The patent – covering GroPep's drug for the treatment of recurrent miscarriage – provides the company with a European market patent exclusivity until at least 2018. GroPep already has two US patents covering the active ingredient of the drug until 2020.
According to the American College of Obstetricians and Gynecologists, at least 50 percent of recurrent miscarriages have no apparent explanation and there is no cure. The size of the market, the lack of competition and the strong patent position held by GroPep, means that the drug has the potential to participate in a market worth up to US$750 million annually.
Listed biopharmaceutical company GroPep Limited (ASX: GRO) today announced that European Patent No. 1028743, covering a method of treating recurrent miscarriage and preeclampsia using GroPep's infertility drug product - PV903, has been granted.
This patent grant is a major product development milestone as it provides the Company with a European market patent exclusivity until at least 2018. The European patent compliments two granted US patents licensed to GroPep by OSI Pharmaceuticals that cover the active ingredient of PV903 and method of manufacture until at least 2020. The combination provides GroPep with patent protection in the world's most valuable markets. The Company is also prosecuting additional patent applications to further extend the patent protection around PV903.
GroPep's Chief Executive Officer, Mr Bob Finder, said that the Company is developing PV903 as a potential treatment for recurrent miscarriage, a traumatic infertility condition with an estimated market potential of over US$750 million per year. There are currently no drugs approved for the treatment of recurrent miscarriage.
The European patent is owned by the University of Adelaide with human infertility applications licensed exclusively to GroPep under an agreement made in 2001. GroPep is responsible for prosecution of the patent.
The invention was made by Dr Sarah Robertson and Dr Kelton Tremellen, both at the University of Adelaide, who were investigating the use of the PV903 active ingredient as a treatment for this type of infertility condition for several years prior to the University licensing the technology to GroPep.
GroPep is currently conducting a phase I clinical trial on PV903 to evaluate the safety and tolerability of vaginally administered PV903 gel and to determine whether PV903 has effects on vaginal immune cells in a manner consistent with its proposed role in treating immune-based infertility.
Results from the trial are expected during the second half of 2006 and if successful, GroPep will seek to partner PV903 with an international pharmaceutical or biotechnology company with an established franchise in reproductive medicine.
GroPep is a world leader in the development, manufacture and commercialisation of biologically active proteins for cell culture and biomedical research. The Company has an active biopharmaceutical development program that establishes proof of concept for products in humans and partners the later stages of product development and marketing with major pharmaceutical companies.
GroPep is listed on the Australian Stock Exchange Limited (ASX code: GRO).
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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