Last week, Eisai Co. Ltd. and Astex Pharmaceuticals Inc. received a complete response letter for their request to expand the use of Dacogen (decitabine), which already is approved for myelodysplastic syndromes, into acute myeloid leukemia (AML) patients 65 years of age and older.
Correctly predicting the future is a necessary but difficult task for biotech executives. Making accurate forecasts about demographic trends, clinical data, regulatory decisions, competition, and prescription trends can guide where to allocate limited capital and even the timing on when to raise more.
Last week, Biogen Idec Inc. announced the purchase of Stromedix Inc. to gain access to the start-up's humanized monoclonal antibody, STX-100. The purchase marks a return home for the integrin avb6-targeted drug, which was originally developed by Biogen. (See BioWorld Today, Feb. 15, 2012.)
Since the beginning of the biotech industry, finding capital has always been a major factor in the success of a company. Without cash, it's hard to develop drugs.
Amylin Pharmaceuticals Inc.'s FDA approval of Bydureon (exenatide extended-release) late last month was a long time coming. The company first applied for approval in 2009, requiring three attempts before the FDA finally signed off.
It's become routine for current venture capital (VC) investors to buy additional shares when a biotech goes public. Initial public offerings (IPO) are no longer an exit strategy, but a further round of funding to get the insiders to the end game. The extra cash from insiders reduces the amount that needs to be raised, helps support the price and, with recent IPO pricing difficulty, has been a way for insiders to reduce their cost base.
Biotechs acquiring rights to commercial drugs before gaining marketing approval of their own lead candidate is nothing new to the industry; an experienced sales force can be worth its weight in gold.
Not everyone is upset about the turmoil in the equity markets. Last year was a record year for the sale of royalty streams and other structured product deals, in large part because of the lack of other options for biotechs.
Last month, Reata Pharmaceuticals Inc. snagged $400 million from Abbott for half of its second-generation antioxidant inflammation modulator (AIM) portfolio, bucking a trend over the last few years of putting the risk on the innovator through milestone payments. (See BioWorld Today, Dec. 13, 2011.)
