QUEBEC CITY (Canada), RIO DE JANEIRO (Brazil), FRANKFURT (Germany), Feb.
2 /PRNewswire-FirstCall/ -- Roche and AEterna Laboratories Inc. (TSX: AEL; NASDAQ: AELA) announced today a partnership for the marketing in Brazil of Impavido(R) (Miltefosine), the breakthrough oral therapy of leishmaniasis. The agreement was signed between Produtos Roche QFSA in Sao Paulo and Zentaris GmbH in Frankfurt, a 100% subsidiary of AEterna Laboratories Inc.
Under this agreement, Roche will support Zentaris in the registration process and will market the product for Zentaris in Brazil. Furthermore, Zentaris will supply Impavido(R) to Roche. Brazil is the country in South America that is most affected with the deadly visceral leishmaniasis (black fever) and the painful cutaneous leishmaniasis (parasitic skin disease). Both parties will immediately start clinical bridging trials, as requested from the Brazilian health authorities.
The registration of the first oral treatment for leishmaniasis in Brazil would be a breakthrough in fighting this awful disease. It is estimated that, every year, up to 50,000 people are newly infected in Brazil, 10% of them with the deadly visceral form. Because of these numbers, there is an urgent need for new treatments for leishmaniasis and Impavido(R) in Brazil.
"The drug has proven to be safe and effective in India for visceral leishmaniasis and in clinical trials for cutaneous leishmaniasis in Colombia and Guatemala," said Prof. Jurgen Engel, Managing Director of Zentaris GmbH, Executive Vice President, Global R&D and Chief Operating Officer at AEterna. "The partnership with Roche is the best opportunity to make the drug available very fast in Brazil where it is urgently needed."
Leishmaniasis is a tropical disease caused by the leishmania parasite. According to the World Health Organization (WHO), more than 12 million people are affected worldwide, with an infection rate of 2 million new cases per year. Impavido(R) has recently been approved in India for the treatment of the visceral form of this disease.
Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation medicine. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
About AEterna Laboratories
AEterna Laboratories, along with its wholly-owned subsidiary Zentaris GmbH, is a biopharmaceutical company with an extensive product portfolio, including 2 already marketed and several other products at early and late- stage development in endocrinology, oncology and infectious diseases. Cetrorelix (Cetrotide(R)) is sold in the U.S. and Europe 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. 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.
In addition, AEterna owns 62% of Atrium Biotechnologies Inc. which develops and markets active ingredients and specialty chemicals in the health and personal care industry for the cosmetics, pharmaceutical, chemical and nutritional sectors. In 2002, sales reached $100 million.
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AETERNA LABORATORIES INC.