THERATECHNOLOGIES GETS US $12 MILLION FOR MACROFLUX.Theratechnologies (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension : TH), Montreal, has received US $12 million (CAD $15 million) from ALZA Corporation of Mountain View, California For the census-designated place, see Mountain View, Contra Costa County, California. For other places called "Mountain View", see . Mountain View is a city in Santa Clara County, in the U.S. state of California. The city gets its name from the views of the Santa Cruz Mountains. (ALZA) for its interest in co-development projects using ALZA's Macroflux(R) transdermal technology. The company also confirmed that it has requested a meeting with 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. ) in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. to discuss advancing ThGRF (TH9507), an analogue of growth hormone growth hormone or somatotropin (sōmăt'ətrō`pən), glycoprotein hormone released by the anterior pituitary gland that is necessary for normal skeletal growth in humans (see protein). releasing factor re·leas·ing factor n. Abbr. RF A substance of hypothalamic origin capable of accelerating the secretion of a given hormone by the anterior lobe of pituitary gland. Also called releasing hormone. , into late-stage development. "The actions we are announcing today are important steps towards meeting the objectives we have set for ourselves in 2005", said Yves Rosconi, the newly appointed president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Theratechnologies. "Advancing ThGRF is clearly the top priority for the company because it is the single most important thing we can do in the near term to build value for shareholders. The ALZA deal supports this goal while enhancing our already strong financial position. In effect we have strengthened our cash position, lowered our burn rate, and narrowed our near-term business focus so that we can devote more time and energy to ThGRF," Rosconi concluded. Rosconi has established four key priorities for Theratechnologies in 2005, emphasizing the need to: (1) strengthen the organization by recruiting additional experienced pharmaceutical executives; (2) tightly focus the company's resources on advancing ThGRF into late-stage development; (3) maintain a sound financial position; and (4) strengthen the product pipeline. Request for meeting submitted to FDA The company's lead compound, ThGRF, is an analogue of a natural hormone known as growth hormone releasing factor. ThGRF showed promising results in Phase II testing for the treatment of HIV-related lipodystrophy, a metabolic disorder Noun 1. metabolic disorder - a disorder or defect of metabolism disorder, upset - a physical condition in which there is a disturbance of normal functioning; "the doctor prescribed some medicine for the disorder"; "everyone gets stomach upsets from time to time" that afflicts HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. patients. The proposed late-stage development program for ThGRF has been thoroughly reviewed in order to maximize the chances of success at both the regulatory and clinical levels. This work has now been completed and a request for a meeting has been submitted to FDA. The meeting is expected to take place in March 2005. Agreements with ALZA Theratechnologies had three previously announced co-development projects with ALZA Corporation utilizing Macroflux(R), a novel transdermal drug delivery technology. In return for its interest in these projects, Theratechnologies received a lump-sum payment of US $12 million (CAD $15 million). The agreement announced today has no impact on Theratechnologies existing development programs for ThGRF and ThGLP-1, which are continuing. Both of these compounds are currently being administered by subcutaneous injection and the company intends to investigate alternative means of delivery for potential application in the future. Outlook "While there are many challenges still ahead, I am pleased with the progress we have made over the past two months. Our lead compound is now that much closer to late-stage development and I am very confident that we are on the right regulatory track", Rosconi stated. "The ALZA deal is about increased focus and it's about cash. We now have close to $60 million available, enough to fund operations for over three years. This allows us to embark on the late-stage development of ThGRF without feeling pressure to issue additional shares," Rosconi concluded. About Theratechnologies Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company engaged in the discovery and development of therapeutic peptides in the field of endocrinology and metabolism. The company is steadily expanding its product portfolio through proprietary discovery technologies. The most advanced clinical program (completed Phase II) targets HIV-associated lipodystrophy. Other clinical programs are investigating wasting associated with chronic disease (Phase II), and type 2 diabetes type 2 diabetes n. See diabetes mellitus. (Phase I). The company is listed on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the symbol TH. For more information, call 514/336-4804, Ext. 215, or visit http://www.theratech.com. |
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