Prescribed Reading: Bristol M&A steals the show
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
- Gilead grabs a PRV for a discount
- How one company is tackling concussions with biomarkers
- A New England insurer bets on value-based deals with drugmakers.
Mergers & analysis
The biggest deal of the week was the prospect of a buyout of big pharma Bristol-Myers Squibb. The rumor mill has spun out of control speculating whether the drugmaker is for sale and which larger pharma might be in position to buy.
From our standpoint, it’s unlikely to happen — with a market cap of $90 billion, Bristol-Myers is an expensive purchase and has little beyond its immuno-oncology assets (although CEO Cafario recently touted the upcoming, early-stage fibrotics pipeline). And with the future of the immuno-oncology landscape still very much in flux, potential buyers would be smart to sit on the sidelines while waiting to see how that field and its multitude of combinations are going to pan out.
Yet, Allegan CEO Brent Saunders made comments to the media suggesting "everyone is looking at [Bristol-Myers Squibb.]" But even the Bloomberg reporters were quick to point out that Saunders didn't mean Allergan. Likely because Allergan is amongst the many companies that can't afford to buy Bristol-Myers.
I think they (and we) were pretty clear that everyone doesn't necessarily mean Allergan https://t.co/lV94FJ06pQ— Drew Armstrong (@ArmstrongDrew) February 23, 2017
In other deal news, AstraZeneca continued to shed assets, selling North American rights to the older cancer treatment Zoladex (goserelin acetate implant). The British pharma has been divesting non-core drugs left and right in an effort to bring in some cash and help bolster revenues. The portfolio clean-out is part of a bigger move to conserve cash and realign its portfolio on areas of strength for the company.
It was a week of high-profile oncology flops. ArQule and Japanese partner Daiichi Sankyo announced late last week that tivantinib failed in a late-stage trial of 368 patients with liver cancer. ArQule didn’t write off the drug completely, but indicated it will shift gears to prioritize its pipeline development.
Fast forward a few days and Argos Therapeutics’ stock tanked on news an independent data monitoring committee determined there is no point in continuing a Phase 3 trial of rocapuldencel-T for patients with renal cell carcinoma. Next steps are still up in the air.
This was followed by the failure of Cyclacel’s sapacitabine, an oral therapy that aims to halt tumor cell division, which did not improve overall survival in the Phase 3 SEAMLESS trial. While the company tried to find a silver lining by pointing to some possible positive signs in a subgroup of patients, investors are not keen about prospects for the AML drug.
In non-oncology news, further possible safety issues reemerged for Roche’s hemophilia drug emicizumab. The drug failed to adequately control bleeds and a patient needed to be treated with bypass agents, resulting in the development of thrombotic microangiopathy and later death. The patient death was ruled not to be caused by the drug, but raises questions about the drug’s effectiveness and ultimate safety for this patient population.
Teva Pharmaceuticals got a reprieve from inbound competition to its best-selling multiple sclerosis drug Copaxone (glatiramer acetate) when Momenta Pharmaceuticals indicated the 40mg dose of its copycat Glatopa (which is already approved in the 20mg dose) would not hit the market in the first quarter of 2017 as previously planned.
The delay is due to a manufacturing infraction at a Pfizer facility that handles the fill/finish services for the drug. The Food and Drug Administration issued a warning letter after an inspection of the facility between May and June 2016, Momenta's CEO Craig Wheeler said during a Feb. 21 earnings call.
Pfizer told Momenta it has already taken care of many of the FDA-cited problems, but Momenta now expects an approval decision won't come during the first quarter.
Copaxone is Teva’s bread and butter and the generic drugmaker has been working overtime to maintain the lifecycle of the drug. A few years ago it rolled out the 40mg dose of the drug and phased out the 20mg dose in order to extend the patent life and switch patients over.
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