Friday, Feb 18, 2005
New Orleans -- February 18, 2005 --Genentech, Inc. (NYSE: DNA) today presented final results from a long-term study that showed sustained improvement in psoriasis symptoms throughout three years of continuous treatment with RAPTIVA® (efalizumab). This three-year study is the longest study of psoriasis patients receiving continuous treatment with a biologic agent.
"RAPTIVA is the first biologic therapy to show sustained benefit for psoriasis patients treated continuously over a three-year period," said Craig Leonardi, M.D., associate clinical professor of dermatology at St. Louis University Medical School, St. Louis, Mo., and a study investigator. "Given that psoriasis is a chronic disease, as dermatologists we must weigh the efficacy and safety of different treatment options over the long term. It is encouraging to see a consistent safety profile for RAPTIVA in this three-year open-label study."
The 36-month, Phase IIIb open-label study evaluated the long-term safety and efficacy of continuous treatment with RAPTIVA in adults with moderate-to-severe chronic plaque psoriasis. The results were presented as a poster at the American Association of Dermatology ACADEMY 2005 meeting in New Orleans.
Key Study Findings:
At 33 months, of the 151 patients who remained in the study and continued to receive weekly RAPTIVA therapy:
At the end of the final three-month transitional period of the three-year study (at 36 months), of the 113 patients who continued in the study and received weekly RAPTIVA therapy:
An analysis of a small number of patients using concomitant systemic therapies demonstrated that the addition of these agents did not have a significant effect on patient response rates.
In this study, 339 patients received RAPTIVA weekly for an initial 12 weeks, and patients with a PASI 50 response or a static Physician?s Global Assessment response of ?mild? or better after 12 weeks of treatment were eligible to continue on a once-weekly maintenance dose of 1mg/kg RAPTIVA for 12-week periods starting at week 13. A total of 290 subjects entered this second phase of the study. For each successive three-month period of treatment, dropouts during that period were analyzed using their last available PASI assessment but were excluded from the subsequent cohorts.
Adverse events in this study were similar to what has been observed in previous clinical trials of RAPTIVA and include headache, non-specific infection (e.g., common colds), chills, pain, nausea, asthenia (weakness), and fever, all of which diminished after the first 1-2 doses. Further, there was no evidence of accumulation or cumulative toxicity. During the final six months of the study, the occurrence of serious adverse events was low and consistent with data from previous RAPTIVA Phase III studies.
RAPTIVA® (efalizumab) is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis. In October 2003, RAPTIVA received U.S. Food and Drug Administration approval for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. The recommended dose of RAPTIVA is a single 0.7 mg/kg SC conditioning dose followed by weekly SC doses of 1 mg/kg.
RAPTIVA can be self-administered by patients as a single, once-weekly, subcutaneous injection after proper training by a healthcare professional. In clinical studies, RAPTIVA demonstrated a rapid onset of action in the reductions of symptoms associated with psoriasis, in some patients within four weeks of initial treatment. More than 3,500 patients in the United States and Europe have been included in RAPTIVA trials to date, creating the largest existing database of patients taking part in studies with a biological therapy for psoriasis.
For full prescribing information, please visit www.raptiva.com or call 877-RAPTIVA.
Serono S.A., Genentech's partner outside the United States and Japan recently announced that it has received approval for RAPTIVA in a total of 33 countries, including those of the European Union, Switzerland, Australia, Argentina, Mexico and Brazil. European Commission approval was received in late September following a unanimous positive opinion from 25 countries of the the Committee of Medicinal Products for Human Use (CHMP) recommending approval. Serono announced earlier this month that RAPTIVA is now available in 15 countries in its territories. It is awaiting the outcomes of marketing applications in a number of other counties in the territories for which it is responsible.
Important Safety Information
Common adverse events that occurred at least two percent more frequently in RAPTIVA patients than in placebo included headache, infection (mostly upper respiratory infections), chills, nausea, pain, myalgia (muscle pain), flu syndrome, fever, back pain, and acne. Five of these events (headache, chills, fever, nausea and myalgia) were predominantly acute adverse events and were principally seen following the first two injections of RAPTIVA. For the third and subsequent doses, the incidence of acute adverse events was similar between the RAPTIVA and placebo groups. Less than one percent of patients were discontinued from treatment due to acute adverse events.
RAPTIVA is an immunosuppressive agent and has the potential to increase the risk of infection and reactivate latent, chronic infections. Many immunosuppressive agents have the potential to increase the risk of malignancy. The role of RAPTIVA in the development of malignancies is not known. Serious adverse events occurring in clinical studies with RAPTIVA were serious infections (0.4% in RAPTIVA vs. 0.1% in placebo), malignancy (the overall incidence of malignancies of any kind was 1.8 per 100 patient-years for RAPTIVA-treated patients compared with 1.6 per 100 patient-years for placebo-treated patients), thrombocytopenia (0.3% RAPTIVA vs. 0.0% placebo), and worsening of psoriasis, typically upon discontinuation (0.7% in RAPTIVA vs. 0.0% in placebo).
Psoriasis occurs when new skin cells grow abnormally, resulting in thick, red, scaly, inflamed patches. Plaque psoriasis, the most common form of the disease, affects approximately 2.3 million Americans and is characterized by inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis can be limited to a few spots or involve extensive areas of the body, appearing most commonly on the scalp, knees, elbows and trunk. Although it is highly visible, psoriasis is not a contagious disease. While there are a number of medications that may help control the symptoms of psoriasis, there currently is no known cure.
Genentech is a leading biotechnology company that discovers, develops, manufactures, and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from, or are based on, Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States, and receives royalties or other income from companies that are licensed to market its products outside of the United States. The company has headquarters in South San Francisco, Calif., and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.