Bio Roundup: Golumbeski’s Legacy, CRISPR Moratorium, Rebate Week & More

Xconomy National — 

While all eyes in the biopharmaceutical world are currently trained on Bristol-Myers Squibb’s proposal to buy Celgene for $74 billion, it wasn’t that long ago that another company’s gaze was fixed on the Summit, NJ, drug maker.

In the early 2000s, before the FDA approved Celgene’s flagship multiple myeloma drug lenalidomide (Revlimid), Novartis (NYSE: NVS considered buying the company. It passed, unwilling to risk billions on an unapproved drug. Those details came from biopharma dealmaker George Golumbeski, who was profiled in Xconomy this week. Golumbeski rose through the ranks to top positions at both companies, eventually earning a reputation for a flexible, creative dealmaking style at Celgene that other industry giants have followed. Bristol wants to buy Celgene, in large part, because of drugs acquired under Golumbeski’s watch.

Still, uncertainty surrounds the Bristol (NYSE: BMY) deal, which in some ways is a referendum on Golumbeski’s Celgene legacy. Some prominent shareholders have opposed the buyout, and questioned Bristol’s belief in Celgene’s future prospects. It all heightens the drama as stockholders prepare to vote on the deal next month. Let’s get to that story and more in this week’s news roundup.

TOP STORIES

—George Golumbeski, the former head of business development at Celgene, is one of biopharma’s most prolific dealmakers. But his workaholic rise to prominence took a heavy toll. In an exclusive profile, Xconomy detailed Golumbeski’s legacy of deals and mentorship, and his struggle to find balance in in life as a biotech executive.

—In the wake of the “CRISPR babies” created by Chinese scientist He Jiankui last year, a high-profile group of scientists have called for a moratorium on the creation of humans with germline editing. (Research on embryos that can’t become fetuses would still be OK.) Not all gene-editing experts signed on, however. STAT detailed why many, including UC Berkeley’s Jennifer Doudna, are hesitant about a moratorium.

—The Discovery Channel has Shark Week; we can top that with… Rebate Week. The powerful Senate Finance Committee scheduled a hearing in April on controversial prescription drug rebates. A leading insurer doubled down on its commitment to put those rebates into consumers’ pockets instead of its own. And as the Trump administration forces the issue with its rebate-reform proposal, we wrote about a new study that explores the pros, cons, and unintended consequences of changing the rebate system.

—The FDA approved netarsudil/latanoprost (Rocklatan), a combination treatment for glaucoma from Aerie Pharmaceuticals (NASDAQ: AERI). Though Rocklatan has, in clinical tests, beaten the eye drops typically used to treat glaucoma, it’s unclear whether it can supplant those drugs given its side effects and the availability of other options, many of which are generic.

LET’S MAKE A DEAL

—The New York Post reported that Starboard Value, an activist investor opposing the Bristol-Celgene deal, is investigating whether other hedge funds are trying to manipulate the outcome of the deal with stock-trading tactics.

—Meanwhile, Bristol CEO Giovanni Caforio continued to promote his company’s planned $74 billion buyout of Celgene. At an investor conference, Caforio said that the buyout isn’t “a defensive deal” to fend off a takeover. Bloomberg has more.

—Rare disease drug developer X4 Pharmaceuticals (NASDAQ: XFOR) became a public company after completing a reverse merger with Arsanis.

— AstraZeneca (NYSE: AZN) agreed to pay Seres Therapeutics (NASDAQ: MCRB) $20 million up front to kickstart a three-year partnership focused on researching how tapping the gut microbiome could make cancer immunotherapies work better.

FROM THE BELTWAY

—Norman “Ned” Sharpless, currently the head of the National Cancer Institute, has been named acting FDA commissioner. He will replace current commish Scott Gottlieb, who announced his resignation last week. Before the NCI, Sharpless led the Lineberger Comprehensive Cancer Center at the University of North Carolina and co-founded two biotech companies.

—The changes at the federal health agencies come as the White House delivered its annual budget proposal. The administration wants to slash funding to the Health and Human Services department, which includes the FDA, National Institutes of Health, and Medicare and Medicaid, by 12 percent. NIH spending would fall 13 percent to $34.4 billion. Such cuts are unlikely to materialize. Even when Republicans controlled both houses of Congress, Trump’s proposed budget cuts for FDA and NIH fell on deaf ears.

CASH GRABS

—Deerfield Management will commit $100 million to Harvard University in a strategic alliance to support the development of the school’s biomedical innovations, launching a company, Lab1636, as part of the effort. Deerfield has similar alliances in place with other schools like UC San Diego and UNC-Chapel Hill.

—InventisBio closed $70 million in Series C financing that the China-based biotech will apply toward clinical development of drugs for lung and breast cancers, and gout.

—Reuters reported that German messenger RNA drug developer BioNTech has hired banks for an IPO that could be worth up to $800 million, a total that would eclipserival Moderna’s (NASDAQ: MRNA) record IPO haul in December.

—Regenerative medicine biotech Surrozen raised $50 million in Series B funding to continue developing treatments for liver diseases. The research of San Francisco-based Surrozen focuses on Wnt, a protein that plays a role in stem cell maintenance and tissue regeneration.

DRUG DEVELOPMENTS

—-Celgene filed for European approval of multiple sclerosis drug ozanimod. The company also says it is on track to refile its FDA application for the drug by the end of March.

—Zafgen (NASDAQ: ZFGN) suspended plans to begin human testing of its experimental drug ZGN-1258 due to worrisome safety signs in preclinical tests. The disclosure marks another setback for Zafgen, which scrapped one drug due to safety problems and saw the FDA temporarily halt testing of another. Shares fell more than 34 percent.

—The European Medicines Agency approved a regimen of the Merck (NYSE: MRK) immunotherapy pembrolizumab (Keytruda) alongside chemotherapy for patients with newly diagnosed, advanced non-small cell lung cancer.

—The FDA approved a combination regimen of the Celgene drug nab-paclitaxel (Abraxane) and the Roche immunotherapy atezolizumab (Tecentriq) for certain patients with triple-negative breast cancer.

—Celgene reported the failure of a Phase 3 study testing nab-paclitaxel and chemotherapy gemcitabine against chemo alone in pancreatic cancer patients.

—The FDA cleared dupilumab (Dupixent), from Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi, for adolescents with moderate-to-severe atopic dermatitis. Dupilumab is already approved for adults with the condition.

—AbbVie (NYSE: ABBV) and Principia Biopharma (NASDAQ: PRNB) are winding down a partnership begun in 2017 to develop treatments for inflammation and autoimmune disorders. South San Francisco, CA-based Principia will regain rights to the preclinical program.

—Axovant (NASDAQ: AXGT) reported positive interim results from a mid-stage study of a gene therapy it’s testing in patients with Parkinson’s disease. Axovant will now test the gene therapy—a rival to a program from Voyager Therapeutics (NASDAQ: VYGR)—at higher doses.

— Ramucirumab (Cyramza), an Eli Lilly (NYSE: LLY) drug already approved for treating gastric and colorectal cancers, succeeded in a Phase 3 study in non-small cell lung cancer. Lilly tested its drug in combination with erlotinib, a lung cancer drug for patients whose tumors have an EGFR mutation.

—The first immunotherapy for breast cancer is here. The FDA approved a combination of Roche’s atezolizumab and Celgene’s nab-paclitaxel for locally advanced or metastatic triple-negative breast cancer, which accounts for about 15 percent of breast cancer cases. The approval is only for patients whose cancer expresses the protein PD-L1, which must be detected by a companion diagnostic from Roche’s Ventana division that was also approved by the FDA.

—The FDA decision date for Karyopharm Therapeutics (NASDAQ: KPTI) multiple myeloma drug selinexor was pushed out three months to July 6 to give the regulator time to review additional information submitted by the company. Last month, an FDA advisory committee voted against recommending accelerated approval of selinexor, a vote that followed a blistering review from the agency’s staff that questioned the drug’s safety and efficacy.

TRIALS AND TRIBULATIONS

—Price gouger, securities fraudster, and Wu-Tang hoarder Martin Shkreli is in prison—and under investigation for allegedly trying to run a company from his jail cell.

—In the first major lawsuit against companies charged with fueling the opioid abuse crisis, Oklahoma’s attorney general is pressing for the public release of confidential documents implicating Johnson & Johnson (NYSE: JNJ). Axios has the scoop.

PEOPLE ON THE MOVE

—Adam Crystal left the Novartis Institutes for BioMedical Research to become chief medical officer of C4 Therapeutics.

Tenaya Therapeutics hired Whittemore Tingley away from Cytokinetics (NASDAQ: CYTK) to become its chief medical officer.

Ben Fidler and Alex Lash contributed to this report.

Photo by Flickr user Ajay Suresh via a Creative Commons license