Endoceutics is a private pharmaceutical company operating in the fields of women’s health and hormone-sensitive cancer prevention and treatment.
Endoceutics is actively committed to advancing basic sciences, clinical research and development, world-class manufacturing, and product commercialization worldwide.
Endoceutics is a private pharmaceutical company operating in the field of women's health and hormone-sensitive cancer prevention and treatment.
Following approval of Intrarosa® by the US FDA in November 2016 for the treatment of moderate to severe dyspareunia, a symptom of vulvovaginal atrophy (VVA) due to menopause as well as by the European Medecines Agency in January 2018 and by Health Canada in November 2019 for the treatment of VVA in postmenopausal women, Endoceutics now focuses its efforts on supporting the worldwide commercialisation of this innovative product through partners of choice, and on the advancement of its pipeline.
Endoceutics has exclusive worldwide rights to patents, patent applications, technology and know-how related to different product candidates addressing large market opportunities.
Fernand Labrie received the Prince of Wales award for graduating first among graduates of all colleges of the province of Quebec affiliated with Laval University. He earned his M.D. (magna cum laude) and then his Ph.D. in Endocrinology (summa cum laude) at Laval University in Quebec City, Canada.
Fernand Labrie pursued postdoctoral research training at the University of Cambridge in England, under the direction of Professor Asher Korner, of the Department of Biochemistry, before joining the Laboratory of Molecular Biology under the direction of Professor Frederick Sanger, twice Nobel laureate in Medicine.
Dr. Labrie joined the Department of Physiology at Laval University where he founded the Laboratory of Molecular Endocrinology. This laboratory then became the largest research group at Laval University, and one of the largest and most renowned research groups in endocrinology on the international scene.
Dr. Labrie founded the Research Group in Molecular Endocrinology of the Medical Research Council of Canada. It was the first endocrinology group financed in Canada by this national agency. This internationally recognized team included over 350 scientists, research professionals and technicians at the cutting edge of this highly competitive field of biomedical research.
Dr. Labrie and his team discovered that chronic administration of GnRH (Gonadotropin-Releasing Hormone) agonists in men induced medical castration. GnRH agonists were found to have an efficacy equivalent to surgical castration. However, they are much better accepted than surgery, thus permitting their generalized use, especially in localized prostate cancer where many years of treatment are often needed. In 1979, the first prostate cancer patient was treated with a GnRH agonist in Quebec City. Rapidly thereafter, GnRH agonists replaced surgical castration worldwide.
Soon afterwards, Dr. Labrie and his group discovered that up to 50% of androgens are left in the prostate after medical castration. He then pioneered the development of combined androgen blockade. At the start of treatment, an anti-androgen is administered to block the action of the androgens made locally in the prostate, while at the same time, testicular androgen secretion is eliminated by a GnRH agonist or surgical castration. Combined androgen blockade (CAB) was the first treatment shown to prolong life in prostate cancer, and it has become the standard treatment worldwide.
Dr. Labrie became Director of Research at the Laval University Hospital Research Center. The CHUL Research Center had over 1200 high-technology employees and nearly 300,000 square feet of research space with $80 million in state-of-the-art equipment. With its annual budget of over $65 million in grants, awards and research contracts, the CHUL Research Center was to become, by 1996, under Dr. Labrie’s leadership, the largest Canadian medical research institute as recognized by the Medical Research Council of Canada in 1996.
Highly motivated by the success of combined androgen blockade which blocks the action of the androgens made from DHEA in the prostate, Dr. Labrie increased his research interests around DHEA. He then realized that after menopause, the only source of sex steroids (androgens and estrogens) is DHEA, which markedly decreases with age. In men, as mentioned above, up to 50% of androgens originate from DHEA.
Based upon a successful fundamental research program on the molecular biology of the intracrine enzymes with Dr. Van Luu-The, and preclinical models with Dr. Jacques Simard, Dr. Labrie and his group discovered and developed acolbifene, the most potent and pure antiestrogen available for the treatment and prevention of breast and uterine cancer.
Dr. Labrie's team coined a term, intracrinology, for this new field of medical knowledge. This new scientific discipline has major implications for the improved therapy of hormone-sensitive diseases, especially prostate and breast cancer, as well as for menopause and osteoporosis.
Dr. Labrie’s team, along with Dr. Alain Bélanger, developed an accurate and highly sensitive steroid assay based on mass spectrometry which replaced the less sensitive and frequently inaccurate radioimmunoassays and became the gold standard for steroid assays.
Dr. Labrie founded Endoceutics, a biopharma company centered on late stage clinical development of compounds discovered by EndoResearch. This company, operating in the field of women’s health and hormone sensitive cancer, is currently focused on developing non estrogen-based therapies for vulvovaginal atrophy, sexual dysfunction and other problems of menopause. Endoceutics interests also include the hormone therapy of breast and prostate cancer as well as endometriosis and male hypogonadism. Endoceutics has an extensive Phase III development program and one recently approved product: Intrarosa for dyspareunia, a symptom of vulvovaginal atrophy due to menopause.
Dr. Labrie developed an Analytical and Bioanalytical services center within Endoceutics. This laboratory offers high-throughput, high-quality analytical and bioanalytical services to the biopharmaceutical industry, research organizations, and academic institutions.
Dr. Labrie and his team published the first scientifically and clinically proven evidence of the efficacy of intravaginal prasterone (DHEA) as replacement therapy at menopause. This demonstration pertains to the treatment of dyspareunia, a symptom of vulvovaginal atrophy due to menopause.
Nov 2016: The US FDA approved Intrarosa (intravaginal prasterone) for the treatment of dyspareunia, a symptom of vulvovaginal atrophy due to menopause.
Jan 2017: Endoceutics acquires a manufacturing plant in Mont-Saint-Hilaire, Quebec, Canada.
Feb 2017: AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) and Endoceutics have entered into an exclusive license agreement that provides AMAG with U.S. commercial rights to Intrarosa(prasterone).
Jan 2018: The EU EMA approved Intrarosa for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Q3 2018: Theramex and Endoceutics announced they have entered into a definitive agreement granting Theramex the license to commercialise Intrarosa (Prasterone) across countries in Europe, Australia, Russia as well as select countries within the Commonwealth of Independent States (CIS).