– First neurotoxin formulation to be developed as a potential biosimilar product to BOTOX®, potentially giving Mylan access to 14 indications upon approval –
– $30 million milestone payable to Revance from Mylan –
NEWARK, CA, USA & HERTFORDSHIRE, UK & PITTSBURGH, PA, USA I June 01, 2020 I Revance Therapeutics, Inc. (NASDAQ: RVNC) and Mylan N.V. (NASDAQ: MYL) today announced Mylan’s decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA), the market-leading neuromodulator.
Feedback obtained from the U.S. Food and Drug Administration (FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in February 2019 indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is viable. Based on this meeting, along with the results from additional characterization and analysis completed by Revance, the two companies are now moving forward with the development program.
“We are excited to move forward with Revance on a clear and achievable development pathway for what will potentially be the first biosimilar to BOTOX®, and to leverage our worldwide reach and commercial expertise to maximize this exciting opportunity globally while expanding access to this important product for patients,” said Mylan President Rajiv Malik. “This collaboration adds another high-profile, large-market, complex biologic, across both aesthetic and therapeutic categories, to our industry-leading biosimilars pipeline.”
Added Mark Foley, President and Chief Executive Officer of Revance Therapeutics, “We are pleased with Mylan’s decision to opt-in to the biosimilar to BOTOX development program, as it reflects our mutual confidence in the path forward. Assuming regulatory approval, it would allow us to financially participate in the short-acting neuromodulator market, while focusing our commercial efforts on creating the new, long-acting neuromodulator category.”
Mylan and Revance signed a collaboration and license agreement in February 2018 for the development and regulatory approval of a biosimilar to BOTOX®, to be followed with commercialization by Mylan in the U.S., Europe and applicable markets throughout the rest of the world. The agreement included an upfront payment of $25 million to Revance. In August 2019, the companies amended the agreement to include an additional one-time payment of $5 million to extend the period in which Mylan could choose to continue its collaboration and license agreement to develop Revance’s biosimilar to BOTOX®.
With Mylan’s decision to move forward with the development program announced today, a payment of $30 million is now payable to Revance by Mylan. Furthermore, the collaboration and license agreement also provides for an additional $70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones. Additionally, per the agreement, Revance is eligible to receive sales target milestone payments and royalties in all relevant markets.
About Mylan
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 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, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in three therapeutic indications – cervical dystonia, adult upper limb spasticity and plantar fasciitis. Beyond DaxibotulinumtoxinA for Injection, Revance gained exclusive rights to commercialize TEOXANE SA’s Resilient Hyaluronic Acid® (RHA®) line of fillers in the U.S., the first and only range of FDA-approved dermal fillers for correction of dynamic facial wrinkles and folds. Revance has also begun development of a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
SOURCE: Mylan
Post Views: 29
– First neurotoxin formulation to be developed as a potential biosimilar product to BOTOX®, potentially giving Mylan access to 14 indications upon approval –
– $30 million milestone payable to Revance from Mylan –
NEWARK, CA, USA & HERTFORDSHIRE, UK & PITTSBURGH, PA, USA I June 01, 2020 I Revance Therapeutics, Inc. (NASDAQ: RVNC) and Mylan N.V. (NASDAQ: MYL) today announced Mylan’s decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA), the market-leading neuromodulator.
Feedback obtained from the U.S. Food and Drug Administration (FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in February 2019 indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is viable. Based on this meeting, along with the results from additional characterization and analysis completed by Revance, the two companies are now moving forward with the development program.
“We are excited to move forward with Revance on a clear and achievable development pathway for what will potentially be the first biosimilar to BOTOX®, and to leverage our worldwide reach and commercial expertise to maximize this exciting opportunity globally while expanding access to this important product for patients,” said Mylan President Rajiv Malik. “This collaboration adds another high-profile, large-market, complex biologic, across both aesthetic and therapeutic categories, to our industry-leading biosimilars pipeline.”
Added Mark Foley, President and Chief Executive Officer of Revance Therapeutics, “We are pleased with Mylan’s decision to opt-in to the biosimilar to BOTOX development program, as it reflects our mutual confidence in the path forward. Assuming regulatory approval, it would allow us to financially participate in the short-acting neuromodulator market, while focusing our commercial efforts on creating the new, long-acting neuromodulator category.”
Mylan and Revance signed a collaboration and license agreement in February 2018 for the development and regulatory approval of a biosimilar to BOTOX®, to be followed with commercialization by Mylan in the U.S., Europe and applicable markets throughout the rest of the world. The agreement included an upfront payment of $25 million to Revance. In August 2019, the companies amended the agreement to include an additional one-time payment of $5 million to extend the period in which Mylan could choose to continue its collaboration and license agreement to develop Revance’s biosimilar to BOTOX®.
With Mylan’s decision to move forward with the development program announced today, a payment of $30 million is now payable to Revance by Mylan. Furthermore, the collaboration and license agreement also provides for an additional $70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones. Additionally, per the agreement, Revance is eligible to receive sales target milestone payments and royalties in all relevant markets.
About Mylan
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 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, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in three therapeutic indications – cervical dystonia, adult upper limb spasticity and plantar fasciitis. Beyond DaxibotulinumtoxinA for Injection, Revance gained exclusive rights to commercialize TEOXANE SA’s Resilient Hyaluronic Acid® (RHA®) line of fillers in the U.S., the first and only range of FDA-approved dermal fillers for correction of dynamic facial wrinkles and folds. Revance has also begun development of a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
SOURCE: Mylan
Post Views: 29
