Columbia Laboratories Announces Marketing Partnership with Mipharm S.p.A. For Striant -Testosterone Buccal System- Mucoadhesive In Italy.Business Editors/Health/Medical Writers LIVINGSTON, N.J. & MILAN Milan, prince and king of Serbia Milan (Milan Obrenović) (mĭl`än ōbrĕ`nəvĭch), 1854–1901, prince (1868–82) and king (1882–89) of Serbia; grandnephew of Miloš Obrenović. , Italy--(BUSINESS WIRE)--June 9, 2003 Columbia to Receive $1.4 Million in Upfront Payments and Future Performance Fees Columbia Laboratories (AMEX AMEX See: American Stock Exchange : COB) and Mipharm S.p.A. announced today that they have executed an agreement for marketing Columbia's Striant(TM) (testosterone testosterone (tĕstŏs`tərōn), principal androgen, or male sex hormone. One of the group of compounds known as anabolic steroids, testosterone is secreted by the testes (see testis) but is also synthesized in small quantities in the buccal buc·cal adj. 1. Of, relating to, adjacent to, or in the direction of the cheek. 2. Of or relating to the mouth cavity. buccal system) mucoadhesive in Italy. Under the terms of the agreement, Mipharm will market, distribute and sell Striant(TM) in Italy. In exchange for these rights, Columbia will receive payments of $1.4 million, including the immediate reimbursement of $350,000 in development costs. A mutual recognition application for marketing in Italy will be filed based on initial regulatory approval of the pending application in the United Kingdom. Mipharm will provide additional performance payments upon achievement of certain levels of sales in Italy, and Columbia will receive a percentage markup (text) markup - In computerised document preparation, a method of adding information to the text indicating the logical components of a document, or instructions for layout of the text on the page or other information which can be interpreted by some automatic system. on the cost of goods for each unit sold. Mipharm is Columbia's manufacturer for Striant(TM) under a May 2002 agreement. Fred Wilkinson, chairman, president and chief executive officer of Columbia Laboratories, stated, "We are pleased to expand our relationship with Mipharm to include the marketing of this promising product, and are confident that Mipharm will successfully launch Striant(TM) in the key market of Italy. We now have supply and distribution agreements in place for 19 countries in Europe, and continue to explore similar agreements that would allow Striant(TM) to be marketed worldwide." Giuseppe G. Miglio, Mipharm's founder, chairman and chief executive officer commented, "We are very excited to be able to commercialize Striant(TM) in Italy. Striant(TM) is based upon an innovative technology and will be introduced into a highly unsatisfied market where this new approach to therapy is expected to be well received by both patients and physicians. This represents an important opportunity to address a significant unmet healthcare need with a convenient therapeutic alternative for patients. In addition to having been part of the development team for Striant(TM) through our Special Services Division, which took care of the final formulation development of this product, we are pleased to be the manufacturer of Striant(TM) for the U.S. and European markets in our new dedicated Potent Drug manufacturing suite." Striant(TM), for which Columbia submitted an 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 with the U.S. Food and Drug Administration in August 2002 and a Marketing Authorization Application in the UK in November 2002, is a controlled- and sustained- release tablet-like mucoadhesive buccal system containing 30mg of testosterone. Striant(TM) allows for the slow release and absorption of testosterone through gum and cheek surfaces that are in contact with the product. Dosing is twice-daily, with applications in the morning and in the evening, which maintains consistent physiologic levels of testosterone. This product utilizes both the Bioadhesive Delivery System (BDS BDS abbr. Bachelor of Dental Surgery BDS Bachelor of Dental Surgery BDS n abbr (= Bachelor of Dental Surgery) → título universitario BDS ) and the hydrating buccal technology platforms previously patented by the company. Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. care and endocrinology endocrinology Medical discipline dealing with regulation of body functions by hormones and other biochemicals and treatment of endocrine system imbalances. In 1841 Friedrich Gustav Henle first recognized “ductless glands,” which secrete products directly into products, including those intended to treat infertility infertility, inability to conceive or carry a child to delivery. The term is usually limited to situations where the couple has had intercourse regularly for one year without using birth control. , dysmenorrhea dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. , endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. and hormonal deficiencies. Columbia is also developing hormonal products for men and a buccal delivery system for peptides. Columbia's products primarily utilize the company's patented Bioadhesive Delivery System (BDS) technology. For more information, visit www.columbialabs.com. Mipharm S.p.A., based in Milan, Italy, is an independent pharmaceutical company focused on dermatology/skin care, gynecology/women's health, and special care. The company has an 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. approved manufacturing facility that supplies products for sale throughout Europe and the U.S. for large pharmaceutical companies. Mipharm was founded in January 1998, by Dr. Giuseppe G. Miglio (formerly President of the Pharmaceutical Business of Novartis in Italy and President and Chairman of Sandoz Holding, Italy) with a spin-off from Novartis' Milan technical production facility. Mipharm recently strengthened its relationship with Novartis Pharma AG (Basel) through the acquisition by Novartis Pharma AG of 10 percent of Mipharm's shares by the way of a capital investment and by conferring the title of "preferred supplier" of the Novartis Group. In addition to its manufacturing capabilities, new technology delivery systems that improve upon traditional systems and add value to effective and well known compounds are one of Mipharm's strengths. For more information, visit www.mipharm.it This press release contains statements that constitute 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 Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Such risks and uncertainties include, among other things, timely and successful completion of clinical studies, success in obtaining regulatory acceptance and approval of new products, including Striant(TM), the successful commercialization of Striant(TM), if approved, competitive economic and regulatory factors in the pharmaceutical and healthcare industry, general economic conditions, and other risks and uncertainties that may be detailed, from time to time, in Columbia's reports filed with the Securities and Exchange Commission. |
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