Starpharma’s VivaGel® BV Will Now Be Seen On US Shelves

  • Dec 20, 2018 AEDT
  • Team Kalkine
Starpharma’s VivaGel® BV Will Now Be Seen On US Shelves

Starpharma authorized the US-based pharmaceutical company ITF Pharma to sell and market its novel VivaGel® BV in the United States.

In an announcement dated 20 December 2018, Starpharma Holdings Limited (ASX: SPL) told that it had signed a license with ITF Pharma that grants rights for the sales and marketing of VivaGel® BV in the United States. In exchange, Starpharma will be entitled to receive up to A$142 million in the milestone in addition to attractive double-digit royalties on sales. This milestone payment reflects A$28 million subject to FDA approval for the two BV indications and up to A$114 million in the commercial milestone.  

United States’ ITF Pharma is a specialty pharmaceutical company that runs an independent Women Choice Pharmaceuticals Division. Currently, its top priority is to launch VivaGel® BV in the United States where a high prevalence of BV is observed among women.

As per the license agreement, Starpharma will initially supply VivaGel® BV to ITF Pharma, and later ITF’s parent company Italfarmaco may apply for FDA approval of its manufacturing facility. Moreover, it has been agreed that ITF Pharmaceuticals will make a substantial investment in sales, marketing, and distribution activities for VivaGel® BV. This will see ITF Pharma expanding its Women’s Health salesforce to 60 specialized representatives.

VivaGel® BV is a novel product of Starpharma that provides a non-antibiotic therapy for the most common vaginal infection, bacterial vaginosis (BV). The company estimates that there is a global market of ~US$750 million for BV treatment and ~US$1 billion for prevention of recurrent BV.

CEO of Starpharma, Dr. Jackie Fairley stated that currently, the US market does not have any approved product for the prevention of recurrent BV because of which the launch of VivaGel® BV in the United States will provide an accepted and effective product for recurrent BV as well as non-antibiotic BV treatment to US patients. He added that it’s a pleasure of the company to license VivaGel® BV to ITF Pharma, which is known for its strong focus on Women Health.

The report read that Starpharma will be responsible for regulatory approval applicable in the United States while ITF Pharma will look into the commercialization of the product, including its launch, reimbursement, market pricing, sales, marketing, and promotional activities.

The term of the US license with ITF Pharma has been fixed to 10 years or expiry of the patent, whichever falls later. Further, the company stated that the regulatory process for VivaGel® BV in the US is progressing well. Starpharma’s New Drug Application (NDA) for VivaGel® BV is currently undergoing FDA priority review under Fast Track status, following acceptance of the NDA in July 2018.

With this update, Starpharma’s stock jumped 2.952% to last trade at $1.395 on 20 December 2018. The stock has witnessed a strong performance change over the past six months of 15.81%. However, the stock price has fallen 10.56% in the past one month.


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