| Paris, 18 March 2003 — The Beaufour Ipsen Group announced today that the company has obtained European Marketing Authorisation from the European Agency for the Evaluation of Medicinal Products (EMEA) on 24 February, 2003 for Nutropin AQ%reg; (somatropin [rDNA origin] solution for injection). The approved name in Europe is NutropinAq. This decision comes after the agreement signed in September 2002 with Genentech, a USA biotechnology company giving Beaufour Ipsen exclusive rights to market Nutropin AQ® and Nutropin AQ PenTM Cartridge in Europe and the rest of the world, excluding North America and Japan. |    |
Nutropin AQ® is produced using recombinant DNA technology and has the same amino acid sequence as human growth hormone (GH) produced naturally in the human body. Nutropin AQ® is used for the treatment of GH deficiency, which occurs when the production of GH secreted by the pituitary gland, is disrupted.
"Pituitary-related endocrine disorders are a key therapeutic area for Beaufour Ipsen. This collaboration with Genentech has added an important product to our portfolio", said Dr Alistair Stokes, Group Vice-President, Corporate Development, Beaufour Ipsen.
Nutropin AQ® is the first ready-to-use liquid GH formulation approved in the USA and is supplied as 10mg of sterile liquid somatropin per vial or cartridge for exclusive use with the Nutropin AQ PenTM.
Beaufour Ipsen is preparing to submit the requisite regulatory dossier to gain approval to market Nutropin AQ PenTM Cartridge for use with the Nutropin AQ PenTM.
"We are pleased to collaborate with Beaufour Ipsen to market Nutropin AQ® and Nutropin AQ PenTM in Europe", said Joseph S. McCracken, Vice-President, Business and Commercial Development of Genentech. "This agreement continues our efforts in providing our family of growth hormone products to patients throughout the world".
Notes to editor
Beaufour Ipsen
Present in over 80 countries with a total staff of 3423, the Beaufour Ipsen Group had a turnover of €704 million in 2001, 57% of which was outside France.
The Group specialises in oncology, haematology, neurology and endocrinology and has a portfolio of 30 products which are either peptides, derived from biotechnology, or based on natural sources. In 2001, 16.4% of Beaufour Ipsen’s turnover was reinvested in Research and Development (R&D).
The Group’s website is www.beaufour-ipsen.com
Genentech
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercialises biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products originated from or are based on Genentech science.
Genentech manufactures and commercialises ten biotechnology products directly in the USA. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.
NutropinAqNutropinAq is indicated for the treatment of:
- Long-term treatment of children with growth failure due to inadequate endogenous GH secretion
- Long-term treatment of growth failure associated with Turner syndrome
- Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation
- Replacement of endogenous GH in adults with GH deficiency of either childhood or adult-onset aetiology. GH deficiency should be confirmed appropriately prior to treatment
Source: Ipsen
