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
Building on its big buyout of Kite Pharma for $11.9 billion earlier this year, Gilead Sciences Inc. is deepening its interest in cell therapies. The company announced after the close on Thursday that it is picking up Cell Design Labs to expand its cell therapy expertise. Kite already owned 12% of the platform company and the total price will include a $175 million upfront payment for a total deal value of $567 million.
Alexion Pharmaceuticals Inc. also inked a platform deal this week, tapping Halozyme Therapeutics Inc. for its subcutaneous technology. The biotech will apply the sub-Q tech platform to its Soliris follow-on ALXN1210. The beleaguered company has been restructuring and rejiggering its resources to make ALXN1210 the priority.
Currently, ALXN120 is dosed once weekly; the Halozyme technology could help change the administration to once every two weeks or even once per month, giving the company a dosing advantage. Yet, analysts question whether the technology will work. "To our knowledge, Alexion previously tried to develop Soliris subcutaneous, but did not seem to have worked out. Given that ALXN1210 doses are even larger than Soliris, feasibility remains to be seen," wrote Jefferies analyst Eun Yang in a note to clients.
Outside the pharma industry, players in the healthcare space continue to consolidate, making moves that could have a drastic impact on the pharma supply chain. In one of the biggest moves, CVS Health is buying Aetna for $69 billion.
Clinically relevant
The liver disease non-alcoholic steatohepatitis, better known as NASH, continues to make headlines as the competition heats up in the space. There are currently no Food and Drug Administration-approved therapies for the condition and patient numbers are growing as the population continues to get more obese.
One company's stock tanked on its results in NASH, while another soared. Galectin Therapeutics Inc. lost nearly half of its value on Tuesday when results from its Phase 2b study showed that its drug GR-MD-02 only worked in a subset of patients.
Meanwhile, Madrigal Pharmaceuticals Inc. doubled its value after announcing MGL-3196 significantly reduced liver fat in patients in a mid-stage study. The results could make the small biotech an attractive takeout target to the number of big companies trying to make headway in the space.
Elsewhere, Roche AG potentially improved its standing in the checkpoint inhibitor race, showing a combo of its immunotherapy Tecentriq (atezolizumab) improved progression-free survival in patients with non-small cell lung cancer.
Stay tuned to BioPharma Dive this weekend for updates from the American Society of Hematology conference in Atlanta. Check out a preview here for what you can expect from the hot space.
Highly regulated
Novo Nordisk A/S garnered a green light from the FDA this week for its once-weekly glucagon-like peptide (GLP) -1 agonist semaglutide. The product will be sold under the brand name Ozempic and will compete directly with Eli Lilly's once-weekly GLP-1 Trulicity (dulaglutide).
The FDA also gave the OK to Amgen Inc.'s cholesterol drug Repatha (evolocumab), expanding the drug's label to include its capabilities as a prevention of heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.
Beyond approvals, the regulatory agency lifted a partial clinical hold that it put on combination studies of checkpoint inhibitors in multiple myeloma. In September, the agency directed Bristol-Myers Squibb Co, Roche AG and AstraZeneca plc to pause patient recruitment into their respective combo studies as it investigated whether pairing PD-1/L1 inhibitors with drugs like Celgene Corp.'s Revlimid or Pomalyst. The hold was triggered when patients died in a combo study of Merck & Co.'s Keytruda (pembrolizumab) with the Celgene Corp. drugs.