Prescribed Reading: J&J closes $30B deal, FDA talks regen med
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
- Celgene exploring pipeline expansion
- PhRMA launches a new ad campaign
- Lilly bolsters neuro pipeline with pain franchise
Mergers & analysis
The biggest deal of the year so far was announced this week; Johnson & Johnson finally sealed the deal with Europe's biggest biotech Actelion after months of reported negotiations. And just in time too, the big pharma reported disappointing earnings just days earlier.
J&J picked up the Swiss biotech for $280 per share, or about $30 billion, adding a slate of already marketed pulmonary arterial hypertension (PAH) drugs to its portfolio. Yet, J&J isn't interested in Actelion's pipeline – at least most of it; the early R&D will be spun out into a separate Swiss biotech run by current management. The deal was essentially a win-win for both companies.
The deal is a good sign for M&A going into the rest of 2017. Other large companies are still looking to bolster their pipelines (Sanofi comes to mind) and we could see some other medium-sized companies picked up (anyone want to buy Biogen?).
BioPharma Dive made a list of projected takeout targets at the beginning of 2017 – check them out here.
Actelion made other headlines this week when it announced it had missed its primary endpoint in a late-stage study for it’s PAH drug Opsumit (macitentan). Analysts weren’t that distressed that the already marketed product showed some iffy clinical data, and only worried how the trial could impact deal talks with J&J – obviously, not much.
Amidst earnings season, Pfizer announced positive data that was largely ignored for its treatment of C. difficile in a mid-stage study. The drug has Fast Track designation from the Food and Drug Administration and could help with the growing problem of antibacterial resistance. Pfizer's vaccines and antibiotics are an area of the company that don't get a lot of attention, but bring in big bucks for the pharma. Pay attention during the company's earnings call next week for comments on these areas.
While Biogen has already gained approval for its spinal muscular atrophy (SMA) drug Spinraza (nusinersen), the company is having trouble getting reimbursement for the high-priced rare disease drug. The big biotech is hoping that further data will help convince payers. Biogen announced positive topline results from the ENDEAR study last week and will present further data from trials at an upcoming medical meeting later this year.
Late last week, the FDA created a new designation for those treatments that could be considered regenerative advanced therapy (RAT). Part of the 21st Century Cures Act, the designation gives cell and gene therapies a faster route to development and potential for an expedited review should the therapy qualify.
The documents from the FDA give companies instructions on how and when to apply for the new designation.
While regenerative medicines have largely been used for bone graft substitutes, the cell and gene therapy space is growing rapidly and branching out into other therapeutic areas.
Follow Lisa LaMotta on Twitter