Saizen(r) for Adult Growth Hormone Deficiency (AGHD) in the USA

Main Category: Public Health
Article Date: 10 Jan 2005 - 10:00 PDT

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Needle-Free Delivery Option Exclusive to Saizen(R) Available for Patients -

Serono Inc, the US affiliate of Serono (virt-x:SEO and NYSE: SRA), announced today the availability of Saizen(R) [somatropin (rDNA origin) for injection] for use in the treatment of patients with adult growth hormone deficiency (AGHD), following its FDA approval.

"This new indication for Saizen(R) represents the evolution of our growth hormone portfolio and further demonstrates our commitment to the metabolic franchise," said James Sapirstein, executive vice president of Metabolic Endocrinology at Serono, Inc. "Patients with AGHD who are treated with Saizen(R) therapy can use our easy-to-use drug delivery devices such as cool.click(R), a needle-free device that is preferred by pediatric patients and is now available for use by adults taking Saizen(R)."

Adult Growth Hormone Deficiency (AGHD) can be effectively treated with Saizen(R). With the U.S. approval, patients who were growth hormone deficient during childhood and have growth hormone deficiency as an adult, may continue to use Saizen(R). In addition, adult patients who have adult onset growth hormone deficiency either alone, or associated with multiple hormone deficiencies, now have access to Saizen(R) and its line of devices.

Saizen(R) can be administered using a needle-free device, cool.click(R), the only FDA approved needle-free device for the administration of growth hormone. It can also be administered with a recently launched autoinjector pen device, one.click(R), or by traditional needle and syringe. Serono's portfolio of innovative devices gives patients the choice they want in growthhormone delivery.

Patients can learn more about Saizen(R) and Serono's growth hormone delivery devices by talking with their physician, or by calling Serono Connections for Growth(R) toll-free at 1-800-582-7989. The full prescribing information for Saizen(R) can be found online at http://www.seronousa.com.

About Adult Growth Hormone Deficiency (AGHD)

Growth hormone deficiency can be a significant problem for adults even though they no longer get taller. AGHD is recognized as a specific clinical syndrome with numerous physiological consequences, with effects on:

- Changes in body composition, including central obesity;

- Lipids in the blood;

- Muscle strength;

- Bone composition;

- Exercise capacity and energy;

- Cardiovascular risk; and

- Psychological well-being (social isolation and depression).

There are also studies indicating that patients with AGHD have an increased risk of mortality from cardiovascular disease, possibly attributable to their growth hormone (GH) deficiency.

GH deficiency in adults can result from a pituitary or peri-pituitary tumor or as a direct result of the surgery/radiation used to manage these conditions. Less commonly, GH deficiency in adults arises from a deficiency acquired in childhood.

About Saizen(R)

Saizen(R) [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. The recommended dose for adults at the start of therapy is .005 mg/kg daily. The dosage may be increased to not more than .01 mg/kg daily after four weeks depending upon the patient's tolerance of treatment.

Saizen(R) is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. It is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency that meets the criteria of adult onset or childhood onset.

In patients with AGHD, the most common adverse events with associated growth hormone therapy are joint and muscle pain, edema, carpal tunnel syndrome, and tingling.

Growth hormone should be used with caution in patients with insulin resistance, glucose intolerance, diabetes, hypothyroidism, intracranial hypertension, and in women who are pregnant or nursing. GH should not be used in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment; in the presence of active neoplasia; and in patients with proliferative or preproliferative diabetic retinopathy; or in patients hospitalized with acute critical illnesses.

Full prescribing information for Saizen(R), including important safety information, is available at http://www.seronousa.com.

About Serono Connections for Growth(R)

Connections for Growth(R) provides reimbursement support and educational materials for practitioners and families. They offer educational materials, reconstitution and dosage information, reimbursement support, access to cool.click(R) supplies, and contact information for local nurses in the

Serono Nurse Network.

Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 25, 2004. These factors include any failure or delay in Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, and government regulations limiting our ability to sell our products. Serono has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.

About Serono

Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are approximately 30 ongoing development projects.

In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net income of US$390.0 million, making it the third largest biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
http://www.serono.com