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.