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.)

In spite of a market with numerous options for patients, Alkermes plc is pressing on with ALKS 9070, its long-lasting schizophrenia treatment. Last month the company started a Phase III trial testing the once-monthly drug in patients experiencing acute exacerbation of schizophrenia. (See BioWorld Today, Dec. 20, 2011.)

Despite biopharmas' best efforts, around 40 percent of cases of drug-induced liver injury aren't discovered in preclinical studies. That stands in stark contrast to toxicity in hematological, gastrointestinal and cardiovascular systems, where only 10 percent to 20 percent of problems aren't caught in preclinical studies.

Despite a better efficacy and safety profile than Rituxan (rituximab, Roche AG and Biogen Idec Inc.), Zevalin ([90Y]-ibritumomab tiuxetan), the radioactive form of Rituxan, has never been a big seller.

Short sellers are generally considered blasphemers by biotech firms. And for good reason; short sellers borrow shares in order to sell them, which puts negative pressure on the stock. The only way shorts make money is if shares go down.

It's been a tough few years for RNAi. Last fall, Roche AG discontinued its preclinical RNAi work, and Novartis AG declined to expand an RNAi partnership with Alnylam Pharmaceuticals Inc. Pfizer Inc. followed suit earlier this year, closing its oligonucleotide therapeutics unit.