PERTH, Australia – In yet another regional carve-out deal for Starpharma Holdings Ltd., the company has out-licensed rights to its Vivagel BV for bacterial vaginosis (BV) to ITF Pharma for the U.S. market for roughly $101 million.
Under terms of the deal, Starpharma will receive $20 million in FDA approval milestones and up to $81 million in commercial milestones, in addition to escalating double-digit sales royalties.
Vivagel BV's new drug application is under FDA priority review with fast track status for the treatment of BV and prevention of recurring BV.
Vivagel is an antimicrobial dendrimer formulated as a water-based gel and delivered vaginally. It inhibits biofilm, the mechanism that causes the BV condition and, unlike antibiotics, isn't absorbed into the bloodstream. BV is currently treated with antibiotics, but existing treatments have low cure rates, high rates of recurrence and high levels of bacterial resistance.
BV is the most common vaginal infection globally and is twice as common as thrush. There is a particularly high prevalence of BV among women in the U.S., with one in three women experiencing recurrent episodes.
A subsidiary of multinational pharma company Italfarmaco SpA, ITF Pharma is a specialty pharma company focused on women's health and is based in Berwyn, Pa. It will significantly expand its sales force for the launch of Vivagel BV through its Womens Choice Pharmaceuticals Division. Milan, Italy-based Italfarmaco employs around 3,100 people globally and has annual sales turnover of more than €720 million.
The global market for BV treatment is estimated to be worth about $750 million and $1 billion for prevention of recurrent BV.
When launched, Vivagel BV will become ITF Pharma's top priority women's health product. ITF has committed to a substantial investment in sales, marketing and reimbursement activities, including significantly expanding its salesforce to 60 specialized representatives.
Initially Starpharma will be responsible for supplying Vivagel BV to ITF; however, Italfarmaco may apply for FDA approval of its own manufacturing facility in the future.
Starpharma is responsible for regulatory activities for Vivagel BV, and ITF will be responsible for all commercialization activities, including product launch, market pricing, reimbursement, marketing, promotion and sales.
The regulatory process for Vivagel BV in the U.S. is well underway as the FDA accepted Starpharma's NDA for Vivagel in July 2018.
"There are currently no approved products in the U.S. for prevention of recurrent BV, and feedback from clinicians and patients indicate a strong interest in new BV therapies, said Starpharma CEO Jackie Fairley.
"Vivagel BV has been described as 'life changing' by BV patients in the U.S.," said ITF Pharma CEO Dennis Willson.
The terms of the U.S. license with ITF Pharma is the later of 10 years or patent expiry (at least 2030 with potential extensions out to 2033) and includes customary provisions to extend the agreement. There are binding performance obligations on ITF Pharma, including commitment to launch within a specified time frame and minimum annual purchases for the duration of the agreement as well as termination provisions under certain circumstances. Additional terms were not disclosed.
Deal builds on other regional carve-outs
In June, Starpharma signed a deal with Mundipharma International Ltd. that gave Mundipharma sales and marketing rights to Vivagel BV in Europe. Under the terms of that deal, Starpharma received a $1.5 million upfront fee and is eligible for $15.5 million in milestones plus revenue sharing.
That deal built upon an earlier regional revenue sharing deal that gave Mundipharma sales and marketing rights to Vivagel BV in Asia, the Middle East, Africa and the majority of Latin America.
Under that deal, Starpharma will receive returns via a revenue share on Vivagel BV sales, and it is eligible to receive signing, regulatory and commercial milestones of A$9.2 million, including a A$1.3 million up-front payment.
At the time, Starpharma CEO Jackie Fairley told BioWorld that the company strategically retained the commercial rights to Vivagel to maximize its commercial value.
Mundipharma will register and launch Vivagel BV as part of its Betadine feminine care portfolio, which is sold in more than 120 countries. Mundipharma will help develop the consumer market for Vivagel BV in developing markets across Asia, the Middle East, Africa and Latin America, where demand for trusted intimate health and hygiene products is growing.
Starpharma submitted the final nodule of its rolling NDA package to the FDA on April 30. The FDA also granted Vivagel Qualified Infectious Disease Product (QIDP) designation, which provides an additional five years' market exclusivity. (See BioWorld, Aug. 9, 2017.)
With the submission of the Vivagel NDA to the FDA, Starpharma joins a very limited club of Australian biotechs to bring their products all the way through to registration.
Fairley said that Starpharma is one of two or three small- to medium-sized biotechs that "have managed to complete phase III trials in Australia. It is no small deal," she said, "and it's not for the faint-hearted." (See BioWorld, Dec. 1, 2017.)
Vivagel BV is already approved in both Europe and Australia. Fairley said the Australia approval will facilitate registration in other geographies, such as Asia and Latin America. In late 2017, Starpharma signed a license agreement with Aspen Pharmacare Australia Pty for marketing Vivagel BV in Australia and New Zealand.
Starpharma's underlying technology is built around dendrimers, a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: its Vivagel portfolio and its DEP drug delivery platform.
It has separate license agreements with Ansell Ltd. globally, Okamoto Industries in Japan, Shenyang Sky and Land in China, and Koushan Pharmed Co. in Iran to market a Vivagel condom. The Vivagel condom has been shown to inactivate up to 99.9 percent of HIV, HPV and HSV-2 and provide "near complete" protection against the Zika virus, Starpharma said.
Fairley said that the Vivagel product line is becoming a cash cow for the company, and as the Vivagel products approach commercialization, additional value creation will come from its DEP drug delivery platform that uses its dendrimer scaffold to enhance existing drugs.