Business briefs: Biogen Idec; Novo Nordisk and Merrion; Pfizer; FDA; inVentiv Health

Biogen's MS oral hopeful gets extra patent life; Novo's novel oral insulin passes Phase I; Pfizer gets clinical research equivalent of Good Housekeeping stamp of approval; FDA's acting generics chief; InVentiv buys stake in an electronic clinical trial company

March 20, 2013

4:49 pm

Biogen Idec won a patent that will extend the patent-protected life of its MS drug Tecfidera, nee BG-12, an extra eight years, to 2028 – should it win FDA approval. The agency is expected to issue a decision on the oral drug by the end of March, and analysts think it will prove a blockbuster. Tecfidera is an oral formulation of the inflammation-fighting compound dimethyl fumurate, used to treat psoriasis in Europe.

Novo Nordisk and Merrion said their novel oral insulin (NN1954) met targets for Phase I clinical trials. The initial trials of the insulin, which uses Merrion’s GIPET drug delivery technology, looked at safety, tolerability, exposure and effect on blood glucose levels.

Pfizer has become the first pharma to win accreditation by (deep breath) the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which accredits companies “that conduct human research and can demonstrate that their protections exceed the safeguards required by the US.” The accreditation follows a “rigorous 15-month examination” of several of Pfizer’s clinical research units, including that in New Haven, CT, by AAHRPP.

The FDA named Dr. Kathleen Uhl, MD acting director of the Office of Generic Drugs. Uhl was previously senior advisor to the director of the office, Greg Geba, who abruptly resigned last week. She’s been at FDA 15 years, having served as director of the agency’s Office of Women’s Health and deputy director of the Office of Medical Policy, in which role she was “instrumental in FDA’s negotiations with industry for the authorization of the new Biosimilar User Fee Act of 2012,” said the agency.

Inventiv Health subsidiary inVentiv Health Clinical, is getting into virtual clinical trials. The company announced Wednesday that it acquired an “equity stake” in Mytrus. The move gives InVentiv partial ownership an FDA-approved program that lets clinical trial patients opt-in and participate from home. Mytrus summarizes the process on its website in four steps: choose a clinical trial, see if you qualify, agree to requirements and join. InVentiv Health Clinical’s president, Ray Hill, said in a statement that the business alignment will “allow us to recruit and retain a broader base of patients more quickly to help meet our clients’ needs.”