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 end of the cholesterol era?
- Biocon biosimilar stalled by manufacturing
- California jumps into drug pricing fray
Mergers & Analysis
Pfizer has been mulling a split of the company for years now, and investors have always been disappointed by management's decision to remain intact. But the big pharma is taking the step of at least trying to sell off its consumer products unit. The sale may never come to fruition, but Pfizer has vowed to stay mum on it until 2018 or when a deal actually materializes.
One deal that did materialize this week was Express Scripts' $3.6 billion takeover of hospital management solutions company eviCore. Pharmacy Benefit Manager (PBM) will gain the oversight of the medical benefits of 100 million lives, giving it even more power over the pricing debate.
Merck & Co. also inked a small deal, shelling out $37 million upfront to KalVista Pharmaceuticals, Inc. for their diabetic macular edema (DME) drug. The big pharma doesn't have any pipeline projects in the queue, but is picking up the program to bolster its standing on the diabetes continuum of care. Merck's best-selling drug franchise is its diabetes drug Januvia (sitagliptin). But sales of the extremely lucrative franchise are coming under threat as the diabetes market gets more crowded. Merck needs more offerings in the space if it's going to stay competitive and extend the life of Januvia.
Clinically relevant
Eli Lilly & Co. has been trying to build up its position in the oncology arena and has staked its claim on the success of its CDK 4/6 inhibitor Verzenio (abemaciclib). While third to the market in the class, Lilly thinks the drug can be best-in-class. Yet, it reported this week that the drug failed to improve overall survival in patients with lung cancer who have a KRAS mutation. While the results are not a death sentence for the drug, they do dent Lilly's prospects in the space.
Elsewhere, Ardelyx reported positive results for its irritable bowel syndrome with constipation (IBS-C) drug, sending shares up and moving the drug just a little closer to market. After years of development and several setbacks with big pharma partners, Ardelyx now plans to file for approval of the drug in the second half of 2018. The drug will face a tough market that already has the likes of Allergan and Ironwood's Linzess (linaclotide).
AnaptysBio also presented some game-changing data this week for its mid-stage atopic dermatitis treatment. A single dose of the drug was able to show a 50% improvement in 83% of patients. While Sanofi and Regeneron's Dupixent (dupilumab) is the hot new drug in the space, the offering from AnaptysBio could change the market completely.
Highly regulated
Spark Therapeutics wowed a Food and Drug Advisory committee on Thursday, which voted unanimously in favor of approval for the biotech's gene therapy for a rare inherited form of blindness. The approval of the drug is expected in January, but the committee and the approval raise questions about pricing and other issues the medical community has never faced before.
The Spark treatment is meant to be a one-time therapy, and therefore is likely to have a high price tag attached. While Spark is yet to reveal what that price is, the company has publicly discussed looking into alternative pricing models. The water gets muddier though when you consider the idea that some of these gene therapies may need a follow-up treatment down the line, changing the pricing dynamic. These questions did not get answers from the panel, but will be ones the industry has to consider in coming months.