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

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.


  • 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.”

The market targeted by Havah includes the following indications:

  • 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;
    • An increased risk of breast cancer
    • An increased difficulty of breast cancer detection
    • Reducing side-effects of breast cancer treatment

Stephen N Birrell, MD PhD
Founder and Chairman


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.

To read more from Dr Birrell

havah t+Ai therapy

Executive staff

Stephen N Birrell, MD PhD FRACS              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.

Kathy Harrison, MSc, FIPTA, GAICD               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.

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.


advisory board
Prof. Jack Cuzick, CBE FRS – John Snow Professor of Epidemiology Queen Mary University UK
Prof Anthony Howell – Professor of Oncology Manchester University UK
Prof Charles Loprinzi – Susan Komen Regis Professor of Oncology Mayo Clinic MN USA
Prof Laura Esserman – Prof Surgery and Radiology UCSF USA
Prof Neal Rosen – Director of Cancer Research MSKCC USA
Prof Suzanne Fuqua – Head Molecular and Cellular Biology, Baylor College Houston USA
Prof Ed Gelman – D-Director for Clinical Research, HICCC Columbia University NY USA
Prof Jason Carroll – Director Breast Cancer Research, Cambridge Institute Cambridge Uni UK
Prof Karen Knudsen – Director Sidney Kimmel Cancer Center PA USA
Prof Ganesh Raj – Dr Paul Peters Chair in Urology UT Southwestern USA
Prof Tom Fleming – Prof of Biostatistics University of Washington USA
Prof Wayne Tilley – Dame Roma Mitchell Chair of Cancer Biology University of Adelaide Australia
Dr Scott Berry – CEO Berry Consultants Austin TX USA
Prof Don Berry – Prof Dept of Biostatistics UT MD Anderson Houston USA
Dr Lois Rosenberger – CEO LBR Consulting KY USA
Mr John Ramsey – ex-Director Global Drug Development AstraZenca UK

HavaH Therapeutics, Pty Ltd
Nyroca House
10-20 New Street
North Adelaide, South Australia  5006

Telephone:   +61 8 7200 5606