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Bio Roundup: Leiden’s Exit, Depression Data, a New Pricing Bill & More

Xconomy National — 

What will the legacy be of Jeff Leiden, the longtime CEO of Vertex Pharmaceuticals?

Vertex surprised Wall Street this week by announcing Leiden’s seven-year run will end next spring. In some ways, his legacy is already written. He steered Vertex through a crisis when its hepatitis C business was squashed by competition, in no small part due to Vertex’s own “hubris,” as Leiden once told Xconomy. Under Leiden’s watch, Vertex has become the leader in cystic fibrosis medicines and climbed industry ranks. Worth more than $44 billion, Vertex is now within shouting distance of another Boston-area biotech stalwart, Biogen.

But a critical chapter is ahead for Vertex, and that will be part of Leiden’s legacy as well, even as he hands the reins to Reshma Kewalramani in 2020. Will Vertex be able to defend its core business this time around? Will Leiden’s plan to diversify by investing in a hodgepodge of rare genetic disease therapies and cutting edge technologies bear fruit? Or will Vertex be caught flat-footed should the competition eventually catch up?

We’ll get to that story, and the rest of this week’s biotech news below.

CAPITOL HILL & CRISPR TOO

—The Senate Finance Committee produced a bipartisan bill that aims to reduce drug prices, and committee members spent Thursday “marking it up” with amendments. To become law it must run a gauntlet of opposition, not least of which is the drug industry. Kaiser Health News rounded up Thursday’s reports on the fast-moving story.

—A big part of the story: a top pharma lobbyist and drug company officials met President Trump in the Oval Office Wednesday, according to Politico. The Senate bill could thwart some of the White House proposals to rein in drug prices but support others.

—Biotech tools company MilliporeSigma has thrust itself into the long-running CRISPR patent fight. Calling the move a “Hail Mary,” Stat reported this week that the company is asking for the same kind of review—an interference—that the US patent office recently launched to sort out competing claims between the Broad Institute and a camp led by the University of California, Berkeley.

FDA STOPS & STARTS

—The FDA approved Hadlima, from Merck (NYSE: MRK) and Samsung Bioepis, a biosimilar version of the world’s top-selling drug, adalimumab (Humira). The FDA cleared another Humira biosimilar from Novartis last year.

—The agency green-lighted Baqsimi, an Eli Lilly (NYSE: LLY) nasal powder for diabetes patients with severe hypoglycemia.

—Zafgen (NASDAQ: ZFGN), which had a drug near an FDA review a few years back, will have to run another animal test if it wants to restart human trials. The company axed 25 percent of its workforce to preserve cash.

—The FDA approved Pfizer (NYSE: PFE) drug Ruxience, a biosimilar to Roche’s cancer drug rituximab (Rituxan). Meanwhile, Pfizer’s pregabalin (Lyrica) is now open to generic competition after the agency approved nine versions of the nerve pain drug.

—Celgene (NASDAQ: CELG) racked up another approval for apremilast (Otezla), this time for oral ulcers tied to the rare anti-inflammatory condition Behcet’s disease. Bristol-Myers Squibb (NYSE: BMY) has to sell Otezla to close its buyout of Celgene.

DATA DUMPS

—Bristol disclosed another setback for its immunotherapy franchise in lung cancer. A combo of Bristol’s nivolumab (Opdivo) and chemotherapy didn’t beat chemo alone—a boost for rival Merck (NYSE: MRK), whose pembrolizumab (Keytruda)-chemo combo has become the standard of care for many lung cancer patients. Bristol said a combination of two immunotherapies, nivo and ipilimumab (Yervoy), did beat chemo in the same study, but didn’t provide details.

—Updates from the International AIDS Society Conference on HIV Science: FiercePharma dug into the latest data from ViiV Healthcare’s two-drug regimen Dovato… Merck discussed early data from an HIV-prevention implantislatravir, the drug in the implant, also showed effectiveness in a combination treatment… a UNAIDS report said the pace of progress reducing new HIV infections was uneven across the globe. Nearly 38 million people worldwide have HIV; 61 percent have access to antiretroviral medicine.

—Myovant Sciences (NASDAQ: MYOV) reported positive data from a second Phase 3 study to treat uterine fibroids, positioning its drug relugolix to compete with one from AbbVie (NYSE: ABBV). Investors were unenthused, as Biopharma Dive explains.

—Ocreotide, an experimental Chiasma (NASDAQ: CHMA) drug for the hormone disorder acromegaly, hit the main goals of a Phase 3 study. The Waltham, MA, company said it will file for FDA approval by the end of 2019.

—Stat reported that wearable fitness trackers like FitBit might not be accurately measuring heart rates of people with darker skin, which has a host of implications for clinical studies, health equity, workplace wellness programs, and privacy.

PSYCH DEVELOPMENTS

—Intra-Cellular Therapies (NASDAQ: ITCI) said the July 31 review of its drug lumateperone by an FDA advisory panel was cancelled because of new information the company recently gave the FDA about “non-clinical studies.” The committee was set to discuss the drug’s prospects as a schizophrenia treatment after mixed results in Phase 3.

—Shares of Marinus Pharmaceuticals fell more than 70 percent after the oral form of its experimental postpartum depression (PPD) drug ganaxalone disappointed in two Phase 2 trials. Marinus has been the “most viable threat” to the PPD drugs developed by Sage Therapeutics (NASDAQ: SAGE), wrote RBC Capital Markets analyst Brian Abrahams, but oral ganaxalone showed “little to no treatment effect” in the studies. Vantage has more.

—Sage, meanwhile, plans to test … Next Page »

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