TheraTech enters agreement with Grelan to market testosterone patch in Japan.SALT LAKE CITY--(HealthWire)--April 17, 1995-TheraTech, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :THRT THRT Tubing Hanger Running Tool (subsea drilling industry) THRT Total Hormone Replacement Therapy ) announced an agreement Monday in which Grelan Pharmaceutical Co., a member of Takeda Chemical Industries Group, acquired exclusive rights to develop and distribute TheraTech's testosterone patch for the Japanese market. Licensed through Theratech Japan, TheraTech will receive milestone payments, royalties on sales and retain manufacturing and co-promotion rights in Japan. In addition, Grelan will pay for all pre-clinical and clinical development costs for product registration in Japan. "We are pleased to establish this alliance with Grelan, a company well known for its expertise and commitment to product development and marketing of new drugs," said Dr. Dinesh C. Patel, president and chief executive officer of TheraTech. "Combining TheraTech's drug delivery technology with Grelan's focus on `research for development' will expedite the market introduction of our innovative product." TheraTech has previously signed marketing and distribution agreements for the testosterone patch with SmithKline Beecham for the U.S., Canada, Eastern and Western Europe (excluding France, Spain, Portugal, Scandinavia), Australia and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. ; with Laboratoires Fournier for France; with Cepa for Spain; with Bioty for Portugal; and with Astra AB for Sweden, Denmark, Norway, Finland and Iceland. The patch, which was developed and clinically tested by TheraTech, is intended for the treatment of male hypogonadism, a syndrome in which the body produces insufficient amounts of the male hormone, testosterone. The patch employs TheraTech's proprietary permeation enhancers, anti-irritant and liquid reservoir system design. A New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) seeking approval for the patch was filed by TheraTech with the U.S. 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. ) in September of last year. Testosterone, a naturally occurring hormone, is essential for the development and maintenance of male physical and sexual characteristics. It is estimated that a large number of men are affected by hypogonadism Hypogonadism Definition Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate. , the symptoms of which include impotence, decreased libido libido (lĭbē`dō, –bī`–) [Lat.,=lust], psychoanalytic term used by Sigmund Freud to identify instinctive energy with the sex instinct. , fatigue and depression. Current treatment primarily consists of intra-muscular injections of a testosterone ester every two to four weeks. The testosterone patch is intended to replace these injections by delivering, on a daily basis, the amount of natural testosterone normally produced by the body. The patch can be applied to numerous sites on the body, and produces physiological levels of testosterone and its metabolites Metabolites Substances produced by metabolism or by a metabolic process. Mentioned in: Interactions , mimicking those seen in healthy young men. Grelan Pharmaceutical Co., a Tokyo-based private company founded in 1930, develops and markets prescription drugs including analgesics Analgesics Definition Analgesics are medicines that relieve pain. Purpose Analgesics are those drugs that mainly provide pain relief. , gastrointestinal agents, respiratory and anti-allergic agents in Japan. Grelan distributes these products through Takeda Chemical Industries, Ltd., one of Japan's largest pharmaceutical companies. In addition to this agreement with Grelan Pharmaceutical Co., TheraTech has ongoing collaborative agreements in Japan with Hisamitsu Pharmaceutical Co., Tsumura & Co., Nihon Iyakuhin Kogyo Co. and two other major pharmaceutical companies. TheraTech, Inc., headquartered in Salt Lake City, Utah For ships of the United States Navy of the same name, see . Salt Lake City is the capital and the most populous city of the U.S. state of Utah. The name of the city is often shortened to Salt Lake, or its initials, S.L.C. , is a leader in the development of innovative products based on controlled release drug delivery technologies, developing products independently as well as with corporate partners. These products include transdermal patches, oral transmucosal products for delivery of macromolecules Macromolecules A large molecule composed of thousands of atoms. Mentioned in: Gene Therapy macromolecules including peptide drugs, oral controlled release products and topical preparations. TheraTech currently has equity and/or multi-product research and marketing agreements with Pfizer, SmithKline Beecham, Solvay Pharmaceuticals and Syntex in the United States and the Sam Yang Group in Korea. CONTACT: TheraTech, Inc. Alexander L. Searl or Myrna Duncan, 801/588-6200 or Burns McClellan Justin Jackson, 415/399-4525 |
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