US News Roundup
pharmafile | March 23, 2007 | News story | Sales and Marketing |
Datamonitor reports on the American market:
FDA grants Ranbaxy tentative approval for insomnia drug
Ranbaxy has received tentative approval from the FDA to manufacture and market a generic version of Sanofi-Aventis' insomnia drug Ambien.
Ranbaxy said that it plans to manufacture the zolpidem tartrate tablets in 5mg and 10mg strengths. The products will be manufactured at the company's New Jersey Ohm Laboratories facility.
Total annual market sales for zolpidem tartrate tablets were $2.12 billion, according to Ranbaxy.
"This product will be launched following final approval from the FDA and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative," said Jim Meehan, vice president of sales and marketing for Ranbaxy in the US.
Related Links
Pipeline and Commercial Perspectives: Insomnia
FDA strengthens warnings on sleep drugs
The FDA has requested stronger labeling for sedative-hypnotic drug products, a class of sleep disorder drugs, to include risks such as severe allergic reactions and sleep driving.
Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
Along with the labeling revisions, the FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. The medications include Sanofi-Aventis' Ambien and Abbott's Placidyl.
"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, director of FDA's Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."
Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), can occur as early as the first time the product is taken. Complex sleep-related behaviors may include sleep-driving, making phone calls, and preparing and eating food while still asleep
Related Links
Sanofi-Aventis: LSA Company report
Abbott Laboratories: LSA Company report
GW signs Otsuka as cannabis drug partner
GW Pharmaceuticals has signed Japanese company Otsuka Pharmaceuticals as a partner to help develop and market its cannabis-based cancer pain drug Sativex.
The deal will see UK-based GW receive milestone payments of up to $273 million, including a signature fee of $18 million from Otsuka. In addition, Otsuka will bear the costs of all US development activities for Sativex. Otsuka will have an exclusive licence to develop and market Sativex in the US.
Sativex is in late stage development in the US for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications, and is already approved in Canada for pain relief in multiple sclerosis. GW and Otsuka currently plan for the first US pivotal efficacy clinical trial to be a phase II/III cancer pain dose ranging study, to commence this year.
The companies are also in discussions to start a cannabinoid research collaboration in central nervous system disorders and cancer treatment.
Russell Portenoy, principal investigator of the first planned US Sativex study, said: "Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role."
Related Links
GW Pharmaceuticals Plc: LSA Company report
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
Regulator Perceptions in Cancer – Evolving opinions about the oncology drug approval process
