Bayer adding to women’s health pipeline with Kandy buy for $425M up front – BioWorld Online

LONDON Womens health specialist Kandy Therapeutics Ltd. is to be acquired by Bayer AG for $425 million up front, with a further $450 million to come in milestone payments up to the launch of NT-814, a treatment for menopause symptoms that recently completed phase IIb.

Following the launch, triple-digit million sales milestones will follow for the Glaxosmithkline plc-discovered compound, which is expected to achieve blockbuster status.

The phase III trial of NT-814, a non-hormonal oral antagonist of both the neurokinin 1 and 3 receptors in the hypothalamus, is expected to start in 2021. Once the acquisition completes, Bayer will take on full responsibility for the study and for registration, marketing and sales.

Im really pleased that NT-814 is going into phase III in great hands, said Mary Kerr, CEO of Kandy. Im also pleased because Bayer will be best at marketing the drug, she told BioWorld. The product is expected to launch in 2025.

The acquisition follows publication in May of phase IIb results, which showed vasomotor symptoms were significantly reduced at the two highest doses of NT-814. Unlike hormone therapy, which can take weeks to reduce symptoms such as hot flashes and night sweats, NT-814 had an almost immediate effect, with reduced frequency of hot flashes from the first week of treatment.

By week four, there was an average reduction of minus 6.7 hot flashes per day for NT-814 vs. 2.7 fewer in the placebo arm (p<0.0001). At the 12-week end of the trial, the treatment arm experienced an average of 7.8 fewer hot flashes per day vs. 4.7 fewer for placebo (p=0.0092). Average hot flash severity improved in a dose-related manner.

The acquisition of Kandy adds to Bayers womens health products, which include birth control, menopause management and gynecological disease therapies. The German pharma has been actively expanding the portfolio, agreeing to a licensing deal with Dar Bioscience Inc., of San Diego, in January for Ovaprene, a non-hormonal intravaginal contraceptive. Bayer paid $20 million up front for an option to license Ovaprene, to be followed by $310 million in milestones as phase III development proceeds.

Also in January, Bayer advanced its collaboration in endometriosis with drug discovery company Evotec AG, taking a fourth program into phase I development, and at the same time establishing a new five-year collaboration with Evotec in polycystic ovary syndrome.

The acquisition of Kandy is another example of how the company is focusing on novel approaches to address unmet medical needs in this area, said Stefan Oelrich, president of Bayer Pharmaceuticals. This acquisition will broaden [Bayers] womens health care pipeline by adding a potential novel non-hormonal oral treatment option for women during menopause, he said.

Kerr said Bayers leading position in womens health made it the preferred partner. She previously discussed the phase IIa and phase IIb data with the pharma company. Formal assessment of NT-814 started in March, and despite COVID-19-related restrictions, soon reached agreement. [Bayers] speed has differentiated them, Kerr said.

Closure of the deal is pending the formality of an antitrust review, but is expected to take place next month. Kandy has agreed to provide transition services as the program is handed over. We want to ensure the ball doesnt get dropped, said Kerr.

Phase III up next

NT-814 began life at Glaxosmithkline and was spun out into Nerre Therapeutics Ltd. (of which Kerr is also CEO) in 2012, when the pharma company moved out of neuroscience. The drug subsequently was moved again when Kandy was set up as a womens health specialist at the end of 2016. It is the only product, and with Kandy operating as virtual company, the development team, including Kerr, will all stay at Nerre.

The name Kandy is an acronym for the kisspeptin/neurokinin B/dynorphin (KNDy) neuron, located in the hypothalamus, which regulates secretion of gonadotropin-releasing hormone through the production of the neuroactive peptide kisspeptin.

Hot flashes are caused when the KNDy neuron tries to respond to a signal to raise estrogen levels, which because of the decline in function of the ovaries is not possible. That causes dysregulated firing of KNDy, disrupting thermoregulation. NT-814 switches off the KNDy neuron, with an immediate reduction in vasomotor symptoms.

The exact shape and size of the phase III program for NT-814 will depend on the phase IIb review. Kerr said she expects it will essentially be a bigger version of the phase IIb trial, referencing Astellas Pharma Inc.s phase III study of fezolinetant for the relief of vasomotor symptoms of menopause, in which 1,740 women are being treated for 52 weeks.

Astellas acquired fezolinetant, a neurkinin-3 antagonist, when it bought Ogeda SA, of Gosselies, Belgium, for $537.7 million up front, plus $312 million in milestones, in April 2017.

Although NT-814 is further behind fezolinetant in development, Kandy believes the dual effect of inhibiting both neurokinin 1 and 3 will be an important differentiator between the two products.

The sale to Bayer is a good payday for the venture capital backers, who invested in Kandy at a time when womens health was not seen as an attractive area. That was part of the reason for the spin out from Nerre.

Advent Life Sciences co-founded Nerre and has supported Kandy, introducing new investors and providing advice on strategy. Kaasim Mahmood, general partner at Advent, said the acquisition is an example of the firms hands-on approach to providing strong returns to our investors whilst enabling discovery and development of truly innovative medicines.

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Bayer adding to women's health pipeline with Kandy buy for $425M up front - BioWorld Online