April 17, 2015

Patch Targets Peanut Allergy
The FDA has awarded breakthrough therapy designation to DBV Technologies’ peanut allergy treatment Viaskin Peanut, marking the first time the agency has granted the designation for a food allergy, the France-based company says.

Using a technique that delivers an allergen directly to the skin’s outer layers to stimulate the immune system, Viaskin’s electrostatic patch targets antigen-presenting cells without letting antigen seep into the bloodstream, the company says.

In a Phase IIb trial, children who used Viaskin Peanut responded positively and significantly to 250 micrograms of the treatment, DBV says, adding the product’s clinical safety profile was also strong across all age groups. The company, which plans to conduct a Phase III trial of Viaskin Peanut, is also developing treatments for milk and dust mite allergies.
Former Ethicon Execs Indicted

The Department of Justice has charged two former Acclarent officials with conspiracy and fraud, citing an alleged off-label marketing scheme for a sinus device.

DOJ accused former CEO William Facteau and Patrick Fabian, former vice president of sales, of speeding the development and sale of the Relieva Stratus microflow spacer in an effort to create projected money flow that would bolster Acclarent’s initial public offering or acquisition prospects.

In 2010, J&J subsidiary Ethicon bought Acclarent for $785 million. Despite the FDA’s rejection of Relieva Stratus as a steroid-delivery product, Facteau and Fabian allegedly marketed the device as such, DOJ claims.

Both were indicted on one count of conspiracy, three counts of securities fraud, four counts of wire fraud and 10 counts of introducing adulterated or misbranded medical devices into interstate commerce.

If convicted, the men face maximum sentence time of more than 100 years each plus a $250,000 fine or twice gross gain.
Senate Device Tax Hearings Set

The U.S. Senate Finance Committee is gearing up for hearings on legislation to repeal the 2.3 percent medical device excise tax, with Sen. Pat Toomey’s (R-Pa.) healthcare subcommittee initiating the deliberations.

Two bills to end the tax are being floated in the Senate — the Hatch-sponsored Medical Device Access & Innovation Protection Act and Sen. Ed Markey’s (D-Mass.) No Taxation on Device Innovation Act. No date has been sent for the Finance Committee hearing has been set.

In the House, Rep. Erik Paulsen (R-Minn.) has introduced the Protect Medical Innovation Act of 2015—a bill that is similar to one passed last year that did not clear the Senate before the 113th Congress adjourned.