Needle-free delivery system offers lower risk of needle-stick injury

The US Food and Drug Administration has granted market clearance for a needle-free device to deliver Serostim [somatropin (rDNA origin) for injection], Serono's recombinant human growth hormone (rHGH) currently indicated for the treatment of AIDS wasting or cachexia.

Serono is the only company to provide a needle-free delivery system for growth hormone in the US. The needle-free delivery device, called SeroJet, offers patients an alternative to traditional needles and syringes for subcutaneous administration of Serostim. Serono plans to launch the device in the US in the second half of 2001 following expected FDA approval to expand the dose volume options for Serostim.

SeroJet was developed for Serostim in partnership with Bioject Medical Technologies, Inc. a leading developer and manufacturer of jet injection systems for drug delivery, under an exclusive licensing agreement announced last year. The device has been customized and tested for exclusive use with Serostim, and will be sold under the Serono brand. Bioject and Serono also received market clearance from the FDA in June 2000 for cool.click, a needle-free device to deliver Saizen [somatropin (rDNA origin) for injection] for the treatment of growth hormone deficiency in children.

"This new technology will provide people living with AIDS with a safe and easy-to-use option for the delivery of growth hormone to treat AIDS wasting," said Jay Mohr, Executive Vice President, Metabolic Endocrinology Strategic Business Unit, Serono USA. "In addition, this system reduces the risk of needle-stick injury, and can help minimize patient anxiety normally associated with traditional syringes."

With SeroJet, Serostim is injected through the skin in a fine stream in less than a second. The drug is delivered subcutaneously, distributed by the bloodstream, and has been shown to be bioequivalent to needle injections. In addition to offering patients an alternative to conventional needles, the SeroJet needle-free growth hormone delivery device eliminates the risks associated with needle-stick accidents. As with a needle injection, some injection site reactions may be experienced with the needle-free delivery device.

"We are extremely pleased to continue building on our collaboration with Serono with the rapid clearance of SeroJet, which was released to market by the FDA less than three months after submitting our application," said Jim O'Shea, Bioject's chairman, president and CEO. "Bioject is committed to improving the lives of patients and healthcare professionals with our innovative needle-free injection technology and this is another important milestone in our strategy to form mutually beneficial partnerships with leading drug companies."

About Serostim [somatropin (rDNA origin) for injection]

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 approval in 1996 based upon the analysis of changes in body weight and lean body mass in clinical studies up to 12 weeks in duration. Serostim is currently approved in 10 countries and achieved worldwide sales of $137.1m in 2000.

Serostim, when taken as prescribed in 4mg, 5mg and 6mg daily doses over 12 weeks, is generally well tolerated. In clinical studies, 2% of patients stopped using Serostim due to drug-related side effects. 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.

Serono, Inc. located in Norwell, MA, is the US affiliate of Serono, SA, a global biotechnology leader headquartered in Geneva, Switzerland. The Company has five recombinant products on the market, Gonal-F, Ovidrel, Rebif, Serostim and Saizen. 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 eleven molecules in development.

In 2000, Serono achieved worldwide revenues of $1.240 billion and net income of $301 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 SA, the holding company, are traded on the SWX Swiss Exchange (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).

Bioject Medical Technologies, Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free drug delivery systems. Needle-free injection works by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid that penetrates the skin, depositing medication in the tissue beneath. Bioject's partners include Amgen, AngioSense, and Serono. Bioject's needle-free injection technology improves patient comfort, virtually eliminates the risk of contaminated needlestick injuries, and can improve the immune response of some vaccines.

Source: Serono, Inc.