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
German drugmaker Bayer AG is making further inroads into oncology with a deal worth $1.55 billion with small Connecticut biotech Loxo Oncology Inc. Bayer is paying $400 million upfront for the ex-U.S. rights to two of Loxo's clinical stage candidates. Loxo's larotrectinib showed impressive results earlier this year at a major medical meeting and Bayer is betting that larotrectinib, as well as an earlier-stage candidate, will be blockbusters.
Oncology-focused Novartis AG is turning its focus to another space — opthalmic and hemoglobinopathy diseases, tapping Homology Medicine for its gene editing technology. Novartis is paying an undisclosed upfront, as well as making an equity investment in Homology to have access to the technology. The research will complement ongoing research being done at the Novartis Institutes for Biomedical Research.
Elsewhere, Johnson & Johnson is teaming up with Zymeworks on six bispecific antibodies, with as much as $282 million tied to unspecified development milestones and up to another $1.12 billion upon reaching certain commercial milestones. The pharma also gains an option to develop two more bispecific programs.
Clinically relevant
Two companies are making the pivot to the hot area of immuno-oncology. First, Mirati Therapeutics is redirecting resources away from its lead program, the mid-stage glesatinib, in favor of an asset being tested in combination with Bristol-Myers Squibb & Co.'s checkpoint inhibitor, Opdivo (nivolumab). The company said that glesatinib has shown clinical promise, but the company is more excited about its immuno-oncology prospects.
Purdue Pharma is also making a move to immuno-oncology, shifting its focus away from the opioid drugs it is known for amid the ongoing opioid crisis. The company has come under fire from government — including a number of lawsuits — for its alleged unsavory marketing practices in relation to its pain drugs.
Outside the field of immuno-oncology, another company is coming under fire for safety issues. Acorda Therapeutics took a major hit to its already-hurting stock when it revealed that it must stop a Phase 3 trial of its Parkinson's disease drug due to five patient deaths. The deaths were due to a condition that depletes the white blood cells and only occurred in the drug arm of the study. Acorda is looking into the problem and talking with regulators, but analysts believe this greatly depletes the chances of the drug getting approved.
Highly regulated
The Food and Drug Administration has been particularly busy this week, issuing more than a half-dozen approvals in the last few days.
Arguably the biggest regulatory decision was issued to Roche, which got a green light for its highly anticipated hemophilia drug emicizumab. Now dubbed Hemlibra, the drug is expected to be a major disruption to the current hemophilia landscape, particularly for Shire and Novo Nordisk, which could sees millions in sales in jeopardy. Yet, the agency slapped the drug with a Black Box Warning, potentially limiting the uptake of the drug.
Roche also gained a major add-on approval for its oncology drug Gazyva (obinutuzumab) for previously untreated fillicular lymphoma. The follow-on to Rituxan (rituximab) could help Roche expand the franchise.
AstraZeneca also gained a significant win, getting the go-ahead for its asthma treatment Fasenra (benralizumab). The drug treats a severe form of the respiratory disease and is one of three biologics the British pharma has flagged as future growth driver.
UltraGenyx also got its first drug approval, signaling its transition from a clinical-stage entity to a commercial company. Mepsevii is only indicated for a small patient population and not likely to reach blockbuster status, but the approval gives the biotech a much-coveted Priority Review Voucher. The PRV could bring in millions for the company.
In another first, the FDA also approved the first digital Abilify pill, which would allow for administration of the anti-depressant to be tracked via a digital sensor. Compliance has been a huge issue for patients with schizophrenia, which often devolve into schizophrenic episodes when medication is not taken as prescribed.
Pfizer also gained an add-on approval this week, getting an OK for Sutent (sunitinib) as a prevention for the recurrence of kidney cancer after surgical removal of a kidney.