Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — with constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations driving the industry this week.
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Mergers & analysis
A $4.3 billion deal between Fresenius Kabi and Akorn Inc. took a strange turn this week when the companies revealed in separate statements they are investigating breaches of data integrity at Akorn. Neither company would give much in the way of details, but Fresenius execs admitted that they would pull the plug on the deal if anything was found. At least one analyst speculated that Fresenius has been looking for a way out of the deal . . . and may have just found it.
Elsewhere in the pharma world, AstraZeneca plc is spinning out six early-stage and preclinical compounds from its MedImmune business into a standalone biotech dubbed Viela Bio. The autoimmune-focused biotech has a strong slate of investors and $250 million in funding to begin its life as a new company. The move fits squarely into AstraZeneca's strategy over the last few years of putting resources behind drugs in its development pipeline that could be the most fruitful, while also trying to monetize or rid itself of compounds that aren't in a tightly focused set of therapeutic areas.
It was a rough week for Allergan plc. The company's stock took a hit after generic drugmaker Mylan NV announced it would team up with Revance Therapeutics Inc. to develop a biosimilar version of Allergan's blockbuster wrinkle remover Botox (onabotulinumtoxinA). The drug now has more than eight indications — both cosmetic and therapeutic — and brings in more than $3 billion annually for the Irish specialty pharma. While Botox has staved off competitive threats before, a biosimliar version of the drug just might put a dent in its upward trajectory.
Clinically relevant
DBV Technologies SA has had a disappointing streak of news over the last few months, all related to its Viaskin allergy treatment platform. The company announced recently it would move ahead with a regulatory filing for its Viaskin Peanut allergy product despite failing to meet its primary endpoint in clinical trials. Now, DBV released results for its Viaskin Milk treatment that are just as muddy. The company took some liberties with the analysis to suggest positive results — a solution biotechs use when there aren't clear data, and that often ends badly. Investors were not pleased, and they aren't expecting positive results once a Phase 3 trial is conducted.
Arca Biopharma Inc. also did some creative data wrangling when reporting a Phase 2b trial for its beta-blocker Gencaro. The biotech has chosen to move into Phase 3 despite unclear results in the mid-stage study. Arca pulled out a small subgroup of patients to make the data appear positive, while the larger data did not show statistical significance.
Meanwhile, fertility drugmaker ObsEva SA reported positive Phase 2 results, no data shenanigans required. The oral drug showed it increased the likelihood of pregnancy in women get infertility treatments. While analysts peg the drug as a small revenue driver in the future, the fertility treatment market is definitely getting more attention of late.
Highly regulated
Celgene Corp. continued its string of bad luck this week when it unexpectedly revealed to investors that the Food and Drug Administration issued a Refusal to File letter for its blockbuster hopeful ozanimod. The agency deemed the New Drug Application incomplete and Celgene was a bit cagey about exactly what the problem was. Refusal to File letters aren't particularly common, with less than 40 being issued over the last 10 years.
Allergan also continued the bad news parade, revealing the FDA pushed back the user fee action date for its uterine fibroid drug Esmya (ulipristal acetate) to August. What Allergan didn't tell investors in its announcement is that the move was related to safety issues that cropped up in post-marketing surveillance in Europe. The EMA is currently investigating cases of severe injury in patients taking the drug and has recommended that no new patients be prescribed it and given no new courses of treatment. This doesn't spell good news for Allergan, which was counting on Esmya as one of its 'six stars' for growth going forward.
Portola Pharmaceuticals also played fast and loose with informing investors about pertinent data. The company said nothing in its earnings release, but revealed on a call with investors that it will likely have to conduct another clinical trial for its Factor Xa reversal agent AndexXa, potentially delaying the drug's entrance to market . . . again.