Novartis' Afinitor wins EU approval; Alnylam and Tekmira to collaborate on RNAi delivery

> Novartis has won approval to sell the kidney cancer drug Afinitor in the EU, marking another stride along the path to blockbuster status. The FDA approved the drug in March. Release

> Alnylam and Tekmira are joining forces to advance a better way to deliver RNAi therapies. The collaboration is focused on finding new particles that can deliver RNAi drugs to various parts of the body that are currently off limits. Release

> Osiris Therapeutics has launched a new division to develop biologics that can be used in orthopedic surgery. Bone repair will be a major focus. Osiris is advancing Prochymal for inflammatory, autoimmune, and cardiovascular indications. Release

> The UK's GW Pharmaceuticals has raised $11.2 million from the sale of shares to institutional investors. Story

> NeurogesX says the FDA has extended the PDUFA date 2009 to review the new drug application for Qutenza to manage pain associated with postherpetic neuralgia from August 16, 2009 to November 16. "The FDA's three-month extension is not unexpected," said CEO Anthony DiTonno. "We previously discussed the potential for this extension as a result of our responses to FDA requests for additional information. The information we submitted in July included the report from our recently completed C123 Study, which was performed at the request of the FDA. We believe that with this updated review timeline, if we gain approval in November, we may still achieve our overall goal of launching Qutenza in the United States in the first half of 2010." Release

> Hayward, CA-based Aradigm says that European regulators have provided orphan drug status for its inhaled cystic fibrosis drug. Story

> Curis and Debiopharm have inked an exclusive licensing deal covering Curis' Heat Shock Protein--Hsp90--technology, including CUDC-305, the company's lead Hsp90 inhibitor candidate. Debiopharm will assume all future development responsibility and incur all future costs related to the licensed Hsp90 technology, including CUDC-305. Curis expects that Debiopharm will file an application with health authorities to begin Phase I clinical testing for CUDC-305 in the fall of this year. Release

> Eiger BioPharmaceuticals has licensed the exclusive worldwide rights to novel Hepatitis C Virus technology from Stanford University. Release

> Shares of Israel's Kamada were buoyed by the news that the FDA has accepted the company's licensing application for its intravenous product alpha-1 antitrypsin. Story

> Spectrum Pharma has gained all rights to RenaZorb. The acquisition includes all uses and thus provides full rights, and intellectual property, for the asset. In consideration, Spectrum will pay to Altair a total of $750,000 in restricted common stock. Report

Pharma News

> Elan and Biogen Idec have come to blows--in court, at least. The Irish drugmaker has sued Biogen, claiming that its Tysabri partner was trying to sandbag a recent $1.5 billion deal with Johnson & Johnson. Report

> Government negotiation of drug prices? Bigger Medicare rebates? No longer in the cards. In a major coup for PhRMA, the White House publicly promised drugmakers that they would stand behind that $80 billion cost-savings deal with Sen. Max Baucus. That means the administration will help block Congressional efforts to wring additional cuts from the pharma industry. Report

> India hasn't been happy with the world lately. It had to fight with China to get that country to crack down on counterfeiters that not only exported fake drugs to Africa--a key market for Indian drugmakers--but slapped those fakes with a "Made in India" label. Now, it's preparing to launch an offensive against the European customs delays that have been plaguing India's pharma industry. Report

Vaccine News

> Shares of Novavax spiked 21 percent after the company announced that it was able to create a swine flu vaccine with its virus-like particle technology in only 11 weeks. Report

> Spurred by the sudden clamor for a huge supply of swine flu vaccine, the world's leading vax manufacturers have started shipping supplies of seasonal flu vaccine weeks ahead of schedule. Report

> Novartis has begun testing a new swine flu vaccine in a clinical trial, but says it expects to get the jab on the market long before the study winds up a year from now. Sanofi-Pasteur, meanwhile, expects to launch human trials in a matter of days. Report

And Finally... Every few months or so, Allergan pops up in the rumor mill. This time it's GlaxoSmithKline and Sanofi-Aventis who've been tagged as suitors for the company. Report

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