USFDA gave tentative approval to the NDA for Stavzor

Noven Pharma. today announced that the USFDA has issued a tentative approval letter related to the New Drug Application (NDA) for Stavzor(TM) (valproic acid delayed release capsules) in 125mg, 250mg and 500mg strengths. The tentative approval relates to the use of Stavzor(TM) in the treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches. The FDA states in the letter that it has completed its review of the amended Stavzor(TM) NDA and that it is tentatively approved. "Tentative approval" generally means that the FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. The NDA for Stavzor(TM), which was submitted by Banner Pharmacaps Inc. (the NDA holder and developer of the product) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories' Depakote(R) product. Based on receipt of the tentative approval letter and Noven's understanding of Depakote(R) exclusivity, Noven continues to expect FDA final approval of Stavzor(TM) by the end of July 2008. Stavzor(TM) was developed using Banner's patent-pending EnteriCare(TM) enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor(TM) in the U.S. as part of Noven's acquisition of JDS Pharmaceuticals in August 2007. If approved for marketing, Stavzor(TM) will be a branded product; it will not be AB-rated to or generically substitutable for Depakote(R), nor will Depakote(R) or any Depakote(R) generics be substitutable for Stavzor(TM). Promotion of the Stavzor(TM) brand will occur through the Noven/JDS sales force. "We are very pleased that Banner's response to the FDA's October 2007 approvable letter for Stavzor(TM) was deemed a complete response by the FDA, and that the FDA has granted tentative approval of this important new product for the treatment of three indications," said Robert C. Strauss, Noven's President, CEO & Chairman. "Stavzor(TM) launch and production planning is underway in support of an expected 2008 launch through the Noven/JDS sales and marketing organization." FDA's letter does not raise any specific concerns about the safety or efficacy of Stavzor(TM). Noven expects that the product label will contain similar warnings to those described in the Depakote(R) product label, including those relating to life threatening adverse reactions concerning hepatotoxicity, teratogenicity, and pancreatitis. Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a global drug delivery and specialty pharmaceutical company developing a proprietary portfolio of unique products and oral dosage forms, including soft gelatin capsules.

Astellas Pharma won patent infringement of cefdinir

Astellas Pharma Inc. today announced that the Supreme Court has dismissed a final appeal by Taiyo Yakuhin Co., Ltd. against a patent infringement lawsuit for its oral cephalosporin antibiotic cefdinir. It implies that Astellas won this lawsuit.
Cefdinir is a semi-synthetic, broad-spectrum antibiotic in the third generation of the cephalosporin class, proven effective for common bacterial infections of the ear, sinus, throat, and skin. It was approved by the U.S. Food and Drug Administration (FDA) in December of 1997.

USFDA cleared Fresenius drug for blood loss

USFDA said on Thursday said they approved a treatment for blood loss during and after surgery made by Germany's Fresenius
The Food and Drug Administration said it cleared the treatment, an intravenous solution called Voluven to prevent and treat a dangerous loss of blood volume during and after surgery.
The treatment is a man-made starch that expands blood plasma volume. The most common side effects were nausea and itching, the FDA said.
In a study, it proved as safe and effective as a drug made by B. Braun Medical Inc, called Hespan, when used during orthopedic surgery, the regulatory agency said.

Generic Donepezil decision

Eisai filed a lawsuit in August 2006 against Mutual Pharma and United Research Laboratories, Inc. (collectively "Mutual") claiming that its submission of an abbreviated new drug application (ANDA) to the USFDA for Aricept ODT(R) (donepezil hydrochloride orally disintegrating tablets) would infringe Eisai's composition of matter patent.

On December 20, 2007 (U.S. EST), the U.S. District Court for the District of New Jersey issued a ruling dismissing the lawsuit against Mutual on the procedural grounds that there is no case or controversy between the parties, because Mutual did not make a certification challenging the patent and does not yet have FDA approval to market its product. The Court recognized that Mutual is required, by a stipulation entered between the parties and signed by the Court, to give Eisai 45 days' notice of any launch of a generic version of Aricept ODT(R), and Eisai may during that 45-day period bring an action against Mutual for patent infringement and seek injunctive relief against Mutual's sales of any such product. Therefore, Mutual cannot market the generic version of Aricept ODT(R) immediately.

The Court did not address the substantive merits of Eisai's infringement action against Mutual. Eisai believes that its donepezil composition of matter patent is valid and enforceable until its expiration date of November 25, 2010, and that Mutual would clearly infringe its donepezil composition of matter patent if Mutual were to launch a generic version of Aricept ODT(R) in the United States prior to the expiration. Eisai intends to vigorously enforce and defend that patent. The Court's ruling has no impact on Eisai's ongoing infringement action against Teva Pharmaceuticals for its ANDA for generic Aricept(R) (donepezil hydrochloride).

With inputs from Esai press release Here

USFDA issued a second approvable letter for bazedoxifene

The USFDA issued a second approvable letter for bazedoxifene, an estrogen receptor modulator being developed by Wyeth to prevent postmenopausal osteoporosis.
In its letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by Wyeth's complete response to the first approvable letter.

Wyeth seeks reimbursement of lost profit from Teva's generic launch of Pentoprazole

A patent dispute over the heartburn drug Protonix escalated Monday when Wyeth said it will sue to recover lost profits from sales of Teva Pharmaceutical Industries Ltd.'s generic version.
The US4758579 which covers Fluoroalkoxy substituted benzimidazoles useful as gastric acid secretion inhibitors including petoprazole as product. The patent is set to expire in July 2010, though Wyeth could extend the date to 2011 if it seeks a pediatric use for the drug. Protonix had sales of $1.4 billion during the first nine months of 2007.
Meanwhile, the companies are still discussing a possible settlement and Teva said it is voluntarily halting additional shipments of the generic drug for 30 days.
Teva has already been awarded a 180-day period of market exclusivity for being the first company to file for a generic version of the drug, which the U.S. Food and Drug Administration approved in August.
Wyeth estimated that Teva likely began shipping the generic drug Friday and, in a conference call, several analysts expressed concern that Teva's launch may have been substantial.
In its own conference call, Teva categorized the Protonix launch as "relatively full" but limited to the United States. Most shipments won't be received until after the new year and will be included in the 2008 financial results. Teva did not provide additional details on the launch.
The companies are already embroiled in a patent infringement lawsuit over the drug. In September, a federal judge in New Jersey denied a motion by Wyeth and its partner Altana Pharma AG to halt sales of Teva's generic version. While Teva is not disputing it infringed the patent, it is arguing the patent itself is not valid.
Both Wyeth and Altana have already filed an appeal over the denied injunction. The drug was licensed to Wyeth by Altana, which was recently bought by Nycomed Holding AS.
Wyeth president Bernard Poussot said the company will stand by its position that the patent is valid and enforceable while heading into further Teva negotiations.
"We are going to use the days ahead to assess our best options," he said in a conference call
Wyeth expects the patent trial to start in the second half of 2008 and said the lawsuit raises significant revenue challenges in the New Year. The company will revise its 2008 business plan and guidance in January.
Sun pharma and Schwarz Pharma are the other two para IV filers.

SIGMA Pharma agreed to buy Orphan Australia for $130 million

Sigma said Melbourne-based Orphan would provide it with an entry into a number of high-value, high-growth specialised therapeutics from international pharmaceutical and biotechnology companies, which Orphan focuses on licensing, marketing and distributing. With double-digit revenue growth in each of the past three years, Orphan is expected to generate sales of around $40 million and earnings before interest, taxation depreciation and amortisation of around $13 million during the year to June 2008, a Sigma statement said.

Teva launched Pantoprazole sodium delayed release tablets

TEVA said on Monday it has commercially launched pantoprazole sodium delayed-release tablets, the generic equivalent of Wyeth's Protonix tablets.The brand product had annual sales of $2.5 billion in the United States for the 12 months ended September 30, 2007.

Pfizer got approvable letter for Dalbavancin

Pfizer in a press release has announced that it has received an approvable letter from theUSFDA issued for dalbavancin HCl, Pfizer's once-weekly two-dose antibiotic under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin, a member of the glycopeptide class of antibiotics, represents an important addition to Pfizer's broad portfolio of antibacterial products and product candidates. Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.

USFDA Drug approvals (december 2007)

NCE and generics approved/ tentatively approved or revisions by USFDA in the month of December (till 23rd Decemeber).
Amlodipine Besylate Tablets, Caraco Pharma, Approval
Atrovent (ipratropium bromide) Nasal Spray, Boehringer Ingelheim, Labeling Revision
Calcium Acetate Capsules, Roxane Labs, Tentative Approval
Diovan (valsartan) Tablets. Novartis Pharma, Patient Population Altered
Granisetron Hydrochloride Injection, Abraxis Pharma, Approval
Letairis (ambrisentan) Tablets, Gilead Sciences, Labeling Revision
Metoclopramide Tablets, Northstar Healthcare, Approval
Ondansetron Oral Solution, Taro Pharma, Approval
SARAFEM (fluoxetine hydrochloride) Tablets, Warner Chilcott, Labeling Revision
Tenofovir Disoproxil Fumarate Tablets, Matrix Labs, Tentative Approval
Triesence (triamcinolone acetonide) Injectable Suspension, Alcon Research, Approval
Colgate Total (sodium fluoride & triclosan) Toothpaste, Colgate-Palmolive, Formulation Revision
Donepezil Hydrochloride Tablets, Ranbaxy, Tentative Approval
INOmax (nitric oxide) Inhalation, INO Therapeutics Inc., Labeling Revision
Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Omeprazole Delayed-Release Tablets, Dexcel Pharma, Approval
Phenytoin Sodium Injection, PharmaForce Inc., Approval
Pregnyl (chorionic gonadotropin) Injection, Organon Inc., Labeling Revision
REBETOL (ribavirin) Capsules and Oral Solution, Schering Corp., Labeling Revision
Venofer (Iron Sucrose) Injection, Luitpold Pharma, Labeling Revision
Gonal-f RFF Pen (follitropin alfa) Injection, EMD Serono, Manufacturing Change or Addition
Lovaza (omega-3-acid ethyl esters) Capsules, Reliant Pharma, Manufacturing Change or Addition
Mevacor (lovastatin) Tablets, Merck & Co., Manufacturing Change or Addition
Aredia (pamidronate disodium) Injection, Novartis Pharma, Labeling Revision
Ciprofloxacin Extended-release Tablets, Sandoz Inc., Approval
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, Hill Dermaceuticals, Patient Population Altered
Kuvan (sapropterin) Tablets, BioMarin, Approval
Lamotrigine Tablets, Mylan Pharma, Tentative Approval
Oxcarbazepine Tablets, Teva Pharma, Approval
Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
Sonata (zaleplon) Capsules, King Pharma, Labeling Revision
Valtrex (valacyclovir hydrochloride) Caplets, GlaxoSmithKline, Labeling Revision
Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision
Vyvanse (lisdexamfetamine dimesylate) Capsules, New River Pharma, Manufacturing Change or Addition
Zetia (Ezetimibe) Tablets, Schering Corp., Labeling Revision
AndroGel (testosterone) Gel, Solvay Pharma, Labeling Revision
Bleomycin Injection, Pharmachemie B.V., Approval
Floxin (ofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in 5% dextrose) Injection, Ortho-McNeil Pharma, Labeling Revision
Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
LEXIVA (fosamprenavir calcium, FPV) Oral Tablets, GlaxoSmithKline, Labeling Revision
Ranitidine Oral Solution Syrup, Ranbaxy, Approval
Stavudine Capsules, Emcure Pharma, Tentative Approval
Cefdinir Oral Suspension, Aurobindo Pharma, Approval
DepoDur (morphine sulfate extended-release liposome) Injection, Pacira Pharma, Labeling Revision
Effexor XR (venlafaxine HCl) Extended-Release Capsules, Wyeth Pharma, New Modified Indication
Heparin Sodium Injection, Abraxis Pharma, Labeling Revision
Heparin Sodium Injection Baxter Healthcare, Labeling Revision
LEXIVA (fosamprenavir calcium) Oral Tablets, GlaxoSmithKline, Labeling Revision
Methimazole Tablets, Actavis, Approval
Omniscan (gadodiamide) Injection, GE Healthcare, Labeling Revision
Paromomycin Sulfate Capsules, X-Gen Pharma, Approval
Thyrogen (thyrotropin alfa) Injection, Genzyme Corp., New or Modified Indication
Buspirone Hydrochloride, Tablet, Actavis Totowa, Approval
Bystolic (nebivolol), Tablet, Mylan Bertek, Approval
Efavirenz, Tablet, Emcure, Tentative Approval
Extended Phenytoin Sodium, Capsule, Wockhardt, Approval
Levalbuterol Hydrochloride, Inhalation Solution, Breath Ltd, Tentative Approval
Metronidazole, Topical Cream, G & W Laboratories, Approval
Pantoprazole Sodium, Extended Release Tablet, Dr. Reddy's Labs, Tentative Approval

Abbott has received marketing authorization for adalimumab

Abbott has received marketing authorization from the European Commission for the use of HUMIRA(R) (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. HUMIRA is the first fully human, self-injectable biologic for the treatment of psoriasis. Psoriasis is the fifth approved indication for HUMIRA in the European Union. A regulatory application for HUMIRA to treat psoriasis is also under review with the U.S. Food and Drug Administration.
"Psoriasis is not only a skin disease -- it is a systemic, autoimmune disorder that, in its more severe forms, may require systemic treatment," said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "HUMIRA is the first and only biologic that has been compared to methotrexate, and this approval brings an important new option for dermatologists to treat this disease."
Earlier Panjab university, Chandigarh had also developed a liposome based formulation of dianthrol for he treatment of psoriasis. A Gurgaon based pharmaceutical firm markets the same formulation.

PhytoMedical Expands Scope of Patented Technology That Kills Cancer Cells

PhytoMedical Technologies (in a press release) announced that it has expanded the research and development of a novel class of anti-cancer agents which have a ‘cytotoxic’ or poisonous affinity for cancer cells.
These patented anti-cancer compounds are designed to bind more tightly to cancer cell DNA than many conventional anti-cancer drugs by a process called bis-intercalation or “double binding,” much like a molecular staple. Because the DNA is the blueprint of life for the cancer cell, such binding stops the replication of the DNA, which prevents the growth of the cancer cell and it dies.
“Initial studies using a leukemia cell line demonstrated that such double binding or intercalation stopped the replication of the DNA, and, ultimately, lead to the death of the cancer cells,” states Mr. Greg Wujek, President, CEO of PhytoMedical Technologies, Inc. “The positive initial results and the strength of intellectual property surrounding the technology has given us the confidence to expand our research in order to improve upon the concept of bis-intercalation and the promise it holds for the control of cancer.”
In response to the success of the studies, PhytoMedical’s collaborating scientists are now synthesizing and testing new derivatives of these anti-cancer agents. Further tests of the “DNA binding” anti-cancer agents are planned for human cancer cell lines specific to glioblastoma (tumors related to the brain) and small cell lung cancer, both of which are associated with a high mortality rate.
Mr. Greg Wujek concludes, “Our goal is to identify the compound that demonstrate the greatest anti-cancer activity and successfully complete the preclinical steps required for an Investigational New Drug Application.”

Changes in european patent law

The patent barista reports a very interesting development in european patent law, The author of the blog has summarised various changes very efficiently http://www.patentbaristas.com/.

The European Patent Convention (EPC) has been revised for the first time since its inception in 1973. The revised version of the Convention, known as EPC 2000, will come into force on December 13, 2007. These changes will bring the EPC into line with recent developments in International Law. These changes will affect European patent applications both before and after grant.
Filing Requirements
The minimum requirements for obtaining a filing date have been relaxed. It is now sufficient to provide the European Patent Office with: i) an indication that a patent is sought; ii) information identifying the applicant; and iii) a description or a reference to a single previous application which will form the description. If a reference to a previous application is relied on, the applicant must supply a copy of the previously filed application within two months of the filing date and, where the previously filed application is not in an official language of the European Patent Office, a translation.
Furthermore, it will no longer be necessary to provide any claims in order to obtain a filing date. If the application is filed without claims, but satisfies all other requirements for obtaining a date of filing, the applicant will be requested to provide claims within a set term. However, the claims cannot be broader than the original disclosure.
Claiming Priority
The provisions on priority have been extended. In particular, priority may be claimed not only from an application filed in any State party to the Paris Convention, but now also from an application filed in any World Trade Organization state .
A further change to the priority provisions is a relaxation of the time limit for claiming priority. Under new Rule 52 EPC it will be possible to add or correct a priority claim up to 16 months from the earliest priority date claimed.
Prior Art Effect of Prior-Filed European Patent Applications
From the date that EPC 2000 comes into force, there will be an amendment to the novelty provisions of Article 54 EPC. From this date, all Contracting States will be deemed to be designated in an application, and it will not be a requirement that designation fees have been paid for a given contracting state in order for a European patent application to have a prior art effect. Thus, the contents of all European patent applications as filed, which have an earlier filing date, but a later publication date, will be considered relevant to the novelty of a European patent application. It should be noted that this revision will not have a retroactive effect.
Further Processing
Further processing (Article 121 EPC) is a procedure permitted under the EPC which allows an applicant, simply by virtue of payment of a fee, to reinstate an application deemed withdrawn when a deadline had been missed. The particular deadlines for which further processing was available were quite restricted. Under EPC 2000 the provisions for further processing have been significantly broadened and the new provisions will apply to any time limit vis-à-vis the European Patent Office, not just those set by the European Patent Office.
A number of time limits are specifically excluded under new Article 121 EPC, these include: the time limits for filing a petition for review by the Enlarged Board; the six month grace period for paying the renewal fee with surcharge; making a declaration of priority; the correction of deficiencies in claiming priority; requesting re-establishment of rights; requesting an appeal; and the one year priority period.
Re-Establishment of Rights
The circumstances where it is possible to make a formal application for re-establishment of rights (Article 122 EPC), in the absence of the availability of further processing, are also extended. Re-establishment of rights is now possible in respect of the priority year. The request for re-establishment must be filed within two months of the end of the priority year.
The time limit for requesting re-establishment is extended in respect of failure to pay a renewal fee. In particular, the six-month grace period for paying the renewal fees is not to be deducted from the one year grace period for requesting re-establishment of rights (new Rule 37(4) EPC).
It should be noted that the evidential burden on the applicant for re-establishment remains the same and the applicant still needs to show that all due care has been taken.
Consideration of Unity by the European Patent Office
Previous Rule 112 EPC has been replaced by new Rule 164 EPC. This has removed the opportunity to have further searches undertaken on PCT applications upon entry into the European regional phase. The opportunity to have multiple inventions searched within the framework of one application will now be limited to the international phase. On entry into the European phase, non-unitary subject matter should be deleted or consigned to a divisional application.
Medical Use Claims
A new Article 54(5) EPC has been introduced which effectively formalizes the patentability of second and subsequent medical uses without requiring “Swiss-type claiming”. Therefore, under EPC 2000, second and further medical use claims may be of the form “substance or composition X for use in the treatment of disease Y.”
Transitional Provisions
Transitional provisions have been introduced to ensure that, wherever possible, the revised provisions will be applicable to pending European patent applications and granted European patents.
Limitation (new Article 105a EPC 2000)
Under EPC 2000, it will be possible for an applicant to limit the claims of a European patent centrally at the European Patent Office (new Article 105a EPC). This is a very significant change, as there is no provision for post-grant amendment under the current version of the EPC other than in the course of opposition proceedings.
Under the existing law, an applicant who wishes to limit aEuropean patent has to make use of national provisions in the designated states where they are available. As the procedure is governed by national law, the process can be time-consuming, costly and complex. Moreover, certain countries, such as France, have no provision for post-grant amendment under their national law. Other countries, such as the UK, only allow post-grant amendments in certain circumstances.
The EPC 2000’s new limitation procedure is intended to be quick and straightforward. No examination of the patentability of the claims will be carried out. The European Patent Office will restrict its examination to whether the requested limitation actually narrows the scope of the claims, whether the amendments are clear (Article 84 EPC) and whether they have basis in the original application as filed (Article 123(2) EPC). Broadening amendments that extend the scope of the claims beyond the scope of the claims as granted will not be allowed (Article 123(3) EPC). A major advantage for the patent proprietor is that there is no provision for a third party to oppose an application for limitation.
Once the European Patent Office decides to allow a request for limitation, the limitation will have a retroactive effect from the date of grant of the patent.
The limitation procedure is available for all European patents, including those that have already been granted at the time EPC 2000 comes into force. A request for limitation may be filed at any time after the patent is granted. However, if a request for limitation is filed while an opposition is pending, the opposition proceedings will take precedence. If limitation proceedings are pending when an opposition is filed, the limitation proceedings will be terminated.
EPC 2000’s new post-grant limitation procedure is expected to provide a useful mechanism for patent proprietors to limit the claims of their patents to distinguish from newly discovered prior art. This will allow patent proprietors to strengthen their patents from a validity perspective prior to enforcement proceedings in the national courts.
Limitation in National Proceedings (Article 138(3) EPC 2000)
EPC 2000 also provides patent proprietors with the right to limit the claims of their Euro-National patents in validity proceedings before national courts (new Article 138(3) EPC).
This new provision provides patent proprietors with a useful tool for improving their position or even circumventing nullity or invalidity proceedings brought against their patents in the national courts.
Review of Board of Appeal Decisions (Article 112a EPC 2000)
Under the current provisions of the EPC it is not possible for an adversely affected party to appeal a decision by a Board of Appeal of the European Patent Office. This will change under EPC 2000. In particular, under new Article 112a EPC 2000, it will be possible for any party adversely affected by a decision of the Board of Appeal to file a petition for review by the Enlarged Board of Appeal.
Such petitions, however, may only be filed under specific circumstances (Article 112a(2) EPC 2000). These include situations where a member of the Board of Appeal took part in the decision despite having a personal or previous interest in the case, or where a criminal act took place that may have had an impact on the Board of Appeal’s decision. Petitions may also be filed in cases where a fundamental procedural defect or violation took place (e.g. if the decision of the Board of Appeal was not based on grounds or evidence on which the parties have had an opportunity to present their comments (Article 113(1)EPC)).
Protocol to Article 69 EPC
Article 69 of the EPC indicates that the extent of protection is determined by the claims. The Protocol”to Article 69 indicates that the scope of protection should combine a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties. The “Protocol” now has an additional article indicating that due account shall be taken of any element which is equivalent to an element specified in the claims.
In the UK case of Kiren & Amgen (RPC 2004, UK House of Lords) the following test was formulated in determining the construction of the claims:
“What would a person skilled in the art have understood the patentee to have used the language of the claim to mean?”
Although a 2004 case, the test was formulated in the knowledge of the new second limb to the Protocol”and so reflects the UK Courts view of how the protocol should now be applied. It remains to be seen how other European Courts apply the amendment to the protocol.

INDIA RECOGNISED AS INTERNATIONAL SEARCHING AUTHORITY AND INTERNATIONAL PRELIMINARY EXAMINING AUTHORITY

In recognition of the efforts made by the Government of India in modernising its intellectual property systems as well as infusing transparency and openness in the system, the 170 plus Member States of the World Intellectual Property Organization (WIPO), in the recently concluded General Assemblies of WIPO, endorsed India’s recognition as an International Searching Authority (ISA) and an International Preliminary Examining Authority (IPEA). “The recognition of India as an ISA/IPEA puts India in a coveted league of only 15 nations and organization which are currently recognized at a global level by ISA/APEA”, Shri Kamal Nath, Union Minister of Commerce and Industry, informed in a press briefing here today. He further said that it is a recognition of our efforts to recognise the intellectual property system as well as lay down benchmark for future milestones that we need to achieve.
The status of ISA and IPEA would be beneficial for India in several ways. Apart from the international recognition that our IP system would get, it would also generate revenues in the form of fees that would be provided to us for functioning as an ISA/IPEA. Being the only English speaking nation in the Asian region to be recognized as an ISA/IPEA would mean that several international applications received by WIPO under the Patents Cooperation Treaty would be sent to the Indian Patent Offices for search and preliminary examination purposes.
E-filing facilities for patents and trade marks applications was launched in July this year. In the last 3 years, several important milestones have been achieved in the field of Intellectual Property rights in India. The Patent Act was amended in 2005 in order to meet our international obligations. A Rs.153 crore modernization programme for augmenting the infrastructure and human resources in Intellectual Property Office, creation of awareness regarding IPRs and introducing IT enabled efficient systems was completed on 31 March 2007.

The www.ippharmdoc.blogspot.com congratulates India on the excellent country's most recent achievement. According to a press release from the Government of India's Press Information Bureau.

OTSUKA ACQUIRES RIGHTS TO IV BUSULFEX FROM PDL BIOPHARMA

Princeton, NJ, Tokyo, Japan and Redwood City, Calif., December 17, 2007 -- Otsuka Pharmaceutical Co., Ltd. (OPC) and PDL BioPharma, Inc. (NASDAQ: PDLI) today announced that they have entered into a definitive agreement under which Otsuka will acquire from PDL the rights to IV Busulfex® (busulfan), including trademarks, patents, intellectual property and related assets, for $200 million, to be paid in cash at closing. IV Busulfex is an oncologic product marketed and sold by PDL in the United States (U.S.) and Canada, and through distributors in a number of other countries.

IV Busulfex was approved by the U.S. Food and Drug Administration (FDA) in 1999 for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation (also referred as blood or bone marrow transplantation or BMT) for chronic myelogenous leukemia (CML). IV Busulfex is the only drug that is FDA-approved for use in combination with cyclosphosphamide as a conditioning agent in allogeneic hematopoietic stem cell transplantation for CML.
During the 12 months ended September 30, 2007, IV Busulfex sales were $29.4 million, a 29.7 percent increase over the $22.7 million in sales in the prior 12-month period. IV Busulfex is marketed in more than 40 countries worldwide.
"The acquisition of IV Busulfex, a first-in-class drug therapy for conditioning prior to allogeneic hematopoietic progenitor cell transplantation, and the oncology expertise of PDL accelerates Otsuka's global oncology business," said Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. "We are currently developing first-in-class oncology drugs in the United States, including drugs to treat severe cancer pain (currently in phase II), along with oral mucositis and leukemia (currently in phase I). Our focus is on global opportunities to contribute to the health of patients who are suffering from severe illness."

This transaction follows PDL's decision, announced on October 1, 2007, to actively pursue the sale of its key assets. PDL continues with this strategic process, which includes working to maximize the value of its royalty stream, commercial products and antibody discovery, development and manufacturing assets.
Following the close of the transaction, OPC will oversee the outsourced manufacturing of the product, while its U.S. affiliate, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), will initiate clinical studies to investigate potential new indications for IV Busulfex. Another OPC affiliate, Otsuka America Pharmaceutical, Inc. (OAPI), will market the product for its current indication in the United States. OPDC was established in 2007 and OAPI was established in 1989 by Otsuka America, Inc. (OAI). Both OPDC and OAPI are wholly owned by OAI, which is the holding company for OPC’s interests in the U.S. OAI is wholly owned by OPC.

Emerging Generic Drug Markets in Europe

Research and Markets (http://www.researchandmarkets.com/reports/c77775) has announced the addition of "Emerging Generic Drug Markets in Europe" to their offering.
Emerging Generic Drug Markets in Europe: France, Italy, Portugal, Spain
The many generic companies and investors looking to Asian and Latin American markets for generic drug market growth could be missing a trick! The four EU countries analysed in this report are expected to deliver significant double digit growth over the next 5 years and present stable, regulated operating environments with excellent prospects.
France
In 2007, the French generic market is valued at US$3.7 billion at retail prices, equal to 8.6% of the total pharmaceutical market. Espicom projects annual real growth in the generic market of 15% which will take the generic market to US$7.4 billion at retail prices by 2012, equal to 15.5% of the total pharmaceutical market. Currently, the generic market remains under-developed, although there has been a marked increase in sales over the past four years. Nevertheless, France remains the third leading generic market in Europe.
The government is keen to control spiralling healthcare costs and therefore reducing pharmaceutical expenditure by using generics is a major aim. France has a number of medium-sized generic companies. These tend to be foreign-owned, by companies such as Merck KGaA (now US company Mylan), Sandoz, Ranbaxy and Teva. In 2006, Merck KGaA expanded its leadership position in France, with market shares of 25.5% in the pharmacy sector and 34% in the hospital sector. The leading domestic company is Biogaran, owned by Servier.
Portugal
Portugal is the only country in the EU where the generic market by value represents a higher percentage than by volume in the pharmacy sector. High generic prices have limited generic market penetration as they are not competitive with original product prices. New government measures have been put in place to reduce generic prices, including a scheme of cumulative price reductions depending on market share, established in 2007.
Growth by value is expected to slow down whilst growth by volume will increase with the market which is expected to reach US$1.7 billion in 2012. The generic market is fragmented, with many companies having low market share. Leading domestic generic producers include Farmoz (part of Tecnimede), Generis (part of Farma-APS), Medinfar, Hovione, Bluepharma and ToLife. Foreign generic producers include Actavis, Alter, Merck (now Mylan), ratiopharm, Stada and Winthrop. Two leading Brazilian generic producers, Medley and EMS, have small subsidiaries in Portugal.
Italy
The current generic market, valued at US$809 million in 2007, is small considering the size of the overall pharmaceutical market, partly due to extended national patent supplementary certificates. In 2007, the Italian generic market value is equivalent to the Portuguese even though the overall Italian pharmaceutical market is over six times bigger. In 2008, the Italian generic market is expected to overtake the Portuguese market and will reach US$1.8 billion in 2012.
Eight blockbuster drugs will be coming off-patent in 2007, increasing market opportunities for the leading generic players. Teva, which acquired Pfizer's Dorom in 2004, claims to be the leading generic producer in Italy while both Sandoz and Merck Generics have strong positions in the generic market. Being generic pioneers in Italy, German companies still retain a significant presence, including Stada (via Eurogenerici) and ratiopharm Germany (via ratiopharm Italia) as well as Merck Generics, which was acquired by the US company Mylan in 2007.
Spain
The Spanish Association of Generic Medicines believes that the industry has the capacity to double its generic market share by volume by 2012. In 2007, the generic market is valued at US$1.7 billion at retail prices. The generic market is expected to grow by 17.4% per year between 2007 and 2012. As a percentage of the pharmaceutical market, generic sales will rise from 6.7% in 2007 to 11.2% in 2012. Of the generic markets analysed in this report, Spain is second behind France. Many producers, most of them domestic, decided to enter the generic market in Spain ten years ago, encouraged by the Ministry of Health. Market consolidation, however, has resulted in many acquisitions by foreign generic producers, including Geminis and Bexal by Sandoz, Bayvit by Stada, Edifen, UR and Pliva by Barr, Merck by Mylan, Mabo by Meiji, Davur by Bentley and Mundogen by Ranbaxy. Leading domestic producers remaining include Normon, Cinfa and Alter, all of which have strengthened their local positioning and, slowly, are increasing their export opportunities

Royalty Pharma Acquires a Portion of Northwestern University's Royalty Interest in Lyrica for $700 Million

Here is a moral boosting news for researchers working in the University and academic institute. Royalty Pharma and Northwestern University (in a press release) announced today that Northwestern has sold a portion of its worldwide royalty interest in Lyrica® to Royalty Pharma for $700 million in cash.
A portion of the payment to Northwestern will go to the researchers who were responsible for the chemical compound that serves as the basis for Lyrica®.
“We’re very pleased to have reached this agreement with Royalty Pharma,” said Eugene S. Sunshine, Northwestern’s senior vice president for business and finance. “Beginning with the original research done at Northwestern, the development of Lyrica® has brought relief to thousands of patients worldwide. This exemplifies the type of cutting-edge research that is occurring at Northwestern.”
“We are happy to add this royalty on an important pain therapy to our diversified portfolio of royalties on leading biopharmaceutical products,” said Pablo Legorreta, Chief Executive Officer of Royalty Pharma. “This transaction exemplifies our commitment to providing leading institutions such as Northwestern with funds that will allow them to continue to pursue their academic and research initiatives. We are confident that these funds will result in continued innovations and advances that will better people’s lives.”
Lyrica® is used to treat nerve pain associated with diabetes and shingles and to help manage pain caused by fibromyalgia. It is manufactured by Pfizer, Inc., the world’s largest research-based biomedical and pharmaceutical company. Lyrica® is based on the chemical compound pregabalin, first synthesized at Northwestern. Pregabalin was initially developed by medicinal chemist Richard Bruce Silverman at Northwestern University. The drug was approved in the European Union in 2004. Pregabalin received USFDA approval for use in treating epilepsy, diabetic neuropathy pain and post herpatic neuralgia pain in June 2005, and appeared on the U.S. market in 2005.

The net proceeds from the partial sale of royalty rights will be placed in the University’s endowment, Sunshine said. As part of the endowment, the proceeds will be used in accordance with federal law to help support financial aid for undergraduate and graduate students; startup costs for the University’s research efforts; construction of new buildings and laboratories and improvements to existing facilities; and for other purposes.
“Essentially, we are converting a potential stream of future royalty revenues from Lyrica into an immediate cash payment,” Sunshine explained. “We continue to believe strongly in Lyrica’s potential and Northwestern retains a large portion of those royalty rights, but by doing this, we are diversifying the University’s investments.”
The percentage of the University’s interest in the royalty payments that was sold today is not being disclosed.

GSK and Santaris Pharma enter global R&D alliance for novel antiviral discovery

GlaxoSmithKline (GSK) and Santaris Pharma today announced that they have entered into a worldwide strategic alliance for the discovery, development and commercialisation of novel medicines against viral diseases. The collaboration provides GSK access to patented RNA antagonist compounds, based on Santaris Pharma’s unique Locked Nucleic Acid technology, for development as potential new therapies for selected viral diseases.
GlaxoSmithKline will participate in the alliance through its Infectious Diseases Centre of Excellence for Drug Discovery (ID CEDD). Under the terms of the agreement, Santaris Pharma will grant GSK options to drug candidates discovered and developed under the collaboration in up to four different viral disease programmes. In each of these R&D programmes, Santaris Pharma will be responsible for the discovery and development of RNA antagonist drug candidates through to completion of Phase IIa (“Clinical Proof of Concept”), at which point GSK has an exclusive option to license each compound for further development and commercialisation on a worldwide basis. GSK also has an option to include as an additional programme in the collaboration, SPC3649, Santaris Pharma’s preclinical LNA-antimiR against micro RNA-122, which is being developed by Santaris Pharma as a potential new therapy for Hepatitis C infection.
Santaris Pharma will receive an upfront fee for the first antiviral programme of $3m (£1.5m) and GSK will make an equity investment of $5m (£2.5m) in Santaris Pharma. If candidate drugs from the first viral target programme are successful and reach the market, GSK could make additional milestone payments to Santaris Pharma of up to $140m (£69.5m) for this first programme. Similar upfront payments and milestones are payable by GSK to Santaris Pharma in respect of each of the further three antiviral programmes if GSK elects to initiate these additional programmes in the collaboration.
In addition, if GSK exercises its option to further develop and commercialise SPC3649, it will make a further up front payment of $5m (£2.5m) and additional milestones of up to $122m (£60.5m) if the drug obtains regulatory approvals in Europe and the USA. Overall, under the collaboration Santaris Pharma could be eligible to receive in excess of $700m (£347m) in upfront fees and development and regulatory milestones payments. If a product is successfully commercialised, Santaris Pharma will receive high single to double-digit royalties on worldwide sales of alliance products.
Announcing the collaboration, Dr Henrik Ørum, Santaris Pharma’s Chief Scientific Officer and VP Business Development commented, “We are delighted that GlaxoSmithKline has chosen to collaborate with Santaris Pharma in the RNA medicines field. We are confident that the high potency and exquisite precision of RNA targeting achievable by LNA oligonucleotides has the potential to achieve clinical breakthroughs in viral infections. I can think of no stronger partner for Santaris Pharma in infectious disease research than GSK.”
Dr Zhi Hong, Senior Vice President and Head of GlaxoSmithKline’s ID CEDD said, “The Locked Nucleic Acid technology platform developed by Santaris Pharma has the potential to transform Gene Interference therapies. We are facing numerous challenges in infectious disease areas where tractable targets are limiting. Innovative medicines with unprecedented mechanisms of action are lacking. This alliance has the ability to accelerate our drug discovery programmes against multiple infectious disease targets.”

GlaxoSmithKline completes acquisition of Reliant Pharmaceuticals

GlaxoSmithKline (in a press release) announced today that it had completed the acquisition of Reliant Pharmaceuticals. This follows the US Federal Trade Commission’s early termination of the waiting period required by US antitrust law.
With the completion of the deal, Reliant’s cardiovascular medicines join the GSK portfolio in the US. These include Lovaza™ (omega-3-acid ethyl esters), an FDA-approved treatment for adult patients with very high levels of triglycerides. Triglycerides are fatty substances in the blood associated with increased risks of coronary artery disease.
Lovaza (formerly known as Omacor®) is indicated as an adjunct to diet to reduce triglyceride levels in adults with very high (≥500 mg/dL) triglyceride levels. In the nine months ending September 30, 2007, net sales of Lovaza were $206 million, an increase of 115% over the first nine months of 2006.
GSK acquired Reliant, based in Liberty Corner, NJ, for $1.65 billion (£800 million) in cash. GSK expects the transaction will be slightly accretive to earnings in 2008, excluding integration costs, and will create additional value in following years.
“We’re eager to begin building on Reliant’s success with Lovaza,” said Chris Viehbacher, President, US Pharmaceuticals, GSK. “We think this medicine has significant potential to help larger numbers of patients, and we expect it to become an important driver of sales growth in the US.”
The acquisition gives GSK marketing rights to Lovaza in the US and Puerto Rico. Pronova BioPharma ASA (Oslo:PRON), the compound’s originator, has licensed rights in other markets to several other companies.
In addition to Lovaza, three other cardiovascular products marketed by Reliant will join the GSK portfolio in the US. They are DynaCirc CR® (isradipine) and InnoPran XL® (propanolol HCl), which treat high blood pressure, and Rythmol SR® (propafenone), which treats abnormal heart rhythms, or arrhythmia.

BioMarin Re-Acquires Rights to Kuvan in Canada

BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that it has re-acquired the Canadian rights for tetrahydrobiopterin (BH4), including Kuvan(TM) (sapropterin dihydrochloride), from Merck Serono, a division of Merck KGaA, Darmstadt, Germany. Kuvan is an oral small molecule for the treatment of phenylketonuria (PKU) developed in partnership with Merck Serono. Based on published literature, there are approximately 1,200 to 1,500 people under the age of 40 with PKU in Canada.

The terms of the agreement specify a reduction in royalties owed to BioMarin on Merck Serono sales outside the United States and Japan. Based on the structure of the amended agreement, the reduction in royalties cannot exceed an undisclosed cap.

ActivBiotics Sells Proprietary Assets and Drug Product Candidates

LEXINGTON, MA, December 18, 2007 -- ActivBiotics, Inc. today announced that following a review of strategic options after its clinical trial of Rifalazil failed in peripheral arterial disease patients, the Company is selling all or substantially all of its assets on an “as is” basis through an Assignment for the Benefit of Creditors, process. “The Board of Directors has decided to pursue the sale of the company’s clinical and preclinical drug assets”, said Steven C. Gilman, Ph.D., Chairman of ActivBiotics. “We believe that our anti-inflammatory Phase II drug candidate and our antibacterial library of compounds are of significant value to companies in those therapeutic areas,” added Gilman. Bidding packages have been assembled and are ready to be distributed subject to a potential purchaser entering into a standard form confidentiality agreement.

The Company assets available for sale include:

1. A superoxide dismutase (SOD) mimetic program consisting of two clinical-stage drug candidates, M40403 and M40419, and a library of 250 small molecules which have potential as novel therapeutic agents for the treatment of inflammatory diseases. M40403, which has been studied in approximately 700 patients/subjects, has an active IND, and a protocol on file with the FDA under which a Phase II clinical trial for the treatment of post-operative ileus can be conducted, and a protocol to initiate a Phase II clinical trial for the treatment of oral mucositis. The Company has submitted and expects to shortly receive Orphan Drug Designation status in Europe and has an Orphan Drug application pending with the US FDA for the treatment of oral mucositis in subjects with advanced head and neck cancer. In addition to these indications, the SOD mimetics have potential therapeutic uses in a variety of inflammatory disorders including asthma, chronic obstructive pulmonary disease, and radiation protection, stroke, and ischemia reperfusion injury.

2. An antibacterial library of compounds consisting of approximately 800 small molecules, all new chemical entities (NCEs), which may be developed for the treatment of serious bacterial infections, including complicated skin and skin structure infections, endocarditis, osteomyelitis, foreign-body infections, Clostridium difficile-associated diarrhea (CDAD), as well as peptic ulcer disease due to Helicobacter pylori, and disease due to Chlamydia infections. In addition, these NCEs have the potential to be administered as topical agents for the treatment of acne and for the eradication of Staphylococcus aureus in nasal passages.

3. Rifalazil, a clinical stage compound which has been tested in approximately 600 patients, is a potent antibacterial agent with activity mainly against pathogenic Gram-positive bacteria. Rifalazil was found efficacious in a Phase II Chlamydia STD clinical trial, and, separately, a protocol has been submitted to the FDA to begin a Phase II clinical trial in carotid artery atherosclerosis. Rifalazil has been granted Fast Track designation for the treatment of CDAD. The Company has open INDs to continue rifalazil development for infectious diseases, and atherosclerosis-related disease.

Pfizer set to aquire Coley Pharma

Pfizer has said that waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired for its acquisition of Coley Pharmaceutical and Pfizer has received clearance from the Federal Cartel Office of Germany for the deal. The tender offer is scheduled to expire on Dec. 28.
The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) is a set of amendments to the antitrust laws of the USA. The HSR Act was signed into law by President Gerald R. Ford on September 30, 1976. The context in which the HSR Act is usually cited is 15 U.S.C. § 18a, title II of the original law.
The Act provides that before certain mergers, tender offers or other acquisition transactions can close, both parties must file a "Notification and Report Form" with the Federal Trade Commission and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice. The filing describes the proposed transaction and the parties to it. Upon the filing, a 30-day waiting period then ensues during which time those regulatory agencies may request further information in order to help them assess whether the proposed transaction violates the antitrust laws of the United States. It is unlawful to close the transaction during the waiting period. Although the waiting period is generally 30 days, the regulators may request additional time to review additional information and the filing parties may request that the waiting period for a particular transaction be terminated early ("early termination"). Early terminations are made public in the Federal Register and posted on the Federal Trade Commission website. Additionally, some types of transactions are afforded the special treatment of shorter waiting periods.
The filing requirement is triggered only if the value of the transaction and, in some cases, the size of the parties, exceed certain dollar thresholds, which are adjusted over time. For the purpose of determining the "size of the parties" one assesses the size of the party to the transaction, its ultimate parent entity, and all subsidiaries of that ultimate parent entity.
The firm that is making the proposed acquisition is required to pay a substantial filing fee when making its filing; the amount of the fees is tied to the size of the transaction.
Title III of the Act allows states to sue companies in Federal court for monetary damages under antitrust laws on behalf of their citizens; previously, only the persons harmed by anticompetitive activity had a right to sue for damages. Title III is in substance the original bill introduced in the House of Representatives by Congressman Peter W. Rodino, Jr.; the other titles of the Act were added as the bill was amended during Congesssional deliberations

Bystolic(TM), a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension

Forest Laboratories and Mylan announced today that the novel beta blocker Bystolic(TM) (nebivolol) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments. Hypertension affects approximately 72 million adults in the U.S. and 65 percent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range (blood pressure <140/90 mmHg), underscoring the need for additional therapeutic options.
Beta blockers are one of the most widely used classes of drugs in the United States. In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 percent Black, 54 percent male, 19 percent elderly and 8 percent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility, and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.
"Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patients and its favorable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."
Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."
Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the U.S. and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.
Forest licensed U.S. and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the U.S. and will pay Mylan undisclosed royalty payments as part of their collaboration agreement.
Forest expects Bystolic to be available to physicians, patients, and pharmacies in January 2008. Interested parties can register to receive immediate notification of Bystolic's availability, get more information on Bystolic, or obtain prescribing information by visiting www.Bystolic.com or by calling 1-800-678-1605.
Important Safety Information
Patients being treated with Bystolic should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt cessation of therapy with beta blockers. When discontinuation is planned, the dosage should be reduced gradually over a one to two week period and the patient carefully monitored.
Bystolic is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
Like other beta blockers, Bystolic should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, severe renal impairment, and any degree of hepatic impairment or in patients undergoing major surgery. Caution should also be used in diabetic patients as beta blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.
In general, patients with bronchospastic disease should not receive beta blockers.
Bystolic should not be combined with other beta blockers.
The most common adverse events with Bystolic were headache, fatigue and dizziness.

Galvus recieve positive opinion from European health authorities

The diabetes medicine Galvus produced by Novartis received a positive opinion from European health authorities after the drug maker made changes to prescribing recommendations amid liver-safety concerns.
The drug, which was expected to generate more than $1 billion in sales before the liver and other safety issues became apparent, will be available in the first European markets in the first half of 2008, Novartis said.
Skin-toxicity worries also have delayed Galvus's approval in the U.S., where the company aims to resubmit the drug in 2009.
"A path for U.S. approval of Galvus is still not clear," said Lanksbanki Kepler analyst Denise Anderson. "Thus, our forecasts for the drug are modest, at $270 million by 2010, as we expect cheaper generics to be preferred in most markets and due to lingering safety concerns," she said.
Vontobel analysts estimate Galvus's peak sales, excluding the U.S., could reach $400 million a year.
In November, Novartis said it had found liver-safety problems with a higher dose of Galvus. The discovery disappointed analysts who had been expecting the drug to generate significant annual sales.
The medicine's launch was pushed back, giving Merck's rival treatment, Januvia, an even greater lead in the market for next-generation diabetes treatments.
Both Galvus and Januvia are DPP-4 inhibitors, designed to boost the body's ability to lower elevated blood sugar. They are expected to become a key way of treating type 2, or maturity onset, diabetes. The drugs are expected to do well as they aren't associated with weight gain, a major side effect of some diabetes drugs.
Formal approval would come from the European Commission, which generally follows the committee's recommendations. A decision is expected within three months.

Lundbeck antidepressant molecule enter phase III clinical trial

H. Lundbeck A/S and Takeda Pharmaceutical Company Limited today announced the advancement of Lu AA21004 for the treatment of mood and anxiety disorders into clinical phase III. Based on the positive clinical phase II data, the first patient in a phase III study in major depressive disorder has been enrolled.

The clinical phase III program will consist of several clinical studies that will be conducted at investigational sites around the world. More than 2,000 patients are expected to be enrolled in the clinical phase III program.

Lu AA21004, discovered by Lundbeck and being jointly developed by Lundbeck and Takeda, belongs to a new chemical class having a mode of action that is different from currently marketed antidepressants. In the clinical phase II study, Lu AA21004 showed highly significant improvements on the primary efficacy endpoints for both 5 and 10 mg doses compared to placebo and had an attractive safety profile.

"Lu AA21004 is the most advanced project in our portfolio of new and innovative compounds for the treatment of mood and anxiety disorders, all of which have the potential to treat unmet patient needs", said Senior Vice President Anders Gersel Pedersen, head of Development at Lundbeck. "Our collaboration with Takeda is working very well and we look forward to advancing the development of Lu AA21004 with Takeda."

Lundbeck and Takeda formed an alliance in September 2007 to develop and commercialize a portfolio of novel compounds in the US and Japan for the treatment of mood and anxiety disorders, including Lu AA21004 and Lu AA24530, which is in clinical phase II development.

"We are pleased with the continued positive results from the Lu AA21004 development program which is under collaboration with Lundbeck," said Dr. Masaomi Miyamoto, General Manager of the Pharmaceutical Development Division of Takeda. "Advancing this compound for the treatment of mood and anxiety disorders to Phase III represents a significant achievement in Takeda's enhancement of our R&D pipeline in the central nervous system field."

Lundbeck will receive a milestone payment from Takeda of USD 40 million in connection with the advancement of Lu AA21004 into clinical phase III. The payment will be booked by Lundbeck as other revenue in the fourth quarter of 2007.

GSK recieve complete response letter from USFDA for cervical cancer vaccine

GlaxoSmithKline announced that it received a FDA complete response letter with regards to its application for new drug status for Cervarix, a cervical cancer vaccine. A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval.
Cervarix, one of the largest drug hopes in Glaxo's pipeline has already been approved in 45 countries and analysts had been expecting FDA approval by next month. The delay will result in a setback of at least a few months and possibly more than a year which will affect the company's intent to secure a market share from Merck's Gardasil which is already well established in the U.S.
A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval.

FDA Accepted ANDA of oxymorphone ER tablets

IMPAX Laboratories, Inc. (OTC:IPXL) today announced that its Abbreviated New Drug Application (ANDA) for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana(R) ER, has been deemed acceptable for filing by the U. S. Food and Drug Administration (FDA) as of November 23, 2007. Despite the acceptance, the Company continues to believe that its ANDA as originally filed met all the requirements for acceptance and thus will continue to pursue its administrative remedies with the FDA to reinstate its original filing date of June 29, 2007.
"We also intend to continue to vigorously defend the ongoing patent litigation as previously announced with Endo and Penwest and look forward to prevailing and bringing this important generic product to market," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer.

Avista Capital Partners Agrees to Acquire Bristol-Myers Squibb Medical Imaging

NEW YORK, Dec. 17 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) and Avista Capital Partners, a leading private equity firm, announced today the parties have signed a definitive agreement for Avista to acquire Bristol-Myers Squibb Medical Imaging ("BMS MI"), a business unit of Bristol-Myers Squibb, for approximately $525 million of cash proceeds. BMS MI is a leading supplier of medical imaging products for nuclear and ultrasound cardiovascular diagnostic imaging procedures.
"As Bristol-Myers Squibb continues to focus on evolving into a next- generation BioPharma company, we determined the best way to maximize the value of Medical Imaging for shareholders was to sell this business and reinvest the proceeds into our pharmaceutical research, development and commercialization efforts," said James M. Cornelius, chief executive officer, Bristol-Myers Squibb. "At the same time, we believe that Medical Imaging can maximize its potential under new ownership, and Avista has a proven track record of success in the healthcare field."
David Burgstahler, a partner at Avista Capital Partners, said, "Bristol- Myers Squibb Medical Imaging is widely recognized as a pioneer in cardiovascular imaging agents, and for its strong technical manufacturing expertise. BMS MI is a great fit for our healthcare portfolio, as it addresses the healthcare industry's increasing need for improved diagnostic tools. We believe it is well-positioned for continued success."
The transaction is expected to be completed by the end of January 2008, subject to customary regulatory approvals, at which time BMS MI will operate as an independent company under a new name. Don Kiepert, the founder and former Chairman, CEO, and President of Point Therapeutics, will become the chief executive officer of the company upon completion of the transaction. "I am thrilled to be partnering with the existing management team of BMS MI and Avista Capital as we transition BMS MI to an independent company," said Kiepert.
"BMS MI has exceptional brands, a cutting-edge research and development facility, and a knowledgeable sales force. It is a great fit for our healthcare portfolio, as it addresses the healthcare industry's increasing need for improved diagnostic tools," said Larry Pickering, Avista Capital Partners' healthcare industry partner. "We believe that BMS MI is well- positioned for continued success and Don Kiepert is the right leader to optimize the growth opportunities within BMS MI's pipeline."
Tim Ravenscroft, president of BMS MI said, "The Avista team is committed to long-term growth, and as the new owner of the business, will renew our focus on developing and expanding our business."

European Commission Approves ATRIPLA®

PRINCETON, N.J. and FOSTER CITY, Calif., Dec. 17 /PRNewswire-FirstCall/ -- The European Commission has granted marketing authorization for ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), formally approving ATRIPLA for commercialization in the 27 countries of the European Union, as well as in Norway and Iceland.
"Historically, HIV treatment regimens have been a challenge for many patients since they often combine multiple medications with complex dosing schedules," said Brian Gazzard, MD, Clinical Research Director, Chelsea and Westminster Hospital, London. "ATRIPLA combines three clinically proven and well-established anti-HIV medicines in a single once-daily pill and represents an important step forward in dosing simplification."
ATRIPLA has been approved in the European Union for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harbored virus strains with mutations conferring significant resistance to any of the three components contained in ATRIPLA prior to initiation of their first antiretroviral treatment regimen.
Efavirenz is marketed by Bristol-Myers Squibb Company (NYSE: BMY) under the tradename SUSTIVA® in the United States, Canada and six European countries (France, Republic of Ireland, Germany, Italy, Spain and the United Kingdom). Efavirenz is commercialized by Merck & Co., Inc, through its affiliate Merck Sharp & Dohme (MSD) Limited under the tradename STOCRIN® in all other countries within the European Union and many countries outside of the United States. Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences, Inc. (NASDAQ: GILD) under the tradenames Emtriva® and Viread®, respectively, and are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada® for use as part of combination therapy.
The marketing authorization application for ATRIPLA in the European Union was filed by a three-way joint venture based in Ireland called Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited.
ATRIPLA is currently the first and only once-daily single tablet regimen approved for the treatment of HIV-1 infection in adults in the United States for use either as stand-alone therapy or in combination with other antiretroviral agents. ATRIPLA was approved by the U.S. Food and Drug Administration in July 2006 and has since become the most-prescribed treatment regimen for patients starting HIV therapy in the United States.
As the commercial launch of ATRIPLA in the countries of the European Union is not anticipated to begin until the early part of 2008, Gilead is not making any adjustments to the full year 2007 Product Revenue guidance provided on the third quarter 2007 earnings conference call on Oct. 18, 2007. Gilead is also not making adjustments to any of the other elements of guidance, including its updated Research & Development guidance of a range from $510 million to $520 million provided on Nov. 6, 2007, which includes the up front licensing payment related to LG Life Sciences collaboration for the caspase inhibitor.

Novo Nordisk licenses global rights to potential new haemostasis therapy

Novo Nordisk has entered a global licence agreement with French biotechnology company C2X Pharma and the French national institute for health and medical research (Inserm) for thrombin-activable factor X. The protein, which is in early preclinical development, is a novel type of bypassing agent, capable of propagating blood clotting independently of factors VIII and IX. Novo Nordisk intends to explore the protein’s potential for becoming a new treatment option for haemophilia and other critical bleeding conditions.
The agreement supports Novo Nordisk’s ambition to expand its portfolio of projects within haemophilia and haemostasis through partnerships with biotech companies and research institutions around the world.
Thrombin-activable factor X was discovered by Professor Martine Aiach, Doctor Bernard Le Bonniec, Doctor Pierre-Emmanuel Marque and their team at Unit Inserm 428 (Pharmaceutical and Biological Sciences Faculty at René Descartes University) and further developed to its current stage by C2X Pharma.

Glenmark got first product patent in India

Glenmark has lately received an Indian IN201170 for novel heterocyclic compounds as Phosphodiesterase type IV (PDV IV) inhibitors against the mail-box Application No. 363/MUM/2003 filed April 11, 2003 with the Mumbai Patent Office. Possibly this could be Glenmark’s first product patent to be granted patent protection in India, which already has been granted US7223789. According to the ‘789 patent disclosure, the compounds are suggested to have reach through indication over the treatment of variety of allergic and inflammatory diseases including asthma, chronic bronchitis, atopic dermatitis, urticaria, allergic rhinitis, allergic conjunctivitis, vernal conjuctivitis, eosinophilic granuloma, psoriasis, rheumatoid arthritis, septic shock, ulcerative colitis, Crohn's disease, reperfusion injury of the myocardium and reperfusion injury of the brain, chronic glomerulonephritis, endotoxic shock and adult respiratory distress syndrome, particularly for the treatment of asthma or chronic obstructive pulmonary disease (COPD).

The invention covers methanesulfonamidodibenzo[d,b]furan-1-carboxamide types of copmpounds

FDA warn wyeth over venlafaxine ad

The FDA today posted on its website a warning letter sent to Wyeth Pharmaceuticals Inc. over a professional journal ad for depression drug Effexor XR (venlafaxine HCl).
EFFEXOR XR is believed to work by affecting the levels of 2 naturally occurring chemicals in the brain — serotonin and norepinephrine. Because EFFEXOR XR works on these 2 chemicals, it is known as an SNRI, or serotonin-norepinephrine reuptake inhibitor.
The letter and promotional material is attached.

Effexor_XR-wl.pdf

Effexor_XRPromo.pdf

USFDA refused OTC status to statins

The USFDA has voted against making Mevacor available over the counter. This drug, used to treat high cholesterol patients, is part of a class of medications called statins. Statins are HMG-COA reductase inhibtors and helps lower cholesterol in people who are at risk for cardiovascualr disease.
Disapproval of making this drug over the counter and worries that people will not be able to make informed decisions on whether they actually need the drug. The FDA said that more monitoring of the drug is necessary, including watching consumer decision making in order to see whether making the drug over the counter would be a safe decision. Many people with high cholesterol go untreated, and making the drug more readily available to the public could decrease the amount of untreated.
Despite Mevacor being “safe and effective” there are serious side effects such as liver abnormalities. It is also unsafe for pregnant women. Making the drug OTC will be discounting the severity of the issue. People need to be monitored and tested not just given the opportunity to control a condition if they feel like they have it. OTC medications will be seen in the same light as headache medications. When you have a headache you take a pill and then you stop. Cholesterol pills need to be taken even when one feels like or even sees that their cholesterol has lowered. Finally, making the pill accessible to just anyone could decrease the people’s view of it being a very serious issue that should create a dietary change and not just a ‘take a pill and get better’ attitude.

Forest Laboratories Receives Notification of ANDA Filings for Generic Equivalents of Memantine

NEW YORK, Dec 13, 2007 Forest Laboratories, Inc. announced today that it has received notification from several companies that they have filed Abbreviated New Drug Applications (ANDA) with Paragraph IV Certifications to obtain approval to market generic equivalents of Namenda, an NMDA receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. The Company intends to pursue all appropriate legal action to defend its intellectual property related to Namenda. Namenda is covered by an issued U.S. patent which is set to expire in April 2010. Forest has applied for patent term restoration which, if granted, would extend Namenda's patent protection until September 2013.

Watson Confirms Patent Litigation With Barr on contraceptiv drug combination

CORONA, Calif., Dec. 14 Watson Pharmaceuticals, Inc. a leading specialty pharmaceutical company, confirmed today that Duramed Pharmaceuticals, Inc., a wholly owned subsidiary of Barr Pharmaceuticals, Inc., has filed a patent lawsuit against Watson and certain of its subsidiaries related to Quasense(TM) (levonorgestrel/ethinyl estradiol tablets USP), Watson's generic version of Seasonale(R), an extended cycle oral contraceptive. The lawsuit asserts that Watson's Quasense(TM) product infringes Duramed's US5895032 ('032).
"We fully intend to continue to market Quasense(TM), our generic version of Seasonale(R) and will defend this case vigorously," commented Paul Bisaro, Watson's President and Chief Executive Officer.
Watson launched its Quasense(TM) product in September 2006 following the U.S. Food and Drug Administration's final approval of its abbreviated new drug application. On September 25, 2007, the U.S. Patent and Trademark Office (PTO) issued to Duramed U.S. Patent No. RE39,861 (the '861 Patent) related to Seasonale(R). On December 13, 2007, Barr filed suit against Watson in the U.S. District Court of New Jersey alleging infringement of the '861 Patent seeking to prevent Watson from further commercializing its Quasense(TM) product.

Ranbaxy gets tentative FDA nod for Donepezil copy

Indian Drug maker Ranbaxy Laboratories Ltd has won tentative approval from the U.S. Food and Drug Administration (USFDA) to make a generic version of Eisai Co Ltd's Alzheimer's treatment Aricept, the regulator's Web site showed.
The U.S. patent on Aricept, which is co-marketed with Pfizer Inc., runs out in November 2010.
Aricept, known generically as donepezil hydrochloride, garnered some $2.3 billion in sales for Eisai in the year ended March 31.

withdrawal of the marketing authorisations for lumiracoxib

The European Medicines Agency (EMEA) has recommended the withdrawal of the marketing authorisations for all lumiracoxib-containing medicines, because of the risk of serious side effects affecting the liver. Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group 'COX-2 inhibitors'. It is used for symptomatic relief in the treatment of osteoarthritis of the hip and knee.
Finalising a review of available information on the safety of lumiracoxib, which concentrated on worldwide data on liver side effects, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded at its December 2007 meeting that the risks of lumiracoxib-containing medicines are greater than their benefits. The CHMP therefore recommended that the marketing authorisation for these medicines should be withdrawn in all European Union (EU) Member States where they are approved.
The Europe-wide review was started on 15 November 2007 following assessment of reports of serious liver injury by the United Kingdom. The CHMP was asked to give a scientific opinion on whether the marketing authorisations for lumiracoxib should be withdrawn, suspended or changed across the EU. On 19 November 2007 the United Kingdom suspended the marketing authorisation of this medicine. Similar regulatory action was taken in Germany, Cyprus and Belgium.

First Specific Drug Therapy Approved for the Treatment of PKU

NOVATO, Calif., Dec. 13 BioMarin Pharmaceutical Inc. announced today that the USFDA has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU). Shipments to the distribution channel will commence tomorrow, and BioMarin will begin promotion of Kuvan immediately.
"The approval of Kuvan represents an important milestone for PKU patients and their families and also for BioMarin. We are extremely pleased to bring this promising treatment option to market in just a little over three years since the IND filing, and we are now ready for an immediate launch," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We would like to thank all the patients, their families and physicians, our corporate partners, the FDA, and BioMarin employees for their hard work and dedication in making Kuvan a reality."
"In clinical trials, Kuvan has been shown to help control blood Phe levels in PKU patients, and I am thrilled that this new therapy is now commercially available to the PKU community," stated Dr. Barbara Burton, Professor of Pediatrics, Northwestern University Feinberg School of Medicine; Director, PKU Clinic at Children's Memorial Hospital; and Clinical Investigator in the Kuvan Phase 2 and Phase 3 trials. "With Kuvan now approved, physicians and patients have, for the first time, a drug therapy option to manage the disease."
Kuvan is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive PKU and is to be used in conjunction with a Phe-restricted diet. To determine if there is a response to Kuvan, the recommended starting dose of Kuvan is 10 mg/kg/day taken once daily for up to a month. If there is no response, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5 to 20 mg/kg/day in patients who respond to Kuvan. Kuvan is developed in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.

Abbot sues Glenmark for filing Tarka ANDA

Glenmark Pharmaceuticals Ltd confirmed that Abbott has filed suit on December 07, 2007 in the US district court of New Jersey, seeking to prevent Glenmark from proceeding with the commercialization of its trandolapril; verapamil hydrochloride products which is currently marketed by Abbott as Tarka.

TARKA® (trandolapril/verapamil hydrochloride ER) combines a slow release formulation of a calcium channel blocker verapamil hydrochloride {benzeneacetonitrile, (alpha)[3-[ [2-(3,4- dimethoxyphenyl) ethyl] methylamino] propyl]-3, 4-dimethoxy-(alpha)-(1-methylethyl) hydrochloride}, and an immediate release formulation of an ACE inhibitor, trandolapril {(2S,3aR,7aS)-1-[(S)-N-[ (S)-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester}. The tablet strengths are trandolapril 2 mg/verapamil hydrochloride ER 180 mg, trandolapril 1 mg/verapamil hydrochloride ER 240 mg, trandolapril 2 mg/verapamil hydrochloride ER 240 mg, and trandolapril 4 mg/verapamil hydrochloride ER 240 mg. The tablets also contain the following ingredients: corn starch, dioctyl sodium sulfosuccinate, ethanol, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate.

The product had sales of approximately $100 million in the US market.

Glenmark has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of trandolapril; verapamil hydrochloride which included a paragraph IV certification with respect to patent listed by "Abbott" in the FDA "Orange Book." Glenmark believes it is the only applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges Abbott's patent, Glenmark will be entitled to a 180 day exclusivity period.

With this filing, Glenmark has four first to file positions for various products e.g. ezetimibe, desloratadine, atomoxetine hydrochloride. On successful patent challenges company will have shared exclusivity for the desloratadine and atomoxetine whereas in the case of ezetimibe Glenmark will be the sole Company who will be entitled for the 180 days exclusivity.Additionally, Glenmark has an on-going shared exclusivity on trileptal (an $800 million product). Having completed two months on the market, Glenmark has garnered a substantial market share to lead the generic pack.The approval of trileptal offered Glenmark its first 180 day exclusivity in the US market and with this the company now has a portfolio of 21 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.

Ivax got setback in extended release Metformin tablets

Depomed has today announced that Judge Charles Breyer of the United States District Court for the Northern District of California has granted Depomed's motion for summary judgment of infringement of US6340475 and US6635280 in the company's patent litigation against IVAX Corporation, and denied all three of IVAX's summary judgment motions.
The impact of the court's rulings is that IVAX's infringement of Depomed's patents has been established as a matter of law, without the need for a trial on that issue. The court ruled against IVAX on IVAX's motions for summary judgment related to the validity and enforceability of the patents, and the lack of willful infringement on the part of IVAX.

The court also rejected an interpretation of a disputed patent term proposed by IVAX in support of its invalidity arguments, and instead affirmed Depomed's interpretation of the disputed patent term.
The court has not yet set a trial date for the case.
In January 2006, Depomed sued IVAX for infringement of US6,340,475 and US6,635,280 by IVAX's extended release metformin hydrochloride tablets. The patents are held by Depomed and are related to the company's AcuForm drug delivery system.

Patent in dispute

US6340475

Claim 1 covers a controlled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising a solid polymeric matrix with said drug dispersed therein at a weight ratio of drug to polymer of from about 15:85 to about 80:20, said polymeric matrix being one that swells upon imbibition of water thereby attaining a size large enough to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug within about eight hours after such immersion, and that remains substantially intact until all of said drug is released.

US6635280

Claim 1 covers acontrolled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising one or more polymers forming a solid polymeric matrix with said drug incorporated therein at a weight ratio of drug to polymer of from 15:85 to 80:20, said dosage form being one that when swollen in a dimensionally unrestricted manner as a result of imbibition of water is of a size exceeding the pyloric diameter in the fed mode to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug after such immersion, and that remains substantially intact until substantially all of said drug is released.