Media Release

FOR IMMEDIATE RELEASE

SERONO ANNOUNCES SIGNIFICANT RESULTS FROM TWO CLINICAL TRIALS OF SEROSTIM^Ò AT THE XIV INTERNATIONAL AIDS CONFERENCE

Rockland, MA and Geneva, Switzerland, July 9^th 2002 – Serono S.A. (virt-x: SEO and NYSE: SRA) announced positive results of two major clinical trials of Serostim^Ò [somatropin (rDNA origin) for injection] for the treatment of AIDS-related metabolic complications at the XIV International AIDS Conference in Barcelona,

“The positive findings from the Serostim^Ò trials provide excellent news for the HIV community and for people living with AIDS,” said Stevo Knezevic, Senior Executive Vice President, Clinical Development.  “The findings of these two trials enhance our understanding of HIV-related metabolic complications and will help us develop improved therapies.”

The Serostim^Ò for the Treatment of Adipose Redistribution Syndrome study, a Phase II/III, double-blind, placebo-controlled study, designed to evaluate Serostim^Ò as a potential therapy for HIV-Associated Adipose Redistribution Syndrome (HARS), demonstrated positive results in reducing adipose tissue maldistribution. HARS, a subset of a condition called HIV-related lipodystrophy syndrome, consists of abnormal fat distribution and altered metabolism.  Serono is working with the US Food and Drug Administration (FDA) to finalize plans for the continued development of this program.  Serostim^Ò is currently not approved for the treatment of HARS.

The Serostim^Ò AIDS wasting study, a Phase IV, confirmatory, randomized, double-blind, dose-ranging study, confirmed the clinical efficacy of Serostim^Ò in the treatment of AIDS wasting by achieving its primary and secondary endpoints.  Following discussions with the FDA, data from this trial will be submitted to the agency.

Serostim^Ò for the Treatment of Adipose Redistribution Syndrome (STARS) Study

“The results of the STARS study indicate that Serostim^Ò has a potential role in the treatment of body composition issues associated with lipodystrophy, which is an important finding for a condition that has a significant impact on HIV positive patients in the US who experience some form of fat maldistribution or lipodystrophy,” said lead investigator, Donald Kotler, M.D., St. Luke’s Roosevelt Hospital, New York.   “The STARS trial is a critical step to learning more about the condition and potential therapies.”

The STARS trial involved 239 patients at trial sites located throughout the US.   The primary objective of the STARS study was to determine whether Serostim^Ò treatment reduces adipose tissue maldistribution more effectively than placebo.  The co-primary endpoints were a reduction in visceral adipose tissue (VAT) as assessed by CT[1] scan and the ratio of trunk to limb fat as assessed by DXA[2] technology. Secondary endpoints included Serostim’s^Ò effect on lean body mass and quality of life/body image self assessment. Patients were randomized into three treatment groups, which included Serostim^Ò 4 mg daily, Serostim^Ò 4 mg on alternate days and placebo.  

The first co-primary endpoint shows that the decrease in VAT from baseline to week 12 was highly significant in the Serostim^Ò 4 mg daily group (p<0.001) as compared to placebo.  The mean reduction in the area of VAT across the mid-abdomen in males receiving Serostim^Ò 4mg daily was 31.0cm² (9.2% of the baseline mean value) and 34.2cm² (13.5% of the baseline mean value) for females.  The Serostim^Ò 4 mg on alternate days group did not reach statistical significance as compared to placebo for this endpoint.  The second co-primary endpoint demonstrates that the trunk to limb fat ratio was significantly reduced in both the Serostim^Ò 4 mg daily (p<0.001) and Serostim^Ò 4 mg on alternate day (p<0.001) groups compared to the placebo group. 

The results of the secondary endpoints were also positive. Compared to the placebo group, results indicate a significant change in lean body mass from baseline to week 12 for those receiving Serostim^Ò 4 mg daily (p<0.001) and 4 mg on alternate days (p<0.001) groups, with the mean increase ranging from 3.0 kg in women and 3.5 kg in men, and 2.1 kg in women and 2.8 kg in men, respectively.  Serum total cholesterol declined by 12.5 mg/dl in the Serostim^Ò 4 mg daily group and by 7.5 mg/dl in the Serostim^Ò 4 mg on alternate days group.  Both of these declines were significantly greater than the change seen in the placebo group.  In addition, the change from baseline Quality of Life summary score was more favorable on Serostim^Ò 4 mg daily (p<0.01) and on Serostim^Ò 4 mg on alternate days (p<0.05) as compared to placebo.  Adverse reactions reported during this clinical trial were consistent with those expected within the current approved indication for Serostim^Ò.

Serostim^Ò AIDS Wasting Confirmatory Trial

“This study confirmed that Serostim^Ò, in a dose dependent manner, was able to restore lean body mass to patients with AIDS wasting,” said trial investigator, Graeme Moyle, MD, Chelsea and Westminster Hospital, London, UK.  “This restoration was accompanied by direct clinical benefits, such as improved physical performance and Quality of Life.” 

The Serostim^Ò AIDS wasting confirmatory trial included more than 700 patients at US, EU and other international trial sites. Following the accelerated approval of Serostim^Ò by the FDA, Serono conducted a Phase IV study to confirm the safety and efficacy of Serostim^Ò.  Trial enrollees were randomized into three treatment groups to receive Serostim^Ò 6 mg daily, Serostim^Ò 6 mg on alternate days or placebo for a 12-week treatment period.

The primary endpoint of the study was to confirm the clinical efficacy of Serostim^Ò compared with placebo, based on exercise function change as assessed by cycle ergometer work output from baseline to week 12.  The results of the primary endpoint were positive and   demonstrated a highly significant increase of work output of 9.9% in the group treated with Serostim^Ò 6 mg daily and a decrease of 1% in the placebo group (p<0.0001). 

The secondary endpoint was the change in lean body mass as measured by bioimpedance spectroscopy (BIS) from baseline to week 12.  Findings demonstrate a dose-response relationship.  The quantity of lean tissue gained in the group treated with Serostim^Ò 6mg daily (median gain in lean body mass 5.2 kg) and in the group treated with Serostim^Ò 6 mg on alternate days (median gain in lean body mass 3.3 kg) was significantly greater compared to the placebo group (median gain in lean body mass 0.6 kg) (p<0.0001 for both Serostim^Ò doses).  Furthermore, patients receiving Serostim^Ò 6 mg daily had a significantly greater effect in terms of median gain in lean body mass than those patients receiving Serostim^Ò 6 mg on alternate days (p=0.017).   Adverse reactions reported during this clinical trial were consistent with those expected within the current approved indication for Serostim^Ò.

The study used two Quality of Life scales to assess patients’ response to treatment with Serostim^Ò for AIDS wasting.  Results were generally favorable.  When asked the question ‘Do you think this treatment has been of benefit to you?,’ Serostim^Ò treated patients responded significantly more favorably than those treated with placebo (p<0.0001).  In addition, patients receiving Serostim^Ò 6 mg daily responded significantly more favorably than those treated with Serostim^Ò 6 mg every other day (p=0.004). 

BACKGROUND

What is AIDS Wasting?

AIDS wasting is a chronically debilitating and potentially life-threatening condition. It is a metabolic disorder that causes the body to use vital muscle and organ tissue, which is critical for survival, for energy instead of primarily using the body’s stored fat.  People with AIDS wasting usually experience a loss of 5-10% or more of lean body mass, which consists of muscle tissue, important body organ and blood cells, including red cells and functioning white cells.  The result can lead to increased risk for opportunistic infections and illness, and extreme fatigue and can profoundly diminish a person’s quality of life.

What is HARS/Lipodystrophy?

HIV-associated lipodystrophy is characterized by a variety of metabolic disturbances and body shape abnormalities that may present individually or in combination.  These abnormalities include elevated cholesterol levels, insulin resistance, abnormal fat depletion and/or abnormal fat accumulation.  Patients with HARS, a subset of HIV-associated lipodystrophy, experience abnormal, pathological accumulation of adipose tissue, which may be present with or without fat depletion and/or metabolic abnormalities.  In general, HARS patients accumulate excess visceral adipose tissue in the abdomen or may develop a pad of fat on the upper back commonly known as a “buffalo hump.”  Unlike the excess subcutaneous fat seen in obesity, visceral adipose tissue lies deep within the abdominal cavity.  Persons with visceral fat accumulation are at increased risk to develop metabolic abnormalities.

About Serostim^Ò

Serostim^Ò is the only growth hormone approved by the U.S. Food and Drug Administration (FDA) for the treatment of AIDS wasting or cachexia.  Serostim^Ò received FDA accelerated approval in 1996 based upon the analysis of changes in body weight and lean body mass in surrogate endpoints in clinical studies up to 12 weeks in duration.  Serostim^Ò is now on the market in 12 countries. 

Serostim^Ò, when taken as prescribed in 6mg doses over 12 weeks, is generally well tolerated.  The most common adverse reactions to Serostim^Ò are increased tissue turgor (generally swelling of hands and feet) and musculoskeletal discomfort (pain, swelling or stiffness).  Generally mild to moderate in severity, these symptoms usually resolve spontaneously with continued treatment or are effectively managed with analgesic therapy or after reducing the weekly dose.  Serostim^Ò must be used in conjunction with antiretroviral therapy.  Elevations in mean blood glucose levels can also occur.  Patients with other risk factors for glucose intolerance should be monitored closely.  Full prescribing information for Serostim^Ò is available at www.aidswasting.com.

A webcast of the satellite symposium that took place at the XIV International AIDS Conference on July 6, 2002 on “Long-Term Challenges of HAART: the Patient’s Concerns” will be available at www.seronosymposia-educational-tv.com July 8, 2002.

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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 May 21, 2002.  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.

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About Serono

Serono is a global biotechnology leader. The Company has six recombinant products on the market, Gonal-F®, Luveris®, Ovidrel®/Ovitrelle®, Rebif®, Serostim® and Saizen® (Luveris® is not approved in the USA). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are fifteen new molecules in development.

In 2001, Serono achieved worldwide revenues of US$1.38 billion, and a net income of US$317 million, making it the third largest biotech company in the world based on revenues. The Company operates in 45 countries, and its products are sold in over 100 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).

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