Starpharma (ASX:SPL) has announced it has licensed US sales and marketing rights for VivaGel BV to ITF Pharma in a deal that could be worth over $140 million.
VivaGel BV is a novel, non-antibiotic therapy for bacterial vaginosis (BV) - the most common vaginal infection in the world and twice as common as thrush. There is a particularly high prevalence of BV amongst US women (1 in 3 women, with around two-thirds experiencing recurrent episodes).
ITF Pharma is a US-based specialty pharmaceutical company with a focus on prescription Women’s Health products through its Womens Choice Pharmaceuticals Division (www.wcpharma.com).
It is the US subsidiary of the private multinational pharmaceutical company, Italfarmaco SpA, which employs around 3,100 people globally and has annual sales turnover of more than €720M.
Starpharma said that, upon launch, VivaGel BV will become ITF Pharma’s top priority Women’s Health product.
Under the licence, ITF Pharma have committed to a substantial investment in sales, marketing and reimbursement activities ahead of the US launch of VivaGel BV including significantly expanding its dedicated Women’s Health salesforce to 60 specialised representatives.
Starpharma is eligible to receive up to US$101 million (A$142 million) in regulatory approval and commercialisation milestones in addition to escalating double-digit royalties on sales.
The milestones are comprised of US$20 million (A$28 million) in regulatory approval milestones for the two BV indications and up to US$81 million (A$114 million) in commercial milestones.
Initially Starpharma will be responsible for supplying VivaGel BV to ITF Pharma, however, in the future, Italfarmaco may apply for FDA approval of its own manufacturing facility.
Starpharma is responsible for regulatory activities for VivaGel BV while ITF Pharma will be responsible for all commercialisation activities, including product launch, market pricing, reimbursement, marketing, promotion and sales.
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.
According to Dr Jackie Fairley, CEO of Starpharma, “We are delighted to licence VivaGel BV to ITF Pharma for the US. ITF Pharma is an organisation with a strong pedigree in Women’s Health, a high calibre commercial team and a great deal of sales and marketing experience in the category. We look forward to working with them to bring this highly anticipated and innovative product to women throughout the US.
“There are currently no approved products in the US for prevention of recurrent BV, and feedback from clinicians and patients indicate a strong interest in new BV therapies. Following approval and launch of VivaGel BV, these patients will finally have an effective, non-antibiotic BV treatment and an approved product for recurrent BV,” added Dr Fairley.