QUEBEC CITY, April 21 /PRNewswire-FirstCall/ -- AEterna Laboratories Inc. (TSX: AEL; NASDAQ: AELA), along with its wholly-owned subsidiary Zentaris GmbH, announced today the initiation of a dose ranging study for its EP-1572 Growth Hormone Secretagogue (GHS), a novel, orally-available peptidomimetic agent which can directly stimulate growth hormone secretion from the pituitary gland. The study will evaluate the safety and pharmacokinetics/pharmacodynamics of the compound administered by oral route and its initiation triggers an undisclosed milestone payment to AEterna from its development partner Ardana Bioscience. Potential indications for EP-1572 include treatment of growth hormone deficiency disorders in adults and children (short stature), frailty of the elderly, as well as metabolic complications associated with critical illnesses, such as AIDS-associated cachexia, cancer, and trauma.
"We believe there is a critical need for effective oral therapies addressing disorders associated with reduced secretion of growth hormone and are very encouraged by EP-1572's potential in this respect as demonstrated by studies to date. Productive partnerships are an important component of a successful commercialization strategy, and the initiation of these studies signifies yet another achievement in our ongoing collaboration with Ardana Bioscience," said Prof. Jurgen Engel, Chairman & Managing Director of Zentaris GmbH, Executive Vice President R&D and Chief Operating Officer at AEterna.
"We are very excited to advance this promising compound into dose ranging studies as we believe it has the potential to represent a major new advance in the treatment of growth hormone deficiency disorders," commented Dr Maureen Lindsay, Ardana Chief Operating Officer. "Ardana has a rich and broad development portfolio comprising products near launch, in clinical development and preclinical evaluation. We look forward to the results of this study before the end of 2004."
About EP-1572 Growth Hormone Secretagogue (GSH)
EP-1572 is a novel, orally-available peptidomimetic agent which can directly stimulate growth hormone secretion (growth hormone secretagogue) from the pituitary gland through binding to GHS receptors without the involvement of growth hormone release hormone (GHRH) or somatostatin. It is also one of the first compounds of this class to enter clinical development. Growth hormone plays a critical role in stimulating body growth and development, including development of bone structure and muscle mass, as well as controls protein synthesis and fat breakdown, leading to increased lean body mass.
Potential indications for EP-1572 include treatment of growth hormone deficiency disorders in adults and children (short stature), frailty of the elderly, as well as metabolic complications associated with critical illnesses, such as AIDS-associated cachexia, cancer, and trauma. The current standard of therapy for most of these disorders is hormone replacement therapy through sometimes daily administration of growth hormone which, unlike EP-1572, cannot be taken orally and has to be injected. Furthermore, whereas current therapy relies on administration of growth hormone produced through recombinant DNA technology, EP-1572 administration has the potential to induce pulsed production of natural growth hormone. Potential sales of effective, orally-administered compounds addressing growth hormone deficiency-associated disorders in all age groups, including frailty of the elderly (worldwide prevalence estimated at 43.5 million people by 2012), currently underserved by existing therapies can have blockbuster (several billion Euros) potential.
About AEterna Laboratories
AEterna Laboratories Inc., along with its wholly-owned subsidiary Zentaris GmbH, is a biopharmaceutical company with an extensive product portfolio, including two marketed products and 14 other product candidates under development in oncology, endocrinology and infectious diseases. Cetrorelix (Cetrotide(R)) is sold in the U.S., Europe and several other countries to the in vitro fertilization market, and is in Phase II clinical trials for endometriosis, uterus myoma and enlarged prostate (BPH). Miltefosine (Impavido(R)) is sold for black fever and has successfully completed a Phase III trial in parasitic skin disease. Neovastat(R) is in a Phase III trial for non-small cell lung cancer. Perifosine, the first orally- active AKT inhibitor, is in Phase II trials for multiple cancers. Several other clinical programs are underway with various potential development candidates, supported by a worldwide network of scientific and marketing partnerships. Furthermore, AEterna benefits from a discovery platform of 100,000 molecules, which is generating promising new compounds.
AEterna also owns 62% of its subsidiary Atrium Biotechnologies Inc. which develops and markets active ingredients and speciality fine chemicals in the health and personal care industry for the cosmetics, chemical, pharmaceutical and nutritional industries. Its international business network and portfolio of over 1,000 products sold to over 2,000 institutional customers and to over 36,000 physicians and other health care professionals, have generated significant growth in sales and earnings since the Company was founded in January 2000. In 2003, Atrium sales exceeded $120 million.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ National Market (AELA). News releases and additional information about AEterna are available on its Web site at http://www.aeterna.com/ .
About Ardana Bioscience
Ardana Bioscience is a specialty pharmaceutical company focused on reproductive health. It aims to become a leading source of clinical and commercial innovation in the $20 billion human reproductive health market, which is growing at 9% per annum. In addition to the androgen replacement therapy which will be launched in the UK in 2004, Ardana has a rich development portfolio including Chronodyne(R) (terbutaline) for endometriosis- related infertility (being developed in collaboration with Columbia Laboratories (NASDAQ CBRX) and GnRH analogs 'Teverelix' and 'Leuprorelin' for a wide variety of reproductive indications. Ardana's therapeutic interests encompass androgen replacement, infertility, sexual dysfunction and obstetrics. http://www.ardana.co.uk/
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AETERNA LABORATORIES INC.