For biotech, an overseas scandal poses a real threat

A worsening shortage of monkeys used for early-stage pharmaceutical research has led to fears that drug companies will soon face costly delays starting clinical trials, slowing development for an untold number of medicines and putting small firms in a difficult situation.

As STAT's Ed Silverman reports, federal regulators are blocking imports of long-tailed macaques from Cambodia, the biggest supplier of research primates, in the wake of a federal investigation into a smuggle ring. The resulting shortage has nearly tripled the price of such primates and doubled the wait time for biotech companies trying to conduct vital toxicology research for new therapies.

"I think that probably in the next two to four weeks, we'll start seeing some trials paused because some companies won't have the supply needed to meet expected demand," said Chris Meekins, a health care policy analyst at Raymond James. He estimated that costs for certain trials may soon double, which will cause some companies to burn through cash faster than they would otherwise.

Obesity

Does every big drug company need a GLP-1?

Promising early data on Viking Therapeutics weight-loss treatment sent the company's stock price up about 70%, driven by speculation that some of the world's largest drugmakers will view it as an acquisition target.

As STAT's Matthew Herper reports, Viking's treatment led patients to lose as much as 6% more body weight than those on placebo in just 28 days, results from a small, early-stage study suggesting the drug might be able to compete with approved medicines from Novo Nordisk and Eli Lilly. The drug, VK2735, is part of an increasingly popular class of diabetes and weight loss drugs that target a hormone called GLP-1, which regulates blood sugar metabolism and appetite. Viking's drug also targets the hormone GIP, which is expected to make the medicines more effective.

The market for newfangled weight-loss treatments is expected to approach $100 billion a year in the next decade, led by Novo, Lilly, and a group of later entrants that includes Pfizer and Amgen. If that market materializes, Merck, Johnson & Johnson, and other major firms that missed out on the first wave of GLP-1s might want to elbow in. And Viking, with a market value of about $1.2 billion, could be an attractive takeover target.

biotech

Why Intra-Cellular's sales could double

Intra-Cellular Therapies' approved treatment for mood disorders appears to benefit patients with major depressive disorder, according to a large clinical trial, data that could significantly expand the drug's use.

As STAT's Adam Feuerstein reports, the drug, called Caplyta, led to an 18.1-point improvement on a scale of depression symptoms, significantly beating the 12.4-point benefit seen in the placebo group. The study enrolled 383 participants diagnosed with mixed features, or greater severity of mental illness, associated with major depressive disorder or bipolar depression.

If Intra-Cellular can persuade the FDA to expand Caplyta's label, the drug's long-term revenue potential could roughly double to more than $2.5 billion a year, RBC analyst Brian Abrahams wrote in a research note to clients.

sustainability

The drug industry is facing pressure to get greener

Amid a widespread corporate reckoning over climate change, biotech and pharma companies are facing louder calls to reduce their carbon footprints, with pressure coming from investors, regulators, and even their own employees.

As Betsy Ladyzhets writes for STAT, investors are increasingly asking large, publicly traded companies to disclose the environmental impacts of their business, and some venture capital firms are specifically scouting for biotech startups that meet strict disclosure requirements on greenhouse gas emissions and other metrics.

Meanwhile, younger employees "want to work in an organization where they know they're doing something about sustainability," said James Connelly, CEO of My Green Lab, a nonprofit focused on sustainability in science. Incorporating environmental programs, Connelly said, can help companies with recruiting and retention.

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