Prescribed Reading: Combos to take center stage at ASCO
A weekly guide to the goings-on in the biopharma industry.
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
- Oncology costs are on the rise.
- FDA approves the first wave of generic Strattera.
- Akari CEO resigns amidst data controversy.
With all of the industry gearing up to head to Chicago for the American Society of Clinical Oncology (ASCO) conference this weekend (including BioPharma Dive), there were some good data drops earlier this week that stood out. One was Eli Lilly & Co.'s strong Phase 3 data for Cyramza (ramucirumab) in bladder cancer. The data sets up the drug to compete with the checkpoint inhibitors in the space. While all of the already-marketed PD-1/L1 inhibitors are already approved in the space, most were approved based on an accelerated approval basis and still need to prove their efficacy. So far, Roche's Tecentriq has failed to do, opening up the space for something a bit more effective.
Elsewhere, Teva Pharmaceuticals showed this week that it might have an advantage over the other companies developing CGRP inhibitors for the treatment of migraine. While therapies from Lilly, Amgen, Novartis and Alder Biopharmaceuticals have all shown similarly strong results in testing, Teva's drug proved this week that it can also best a placebo when dosed every three months. This gives it a sure advantage over the monthly treatments being developed by some competitors.
Mergers & analysis
The only deals making waves this week are those for combination oncology therapies. Like HIV and hepatitis C, the working theory is that cancer is going to be cured using a variety of combined treatments. According to a recent report released by EP Vantage, immuno-therapy combos are skyrocketing —the number of combo trials has gone from 215 in 2015 to 765 and rising, currently.
While Bristol-Myers Squibb's Opdivo (nivolumab) is trailing Merck & Co.'s Keytruda (pembrolizumab) in combo trials, Bristol-Myers has been wasting no time in inking more deals to pair its PD-1 inhibitor with other therapies. Just this week, it announced it will be testing Opdivo with Array BioPharma's MEK inhibitor binimetinib as well as with Advaxis' ADXS-DUAL for metastatic cervical cancer. And just this morning, Bristol-Myers revealed that it was expanding its deal with Seattle Genetics to test Opdivo with Adcetris for relapsed Hodgkin lymphoma.
Expect combo therapy data to feature prominently at ASCO. Some skeptics are accusing the checkpoint inhibitor developers of throwing spaghetti at the wall in an effort to find something that might stick. Many of the combos trials are based on either pre-clinical data or very small early basket trials, suggesting there might not be a whole lot of evidence to back up these lines of investigation.
While the Food and Drug Administration made some moves this week, including approving a hemophilia B therapy from Novo Nordisk, there were others stepping in to regulate the industry. We learned from Senator Chuck Grassley's office (R-IA) that the U.S. may have overpaid for Mylan's EpiPen by $1.3 billion —up significantly from the $465 million settlement the company announced it would pay previously. Oops.
While no action has been taken against Mylan just yet, the company could face heftier fines and worse if it is found that they acted improperly and knowingly when they overcharged Medicaid.
Meanwhile, the state of Maryland enacted legislation at stopping indefensible drug cost hikes. Under the new legislation, generics developers suspected of price gouging an essential medicine must hand over to the state's Attorney General any relevant documents related to the cost of that product. If government officials determined price gouging did in fact take place, they can levy fines and restrictions on the manufacturer. It will be interesting to see if other states follow suit in an effort to curb high drug prices.
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