U.S. sales of Xtandi (enzalutamide) jumped 74 percent in the second quarter over the same period a year earlier, to $143.7 million, Medivation Inc. reported after Thursday's market close, and the company's second quarter revenue from its collaboration with partner Astellas Pharma Inc. soared 111 percent over the same period in 2013, to $148.1 million.
On the heels of its initial public offering (IPO), Immune Design Corp. lured Sanofi SA to an exclusive discovery, development and commercialization license valued at up to $168 million plus an undisclosed up-front payment for therapeutic agents targeting an unspecified food allergy. Immune Design also is eligible for tiered royalties on sales of products emerging from the collaboration.
Shares of Cytori Therapeutics Inc. (NASDAQ:CYTX) fell to a one-year low of $1.46 Wednesday morning after the company disclosed late Tuesday that it placed a clinical hold on enrollment in the phase II ATHENA and ATHENA II trials of its adipose-derived regenerative cells (ADRCs) in heart failure patients.
Regeneron Pharmaceuticals Inc. had more good news to crow about Tuesday, reporting that second quarter global net sales of Eylea (aflibercept) increased 53 percent, to $662 million, over the same period a year earlier, including sales of $415 million in the U.S. – a 26 percent jump based on a modest decrease in distributor inventory in the second quarter of 2013 – and $247 million in the rest of world.
Specialty pharma Tesorx Pharma LLC looked to muscle in on the testosterone market by closing a $10 million series B-1 funding from existing and new private investors to prepare for phase III trials of lead compound TSX-002, a first-in-class oral formulation of unmodified testosterone, and to build out its commercial manufacturing facilities to scale up for the pivotal trial and commercial production.
Isis Pharmaceuticals Inc. advanced another candidate from its rare drug portfolio into phase III development, initiating a pivotal study of the antisense drug ISIS-SMNRx in infants with spinal muscular atrophy (SMA), the most common genetic cause of infant mortality.
Editor's note: Last week, BioWorld Insight examined efforts to improve the efficiency of cancer trials and cited promising examples of adaptive design. In part II, we examine the business, cultural and regulatory challenges to adaptive design in cancer trials.
Health care investment firm Ally Bridge Group, which has offices in Hong Kong and the U.S., warmed up to Cold Genesys Inc., funding the cancer immunotherapy firm's $13.6 million series A. The Newport Beach, Calif., biotech has advanced its lead program, CG0070, into a phase II/III trial in patients with high-risk carcinoma in situ nonmuscle invasive bladder cancer (NMIBC).
Shares of Targacept Inc. (NASDAQ:TRGT) fell to a 52-week low of $2.76 Tuesday after the company disclosed late Monday that it was sacking lead compound TC-5214 in the treatment of overactive bladder (OAB) after top-line phase IIb findings failed to show statistical significance in improving urinary incontinence.
No one in biotech – industry, academia, regulators, nonprofits or patients themselves – disputes that cancer drug development is at a critical juncture. A raft of young companies has joined early movers in the space and the pipeline is filled with promising drugs.
