ANI Pharmaceuticals (ANIP)

[Just the facts maam]

BesaoT35, Art or ANIP never made a public disclosure with respect to Libigel. What you see on their website is all we get. Initially he spoke to early investors and stated his intention was not going to spend any money on it. Hoping o find a larger pharma partner with deeper pockets to take it the rest of the way.

Allegedly Biosante completed the pre-marketing phase of the safety trial in December 2012. 3656 patient with an average of 2 years exposure over 7300 patient years as of September 2012. .

Biosante never disclosed the fact that restoring Testosterone (Libigel) reduced cardiovascular events breast cancer events by at least 70%. This information was only learned by reading through patent applications. It would have been disclosed two months after Biosante announced the merger proposal with ANIP. which put as top to the analysis and announcing the discovery. This was under Simes watch as CEO.

December 19, 2015 the patent lawyers added the claim that restoring testosterone reduced breast cancer as well. This information was never disclosed to shareholders or the public. And numerous request to specify how they came to make this claim went unanswered. This is under Art's watch.

If you look at the patent application filed on behalf ANIP, you will see that there is no information supporting the breast cancer reduction claim. By comparison there is much information supporting the the cardiovascular event reduction claims (inlcuding the definition of Cardiovascular events, number of patient years and percentage in reduction of events) None of that is articulated for breast cancer reduction.. Why withhold this information.

My belief is that the breast cancer benefit did not materialize until later in the trial way beyond the alleged conclusion of the first phase of the trial. According to the an American Heart Journal Article the trial was set up as such:

Breast and endometrial safety examinations

Breast examination and mammography will be performed at baseline and annually. Endometrial biopsy will be performed at baseline and at study years 1, 2, and 5. Participants with vaginal bleeding will undergo uterine evaluation that includes an endometrial biopsy. Study medication will be discontinued in participants with evidence of uterine cancer, complex or adenomatous hyperplasia, or atypia

It is likely a partner such as AbbVie which had hired Dr Michael Snabes as their Sr. Medical Director of Men and Women's Health in April 2013. From January to March 2013 he worked for both Biosante and AbbVie simultaneously. He was the study director of the Libigel trials and listed as an inventor in the patent applications claiming to testosterone restoration reduces cardiovascular events and breast cancer.

September 2, 2019 a Global Consensus Position Statement on the Use of Testosterone Therapy for Women was issued. which support restoring Testosterone to treat HSDD

Endorsed by 11 organizations/ societies.

ANIP just authorization got a 10 year extension on keeping protected information in Libigel licence agreement confidential. All previous extensions were 5 years or less.

Anyone partnering with ANIP gets a 5 year head start as they have the safety data which the FDA requires. There is a possibility that once the AbbVie/Allergan is approved and they are integrated you will see them make an FDA application for Intrinsa which proved efficacy but required more safety data, but in a smaller patch form which has patent protection to the Mid 2030's and proved non-inferiority over Intrinsa in a clinical trial. They will use the Libigel trial data to prove testosterone is safety If they go that route look for them to conduct phase 4 trials to address the other indications listed in the Consensus statement (e.g., Cardiovascular (Diabtetes, Hypertenison, etc..) and Breast Cancer event reduction, reduction in bone fractures, improved cognitive function)

Corti appears to be a minor set back which according to Art should be easily addressed.

As for Art, we don't know what caused his sudden departure and all of us are just speculating. We should find out more May 7th. hopefully they will announce his replacement.

JMHO