Big Bambino, I too was hoping to get a completion date.
I still find it hard to believe that AbbVie after hiring Dr. Snabes, at a minimum, was not interested in Libigel. Even as partner, with no upfront cash payment, but funding the $30 - $36 million HSDD efficacy trials and assuming responsibility for the second half of the safety study. In addition they could have worked with the FDA for CV and Breast Cancer protocols for additional indications. Especially since they could have patent protection on TRT to 2033. Something that AbbVie (Abbott Labs) had been working on up to the time ATRS got the patents.
Especially after wasting $5.8 billion on Rova T (Stemcentrx). Seems a deal for Libigel would be a no-brainer.
If Libigel is still in play, it might be timed to counter falling Hunmira sales. Or, part of a larger deal possibly a company like Pfizer acquiring Abbvie.
Interestingly, AbbVie still has not used their Priority Review Voucher. All proposed uses by analysts at the time of the acquisition have gone to NDA submission without being used. I just find it very ironic that they picked it on August 19, 2018, the day after the first drug to treat HSDD for pre-menopausal women was approved. What are the odds that Dr Louis Sullivan (Biosante's Chairman of the BOD from the start of Libigel development to recommending the merger with ANI) would be sitting on the BOD of United Therapeutics, the company that sold the Priority Review Voucher to AbbVie.
Though no deal has ever been disclosed, what are the odds of no deal when you consider all the following:
- Up to 2012 Abbott/AbbVie was chasing a TRT patent treating HSDD and other conditions. That when ATRS got the patents it gave longer patent protection than what Abbott would have received. That Abbott/AbbVie would no longer want to have the Women's TRT market to themselves.
- That Biosante would advertise Libigel as a licensing opportunity on Deals.bio as follows:
Phase III Safety Study: BioSante continues to conduct the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular(CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued over 5,100 women-years of exposure, to date. The study is designed for a total of five years; however, BioSante could use the safety study data as part of a NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo. The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to demonstrate the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women. And not state that based on 4000 patient years of data Libigel reduced Cardiovascular events by 70% (as per patent application).
- That AbbVie would hire Dr Snabes as Sr Director of Men and Women's Health in 2013 (there was a period where he worked simultaneously for AbbVie and Biosante) and that he would not make a pitch to continue the Libigel study. If that was not already AbbVie's original intent. After all the CV discovery was his invention.
- That Patricia Fuller VP IT Biosante would be contracted to do IT work for AbbVie in 2013. (Libigel Tech transfer?)
- That in August 2015 the CVRs ($0) started showing up in trading accounts.
- That August 19th, 2015 Abbvie acquires United Therapeutic's PRV (issued March 10, 2015) for $350 million when Addyi is approved the day before to treat HSDD pre-menopausal.
- That Dr Louis Sullivan would be sitting on United Therapeutics BOD.
- That December 19, 2015 patent prosecutors added that TRT reduces Breast Cancer events
- That patent prosecution would not provide supportive evidence to the Breast Cancer reduction claims.
- That in September 2016 that Dentons let the trademark for Libigel expire and then a little over one month later file new patent applications.
- That in between August and December 2016 Ani Pharmaceuticals would would have removed Libigel as a licencing opportunity. No cost to list on Deals.bio site.
-That Ani’s largest shareholder (over 20%) MVP has two seats on the BOD voting the same shares. MVP shares. MVP is a subsidiary of Wells Fargo.
In addition to the suspicious actions that shortly after Abbott employee Linda Andrews (Document Specialist) started working at both Abbott and Biosante at the same time, changes to the inclusion criteria for the safety study were made leading to a patient population at greater risk of a CV event. Later as we started discussing Linda Andrews work history her Linkedin profile was altered to no longer show her working at Biosante between Nov 2009 and March 2010. Note: November 12, 2009 major changes were made to Libigel and interestingly an Andrgogel trial (by Solvay which had entered into a buyout agreement With Abbott/Abbvie in September 2009 and completed the buyout February 2010). Why hide your work at Biosante?
If no deal was in place for Libigel, ANI could have spent $6 million (maybe less) of the $143.75 million raised in December 2014 and analyse the safety data. The odds are good that 7300 patient years of data would be consistent with the results after 4000 patient years of data that produced the 70% reduction in CV events. Then re-advertise the licensing opportunity which would easily have attracted more suitors.
Then again it may all be a bunch of coincidences. But what are the odds.
In any event we should know by the end of the year.
