JERUSALEM, Israel & BURNABY, Canada I April 2, 2015 I Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Xenon Pharmaceuticals Inc. (Nasdaq:XENE) today announced that the first patient has been enrolled into the Phase 2b study designed to evaluate the safety and efficacy of the novel topically applied TV-45070, (4% and 8% w/w ointment) in patients with postherpetic neuralgia (PHN).
TV-45070 is a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. It is being developed for the treatment of patients with various pain indications, including neuropathic and osteoarthritis pain.
“Postherpetic neuralgia leaves patients with lasting and very painful sensations that seriously impact the ability to function. It is often highly refractory to existing treatments and there is a significant need for new treatment options,” said Dr. Jon Isaacsohn, Teva’s Chief Medical Officer. “The field of pain management in general is in need of new options. Teva is making advances with a range of innovative new treatments that will hopefully improve the lives of millions of people suffering from pain caused by debilitating conditions such as PHN and osteoarthritis.”
“The initiation of this TV-45070 Phase 2b clinical trial is an important step on the way to fully understanding the potential for Nav1.7 inhibition in relieving patients from the suffering caused by neuropathic pain. This trial, together with the ongoing study in osteoarthritis pain, from which we expect results later this year, should give us a better indication of the value of this novel approach to pain management,” said Dr. Simon Pimstone, Xenon’s President and Chief Executive Officer.
The Phase 2b clinical study in PHN is a randomized, double-blind, placebo controlled, multi-site study that will evaluate the safety and efficacy of topically applied TV-45070 ointment compared with placebo. Additional information about the trial is available at www.clinicaltrials.gov/ct2/show/NCT02365636.
About Postherpetic Neuralgia (PHN)
PHN is a painful complication of Herpes Zoster or “shingles” in which pain persists for more than 3 months after resolution of the rash. It affects approximately 20% of people who have herpes zoster and increases with age. Elderly patients tend to have more severe and longer lasting PHN. Despite the numerous compounds available for treating PHN, 40% to 50% of PHN patients do not respond to any treatment. The negative impact of PHN on the quality of life can be similar to that caused by life-threatening diseases or serious psychological conditions. PHN can have a significant effect on many aspects of a patient’s life, causing chronic fatigue, sleep disorders, difficulty in concentrating, depression and anxiety, anorexia, loss of bodyweight and social isolation.
About TV-45070
TV-45070 (formerly XEN402) is a topically applied small-molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. TV-45070 has potentially broad application in nociceptive pain, mediated by damage or injury to tissues, including the pain sensitivity caused by inflammation, and neuropathic pain mediated by damage, dysfunction or injury of nerves. The pain target Nav1.7 was identified by Xenon using its Extreme Genetics discovery platform. Xenon developed TV-45070 through early clinical development and partnered with Teva through a collaborative development and license agreement established in 2012, providing Teva with an exclusive worldwide license to develop and commercialize TV-45070. Teva is currently conducting a 300-patient, randomized Phase 2b clinical trial of TV-45070 in osteoarthritis of the knee, with data expected in the third quarter of 2015.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical-stage biopharmaceutical company discovering and developing a pipeline of differentiated therapeutics for orphan indications that it intends to commercialize on its own and for larger market indications that the company intends to partner with global pharmaceutical companies. Xenon has built a core enabling discovery platform, referred to as Extreme Genetics, for the discovery of validated drug targets by studying rare human diseases with extreme traits, including diseases caused by mutations in ion channels, known as channelopathies. Xenon’s Extreme Genetics platform has yielded the first approved gene therapy product in the European Union and a broad development pipeline and multiple pharmaceutical partnerships, including with Teva and Genentech. For more information, please visit www.xenon-pharma.com.
SOURCE: Teva Pharmaceutical Industries
Post Views: 644
JERUSALEM, Israel & BURNABY, Canada I April 2, 2015 I Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Xenon Pharmaceuticals Inc. (Nasdaq:XENE) today announced that the first patient has been enrolled into the Phase 2b study designed to evaluate the safety and efficacy of the novel topically applied TV-45070, (4% and 8% w/w ointment) in patients with postherpetic neuralgia (PHN).
TV-45070 is a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. It is being developed for the treatment of patients with various pain indications, including neuropathic and osteoarthritis pain.
“Postherpetic neuralgia leaves patients with lasting and very painful sensations that seriously impact the ability to function. It is often highly refractory to existing treatments and there is a significant need for new treatment options,” said Dr. Jon Isaacsohn, Teva’s Chief Medical Officer. “The field of pain management in general is in need of new options. Teva is making advances with a range of innovative new treatments that will hopefully improve the lives of millions of people suffering from pain caused by debilitating conditions such as PHN and osteoarthritis.”
“The initiation of this TV-45070 Phase 2b clinical trial is an important step on the way to fully understanding the potential for Nav1.7 inhibition in relieving patients from the suffering caused by neuropathic pain. This trial, together with the ongoing study in osteoarthritis pain, from which we expect results later this year, should give us a better indication of the value of this novel approach to pain management,” said Dr. Simon Pimstone, Xenon’s President and Chief Executive Officer.
The Phase 2b clinical study in PHN is a randomized, double-blind, placebo controlled, multi-site study that will evaluate the safety and efficacy of topically applied TV-45070 ointment compared with placebo. Additional information about the trial is available at www.clinicaltrials.gov/ct2/show/NCT02365636.
About Postherpetic Neuralgia (PHN)
PHN is a painful complication of Herpes Zoster or “shingles” in which pain persists for more than 3 months after resolution of the rash. It affects approximately 20% of people who have herpes zoster and increases with age. Elderly patients tend to have more severe and longer lasting PHN. Despite the numerous compounds available for treating PHN, 40% to 50% of PHN patients do not respond to any treatment. The negative impact of PHN on the quality of life can be similar to that caused by life-threatening diseases or serious psychological conditions. PHN can have a significant effect on many aspects of a patient’s life, causing chronic fatigue, sleep disorders, difficulty in concentrating, depression and anxiety, anorexia, loss of bodyweight and social isolation.
About TV-45070
TV-45070 (formerly XEN402) is a topically applied small-molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. TV-45070 has potentially broad application in nociceptive pain, mediated by damage or injury to tissues, including the pain sensitivity caused by inflammation, and neuropathic pain mediated by damage, dysfunction or injury of nerves. The pain target Nav1.7 was identified by Xenon using its Extreme Genetics discovery platform. Xenon developed TV-45070 through early clinical development and partnered with Teva through a collaborative development and license agreement established in 2012, providing Teva with an exclusive worldwide license to develop and commercialize TV-45070. Teva is currently conducting a 300-patient, randomized Phase 2b clinical trial of TV-45070 in osteoarthritis of the knee, with data expected in the third quarter of 2015.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical-stage biopharmaceutical company discovering and developing a pipeline of differentiated therapeutics for orphan indications that it intends to commercialize on its own and for larger market indications that the company intends to partner with global pharmaceutical companies. Xenon has built a core enabling discovery platform, referred to as Extreme Genetics, for the discovery of validated drug targets by studying rare human diseases with extreme traits, including diseases caused by mutations in ion channels, known as channelopathies. Xenon’s Extreme Genetics platform has yielded the first approved gene therapy product in the European Union and a broad development pipeline and multiple pharmaceutical partnerships, including with Teva and Genentech. For more information, please visit www.xenon-pharma.com.
SOURCE: Teva Pharmaceutical Industries
Post Views: 644
