Starpharma's VivaGel BV NDA advances to next stage of FDA review

10 July 2018

Australian biotech company Starpharma (ASX: SPL) just announced its product VivaGel (astodrimer sodium) BV’s New Drugs Application (NDA) has advanced to the next stage of review by the US Food and Drug Administration, with the news pushing the firm’s shares up 2.64% to A$1.16.

This announcement follows the company signing two license deals with Mundipharma to sell and market VivaGel BV in Europe, Asia, Middle East, Latin America and Africa. VivaGel BV is a water-based vaginal gel for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV, and was discovered and developed by the Melbourne-based firm.

Confirmation by the FDA that the NDA has been accepted for filing is a significant regulatory milestone for Starpharma. The achievement reflects the completeness of the VivaGel BV data package and is expected to positively impact on licensing for the North American region, which is in the advancement stages of negotiation.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK