|Pfizer Says CHMP Confirms Prior Opinion on Xeljanz in Europe; BioMarin Provides BMN 673 Program Update|
|By Staff and Wire Reports|
|Thursday, 25 July 2013 20:25|
Pfizer Inc. (NYSE: PFE) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its April 25, 2013, opinion to recommend against approval of XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). After re-examination of the application as requested by Pfizer, the CHMP is of the opinion that XELJANZ does not demonstrate a favorable benefit:risk profile.
While the CHMP considered that treatment with XELJANZ resulted in reduction in the signs and symptoms of RA and improvement in the physical function of patients, it has outstanding concerns on safety, including serious infections.
The Company is currently evaluating the feedback from the CHMP and will determine next steps to resubmit a MAA to the EMA.
“We are disappointed in the outcome of the re-examination process. A narrow majority of the CHMP felt there is too limited experience in the patient population to fully characterize the profile of XELJANZ and the Committee did not recommend approval at this time,” said Dr. Steven Romano, senior vice president and the head of the Medicines Development Group for Pfizer Specialty Care. “The clinical experience with XELJANZ to date, which includes data from approximately 5,000 patients treated for RA, demonstrates a consistent efficacy and safety profile across a range of patient types and a risk profile that is familiar to rheumatologists who have experience utilizing the range of treatments available to treat this disease. We believe that the benefit:risk profile of XELJANZ is favorable, and we remain committed to working with the EMA to make XELJANZ available to appropriate patients in Europe.”
About the Marketing Authorization Application -- The MAA included data from the comprehensive, global, multi-study clinical development program for XELJANZ, which included approximately 5,000 patients across Phase 2 and Phase 3 trials in more than 40 countries, resulting in 7,000 patient-years of exposure at the time of regulatory submission. The application was based on the same pivotal efficacy and safety data package that was provided to regulatory agencies around the world.
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) provided an update on its ongoing Phase 1/2 study for its poly ADP-ribose polymerase (PARP) inhibitor BMN 673 for the treatment of solid tumors. As of July 24, the RECIST response rate from the ongoing trial is nine out of 18 breast cancer patients, or 50 percent, including one confirmed complete response. This response rate includes three additional confirmed responses since the last update at the ASCO Annual Meeting, and two new patients are yet to be confirmed. Four patients are ongoing with stable disease with potential for additional responses. The study is still ongoing, and the company will provide additional updates later this year, including data in ovarian cancer, Ewing's sarcoma and small cell lung cancer.
Since the ASCO Annual Meeting, the company has met with the FDA and MAA to review its planned clinical program in deleterious gBRCA mutation metastatic breast cancer. At those meetings, health authorities confirmed that a primary endpoint of Progression Free Survival (PFS) could serve as the basis for a potential approval. BioMarin now expects to initiate a Phase 3 trial for BMN 673 in deleterious gBRCA mutation metastatic breast cancer in late third quarter of 2013, earlier than previously announced at the ASCO Annual Meeting in early June.
National Breast Cancer Coalition (NBCC) has announced its intention to assist BioMarin's development of the PARP inhibitor for the treatment of hereditary breast cancer with BRCA mutations. NBCC intends to participate with BioMarin on enrollment initiatives in the United States and around the world. In addition, NBCC will be a resource on study design, implementation and execution.
"NBCC is an organization committed to ending breast cancer in large part by participating in and contributing to the scientific process. The application of drug development science to well-defined problems is an important step in our mission. Therefore, we are pleased to collaborate with BioMarin to develop BMN 673 as a potential first and/or best in class PARP inhibitor for patients with hereditary forms of cancer, namely BRCA mutations. This project offers the hope of improving the length and/or quality of life for patients," said Fran Visco, President of the National Breast Cancer Coalition.
"We look forward to conducting a world-class study, in collaboration with the finest clinical investigators in the world to evaluate the safety and efficacy of BMN 673 in the metastatic setting. Our advocates are poised to change the world through our actions. Ultimately, we hope to prevent women from getting breast cancer and prevent it from spreading outside the breast," Visco added.
"BioMarin is an organization that wants to make big differences in the lives of patients. The data emerging from the ongoing BMN 673 study is progressively more encouraging. We are committed to the successful execution of the Phase 3 program in hopes of offering patients a safe and easily administered pill, which is an effective treatment option," said Hank Fuchs, M.D., Chief Medical Officer of BioMarin. "We are honored to include a seat at the table for our colleagues from NBCC. The purpose of our efforts is best served hearing their voice from the beginning and taking action together."
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