Pharmaceutical industry critics lament the cost of rare disease drugs, but some of the steepest price hikes have come on widely used insulin.
The patent holder, the University of Toronto, gave companies the right to manufacture insulin. But the university also allowed them to patent the improvements they made, which enabled them to slap higher prices on each new version.
In the nearly 100 years since insulin’s discovery, no generic version has become available in the U.S. to offer competitive pricing pressure. FDA commissioner Scott Gottlieb is trying to change that. Speaking this week at the FDA/CMS Summit in Washington, he explained plans to change insulin’s regulatory classification to open it up to generic competition. Let’s get to that story and more in this week’s bio news roundup.
FROM THE FDA
—Starting in 2020, the FDA will reclassify insulin and allow more generic competition to bring down prices, commissioner Scott Gottlieb said this week. He excoriated insulin providers, saying that access to affordable insulin, “a matter of life and death,” is still difficult because “limited competition keep[s] prices artificially high.”
—The FDA cleared Pear Therapeutics to begin selling its mobile app, reSET-O, as a treatment for patients recovering from opioid abuse. Pear’s app is to be used in tandem with outpatient care; it is already cleared for substance abuse disorder.
—The FDA approved a four-drug Roche regimen including bevacizumab (Avastin), the immunotherapy atezolizumab (Tecentriq), and chemotherapy for patients with newly diagnosed, advanced non-small cell lung cancer. The nod is the latest shift in the fast-changing treatment landscape for lung cancer, where multiple immunotherapies have made their mark.
DOLLARS & DEALS
—After raising $604 million last week in the biggest biotech IPO in history, shares of Moderna (NASDAQ: MRNA) opened below their $23 IPO price, fell about 19 percent in their first trading day, and currently sit under $19 apiece. But among those who have made out nonetheless: Boston area scientific entrepreneur Timothy Springer, whose $5 million investment in Moderna landed him a stake now worth $320 million, Bloomberg reports.
—With a debt default looming, Synergy Pharmaceuticals (NASDAQ: SGYP) filed for bankruptcy to sell itself to Canadian specialty pharma company Bausch Health for $200 million.
—Eli Lilly (NYSE: LLY) paid Swiss biotech AC Immune approximately $80 million in cash and a roughly $50 million convertible note up front to co-develop a group of drugs meant to stop the buildup of the protein tau in the brains of Alzheimer’s disease patients.
—Black Diamond Therapeutics launched from Versant Ventures’s Europe-based drug discovery unit with $20 million in Series A financing to develop drugs aimed at hidden cancer targets.
—Philadelphia-based Aro Biotherapeutics emerged with $13 million in funding to advance targeted cancer drugs that are based on proteins called centyrins.
—Akero Therapeutics raised $70 million in new capital to support clinical development of its experimental treatment for the fatty liver disease NASH. The new cash comes less than six months after the San Francisco company emerged with a $65 million Series A.
—Mission Bio, which has commercialized a device that analyzes the DNA of single cells, raised a $30 million Series B to expand its product’s use in blood cancer research and add CRISPR. The South San Francisco, CA, startup got a $20 million Series A last year.