QDIS Blog

Recently Roche announced it had reached an agreement with Sanofi-aventis to produce shimikic acid by fermentation at Sanofi’s plant in Saint-Aubin-les-Elbeuf France. This is indeed good news since extraction of shikimic acid from the spice star anise (mainly in China) was the bottleneck in the process. The extraction process is about ten steps and takes quite a bit of time. Production from femermentation should alleviate this problem and is probably the only way that Roche could also announce that 13 other contract manufacturers have been identified to produce the drug in case of a world pandemic. While I’m not sure of how likely this is to happen, it is good to see that Roche is taking steps to ensure production can be increased if needed.

Technorati Tags: shikimic acid, Tamiflu

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I found this article on the Miami Herald website interesting. The article deals with the proposed merger between Andrx and Watson Pharmaceuticals to form what would be the third largest generic manufacturer. On an amusing note, the paper has a section headline stating “FAA Inspection”. Now when I first read this I was scratching my head; why exactly was the Federal Aviation Administration doing an inspection of a pharmaceutical company?? Seems it’s a typo and should really be FDA. At first, I thought maybe Andrx had added an airport at the site.

It seems MMI investments who owns 12 percent of Andrx thinks the $1.9 billion price that Watson Pharmaceuticals has offered falls short of what Andrx is truly worth. The president of MMI states they although they have had their problems (the FDA has refused to review any more of Andrxs’ drug applications until certain problems are corrected at their ) it was better for Andrx to clean up itself before being put on the market. He draws the analogy to a trophy home hit by a storm and wouldn’t it be better to fix it up before putting it up for sale. Having spent some time in pharmaceutical development, I think the analogy falls short. Fixing quality issues takes more time and is harder to fix than remodeling a home.

My guess is that the quality control problems at the Davie, FL plant may be of greater concern than the company has publicly stated. While I have been lucky enough in my career to not have been in such a situation, I do know that it takes quite an effort to make changes, especially those involving corporate culture. Leaving out the question of price, I think a merger could produce a viable company. Both have been struggling of late.

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I read today that Genentech expects to get 15 new treatments approved for a variety of diseases by 2010. I can only say I will be greatly impressed if hey can indeed pull this off. Genentech currently has 12 products on the market with Avastin being their biggest seller ($1.1 billion in 2005). From the article and other places I’ve read about it, it is unclear how many specific drugs they are talking about. It appears that they are counting the number of indications rather than the number of new biological entities. So say a new drug is used for 3 different indications, that would count as 3 towards that total. They do have about 20 potential drugs at various stages of development but given the odds in the drug development process, I wouldn’t count on all of them getting through their trials.

In the interest of full disclosure, I do own a few shares of Genentech stock. While I really hope this is the case, I’m being cautiously optimistic.

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