Blue Water changes tides again, dropping all vaccine programs and 6 approved drugs

2023 has been a year of changing tides for Blue Water Biotech, and the last few months appear to be producing some particularly rough seas. With a freshly minted CEO, the biotech is redefining its mission to focus solely on oncology, a move that includes dropping six FDA-approved drugs and its wide-ranging vaccine portfolio. 

Blue Water Biotech—which changed its name from Blue Water Vaccines this May after buying FDA-approved benign prostatic hyperplasia (BPH) drug Entadfi from Veru—is deprioritizing all vaccine work, according to an Oct. 30 letter to shareholders from CEO Neil Campbell.

Vaccines were once the centerfold of the company, with programs in at least eight separate indications such as the flu, malaria and monkeypox. None of the programs had made it to the clinic yet, according to the company’s online pipeline.

“These vaccine programs were targeting a wide number of diseases and conditions that would have consumed an enormous amount of company resources,” Campbell wrote, adding that evolving market dynamics and post-pandemic challenges prompted the company to conduct the strategic assessment that ultimately has resulted in the pipeline upheaval.

The biotech is also abandoning six FDA-approved assets acquired from an $8.5 million deal made with WraSer and Xspire Pharma earlier this year. The drugs—which CEO Campbell says won’t meet requirements for creating greater shareholder value in 2024—include thrombin receptor antagonist Zontivity; antibiotics Otovel and Cetraxal and authorized generics distributed by WraSer; calcium channel blocker Conjupri; and pain medications Trezix and Nalfon.  

Blue Water has also discontinued its commercial operations related to the six drugs due to “misalignment” with the biotech’s “evolving objective” in the cancer field.

Part of the strategic assessment also included overhauling the company’s management team, with CEO Campbell joining earlier this month from Marizyme. Chief Financial Officer Jon Garfield also exited the company, with Bruce Harmon taking on the CFO title.

The newest changes leave Campbell with a portfolio of one—Entadfi, which won approval from the FDA in December 2021 for men with BPH. While the condition is a noncancerous enlargement of the prostate, Campbell wrote that the expected 2024 market launch will make it “the inaugural therapeutic drug in our expanding portfolio of oncology therapeutics.”