Prescribed Reading: Dealmaking sparse, despite earnings reports
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
- The Medicines Company is moving its PCSK9si forward
- Patients still aren't switching to Celgene's Otezla
- And just for fun, a look at the weird ingredients in meds
Mergers & analysis
Despite earnings season being in full swing, deal activity continues to be slow.
Allergan had one of the only M&A announcements this week, exercising its option to buy Motus Therapeutics for $200 million upfront. The "stepping stone" deal gives the spec pharma access to the Phase 3-ready diabetic gastroparesis drug relamorelin. But the acquisition raised eyebrows from analysts.
Results from the drug's Phase 2 trial didn't appear to hit the primary endpoint for efficacy (or at least Allergan is being circumspect about it if it did). But Evercore ISI analyst Umer Raffat speculated Allergan's interest may be due to positive results in secondary endpoints.
Allergan has cash to spend in the wake of its deal with Teva and has been making bolt-on acquisitions to flesh out its pipeline. The company is well-known for having a slim R&D engine — relying instead on its 'open science' model to acquire late stage assets it can push across the finish line.
The biggest clinical development didn't come in the way of data this week, but in an announcement from Bristol-Myers Squib which it slipped under the radar into its third quarter earnings release Thursday.
Like many of its big pharma brethren, Bristol has been right-sizing its organization. In the company's earnings statement, CEO Giovanni Caforio mentmentioned there would be some refocusing of its R&D organization. While details were sparse, the announcement took on more significance coming after the recent failure of Opdivo (nivolumab) in first-line lung cancer.
Caforio did lay out four general areas which would receive greater investment, but Bristol was light on details for what the reshaping might mean for its pipeline — only emphasizing it still has faith in Opdivo.
And it should, at least for now. Opdivo sales grew more than 200% year-over-year to total more than $920 million during the third quarter, well above the $356 million earned by rival Keytruda (pembrolizumab).
Meanwhile, AstraZeneca announced positive results for Lynparza (olaparib) in ovarian cancer, setting it up for a showdown with Tesaro's rival PARP inhibitor niraparib.
The FDA made label changes to testosterone products this week, updating the labels to includes warnings about abuse and dependence on the products. While testosterone can be prescribed to treat problems which arise after chemotherapy or due to genetic defects, it is often abused in conjunction with anabolic steroids, and at much higher levels than prescribed. Abuse of these products can result in heart problems, liver toxicity, and male infertility.
On the flip side, the regulatory agency also issued draft guidance for drugs being developed for low sexual desire or arousal in women. This type of drug made headlines when Valeant's Addyi (flibanserin) was approved in 2015. Despite the hype, the drug has failed to take off and has not lived up to its somewhat inaccurate nickname as the "female Viagra."
The guidance also addresses the clinical endpoints manufacturers should use in Phase 3 trials, as well as the conditions of low sexual interest. The document comes about a year and half after the agency was criticized for approving the drug and just months before the advertising ban on the drug is up.
Off the bench
It was a light news week for academic partnerships.
GlaxoSmithKline's Discovery Partnerships with Academia (DPAc) team has linked up with Fimbrion Therapeutics to develop small molecules drug to treat and prevent urinary tract infections. The partnership is looking at a new way of treating bacterial infections called mannosides which the group hopes will help avoid antibiotic resistance.
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