BOSTON, April 14, 2020 /PRNewswire/ -- IBSA Group and Granata Bio today announced a strategic partnership focused on the clinical development of IBSA's subcutaneous progesterone (Prolutex®) in the United States (US). Prolutex® is an investigational drug product that is being developed to provide luteal phase supplementation in women undergoing In Vitro Fertilization ("IVF") as part of an Assisted Reproductive Technology ("ART") treatment program.
Currently available FDA-approved progesterone options for US IVF patients include intravaginal effervescent tablets and gels. Progesterone-in-oil (progesterone injection) is used off-label via an intramuscular injection usually administered by a partner or caregiver.
"Prolutex® is a proprietary aqueous progesterone hydroxypropyl betadex solution for subcutaneous injection, developed and manufactured by IBSA. Since its approval in Europe in 2014, it has outperformed our commercial expectations in European and extra-European markets. We are excited about its potential impact in the United States," stated Giuseppe Mautone, Head of R&D Scientific Affairs of IBSA Group.
"US patients undergoing fertility treatment – especially those utilizing frozen embryo transfer - have limited options for luteal phase support. We hope that subcutaneous progesterone, if approved, can help address this unmet patient need. We are excited to collaborate with IBSA, a leader in fertility, in advancing towards that goal," said Evan Sussman, Co-Founder and CEO of Granata Bio.
Prolutex® is an investigational aqueous, subcutaneous progesterone solution being developed for the U.S. market to provide luteal support as a part of an ART treatment program. The drug product is currently approved for marketing and available in 32 countries under the trade names Pleyris®, Lubion® Progiron® and Inprosub®.
Progesterone should not be used in patients with current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy, liver dysfunction or disease, known or suspected malignancy of breast or genital organs, undiagnosed vaginal bleeding, missed abortion, and/or known sensitivity to progesterone products.
About IBSA Group
IBSA Group, headquartered in Lugano, Switzerland, is a leader in reproductive health and has a diversified product portfolio of prescription drugs and biologics. With products on five continents and in over 80 countries, IBSA has a commitment to scientific research and improving the health of patients.
For more information, visit www.ibsagroup.com
About Granata Bio
Granata Bio is a biotechnology company focused on women's health and fertility. Founded in 2018, Granata Bio is targeting and growing solutions to address unmet patient needs.
For more information, visit www.granata.bio.
SOURCE Granata Bio