MEDIGENE AG SUBMITS ELIGARD MAA TO GERMAN REGULATORY AGENCY.Atrix Laboratories, Inc. (Nasdaq: ATRX ATRX Alpha-Thalassemia/Mental Retardation Syndrome, Nondeletion Type, X-Linked ), Fort Collins, Colo., has announced that the company's European marketing partner, MediGene AG, has submitted a Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin ) for Eligard(TM) 22.5 mg three-month depot, leuprolide acetate leu·pro·lide acetate n. A synthetic polypeptide analog of naturally occurring gonadotropin-releasing hormone used in the treatment of advanced prostate cancer. for the treatment of advanced 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. , to the German regulatory authority Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities , Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), as the reference member state under a mutual recognition process. This is the second MAA MediGene has submitted for the Eligard products -- in December of 2001 they submitted an MAA for the 7.5 mg one- month product. "MediGene has put forth superb effort in submitting this second MAA," said David R. Bethune, chairman and chief executive officer at Atrix. In April 2001, Atrix entered into an exclusive European marketing agreement with MediGene AG, an emerging European leader in biotechnology with a focus on oncology and cardiovascular medicine, for the Eligard prostate cancer products. Following marketing approval in Europe, Atrix would receive a royalty on sales of the individual Eligard products and would manufacture the products in its facility in Fort Collins, Colorado The City of Fort Collins, a home rule municipality situated on the Cache la Poudre River along the Colorado Front Range, is the county seat and most populous city in Larimer County, Colorado. . Atrix has obtained 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. approval for the one-month Eligard 7.5 mg product and is in late-stage development of two other Eligard products that release leuprolide acetate over a period of three, and four months. The Eligard products use Atrix's Atrigel(R) depot drug delivery system. In 2001, Atrix filed a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Eligard 22.5 mg three-month depot product. In April 2002, the company filed an NDA for the Eligard 30 mg four- month product. The goal of this therapy is to reduce testosterone in the body to inhibit the growth of hormone-responsive advanced prostate cancer. The liquid Eligard products are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed. Atrix Laboratories, Inc. is an emerging specialty pharmaceutical company focused on advanced drug delivery. With five unique patented technologies, Atrix is currently developing a diverse portfolio of proprietary products, including oncology, pain management, and dermatology products. The company also partners with large pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or to extend the patent life of existing products. Additional information is available on the Atrix Laboratories, Inc. For more information, visit http://www.atrixlabs.com or call +1-970-482-5868. |
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