Replies to post #11089 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

BesaoT35, I agree that it need to become public knowledge. FYI, the 70% reduction was in cardio vascular events.
The following is significant information from the patent application.

Claim 29

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.

The patent application defines "cardiovascular events" as one of the following occurrences:

a cardiovascular death, a non-fatal stroke, a non-fatal myocardial infarction, hospitalized unstable angina (including acute coronary syndrome), angioplasty, coronary bypass surgery, a pulmonary embolism and deep vein thrombosis

More importantly it states the following in the Method of Treatment

[0088] In certain embodiments, the reduction in the observed number of cardiovascular events compared to the expected number of cardiovascular events is at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 99% compared to the expected number of cardiovascular events for a postmenopausal woman or a population of postmenopausal women.

In the examples they also claim the following.

[0103] There were twelve adjudicated cardiovascular events determined from this Phase 3 clinical trial after over 4,000 woman-years of therapy. A comparison of the observed number of cardiovascular events to the expected rate of cardiovascular events revealed that the number of observed events was only about 29% of those expected, resulting in a 71% reduction in cardiovascular events

Patent Application

If you look at the patent application all hey have is the claim that it reduces breast cancer events.

Claim 56.

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.

There is no definition for breast cancer, no details in the in the method of treatment which gives a breakdown of the benefits by embodiment. Nor did they site examples giving the reduction in the form of a percentage as they did for Cardiovascular events.

Dentons is/was representing ANIP in teh patent prosecution. Dentons was ranked the top Patent Prosecution Firm in the US in 2017 & 2018. These guys know full well what they are doing.

Dentons

In the earliest application on December 19, 2015 they added the breast cancer reduction claim to a patent application which had been filed June 29, 2011. They know full well this would not fly. The patent reviewer responded that the additional claim must be part of a new application. What it do, as some have suggested, it set a date stamp for claiming priority in a future patent application.

In the application ,that I linked ,they used basically the same Specification information from the earlier application. Plenty of cardiovascular event reduction related information. But nothing related to breast cancer event reduction.

The only logical reason for omitting this information, is that they have/had a partner and it would have shown someone was looking at Libigel (Most likely Abbvie) With such a small float , what would that have done for ANIP's share price? Especially if they were contemplating buyout vs partnership. AbbVie's.had taken a $5.2 billion hit on Stemcentrx and it did not work out to well for them.