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.
—Amag Pharmaceuticals (NASDAQ: AMAG) agreed to pay $50 million up front to acquire Perosphere Pharmaceuticals and its lead compound ciraparantag, a drug developed to reverse the effects of blood thinners. Depending on the progress of the Phase 2 drug, shareholders of the Danbury, CT, company could earn up to $140 million more in milestones.
—Marinus Pharmaceuticals (NASDAQ: MRNS) said its postpartum depression (PPD) treatment ganaxalone hit the goals of a Phase 2 study but analysts were unconvinced the data show it can compete against Sage Therapeutics (NASDAQ: SAGE) PPD drug brexanolone.
—Biogen (NASDAQ: BIIB) ended a gene therapy alliance with AGTC (NASDAQ: AGTC) after the Gainesville, FL, company’s experimental treatment for the rare eye disease x-linked retinoschisis offered “no signs of clinical activity” in an early stage trial. Biogen paid AGTC $124 million up front in 2015 for rights to two gene therapies and an option to three others; the programs will return to AGTC, whose shares plummeted 48 percent.
—Celgene (NASDAQ: CELG) chose to license two cancer drug candidates from Dragonfly Therapeutics, netting the Waltham, MA, startup $24 million. Celgene recently deepened its ties with Dragonfly, a startup co-founded by cancer research pioneer Tyler Jacks.
—The FDA has begun a review of lumateperone, an experimental schizophrenia drug from Intra-Cellular Therapies (NASDAQ: ITCI) that has had mixed results in clinical testing. It’ll decide the drug’s fate by Sept. 27, 2019.
—In a head-to-head study of two marketed drugs, Johnson & Johnson (NYSE: JNJ) reported that its psoriasis treatment guselkumab (Tremfya) outperformed secukinumab (Cosentyx), from Novartis (NYSE: NVS), but it wasn’t a slam dunk.
—Kaleo, a maker of a $4,100 device to treat opioid overdoses, will produce a $178 generic version. Kaleo has been under investigation for raising the device’s price sevenfold over a four-year span. Stat has more.
—A new study in the Journal of Clinical Oncology charged that genetic screening for breast cancer is out of date and needs to expand to include more recent advances.
PEOPLE ON THE MOVE
—Gilead Sciences (NASDAQ: GILD) named Daniel O’Day, a veteran executive from Roche, its new CEO. O’Day will take over as sales of Gilead’s hepatitis C drugs have fallen considerably, and just as the company has made a big bet on the future of CAR-T cell therapy, most notably through its $12 billion buyout of Kite Pharma.
—Nine months after activist investor Alex Denner gained control of the board at The Medicines Co. (NASDAQ: MDCO), Mark Timney was named its new CEO, replacing longtime top executive Clive Meanwell, who will now serve as chief innovation officer. MedCo has significantly trimmed its business over the last year, and is focusing its development efforts on the cholesterol-lowering drug inclisiran.
Ben Fidler and Alex Lash contributed to this report.