The complete response letter stated that the
This response supports Teva's belief that even slight changes to a glatiramoid like Copaxone® can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound. Teva intends to continue working closely with the
The sNDA was based on the SONG trial which examined a lower-volume injection of Copaxone® containing 20mg of glatiramer acetate, the currently approved dose, in a 0.5mL injection. The trial was designed to explore whether a reduced-volume injection enhances the patient injection experience. The trial included nearly 150 patients in 21 centers in the U.S.
Copaxone® is indicated for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of Copaxone® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.
Copaxone® (glatiramer acetate injection) is now approved in 51 countries worldwide, including
See additional important information at http://www.sharedsolutions.com/pdfs/PrescribingInformation.aspx or call 1-800-887-8100 for electronic releases.About the Study
Patients (N=148) enrolled in an open-label randomized two-arm single crossover study. Half of the patients (n=76) were randomized to inject 20mg/1.0mL daily for the first 14 day period (Period 1). The other half of the patient group (n=72) injected 20mg/0.5mL daily during Period 1. During the second 14 day period (Period 2), the groups switched their injection volume formulation. The first group injected 20mg/0.5mL glatiramer acetate daily and the second group injected daily 20mg/1.0mL glatiramer acetate. Safety, tolerability, clinical and laboratory assessments occurred at the end of each period.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel®, Protonix® and Yaz®, the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone® (including potential generic and oral competition for Copaxone®), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of ratiopharm), interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex