Tuesday, Apr 23, 2002

FDA Approves Nutropin AQ PEN (TM) For Delivery Of Nutropin AQ (R) Recombinant Growth Hormone

Latest Innovation from Genentech's growth hormone product line offers convenient transport and safety features

South San Francisco, Calif. -- April 23, 2002 --

Genentech, Inc. (NYSE: DNA) announced today that the Nutropin AQ Pen™ received clearance from the U.S. Food and Drug Administration (FDA).  The Nutropin AQ Pen™ is designed for exclusive use with the Nutropin AQ Pen™ Cartridge [somatropin (rDNA origin) injection].  Nutropin AQ® is indicated for the long-term treatment of growth failure in pediatric patients due to inadequate endogenous growth hormone (GH) secretion, for short stature associated with Turner’s syndrome or chronic renal insufficiency (CRI) up to the time of renal transplantation, and as a replacement therapy in eligible patients diagnosed with adult growth hormone deficiency (AGHD). 

The Nutropin AQ Pen was developed to give patients the option of a simple, convenient and safe way to administer their growth hormone.  The simple design of the Nutropin AQ Pen allows for a single pre-filled 10 mg/2 ml cartridge containing liquid Nutropin AQ to be placed in the pen, reducing the number of steps it takes from preparation to administration.  The Pen and pre-filled liquid cartridge help provide accurate and consistent growth hormone dosing concentrations.  Two needle shields provide options for patient convenience and comfort and hide the needle from the patient during administration.  The digital dose display is easy to read and the knob is designed to provide precise dosing.  The Pen also provides a dial-back dose knob feature to correct over-dialing errors.

“The approval of the Nutropin AQ Pen provides patients with growth hormone deficiency an easy and convenient way to administer their daily growth hormone replacement therapy while providing important safety features,” said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer.  “With the addition of the Nutropin AQ Pen, Genentech offers a comprehensive range of growth hormone products and services."

The Nutropin AQ Pen is manufactured by Disetronics Medical Systems (DMS) for Genentech, Inc. and designed for exclusive use with the Nutropin AQ Pen Cartridge.  The 10 mg/2 ml Nutropin AQ Pen Cartridge is manufactured by Meridian Medical Technologies.

Growth hormone deficiency, GHD, is a pituitary disorder resulting in short stature and other physical problems.  Approximately 20,000 children are affected nationwide.  GHD occurs when the production of growth hormone, secreted by the pituitary gland, is disrupted.  Growth hormone plays a critical role in stimulating body growth and development, and is involved in the production of muscle protein and in the breakdown of fats.  A decrease in growth hormone affects numerous body processes including metabolism.

GHD may occur in adults who were GH deficient as children or who have become GH deficient as adults due to pituitary disease, tumor or trauma.  In 1999, there were approximately 55,000 growth hormone deficient (GHD) adults in the United States.

Turner’s syndrome affects approximately one in 2,500 female, live births. Turner’s syndrome is a chromosomal disorder that affects females exclusively and is characterized, in part, by short stature and ovarian dysfunction.  It is caused by the absence of all or part of one of the X chromosomes.

Chronic renal insufficiency, CRI, affects about 3,000 children in the United States.  It manifests through a gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes.  Kidney transplants can help a child start growing normally again, but most children do not make up the growth lost prior to transplantation.

Treatment Indications

Nutropin AQ [somatropin (rDNA origin) injection], a liquid formulation of growth hormone, was first approved for marketing in 1995 for the long-term treatment of children with GHD and growth failure associated with chronic renal insufficiency (CRI).  It was the first ready-to-use liquid formulation of growth hormone therapy.  In 1997, Nutropin AQ was approved for use in adults with GHD as well as growth failure associated with Turner’s syndrome. 

Safety Information

Nutropin AQ should not be initiated to treat patients with acute critical care 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 or in patients with active neoplasia.  GH therapy should be discontinued if evidence of neoplasia develops.  Intracranial hypertension has been reported in a small number of patients.  Patients with CRI and Turner’s syndrome may be at increased risk.

Adverse events frequently reported in adult patients were edema (41%) and arthralgias and other joint disorders (27%).  Thirty-five percent of childhood-onset adult growth hormone deficient subjects treated with growth hormone 0.025 mg/kg/day for 2 years had supraphysiologic levels of insulin-like growth factor-I (IGF-I) at some time during the study, which may carry unknown risks.  During therapy, dosage should be decreased if required by the occurrence of side effects or excessive IGF-I levels.

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs.  Fifteen of the currently approved biotechnology products stem from or are based on Genentech science.  Genentech manufactures and commercializes ten 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 under the symbol DNA.

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Please contact Page Sargisson at 650-225-1000 for a copy of the full prescribing information.