Marty is a good Man too.
He also watches the back of Metabolic.
When the products we have die, they will just have new things for us to sell, there will not be a layoff and you troublemakers should get to work, your a bunch of crybabies and pussies.
One product that is set up for acquisition or partnering is ANI's (fornerly Biosante) Libigel. ANI bought the Baudette manufacturing plant. Many former Solvay employees still work there. Stephen Bell former VP of R&D for Biosante worked at both Biosante and Solvay prior to the launch of the Libigel safety/efficacy trial. It should be noted that Stephen Simes the CEO of Biosante was the CEO of Unimed when Androgel was in Phase III trials.
During the course of the safety safety/efficacy trial a number of Abbott employees worked at Biosante. Some returned others moved on.
Dr Michael Snabes formerly he Director Senior Vice President, Medical Affairs at Biosante in March 2013 was hired by Abbvie as Sr Medical director of Men and Women's health.
Dr Snabes was the Director of the Libigel safety/efficacy study, which has over 7000 person
years of data.
Most interestingly Dr Snabes is listed as one of the inventors for the following patent application (US Patent Application # 20120022033) filed July 20, 2011.
"Methods for decreasing cardiovascular risk in postmenopausal women"
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.
Which makes the following assertions:
Patient population inclusion criteria:
Inclusion Criteria:
Postmenopausal female subjects
at least 50 years of age
with at least two points of cardiovascular risk
with a clinical diagnosis of HSDD.
Patent application makes the following claims/assertions:
[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.
[0090] In certain embodiments the decrease in the risk of a cardiovascular event in the treated women compared to the risk of cardiovascular events in untreated women 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%.
[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.
[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.
They are still working on getting the patent. If as expected they obtain a patent this year they will have patent protection until July 2031. It should be noted that the SPA in relation to the trial also had a efficacy component regarding FSD which was much less onerous then the FDA experiment with Libigel efficacy trials for surgically induced menopausal women.
It should also be noted that approx. 65% of the patient population suffered from Hypertension and Dyslipidemia.
Unfortunately the delay in obtaining a patent may not be able to save all jobs but once received and FDA approved Libigel will be first to market with a long runway of patent protection. Market potential is huge.
Good luck to everyone
