CIMA Labs Announces FDA Approval of Zomig-ZMT.Business Editors & Health/Medical Writers EDEN PRAIRIE Eden Prairie A city of eastern Minnesota, a residential suburb of Minneapolis. Population: 57,300. , Minn.--(BUSINESS WIRE)--Feb. 14, 2001 Antimigraine Product Based on CIMA's Fast-Dissolve DuraSolv(TM) Drug Delivery Technology CIMA Labs, Inc. (Nasdaq:CIMA) today announced that AstraZeneca (NYSE NYSE See: New York Stock Exchange :AZN AZN Asian ) has received U.S. marketing approval from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for Zomig-ZMT(TM) (zolmitriptan zolmitriptan /zol·mi·trip·tan/ (zol?mi-trip´tan) a selective serotonin receptor agonist used to relieve acute migraine. zol·mi·trip·tan n. ), an orally disintegrating antimigraine compound incorporating CIMA's DuraSolv fast-dissolve drug delivery system with AstraZeneca's active drug ingredient, zolmitriptan. AstraZeneca is expected to begin U.S. marketing and distribution of Zomig-ZMT in the second quarter of 2001 for the acute treatment of migraine attacks, with or without aura. Zomig-ZMT is the second branded prescription product based on a CIMA fast-dissolve technology approved by the FDA in 2001. In January, Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. Inc. received FDA approval for Remeron(R) SolTab(TM), an orally disintegrating antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. incorporating CIMA's OraSolv(R) drug delivery system with Organon's active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. , mirtazapine. A conventional tablet dosage form of Zomig has been commercially available in the U.S. since 1997. In addition, AstraZeneca launched Zomig-ZMT in Europe in September 1999 where it is marketed as Zomig Rapimelt. This product is currently available in 14 European countries. Except for their marketing names, Zomig Rapimelt and Zomig-ZMT are the same product. AstraZeneca recently reported that worldwide sales for all dosage forms of Zomig increased 31% in constant currencies in full-year 2000 to U.S. $237 million. CIMA is AstraZeneca's exclusive supplier of Zomig-ZMT for the U.S. market and Zomig Rapimelt for the European market. John M. Siebert, Ph.D., president and chief executive officer, commented: "With the FDA approval of Zomig-ZMT, CIMA now manufactures five products based on our OraSolv and DuraSolv technologies: three branded prescription drugs, including launch supplies of an undisclosed Schwarz Pharma product, and two over-the-counter products. Our growing product family makes us believe that CIMA's fast-dissolve technology has been thoroughly validated by regulatory authorities and the marketplace. Equally important, we are rapidly attaining our strategic goal of shifting CIMA's focus to higher-margin prescription products, which is having a positive impact on CIMA's profitability." About CIMA CIMA develops and manufactures prescription and over-the-counter products for pharmaceutical companies based upon its proprietary, fast-dissolve drug delivery technologies, OraSolv and DuraSolv. CIMA formulates a pharmaceutical company's active drug ingredient into a new, orally disintegrating dosage form that dissolves quickly in the mouth without chewing or the need for water. Taste masking agents may be used with the Company's fast-dissolve technologies to prevent or minimize the unpleasant taste associated with many active drug ingredients. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15.8 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) and respiratory products. In the United States, AstraZeneca is a $7.9 billion healthcare business with more than 10,000 employees. For more information, please refer to our website www.astrazeneca-us.com. The information in this press release, including the information related to the Company's expectations about the timetable for AstraZeneca's introduction of Zomig-ZMT in the U.S., contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. A number of factors could cause actual results to differ materially from CIMA's assumptions and expectations. These factors include AstraZeneca's actual product introduction schedule and those set forth in the cautionary statements included in Exhibit 99.1 to CIMA's most recent Form 10-Q Form 10-Q See 10-Q. or Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , as amended, filed with the Securities and Exchange Commission. All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements. |
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