SAN DIEGO – In a session at the third annual Global Life Science Partnering Conference put on by Southern California life sciences industry organization BIOCOM, representatives from large pharmaceutical companies offered insights for biotechs looking to partner.
After seeing its clinical program stall following the failure of a Phase IIb trial testing NTx-265 in acute stroke, Stem Cell Therapeutics Corp. is reinventing itself. (See BioWorld Today, May 26, 2010.)
Pexa-Vec (JX-594), developed by San Francisco-based Jennerex Inc., is a triple cancer killer. A publication in Cancer Research confirms anti-angiogenesis is part of Pexa-Vec's mechanism of action to attack tumors.
During the past 10 years, overall outsourcing has grown 13.3 percent per year, outpacing a 9 percent annual growth of total R&D spending. In Europe, Frost & Sullivan estimates the contract research organization (CRO) market will grow at an annual rate of 9.6 percent between 2011 and 2018.
The FDA approved 39 new drugs in 2012, the highest since 1996, so it should come as no surprise that regulatory affairs and clinical development experts are in high demand these days.
Liposome nanoparticles have been in existence for nearly two decades. Doxil (doxorubicin liposomal), developed by Sequus Pharmaceuticals Inc., gained FDA approval in 1995. But liposomes have limited use because it's hard to target them to specific tissue and there are very few drugs that can be loaded into and released from liposomes.
Last month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion of the marketing authorization application for Kynamro (mipomersen), developed by Isis Pharmaceuticals Inc. and Genzyme Corp., a unit of Sanofi SA, for the treatment of homozygous familial hypercholesterolemia (HoFH). Genzyme is appealing the decision, which should be completed in the second quarter of 2013.
There's a large $2 billion market for over-the-counter products to treat the roughly 39 million Americans with lactose intolerance, but even with the available options, 82 percent of lactose-intolerant patients report they still experience symptoms.
"I absolutely believe there will be an RNAi drug [on the market] within 10 years," Nassim Usman, COO and senior VP, Sirna Therapeutics Inc., said in a 2005 interview for BioWorld's RNAi Report.
Whether it's Congress making decisions or venture capitalists making investments, leaving things to the last minute seems to be all the rage these days.
