Prescribed Reading: FDA on a roll, while pharma continues sell off
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
- Roche looking into PML report for Ocrevus.
- Puma gets greenlight from adcomm for neratinib.
- Novartis continues to reshuffle headcount.
The Food and Drug Administration has been on a tear of late, approving new drugs at a rapid clip. The agency has already nearly met the number of novel drug approvals that it hit for the entire year of 2016. So far in 2017, 21 novel new drugs have been approved (22 new drugs were approved in 2016).
The latest approval was granted to Sanofi and Regeneron's most recent collaboration, the rheumatoid arthritis drug Kevzara (sarilumab). The drug has faced regulatory scrutiny previously, but approval was delayed due to manufacturing issues. This is the third approved drug on which the two companies have collaborated.
Beyond novel drug approvals, the FDA has also been approving new indications for already-marketed drugs. A recent first for the FDA was the approval of Merck & Co.'s Keytruda for tumors with a certain genetic mutation —typically the agency approves cancer drugs based on tissue type, such as breast or prostate.
Keytruda has been racking up approvals and is rapidly catching up to the immuno-oncology market leader from Bristol-Myers Squibb in sales.
Mergers & analysis
AstraZeneca kicked off the week by unloading another non-core asset, this time getting $300 million upfront from Italian biotech Recordati for the European rights to the beta-blocker Seloken (metoprolol tartrate).
The British pharma has been selling off older assets that aren't key to its current vision in an effort to further monetize the products, while also being able to redirect resources toward the products that are going to help it reach its goal of $40 billion in revenues by 2023. This sort of restructuring has become a core element of big pharma strategies over the last couple of years as many of them shift their focus from being primary care companies to being specialty-focused companies.
Selling off non-core assets is not exclusive to big pharma; Massachusetts biotech ImmunoGen sold off one of its antibody-drug conjugates to Switzerland's Debiopharm in order to get some near-term cash to fund its wholly-owned pipeline. While the biotech didn't retain any royalties on the cancer drug, analysts agree that the cash is more important for the company at this time, which has been burning through funds at a fast pace.
Meanwhile, newly spun out company Bioverativ struck its first big deal, buying True North Therapeutics for $400 million upfront and another $425 million in potential milestones. Bioverativ was spun out of Biogen earlier this year and consists of the big biotech's hemophilia assets.
Amgen hit a surprising snag this week, revealing it doesn't expect to gain approval for its osteoporosis drug romosozumab this year, after an unexpected cardiovascular safety signal was picked up in a Phase 3 comparator trial testing the bone-building drug against the generic alendronate. While a setback for the big biotech and its partner UCB, it was a boon to competitor Radius Health, which recently gained approval of its osteoporosis drug Tymlos (abaloparatide).
Elsewhere, La Jolla Pharmaceuticals presented mixed Phase 3 data for its shock treatment, sending shares downward. While meeting the primary endpoint, the drug did not improve total organ function or significantly reduce all-cause mortality at one to four weeks following treatment, although the study showed a numerical improvement.
Celgene's multiple sclerosis drug ozanimod also showed mixed results this week in a Phase 3 study, meeting its primary endpoint, but failing to slow disability progression when compared with Biogen's older drug Avonex. While the results weren't a home run, Celgene expects the drug could be a blockbuster and eventually gain approval in multiple indications.
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