Sernova, FDA clarify details of diabetes drug trials
WASHINGTON Sernova has concluded a pre-investigational new drug application meeting with the Food and Drug Administration, establishing clinical trial requirements for its diabetes treatment Sertolin.
The meeting clarified details of the development path for the company’s xenotransplantation approach to treating diabetes, which involves cotransplantation of insulin-producing pig islet cells and Sertoli cells using a small subcutaneous medical device. Sertoli cells act as an anti-rejection agent, eliminating the need for anti-rejection drugs, which are immunosuppressants.
The next stage for Sertolin will be a pivotal large-animal trial, leading to a Phase I/II human trial, the company said.
Sernova plans to begin the large-animal trial in approximately six months, according to chief executive officer Justin Leushner. It is expected to take 18 months to complete and will assess the long-term safety and efficacy of Sertolin.
Sanofi-Aventis, Debiopharm sue W.C. Heraeus over Eloxatin patent
BRIDGEWATER, N.J. Sanofi-Aventis and Debiopharm have filed a lawsuit in the U.S. District Court for the District of New Jersey against W.C. Heraeus, in which they accuse the company of helping generic drug makers infringe a patent on their active ingredient for the colorectal cancer drug Eloxatin.
In the suit, the plaintiffs claim that Heraeus manufactured the active pharmaceutical ingredient in Eloxatin for Mayne Pharma, Sandoz and Ebewe Pharma. The three companies independently submitted applications to sell generic versions of the drug before the 2013 expiration of the ‘874 patent.
Sanofi and Debiopharm have asked the court to issue a permanent injunction restraining Heraeus and its officers from selling and importing generic oxaliplatin products claimed in the patent into the U.S.
Currently, there are no FDA-approved generic versions of the drug, which had worldwide sales of $2.35 billion in 2007, according to Sanofi.
FutureScripts launches new Web site
PHILADELPHIA FutureScripts, a pharmacy benefit manager in Philadelphia, has unveiled a new website, www.futurescripts.com. The website is a tool for plan participants, health care professionals and benefit managers to help find key information about the drugs on FutureScripts’ formulary, how safe prescribing procedures work and much more.
“The new website allows our customers to find vital information about their medications—whether a drug is available as a generic and what that drug costs compared to similar medications,” said Paul Urick, senior vice president of FutureScripts. “Our website also provides health care professionals and plan participants the latest updates on the drugs on our formulary.”
Through the site, plan participants can find a participating pharmacy within the FutureScripts’ national network of more than 60,000 retail and specialty locations by ZIP code search or by entering a pharmacy name benefit managers can read about the latest pharmacy trends through the online FutureScripts InSight newsletter. The frequently asked questions section features the most common inquiries received by FutureScripts, ranging from ‘What is a 96-hour temporary supply?’ to ‘How do I request an exception to an age, gender, or quantity limit?’
“Overall, our new site was designed to service the needs of our customers and was developed in response to their suggestions,” said Urick. “We expect to further enhance and customize our website to fit the evolving needs of plan participants, employers, health care providers, and pharmacists.”