Friday, Jan 29, 1999
South San Francisco, Calif. and Monheim, Germany -- January 29, 1999 --Genentech, Inc. (NYSE: GNE) -- the leading supplier of growth hormone in the United States -- and Schwarz Pharma AG, announced today that they have signed an agreement for the development and distribution of two human growth hormone (hGH) products for the treatment of certain pediatric and adult growth disorders.
Under the terms of the agreement, Schwarz Pharma obtained exclusive rights to import, distribute and develop Genentech's Nutropin AQ® [somatropin (rDNA origin) injection] and Nutropin Depot [somatropin (rDNA origin) for depot suspension] in Europe and certain other countries outside of the United States, Canada and Japan. Nutropin AQ is the only liquid (aqueous) recombinant injectable hGH product marketed in the United States which does not require reconstitution of a freeze-dried powder. Nutropin Depot is a sustained release formulation of Genentech's hGH based on
Alkermes, Inc.'s ProLease injectable sustained release drug delivery system. Based on a successful Phase III trial, Genentech and Alkermes are preparing submission for a new drug application (NDA) to market Nutropin Depot for the treatment of hGH in children in the United States. The European drug application for Nutropin AQ and Nutropin Depot will be filed by Schwarz Pharma. These products are expected to be launched in Europe in 2001.
"We are very pleased to partner with Schwarz Pharma. Together with Sumitomo in Japan, they give Genentech a worldwide presence as a supplier of human growth hormone for the treatment of certain pediatric and adult growth disorders. After evaluating many companies, we chose Schwarz Pharma because they demonstrated a strong and focused commitment to build a strategic development and commercial infrastructure to effectively compete in the human growth hormone market place," said Arthur D. Levinson, Ph.D., Genentech's president and chief executive officer.
Genentech will receive an upfront payment and additional benchmark payments upon Schwarz Pharma's achievements of development milestones. In addition, Schwarz Pharma will contribute to future development of these products. Genentech and Alkermes will manufacture the products for sale by Schwarz Pharma.
"We have selected Genentech as a business partner because of its extensive product development expertise with human growth hormone. We are convinced that these products offer significant benefits for patients with growth hormone deficiency and therefore exciting opportunities for Schwarz Pharma. Currently, human growth hormone is used to treat pediatric growth hormone deficiency with daily injections. Nutropin Depot is designed to reduce injections to once or twice a month," said Patrick Schwarz-Schutte, Schwarz Pharma's chief executive officer.
Schwarz Pharma AG has its headquarters in Monheim, Germany. In 1998, the company generated sales of DM 1.33 billion worldwide. Schwarz Pharma searches and develops innovative pharmaceutical products and therapies that address unmet medical needs. The company has a strong international presence with affiliated companies in key countries such as Germany, France, Great Britain, the USA, Italy, France, and China. There are also licensing agreements for Schwarz Pharma products in 50 countries worldwide. Its shares are traded both at the Dusseldorf (SRZG.D) and the Frankfurt (SRZG.F) stock exchanges.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Twelve of the currently marketed biotechnology products stem from Genentech science. Genentech markets seven biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
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