Prescribed Reading: ShiTake a go; Novartis in hot water
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Trump might change drug pricing, or might not
- Ironwood tries to crack gout market with Duzallo
- China pushes beyond its own borders
Mergers & analysis
After a protracted public courting, ShiTake is finally an item. Takeda secured its takeover of big biotech Shire — after four failed bids — with its final $62 billion offer. The new company will be one of the top 10 pharmas in the world by revenue and will finally give Takeda the U.S. presence it has desired. The takeover isn't all sunshine and rainbows though; the Japanese pharma plans to reduce the combined company's headcount by 6% to 7% over the next three years.
Major takeovers weren't the only deals making headlines this week. Turns out Novartis hasn't been on its best behavior. It came to light this week the Swiss pharma paid an apparent shell company started by President Trump's lawyer Michael Cohen — the same firm earlier used to pay off the adult fim star Stormy Daniels. Original reports had Novartis handing the Cohen-linked firm nearly $400,000 for "insights," but the big pharma later admitted payments totaled $1.2 million. Novartis has been quick to pin blame on former CEO Joe Jimenez, who retired at the end of January, while emphasizing that current CEO Vas Narasimhan was not involved in the dealings.
In the more normal course of business, Eli Lilly & Co. picked up Armo BioSciences for $1.6 billion in cash. The Indianapolis pharma aims to bolster its immuno-oncology offerings in hopes of better competing with oncology heavyweights like Merck & Co. and Bristol-Myers Squibb. The deal will give it a late-stage asset that the company hopes will be an integral part of its combination strategy.
Elsewhere, Roche's Genentech inked a deal that could be worth as much as $1 billion with biotech Lodo Therapeutics. Roche is tapping the company to discover new products by digging through the dirt.
The industry has long theorized the psycho-active drug ketamine could have applications as a treatment for depression and related mental health disorders. Johnson & Johnson has chased this idea with its drug esketamine, and is close to submitting an application for approval to regulators. Yet, recent late-stage results were mixed — the drug failed beat out control in a study of older adults. This certainly doesn't knock the drug out, but raises questions about its profile.
Roche also reported results that could affect the commercial potential of one of its drugs. The big pharma announced earlier this week that a combo of its checkpoint inhibitor Tecentriq (atezolizumab) and Exelixis' Cotellic (cobimetinib) failed to improve surivival in colon cancer patients. The failure is a setback in Roche's strategy to catch up to other oncology players.
Meanwhile, The Medicines Company is working to polish up its case for its synthetic PCSK9 inhibitor, reporting further Phase 2 efficacy data this week. Yet MedCo's problems may go beyond the risk/benefit profile of the drug. Other, already marketed, PCSK9 inhibitors have failed to gain traction in the commercial market, and MedCo is likely to face the same pushback, regardless of clincial profile.
The Food and Drug Administration revealed this week that the U.S. is currently facing a shortage of the emergency allergic reaction treatment EpiPen. Mylan attributed the problem to manufacturing issues at the plant run by a Pfizer subsidiary. But both companies are quick to point out a supply of the drug is still being sent to wholesalers.
The FDA also put roadblocks in front of two companies this week. Cosmo Pharmaceuticals was notified that its cancer diagnostic will not be approved by its May 21 user fee action date, instead, the agency needs to have further discussions with the company.
And Lipocine got a rejection from the agency for its testosterone drug — its second so far.
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