Aphton and SmithKline Beecham Form Strategic Alliance.MIAMI--(BW HealthWire)--June 19, 1998--Aphton Corporation (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 :APHT APHT Advance Physical Test ) and SmithKline Beecham today announced the signing of a Collaboration and License Agreement for a worldwide strategic alliance for Aphton's Gonadimmune(TM) anti-Gonadotropin Releasing Hormone (anti-GnRH) vaccines. The agreement covers the diagnosis, treatment and prevention of GnRH-related cancers and other diseases in humans - including - prostate, breast, ovarian and endometrial cancers; and 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. , polycystic polycystic /poly·cys·tic/ (-sis´tik) containing many cysts. pol·y·cys·tic adj. Having or containing many cysts. polycystic containing many cysts. ovaries Ovaries The female sex organs that make eggs and female hormones. Mentioned in: Choriocarcinoma ovaries (ō´v , uterine fibroids Uterine Fibroids Definition Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer. , contraception, infertility and precocious puberty Precocious Puberty Definition Sexual development before the age of eight in girls, and age 10 in boys. Description Not every child reaches puberty at the same time, but in most cases it's safe to predict that sexual development will . Under the terms of the agreement, SmithKline Beecham will receive exclusive rights worldwide to Aphton's related patents and proprietary technology. Aphton and SmithKline Beecham will collaborate in a development program with the objective of developing products in the field. The program will be directed by a joint steering committee, under which the clinical trials teams of Aphton and SmithKline Beecham will conduct trialsjointly. SmithKline Beecham will be responsible for funding all costs of product development, clinical trials and approvals for worldwide marketing and distribution. The agreement uses a royalty mechanism based on product sales, in dollars, worldwide to determine Aphton's revenues. Aphton indeed elected to forego significant upfront and milestone payments in favor of receiving a larger further income under the agreed mechanism. As part of the Agreement, SmithKline Beecham made an equity investment of US$5,000,000 for 237,867 shares of newly issued Aphton common stock. The price per share included a premium. In addition, SmithKline Beecham has granted Aphton an irrevocable two-year option to sell to SmithKline Beecham additional shares of newly-issued Aphton common stock for a value of US$5,000,000 at the then current market price. If and when Aphton exercises that option, SmithKline Beecham shall have the right for 90 days to purchase a number of additional shares of newly-issued Aphton common stock for a value of US$5,000,000 at the then current market price. Aphton's Chairman and Chief Executive Officer, Philip Gevas, said: "With its continued commitment and excellence in the cancer field, SmithKline Beecham makes an ideal partner as we begin the next phases of global development and marketing on Gonadimmune(TM)." Jean Stephenne, Ph.D., Senior Vice President-General Manager, SmithKline Beecham Biologicals, said: "We have very high regard for Aphton's people, science, technology and products. Gonadimmune(TM) represents an exciting new paradigm New Paradigm In the investing world, a totally new way of doing things that has a huge effect on business. Notes: The word "paradigm" is defined as a pattern or model, and it has been used in science to refer to a theoretical framework. for the treatment and prevention of a wide variety of cancers and this agreement is in line with SB's scientific strategy to develop a new range of cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine or pharmaccines." Gonadimmune(TM), for which Aphton was issued a US patent in November 1997, induces antibodies in the patient which neutralize (or block) GnRH. The immunological neutralization neutralization, chemical reaction, according to the Arrhenius theory of acids and bases, in which a water solution of acid is mixed with a water solution of base to form a salt and water; this reaction is complete only if the resulting solution has neither acidic nor of GnRH shuts down the production of estrogen, progesterone progesterone (prōjĕs`tərōn'), female sex hormone that induces secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. and testosterone in the gonadal gonadal pertaining to or arising from a gonad. See also testicular, ovarian. gonadal cords cords formed by epithelial cells which migrate from the mesonephric tubules in the embryo to the gonadal ridge and establish the indifferent organs (a biological blocking, which is reversible, in males and females). Estrogen fuels the growth of breast cancer and testosterone fuels prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , both primary and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. (spread) in each cancer. Like physical castration castration, removal of the sex glands of an animal, i.e., testes in the male, or ovaries and often the uterus in the female. Castration of the female animal is commonly referred to as spaying. , hormonal, or biological, blockage has been shown to be efficacious in humans for the treatment of prostate and breast cancers; Gonadimmune(TM) induces such biological blockage. Aphton's Gonadimmune(TM) vaccines consist of synthetic peptides (constructed to "look like" GnRH), which are bound chemically to a carrier and suspended in a liquid solution. The vaccine is administered to the patient by injection. After immunity has been established in an initial series of injections, a periodic "booster shot Booster Shot The name given to the first formal recommendation report issued by an underwriter for an IPO. It is presented in the process of the public offering. Notes: The booster shot acts as a way to reinforce attractiveness of the new issue. " will be given regularly to maintain high levels of neutralizing antibodies directed against GnRH. Gonadimmune(TM) has successfully completed extensive toxicology and preclinical testing, including safety and efficacy. The efficacy test results compared Gonadimmune(TM) positively to therapeutic drugs currently used in humans; these results were reported at a meeting of the American Association of Cancer Research (AACR AACR American Association for Cancer Research AACR Anglo-American Cataloging Rules AACR Australasian Association of Cancer Registries AACR African Armed Conflicts Resolved ). Building on the experience with Aphton's Gastrimmune(TM), which is a similarly constructed and manufactured vaccine, scaled up quantities of Gonadimmune(TM) have been manufactured in accord with the required governmental standards. Aphton and SmithKline Beecham have selected prostate cancer for the first human clinical study for Gonadimmune(TM). An aggressive, combined safety and dose ranging Phase I/II clinical trial will be initiated shortly in the UK with prostate cancer patients. There is a need for an improved therapy for prostate cancer patients, particularly for those whose cancer has spread or can be expected to spread. The number of new cases of prostate cancer in the US and Western Europe (WE) exceeds 370,000 annually; the number of existing prostate cancer cases in the US and WE is estimated to exceed 2,300,000. Of these large numbers, only a small fraction of patients are currently treated with anti-GnRH drugs, primarily those in late-stage disease. These drugs, called GnRH agonists, have a net benefit but cause an initial "surge," or "flare," in testosterone. This "surge" is the opposite of the desired effect, namely testosterone suppression, which can fuel the cancer. Gonadimmune(TM) in contrast, is a "pure" antagonist, with no "surge". The medical science literature increasingly points to the prospect of a significant increase in anti-GnRH treatment, at all stages of disease, not merely late-stage. The annual revenues for such drugs, already in excess of one billion US dollars per year, can be expected to increase. Aphton Corporation is a biopharmaceutical company developing products using its innovative vaccine-like technology for neutralizing hormones that participate in gastrointestinal system gastrointestinal system: see digestive system. and reproductive system reproductive system, in animals, the anatomical organs concerned with production of offspring. In humans and other mammals the female reproductive system produces the female reproductive cells (the eggs, or ova) and contains an organ in which development of the fetus cancer and non-cancer diseases; and the prevention of pregnancy. In addition to SmithKline Beecham PLC, Aphton has strategic alliances with Pasteur Merieux Connaught (Rhone-Poulenc Group), Schering Plough Animal Health and the World Health Organization (WHO). Aphton's Web page, describing the company, its technology, products, strategic alliances, news releases and reports of independent research analysts, can be visited at: www.aphton.com SmithKline Beecham is one of the world's leading Healthcare companies. SmithKline Beecham discovers, develops, manufactures and markets human pharmaceuticals, including vaccines, over-the-counter medicines and health-related consumer products. In addition, SmithKline Beecham provides Healthcare services, including disease management, clinical laboratory testing, and pharmaceutical benefit management. SmithKline Beecham Biologicals is located in Rixensart, Belgium, and is the centre of all SB's activities in the field of vaccine research, development and production. SB Biologicals employs over 500 research scientists who are devoted to discovering and developing cost-effective and more convenient combination vaccine products to prevent infections which cause serious medical problems worldwide. SB produces 700 million doses of vaccines per year. Every second, over 20 doses of SBBio vaccines are distributed around the world. Except for the historical information herein, the matters discussed herein include forward-looking statements that may involve a number of risks and uncertainties. Future results may vary significantly based on a number of factors including, but not limited to, intellectual property risks, risks in regulatory and market acceptance of new products and continuing demand for same, the impact of competitive products and pricing, changing economic conditions and other risk factors detailed in Aphton's most recent 10-K and other filings with the Securities and Exchange Commission.
CONTACT: Aphton Corporation
J. L. Whitmore, Investor Services
Phone: 305/374-6717
or
SmithKline Beecham Biologicals
Anne P. Walsh, Marketing Communications
Phone: +32 2 656 9831
|
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion