HERTFORDSHIRE, UK and PITTSBURGH, PA, and NEWARK, CA, USA I February 28, 2018 I Mylan N.V. (NASDAQ: MYL) and Revance Therapeutics, Inc. (Nasdaq: RVNC) today announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to BOTOX® (onabotulinumtoxinA). BOTOX is the market-leading neuromodulator approved for the treatment of multiple indications and usage in the United States with additional approvals globally. The addition of this product further solidifies Mylan’s long term commitment to the development and commercialization of biosimilars and complex products globally.
“This will be a significant opportunity for Mylan as we add another difficult-to-manufacture product to our pipeline. We have reviewed the work done to date by Revance and we are extremely excited and confident about our ability to bring this important product to market. Bringing an affordable biosimilar version of BOTOX to commercialization will offer patients a safe alternative to this popular and highly effective treatment,” commented Mylan President Rajiv Malik. “Mylan is pleased to partner with Revance in the global collaboration, and share our scientific, regulatory and manufacturing capabilities and commercialization expertise. Our global platform enables investing in worldwide R&D collaborations for hard to make products that will benefit patients across the globe.”
The companies plan to work together to gain regulatory approval in the development of this important biosimilar product, and commercialize this product in the U.S., Europe and applicable markets throughout the rest of the world. The collaboration includes an upfront payment of $25 million to Revance, with contingent milestone payments upon achievement of additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets.
“Global neuromodulator sales today are estimated at $4 billion and forecasted to grow steadily, exceeding $7 billion by 2024*. Strategically, this partnership with Mylan allows Revance to remain focused on the development and launch of our own premium, long-acting RT002 neuromodulator, while also benefitting financially from potential future milestones and sales royalties on a short-acting biosimilar to BOTOX,” said Dan Browne, President and Chief Executive Officer of Revance Therapeutics. “We believe Mylan is the ideal partner to co-develop, seek regulatory approval and market a biosimilar to BOTOX, due to its significant expertise in the field and its global commercial infrastructure.”
About Mylan N.V.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.Mylan.com.
About Revance Therapeutics, Inc.
Revance Therapeutics is a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, including muscle movement disorders and pain. The company’s lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis, with the potential to be the first long-acting neuromodulator. Revance has developed a proprietary, stabilizing excipient peptide technology designed to create novel, differentiated therapies. The company has a comprehensive pipeline based upon its peptide technology, including injectable and topical formulations of daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
BOTOX® is a registered trademark of Allergan, Inc.
*Sales estimates based on GIA Jan 2018 Report: Botulinum Toxin – A Global Strategic Business Report
SOURCE: Mylan
Post Views: 122
HERTFORDSHIRE, UK and PITTSBURGH, PA, and NEWARK, CA, USA I February 28, 2018 I Mylan N.V. (NASDAQ: MYL) and Revance Therapeutics, Inc. (Nasdaq: RVNC) today announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to BOTOX® (onabotulinumtoxinA). BOTOX is the market-leading neuromodulator approved for the treatment of multiple indications and usage in the United States with additional approvals globally. The addition of this product further solidifies Mylan’s long term commitment to the development and commercialization of biosimilars and complex products globally.
“This will be a significant opportunity for Mylan as we add another difficult-to-manufacture product to our pipeline. We have reviewed the work done to date by Revance and we are extremely excited and confident about our ability to bring this important product to market. Bringing an affordable biosimilar version of BOTOX to commercialization will offer patients a safe alternative to this popular and highly effective treatment,” commented Mylan President Rajiv Malik. “Mylan is pleased to partner with Revance in the global collaboration, and share our scientific, regulatory and manufacturing capabilities and commercialization expertise. Our global platform enables investing in worldwide R&D collaborations for hard to make products that will benefit patients across the globe.”
The companies plan to work together to gain regulatory approval in the development of this important biosimilar product, and commercialize this product in the U.S., Europe and applicable markets throughout the rest of the world. The collaboration includes an upfront payment of $25 million to Revance, with contingent milestone payments upon achievement of additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets.
“Global neuromodulator sales today are estimated at $4 billion and forecasted to grow steadily, exceeding $7 billion by 2024*. Strategically, this partnership with Mylan allows Revance to remain focused on the development and launch of our own premium, long-acting RT002 neuromodulator, while also benefitting financially from potential future milestones and sales royalties on a short-acting biosimilar to BOTOX,” said Dan Browne, President and Chief Executive Officer of Revance Therapeutics. “We believe Mylan is the ideal partner to co-develop, seek regulatory approval and market a biosimilar to BOTOX, due to its significant expertise in the field and its global commercial infrastructure.”
About Mylan N.V.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.Mylan.com.
About Revance Therapeutics, Inc.
Revance Therapeutics is a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, including muscle movement disorders and pain. The company’s lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis, with the potential to be the first long-acting neuromodulator. Revance has developed a proprietary, stabilizing excipient peptide technology designed to create novel, differentiated therapies. The company has a comprehensive pipeline based upon its peptide technology, including injectable and topical formulations of daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
BOTOX® is a registered trademark of Allergan, Inc.
*Sales estimates based on GIA Jan 2018 Report: Botulinum Toxin – A Global Strategic Business Report
SOURCE: Mylan
Post Views: 122
