Clarus Therapeutics & McGill University Announce Exclusive Worldwide Licensing Agreement to Develop & Commercialize Technology to Treat Rare Conditions Associated With Coenzyme-Q10 (Ubiquinone) Deficiencies

Clarus Therapeutics Holdings, Inc. and McGill University recently announced a licensing agreement whereby Clarus will develop and commercialize McGill’s proprietary technology designed to treat conditions associated with CoQ₁₀ deficiencies in humans.

CoQ₁₀ is synthesized in the inner membrane of mitochondria, a cellular organelle whose primary function is to produce the body’s chemical energy. Deficiencies of CoQ₁₀ can lead to severe multiple organ dysfunctions that involve the brain, nerves, kidneys, heart, GI tract and muscle. Oral CoQ₁₀ is largely ineffective because it does not result in intracellular uptake of CoQ₁₀. McGill has identified a method to substantially increase such uptake, thereby forming the basis for a new, and potentially profound, method of addressing deficiencies of CoQ₁₀.

“This collaboration with world-renowned McGill University expands our focus beyond androgen-based medicines to a metabolic therapy for CoQ₁₀ deficiencies that have very limited treatment options,” said Dr. Robert Dudley, Clarus’s Founder, President and Chief Executive Officer. “Knowing the role McGill’s discovery may have to address this important, unmet medical need is a terrific opportunity, and we are excited to get started.”

McGill’s discovery, a combination of CoQ₁₀ plus caspofungin (an FDA-approved antifungal drug for adults and children), was made by Dr. Siegfried Hekimi and his colleague, Dr. Ying Wang. Dr. Hekimi is a Professor of Biology and holds the Robert Archibald & Catherine Louise Campbell Chair in Developmental Biology. He is an expert in aging research and a Fellow of the Royal Society of Canada, which awarded him the Flavelle Medal for his outstanding contribution to biological science.

“Deficiencies of CoQ₁₀ are a major medical challenge, and I am delighted that a discovery from my laboratory has been licensed by Clarus,” said Dr. Hekimi. “We look forward to working with the excellent team at Clarus to bring forward a treatment that could be potentially game changing for individuals afflicted with a severe lack of CoQ₁₀ as well as individuals with other mitochondrial disease.”

Under the terms of the licensing agreement, Clarus will pay McGill a one-time upfront payment of $350,000 and up to $10.5 million in potential development and regulatory milestone payments. Additionally, McGill would be eligible for up to $30 million in potential commercial milestone payments. The success-based milestones denote important steps associated with building value for these programs.

Mitochondrial diseases are chronic, genetic diseases that occur when the mitochondria, structures in our body cells that produce energy from oxygen and food, fail to function properly. Mitochondrial diseases can affect almost any area of the body and can occur at any age, making them often misdiagnosed. It is estimated that approximately one in 5,000 adults worldwide has a mitochondrial disease.

Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus Therapeutics’ first commercial product is JATENZO. For more information, visit www.clarustherapeutics.com.

Founded in Montreal, Quebec, in 1821, McGill University is Canada’s top ranked medical doctoral university. McGill is consistently ranked as one of the top universities, both nationally and internationally. It is a world-renowned institution of higher learning with research activities spanning two campuses, 11 faculties, 13 professional schools, 300 programs of study and over 40,000 students, including more than 10,200 graduate students. McGill attracts students from over 150 countries around the world, its 12,800 international students making up 31% of the student body. Over half of McGill students claim a first language other than English, including approximately 19% of our students who say French is their mother tongue.