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Prescribed Reading: ADA, Mylan, and an executive order?

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

Mergers & analysis

Deals continue to be slow, but Japanese chemicals company JSR Corp. did announce it is picking up cell line developer Selexis. The acquisition gives JSR and its subsidiary KBI access to mammalian cell-line generation for the production of biologics such as bispecific antibodies, multimeric proteins and Fc-fusion proteins. These are all the essential parts of many of the high-cost therapeutics that are reaching the market.

On another front, Mylan is facing pressure from proxy firm Institutional Shareholder Services (ISS) urging shareholders to vote for a change at the board level and to vote against the ratification of a compensation package for Chairman Robert Coury. 

Despite the image problems that Mylan has been experiencing concerning the Epipen and its drug pricing issues, the company says that Coury's compensation is in-line with the company's stock performance, and the board is "engaged, refreshed and responsive."

This pressure may come at a bad time; another potential competitor to the EpiPen has just gotten the green light from the Food and Drug Administration. Adamas Pharmaceuticals plans to bring to market its pre-filled epinephrine syringes. However, Adamas poses little threat to Mylan — consumers are unlikely to want the inconvenience of using a syringe versus Mylan's easy-to-use autoinjector. 

Clinically relevant

Johnson & Johnson reported positive results from its cardiovascular outcomes study for its SGLT2 inhibitor Invokana (canagliflozin) at the American Diabetes Association conference last weekend. While the drug was able to lower the risk of cardiovascular events in diabetes patients, it didn't perform as well as Eli Lilly & Co. and Boehringer Ingelheim's own SGLT2 inhibitor Jardiance (empagliflozin) had in the previously announced EMPA-REG cardiovascular outcomes trial. 

Jardiance sales have not caught up to that of other SGLT2 inhibitors, despite an expanded label that includes the CV data — partly because many physicians assumed it was a class-wide effect. The results of Invokana's CANVAS study could actually help Lilly and Boehringer boost sales and may help prove that Jardiance is best-in-class. 

Also at ADA, Merck & Co. and Pfizer presented data for their own SGLT2 inhibitor ertugliflozin. The drug performed well in combination with both metformin and Merck's DPP-4 inhibitor Januvia (sitagliption). Unlike the other drugs, ertugliflozin is not yet approved, but the companies have three applications pending with the Food and Drug Administration for the drug and its respective combinations. Merck and Pfizer might have an uphill battle entering this market, but the approvals could help boost Januvia — so it's a win for Merck. 

Highly regulated

Reports indicate that President Trump could be prepping an Executive Order that aimed at lowering U.S. drug costs. Top health and budget officials are slated to meet today and the order could include things related to value-based drug pricing. 

Yet, details are slim and analysts are skeptical. Evercore ISI analyst Umer Raffat said in a Friday note to clients that drug pricing regulations are unlikely to happen before 2018. Terry Haines, Raffat's colleague who covers Washington, agrees, adding, "If anything, the limited scope of the discussions should be good news for the pharmaceutical and bio industries and investors because nothing like sweeping action to curb drug prices is under discussion and the industry probably will not view the subjects of the Trump discussions negatively."

Drug pricing is a hot topic everywhere: South African officials are looking into cancer drug pricing from the likes of Roche, Pfizer and others. 

Elsewhere on the regulatory front, new Food and Drug Administration Commissioner Scott Gottlieb wrote about fostering innovation between medical products and digital health technology. He hopes to put in place a post-market approach to regulating apps and devices that can help patients monitor their health. 

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Filed Under: Clinical Trials Mergers and Acquisitions / Deals Regulatory / Compliance