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
- What you missed from ASH17
- VIDEO: BioPharma Dive sits down with PwC
- Shire's Ornskov talks hemophilia
Mergers & analysis
Some small end-of-year M&A is happening this week. Allergan paid a pittance to pick up beleaguered Repros Therapeutics Inc. and its women's health offerings. The specialty pharma has been focusing its pipeline on six therapeutic areas (not oncology because CEO Brent Saunders has said he doesn't want to just follow the crowd). It has one late-stage offering in women's health, but the Repros acquisition will give it a second compound in the space. It's going to take some TLC from Allergan though to get the compound up to snuff, but $26 million is a small price to pay.
Meanwhile, Vertex Pharmaceuticals Inc. is ready to move beyond its leading position in cystic fibrosis and start thinking about what happens for the company next. The big biotech has selected the first compound in a collaboration with CRISPR Therapeutics AG. The pair are getting ready to conduct trials in both beta thalassemia and sickle cell disease.
Roche AG is also moving forward with a licensing agreement it has with Ionis Pharmaceuticals Inc. The Swiss pharma is paying a licensing fee of $45 million to assume responsibility of development and commercialization of Ionis' Phase 2-ready drug for the treatment of Huntington's disease.
Elsewhere, Bristol-Myers Squibb Co. is expanding its immuno-oncology offerings by hooking up with Ono Pharmaceutical Co. Ltd. for its selective PGE2 antagonist. The drug will provide another option for the big pharma to test its blockbuster Opdivo (nivolumab) in combination.
Clinically relevant
It was a big week for clinical trial data as one of the most important biopharma conferences of the year took place in Atlanta. The American Society of Hematology conference showcased some of the hottest innovations in gene editing, hemophilia and blood cancers.
BioMarin Pharmaceuticals Inc. was the unofficial 'winner' of the event, presenting strong early data for its gene editing therapy for hemophilia A. The results outshined similar data from closely watched Spark Therapeutics Inc., setting up the companies for a bit of a showdown. See other highlights from ASH here.
That wasn't the only clinical news this week. Eli Lilly & Co. announced results from its Phase 3 study of its blockbuster hopeful Cyramza (ramucirumab) in first-line treatment in patients with HER2-negative metastatic stomach cancer. The drug improved progression-free survival, but failed on the overall survival endpoint. The mixed data means Lilly doesn't plan to move forward with the pursuit of approval in the indication because Cyramza wouldn't be commercially competitive.
Elsewhere, Regeneron Pharmaceuticals Inc. and Sanofi SA continued their hot streak together as partners. The pair presented Phase 2 results from a study of their PD-1 inhibitor cemiplimab, showing the drug could be a late contender in immuno-oncology. The companies have begun submitting data to the Food and Drug Administration in the form of a rolling Biologics License Application.
Highly regulated
A few markets are set to get more interesting in coming months now that the FDA has made several approvals that broaden competition in multiple areas. The regulatory body gave the green light to Sanofi's follow-on of Lilly's blockbuster fast-acting insulin Humalog. While not considered a generic or a biosimilar, Admelog will function the same way in the marketplace.
Another treatment that will increase competition and potentially bring down costs, is the third approved biosimilar version of Johnson & Johnson's Remicade (infliximab). The FDA gave the OK to Pfizer Inc.'s Ixifi, the big pharma's second biosimilar version of the blockbuster rheumatoid arthritis drug.
It was an interesting move from Pfizer, which has been struggling to gain traction with its other Remicade biosimilar Inflectra. The company has brought suit against J&J for anti-competitive behavior in regards to its Remicade contracts with payers. Yet, Pfizer said it will not launch the second version, but did not elaborate on plans for the drug.