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.
In a time when it's difficult to raise capital through the public markets, licensing deals are necessary to fund programs, and M&A has developed into the go-to exit strategy for private biotechs.
The decision of when to raise capital sometimes becomes more of a macroeconomic issue than one based solely on the status of an individual company. Yet the macro picture remains hazy – some analysts think things will get better, while others think they will get worse.
As the biotech industry matured – and drug makers both big and small faced capital constraints – spinning off assets into separate companies developed into a popular mechanism to increase shareholder value.
The annual meeting of the American Association for the Study of Liver Diseases kicks off this week, but biotechs with hepatitis C drugs may be busier talking with potential partners than with hepatologists during the event.