ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Jeff I sent the company the following message.

Hello Mr. Przybyl.

Congratulations on success successfully filing an sNDA for Corticotropin and the growth you and your team have created.

Myself and other investors realize that this is an exciting and busy time for you. When you have time, we would like an update on Ani
Pharmaceuticals’ female testosterone asset (formerly known as Libigel).
We realize that the trademark for Libigel was allowed to expire. In addition, patent applications related to ANI Pharmaceuticals’ female testosterone have been abandoned for failing to respond to Office Action.

With respect to patent application # 15/331360 titled “METHODS FOR TREATING FEMALE SEXUAL DYSFUNCTION WHILE DECREASING CARDIOVASCULAR RISK”, the following claims were made:

Claim 55. The method of claim 29, wherein the method also reduces the number of breast cancer events.

Claim 56. A method for reducing the number of breast cancer events in a postmenopausal woman comprising: administering to the woman a topical formulation comprising a therapeutically effective amount of an androgen, whereby administering the formulation results in a reduction in breast cancer events in the woman compared to an expected number of breast cancer events in an untreated postmenopausal woman.

Q. Who analyzed the data to support the breast cancer event reduction claim?

Q Why was the supporting information regarding the breast cancer event reduction not included in the description or the specifications of this patent application?

Q What percentage of reduction in breast cancer events was observed and how many patient years of data was used to make this claim? (e.g. Cardiovascular event reduction was pegged at a 70% reduction with 4,000 patient years of data)

Q Was the breast cancer event reduction discovered by a partner? If so who? And why was this partnership never disclosed? Is the partnership still in place.

On September 2, 2019 a Global Consensus Position Statement on the Use of Testosterone Therapy for Women was announced recommending its use to treat HSDD, and endorsed by 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, and The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. (see link below)

https://www.menopause.org.au/images/docs/ICMT_A_1637079_O.pdf

The position statement was based on a systematic review of 46 reports of 36 randomised controlled trials comprising 8480 participants. It appears that the only Libigel related information included in the review was from the phase 2 cognitive study conducted by Dr Susan Davis.
The International Menopause Society’s theme for World Menopause Day 2019 on October 18, 2019 was Testosterone for Women at Midlife.

https://www.imsociety.org/world_menopause_day.php?year=2019

Q In the past you have indicated that Ani Pharmaceuticals would not spend money on furthering Libigel (female testosterone), leaving it to a potential partner. In light of the Position Statement and new attention being given to testosterone use in women, has your strategy changed? What is you intention?

Q In the most recent earnings conference call, you alluded to having identified high risk, but high reward opportunities in Ani Pharmaceuticals’ pipeline that you intend to advance. Is female testosterone become one of those opportunities?

Thank you and keep up the good work


I will keep the board informed. But I also realize that if they have an agreement in place he won't be able to provide me wth information.