Bio Roundup: POTUS on Prices, a16z’s Fund, Aimmune’s Approval & More

Xconomy National — 

The president’s State of the Union address was wide-ranging, as they tend to be, but those who tuned in heard mention of two hot health policy topics: price transparency and drug pricing reform.

President Trump asserted that an executive order he signed last year directing various federal agencies to come up with new rules requiring hospitals to provide patients with more information on prices will save people “massive amounts of money for substantially better care” once they can shop around more easily. Experts say the impact of such rules are unclear given the inherent difficulty comparing costs in an emergency and the role of patient-doctor relationships.

He took a swipe at Big Pharma, asserting his administration was “taking on” the firms and calling for bipartisan legislation that would “dramatically” lower prescription drug prices. He also name-checked Sen. Chuck Grassley (R-IA) for his work on the issue—a mention that Grassley said could help advance a drug-pricing package he put together with Sen. Ron Wyden (D-OR).

Speechifying aside, the week was a busy one in biotech, with multiple companies making public market debuts, a pharma giant downsizing to focus on R&D, and the first oral immunotherapy for a food allergy getting the FDA’s OK. Let’s round it all up.

LET’S MAKE A DEAL

—Merck (NYSE: MRK) is spinning out its women’s health business, off-patent products, and biosimilars into a separate company, allowing the pharmaceutical giant to focus on developing and commercializing new medicines for cancer, diabetes, and more.

—Titan Medical (NASDAQ: TMDI) is exploring “strategic options” including a possible sale if it can’t raise the $85 million it needs to finish development and testing needed to file for FDA clearance of its robotic surgical system.

—Aimmune Therapeutics (NASDAQ: AIMT) received a $200 million equity investment from existing backer Nestlé Health Science and licensed an experimental antibody from Xencor (NASDAQ: XNCR) as a potential complementary treatment to its oral immunotherapies for food allergies.

—Google spinout Verily and Japanese ophthalmology company Santen Pharmaceutical are teaming up to develop new ophthalmic devices and tech-enabled solutions for a range of ophthalmic conditions.

—Coda Bio acquired a company called Attenua and its experimental small molecule drugs, which it intends to pair with its pipeline of engineered neurotransmitter receptors to treat neurological conditions.

—Collegium Pharmaceuticals (NASDAQ: COLL) agreed to pay Assertio Therapeutics (NASDAQ: ASRT) $375 million for US rights to opioid painkiller tapentadol (Nucynta). Stoughton, MA-based Collegium had entered an agreement with Assertio in 2017 covering US commercialization of extended-release and immediate-release formulations of the drug.

FRESH CASH AND NEW STARTS

—Bristol-Myers Squibb (NYSE: BMY) and accelerator BioMotiv launched a startup, Anteros Pharmaceuticals, that is developing a small molecule drug to treat fibrosis.

—Beam Therapeutics (NASDAQ: BEAM) raised $180 million in its initial public offering to advance its gene-editing technology, which is designed to allow single-base edits.

—Schrödinger (NASDAQ: SDGR) raised $202 million in its IPO, which plans to use the cash to further develop its drug discovery software and advance its pipeline of preclinical cancer drugs. In the company’s first day of trading, shares closed at $28.64, more than 68 percent higher than the IPO price.

Sonoma Biotherapeutics raised $40M in Series A financing to develop regulatory T cell therapies for autoimmune diseases and degenerative disorders.

—Philadelphia-based Passage Bio, which launched last year, filed regulatory papers laying out its plans to raise $125 million in an initial public offering to advance its gene therapies, which were discovered at the University of Pennsylvania.

—Venture capital firm Andreessen Horowitz (a16z) raised a third Bio Fund, pulling together $750 million to back entrepreneurs creating companies at the intersection of tech, biotech, and healthcare.

—The Bill & Melinda Gates Foundation increased its commitment to supporting the global response to the 2019 novel coronavirus (2019-nCoV) from $10 million to up to $100 million, earmarking the money helping to strengthen detection, isolation and treatment efforts; protect at-risk populations; and develop vaccines, treatments and diagnostics.

DRUG DEVELOPMENTS

—Aimmune Therapeutics (NASDAQ: AIMT) won FDA approval for Palforzia, the first oral immunotherapy for a food allergy.

—Rare disease drug developer Insmed (NASDAQ: INSM) saw its stock jump 40 percent after it reported that a Phase 2 trial of its daily pill for adults with non-cystic fibrosis bronchiectasis had met its goals.

—United Therapeutics (NASDAQ: UTHR) drug dinutuximab (Unituxin) failed a pivotal study intended to support expanding its use to small cell lung cancer. The antibody drug is already approved to treat neuroblastoma.

—MLP Ventures launched an incubator called Discovery Labs at the former GlaxoSmithKline R&D campus in King of Prussia, PA, a site that’s slated to include custom-built labs, housing for scientists, and “end-to-end” manufacturing services.

—AbbVie (NASDAQ: ABBV) drug upadacitinib (Rinvoq) met the main goal of a pivotal test in psoriatic arthritis. Last year, the FDA approved the drug as a treatment for moderate-to-severe rheumatoid arthritis.

—The Feb. 14 decision date for accelerated approval of Blueprint Medicines (NASDAQ: BPMC) drug avapritinib has been pushed back three months. The Cambridge, MA, biotech says the FDA wants to review preliminary data from an ongoing Phase 3 test of the drug as a treatment for gastrointestinal stromal tumor.

PEOPLE ON THE MOVE

—BioMarin Pharmaceutical (NASDAQ: BMRN) Chief Financial Officer Dan Spiegelman stepped down, replaced by acting CFO Brian Mueller… Craig Basson was named chief medical officer of Boston Pharmaceuticals… CytomX (NASDAQ: CTMX) appointed Alison Hannah senior vice president and chief medical officer… Jeffrey Trigilo joined Amylyx Pharmaceuticals as its first CFO… DBV Technologies (NASDAQ: DBVT) named Pascal Wotling to serve as chief technical operations officer… Myriad Genetics (NASDAQ: MYGN) president and CEO Mark Capone resigned … Ichnos Sciences named Gabriela Gruia its chief development officer… and Aerami Therapeutics appointed Timm Crowder its chief operations officer.

Frank Vinluan contributed to this report. 

Photo by Joyce N. Boghosian via public domain