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Serono Implements New Serostim(R) Secured Distribution Program
Wednesday October 2, 9:31 am ET
Program Designed to Manage, Monitor and Secure Serostim(R) Distribution while Maintaining Appropriate Access to Treatment for Patients with AIDS Wasting
ROCKLAND, Mass., Oct. 2 /PRNewswire-FirstCall/ -- Serono, Inc. today announced the implementation of the new Serostim® Secured Distribution program. In this program, a network of pharmacies that met pre-defined criteria will serve as exclusive distributors of Serostim® [somatropin (rDNA origin) for injection], the company's product for the treatment of AIDS wasting. Serono has contracted with this group of pharmacies to distribute Serostim® in all major US markets through both retail locations and mail order.
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The Serostim® Secured Distribution program was created to manage the process by which Serostim® is distributed to patients in order to maintain the integrity of the product and provide the ability to track each individual box of Serostim® from Serono to the contracted network pharmacy. Serono has partnered with NDCHealth to track and monitor the distribution of Serostim®.
"The Serostim® Secured Distribution program greatly advances our efforts to ensure that patients who are prescribed Serostim® receive it appropriately by allowing us to manage and monitor Serostim® through the distribution chain from prescription to delivery," said James Sapirstein, Executive Vice President, Metabolic Endocrinology, North America.
Beginning on October 1, 2002, patients with new Serostim® prescriptions should have their prescriptions filled at one of the contracted network pharmacies participating in the program. Patients who had a current Serostim® prescription filled at a non-contracted network pharmacy may have their Serostim® refills dispensed at a non-contracted network pharmacy until their course of treatment is completed. In the alternative, patients can choose to have their Serostim® refills transferred to a contracted network pharmacy. After October 31, 2002, all Serostim® prescriptions should be filled at a contracted network pharmacy. Under this program, physicians will continue to prescribe Serostim® as they normally have done in the past.
"I am pleased that Serono is implementing this program to further ensure appropriate patient access and safety," said Gary Blick, MD, Norwalk Medical Center, Norwalk, Connecticut. "The program provides me with the confidence in knowing that my AIDS wasting patients are receiving authentic Serostim® product."
About Serostim®
Serostim® is the only growth hormone approved by the U.S. Food and Drug Administration (FDA) for the treatment of AIDS wasting or cachexia. Serostim® 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® is now on the market in 13 countries.
The most common adverse reactions to Serostim® 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® 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® is available at www.aidswasting.com.
For more information about the Serostim® Secured Distribution program and a listing of contracted network pharmacies, go to www.aidswasting.com.
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.
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, S.A., a global biotechnology leader, headquartered in Geneva, Switzerland. The Company has six recombinant products on the market, Gonal-F® (follitropin alfa for injection), Luveris® (lutropin alfa), Ovidrel®/Ovitrelle® (choriogonadotropin alfa for injection), Rebif® (interferon beta-1a), Serostim® [somatropin (rDNA origin) for injection] and Saizen® [somatropin (rDNA origin) for injection]. (Luveris® is not approved in the USA)(1). 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 seventeen 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).
Wednesday October 2, 9:31 am ET
Program Designed to Manage, Monitor and Secure Serostim(R) Distribution while Maintaining Appropriate Access to Treatment for Patients with AIDS Wasting
ROCKLAND, Mass., Oct. 2 /PRNewswire-FirstCall/ -- Serono, Inc. today announced the implementation of the new Serostim® Secured Distribution program. In this program, a network of pharmacies that met pre-defined criteria will serve as exclusive distributors of Serostim® [somatropin (rDNA origin) for injection], the company's product for the treatment of AIDS wasting. Serono has contracted with this group of pharmacies to distribute Serostim® in all major US markets through both retail locations and mail order.
ADVERTISEMENT
The Serostim® Secured Distribution program was created to manage the process by which Serostim® is distributed to patients in order to maintain the integrity of the product and provide the ability to track each individual box of Serostim® from Serono to the contracted network pharmacy. Serono has partnered with NDCHealth to track and monitor the distribution of Serostim®.
"The Serostim® Secured Distribution program greatly advances our efforts to ensure that patients who are prescribed Serostim® receive it appropriately by allowing us to manage and monitor Serostim® through the distribution chain from prescription to delivery," said James Sapirstein, Executive Vice President, Metabolic Endocrinology, North America.
Beginning on October 1, 2002, patients with new Serostim® prescriptions should have their prescriptions filled at one of the contracted network pharmacies participating in the program. Patients who had a current Serostim® prescription filled at a non-contracted network pharmacy may have their Serostim® refills dispensed at a non-contracted network pharmacy until their course of treatment is completed. In the alternative, patients can choose to have their Serostim® refills transferred to a contracted network pharmacy. After October 31, 2002, all Serostim® prescriptions should be filled at a contracted network pharmacy. Under this program, physicians will continue to prescribe Serostim® as they normally have done in the past.
"I am pleased that Serono is implementing this program to further ensure appropriate patient access and safety," said Gary Blick, MD, Norwalk Medical Center, Norwalk, Connecticut. "The program provides me with the confidence in knowing that my AIDS wasting patients are receiving authentic Serostim® product."
About Serostim®
Serostim® is the only growth hormone approved by the U.S. Food and Drug Administration (FDA) for the treatment of AIDS wasting or cachexia. Serostim® 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® is now on the market in 13 countries.
The most common adverse reactions to Serostim® 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® 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® is available at www.aidswasting.com.
For more information about the Serostim® Secured Distribution program and a listing of contracted network pharmacies, go to www.aidswasting.com.
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.
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, S.A., a global biotechnology leader, headquartered in Geneva, Switzerland. The Company has six recombinant products on the market, Gonal-F® (follitropin alfa for injection), Luveris® (lutropin alfa), Ovidrel®/Ovitrelle® (choriogonadotropin alfa for injection), Rebif® (interferon beta-1a), Serostim® [somatropin (rDNA origin) for injection] and Saizen® [somatropin (rDNA origin) for injection]. (Luveris® is not approved in the USA)(1). 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 seventeen 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).
