New Data on the Safety and Efficacy of XELJANZ

Pfizer Inc. announced that 26 new scientific abstracts, including 20 presentations for XELJANZ® (tofacitinib citrate) in rheumatoid arthritis (RA) will be presented on behalf of Pfizer at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) 2015 Annual Meeting.

XELJANZ (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) Inhibitor. XELJANZ is the first and only JAK inhibitor approved in over 40 countries around the world for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs). The benefit:risk profile of XELJANZ in RA has been studied in approximately 6,200 patients with more than 19,000 patient-years of drug exposure in the global clinical development program for XELJANZ in moderate to severe RA. A new drug application (NDA) for XELJANZ 11 mg once-daily modified release for the treatment of moderate to severe RA is under review with the U.S. Food & Drug Administration (FDA). In the United States, XELJANZ has a boxed warning for serious infections and malignancies.

Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program in a range of immune-mediated inflammatory conditions.

Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including stiffness and swelling in the joints, particularly those in the hands, feet and knees. Although the exact cause of RA is unknown, it is considered to be an autoimmune disease, because the immune system in people with RA mistakes the body’s healthy tissues as a threat and attacks them. Some people are at increased risk of developing RA, including people with a family history of RA, smokers and women. Three times as many women are affected by RA compared to men. RA affects an estimated 17.5 million people worldwide. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.

India rejects patent on Pfizer's arthritis drug

India has again denied Pfizer Inc a patent on its rheumatoid arthritis drug tofacitinib, the latest setback for a multinational drugmaker seeking to enforce its intellectual property rights in the country. Pfizer sought a patent that covers an important chemical formulation of the active compound in the medicine, but the Indian Patent Office said the company would have to establish that the compound for which it is seeking a patent is therapeutically more effective than the active compound.

"The invention disclosed and claimed in the instant application ... is not considered as an invention under the provisions of the Act," Bharat N S, an assistant controller at the patent office, wrote in an order dated Sept. 3. Pfizer is reviewing its options for further action, a Mumbai-based company spokesman said in an emailed statement. 

Drug patents have become a thorny issue for global drugmakers seeking to expand in India's fast-growing healthcare market. Companies including Pfizer, Bayer and Roche have in recent years struggled to retain exclusivity on drugs in India, and have blamed patent laws they say are designed to favor the local industry.

India, however, has said its drug patents policy is designed to ensure medicines remain affordable for the country where less than 15 percent of the population has health insurance.

India's patent office had rejected Pfizer's application to patent tofacitinib in 2011, but was ordered to reconsider the decision by the Intellectual Property Appellate Board, after Pfizer appealed.