Business briefs: Chandler Chicco, Pfizer, FDA, Dainippon, CDC
Spring brought in more than warmer temps—Edelman's VP of Digital Health Shwen Gwee kicked off April with a new title and a new office: Chief Digital Officer for communications agency Chandler Chicco. Word officially went out with Gwee's foursquare check in and Facebook posts, as well as a welcoming tweet from the new home office. Gwee's experience includes leading digital marketing for Vertex, and serving as an advisory board member the SXSW health track. He also founded PharmaFresh.TV and Med20.com.
Pfizer closed out March dogged by Celebrex and Bextra: a federal judge is allowing a shareholder lawsuit against the company over allegations that Pfizer misrepresented the drugs' safety to go ahead, reported Reuters. While the company pulled Bextra from the market in 2005, based on FDA's recommendation, it has continued to sell Celebrex. The drugs were associated with cardiovascular risk, like Merck's Vioxx, which was pulled from the shelves in 2004 after being linked to higher risk of stroke and heart attacks. Bextra was removed for heart, stomach and skin issues. Also in the Pfizer-verse: Viagra closed in on its 15th year in the market, reported Good Morning America. The ED drug has garnered almost $6 billion in sales over the past three years and has a patent clock that doesn't go off until 2020.
Although FDA is still ironing out the biosimilars approval pathway, the regulator has already pieced together a framework of what kind of preparation drug makers should expect once they can start booking review appointments. The meeting draft guidance, posted Friday with an April 1 publishing date, looks similar to the current meeting requirements for non-biologics: filers need to choose a type of meeting as well as compiling documentation for meetings and information packages for later discussions. The difference is in the expected timing. Unlike current PDUFA guidance which pegs formal meeting documentation prep as requiring around 10 hours to compile, and information packages as taking around 18 hours, biosimilars will require digging deeper: FDA recommends manufacturers allot around 15 hours to put together meeting documents and 30 hours for information packages. Altogether, it's a 60% increase in compilation time. The regulator also estimates that the industry will make around 30 meeting approaches during the year and submit 30 information packages, meaning the industry will devote close to 1,440 hours per year putting together the paperwork.
Japanese drug maker Dainippon Sumitomo has announced a $545 million research and development pact with Edison Pharmaceuticals. In doing so, Dainippon receives the rights to EPI-734 and EPI-589 in Japanese markets. EPI-734 was granted orphan drug designation from FDA in 2011 for treatment in orphan pediatric mitochondrial disease. Both Dainippon and Edison will collaborate on the research and development of EPI-589 with a focus on adult central nervous system disease. This collaboration is based upon the emerging body of data implicating redox and mitochondrial dysfunction as a root cause of neurological disorders.
Today, The Centers for Disease Control and Prevention released new data showing that nearly one in five high school boys in the U.S., and 11% of school-age children, have a received a medical diagnosis of attention deficit hyperactivity disorder (ADHD). Approximately 6.4 million children from ages 4-17 have received a diagnosis at some point, which signals a 53% increase in the past ten years. CDC Director Thomas Frieden said of the growing diagnoses: “The right medications for ADHD, given to the right people can make a huge difference. Unfortunately, misuse appears to be growing at an alarming rate.” Experts cited pharmaceutical advertising as one factor for rising rates, which “emphasizes how mediation can substantially improve a child's life,” as well as parents pressuring doctors to help with children's “troublesome behavior and slipping grades," The New York Times reported.