Developing androgen therapies for breast disease by utilizing the innate breast-tissue-specific hormone/immune interface

RECENT NEWS

Havah is pleased to see the announcement of the merger of Clarus Therapeutics with Blue Water Acquisition (a Special Purpose Acquisition Company) was approved by Shareholders.

Havah has signed an exclusive Global licence with Clarus for their proprietary medication (T+Ai).

Who We Are

Havah has completed world leading pre-clinical and clinical trials (Phase I,II and III) to develop androgen-based pharmaceuticals for use in breast disease.

Havah is one of the first biotechs to utilize the breast tissue specific innate hormone/immune interface.

Background

Androgens are an essential hormone in both men and women-the balance between estrogens and androgens is critical in the maintenance of hormonal homeostasis and the interface between hormonal function and the immune system.

Havah Therapeutics lead product delivers a unique androgen product to effect a beneficial tissue specific alteration in estrogen:androgen ratio and reduce breast tissue autoimmune inflammation

The Market

An unmet need as recently declared in A Global Consensus Position Statement on the Use of Testosterone Therapy for Women that:

“As no approved female product is presently approved by a national regulatory body, the panel highlighted the pressing need for more research into testosterone therapy for women and the development and licensing of products indicated specifically for women.”

Orphan indications in rare breast disease where autoimmunity is the underlying mechanism of the pathogenesis e.g. granulomatous and peri-ductal mastitis

Reducing high mammographic breast density known to be associated with;

Introduction

There have been over last 20 years many attempts at trying to introduce an androgenic product for women. For numerous reasons there have been no successful registered products available for clinicians despite over 4 million off label prescriptions per annum being written for a testosterone product for women in the USA alone.
A recent consensus opinion from the representative clinical colleges outlined the importance of a registered product being made available for women diagnosed with hypoandrogenism. This would then open the door for multiple other uses for androgenic products as a therapeutic intervention in conditions which are being targeted by company such as HavaH Therapeutics.

HavaH Therapeutics is dedicated to developing androgenic products for women and draws on an extensive international network of experts.

After 30 years of preclinical and clinical research into androgen function in women I intend to use this blog to elaborate on how I personally view the developments occurring in the andrology of women.

Stephen N Birrell

MD PhD
Founder and Chairman

HavaH T+Ai Therapy

THE BASIS OF T+Ai THERAPY
Shifting the fulcrum of the breast tissue testosterone: estradiol axis to cause favourable breast tissue specific change by utilising the dimorphic nature of natural testosterone i.e whether it covers to the potent androgen 5α-dhydrotestosterone (DHT) or estradiol

Executive Staff

Stephen N Birrell, Founder and Chairman

Founder and inventor, 30-year breast cancer specialist/surgeon and renowned medical innovator, clinical oncologist, widely published molecular oncologist in leading journals incl. Nature, founder/ pioneer of three leading (Australian) multi-disciplinary breast centres in both the public and private sectors. Dr Birrell, with his scientific research partner, Prof Wayne Tilley, are internationally recognized for pioneering the use of androgens in breast disease.

MD PhD FRACS

Kathy Harrison, CEO

More than 25 years in biotechnology including 9 years in patent attorney practice. Leadership roles in biotech companies have included CEO of ASX listed Dimerix Ltd and current Director of Disruptive Nutrition Pty Ltd. Kathy has extensive experience in intellectual property strategy, commercial drug development strategy and achieving drug development milestones. Kathy’s qualifications in science, intellectual property law and governance provide the depth of skill to lead HAVAH through its next stage of growth.

MSc, FIPTA, GAICD

Ron Martell, Executive Director

Mr Martell is a biopharma entrepreneur with 30+ years experience founding, leading and managing companies. He has overseen numerous business development agreements and transactions worth billions of dollars. He is the President and CEO of Nuvelution Pharma. Before joining Nuvelution, he was Founder and Executive Chairman of Indapta and Chief Executive Officer of Achieve Life Sciences, where he led the merger of the company with Oncogenex. Prior to that, he held similar roles at Sevion, NeurogesX and Poniard Pharmaceuticals. Earlier in his career, Mr Martell served as Senior Vice President of Commercial Operations at ImClone Systems, where he was instrumental in deals with Bristol-Myers Squibb and Merck KGaA, and built ImClone Systems’ worldwide commercial operations and field sales force to market and commercialize Erbitux®. Before joining ImClone Systems, Mr Martell worked for more than 10 years at Genentech in a variety of leadership positions, the last of which was Group Manager, Oncology. At Genentech, he was responsible for building the company’s oncology franchise, including the launch of Herceptin® for metastatic HER-2 positive breast cancer and Rituxan® for non-Hodgkin’s lymphoma. Mr Martell began his career at Roche Pharmaceuticals.

Joe Schacter, Business Development

Previous experience with Business Development and Operations at two technology startups. Prior to that, Joe was an Analyst on the licensing team at Torreya Partners, a boutique advisory firm in New York. He helped Torreya source Iota Biosciences, which Torreya founded and then was acquired by Astellas

Advisory Board

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HavaH Therapeutics, Pty Ltd