Two new battlegrounds emerged this week in the nation’s ongoing drug pricing debate. The first involved television: The federal government hopes that blaring prices in TV ads will essentially pressure drug makers into lowering them, and the pharma lobby fired back. The second centered around a group of pricey new migraine drugs: The nation’s largest drug-pricing middleman used a familiar muscle-flexing tactic to grab some discounts, and kicked one drug in the class to the curb as a result.
Elsewhere, Novartis made another splashy buyout, an unusual biotech startup’s saga came to an unexpected conclusion, and the top- selling drug in the world will start to face generic competition—in Europe, at least. Don’t cut to a commercial just yet, it’s roundup time.
THE PRICE IS RIGHT
—As part of the Trump administration’s plan to lower drug prices, the U.S. Health and Human Services Department wants drug makers to disclose prices in TV ads, as Politico first reported late last week. The trade group PhRMA pushed back with its own plan, as Vox reported here.
—-Pharmacy benefits manager Express Scripts (NASDAQ: [[ticker:ESRX]]) announced that starting next year, it will cover the new migraine drugs from Amgen (NASDAQ: [[ticker:AMGN]]) and Eli Lilly (NYSE: [[tickerLLY]]), but not a treatment from Teva Pharmaceutical (NYSE: [[ticker:TEVA]]). Express Scripts cut deals with Amgen and Lilly that will include partial refunds to insurers if their migraine drugs don’t work.
—Nonprofit drug-price watchdog ICER (the Institute for Clinical and Economic Review) is mulling a plan to offer drug makers consultation on trial designs. Observers questioned whether ICER could maintain a critical eye while taking drug-industry money, but ICER pointed to similar services provided by British and Canadian national watchdogs. More here from Fierce Biotech.
—Novartis (NYSE: [[ticker:NVS]]) is buying Indiana biotech Endocyte (NASDAQ: [[ticker:ECYT]]) for $2.1 billion, its second big splash in as many years for drugs that use radiation to attack tumors. Endocyte’s lead product Lu-PSMA-617 is a prostate cancer treatment in Phase 3 testing.
IN MEMORIAM
—Microsoft (NASDAQ: [[ticker:MSFT]]) co-founder Paul Allen died this week from complications of non-Hodgkin lymphoma. While Allen has long been regarded as a tech pioneer, his impact was also felt in the life sciences. In 2003, he committed $100 million to found the Allen Institute for Brain Science. Two years ago, he pledged another $100 million to back Allen Discovery Centers around the country that are conducting research at the “frontier of knowledge.”
RED LIGHT, GREEN LIGHT
—After a patient death in a leukemia trial and two serious side effects in a lymphoma trial, German firm Affimed (NASDAQ: [[ticker:AFMD]]) halted a study of its cancer drug AFM11 last week. This week the FDA placed the drug on an official hold.
—A few weeks after hinting it might seek a speedy FDA nod, Alnylam Pharmaceuticals (NASDAQ: [[ticker:ALNY]]) ultimately decided not to seek accelerated approval of givosiran, a drug for acute hepatic porphyrias that could become the second-ever RNA interference medicine to market. Alnylam now plans to file for approval after its Phase 3 trial produces data next year.
— Pfizer (NYSE: [[ticker:PFE]]) plans to ax 2 percent of its workforce worldwide by offering early retirements to employees ahead of layoffs next year, CNBC reported. The move comes just a week after Pfizer rejiggered its senior management team ahead of the promotion of new CEO Albert Bourla, who moves from chief operating officer to Pfizer’s head seat on Jan. 1.
—The FDA approved talazoparib (Talzenna) from Pfizer to treat BRCA-positive, HER2-negative breast cancer. It’s the fourth approval in the drug class known as PARP inhibitors and will compete with a drug from partners AstraZeneca (NYSE: [[ticker:AZN]]) and Merck (NYSE: [[ticker:MRK]]). Clovis Oncology (NASDAQ: [[ticker:CLVS]]) and Tesaro (NASDAQ: [[ticker:TSRO]]) also have approved PARP inhibitors that they are testing in breast cancer.
—Biosimilar versions of anti-inflammatory drug adalimumab (Humira), the world’s top-selling drug at $18 billion a year and growing, launched in Europe. But the cheaper versions won’t reach U.S. markets until perhaps 2023 because of adalimumab owner AbbVvie’s (NYSE: [[ticker:ABBV]]) patents. More here from Biopharma Dive.
DEALS & AWARDS
—Six years after Warp Drive Bio emerged with $125 million in funding and a potential buyout in place by Sanofi (NYSE: [[ticker:SNY]]), the biotech cut a deal to be acquired by another startup, Revolution Medicines of Redwood City, CA, for stock.
—Roche expanded its alliance with SQZ Biotechnologies, aiming to develop new cancer cell therapies using the Watertown, MA-startup’s technology for getting proteins inside cells.
—AbbVie agreed to pay Morphic Therapeutic $100 million up front to co-develop new drugs to treat fibrosis.
—Pain drug developer Adynxx is going public via a reverse merger with Alliqua Biomedical (NASDAQ: [[ticker:ALQA]]).
—CuraSen, a San Mateo, CA, biotech with technology licensed from Stanford, emerged with $54 million in Series A financing to develop of small molecule drugs for neurodegenerative disorders such as Parkinson’s and Alzheimer’s disease.
—LogicBio Therapeutics had to cut its IPO price and sell more shares in order to pull off the stock offering, which raised $70 million to finance tests of its gene therapy for a rare liver disease.
—Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]) continued its gene therapy acquisition spree by acquiring rights to LYS-SAF302, an experimental treatment for the rare neurological disease Sanfilippo Type A syndrome. Sarepta paid the drug’s developer, Lysogene, $15 million up front. A late-stage trial should begin by the end of the year.
—Adrian Krainer, inventor of the first FDA-approved drug for spinal muscular atrophy, nusinersen (Spinraza), was among the winners of the $3 million Breakthrough Prize in Life Sciences award. Frank Bennett, senior vice president of research at Ionis Pharmaceuticals (NASDAQ: [[ticker:IONS]]), was also among the winners. Ionis developed nusinersen before licensing it to Biogen (NASDAQ: [[ticker:BIIB]]) in 2016.
DATA DUMPS
—Merck amped up the pressure on its cancer immunotherapy rival Bristol-Myers Squibb (NYSE: [[ticker:BMY]]) yet again, touting positive results—more than a year earlier than expected—in a Phase 3 study testing its blockbuster pembrolizumab (Keytruda) with axitinib (Inlyta) in patients with first-line kidney cancer. Bristol’s two-drug immunotherapy combination ipilimumab (Yervoy)/nivolumab (Opdivo) is already approved for kidney cancer, and a rival regimen of axitinib and Pfizer’s immunotherapy avelumab is in late-stage testing.
—Clovis Oncology said that 11 of 25 men with advanced prostate cancer who got its PARP blocker rucaparib (Rubraca) after failing two other drugs responded to treatment in a Phase 2 study called TRITON2. Rucaparib, if successful, could become the first PARP inhibitor approved for prostate cancer. Clovis aims to collect data from more patients and could file for approval next year, STAT reports.
—Shares of Proteostasis Therapeutics (NASDAQ: [[ticker:PTI]]) more than quadrupled after the Cambridge, MA, company disclosed positive preliminary results from a study testing an in-house, two-drug combination for cystic fibrosis.
—Seeking to broaden the label for their antibody drug Dupilumab (Dupixent), which is already approved for eczema, Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]) and partner Sanofi touted successful Phase 3 results in patients with chronic sinusitis with nasal polyps. The drug could be approved later this month to treat asthma patients.
Alex Lash and Frank Vinluan contributed to this report.
