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Bio Roundup: Tom Price, Patient Conflicts, Orphan Games & More

Xconomy National — 

The new president of the United States, Donald Trump, is being sworn in today amid a storm of questions about the plans that he, and those who might work for him, have in store for American healthcare and medicine.

Trump’s nominee to run the $1 trillion Health and Human Services Department, Tom Price, answered—or didn’t answer—many of those questions in a Senate hearing Wednesday. The back and forth with Bernie Sanders, Elizabeth Warren, and others illustrated how some of Trump’s heated rhetoric about drug pricing and parts of the Affordable Care Act could put the administration at odds with Republican proposals and ideals.

Price also fielded questions about financial conflicts of interest, a common theme for this new administration that starts from the top.

Price said many times that giving healthcare decisions back to the states was a top priority. It’s noteworthy, then, that several Republican state governors are warning Washington lawmakers to move cautiously with the repeal-and-replace of Obamacare.

There’s still no word from Trumpland about an official pick to run the Food and Drug Administration, however. One name floated, Silicon Valley investor Balaji Srinavasan, reportedly shot himself in the foot with a series of anti-FDA tweets. Matt Herper of Forbes wrote a thoughtful commentary here about the Trump team’s flirtation with libertarian views of health regulation.

Whether the swearing-in of the new POTUS has you swearing or swaying, we’ve got a week of bio news to round up. Let’s get to it.

IN THE NATIONAL INTEREST

—Speaking of conflicts of interest, the Journal of the American Medical Association published a paper examining the relationship between patient advocacy organizations and the drug makers that often fund them. (Here’s more on that issue from an Xconomy report in August.) The report concluded that more transparency and “robust conflict of interest policies” are needed to help these groups maintain independence.

—The Kaiser Health Network reported that the drug industry for years has been stretching the definition of “orphan drug” to take advantage of federal incentives.

—Two prominent healthcare policy thinkers wrote in a Forbes op-ed that the U.S. should buy Gilead Sciences (NASDAQ: GILD) for $156 billion to save money on hepatitis C costs. Gilead owns top-selling hepatitis C drugs that cure the disease, but the authors say their high cost has resulted in a “snail’s-pace adoption.”

—A project to reproduce pre-clinical cancer studies released its first five findings. One scientist whose results the project tried to repeat told Nature that the effort, which he contests, will make it hard to raise money for his biotech startup.

CANCER DATA… OR NOT

—Bristol-Myers Squibb (NYSE: BMY) reported positive data for its cancer treatment nivolumab (Opdivo) in advanced stomach cancer. The Phase 3 study reported a 26.6 percent overall survival rate at 12 months of patients on nivolumab compared with 10.9 percent in the placebo group.

—Separately, Bristol said that it would not seek accelerated approval of a combination of nivolumab and ipilimumab (Yervoy) in newly diagnosed lung cancer patients “based on a review of data available at this time.” The news widens Merck’s lead with pembrolizumab (Keytruda)—already approved for a subset of first-line lung cancer patients—and means Bristol won’t file for approval without the results of a study, Checkmate-227, that won’t wrap up until early next year.

—The two rivals, meanwhile, settled a patent infringement suit regarding Merck’s pembrolizumab. Bristol will get $625 million in cash from Merck in the settlement, plus royalties on pembrolizumab sales that extend through 2026.

—Data from AstraZeneca’s high-profile “Mystic” study, which tests a combination of drugs in newly diagnosed lung cancer patients, were delayed. Once expected imminently, they now won’t come until mid-2017.

ON THE DEAL FRONT

—Big companies are always on the hunt for promising drugs from small biotechs. But an unusual deal between tiny Ovid Therapeutics and pharma giant Takeda—Ovid will develop an experimental epilepsy drug discovered in Takeda’s labs—is an example that the reverse is true, too.

—Cambridge, MA-based Biogen (NASDAQ: BIIB) agreed to pay Danish firm Forward Pharma (NASDAQ: FWP) $1.25 billion to settle a patent infringement suit over the multiple sclerosis pill, dimethyl fumarate (Tecfidera).

—Eli Lilly (NYSE: LLY) is paying $960 million to buy Cambridge-based CoLucid Pharmaceuticals (NASDAQ: CLCD), enabling the Indianapolis firm to reacquire a migraine drug, lasmaditan, that it first discovered more than a decade ago.

—Durham, NC-based Novan (NASDAQ: NOVN) landed $11 million up front in a licensing deal for acne drug candidate SB204. Sato Pharmaceutical gains Japanese rights and would owe Novan future payments depending on progress with the topical drug.

—Ginkgo Bioworks paid an undisclosed sum to acquire Cambridge-based Gen9, a synthetic DNA supplier co-founded in 2009 by Harvard University’s George Church, Stanford University’s Drew Endy, and MIT’s Joseph Jacobson. The Boston Globe reports, however, that the sale came after Gen9 couldn’t raise new cash and laid off much of its staff.

IN OTHER NEWS…

—New York-based Synergy Pharmaceuticals (NASDAQ: SGYP) won FDA approval of plecanatide (Trulance), a drug for chronic idiopathic constipation that will compete for market share with Ironwood Pharmaceuticals’ (NASDAQ: [[ticker:]]) linaclotide (Linzess). Synergy will soon seek approval of plecanatide for patients with irritable bowel syndrome with constipation as well.

Ben Fidler and Frank Vinlaun contributed to this report
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U.S. map from Dave Winer via a Creative Commons 2.0 license.