Disappointing, but hardly a message of doom: Such was the general view – and the opinion of the company – on Allergan Inc.'s complete response letter (CRL) for Levadex, an orally inhaled formulation of the intravenous migraine drug dihydroergotamine (DHE).
When it comes to getting venture capital (VC) deals done, the science and the financial terms naturally take center stage, but the personalities of the players need to mesh, too, for the best outcomes.
Word from the FDA that Acadia Pharmaceuticals Inc. will not need another Phase III trial in order to ask for approval of the oral tablet pimavanserin for Parkinson's disease psychosis (PDP) moved the likely launch date up about nine months, analysts estimated, and made at least some investors more sanguine about the chances for market clearance in Alzheimer's disease psychosis (ADP).
Backed by $16 million from investors that include Pfizer Inc.'s venture arm, a new orphan drug accelerator called Cydan LLC aims to spin out as many as five new companies in the first four years.
Analysts took as less serious one of two primary endpoints that fostamatinib, the oral spleen tyrosine kinase (syk) inhibitor for rheumatoid arthritis (RA), missed in Phase III trial, and focused skeptically instead on the successfully reached goal in the study, known as OSKIRA-1.
The new round of Phase II studies funded by Aquinox Pharmaceuticals Inc.'s $18 million Series C financing should let the company bolster data gained already in chronic obstructive pulmonary disease (COPD), gain data in bladder pain syndrome/interstitial cystitis (BPS/IC) and then make decisions on whether to partner at the pivotal-trial stage.
Chimerix Inc. and Omthera Pharmaceuticals Inc. – one with an antiviral based on lipid delivery, the other with a lipid-lowering therapy – established terms for their initial public offerings (IPOs), raising investor hopes for a debut like that experienced last month by Enanta Pharmaceuticals Inc., but whether the fabled "window" will open for biotech firms this year remains in question.
Repros Therapeutics Inc.'s first pivotal study, called ZA-301, with the hypogonadism therapy Androxal (enclomiphene) hit both of its primary endpoints – testosterone and sperm count – in the intent-to-treat population, as mandated by the FDA, and CEO Joseph Podolski said the $2 billion demand for such therapies could get bigger than the market for erectile dysfunction drugs.
Ziopharm Oncology Inc.'s Phase III trial with the alkylating agent palifosfamide for first-line, metastatic soft tissue sarcoma failed to meet the primary endpoint of progression-free survival (PFS), but the company – shifting its efforts to synthetic biology programs partnered with Intrexon Corp. – will continue to follow patients' overall survival (OS) rates.
Having taken one step forward, Idenix Pharmaceuticals Inc. got pushed one back when the U.S. Patent and Trademark Office (USPTO) appeals board flipped a decision made earlier that favored Idenix over Gilead Pharmaceuticals Inc. in an interference dispute over patents related to hepatitis C virus (HCV) drugs.
