Bio Roundup: PARP Progress, A New Commish, IPO-Palooza & More

Xconomy National — 

It’s been a strange up and down ride for PARP inhibitors, a relatively new class of cancer drugs.

Named for the tumor protein they target, PARPs rebounded after a big clinical setback in 2011 and have been at the center of many buyouts and big alliances—Pfizer and Medivation, GlaxoSmithKline and Tesaro, AstraZeneca and Merck. Four of them have received FDA-approval since 2014 to treat subsets of patients with ovarian and breast cancer. They’re typically used in “maintenance” settings, meant to keep cancer at bay after chemotherapy.

Yet PARP inhibitors have been a tough sell. Developers have had “persistent challenges in growing the market,” as one analyst noted last year, because doctors have been reluctant to prescribe them as maintenance agents.

The tide may be turning. PARP blockers were featured at a big medical meeting in Barcelona this week. In a swath of studies, there were signs that the drugs could soon benefit more ovarian cancer patients, and that the first PARP approval in prostate cancer could be coming.

More tests are underway in breast and other cancers, including studies that combine PARPs with various other drugs.

GSK president and chief scientific officer Hal Barron called PARP blockers “under-appreciated” when the firm bought Tesaro and its drug niraparib (Zejula) last December. He and others may yet be proven right.

We’ll round up that story and the rest of the week’s biotech headlines below.


—The European Society of Medical Oncology’s annual meeting featured notable updates for PARP inhibitors, potential advances in breast and prostate cancer treatment, and much more. Xconomy rounded up some of the top headlines and put them in context.

BioCentury scooped that President Trump would soon nominate Stephen Hahn, chief medical executive of Houston’s MD Anderson Cancer Center, as the next FDA commissioner.

—The heat was turned up more this week on Sarepta Therapeutics (NASDAQ: SRPT), whose shares have been sliding since an FDA rejection of its Duchenne muscular dystrophy drug golodirsen. Japan’s NS Pharma filed for FDA approval of viltolirsen, which is meant to treat the same subset of Duchenne patients as golodirsen. Sarepta will disclose updated results on one of its experimental gene therapies this morning.

—Shares of Minerva Neurosciences (NASDAQ: NERV) fell 28 percent after the company disclosed that a “cyberattack” at one of its contractors delayed enrollment in a Phase 3 trial of its schizophrenia drug roluperidone. Xconomy has more on that drug and its prospects here.

—Chinese regulators approved the Merck (NYSE: MRK) immunotherapy pembrolizumab (Keytruda) for some patients newly diagnosed with the most common form of lung cancer.


—Johnson & Johnson (NYSE: JNJ) reached a $20 million settlement with two Ohio counties in one of the nation’s highest-profile opioid lawsuits, joining other defendants in reaching settlements. Oxycontin maker Purdue Pharma has filed for bankruptcy and offered up to $12 billion, which state attorneys general have rejected.

—Dova Pharmaceuticals (NASDAQ: DOVA), which has commercialized a drug that treats low platelet counts, agreed to be acquired by Swedish Orphan Biovitrum for as much as $915 million.

—Novartis (NYSE: NVS) is tapping Microsoft to put artificial intelligence tools in its employees’ hands. The first projects will focus on treatments for eye disease, cell and gene therapy manufacturing, and drug discovery, the companies said. No deal terms were disclosed.

—Last Friday federal officials charged 35 people for genetic testing scams targeting Medicare recipients that caused more than $2 billion in losses. Sen. Chuck Grassley (R-IA) said this week that he wants more answers.

—Congressman Chris Collins (R-NY) resigned his House seat upon plans to change his plea to guilty for insider trading in Australian biotech Innate Immunotherapeutics.

—Drug-pricing watchdog the Institute for Clinical Economic Review rescinded a preliminary report on … Next Page »

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