ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Smile86, it surrounds 3656 patient phase 3 Libigel Safety/Efficacy trial discoveries. Which have only been disclosed in the patent applications. I was speaking to an AbbVie employee this summer who was blown away by the discovery of 71 % reduction in CV events and believe that with all the potential indication it could generate Humira type revenue. After telling the employee everything that had been uncovered they stated they would be surprised if Abbvie weren't working on it behind the scenes.

The trial was set up to follow the patients for 5 years and broken down into two phases. Phase one pre-marketing phase of the trial. This was to be used to support the safety argument in NDA application when the last patient had been followed for at least one year. This along with the data from the efficacy trials data were to be used in filing an NDA. The remaining follow up for a total of 5 years was to done post marketing.
Unfortunately in the efficacy trials, though Libigel worked as expected, there was a very high placebo effect as compared to both phase 2 Libigel trials and phase 3 Intrinsa trials.

The Major Discoveries

1) Restoring t-levels reduced cardiovascular events by 71%. Discovered by Biosante with 4000 patient years of data, when they got a mid-trial peek to help identify the final number of patients the FDA would require for the trial. Plenty of documentation to support this claim.

2) It also reduces Breast Cancer events. This was only added to the patent application process December 19, 2015. There is no information whatsoever to support the claim support. If Ani or Biosante had made his discovery it would have been in the more recent patent application published May 11, 2017. It may have taken longer to differentiate itself from placebo.

Now consider:

1) As a result of the failed Phase 3 trials BPAX PPS tanked December, 2011 to the point that it was facing delisting. This led to a 1:6 reverse split in June 2012 to remain listed, meanwhile the CEO, Stephen Simes does not say anything about the Cardiovascular discovery. This is major material event and unless he is bound by a confidentiality agreement (AbbVie?), he has a fiduciary obligation to disclose the discovery.

Methods for treating sexual dysfunction while decreasing cardiovascular risk

Methods for decreasing cardiovascular risk in postmenopausal women


2) I asked the Simes about efficacy being collected in the larger safety trial. He stated that they decided not to do it at the time, concentrating on safety. This seems to contradict the AHJ Article titled A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder , with 2889 patients registered in the trial at the time the article was received, June 28, 2011, they were measuring efficacy. Look who is listed as one of the authors Dr Michael Snabes himself. They started the trial in 2008.

Simes response

AHJ article

3) During 2011 regarding Libigel Antares secured a patent for method of use to treat FSD and HSDD. This was announced publicly. Patent protection until December 29, 2028.

Method of use

4) More importantly on December 25, 2012 Antares was issued a broader patent for restoring testosterone in women. No announcement were ever made by Biosante or Antares with respect to this patent. Patent Protection until September 7, 2031

Anatres TRT patent

5) BPAX was planning to announce the results of the first part of the safety/efficacy trial in December 2012. However in October 2012 they announce the proposed merger with Ani Pharmaceuticals and cease all further work on Libigel. Anip owned large manufacturing facilities previously owned by Solvay (now Abbvie). Abbvie as part of the spin off agreement with Abbott labs, had a 5 year window to seek manufacturing facilities. Anip‘s factories were grossly underutilized.

I believe that Biosante entered into a confidentiality agreement with Abbvie to continue the second phase of the safety study, however because of placebo effect they would not be able to it as post-marketing surveillance. Anip to date has really had nothing to do with Libigel other than lend its name to the patent application. They will however be involved in the manufacturing and possibly the marketing. Abbvie has continued the trials. This would explain why on at least two occasions Denton’s accidentally filed documents as a Large entity (ANIP is a small entity).

If Biosante were to try to stay afloat, without disclosing the the CV discovery it would have led to much more dilution. The merger with ANIP a company starting to show a profit with stale growth allowed Biosante to ride out trail completion with no more dilution just to stay afloat. It also consolidated the controlling interest of the merged company.

This would explain Dr Snabes working simultaneously at Biosante and Abbvie and his being hired by Abbvie. It would also explain why Pat Fuller was promoted to VP IT at Biosante on the heels of a Reverse Split to remain listed. Pat Fuller’s company Technology Management Group cites Abbvie as one of Key clients. Pat fuller Linkedin profile states she was VP IT August 2011 – June 2013, but in reality she was promoted June 2012. Was the promotion in relation to the tech transfer to Abbvie of the Libigel data?

Pat Fuller

Now consider, why did Snabes pull his linked in page? Why are they claiming he worked at Relypsa in between Biosante and Abbvie? Likewise why did Linda Andrews falsify her work history to no longer show her working simultaneously at Abbott and Biosante from November 2009 to March 2010. This when the key changes were made to the Clinical trial resulting in the CV event reduction.

The second part of the trial would have been completed August 2016. Since then:
1) Libigel trademark has been allowed to expire.
2) Three new patent applications have been filed replacing the originals submitted in 2011, Two of which have been posted to the USPTO website with the assignee not being named. The third patent application is still outstanding.
3) The Deals.bio website no longer advertises Libigel or any other product matching its description as a licensing opportunity.

Certainly looks they are going to a lot of effort to cover their tracks.