NEWS & COMMENTS

PROHOST    FILTER       

AND COMMENTS

As we told you in the Prohost N-Letters and E-Letters, the market has a mind of its own, representing a mixture of ingenious profiteers, gullible investors, manipulators, and correctors for final fairness. The worst of the investors, though, are those who transform it into a nutrient culture for the short sellers. They panic at the sight of any discomforting news, hysterically selling their stocks on gossip. That is why short-lived rumors sometimes cause excellent stocks to take a dive. The bad news is that the harm, in many cases, is long-lived.  

IDENIX: A DRUG APPROVAL

      In today’s news, Swissmedic approved Idenix Pharmaceuticals (IDIX) product telbivudine for chronic hepatitis B (CHB). The approval was granted for the treatment of compensated (WHAT DOES COMPENSATED MEAN IN THIS CONTEXT?) patients with evidence of viral replication and active liver inflammation. Finally, Idenix’ single, oral, once daily pill has put to rest the unnecessary pessimism sprayed around about the drug, which caused a hysterical selling of the stock. IDIX lost over 50% of its value at the time. Our subscribers know what we mean. (Read past Prohost N-Letters and E-Letters.)    

     Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix said,"We are committed to improving the therapeutic options for patients with viral diseases with new drugs, such as telbivudine. For Idenix, this is a major milestone as it is the first approval of Idenix's first drug candidate, telbivudine, in a European country, just 6 years after it entered clinical development. Having achieved this milestone is an inflection point in Idenix's evolution to a fully integrated pharmaceutical company." 

      So, the drug is good and worth marketing. And, the sufferers of hepatitis B around the world will be able to obtain it, thanks to the Swiss authority. We are now waiting for the FDA to approve the drug. The new drug application with the FDA was submitted in late 2005 and is currently under review. Applications seeking marketing approval of telbivudine for the treatment of CHB were submitted by Novartis in 2006 in a number of regions including the European Union, Canada, Australia, Switzerland, Taiwan, South Korea and China.

Telbivudine will be called SEBIVO® in Switzerland.

       We congratulate the firm and our subscribers.   

GOOD NEWS FOLLOWED BY ACQUISITION

      At the same time the FDA granted Fast Track to Serono’s (SRA) oral product cladribine for relapsing forms of multiple sclerosis, Merck KGaA, announced its decision to buy a majority stake Serono SA. The deal’s cost is 16.6 billion Swiss francs ($13.31 billion). Merck Chief Executive Michael Roemer believes that the acquisition will create a leading position for Merck KGaA in the world of biologic medicines.

RNAi DRUGS

       Biogen Idec (BIIB) and Alnylam Pharmaceuticals Inc (ALNY) decided to collaborate on the development of a treatment for progressive multifocal leukoencephalopathy caused by a virus infection of the central nervous system. Biogen Idec will fund all research and development activities and pay a $5 million upfront fee to Alnylam, which could receive up to $51 million in milestone payments and royalties if a successful product is developed from the technology.

        The technology? RNAi of course. Biogen Idec partner in this project is Alnylam, which is a leader in this promising technology. The RNAi (RNA interference) molecules block the RNA from producing disease-causing proteins. RNAi exists within cells to selectively silence and regulate specific genes. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence genes selectively through RNAi is expected to provide a new way to treat a wide range of human diseases. RNAi is induced by small, double-stranded RNA molecules.

        Progressive multifocal leukoencephalopathy is a condition that occurs in immune-suppressed patients. It affects the brain, often causing death or disability.

Another firm developing RNAi products is SIRNA (RNAI). Both firms are in Prohost Selection under firms with strong technological fundamentals.  

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