Prescribed Reading: Icahn stokes M&A flames
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Ironwood taps into the frustrations of constipation
- Allergan focusing on dry eye with new campaign
- Valeant puts more backing behind Salix products
Mergers & analysis
After last week's speculation that Bristol-Myers Squibb might be on the auction block, activist investor Carl Icahn stoked those flames by hiring biotech industry veteran and geneticist Richard Mulligan as a portfolio manager.
Mulligan has significant experience in biotech and finance, and has worked with Icahn in the past on some of his major deals in the biotech space. In a statement earlier this week, Icahn said he's pleased to have Mulligan join his team as he expands his focus on the biotech sector.
Meanwhile, plagued generic company Perrigo finally unloaded the royalty stream for the multiple sclerosis drug Tysabri that it picked up in its 2013 acquisition of Elan. Perrigo, which has been struggling over the last two years, sold off the revenue stream to Royalty Pharma in a deal worth nearly $3 billion in near-term assets. The company determined that the cash would help it way more than the long-term benefits of holding on to the asset. As for Royalty Pharma — which collects pharma royalty streams and doesn't make drugs — has been trying to get its hands on the Tysabri royalty for several years now.
Biotech stocks have been all over the place this week as some have announced promising results that please investors, while others had clinical flops. The CAR-T space took center stage this week as Kite Pharma announced positive results for its lead compound that will allow it to move ahead with a regulatory filing this quarter. The data puts Kite firmly in the lead to get the first CAR-T therapy to market.
Meanwhile, competitor Juno Therapeutics was forced to throw in the towel and shelve its lead CAR-T therapy due to safety problems. The decision to focus on earlier — potentially safer — compounds was likely the best move for the company in the long-term, but will mean Juno is virtually out of the CAR-T race for now.
PTC Therapeutics had the other high profile failure this week; chalking up a second failure for its nonsense mutation drug ataluren in cystic fibrosis. The biotech will abandon the indication — a move that was not entirely unexpected, but the failure could hurt the drug's chances of ever gaining approval in the U.S. as a treatment for Duchenne muscular dystrophy (DMD).
Working with its European counterpart, the Food and Drug Administration is putting measures in place to cut down on duplicate inspections of foreign manufacturing facilities. The FDA and European Medicines Agency jointly agreed to amend the pharmaceutical rules outlined in the U.S.-EU Mutual Recognition Agreement of 1998 so that inspections conducted by each party in their respective territories can be used by the other.
Meanwhile, the FDA gave the go ahead to Lexicon's drug for carcinoid syndrome symptoms. A 28-day regimen of Xermelo will cost $5,164, on par with a competing drug from Novartis. Lexicon is hoping to bring in $350 million annually from the product.
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