Monday, Mar 21, 2005
South San Francisco, Calif. and Paris -- March 21, 2005 --Genentech, Inc. (NYSE: DNA) and Ipsen today announced the recent execution of a collaborative research and development (R&D) agreement to develop sustained-release formulations of Genentech's recombinant human growth hormone [somatropin (rDNA origin)].
This R&D collaboration is in addition to and supplements a previous agreement signed in 2002 whereby Ipsen gained exclusive rights to market NutropinAq Pen throughout Europe and the rest of the world, excluding North America and Japan. Nutropin AQ Pen® for use with the Nutropin AQ Pen® cartridge was cleared for marketing by the U.S. Food and Drug Administration in April 2002 and obtained marketing authorization under the trade name NutropinAq Pen from the European Medicines Agency in March 2004. Ipsen has already launched NutropinAq Pen in 12 European countries.
"We at Ipsen are proud to bring our expertise in sustained-release technology to this new collaboration with Genentech," said Mr. Jean-Luc Belingard, president and chief executive officer of the Ipsen Group. "Our common objective is to develop sustained-release formulations of recombinant human growth hormone to meet the needs of pediatric and adult growth hormone deficiency (GHD) patients."
"Genentech has a 20 year heritage of exploring new product options for growth hormone delivery to patients," said Joseph S. McCracken, Genentech's vice president of Business Development. "We value our collaboration with Ipsen and their experience with novel sustained release technology."
About Nutropin AQ
Nutropin AQ [somatropin (rDNA origin) injection] is produced using recombinant DNA technology and has the same amino acid sequence as human growth hormone produced naturally in the human body. It is marketed as NutropinAq in Austria, Denmark, Finland, France, Germany, Ireland, the Netherlands, Norway, Sweden, Portugal, Spain and the United Kingdom. Other regulatory reviews are underway in Europe and worldwide, excluding North America and Japan.
Nutropin AQ is supplied as 10 mg of sterile liquid somatropin per cartridge for exclusive use with the Nutropin AQ Pen, a simple, convenient, easy-to-use device for subcutaneous injection. Nutropin AQ is approved for the treatment of GHD in children and adults, for the long-term treatment of short stature in children with Turner syndrome and the treatment of growth failure in chronic renal insufficiency patients prior to transplantation.
Nutropin AQ Safety Information
Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure.
Nutropin AQ should not be used for growth promotion in pediatric patients with closed epiphyses. Nutropin AQ should not be used in patients with active neoplasia. Growth hormone therapy should be discontinued if evidence of neoplasia develops.
Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Nutropin AQ is not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from, or are based on, Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States, and receives royalties or other income from companies that are licensed to market its products outside of the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
Ipsen in Endocrinology and Drug Delivery Technology
Endocrinology is one of the therapeutic areas targeted by Ipsen. Ipsen endocrinology sales are driven by its somatostatin analog (Somatuline® and Somatuline® Autogel®) mainly indicated in the treatment of acromegaly and neuroendocrine tumors. Among Ipsen R&D programs in endocrinology & metabolic diseases, two major molecules are under clinical development:
Regarding drug delivery technology, Ipsen is one of the world leaders in the production of sustained-release systems with two peptides, triptorelin (Decapeptyl®) and lanreotide (Somatuline® and Somatuline® Autogel®).
Present in over 110 countries, with a total staff of nearly 4,000, Ipsen recorded sales of &€ 737.2 million in 2003, a third of which originated outside the five major countries in Western Europe (France, Germany, Italy, Spain and the United Kingdom). The Group develops products in three targeted therapeutic areas: oncology, endocrinology and neuromuscular disorders, and is also engaged in developing certain biological derived products. Ipsen is currently marketing more than 20 products, both to specialists working in its targeted therapeutic areas and in therapeutic areas related to the Group's history. In 2003, 18.5% of Ipsen's turnover was invested in Research and Development, carried out through an international network of about 615 people from 4 centres: Paris, Boston, Barcelona and London. Ipsen's Internet website is www.ipsen.com.