The company will be eligible to receive up to $142 million in regulatory approval and commercialisation milestones in addition to attractive tiered royalties on sales.
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.
The global market for BV treatment is estimated to be between roughly $US750 million and US$1 billion for prevention of recurrent BV.
ITF Pharma is a subsidiary of multinational pharmaceutical company Italfarmaco SpA which employs around 3,100 people globally and has annual sales turnover of more than €720 million.
“High-calibre commercial team”
Starpharma chief executive officer Dr Jackie Fairley said the company was delighted to licence VivaGel to ITF Pharma for the US.
She said: “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.”
“Strong interest in new BV therapies”
Upon its launch, VivaGel will become ITF Pharma’s top priority women’s health product and the US-based specialty pharmaceutical company will have by then committed to a substantial investment in sales, marketing and reimbursement activities.
This includes significantly expanding its dedicated women’s health sales force to 60 specialised representatives.
Fairley continued: “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 BC treatment and an approved product for recurrent BV.”
Regulatory process ongoing
Starpharma is responsible for all regulatory activities for VivaGel while ITF Pharma will be responsible for all commercialisation activities, including product launch and market pricing.
The regulatory process for VivaGel in the US is already well-advanced with a new drug application (NDA) currently undergoing US Food and Drug Administation priority review under fast-track status.
ITF Pharma chief executive officer Dennis Willson said: “We’re very pleased to be partnering with Starpharma in an area of such significant unmet need with this innovative product.
“VivaGel BV has been described as ‘life-changing’ by BV patients in the US – we think it’s a breakthrough product in the management and prevention of BV.”
The term of the US licence with ITF Pharma is the later of 10 years or patent expiry and includes customary provisions to extend the agreement.
The patent will be valid until 2039 and can potentially be extended until 2033.
There are binding performance obligations for ITF Pharma including commitment to launch within a specified timeframe and minimum annual purchases for the duration of the agreement.