Calling the tie "magic," Pfizer Inc. CEO Albert Bourla defended his firm's decision to spin off its Upjohn unit and merge in an all-stock deal with Mylan N.V., creating a new entity to be named later with pro forma revenues as high as $20 billion. "We have a commercial footprint that is very much focused on China, on emerging markets," he said, which will help Mylan.
In late June, when Pfizer Inc. unveiled the first phase Ib data, mixed safety signal and all, for its Duchenne muscular dystrophy (DMD) gene therapy, PF-06939926, investors in Sarepta Therapeutics Inc. as well as Solid Biosciences Inc. watched with particular interest. The latter firm seems none the worse for wear, though, raising $60 million in a private placement.
With Incyte Corp. expecting data from a trio of phase III trials across chronic and acute graft-vs.-host disease (GVHD) and the indication's treatment paradigm continuing to evolve, investors have begun paying more heed to clinical efforts underway by firms trying varied approaches.
Eli Lilly and Co.'s FDA win with Baqsimi (glucagon) nasal powder, the first non-injected therapy to gain clearance for emergency treatment of hypoglycemia, makes the rescue of severely hypoglycemic patients quicker and easier, and coming down the pike are more treatments that could simplify therapy.
Although the placebo response proved better than expected in Chiasma Inc.'s phase III trial of Mycapssa (octreotide) capsules for acromegaly, "we believe that the response of the patients on Mycapssa is the clinically relevant indicator," said William Ludlam, the Waltham, Mass.-based firm's senior vice president of clinical development and medical affairs.
Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell.
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
Amarin Corp. plc's sale of $400 million in American depositary shares (ADSs) ahead of the Sept. 28 PDUFA date for Vascepa (icosapent ethyl) boosted investor confidence while sparking buzz about another player in the space: Acasti Pharma Inc., of Laval, Quebec, which has a krill oil-based product due to report pivotal data soon.
