Merck and Co Inc (MRK)

[Just the facts maam]

Thanks DewDiligence. The reason I ask, is that after no trial updates since January 2013, on October 27, 2021, ANIP or an undisclosed partner filed a Clinical Trial Certification/Extension request for their 3,656 patient long-term safety/efficacy Libigel trial. A request to delay submitting results for up to 2 years or 30 days after approval. Though it does not specify if it was a Certification or Extension request, a Certification is usually submitted in relation to filing an NDA.

Certification/Extension Submission

In looking at the study design, the trial was completed on December 2012 (pre-commercialization part of the study). However even the if full trial was completed in August 2016, as listed in the clinical trial history (full safety/efficacy study including post approval observations), there is no obligation to submit results, let alone make request for a delay in submitting results, unless they have or were about to file an NDA.

History of Change Comparison

Then Ms. Elizabeth Powell joined the Rare Disease Business Unit at ANI as Chief Compliance Officer and Head of Legal, Rare Disease in February 2022, assuming responsibility for the Legal and Compliance functions. For the past 24 years, Ms. Powell worked at Merck & Co., Inc., where she was responsible for strategic counsel related to commercial, compliance and FDA regulatory issues, and most recently served as Managing Counsel and Executive Director, U.S. Commercial & Compliance Legal.

Ironically, ANIP advanced their Annual Stockholder meeting from June 2, 2021 to April 27, 2022, which is exactly 6 months after they submitted their Certification/Extension request. It makes me wonder if ANIP or more likely a partner filed an NDA and got a 6-month Priority Review for Libigel.

To date ANIP has never publicly released that Libigel reduced Cardiovascular events in post menopausal women at risk of cardiovascular events by at least 70% (discovered in 2011 or earlier) and they never announced the that it reduced Breast Cancer events by an undisclosed amount (discovered in December 2015 or sooner). Both discoveries are only publicly available in patent applications and related prosecutions.

I realize Merck is facing an LOE for Januvia and Janumet in 2022 (China and EU) and January 2023 (US) and wondered if they are looking to Libigel to offset some of the losses. It would be the first FDA approved female testosterone drug with an instant market in replacing existing off label and compounded testosterone, currently being prescribed.

It appears to fit Merck's criteria for acquisition and partnership
- Fills an unmet need.
- Looking at their R&D and Products page, it appears to fit into at least two of their Areas of Focus, Cardio-metabolic disorders and Oncology.

Areas of Focus

If Merck is interested in female testosterone the Global Consensus Position Statement on the Use of Testosterone Therapy for Women will help in marketing it out of the gate.

The following are some indications that the Position Statement identified as needing more information before making recommendations:
- Cognitive performance, or to delay cognitive decline, in postmenopausal women.
- Impact of testosterone treatment on musculoskeletal tissues
- Prevention of breast cancer (Libigel trial appears to answer this)
- Cardiovascular safety in women at risk (Libigel trial appears to answer this and indicates prevention capbilities).
It creates an R&D roadmap, with the potential of female testosterone eventually becoming a franchise drug with multiple indications.

FYI the patient population from the of the Libigel safety/efficacy trial included postmenopausal women suffering from the following.
- Hypertension
- Dyslipidemia
- Diabetes mellitus
It also included smokers.

It may all be coincidences, but evidence supporting an NDA filing, Ms. Powell coming over ANIP after 24 years with Merck, the Areas of Focus for Merck that Libigel addresses and the Pipeline Page's Key Therapeutic Ares having an empty Women's Health box, left me wondering if as you stated was a clerical error. Or, if Merck and ANIP have entered into a yet to be disclosed partnership.

Keep up the good work DewDilligence.