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 latest research on orphan drug spending
- Roche faces Rituxan biosimilar competition in Europe
- Anthem rolls out its own Pharmacy Benefit Manager
Mergers & analysis
Consolidation within the generics industry continues, as Amneal Pharmaceuticals LLC combines with Impax Laboratories Inc. to make the fifth largest generic drugmaker in the U.S. by gross revenue. The last several years have seen dramatic changes amongst generic drugmakers. While the industry perspective was once that diversified portfolios were the way to go — with big pharma dabbling in generics and traditional generics makers moving into specialty pharmaceuticals — that mindset is now changing. The sector has been moving back to being comprised of strict generic drugmakers, and this movement has resulted in increased consolidation.
Meanwhile, as major drugmakers continue to specialize, they are increasingly shedding other assets, which can be great for small start-ups. Former Biogen CEO George Scangos is making the best of this with his new biotech, Vir Biotechnology Inc. The newly launched company is jumping into infectious diseases through separate development collaborations with Alnylam Pharmaceuticals Inc. and Visterra Inc., which will flesh out the new company's pipeline and give it rights to develop two compounds.
Eli Lilly & Co. is throwing its might behind a hot technology — messenger RNA. The tech has had a storied past, but Lilly is lending it some validation through its deal with CureVac. The big pharma will pay $50 million upfront and the biotech has the potential to take home $1.7 billion in milestone payments.
Clinically relevant
Two big drug makers made strategic decisions this week to end development of major products. While investors reacted badly to the decisions, "failing faster" has been a motto that big pharma has embraced — it allows the company to save on resources if a product doesn't offer a strong commercial opportunity.
Just months after Johnson & Johnson rolled out a presentation to analysts about the 10 late-stage products it expects will bring in more than $1 billion each in the next few years, the multi-national nixed development of two of those potential blockbusters. J&J said during its earnings call that the rheumatoid arthritis drug sirukumab would be discontinued because it was no longer commercially viable. Meanwhile, it also dropped the cancer drug talacotuzumab because of safety concerns.
Celgene announced Thursday evening that its promising late-stage immunology candidate mongersen is being discontinued due to lack of efficacy. The drug will be stopped in Crohn's disease and its future in ulcerative colitis is still questionable as well. This discontinuation puts a major dent in the big biotech's pipeline, leaving it to rely more heavily on its promising multiple sclerosis drug, ozanimod.
Elsewhere, oncology drug company Ignyta Inc. skyrocketed this week on interim results that showed entrectinib could be best-in-class in lung cancer. An approval will set the drug up to take on Pfizer Inc.'s Xalkori (crizotinib).
Highly regulated
In another high-profile move, the Food and Drug Administration gave the green light to Gilead Sciences' newly acquired CAR-T therapy, developed by Kite Pharmaceuticals. Even though the drug is for a different patient population than Novartis' recently approved CAR-T drug, the therapies have similar labels. Due to the different indications, the drugs are not competitors ... yet. But, they will likely come up against each other in the near future. Ahead of that showdown, Gilead undercut Novartis on price, coming in more than $100,000 cheaper for its therapy.
Novo Nordisk A/S got some positive news this week as well. An advisory panel to the FDA unanimously recommended the once-weekly GLP-1 treatment the company has been developing. Semaglutide is the Danish company's follow-on to its uber-blockbuster Victoza (liraglutide), which currently dominates the GLP-1 space. The approval could have Lilly running scared, as semaglutide will be a major competitor to Lilly's Trulicity (dulaglutide).