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.
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Mergers & analysis
Regeneron Pharmaceuticals Inc. has put significant resources behind a Genetics Center it opened in 2014. The lab aims to use genetic information along with electronic medical records to suss out genes which could play a role in disease. The Center has made several promising finds, with its latest featured in a New England Journal of Medicine publication.
Regeneron, however, realizes it may not have all the tools it needs to develop drugs from the discoveries it makes. Enter its most recent deal with Alnylam Pharmaceuticals Inc. — the pioneer of RNA interference treatments. Regeneron and Alnylam will team up to hopefully develop a therapeutic to treat chronic liver diseases such as non-alcoholic steatohepatitis (NASH) by silencing the genetic variant uncovered by Regeneron.
Elsewhere in the pharma world, Celgene Corp. continued to execute on its deal strategy, adding several early stage neuroscience compounds from Prothena Corp. plc. The deal fits into Celgene's typical modus operandi — a Phase 1 or preclinical deal with a small upfront and big milestone payments. Should any of these compounds pan out, Prothena stands to get a small fortune in milestones.
The deal fits squarely into the pattern of big biotechs continuing to invest in neuroscience as a therapeutic area. In the wake of several high-profile clinical setbacks, some companies have de-emphasized the area or pulled out altogether. But as BioPharma Dive has predicted, unmet need and the potential for a major payoff if successful will lure companies to the space.
Clinically relevant
AbbVie Inc. has risen to new highs over the last few years on the back of its uber-blockbuster Humira (adalimumab) and a maturing pipeline of new drugs and promising candidates. But the big pharma hit a major setback this week, revealing disappointing results from a Phase 2 study of Rova-T in third-line small-cell lung cancer (SCLC).
AbbVie acquired the drug in one of its largest deals — a $5.8 billion pick up of Stemcentrx. Now, its M&A strategy, as well as its revenue guidance face new questions, as does its ability to expand its oncology business into solid tumors.
Roche AG, on the other hand, notched another success in non-small cell lung cancer (NSCLC), releasing results which showcased Tecentriq (atezolizumab)'s efficacy in a subtype of the disease that hasn't seen as much activity.
The new data could help it better compete with the market leaders in the space, Merck & Co.'s Keytruda (pembrolizumab) and Bristol-Myers Squibb Co.'s Opdivo (nivolumab).
In the obesity space, Novo Nordisk A/S reported positive results for its once-daily injectable of semaglutide in patients who are obese but without diabetes. This brings the Danish company one step closer to bringing forward semaglutide for this patient population and potentially succeeding where other companies have failed.
Arena Pharmaceuticals Inc. gave up its obesity drug in January 2017 and has since been working on making its biotech comeback. This week, the company reported a second slate of positive results for one of its pipeline compounds — the new diet seems to be agreeing with the company.
Highly regulated
Generics drugmaker Sun Pharma Industries Ltd.'s hopes to break into the biologics market were realized as the company secured approval from the Food and Drug Administration for its IL-23 inhibitor tildrakizumab for plaque psoriasis. But the Indian drugmaker has plenty of entrenched competition to take on before it can claim success.
Seattle Genetics Inc. also got an expansion to the label of its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin), adding an indication for Hodgkin's lymphoma in combination with chemotherapy.