune of Rs 25 lakh from Dabur for using its trademark in the 'Sugar Free Chyawanprakash'. Justice B D Ahmed issued notice to Dabur on Cadila's suit seeking an order restraining the former from using the 'Sugar Free' trademark or any other mark that is identical or deceptively similar to it. Contending that Cadila is the proprietor of the 'Sugar Free' trademark since 1988, Singh said that from the packaging of Dabur's product 'Sugar Free Chyawanprakash', it appears that the mark 'Sugar Free' was emphasised and written in big sized fonts. Cadila alleged that Dabur has tried to capitalise upon the reputation and goodwill of Cadila's trademark 'Sugar Free' by using the same words prominently on the packaging of its product 'Chyawanprakash'. Cadila, which has 74 per cent of total market share of sugar substitute, contended that such use of its mark by Dabur would create confusion in the minds of the public at large that Dabur's product is having some connection with it as "Sugar Free" has come to be denoted and identified as Cadila's products only

Ranbaxy challenges decision to grant patent for Valganciclovir

Ranbaxy Laboratories Ltd, has legally challenged the Chennai patent office’s decision to grant a patent for the Valcyte (Valganciclovir, innovator: F Hoffman-La Roche) .
The Indian patent for Valcyte has been controversial as it was granted without hearing an opposition filed by two non-governmental organizations (NGOs)—the Indian Network for People Living with HIV/AIDS and the Tamil Nadu Networking People with HIV/AIDS.
Ranbaxy filed a post-grant opposition in the Chennai patent office last week questioning the validity of the Valcyte patent here as the drug was not proved for enhanced efficacy than what is already known.
Indian patent law, which was last amended in 2004 just before the country restarted product patents for drugs, doesn’t allow patent for drugs that are already known, unless they are proved for substantial improvement in treatment quality.
The USPTO has not granted a patent for valganciclovir way back in 1994 because the drug had been in the public domain for three years then, exposing the controversial decision of the Chennai patent office to grant a patent for the same drug here in 2007.
Valganciclovir, an anti-infection drug prescribed for HIV/Aids and organ transplantation-related infections, is the basic compound in Valcyte.
The USPTO document also shows that while the original Roche claim for a comprehensive patent was indeed rejected, a patent was granted to the crystalline form of the drug based on findings that the crystalline modification eases the manufacturing process for the drug.
Ranbaxy’s patent attorney Laxmi Kumaran confirmed that a post-grant opposition has been filed at the Chennai patent office. This comes after the Mumbai-based law firm Lawyers Collective, which filed a pre-grant opposition to Roche’s patent application in 2006, contested the patent grant saying it was denied a hearing.
Another generic drug maker Cipla Ltd had also said that it would contest the patent by filing a post-grant opposition though it hasn’t yet done so.
Lawyers Collective is likely to contest the grant in the Madras high court.
Roche, which is currently fighting another patent case at the Delhi high court against Cipla for alleged infringement of its Indian patent for a cancer drug Tarceva, could not be contacted as its office was closed for the weekend.
Valcyte was granted a patent in India in June 2007.
An interested party has time until June to oppose the grant on valid grounds. Though there are no domestic generic brands of this drug launched in India so far, Cipla has plans to come out with a generic version soon, Cipla’s managing director Amar Lulla had said in an earlier interview.
A Ranbaxy executive, who doesn’t want to be identified, also said, “The company may launch a cheaper version of Valcyte in the domestic market.”
Roche charges around $9,900 (Rs3.92 lakh) for a three-month treatment of valganciclovir although it has reduced the price to $1,800 for NGOs and customers in Africa and some other countries in the developing world. (Source:

Friday, 8 February, 2008

Ciprofloxacin antitrust litigation

The innovator always tried to stop generic players from entering into the market. The innovator companies have deviced various novel plans for settlement. The settlement between generic player and innovator results in loss to consumer. Orange book blog has published a following article on antitrust litigation of ciprofloxacin.

The Federal Trade Commission announced last week that it recently filed an amicus brief in In re Ciprofloxacin Hydrochloride Antitrust Litigation , currently pending in the Federal Circuit. In the case, direct purchaser plaintiffs of Ciprofloxacin alleged that settlements of patent litigation between Bayer and several generic drug companies violated federal and state antitrust laws. The case is an appeal of a 2005 decision granting motions for summary judgment filed by Bayer and the generic defendants.
According to the FTC's brief , the case involves agreements between Bayer and generic manufacturers Barr Labs and The Rugby Group (which has since been acquired by Watson Pharmaceuticals). The FTC states that under the agreements (executed in January 1997), Bayer paid the generic companies $398 million to agree not to manufacture any form of Cipro and for Barr's agreement to convert its paragraph IV certification (challenging the validity of the US4670444 ) to a paragraph III certification (permitting Barr to market its generic drug only upon expiration of the '444 patent, in December 2003). The FTC states that the case "illustrates the kind of abuse of the Hatch-Waxman law that prompted congressional intervention in 2003," when it required such agreements to be submitted to the FTC for review.
In short, FTC's brief makes three arguments:
The district court erred in holding that patent settlement agreements containing exclusion payments are immune from antitrust scrutiny;
Paying a potential competitor not to compete is a well established antitrust violation; and
The district court misconstrued the policies and incentives of the Hatch-Waxman Act and misconceived the practical implications of its ruling.

Why Cobalt got exclusivity on Ramipril

So finally FDA decided on Ramipril. The hard fought battle of Lupin in invalidating innovators patent on Ramipril bring no gains for Lupin. The ultimate winner is Cobalt who should thank Lupin for cleaning the way for its generic launch.
Cobalt's 180-day exclusivity period began on December 10, 2007, when the Federal Circuit's mandate issued, and that no other ramipril ANDAs will be eligible for final approval until June 7, 2008, when Cobalt's exclusivity expires. Although the Federal Circuit's decision came in the litigation involving Lupin, Cobalt was the first to file a Ramipril ANDA.
Lupin argued first that Cobalt forfeited its 180-day exclusivity by entering into a settlement of its patent litigation with King Pharmaceuticals. But FDA rejected this argument, concluding that there is no legal basis for it to find that Cobalt forfeited its exclusivity. FDA stated, "Because the Act addresses directly the question of forfeiture as a result of a settlement [in 21 USC 355(j)(5)(D)(i)(V)], the agency does not have the discretion to determine that settlements not otherwise meeting the statutory requirements also will result in forfeiture."
In addition, Lupin argued that Cobalt's settlement rendered its paragraph IV certification inaccurate because, by settling its patent litigation, Cobalt had effectively stopped asserting that the '722 patent was invalid. FDA rejected this argument as well, because "there is no evidence that at any point Cobalt conceded the '722 patent as valid, enforceable, and infringed by the product described in its ANDA." Here, it appears important that Cobalt's settlement was made "without prejudice to Cobalt's allegations that the claims of the '722 patent are invalid and unenforceable." FDA stated in its response that its regulations provide only three circumstances under which a patent certification should be amended, and none apply in this case.
Finally, Lupin argued that it "should be permitted to amend its certification so that its approval is not affected by Cobalt's exclusivity" because FDA's regulations provide for changes in certification when circumstances change. FDA, however, was not persuaded, because its regulations also preclude the withdrawal of a paragraph IV certification until expiration of 180-day exclusivity. FDA stated: "a subsequent applicant such as Lupin may not make an end run around the continued listing of an invalid patent--and the related 180-day exclusivity--merely by changing its certification. The fact that Lupin, not Cobalt, was successful in obtaining a judgment that the '722 patent is invalid does not alter this conclusion." (Source: Orange book Blog)

Merck to pay hefty amount to settle US drug pricing probe

Pharmaceutical giant Merck & Co. has agreed to pay over 650 million dollars to resolve allegations of fraudulent drug pricing and improper kickbacks, the US Justice Department announced Thursday.
The settlement hinged on two separate lawsuits relating to claims that Merck failed to pay proper rebates to government health care programs and that it made illegal payments to health care providers as inducements to use Merck products.
Attorney General Michael Mukasey said the accord marked "one of the largest healthcare fraud settlements ever achieved by the Justice Department."
"It reflects our continuing effort to hold drug companies accountable for devising pricing schemes that deliberately seek to deny federal health care programs the same lower prices for drugs that are available to other commercial customers," Mukasey said.
The settlement was partly based on a whistleblower lawsuit brought by former Merck employee, H. Dean Steinke, who claimed that the pharmaceutical firm violated the Medicaid Rebate Statute in connection with its marketing of Zocor and Vioxx.
Zocor is a cholesterol lowering drug. Vioxx was used to treat acute pain and in the treatment of arthritis and was withdrawn from the market by Merck in September 2004.
Steinke's lawsuit alleged that Merck offered deep discounts for the two drugs if hospitals used large quantities of the drugs instead of rival treatments produced by Merck's competitors.
The Medicaid Statute requires drug manufacturers to report their "best prices" and other pricing information to the government in order to ensure that Medicaid, a government health care scheme, benefits from the same discounts and pricing enjoyed by other drug purchasers.
The government said, however, that Merck improperly did not fully reveal discounted prices it had offered to hospitals to boost its sales.
The New Jersey-based drugmaker confirmed separately that it had reached a settlement with the government and state authorities in the cases.
"The settlements do not constitute an admission by Merck of any liability or wrongdoing," Merck said in a statement.
The firm's general counsel and executive vice president, Bruce Kuhlik, said: "We have taken and will continue to take a leadership position in restoring trust in this industry and in ensuring that our interactions with healthcare professionals support the care of patients and further the public health."
Merck's stock closed a scant one cent lower at 45.70 dollars in the wake of the announcement amid wider market gains.
Steinke also claimed that Merck between 1997 and 2001 ran different schemes aimed at inducing doctors to use its drugs.
The whistleblower lawsuit claimed Merck sought to give doctors excessive payments disguised as fees paid to them for "training," "consultation" or "market research."
The Justice Department claimed these fees were "illegal kickbacks" intended to induce the use of Merck drugs.
A separate lawsuit filed by a New Orleans doctor, which also formed part of the overall settlement, alleged that Merck ran a marketing scheme which offered substantially reduced prices for its Pepcid products once hospitals agreed to use the drug instead of a competitors.
Pepcid is used to reduce stomach acid and to treat heartburn and acid reflux.
The government will receive 360 million dollars under the accord while 49 states and the District of Columbia will receive over 290 million dollars.
Steinke will receive over 64 million dollars from the settlements under government whistleblower laws.

Thursday, 7 February, 2008

Forest Pharma news

Memantine OD is safe: Forest
Forest Lab said on Tuesday that patients in a late-stage clinical trial who took a once-daily formulation of its Alzheimer's drug Namenda (Meantime Hydrochloride) had a significant improvement in symptoms compared with those who took a placebo.
The company, which already sells a twice-daily formulation of the drug, evaluated the efficacy and safety of an extended release version of the drug in patients with moderate to severe Alzheimer's disease currently treated with a drug in the class known as cholinesterase inhibitors.
The company said that based on the results, which showed marked improvement in certain tests of mental function, it will pursue a marketing application for the drug.

Glenmark license anti-asthmatic drug to Forest
Glenmark received $15 million from Forest Lab as part payment for an asthma drug it licensed to the U.S.- based company in 2004. Glenmark got the so-called milestone payment after the USFDA allowed Forest to conduct additional phase 2 trials on humans for the drug GRC3886, or oglemilast. Glenmark, which earlier received $10 million from Forest, expects to get as much as $190 million as milestone payments for the asthma treatment, if it is successful. Glenmark said on Feb. 1 its agreement with a unit of Germany's Merck KGaA to develop a diabetes drug had ended and that it would continue trials on the treatment on its own, a move that could increase its research costs. Glenmark has also licensed oglemilast to Japan's Teijin Pharma Ltd. for development and sale in Japan and is seeking to license the drug to companies in Europe

Alendronate sodium Trihydrate Generics News

Watson to market authorized generic
Merck’s blockbuster osteoporosis drug Fosamax will lose patent protection tomorrow with the expiration of Orange Book listed US4621077 (which covers method of use for approved indication), losing significant $ 1.6 billion US market to generic competition. Earlier in January, Merck announced to sign a deal for an authorized generic but did not disclose the name of its partner. Finally, it is Watson Laboratories that will be selling the authorized version of Fosamax. Barr Pharmaceuticals and Teva Pharmaceutical Industries are also expected to launch generic versions Fosamax this week.
Teva press release-1
Teva Pharma announced today that the USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's osteoporosis treatment Fosamax(R) (Alendronate Sodium) Tablets, 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. Shipment of the product will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Teva press release-2
Teva Pharmaceuticals is pleased to announce the introduction and availability of Alendronate Sodium Tablets. This product is AB rated and bioequivalent to Fosamax®* Tablets. Alendronate Sodium Tablets are available in 5 mg, 10 mg, 35 mg, 40 mg, and 70 mg strengths. “Our customers count on Teva for a continuous supply of new generic products,” states John Denman, V.P. Sales and Marketing. “With the launch of Alendronate Sodium Tablets, we add another quality product to our broad line of affordable generic pharmaceuticals.”
Barr press release
Barr Pharma today announced that its subsidiary, Barr Laboratories, Inc., has launched a generic version of Merck & Co., Inc.'s Fosamax(R) (Alendronate Sodium) Tablets, 70 mg after receiving final approval from the U.S. Food and Drug Administration (FDA). The FDA approved the Company's application on February 06, 2008, 2008, following the expiration of pediatric exclusivity associated with the earliest to expire of the patents listed with the FDA for Fosamax, 70 mg tablets. Barr obtained favorable resolutions with regard to the other patents listed for this product. Barr is entitled to share 180 days of marketing exclusivity for its 70 mg Alendronate Sodium product. This exclusivity bars the entry of competition for this product against generic competitors, other than an authorized generic and another company with which Barr shares exclusivity. "Barr is pleased to be able to provide people suffering from osteoporosis and Paget's disease with a more affordable generic alternative," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "This is particularly critical as our elderly population increases and seeks to maintain their quality of life in their advanced years." Barr's Alendronate Sodium product is indicated for the treatment and prevention of osteoporosis in postmenopausal women; for the treatment to increase bone mass in men with osteoporosis; for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density; and for the treatment of Paget's disease of bone in men and women. Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion in the United States, based on IMS sales data for the 12 months ending November 2007.

Pharma news in brief

Ranbaxy got approval of Cefuroxime Axetil for Oral Suspension
Ranbaxy Lab announced today that RLL has received approval from the USFDA to manufacture and market Cefuroxime Axetil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Ceftin(R) by GlaxoSmithKline. Total annual market sales for Cefuroxime Axetil Suspension were $28.7 million.
Cefuroxime Axetil Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: Pharyngitis/Tonsillitis, Acute Bacterial Otitis Media and Impetigo. Ranbaxy is pleased to receive this approval for Cefuroxime Axetil Suspension that now allows us to offer both dosage forms for a product that is highly prescribed. We will offer Cefuroxime Axetil Suspension as a pleasant tasting liquid intended primarily for children that will ease in the acceptance and administration of this anti-infective. This product will further expand our product portfolio of affordable generic alternatives and will be launched immediately to all classes of trade," said Jim Meehan, Vice President of Sales and Distribution for RPI.
Daptomycin orange book listing
Cubist Pharma announced that the USFDA has received today the re-listing application for its U.S. Patent RE39071. Patents are considered listed in the Orange Book upon receipt by FDA, and this is one of three patents for daptomycin listed in the Orange Book. We expect that the FDA will publish the re-listed patent information in its next regular Orange Book update.US RE39071 covers the pharmaceutical composition of CUBICIN(R) (daptomycin for injection) and expires in June 2016. On September 11, 2007 Cubist had asked the FDA to de-list the pharmaceutical composition patent from the Orange Book so that it could seek a technical correction. The U.S. Patent and Trademark Office on January 29, 2008 granted a Certificate of Correction for the pharmaceutical composition patent.
Invitrogen, Agilent Technologies Settle Multiple Patent Litigations
Invitrogen Corporation and Agilent Technologies (Source: BUSINESS WIRE) have jointly announced a confidential settlement of multiple patent litigations pending between the two companies. The settlement resolves three patent infringement lawsuits between Invitrogen and Stratagene, Inc. Agilent acquired Stratagene in 2007.
These patent litigations between the companies had been pending since 2000 and 2001. In June 2000, Invitrogen sued Stratagene in the United States District Court for the District of Maryland, Southern Division, for infringement of Invitrogen's U.S. Patent Nos. 6,063,608, 5,244,797, and 5,405,776 relating to the use and sale of RNase H minus reverse transcriptase (RT) products. This case had been stayed pending resolution of a related litigation with Clontech.
On March 12, 2001, Invitrogen filed suit against Stratagene for infringement of U.S. Patent No. 4,981,797. That patent covers a process for producing E. coli cells that are more effective at absorbing foreign DNA and thereby more "competent." In 2006, the United States District Court for the Western District of Texas, Austin Division, entered judgment awarding Invitrogen $16.2 million plus prejudgment interest, post-judgment interest, attorneys' fees and costs, and entered an injunction against further infringement. Stratagene appealed the judgment to the United States Court of Appeals for the Federal Circuit.
In November 2001, Stratagene filed suit against Invitrogen in the United States District Court for the District of Maryland, Southern Division, for infringement of U.S. Patent No. 5,556,772 related to the use and sale of certain DNA polymerase blend products. The case had been stayed by the Court pending a reissuance proceeding before the United States Patent Office.
Under the terms of the agreement, Agilent will make an undisclosed settlement payment to Invitrogen. In addition, Agilent will discontinue sales of its RNase H minus RT products and Invitrogen will obtain a license from Agilent and pay an undisclosed royalty to sell its DNA polymerase blend products. All litigation will be dismissed. No other details of the settlement were disclosed.
Meditrina Signs Exclusive Global Licensing Agreement with AstraZeneca
Meditrina Pharmaceuticals, Inc., today announced that it is has completed a global licensing agreement to make, develop and commercialize products under AstraZeneca’s IP and know-how regarding the use of aromatase inhibitors (AI) in combination with estrogen and progestin to treat endometriosis. This agreement expands Meditrina’s clinical stage product portfolio which currently includes Femathina (MPI-674), an AI that Meditrina is repurposing for the treatment of several serious women’s health conditions including endometrial thinning prior to endometrial ablations in premenopausal women with abnormal uterine bleeding (AUB). Femathina recently completed a phase II clinical trial.
USFDA to take more time for reviewing Ropinirole Extended Release Tablets
SkyePharma PLC has been informed that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for GlaxoSmithKline's (NYSE: GSK) Requip(R) XLTM Extended Release tablets. The PDUFA action date is the date by which the FDA is expected to issue a response on a pending new drug application. Following the approvable letter for Requip XL issued in December 2007, GlaxoSmithKline submitted a response to the FDA. A final decision from the FDA had been expected in Q1 2008. However, GSK has recently submitted additional information on food effect to the FDA. The Agency has determined that they would not have sufficient time to review this information prior to the Q1 action date and the final decision is now expected to be received in Q2 2008. Requip(R) XLTM is the first and only once-daily oral non-ergot dopamine agonist indicated to treat the signs and symptoms of idiopathic Parkinson's disease. It uses SkyePharma's patented GEOMATRIXTM technology and has been designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. The product is expected to be available in pharmacies shortly after the anticipated approval. SkyePharma PLC is pleased to note the launch in France last week of Requip(R) LP Extended Release tablets (as Requip(R) XLTM Extended Release tablets are known in France).
European Commision approves Roche drug
Roche said the European Commission has approved its oral chemotherapy Xeloda (capecitabine) for the treatment of metastatic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin. The new approval means that more patients suffering from colorectal cancer that has spread will now be able to take advantage of effective and innovative treatments with proven patient benefits. Approval was based on the pivotal studies demonstrating Xeloda tablets providing patients with a more flexible treatment option with less hospital treatment time, whilst continuing to deliver the same survival benefits and safety as the previous standard chemotherapy intravenous (iv) 5-FU. The study also proved that Avastin in combination with chemotherapy allows patients to live significantly longer without their cancer progressing.
Tramadol OD in Canada
Paladin and Nycomed announced that the companies have entered into a Canadian Co-Promotion Agreement for Tridural once-daily tramadol. Paladin acquired the Canadian license to Tridural from Labopharm Inc. in July 2007 and launched Tridural in September 2007. Under this Co-Promotion Agreement, Nycomed Canada will share brand responsibilities and expenses with Paladin and will deploy a national primary care sales force to promote Tridural. Paladin will continue to handle distribution of Tridural and will also continue to promote Tridural using its primary care sales force. Tridural is a unique treatment option developed as a first-line therapy that provides 24-hour pain relief from a single tablet taken once-daily for adult patients with persistent pain who require treatment for several days or more. Tridural is based on Labopharm's proprietary controlled-release technology, Contramid, and a novel dual matrix delivery system that facilitates both rapid and sustained drug release, maintaining optimal therapeutic blood levels of tramadol for a full 24-hour period. Tridural offers physicians and patients greater treatment flexibility based on its relatively rapid two-day titration schedule, which could help patients reach their optimum daily dose faster than any other approved once-daily tramadol product and quickly achieve effective pain relief. In addition, Tridural has a demonstrated safety profile based on clinical trial experience of more than 2,400 patients globally and almost two years of commercial experience. As a tramadol product, Tridural provides pain relief through its action at three sites related to analgesic activity: the mu-opioid receptor, the serotonin receptor, and the norepinephrine receptor. "Our agreement with Nycomed to share brand expenses and to deploy an additional primary care sales force to promote Tridural will allow us to increase the potential for this important product," said Jonathan Goodman, president and CEO of Paladin. "We are excited to find a likeminded partner who shares our commitment to improving the treatment of pain in Canada to the benefit of patients". "Tridural presents a compelling product opportunity in a large, underserved market. We believe that Nycomed's additional marketing and sales resources will more rapidly drive the adoption of Tridural as the cornerstone of treatment for patients with persistent, moderate pain. We are very pleased to be working in partnership with Paladin,." said John Suk, president and CEO of Nycomed Canada.

Tuesday, 5 February, 2008

Enoxaparin: Antitrust case against Sanofi-Aventis in line

Even though the FDA has not approved any follow-on versions of Sanofi-Aventis’s anticoagulant Lovenox (Enoxaparin), lawyers for generics makers have disclosed that they will seek monetary damages in an antitrust case if they win a patent infringement suit.
Sanofi-Aventis is seeking to overturn a district court decision that found two of its patents invalid due to inequitable conduct. The case involves whether Sanofi-Aventis knowingly misled USPTO when comparing Lovenox’s half-life to the prior art.
Amphastar and Teva are alleging that Sanofi-Aventis compared Lovenox to another drug at a different dose, when their drug would have had the same half life if it had been compared at the same dosage, according to Amphastar’s attorney Jan Weir.
This is the second time that Sanofi-Aventis and generics makers Amphastar and Teva are appearing in front of the Federal Circuit. Sanofi-Aventis has already lost twice in the district court of California - first in a summary judgment ruling and again in a jury trial.
Weir, a shareholder at law firm Stradling Yocca Carlson & Rauth, noted that the Federal Circuit has already upheld the half life issue as ”highly material” to the case, and is now deciding on the question of whether Sanofi-Aventis intentionally defrauded the patent office.
Neither Sanofi-Aventis nor an attorney responded to a request for comment.
Weir noted that Amphastar’s abbreviated new drug application for generic enoxaparin, a protein-based drug, is still pending. Yet he noted that the clock on the 180-day period of exclusivity won’t begin to run until its product is approved.
In addition, if the district court ruling is upheld, attorneys for Teva and Amphastar will proceed with an antitrust case against Sanofi-Aventis, Weir said, which would mean that the innovator company could be on the hook for monetary damages.
”There are substantial penalties in the antitrust case,” he said. ”It’s an important case, in that the patent office relies on the data that companies submit to them.”
He cited as precedent the Supreme Court case of Walker Process v. Food Machinery, which held that a company can be prosecuted under the Sherman Act if it used a fraudulently obtained patent to maintain a monopoly.
He noted that if Amphastar prevails in the antitrust case, damages will be ”automatically trebled.”
The Federal Circuit heard arguments in January, and a decision could take anywhere from two to eight months, according to Aaron Barkoff, a partner at law firm McDonnell Boehnen Hulbert & Berghoff, who is not involved in the case.
While not commenting on the strength of Amphastar’s argument, Barkoff suggested that the generics maker, which is based in California, might have an advantage since the case is being heard in the company’s backyard.
Momenta Pharmaceuticals and partner Sandoz are also trying to develop a generic version of Lovenox, and a decision in favor of Amphastar could benefit them as well, Barkoff noted. Yet he added that Momenta will need to wait until after Amphastar’s marketing exclusivity ends before launching its product.
Momenta received a non-approvable letter for its follow-on protein product in November after the FDA required that the company submit more immunogenicity data. The decision raised questions about whether the agency is ready to approve a bio-similar product before a regulatory pathway is in place.
Lovenox had sales of USD 2.88bn in the first nine months of last year, achieving double-digit growth in some markets. Its patent expires in 2012. (

Law firm sued Merck for Vytorin (Ezetimibe/simvastatin) and Zetia

A Nevada law firm has sued the makers of popular cholesterol drugs Vytorin and Zetia, claiming Merck and Schering-Plough Corp. misled thousands of Nevada heart patients into believing the drugs were more effective than generic ones.The suit, filed Friday in U.S. District Court in Reno by the firm of White, Meany and Wetherall, makes Nevada the latest state with such a consumer fraud complaint. Similar lawsuits have been filed in federal courts across the country, including in California, Florida, New York and Ohio.The lawsuit also alleges Merck and Schering-Plough deliberately delayed for nearly two years a controversial internal study that raised questions about whether Vytorin and Zetia are more effective than generic drugs. The study was released last month under pressure from Congress.The suit, which seeks class-action status, could provide damages for more than 10,000 Nevadans who use the drugs, lawyer Geoffrey White said.'We think the chances of success are excellent and the facts are clear,' White said. 'The drugs are way, way overpriced, and they really are no different than the generic form. It really is an outrageous fraud what these two companies have done to Nevadans.'Both companies have said they would put up a vigorous defense.'Vytorin and Zetia have been shown to reduce LDL cholesterol in numerous clinical studies and they have been approved by the FDA for that indication,' Merck spokeswoman Amy Rose said last week.The lawsuit seeks to recoup the difference in cost between generic cholesterol drugs that cost about one-third as much as Vytorin or Zetia.Nevada users 'could collect damages between what they or their insurance company paid for the two drugs and what they could have paid for the generic form,' White said.The day after the results were released, the American Heart Association and American College of Cardiology essentially defended the companies, saying patients should not panic or stop taking Vytorin or Zetia without consulting their doctor, and that further research is needed to determine the best cholesterol-cutting strategy.White's firm also is taking on Merck in a separate case over its drug Vioxx, alleging heart damage to hundreds of Nevadans.Last year, the firm won a $99 million jury award against pharmaceutical giant Wyeth on behalf of three Nevada women who claimed hormone replacement drugs caused their breast cancer.
Ezetimibe/simvastatin is a drug combination used for the treatment of dyslipidemia. It is a combination of ezetimibe (best known as Zetia in the United States) and the statin drug simvastatin (best known as Zocor in the U.S.). The combination preparation is marketed by Merck & Co./Schering-Plough Pharmaceuticals (joint venture) under the trade names Vytorin and Inegy.
Ezetimibe is prescribed to reduce the amount of cholesterol that the body absorbs from the food ingested. But a recent study by the drug's manufacturers revealed that it did not reduce the buildup of plaque in the coronary arteries -- a key indicator of progression toward heart disease.
Simvastatin is an HMG-CoA reductase inhibitor or statin. It works by blocking an enzyme that is necessary for the body to make cholesterol.(Source:

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
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