INVO Bioscience, Inc., developers of the INVOcell intravaginal culture system, and Ferring Pharmaceuticals, a specialty biopharmaceutical group committed to helping people around the world build families and live better lives, announced today that the companies have entered into an exclusive U.S. commercialization rights agreement for INVOcell. Ferring will be responsible for all U.S. commercial activities for INVOcell. INVO Bioscience will be responsible for manufacturing and supplying INVOcell to Ferring for commercial sales and to obtain a five (5) day label enhancement from the FDA for the current incubation period for the product. INVO Bioscience also retains certain limited rights to establish INVO clinics that exclusively commercialize INVO cycles and will retain commercialization rights outside the U.S.
The agreement is expected to close in January 2019, subject to customary closing conditions.
“We are pleased to have reached this agreement with Ferring to commercialize INVOcell in the U.S.,” said Katie Karloff, Chief Executive Officer of INVO Bioscience. “Ferring has commercial strength and market presence within the pharmaceutical fertility market and understands the unique opportunity that INVOcell provides to revolutionize fertility treatment. Our joint mission at INVO Bioscience and Ferring is to increase access to care and expand fertility treatment across the U.S., and with Ferring we’ve found a natural partner to accomplish this goal.”
“As a leader in reproductive medicine, Ferring understands that women seeking to start or expand a family want options that suit their individual circumstances,” said Paul Navarre, CEO, Ferring Pharmaceuticals. “With this agreement, Ferring aims to make INVOcell, a novel technology used in the treatment of infertility, widely available as an option for women and their healthcare providers.”
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INVOcell is a novel fertility treatment that uses a woman’s own body as a natural incubator for the incubation of eggs and sperm during fertilization and early embryo development. In 2015, INVOcell received US Food & Drug Administration clearance. INVOcell is the first intravaginal culture device and is a small polystyrene capsule used for egg fertilization and embryo development using vaginal incubation. In clinical studies supporting the FDA clearance, INVOcell has shown results comparable to traditional assisted reproductive techniques.
“In my practice, an increasing number of women and couples are choosing INVOcell with favorable results,” said Amber R. Cooper MD, MSCI, FACOG, Medical and IVF Practice Director of Vios Fertility Institute St. Louis, MO. “There is a growing consensus around the need for personalized medicine in reproductive health. That Ferring and INVO Bioscience are moving to make INVOcell an available option for infertility patients across the country is very welcome news.”
In the United States, statistics show that over 1.4 million women may benefit from advanced fertility treatment. However, only approximately 130,000 people begin such treatment.i
Additional details pertaining to the agreement will be filed by INVO Bioscience with the SEC.
Date: November 19, 2018
Source: Yahoo Finance
