CIMA Formulating Migraine Drug for Zeneca
CIMA Labs (Eden Prairie, Minn.) has announced that its fast-melt OraSolv technology will be used in a development program for Zomig. Zomig (Zolmitriptan), an antimigraine product from U.K.-based Zeneca Group plc, has been approved in several European countries and was launched in the United States last week. Markets for migraine products are expected to reach $2.3 billion per year by 2000; prescription antimigraine drug sales in the United States were $639 million in 1996, an increase of almost 61 percent over 1995.
OraSolv is a patented combination of mannitol, sweeteners, and other ingredients that encapsulate drugs to make them more easily administered by mouth. Drugs formulated with OraSolv have a pleasant taste and dissolve on contact with saliva, which reduces compliance problems arising from difficulty swallowing tablets and bad-tasting medications. As patients suck gently on an OraSolv tablet, saliva triggers a mild effervescent reaction that disintegrates the tablet quickly, releasing the drug as a microsuspension. Non-compliance, an acute problem in children and the elderly, carries significant health risks. According to CIMA it also costs the pharmaceutical industry $20 billion in lost sales.
OraSolv tablets are made on a tablet press in a manner similar to conventional tablets. Since the formulation is moisture-sensitive, manufacturing is carried out in a humidity-controlled environment and the individual tablets are blister-packed to prevent moisture damage. Tests show the formulation is stable for two years, which is longer than the expiration date for some potential OraSolv-drug combinations.
Under the Zomig agreement, Zeneca will deliver bulk active to CIMA, which will formulate the drug and deliver it to Zeneca for distribution. In return CIMA will receive direct payments and royalties based on sales.
CIMA CFO Keith Salenger told Pharmaceutical Online, "Almost any drug is a good candidate for the OraSolv formulation, but CIMA is focusing on pediatric and geriatric markets since non-compliance is especially severe in these patient groups." CIMA has entered collaborations with at least six pharmaceutical companies for at least eight different drugs: Bristol- Myers Squibb (pediatric analgesics and "multiple" products); Glaxo Wellcome (gastric drugs); SmithKline Beecham (analgesics, cough/cold/flu, and "undisclosed" medications); Schering-Plough and Zeneca (undisclosed) and Merck (on a different formulation product, Autolution).
CIMA Labs Inc., 10000 Valley View Rd., Eden Prairie, MN 55344. Tel: 612-947-8700.
By Angelo DePalma