Prescribed Reading: I/O is the only game in town
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.
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Mergers & analysis
Oncology is still the hottest place for deal activity (of what few deals are being made). Celgene struck a deal on Thursday that will expand its oncology pipeline in solid tumors — an area in which they historically haven't had a strong presence — and could be worth more than $1 billion when all is said and done. As typical of Celgene dealmaking, the transaction with BeiGene for its PD-1 inhibitor is heavily-weighted toward back-end milestones based on development, regulatory and sales. That doesn't mean Celgene got off cheap; the big biotech is paying $263 million upfront plus taking a $150 million equity investment in the Chinese biotech.
Novartis struck a different kind of oncology deal this week. Instead of adding to its pipeline, it inked an agreement with Oxford BioMedica to have them develop lentiviral vectors for its highly anticipated drug CTL019 (tisagenlecleucel), as well as other CAR-T candidates. Manufacturing will be a major hurdle for these therapies, so getting it right at the beginning could make or break the space.
There had been fears that the big pharma was backing away from CAR-T when it canned its fairly new cell and gene therapy unit. But the company's CAR-T is moving on pace. It will face a Food and Drug Administration advisory committee next week and has a user fee goal date in the fall.
Bristol-Myers Squibb is trying to prove that Opdivo (nivolumab) should not be judged by its failure in lung cancer. The big pharma announced topline results from a head-to-head study of the checkpoint inhibitor as compared with its older immuno-oncology drug Yervoy (ipilimumab). Opdivo bested Yervoy, leaving investors waiting for the rest of the data, further confusing the story of checkpoint inhibitors.
Elsewhere, the spinal muscular atrophy market could be heating up. Roche and partner PTC Therapeutics announced positive topline results from a mid-stage study in the rare genetic disorder. While still a few years from market, the oral drug could offer a very compelling alternative to Biogen's injectiable Spinraza (nusinersen).
After Merck & Co. provided a vague report that there was a higher incidence of death in a few of its cancer studies, the company gave an update revealing the Food and Drug Administration has put a clinical hold on three of its combination studies of its blockbuster checkpoint inhibitor Keytruda (pembrolizumab) being tested with Celgene's Revlimid (lenalidomide) or Pomalyst (pomalidomide) plus dexamethasone in multiple myeloma.
The news is just the latest black mark for the highly touted checkpoint inhibitors. Both Bristol-Myers Squibb and Roche have reported high-profile failures for their respective PD-1/L1 inhibitors that have raised questions about the profile of checkpoint inhibitors. Like many discoveries before them, the checkpoint inhibitors are starting to look too good to be true.
Meanwhile, Bristol-Myers Squibb's Orencia (abatacept) was granted a third indication from the FDA for its label. The drug is now approved in rheumatoid arthritis, juvenile idiopathic arthritis and, most recently, psoriatic arthritis. Sales of the drug grew 13% year-over-year in the first quarter to $535 million. Bristol-Myers considers the drug one of its key growth drivers.
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