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
- Mylan exec fingered in generic drug pricing suit
- ICER expands its role with new funding
- Deep dive into pharma globalization
Mergers & analysis
Despite a slate of high-profile earnings calls this week, there weren't many major deals announced. Novartis picked up radiopharmaceutical specialist Advanced Accelerator Applications for $3.9 billion, in an effort to build out its oncology offerings further.
Boehringer Ingelheim GmBH struck a licensing deal with Dicerna Pharmaceuticals Inc. for its RNA interference technology to collaborate on the development of drugs for the hot liver disease non-alcoholic steatohepatitis (NASH). The German drugmaker is potentially bolstering its offerings in the space, while only staking a small amount of cash the yet-unproven technology. The deal is worth only $200 million when all is said and done.
No deal. Voyager Therapeutics revealed during a third quarter earnings call this week that big pharma partner Sanofi SA has opted to pass on ex-U.S. rights for its gene therapy in Parkinson's disease. The move sent shares of the biotech tumbling, but analysts believe this could be a positive for Voyager. The original deal, struck in 2015, didn't have the most favorable economics for the biotech. Now that the first gene therapies are hitting the market, the technology is worth a bit more.
French biopharma Poxel SA picked up a partner to help develop and commercialize its type 2 diabetes drug in Asian nations. Sumitomo Dainippon Pharma will help foot the bill for imeglimin, as it looks to bring the drug to 12 markets, including China, South Korea and Taiwan.
Clinically relevant
In an under-the-radar announcement Wednesday morning, AstraZeneca quietly revealed that its asthma drug tralokinumab failed two more late-stage studies, bringing its total failures to three. The British pharma had tried to boost the likelihood that these two most recent studies might succeed by using a biomarker to focus on a subgroup of the larger patient population, but the effort was for naught. AstraZeneca didn't reveal the actual data behind any of the studies, and is waiting for an upcoming medical meeting to roll out results.
While focusing on the sub-population didn't work for AstraZeneca, Swiss biotech GeNeuro got a boost this week when it announced the results of a post-hoc analysis that showed its multiple sclerosis drug worked in a subset of patients. The results were contrary to the overall study results that were announced earlier this year and showed the drug was a flop.
Meanwhile, changes in a manufacturing procedure are panning out for once-hot stem cell biotech bluebird bio. Early data announced this week from a small number of patients showed the sickle cell disease therapy may be working now that the company was able to increase its potency.
"What we have seen in both these patients is that we have been able to pretty dramatically increase the copy number, meaning in these patients the number of cells that are working ... We have a greatly increased dose," bluebird CEO Nick Leschly told BioPharma Dive in an interview.
Highly regulated
Despite the setback in its asthma franchise, AstraZeneca got a clutch approval from the Food and Drug Administration for its blood cancer drug Calquence (acalabrutinib), setting it up to compete with AbbVie Inc.'s ultra-hot Imbruvica (ibrutinib). AstraZeneca CEO Pascal Soriot called the approval a "landmark moment," pinning Calquence as the cornerstone of the British pharma's burgeoning hematology franchise. Yet, AbbVie's Imbruvica already as a handful of indications under its belt and is going to be a tough competitor to unseat.
Merck & Co. disappointed investors, quietly pulling its application for approval of Keytruda (pembrolizumab) in first-line non-small cell lung cancer in Europe late Friday night. Unlike the FDA, the European Medicines Agency rarely approves a drug based on mid-stage data alone, and Merck will likely have to wait for late-stage results before it can refile. While the move wasn't the end of the world, it spooked investors who worry the company could lose its edge in the highly competitive lung cancer market.