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Bio Roundup: Opioids in Court, IPO Parade, Brain Cancer Bet & More

Xconomy National — 

[Corrected 5/31/19, 8:48 am ET. See below.] Pharmaceutical companies that make or market opioids have found themselves in legal hot water, and much of the heat is coming from Oklahoma. This week, a trial began litigating Johnson & Johnson’s responsibility for opioid addiction in the Sooner State.

Johnson & Johnson (NYSE: JNJ) entered the Norman, OK, courtroom without any of its industry peers. OxyContin maker Purdue Pharma reached a $270 million settlement with Oklahoma in March. And days before the trial started this week, Teva Pharmaceutical (NYSE: TEVA) settled with the state for $85 million. In those agreements, Purdue and Teva said they did nothing wrong.

Oklahoma prosecutors allege that the industry’s misleading marketing of opioids played down the addictive properties of the drugs and pushed physicians to overprescribe them. J&J’s attorneys argued that the company marketed drugs using the same language as the FDA. Drug companies and state attorneys general are watching closely. The Oklahoma trial is the first of an estimated 1,600 state and local lawsuits aiming to recover money spent addressing opioid addiction.

In other news this week, a new liquid biopsy startup made a splash, the US moved closer to an ignominious vaccine milestone, and the biotech IPO train picked up steam. Let’s get to those stories in this week’s roundup.

TOP STORIES

—As Chicago gears up for the annual American Society of Clinical Oncology meeting, Xconomy delved into a topic you won’t see much this weekend in papers and presentations: immunotherapy’s frustratingly slow progress in breast cancer.

—The brain cancer glioblastoma multiforme is a terrible curse. One woman’s $90 million quest to find treatments with her family fortune has turned up nothing in more than a decade. Now, she’s betting a cutting-edge idea can break the stalemate.

—Based mainly on a three-year Phase 1/2 study of seven people, BioMarin Pharmaceutical (NASDAQ: BMRN) said its hemophilia A gene therapy known as valrox should last at least eight years, if not more, hoping to quell concerns about the one-and-done medicine’s durability. BioMarin also said it would ask regulators this year to consider early approval of valrox based upon a 20-person Phase 3 study. Company shares were down 7 percent for the week, as of midday Thursday.

—Amid talk of a coming presidential executive order to force disclosure of drug prices, health economists told Politico that President Donald Trump’s promise last year that drug firms would soon issue “massive voluntary cuts” in prices has not panned out. The administration begs to differ.

NEW STARTS & CASH GRABS

Thrive Earlier Detection launched with $110 million in venture cash to build an early cancer detection business centered upon CancerSEEK, a liquid biopsy developed at Johns Hopkins School of Medicine. Thrive faces a lot of well-funded competition, such as Grail, which is trying to do the same thing and has already raised more than $1.5 billion.

—Microbiome startup Whole Biome closed a $35 million Series B round, which it will use to commercialize its first product: a medical food developed to try and manage diabetes by restoring gut microbes that diabetics lack.

—The parade of biotech companies targeting the public markets shows no sign of slowing. Akero Therapeutics, Prevail Therapeutics, Dermavant Sciences, BridgeBio, Atreca, and Adaptive Biotechnologies all submitted paperwork to get the IPO process started.

—The biggest IPO target of the week goes to Genmab, whose stock is already publicly traded in Denmark, where it is based. The pharmaceutical company set a goal of raising $500 million in a US IPO to finance its cancer drug R&D.

DRUG DEVELOPMENTS

—Late last Friday, the FDA approved Zolgensma, a gene therapy for spinal muscular atrophy. Novartis (NYSE: NVS) gave the one-shot medicine a list price of $2.1 million and said it would work with insurers on installment plans.

—The FDA gave Novartis more good news just before the long weekend, approving its breast cancer drug alpelisib (Piqray).

—Cara Therapeutics (NASDAQ: CARA) reported positive preliminary Phase 3 data for difelikefalin, the company’s experimental treatment for a severe itching condition known as pruritus. Shares of the Stamford, CT, biotech jumped more than 20 percent.

—Vertex Pharmaceuticals (NASDAQ: VRTX) said it plans to submit cystic fibrosis drug VX-445 for regulatory approval in the US and Europe. Compared to another three-drug combination therapy that Vertex tested, the company said VX-445 offered the potential to treat more CF patients.

—Celgene (NASDAQ: CELG) chalked up another approval for lenalidomide (Revlimid) for two types of previously treated lymphoma.

—Vaccines helped the US eliminate measles in 2000. This week, the Centers for Disease Control and Prevention reported more measles cases in the first five months of this year than in any year since 1992, a pace that threatens the disease’s elimination status. [An earlier version of this paragraph listed the wrong year for the previous highest annual total of US measles cases. We regret the error.—Eds.]

LET’S MAKE A DEAL

—Eli Lilly (NYSE: LLY) paid Centrexion Therapeutics $47.5 million up front to license global rights to CNTX-0290, an experimental pain treatment in Phase 1 testing. Boston-based Centrexion could earn up to $575 million in milestone payments pegged to the drug’s progress, plus even more if it reaches the market.

—Rare disease drug developer Amicus Therapeutics (NASDAQ: FOLD) is expanding its research pact with the University of Pennsylvania. For the next five years, the Cranbury, NJ-based biotech will invest $10 million annually into Penn’s gene therapy program as the partnership adds 12 more rare diseases.

PEOPLE ON THE MOVE

—Gilead Sciences (NASDAQ: GILD) hired Johanna Mercier away from Bristol-Myers Squibb (NYSE: BMY) to become its chief commercial officer… Pascal Touchon is leaving Novartis to become CEO of Atara Biotherapeutics (NASDAQ: ATRA), where he will succeed Isaac Ciechanover… Laura Sepp-Lorenzino left Vertex Pharmaceuticals for the chief scientific officer post at Intellia Therapeutics (NASDAQ: NTLA)… and Alnylam Pharmaceuticals (NASDAQ: ALNY) promoted Kevin Fitzgerald to chief scientific officer.

Alex Lash contributed to this report.

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