Besides the aforementioned key events in biotech during 2010, we’d also like to point out certain topics that we will be watching closely in 2011.
Genzyme’s manufacturing issues that started in 2009 and shut down a plant in Allston, MA, bled into its operations last year. In the wake of dipping share prices, sanofi-aventis made an unsolicited $18.5 billion bid for Genzyme. While the takeover battle is ongoing, Genzyme is divesting three business units as per strategic plans announced in May. In September LabCorp bought Genzyme Genetics for $925 million, and in November Sekisui Chemical paid $265 million for the diagnostics products business, leaving only the pharmaceutical intermediates division up for grabs.
Intensified regulatory vigilance of marketed drugs was another binding theme for 2010. Avandia, GSK’s type 2 diabetes drug, was pulled from the European market and use was restricted in the U.S. The changes were made in response to data that suggests an elevated risk of cardiovascular events and stroke in patients treated with Avandia. Avastin, Roche/Genentech’s cancer drug, has also been subjected to a higher level of post-marketing scrutiny. The company will have a hearing with the FDA to address the agency’s request to remove breast cancer from Avastin’s label entirely. The EMA, on the other hand, has recommended to the EC that Avastin only be used with paclitaxel and not with docetaxel. Avastin’s potential to be used in multiple cancer settings was touted as being a big part of why Roche doled out $46.8 billion to take full control of Genentech, which discovered the drug.
Medicinal marijuana was definitely in the news a lot. Six states put the issue on the November ballot, taking steps to decriminalize and in some cases legalize marijuana, however, all fell through. Some companies trying to pharmaceuticalize this green weed are having better luck, with GW Pharmaceuticals and Bayer winning approval in Canada, Spain, and the U.K. for its cannaboid Sativex as a treatment for spasticity in multiple sclerosis.
Sam Waksal, Ph.D., has re-entered the biotech industry. After serving about five years of a seven-year, three-month sentence for insider trading, the ex-CEO of ImClone was released in 2009. He got busy quickly, forming a private venture called Kadmon Pharmaceuticals, which is investing in the HCV market.