The following, though speculative in nature is supported by fact, and advances the possibility of an ANI Pharmaceuticals (Nasdaq:ANIP) and AbbVie Inc. (NYSE:ABBV) partnership, which has yet to be disclosed. It builds on information collected for previously written Seeking Alpha articles titled: "AbbVie And ANI Pharmaceuticals Appear Poised To Announce A Deal For Libigel" and "Libigel Lowers Risk Of Breast Cancer And Cardiovascular Events. Who Benefits?" The article provides additional information in order for you to assess the likelihood of a deal in the near future for Libigel, and whether it presents an investment opportunity.
May 11, 2017, UPSTO published Patent Application # 15/331360 titled "Methods for treating Female Sexual Dysfunction while decreasing cardiovascular risk", which was filed by Dentons on behalf of Ani Pharmaceuticals. This patent application claimed benefit of priority from Patent Application #13/135224.
The claims in the more recent patent application are important, but equally important and much more fascinating is what is missing from the patent application and why the information might be missing.
Patent application claim # 29 reads as follows:
A method for reducing the number of cardiovascular 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 cardiovascular events in the woman compared to an expected number of cardiovascular events in an untreated postmenopausal woman, and wherein the reduction in the number of cardiovascular events is reduced by at least 70% compared to the expected number of cardiovascular events for a postmenopausal woman.
While claim # 56 reads as follows:
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.
Upon reviewing the patent application and supportive documentation, obtained from the Public Pair Portal Application, the patent application, presently, fails to provide any supportive information with respect to the Breast Cancer reduction claim. Whereas, the cardiovascular event reduction claim is clearly supported by over 4000 patient years of data from the Libigel safety trial and the specification submission, which clearly describes how the baseline for expected cardiovascular events was established. Why would Dentons exclude this information? Would the missing information prematurely expose the existence of a partner for Libigel?
Libigel Clinical Trial
According to the American Heart Journal article "A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder" (January 2012), the study attempted to rule out a pre-approval level of risk after an average of 2 years of treatment. "It also included a postapproval commitment to follow participants for a total of 5 years, including a period after the primary regulatory analysis and potential approval."
In addition, the American Heart Journal article provided information related to monitoring breast cancer events during the trial. Patients would undergo breast examinations and mammographies at baseline and annually for all 5 years and have endometrial biopsies performed at baseline at years 1, 2 and 5.
According to Biosante Pharmaceuticals' press release dated September 4, 2012 (now Ani Pharmaceuticals) appeared to have successfully met the two year pre-approval condition of the Libigel trial. Where they collected approximately 7300 patient years of data with an average of 24.5 months of data per patient.
The big question is "did another pharmaceutical company pick up the baton and follow up with the trial participants for the full 5 years?" If so, is this where the breast cancer reduction benefit of Libigel was able to differentiate itself from placebo, as it was not evident during the initial analysis of 4000 patient years of data? The lack of details supporting the breast cancer reduction claim appears to support this possibility.
Something To Consider
March, 2013, AbbVie hired Dr Michael Snabes, one of the listed inventors and Study Director for the Libigel trials, as their Sr. Director of Men and Women's Health. This occurred shortly after Biosante Pharmaceuticals had completed the preapproval requirements of the Libigel Safety Trial December, 2012.
Note: If the trial continued as per protocol, it would have been completed August, 2016 where they would have would have collected approximately 18,250 patient years of data from the 3656 patients.
Ani Pharmaceuticals Staying Below The Radar
Since August 2016, Ani Pharmaceuticals has:
- Filed three new patent applications replacing existing patent applications filed in 2011.
- Allowed the Libigel trademark to expire without seeking a replacement name. Therefore it appears the product will be marketed under a new name, most likely chosen by a company other Ani Pharmaceuticals.
- Removed Libigel as a licensing opportunity from the Deals.bio website.
- Not presented at an investor conference. The last publicly announced presentation was May 23, 2016 at the UBS Global Healthcare Conference. Whereas in 2015 Ani Pharmaceuticals presented at four investor conferences.
Ani Pharmaceuticals is only listed as an applicant in the most recent patent application. The assignee for the patent application is not listed, it appears to have been purposely omitted from the Application Data Sheet. With respect to assignment the UPSTO issues the following disclaimer: "If the assignment for a patent was not recorded, the name of the assignee on the patent application publication or patent may be different".
Does the combination of no assignee being listed in the patent application, in addition to the lack of supportive data for the breast cancer reduction claim indicate the possibility that Ani Pharmaceuticals has a deal for Libigel? If so, who other than AbbVie would have been in a better position to continue the study?
Potential Markets For Libigel
Additional information on the following potential markets for Libigel is available in the Seeking Alpha article title "AbbVie and ANI Pharmaceuticals appear poised to announce a deal for Libigel":
- HSDD: Peak annual sales of approximately $5.4 Billion, based on 9 million prescriptions, 4 million of which can be achieved simply by switching existent off label and compounded testosterone users and supported by 96% of physicians surveyed
- Hypertension: According to Technovia the Global Hypertension market will reach $32 billion in 2020 with steady growth as the population ages.
- Dyslipidemia: According to GlobalData`s research the global dyslipidemia market is expected to grow to $37.9 billion by 2023
- Breast Cancer: According to Global Business Intelligence`s research the global breast cancer market is expected to grow to $17.2 billion by 2021.
In addition, results from a Phase 2 Libigel trial found the following:
"Postmenopausal women had better improvement in verbal learning and memory after receiving treatment with testosterone gel, compared with women who received sham treatment with a placebo."
The results appear to justify a Phase 3 study.
- As previously stated a partnership between Ani Pharmaceuticals and AbbVie is still speculative and may not materialize.
- If a partnership is announced it should have an immediate upside to PPS, presumably for both Ani Pharmaceuticals and AbbVie, however if they fail to obtain FDA approval for Libigel expect to give back much of the gains.
- Since further studies will most likely be required in some or all indications, the potential for failing to prove efficacy still exist.
- Though patents exists covering formulation and method of use 2027 to 2031. The patents related to cardiovascular and breast cancer event reduction may not be allowed.
As originally stated, the idea of Ani Pharmaceuticals and AbbVie partnership is speculative. However, in assessing if an investment opportunity exist, you must ask the following questions:
- Why Dentons would insert the breast cancer reduction claim in the a patent application without providing the supportive data?
- Who provided the data to support such a claim?
- Why did Dentons omit the assignee information in the most recent patent application? Is the patent application to be reassigned or will Ani Pharmaceuticals share the assignment?
- Why has Ani Pharmaceuticals not attended an investor conference since May23rd, 2016?
The information provided points to something going on behind the scenes with respect to Libigel. I leave it to you to determine if there is a theme there.
Libigel does not appear to be factored into the present share price for either Ani Pharmaceuticals or AbbVie. Therefore, if a deal is consummated, it presents a buying opportunity for both stocks. Particularly if the announcement of a partnership is further supported by peer reviewed articles demonstrating the reduction of the cardiovascular and breast cancer events.
Ani Pharmaceuticals as a small cap company stands to gain the most from the potential partnership. However, quantifying the upside is difficult without knowing the terms of an agreement. Likewise, AbbVie would benefit from adding another franchise to offset Humira's projected future revenue lost. This should allay investor apprehension that AbbVie may have trouble replacing future revenue losses to their Humira franchise, which should put upward pressure on share price.
Disclosure: I am/we are long ANIP.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.