Replies to post #3586 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Dasgrunt, a patent for using testosterone as a Methods for decreasing cardiovascular risk in postmenopausal women.

Patent Application Abstract
Methods for decreasing the risk of cardiovascular events in postmenopausal women having a high risk for a cardiovascular event are provided. In particular, methods for decreasing the risk of cardiovascular events in postmenopausal woman at high risk for cardiovascular events by administering to the woman a therapeutically effective amount of an androgen, whereby administering the androgen decreases the risk of cardiovascular events in the woman compared to untreated postmenopausal woman at high risk for cardiovascular events are provided.

I have added some of the more important definitions and claims in the patent application:

[0027] As used herein, a "cardiovascular event" or "cardiovascular events" means 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.

[0029] As used herein, "high risk of cardiovascular events" means a woman has a minimum of a 2-point cardiovascular disease risk factor as determined by the following point scale: 1) age 60 to less than 70 years (1 point), 2) 70 years or greater (2 points), 3) diabetes mellitus (2 points), 4) presently smoking at least 10 cigarettes/day (or the equivalent, e.g. uses chew tobacco a minimum of 2 hours daily) (1 point), 5) blood pressure (1 point): systolic.gtoreq.150 mmHg and/or diastolic.gtoreq.95 mmHg (based on two readings taken at least 30 minutes apart) and/or taking antihypertensive medications (for treatment of hypertension), 6) dyslipidemia (1 point): LDL>160 mg/dl and/or HDL<45 mg/dl and triglycerides>250 mg/dl and/or taking lipid-lowering medication (over-the-counter products are not considered to be acceptable treatment forms), 7) ankle-brachial index<0.6 (2 points), 8) documented history of cardiovascular disease, i.e., myocardial infarction, stroke, hospitalization for unstable angina/acute coronary syndrome, revascularization of the coronary, carotid, or peripheral circulations.


[0104] There were eight adjudicated cardiovascular events determined from this Phase 3 clinical trial after greater than 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.

[0105] A greater number of observed cardiovascular events in the untreated postmenopausal women group reveals that administering a therapeutically effective amount of an androgen, i.e., testosterone, decreases in the risk of having a cardiovascular event in postmenopausal women at high risk for cardiovascular disease.


Patent application

The patent application or implications have never been publicly disclosed or mentioned by the company, other than in the application process which once accepted becomes public record.
The patent application is basically claiming that if your are a postmenopausal women with a high risk of having a cardiovascular event and are not restoring your testosterone levels to premenopausal levels you are 244 % more likely to suffer a cardiovascular event.

This patent application has been examined and rejected several times but I believe they have addressed all the Patent Office’s concerns, The lawyer representing ANI in this patent application was a Patent Examiner for over 9 years. They are in the process of narrowing down the scope of the patent in order for it to be approved. They (Antares with Simes as one of the inventors) have already received patents from this patent examiner before for the use of testosterone to treat HSSD and as a hormone replacement. If I am correct we they will probably get the patent approval, by end of the month, which will allow them to move forward on the development of Libigel.