AIM-listed biopharmaceutical company, , announced on Thursday that it had filed a marketing authorisation application for its drug, BP-101 which addresses the treatment of female sexual dysfunction.
The MA application for the drug, a novel synthetic peptide administered through a nasal spray, was filed by its subsidiary, IVIX, with the Russian Ministry of Health, otherwise known as the Minzdrav.
IVIX submitted an application for BP-101 which acts as a treatment for hypoactive sexual desire disorder (or “HSDD”), a condition characterised by a distressing lack or loss of sexual desire found specifically in premenopausal women.
So far, IVIX has reached and completed both Phase II and Phase III clinical studies in Russia. The MA is based on data collected from two Phase I studies as well as data from both the second and third clinical studies.
Shares in Ovoca Bio increased to over 11% following this morning’s announcement.
After the completion of the submission is confirmed, the Minzdrav will automatically commence a period of review. Should the application be approved, this would allow the possibility for BP-101 to be marketed in the Russian Federation towards the end of 2020.
The firm’s wishes to seek approval for BP-101 mark its wider efforts to see the drug firmly established on the Russian market, a first step towards expanding internationally.
Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, commented: "The submission of the BP-101 MA application marks an important milestone on our journey to ensure that this innovative therapy is available to patients as quickly as possible.”
Mr Golovanov added, “We are committed to advancing BP-101 in the Russian Federation and then globally as a new treatment option for patients with HSDD and look forward to receiving the outcome of our submission to the Minzdrav."
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