Evofem and Windtree Therapeutics Join Forces for Cost-effective PHEXXI Manufacturing

Evofem Partners with Windtree to Cut PHEXXI Manufacturing Costs

Evofem Biosciences, Inc. recently announced an exciting development in their mission to expand the availability of PHEXXI, a non-hormonal contraceptive vaginal gel. In a strategic move, Evofem has formally entered into a License and Supply Agreement with Windtree Therapeutics, Inc., aimed at lowering the manufacturing costs associated with PHEXXI.

Through this collaboration, Evofem anticipates a remarkable decrease of 55% to 60% in the cost of goods sold (COGS) for PHEXXI. This significant reduction is expected to take place with no direct costs incurred by Evofem for the technology transfer to Windtree’s new manufacturing partner. The resulting savings will empower Evofem to introduce PHEXXI into markets with sensitive pricing where there is a pressing need for accessible contraceptive options.

Saundra Pelletier, CEO of Evofem, expressed her enthusiasm about the partnership. She emphasized that high manufacturing costs have historically posed a barrier to the commercialization of PHEXXI in various international markets outside of the U.S. With Windtree’s expertise and connections in pharmaceutical manufacturing, Evofem expects to overcome these hurdles effectively. Pelletier stated, “The meaningful decrease in the per-box cost of PHEXXI that we expect to achieve with Windtree's assistance should allow Evofem to take PHEXXI into new, price-sensitive global markets where there is great need for non-hormonal contraceptives that women control.”

PHEXXI, which consists of lactic acid, citric acid, and potassium bitartrate, is designed to maintain a natural vaginal biome, making it inhospitable for sperm. The gel is applied shortly before sexual intercourse, providing a user-controlled contraceptive option without the hormonal effects associated with many traditional contraceptives. The aim is to empower women, ensuring they have safe and effective options for reproductive health.

Windtree Therapeutics’ CEO, Jed Latkin, pointed out that they will utilize their extensive networks to facilitate the production of PHEXXI at a significantly lower cost while ensuring the same high-quality standards that are integral to its effectiveness. Collaboration between Evofem and Windtree will focus on the operational aspects of technology transfer, including manufacturing initial and validation batches in compliance with FDA requirements.

Evofem continues to hold ownership of PHEXXI and will maintain its commercialization efforts in the United States through its experienced sales team. Moreover, Evofem is making strides in the international market, highlighted by the recent license agreement with Emirati pharmaceutical firm Pharma 1 Drug Store. Set to launch PHEXXI in the UAE upon receiving necessary approvals, this move is a testament to Evofem's dedication to global health innovation.

Additionally, Evofem has broadened its line of women's health products, recently acquiring SOLOSEC, an FDA-approved oral antibiotic for the treatment of both bacterial vaginosis and trichomoniasis. By diversifying their offerings, Evofem reinforces its commitment to addressing unmet needs in women's sexual and reproductive health.

In closing, the partnership between Evofem and Windtree Therapeutics represents a significant step forward in making PHEXXI more accessible to women worldwide. As Evofem seeks to expand its reach, this collaboration not only highlights innovative problem-solving but also showcases the company’s mission of empowering women through safer and more accessible contraceptive options.