WASHINGTON – Amid the usual sessions on finance, business development and biomarkers, a fledgling emerging leaders workshop met Monday at BIO 2011 International Convention to discuss commercialization, an activity that has become a bigger focus for biotech, as the industry matures and as policy makers put increasing pressure on reimbursement and differentiation.
On a call with investors earlier this month, Aegerion Pharmaceuticals Inc.'s CEO, Marc Beer, said the firm was "in filing mode now," with plans to submit a new drug application for lomitapide in homozygous familial hypercholesterolemia (HoFH) by the end of this year.
Reverse mergers, which had dropped in status as the initial public offering (IPO) window creaked open for biotechs in the past year, look to be making a comeback, if the recent spate of deals is any indication. The latest deal has private firm Allozyne Inc. merging with struggling public biotech Poniard Pharmaceuticals Inc. in a stock-for-stock transaction.
The challenge in treating cancer has been delivering cell-killing agents to tumors while sparing normal tissue, and Cyterix Pharmaceuticals Inc., an April 2010 start-up, is moving toward the clinic with a new targeted approach by taking advantage of extra-hepatic cytochrome P450.
The injectable aesthetics market has a new player following the FDA's late Tuesday approval of laViv (azficel-T) from Exton, Pa.-based Fibrocell Science Inc., but don't expect the autologous cell therapy to go head-to-head – or face-to-face – with the market-leading injectable Botox (onabotulinumtoxin A).
German firm Biotest AG is getting $85 million up front in an autoimmune disease deal, with new partner Abbott hoping that the mechanism for midstage candidate BT-061 will be enough to differentiate it in crowded markets such as rheumatoid arthritis (RA) and psoriasis.
Proving that big pharma firms aren't the only ones interested in the orphan disease space, venture investors are getting behind 2010 start-up Ultragenyx Pharmaceutical Inc. to the tune of $45 million.
Celgene Corp.'s Istodax (romidepsin) got an accelerated nod, as expected, in peripheral T-cell lymphoma (PTCL) patients who have received at least one prior therapy, pitting it against Allos Therapeutics Inc.'s Folotyn (pralatrexate), a drug that suffered slower-than-expected sales despite being the first approved for PTCL.
Three years after restrictive labeling and labor-intensive postmarketing requirements crushed hopes for a potential blockbuster, GlaxoSmithKline plc handed back the last of its stake in constipation drug Entereg (alvimopan) to Adolor Corp., but analysts see the move as a positive for the Exton, Pa.-based biotech.
Only a few months after pulling in $25 million in equity funding, privately held Synageva BioPharma Corp. is gaining access to the public markets, as well as a nice chunk of cash, in a planned stock-for-stock merger with Trimeris Inc.
