- Further expansion of Bayer’s drug development pipeline in Women’s Healthcare
- Phase IIb dose range finding study results recently published for the investigational non-hormonal oral compound NT-814 to treat moderate to severe vasomotor symptoms due to menopause
- Reinforces Bayer’s position in Women’s Healthcare
- Upfront consideration of $425 million and additional potential consideration in the form of milestone payments
WHIPPANY, NJ, USA I August 11, 2020 I Bayer®, a leader in women’s healthcare, and KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, announced today that Bayer will acquire KaNDy Therapeutics Ltd. to expand its drug development pipeline in women’s healthcare. KaNDy Therapeutics Ltd. recently completed and published the Phase IIb dose range finding study results for its’ investigational compound, NT-814, a potential first in class, orally administered once-daily, neurokinin-1,3 receptor antagonist which showed positive findings for the treatment of moderate to severe vasomotor symptoms due to menopause. The start of Phase III clinical trial is expected for 2021. Once approved, the compound could generate peak sales potential of more than €1 billion globally.
Up to 75% of women, over the age of 50, going through menopausal transition, experience menopausal vasomotor symptoms.1 These symptoms can be debilitating for several years for those affected and may result in significant incremental healthcare and economic costs.2
Under the terms of the agreement Bayer will pay an upfront consideration of $425 million, potential milestone payments of up to $450 million until launch followed by potential additional triple digit million sales milestone payments. Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.
“As a leader in Women’s Health, Bayer is focused on providing new options for women and their healthcare needs,” said Dr. Sebastian Guth, Bayer’s President of Pharmaceuticals, Americas Region. “This acquisition is another testament to our commitment to the health of women, which not only broadens our pipeline, but has the potential, if approved, to deliver a new treatment option that could have a meaningful impact on women’s lives.”
“Bayer has been our preferred partner due to its leading position in the area of women’s healthcare”, said Dr. Mary Kerr, Co-Founder and CEO of KaNDy Therapeutics Ltd.. “We believe that under the ownership of Bayer, this potential first in class medicine can be optimally developed to become an important non-hormonal treatment option for women suffering vasomotor symptoms due to menopause.”
The acquisition of KaNDy Therapeutics Ltd. is another important milestone in augmenting Bayer’s own women’s healthcare portfolio through strategic collaborations and agreements. Earlier in 2020, Bayer announced the expansion of its partnership with Evotec with a new five-year, multi-target collaboration to develop multiple clinical candidates for the treatment of polycystic ovary syndrome (PCOS), the most frequent endocrine disorder in pre-menopausal women. Also, in January 2020, Bayer signed an exclusive license agreement with Daré Bioscience for the U.S. market, focused on its investigational, hormone-free, monthly vaginal contraceptive currently in clinical development for the prevention of pregnancy.
The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.
Morgan Stanley is serving as financial advisor to Bayer, while Linklaters is serving as legal counsel. Goldman Sachs International is serving as financial advisor to KaNDy Therapeutics Ltd., while Goodwin is serving as legal counsel.
About KaNDy Therapeutics Ltd.
KaNDy Therapeutics Ltd. is a UK-based private clinical-stage biotech that was founded in 2017 as a spin-off from NeRRe Therapeutics Ltd. It is led by an experienced management team and backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and Longitude Capital. KaNDy Therapeutics is based at the state-of-the-art Stevenage Bioscience Catalyst, a leading location for companies to develop and commercialize cutting edge therapeutics.
About NT-814
NT-814 is an orally administered investigational small molecule dual antagonist of both the neurokinin-1 and 3 receptors and is believed to address vasomotor symptoms by modulating a group of estrogen sensitive neurons in the hypothalamus in the brain (the KNDy neurons), that in menopausal women due to the absence of estrogen, become hyperactive and consequently disrupt body heat control mechanisms.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.
About Gynecology at Bayer
Bayer is committed to delivering Science For A Better Life by advancing a portfolio of innovative treatments. Women’s health, including family planning and menopause management, has been at the center of Bayer’s gynecology franchise for many years. Today, Bayer’s research efforts focus on finding new treatment options for gynecological diseases with a high medical need, and includes several investigational compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated.
1 Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial., 2020.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188053/
2 Am Health Drug Benefits, 2017
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620512/
SOURCE: Bayer
Post Views: 255
- Further expansion of Bayer’s drug development pipeline in Women’s Healthcare
- Phase IIb dose range finding study results recently published for the investigational non-hormonal oral compound NT-814 to treat moderate to severe vasomotor symptoms due to menopause
- Reinforces Bayer’s position in Women’s Healthcare
- Upfront consideration of $425 million and additional potential consideration in the form of milestone payments
WHIPPANY, NJ, USA I August 11, 2020 I Bayer®, a leader in women’s healthcare, and KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, announced today that Bayer will acquire KaNDy Therapeutics Ltd. to expand its drug development pipeline in women’s healthcare. KaNDy Therapeutics Ltd. recently completed and published the Phase IIb dose range finding study results for its’ investigational compound, NT-814, a potential first in class, orally administered once-daily, neurokinin-1,3 receptor antagonist which showed positive findings for the treatment of moderate to severe vasomotor symptoms due to menopause. The start of Phase III clinical trial is expected for 2021. Once approved, the compound could generate peak sales potential of more than €1 billion globally.
Up to 75% of women, over the age of 50, going through menopausal transition, experience menopausal vasomotor symptoms.1 These symptoms can be debilitating for several years for those affected and may result in significant incremental healthcare and economic costs.2
Under the terms of the agreement Bayer will pay an upfront consideration of $425 million, potential milestone payments of up to $450 million until launch followed by potential additional triple digit million sales milestone payments. Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.
“As a leader in Women’s Health, Bayer is focused on providing new options for women and their healthcare needs,” said Dr. Sebastian Guth, Bayer’s President of Pharmaceuticals, Americas Region. “This acquisition is another testament to our commitment to the health of women, which not only broadens our pipeline, but has the potential, if approved, to deliver a new treatment option that could have a meaningful impact on women’s lives.”
“Bayer has been our preferred partner due to its leading position in the area of women’s healthcare”, said Dr. Mary Kerr, Co-Founder and CEO of KaNDy Therapeutics Ltd.. “We believe that under the ownership of Bayer, this potential first in class medicine can be optimally developed to become an important non-hormonal treatment option for women suffering vasomotor symptoms due to menopause.”
The acquisition of KaNDy Therapeutics Ltd. is another important milestone in augmenting Bayer’s own women’s healthcare portfolio through strategic collaborations and agreements. Earlier in 2020, Bayer announced the expansion of its partnership with Evotec with a new five-year, multi-target collaboration to develop multiple clinical candidates for the treatment of polycystic ovary syndrome (PCOS), the most frequent endocrine disorder in pre-menopausal women. Also, in January 2020, Bayer signed an exclusive license agreement with Daré Bioscience for the U.S. market, focused on its investigational, hormone-free, monthly vaginal contraceptive currently in clinical development for the prevention of pregnancy.
The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.
Morgan Stanley is serving as financial advisor to Bayer, while Linklaters is serving as legal counsel. Goldman Sachs International is serving as financial advisor to KaNDy Therapeutics Ltd., while Goodwin is serving as legal counsel.
About KaNDy Therapeutics Ltd.
KaNDy Therapeutics Ltd. is a UK-based private clinical-stage biotech that was founded in 2017 as a spin-off from NeRRe Therapeutics Ltd. It is led by an experienced management team and backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and Longitude Capital. KaNDy Therapeutics is based at the state-of-the-art Stevenage Bioscience Catalyst, a leading location for companies to develop and commercialize cutting edge therapeutics.
About NT-814
NT-814 is an orally administered investigational small molecule dual antagonist of both the neurokinin-1 and 3 receptors and is believed to address vasomotor symptoms by modulating a group of estrogen sensitive neurons in the hypothalamus in the brain (the KNDy neurons), that in menopausal women due to the absence of estrogen, become hyperactive and consequently disrupt body heat control mechanisms.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.
About Gynecology at Bayer
Bayer is committed to delivering Science For A Better Life by advancing a portfolio of innovative treatments. Women’s health, including family planning and menopause management, has been at the center of Bayer’s gynecology franchise for many years. Today, Bayer’s research efforts focus on finding new treatment options for gynecological diseases with a high medical need, and includes several investigational compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated.
1 Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial., 2020.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188053/
2 Am Health Drug Benefits, 2017
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620512/
SOURCE: Bayer
Post Views: 255
