Last month, Anthera Pharmaceuticals Inc.'s Phase III VISTA-16 trial testing varespladib in acute coronary syndrome (ACS) patients was stopped for futility, a surprise considering the robust changes in biomarkers seen in the Phase II trial.
C3 Jian Inc. has found funding from an unusual place: Three Delta Dental member companies contributed $30 million to help the biotech develop C16G2, a peptide drug targeting the bacteria that cause dental cavities, and the rest of its oral health pipeline.
In 1998, Organogenesis Inc. received approval for its first allogeneic product, Apligraf, from the FDA's Center for Devices and Radiological Health (CDRH).
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.
