Blue Water acquires ENTADFI, an FDA-approved benign prostatic hyperplasia treatment

Blue Water Vaccines (BWV) has signed an Asset Purchase Agreement with Veru Inc. for ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia (BPH) that counteracts negative sexual side effects seen in men on alternative BPH therapies.

Under this agreement, Blue Water will purchase ENTADFI for a total consideration of $100 million, with $20 million upfront, paid in defined tranches through September 2024, and the possibility of an additional $80 million based on predetermined annual sales milestones.

Blue Water will also assume royalty and milestone obligations under a previous asset purchase agreement, including a royalty on all sales and sales milestone payments of up to $22.5 million. In addition to all commercial materials, contracts, intellectual property, and regulatory records and filings, BWV will acquire all available inventory of ENTADFI, approximately 125,000 bottles.

BPH, a condition in men in which the prostate gland is enlarged but not cancerous, is a common problem that affects the quality of life in approximately half of men over the age of 50 and over 90% of men over the age of 85. Men with BPH suffer from challenges with urination flow, frequency, and urgency, and about 70% of men with BPH also experience sexual dysfunction.

In 2022, according to IQVIA, there were approximately 44 million total prescriptions and 20 million new prescriptions related to BPH symptoms. ENTADFI is designed to treat BPH and its associated symptoms. Over 55 million patients in the United States have or are at risk for BPH.

ENTADFI, approved by the FDA in December 2021 for the treatment of BPH in men with an enlarged prostate, combines finasteride, a traditional BPH medication, and tadalafil, a BPH and erectile dysfunction medication, into a once daily pill. This allows patients to receive BPH medication without the negative side effects of traditional medication and has proven both safe and effective in multiple clinical trials prior to its FDA approval.

In a pivotal Phase 3, double blinded, parallel-design clinical trial, 696 men, including those with co-morbid conditions, were randomized to initiate either tadalafil plus finasteride or placebo with finasteride over 26 weeks. Tadalafil and finasteride administered together demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride.

“With millions of men suffering from BPH and facing adverse side effects associated with current treatments, we are excited to support those patients and make ENTADFI readily available for all,” said Joseph Hernandez, chairman and Chief Executive Officer of Blue Water.

“This purchase provides us an opportunity to advance Blue Water into the commercial space and to offset burn to provide key revenue supporting our vaccine candidate pipeline. Our core mission of helping patients in need remains strong and steadfast, and we look forward to developing this asset and our pipeline for patients around the world.”

“With completion of this deal and subsequent influx of capital, we are able to focus our efforts on advancing our late-stage clinical drug pipeline within our key markets, including Veru’s late-stage assets in oncology and infectious diseases,” said Mitchell Steiner, M.D., Chief Executive Officer of Veru.

“With their commercially driven management team, we are confident that Blue Water is the right partner to take on ENTADFI and continue to offer patients a new treatment for BPH with low potential for sexual side effects.”

ENTADFI is currently available at pharmacies nationwide for prescription, but upon execution of this purchase, Blue Water intends to optimize sales, distribution, and marketing strategies to maximize access to ENTADFI for BPH patients. Through this transformative acquisition, Blue Water expands to become a broader pharmaceutical company.

To reflect the company transformation and robust pipeline, spanning multiple sectors, the company’s Board of Directors has approved a corporate name change and rebranding to Blue Water Biotech.

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