March 23, 2015 I Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) announced today that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200 million upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February 2015.
In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
“We are pleased with the FDA’s decision as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option,” said Steve Romano, MD, senior vice president and head of Global Medicines Development at Pfizer’s Global Innovative Pharmaceuticals Business.
“We’re pleased to work with Pfizer to resume the Phase 3 program, and we’re confident that tanezumab, if approved, can be an innovative treatment with the potential to help millions suffering from painful conditions,” said David Ricks, Lilly senior vice president and president, Lilly Bio-Medicines.
It is estimated that nearly one in five adults suffer from chronic pain.
About Tanezumab
Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), a regulator of pain processing and sensitivity. NGF levels increase as a result of injury or inflammation and in chronic pain states. Tanezumab selectively binds to NGF, thereby inhibiting this protein from activating pain-signaling neurons.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
About Eli Lilly and Company (NYSE: LLY)
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atwww.lilly.com
SOURCE: Pfizer
Post Views: 131
March 23, 2015 I Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) announced today that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200 million upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February 2015.
In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
“We are pleased with the FDA’s decision as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option,” said Steve Romano, MD, senior vice president and head of Global Medicines Development at Pfizer’s Global Innovative Pharmaceuticals Business.
“We’re pleased to work with Pfizer to resume the Phase 3 program, and we’re confident that tanezumab, if approved, can be an innovative treatment with the potential to help millions suffering from painful conditions,” said David Ricks, Lilly senior vice president and president, Lilly Bio-Medicines.
It is estimated that nearly one in five adults suffer from chronic pain.
About Tanezumab
Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), a regulator of pain processing and sensitivity. NGF levels increase as a result of injury or inflammation and in chronic pain states. Tanezumab selectively binds to NGF, thereby inhibiting this protein from activating pain-signaling neurons.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
About Eli Lilly and Company (NYSE: LLY)
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atwww.lilly.com
SOURCE: Pfizer
Post Views: 131
