Bio Roundup: Agile Approval, Coronavirus Collabs, Spruce’s $88M & More

Xconomy National — 

The price of insulin, a life-saving treatment discovered a century ago, has been a flashpoint amid the broader drug pricing debate. The FDA is trying to tame high insulin prices by encouraging price competition.

The FDA has historically regarded insulin as a drug. But insulin isn’t a chemical drug, it’s made from biological material. Under a rule change published this week, the FDA will classify insulin as a biological product. When the change takes effect on March 23, would-be competitors will be able to seek approval for products that are biologically similar to the branded insulin now on the market, the FDA says. The hope is that the clearer regulatory framework will encourage companies to develop these biosimilars, improving the affordability of such medications.

As visions of less costly diabetes care danced in regulators’ heads, another biotech revealed IPO plans, two pharma giants intend to work with the government on coronavirus infection treatments, and two former industry executives face time behind bars. We’ll roundup those stories and the rest of the week’s headlines below.

DRUG DEVELOPMENTS

—After receiving two FDA rejections in the past seven years, Agile Therapeutics (NASDAQ: AGX) last week won FDA approval for Twirla, a hormonal contraceptive skin patch applied once weekly.

—Despite failing a pivotal lung infection study, resTORbio (NASDAQ: TORC) believes its drug still has applications addressing neurodegenerative disorders. The Cambridge biotech is now looking for someone to buy the company or its technology.

—A Five Prime Therapeutics (NASDAQ: FPRX) antibody that Bristol-Myers Squibb (NYSE: BMY) was testing in combination with its cancer immunotherapy nivolumab (Opdivo) failed to beat the standard of care in a Phase 2 trial in patients with pancreatic cancer.

—The FDA rejected a Merck (NYSE: MRK) request to OK the delivery of its drug pembrolizumab (Keytruda), which is approved to treat a number of cancers with a certain genetic signature, in 400 mg doses infused over 30 minutes every six weeks in multiple indications. Currently patients receive infusions every three weeks.

—The vaccine unit of France’s Sanofi (NASDAQ: SNY) said it will use previous SARS research to work on a vaccine to treat coronavirus infection, or COVID-19, together with long-standing partner the Biomedical Advanced Research and Development Authority (BARDA).

—Johnson & Johnson (NYSE: JNJ) also said it would expand its BARDA partnership to work on potential COVID-19 treatments.

—An Allergan (NYSE: AGN) plan to sell the rights to its drug brazikumab in order to ease antitrust concerns regarding its acquisition by AbbVie (NYSE: ABBV) isn’t enough, according to some unions and consumer groups. In a letter to the Federal Trade Commission, the groups contend that the buyer, AstraZeneca (NYSE: AZN), has little incentive to commercialize the drug and even if it does, brazikumab’s launch would be slowed by rebates AbbVie offers for its competing drug.

DOLLARS & DEALS

—Five Prime licensed to Seattle Genetics a family of antibodies for the Washington state biotech to evaluate as components in new antibody-drug conjugate therapies for cancer.

—EnClear Therapies raised a $10 million Series A round of financing to move ahead a device it is developing to provide a dialysis-like offering for neurodegenerative disease, starting with amyotrophic lateral sclerosis.

—Spruce Biosciences closed an $88 million Series B round to advance clinical development of a drug that treats congenital adrenal hyperplasia, a rare inherited endocrine disorder that leads to a hormonal imbalance.

—Q Bio, which is developing a digital health platform that it says will help patients and their physicians better track their medical history, emerged from stealth with a $40 million Series B financing round led by Andreessen Horowitz.

—Cambridge, MA-based Imara filed plans for an IPO to finance clinical development of its lead drug candidate as a potential treatment for sickle cell disease and beta thalassemia.

—Torrance, CA-based Forte Biosciences is going public via a reverse merger with Tocagen (NASDAQ: TOCA). The agreement, which still needs shareholder approval from both companies, comes five months after the Phase 3 failure of Tocagen’s experimental brain cancer treatment. The combined company will be led by Forte CEO Paul Wagner and will focus on Forte’s drugs for inflammatory skin diseases.

TRIALS & TRIBULATIONS

—PixarBio CEO Frank Reynolds was sentenced to seven years in prison for defrauding investors and making false and misleading statements about the company’s finances, its drug, and his background. Though he claimed the Boston company’s drug cured his own paralysis, evidence presented at trial showed he was never paralyzed.

—Hector Armando Kellum, a former executive at Novartis (NYSE: NVS) generics unit Sandoz, pleaded guilty for his role in a price-fixing scheme. Kellum is the fourth executive charged in the federal investigation, and the third to plead guilty. Per statute, he faces a maximum of 10 years in prison and a $1 million fine.

DATA & DECISIONS

—The European Commission approved Novartis drug brolucizumab (Bevou) as a treatment for the “wet” form of age-related macular degeneration. The European decision follows FDA approval of the injectable treatment last October.

—Pfizer (NYSE: PFE) won European Commission approval for tafamidis (Vyndaqel), a treatment for heart problems in patients who have hereditary transthyretin amyloidosis. The FDA approved the drug last May.

—VistaGen Therapeutics (NASDAQ: VTGN) reported and published positive results from an exploratory Phase 2a study testing PH10, an experimental treatment for major depressive disorder. The South San Francisco biotech’s drug is administered as a nasal spray for rapid onset of the therapeutic effect.

PEOPLE ON THE MOVE

Gene therapy developer Voyager Therapeutics (NASDAQ: VYGR) Chief Operating Officer Matthew Ottmer resigned… Immunomedics (NASDAQ: IMMU) appointed Loretta Itri as chief medical officer… Gavin Wood joined Adaptimmune Therapeutics (NASDAQ: ADAP) as chief financial officer… Shattuck Labs’ co-founder Taylor Schreiber was promoted from chief scientific officer to CEO … Victor Clavelli was appointed chief commercial officer of Optinose (NASDAQ: OPTN) … Endo International (NASDAQ: ENDP) tapped Chief Financial Officer Blaise Coleman to become president and CEO… and Turning Point Therapeutics (NASDAQ: TPTX) brought aboard Siegfried Reich as chief scientific officer.

Frank Vinluan contributed to this report. 

Image: iStock/kirstypargeter