On May 25, 2021 Clarus Therapeutics Inc. ("Clarus"), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, and HavaH Therapeutics ("HavaH"), an Australia-based biopharmaceutical company developing androgen therapies for inflammatory breast disease and certain forms of breast cancer by using the innate breast-tissue-specific hormone/immune interface, reported a licensing agreement whereby Clarus will acquire the exclusive worldwide (excluding Australia) development and commercialization rights for HAVAH T+Ai (CLAR-121) (Press release, clarus therapeutics inc, MAY 25, 2021, View Source [SID1234580587]).

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CLAR-121 is a proprietary combination of testosterone (T) (natural ligand for the androgen receptor; AR) and anastrozole (inhibitor of T conversion to estradiol) delivered by a subcutaneous implant for treatment of AR-mediated breast disease that predominantly affects women. If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease, including inflammatory periductal mastitis (PDM) and estrogen receptor-positive (ER+) breast cancer. Clarus’s initial clinical development target is PDM — a destructive autoimmune inflammatory process of the retro-areolar milk ducts that results in multiple fistulae and inevitably results in disfiguring surgery and a high risk of recurrence. There is no known treatment for this condition apart from surgery, which has significant limitations.1 Due to the low prevalence of PDM in the U.S., Clarus anticipates this disease could qualify for orphan drug designation by the U.S. Food and Drug Administration and plans to petition the agency for that status for CLAR-121.

If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.

HavaH has extensive clinical experience with CLAR-121 in more than 1,000 Australian women (more than 6,200 implants) with breast disease, and Clarus expects that access to HavaH’s pharmacokinetics, safety and early efficacy data in PDM will expedite progression to Phase 2/3 clinical studies in the U.S. Clarus estimates that the annual U.S. market size for PDM exceeds $400 million.2,3,4 With this new pipeline asset, Clarus may also pursue, alone or in partnership, future indications in ER+ breast cancer, macromastia, granulomatous mastitis, and autoimmune induced breast pain.

"This licensing agreement marks the beginning of an exciting new partnership with HavaH. Their experience coupled with the significant amount of clinical data generated in Australia will benefit Clarus greatly as we begin our development activities in the U.S.," said Dr. Robert Dudley, Clarus’s founder, president and CEO. "CLAR-121 allows us to leverage our expertise in androgen biology, as exemplified by JATENZO, a testosterone replacement therapy (TRT) for male hypogonadism and Clarus’s first commercial product, and expands our development pipeline with an initial focus on PDM in women — a debilitating, painful disease with very limited treatment options, short of invasive surgery. This treatment, if approved, has the potential to be life-changing for women who suffer from PDM, and its development fits well with our mantra: ‘good is never good enough’. Our goal is to provide treatment options that not only produce a positive clinical outcome, but also provide a positive therapeutic experience for patients."

Under the terms of the licensing agreement, Clarus will be responsible for future global development and regulatory activities for CLAR-121, excluding Australia. Clarus will pay HavaH an upfront payment of $500,000 upon signing and HavaH may be eligible for up to $10.75 million in potential development and regulatory milestone payments. HavaH will retain the right to promote HAVAH T+Ai in Australia. Additionally, HavaH would be eligible for a modest royalty and up to $30 million in potential commercial milestones.

"We developed HAVAH T+Ai to address a significant unmet need in women’s health, and our partnership with Clarus will enable us to advance this therapeutic approach not only for inflammatory breast disease but, more widely we hope, for ER+ breast cancer where data now unambiguously demonstrates that the androgen receptor has an important tumor suppressor role in this form of breast cancer,"5 said Stephen Birrell, MD, PhD, HavaH founder, chairman and chief medical officer.

"In Clarus, we found a partner who understands and appreciates the potentially profound importance of androgen action in the context of inflammatory breast disease, as well as its role as an adjunctive endocrine therapy for certain forms of breast cancer," said Kathy Harrison, HavaH CEO.

Reedland Capital Partners, acting through Weild & Co., member FINRA/SIPC, served as financial advisor to HavaH in connection with this transaction. For more information, please visit www.reedland.com.