Blue Water to acquire ENTADFI from Veru for $100M

Blue Water Vaccines (BWV) announced the signing of an Asset Purchase Agreement with Veru (VERU) for the purchase of ENTADFI(R), an FDA-approved treatment for benign prostatic hyperplasia that counteracts negative sexual side effects seen in men on alternative BPH therapies. Under this Agreement, Blue Water will purchase ENTADFI(R) 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. 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. 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 and will rely on its experienced management and leadership to drive success. In January 2023, Frank Jaeger joined Blue Water as Vice President of Marketing and Business Development and is expected to lead commercialization and sales of ENTADFI with his significant experience in men’s health products, such as JATENZO and AndroGel 1.62%. In his new role at Blue Water, Mr. Jaeger is expected to lead the growth and development of ENTADFI with his expertise and knowledge within both the drug commercialization and men’s health spaces. 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. The name change is expected to take effect during, and rebranding activities will continue through, the second quarter of 2023. Prior to effectuating the name change, the Company’s common stock will continue to trade under the ticker symbol NASDAQ: BWV.