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
- AstraZeneca secures approval for its PARP inhibitor in breast cancer
- ICER says Spark gene therapy priced too high
- Industry, payers clashing over Part B rebate plan
Mergers & analysis
One deal announced this week, and another rumored to be in the works, could have a major impact on the biopharma sector.
First, the deal which actually came to fruition was unique: several major hospital systems, including the Catholic hospital network Ascension and the Utah-based network Intermountain Healthcare, teamed up to start a nonprofit generic drug manufacturer.
Outraged by the high cost of generic drugs and by recent drug shortages, the hospitals aim to take some power into their own hands. The mooted not-for-profit will either directly manufacture certain drugs or will contract out the manufacturing to third parties. Rising drug prices have stirred up much controversy, but concrete actions have been few. The hospitals' plan could be just the first of many proactive solutions.
Elsewhere, Celgene Corp.'s reported interest in a takeout of Juno Therapeutics Inc. set the industry buzzing.
The big biotech had announced the only major deal of the annual J.P. Morgan Healthcare Conference with a $7 billion pick-up of privately held Impact Biomedicines. But investors left the conference unsatisfied by the deal, giving voice to the thinking that the Impact deal would only begin to solve some of Celgene's problems.
While the Juno deal is only rumored, analysts estimate Celgene would likely have to pay between $10 and $12 billion for the CAR-T company. Considering Gilead Sciences Inc.'s buyout of Kite Pharma last year, it wouldn't be a major surprise to see Juno end up in the hands of another large-cap biotech seeking new growth.
Shares in Juno jumped on the rumors. Yet market indices for the biotech sector as a whole barely budged, suggesting the deal might not move the needle for industry optimism as much as some might expect.
Clinically relevant
While Merck & Co.'s checkpoint inhibitor Keytruda (pembrolizumab) took an early lead in lung cancer after a clinical setback for Bristol-Myers Squibb Co., investors began to worry Keytruda's lead wouldn't last when the company unexpectedly pulled a regulatory filing in Europe in the space, prompting worries over potentially weak results.
Competitors Bristol-Myers, Roche AG and AstraZeneca plc are all studying their respective PD-1/L1 inhibitors in first-line lung patients, both as monotherapies and paired with chemo. But Merck surprised the market recently, announcing results almost a year early from its KEYNOTE-189 study, which compares Keytruda plus chemo compared with chemo alone in first-line lung patients. The study hit both progression-free survival and overall survival endpoints — likely solidifying Merck's lead in the lucrative market.
Elsewhere, small biotech shares in Eiger BioPharmaceuticals Inc. plummeted this week after the company announced the failure of its blood pressure drug and plans to shutter development of ubenimex for pulmonary arterial hypertension. The company will continue to study the drug in lymphedema.
Highly regulated
The Food and Drug Administration under Commissioner Scott Gottlieb has been prolific in its publication of guidance and opinions on seemingly everything. Just this week, the agency's head honcho released a framework to work with the Department of Defense on accelerating the approval of medical products for use on the battlefield, an update on what the FDA is doing to ensure shortages of saline don't continue, and an initiative to further transparency.
Yet, one thing that has critics up in arms is the reversal by Gottlieb on Complete Response Letters (CRLs). During his confirmation hearings, Gottlieb promised to be more transparent about the rejection letters given to drug manufacturers. Under current practice, when a drug is rejected, a company doesn't have to tell its investors and can pick and choose what to disclose about the rejection. The industry is fond of this practice, but the FDA has said in the past that drugmakers haven't been particularly honest with investors about what the letters contain.
Gottlieb is now saying that the FDA is going to try to release some information some of the time, citing concerns about protecting trade secrets. We want more Mr. Commissioner.