Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More

While business is historically slow in August, this month seems to be bucking the trend, just like so many other unexpected developments in 2020. Perhaps life sciences executives have been less distracted by summer excursions this year in a world in which the COVID-19 pandemic has significantly curtailed travel.

This week two pharmaceutical companies announced major acquisition agreements collectively valued at more than $10 billion, and a trio of biotechs—one with preclinical programs, another with Phase 1 trials underway, and a third with its first drug commercialized less than a year ago—raised a combined $421 million from public investors. It was a busy week on the regulatory front, too. The FDA put a clinical hold on a prostate cancer study following a patient death. The agency also awarded multiple approvals and issued two rejections. Find those stories, and more, in this week’s roundup.

LET’S MAKE A DEAL

—Johnson & Johnson (NYSE: [[ticker:JNJ]]) agreed to pay $6.5 billion to buy Momenta Pharmaceuticals (NASDAQ: [[ticker:MNTA]]) and its pipeline of antibody drugs, which have blockbuster potential as treatments for autoantibody-driven autoimmune disorders.

—Sanofi (NYSE: [[ticker:SNY]]) is acquiring Principia Biopharma (NASDAQ: [[ticker:PRNB]]) in a cash deal that values the biotech at $3.68 billion. The companies are already partners developing a multiple sclerosis drug for the most severe form of the disease.

—Bristol Myers Squibb (NYSE: [[ticker:BMY]]) plans to pay $475 million to license an early-stage immunotherapy developed by Dragonfly Therapeutics. The treatment entered human testing this summer.

BIOTECH CASH

—Cancer drug developer Tango Therapeutics raised $50 million in outside financing and expanded an existing partnership with Gilead Sciences (NASDAQ: [[ticker:GILD]]), a move that added another $125 million in the form of an upfront payment. The companies are working together to discover cancer drugs that leverage a genomic vulnerability called synthetic lethality.

—The National Institutes of Health awarded Alzheon a $47 million grant, which the Framingham, MA-based biotech will use to test its Alzheimer’s disease drug candidate, ALZ-801, in a Phase 3 study.

—Chinook Therapeutics secured $106 million in financing via a private placement set to happen just before the biotech’s merger with Aduro Biotech (NASDAQ: [[ticker:ADRO]]) closes. The two kidney disease drug developers said they expect to complete their merger in the second half of this year.

—Plymouth Meeting, PA-based Harmony Biosciences, which last year launched a new narcolepsy drug, and cancer drug developer Inhibrx of La Jolla, CA, raised $128 million and $119 million in their respective initial public offerings.

—Kymera Therapeutics of Watertown, MA, netted $174 million in its IPO. The preclinical biotech, which is developing protein degradation drugs, offered 8.7 million shares at $20 apiece, topping its estimated price range. Those shares are slated to begin trading Friday on the Nasdaq under the stock symbol “KYMR.”

—Camarillo, CA-based ImmPACT Bio USA, which is developing cell therapies for cancer, closed an $18 million round of financing from investors including OrbiMed and the investment arms of Johnson & Johnson (NYSE: [[ticker:JNJ]]), Takeda (NYSE: [[ticker:TAK]]), and Novartis (NYSE: [[ticker:NVS]]).

DRUG DECISIONS

—The FDA OK’d a drug that can be administered at home for adults with neuromyelitis optica spectrum disorder, a rare central nervous system disorder that damages the optic nerves and spinal cord. The treatment, satralizumab (Enspryng), is from Roche’s Genentech subsidiary.

—A BioMarin Pharmaceutical (NASDAQ: [[ticker:BMRN]]) hemophilia A gene therapy was rejected by the FDA, which requested more data on the durability of the investigational treatment, valoctocogene roxaparvovec (Roctavian).

—The FDA also rejected filgotinib, an experimental rheumatoid arthritis drug developed by partners Gilead Sciences and Galapagos. Gilead said the agency wants to see data from two ongoing studies assessing the drug’s impact on sperm.

—Novartis was awarded FDA approval for ofatumumab (Kesimpta), an injectable B-cell therapy for relapsing forms of multiple sclerosis. Patients will be able to administer the drug themselves via an autoinjector pen.

DRUG AND DEVICE DEVELOPMENTS

—A Poseida (NASDAQ: [[ticker:PSTX]]) clinical trial testing a CAR-T therapy in patients with prostate cancer was put on hold by the FDA after a patient in the study died nearly three weeks following treatment.

—Unity Biotechnology (NASDAQ: [[ticker:UBX]]) reported that its lead drug candidate failed to beat a placebo in a Phase 2 study testing it in patients with osteoarthritis knee pain. The company stopped work on that drug and turned its focus to a preclinical program for eye diseases.

—Bayer agreed to a $1.6 billion settlement covering about 90 percent of the nearly 39,000 legal claims alleging that its Essure implantable birth control device caused injury. Reuters reports that the company is working to resolve litigation with the remaining plaintiffs.

—Phase 3 results for evinacumab, a Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]) drug candidate for an inherited form of high cholesterol, were published in the New England Journal of Medicine. An FDA decision on the drug is expected in February.

—Merck (NYSE: [[ticker:MRK]]) immunotherapy Keytruda, in combination with chemotherapy, met the main goals of a Phase 3 clinical trial in patients with esophageal cancer.

—Roche and Regeneron (NASDAQ: [[ticker:REGN]]) struck a distribution deal for REGN-COV2, Regeneron’s investigational COVID-19 treatment. Regeneron will distribute the treatment in the US while Roche will handle distribution elsewhere in a pact the companies said would more than triple capacity.

—Pfizer (NYSE: [[ticker:PFE]]) and BioNTech (NASDAQ: [[ticker:BNTX]]) reported additional preliminary Phase 1 data for their lead COVID-19 vaccine candidate, which is now in pivotal testing. The pre-print data show that seven days after a second dose of the vaccine, antibody levels on average were 3.8 times higher than the average levels found in patients who recovered from COVID-19 infection.

PEOPLE ON THE MOVE

Agile Therapeutics (NASDAQ: [[ticker:AGRX]]) appointed Paul Korner as its chief medical officer… Edward Dulac joined Fate Therapeutics (NASDAQ: [[ticker:FATE]]) as its chief financial officer… Sorrento Therapeutics (NASDAQ: [[ticker:SRNE]]) fired Chief Financial Officer Jiong Shao… Seneca Therapeutics named James Hussey as its CEO… Xenon Pharmaceuticals (NASDAQ: [[ticker:XENE]]) tapped Chris Von Seggern as its chief commercial officer… Sergio Santillana joined Ikena Oncology as chief medical officer… Rome Therapeutics added Dennis Zaller as chief scientific officer… Alka Chaubey became the first chief medical officer at Bionano Genomics (NASDAQ: [[ticker:BNGO]])… and Aerin Medical announced Matt Brokaw as CEO.

Frank Vinluan contributed to this report. 

Image: iStock/BrianAJackson