CollaGenex Pharmaceuticals Signs Agreement with EpiTan to Develop Topical Formulation for Melanotan.Business Editors/Health/Medical Writers NEWTOWN, Pa. & MELBOURNE, Australia--(BUSINESS WIRE)--May 20, 2003 CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced the signing of a strategic collaborative agreement with EpiTan Limited (ASX ASX See: Australian Stock Exchange :EPT EPT European Poker Tour EPT Éducation Pour Tous EPT English Placement Test EPT Early Pregnancy Test EPT Ephemeroptera, Plecoptera, and Trichoptera EPT El Paso, Texas (border patrol sector) EPT Error Proof Test ) and Thomas Skold of Norrtalje, Sweden, to develop a topical formulation for EpiTan's lead drug candidate, Melanotan(R), based on the Restoraderm(TM) topical drug delivery technology. The Restoraderm technology is exclusively licensed to CollaGenex and has been sublicensed to EpiTan. Mr. Skold, the inventor of Restoraderm, will be working directly with EpiTan on the development of the topical delivery of Melanotan. The collaborators believe that the novel characteristics of the Restoraderm technology may improve the feasibility of developing a topical formulation for Melanotan. Previous technology was unable to achieve this objective. It is envisaged that a new formulation will enable Melanotan to be released directly into the skin to the melanin-producing cells. Melanotan, like sunlight, stimulates the production of melanin melanin (mĕl`ənĭn), water-insoluble polymer of various compounds derived from the amino acid tyrosine. It is one of two pigments found in human skin and hair and adds brown to skin color; the other pigment is carotene, which contributes in the skin, allowing a natural tan to develop without exposure to harmful levels of ultraviolet light. EpiTan believes that Melanotan may reduce skin damage from sun exposure and thus reduce the incidence of skin cancer. "We are interested in developing collaborations with companies owning novel and exciting active ingredients which can benefit from the unique characteristics of the Restoraderm technology," said Robert A. Ashley, senior vice president of CollaGenex Pharmaceuticals. "Melanotan presents the type of topical drug delivery challenge which we believe can be addressed with Restoraderm, and we will be actively involved not only in the development of Restoraderm-based products for our own portfolio but also in attempting to solve topical delivery challenges faced by other companies." "The successful development of a topical lotion for Melanotan based on the Restoraderm technology will offer patients and doctors the choice of an alternative user-friendly and convenient delivery system for Melanotan," said Dr. Wayne Millen, EpiTan's Managing Director. "We are very pleased to be working with CollaGenex and Mr. Skold and this collaborative agreement builds on our success in developing a single-dose, slow-release implant which was announced earlier this year." Dr. Millen added, "This work is extremely well positioned behind the excellent progress of our Phase IIb clinical trials reported recently." About CollaGenex CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's 115-person professional dental pharmaceutical sales force markets Periostat(R), which is indicated as an adjunct to scaling and root planing The objective of scaling and root planing, otherwise known as conventional periodontal therapy, is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] for the treatment of adult periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. . Periostat(R) is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues, and by enhancing bone protein synthesis. The sales force also promotes Vioxx(R), a Merck & Co. drug that CollaGenex co-promotes for the treatment of acute dental pain, Denavir(R), a Novartis Group prescription anti-viral medication for the treatment of cold sores, Sirius Laboratories' AVAR(TM) product line for the topical control of acne vulgaris, rosacea Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and and seborrheic dermatitis, and Atridox(R), Atrisorb(R) FreeFlow(TM) and Atrisorb-D(R) FreeFlow(TM), Atrix Laboratories Inc.'s products for the treatment of adult periodontitis. Research has shown that certain unique properties of the tetracyclines Tetracyclines Definition Tetracyclines are medicines that kill certain infection-causing microorganisms. Purpose Tetracyclines are called "broad-spectrum" antibiotics, because they can be used to treat a wide variety of discovered during the development of Periostat may be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues, including acne, rosacea, meibomianitis and cancer metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to , among others. CollaGenex is further evaluating Periostat, as well as the new IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service (R), to assess whether they are safe and effective in these applications. In addition, CollaGenex has licensed the Restoraderm technology, a unique, proprietary dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. drug delivery system, in order to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties. To receive additional information on the Company, please visit our website at www.collagenex.com which does not form part of this press release. About EpiTan EpiTan Limited (ASX:EPT) is an emerging biotechnology company with a pre-eminent position on the prevention of DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. & skin damage from ultra-violet (UV) radiation exposure. Based in Melbourne, Australia, EpiTan holds a unique technology platform centered on its leading drug candidate Melanotan. The company has the exclusive worldwide rights to develop Melanotan, which, like sunlight, stimulates the production of melanin in the skin resulting in a natural tan. It allows a tan to develop without exposure to harmful levels of UV light. Melanotan is currently in Phase IIb clinical trials at two sites - the Royal Prince Alfred Hospital RPA Hospital is sometimes confused with The Alfred Hospital in Melbourne, Victoria. The short form "PA Hospital" also refers to Princess Alexandra Hospital in Brisbane, Queensland. in Sydney and the Royal Adelaide Hospital The Royal Adelaide Hospital is Adelaide's largest hospital with over 700 beds. Founded in 1840, the Royal Adelaide provides tertiary health care services for South Australia and provides secondary care clinical services to residents of Adelaide's inner city. . These trials are designed to demonstrate that Melanotan can reduce the incidence of skin damage resulting from harmful exposure to ultra-violet light. EpiTan has now successfully developed a more user-friendly drug delivery formulation of Melanotan in the form of a slow release implant. This will be used in the remaining clinical program and the commercialized product. EpiTan is also investigating Melanotan as a therapeutic agent for other indications such as vitiligo vitiligo or leukoderma Skin disorder manifested by smooth, white spots on various parts of the body. Though the pigment-making cells of the skin, or melanocytes, are structurally intact, they have lost the ability to synthesize the pigment. , albinism albinism Absence of the pigment melanin in the eyes, skin, hair, scales, or feathers. It arises from a genetic defect and occurs in humans and other vertebrates. Because they lack the pigments that normally provide protective coloration and screen against the sun's , psoriasis and various recognized sun allergies such as polymorphous light eruptions and solar urticaria. Potential markets worldwide for Melanotan for dermatology purposes are estimated at US$1.5 billion. An even greater market (more than US$5 billion) exists for Melanotan as a new safe (sunless) tanning drug. EpiTan is listed on the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. (ASX:EPT). Periostat(R), Metastat(R), Dermostat(R), Nephrostat(R), Osteostat(R), Arthrostat(R), Rheumastat(R), Corneostat(R), Gingistat(R), IMPACS(R), PS20(TM), The Whole Mouth Treatment(R), Restoraderm(TM) and Dentaplex(R) are United States trademarks of CollaGenex Pharmaceuticals, Inc. Periostat(R), Nephrostat(R), Optistat(R), Xerostat(R) and IMPACS(TM) are European Community trademarks of CollaGenex Pharmaceuticals, Inc. Periostat(R), Nephrostat(R), Optistat(R), Xerostat(R), IMPACS(R), Dentaplex(R), Restoraderm(R), Dermastat(R), Periocycline(R), Periostatus(R) and Periostan(R) are United Kingdom trademarks of our wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , CollaGenex International Limited. CollaGenex(R), PS20(R), "C" Logo(R) and The Whole Mouth Treatment(R) are European Community and United Kingdom trademarks of CollaGenex International Limited. Periocycline(TM) and Periostan(TM) are European Community Trademarks of CollaGenex International Limited. All other trade names, trademarks or service marks are the property of their respective owners and are not property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries. Pandel(R) is a trademark of Taisho Pharmaceuticals. VIOXX(R) is a trademark of Merck & Co., Inc. AVAR(TM) is a trademark of Sirius Laboratories, Inc. Atridox(R), Atrisorb(R) and Atrisorb-D(R) are trademarks of Atrix Laboratories, Inc. Melanotan(R) is a trademark of EpiTan Ltd. |
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