CIMA LABS Issued Second Patent for OraVescent Oral Drug Delivery Technology.Business Editors & Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--March 5, 2002 Technology Designed to Improve Absorption Rates of Active Drug Ingredients Across Mucosal Mucosal Refers to tissues that produce mucus, such as the digestive, genital and urinary tracts. Mentioned in: Intestinal Polyps mucosal pertaining to or emanating from mucosa. Membranes Lining Gastrointestinal Tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract CIMA LABS INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq:CIMA) today announced the issuance of a second patent (U.S. patent No. 6,350,470) from the U.S. Patent and Trademark Office covering its OraVescent(TM) technology. This patent applies to an oral drug delivery system designed to improve the transport of active drug ingredients across mucosal membranes lining the gastrointestinal tract. Patent protection will extend through 2019. A first patent on CIMA's OraVescent technology, which was issued in March 2001, applies to a drug delivery system that utilizes a tablet See digitizer tablet and tablet computer. TABLET - A query language. ["Human Factor Comparison of a Procedural and a Non-procedural Query Language", C. Welty et al, ACM Trans Database Sys 6(4):626-649 (Dec 1981)]. placed under the tongue or between the gum and cheek to improve drug absorption across mucosal membranes lining the mouth. The second OraVescent patent applies to tablets or capsules that are swallowed by the patient. The drug is released when the tablet or capsule capsule In botany, a dry fruit that opens when ripe. It splits from top to bottom into separate segments known as valves, as in the iris, or forms pores at the top (e.g., poppy), or splits around the circumference, with the top falling off (e.g., pigweed and plantain). reaches the targeted part of the gastrointestinal tract for optimal absorption. OraVescent uses a barrier coating that prevents premature release of the drug, and effervescence ef·fer·vesce intr.v. ef·fer·vesced, ef·fer·vesc·ing, ef·fer·vesc·es 1. To emit small bubbles of gas, as a carbonated or fermenting liquid. 2. To escape from a liquid as bubbles; bubble up. 3. to drive the drug across mucosal membranes. Mucoadhesives and pH adjusting substances may be used with the OraVescent technology to further enhance the absorption process. John M. Siebert, Ph.D., president and chief executive officer, commented: "We are extremely pleased to have additional patent protection extended to our OraVescent technology. OraVescent has the potential to rival the importance of our current OraSolv(R) and DuraSolv(R) fast-dissolve drug delivery systems over the next few years." CIMA is currently developing a proprietary product that incorporates its OraVescent technology (for mucosal membranes lining the mouth) with fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and , a drug used to treat breakthrough cancer pain. Three human studies on OraVescent fentanyl have been completed, and the results have confirmed CIMA's initial hypothesis that effervescence drives active drug compounds across mucosal membranes. These studies found that OraVescent fentanyl was absorbed 50% more quickly than Actiq(R), the commercial control used in these studies. It was also determined that the extent of absorption was 50% to 60% greater for OraVescent fentanyl than for Actiq. CIMA presented this human data to the Food and Drug Administration at a pre-IND (Investigational New Drug) meeting in November. Based upon the clinical development plan discussed at that meeting, the Company believes OraVescent fentanyl could be introduced to the U.S. market by late 2004. About CIMA LABS CIMA develops and manufactures prescription and over-the-counter products based upon its proprietary, fast-dissolve drug delivery technologies, OraSolv and DuraSolv. Based on our technologies, an active drug ingredient is formulated into a new, orally disintegrating dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. that dissolves quickly in the mouth without chewing chewing or mastication Up-and-down and side-to-side movements of the lower jaw, using the teeth to grind food for easier swallowing. During chewing, the tongue shapes food into a lump and saliva lubricates it for swallowing. or the need for water. CIMA's fast-dissolve technologies also incorporate taste masking mask·ing n. 1. The concealment or the screening of one sensory process or sensation by another. 2. An opaque covering used to camouflage the metal parts of a prosthesis. agents to prevent or minimize the unpleasant taste associated with many active drug ingredients. Our business is currently focused on pharmaceutical company partners for whom we manufacture three branded prescription pharmaceuticals and two over-the-counter brands. In a new strategic initiative, CIMA is internally developing proprietary products based on pharmaceuticals that are expected to lose marketing exclusivity over the next several years. These new proprietary products will utilize our OraSolv and DuraSolv fast-dissolve technologies, as well as our new OraVescent technology, an enhanced absorption, transmucosal drug delivery system. Cautionary Statement This press release, including the information related to CIMA's expectations about product introductions, contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 the timely and successful completion of product development activities and regulatory approvals for proposed products. Additional factors that may cause actual results to differ from CIMA's assumptions and expectations include those set forth under the heading "Factors That Could Affect Future Results" included in CIMA's most recent filings with the Securities and Exchange Commission. All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion