ANI Pharmaceuticals (ANIP)

[Just the facts maam]

I sent the following email to Investor Relations

Hello Mr. Lalwani,

Congratulations on your appointment as Ani Pharmaceuticals’ CEO and the recent additions to your leadership team. I, as many fellow investors are looking forward to your long-term vision for the company.

You may already be looking at the following. However, with everything currently on your plate, I thought I would raise the issue on behalf of many fellow investors

In light of the Global Consensus Position Statement on the Use of Testosterone Therapy for Women, many investors are confused as to why Ani Pharmaceuticals has never announced the amazing discoveries (during the Libigel trials) that restoring testosterone in at risk menopausal women reduced cardiovascular events by at least 70% over the expected number of cardiovascular events. Additionally, according to the patent applications restoring testosterone reduced the number of breast cancer events by an undisclosed percentage.

Global Consensus Position Statement on the Use of Testosterone Therapy for Women (menopause.org.au)


This information is publicly available in Biosante Pharmaceuticals and Ani Pharmaceuticals patent applications and subsequent patent prosecutions.

United States Patent Application: 0170128462 (uspto.gov)

United States Patent Application: 0120022033 (uspto.gov)

United States Patent Application: 0120004204 (uspto.gov)


The clinical information within patent applications and the patent prosecutions appear to answer a number of questions outstanding within the Global Position Statement. This Position Statement has been endorsed by the following:

The International Menopause Society,

The Endocrine Society,

The European Menopause and Andropause Society,

The International Society for Sexual Medicine,

The International Society for the Study of Women's Sexual Health,

The North American Menopause Society,

The Federacion Latinoamericana de Sociedades de Climaterio y Menopausia,

The Royal College of Obstetricians and Gynaecologists,

The International Society of Endocrinology,

The Endocrine Society of Australia,

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

As part of Ani Pharmaceuticals long term vision, a number of investors would like to see the announcement of the discoveries in relation to cardiovascular event and breast cancer reduction. In addition to how it addresses a number of unanswered questions within the Global Position Statement on Testosterone an asset being considered for future development.