ANI Pharmaceuticals (ANIP)

[Just the facts maam]

I think ANIP's lawyers figure a way to get the patent application to overcome the Dudley's prior art from "Method of increasing testosterone and related steroid concentrations in women"

In Dudley's patent application being used to reject Ani's application, Dudley claimed the following:

Claims

1. A method of treating, preventing or reducing the risk of developing a testosterone-deficient disorder in a female subject in need thereof, comprising: administering an amount of a composition to an area of skin of the subject, which delivers a therapeutically-effective amount of testosterone to the blood serum of the subject, wherein the composition comprises: a. about 0.1% to about 10% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof; b. about 30% to about 98% alcohol selected from the group consisting of ethanol or isopropanol; c. about 0.1% to about 5% isopropyl myristate; d. about 0.1% to about 10% sodium hydroxide; and e. about 0.1% to about 5% of a gelling agent; wherein the percentages are on a weight to weight basis of the composition and the sum of components of the composition is about 100 weight %; and the composition is capable of releasing the testosterone to the skin at a rate and duration that raises testosterone blood serum concentration to at least about 3 pg testosterone/ml blood serum within about 24 hours after administration.

Detailed description

[0061] The phrase "testosterone deficient disorder" refers to a to a condition, disorder, or disease that occurs in a mammal due to lack of endogenous testosterone production or utilization thereof. In women, such conditions, disorders, or diseases include, but are not limited to, hypogonadism, sexual dysfunction, decreased libido, hypercholesterolemia, abnormal electrocardiograms, vasomotor symptoms, diabetic retinopathy, hyperglycemia, hyperinsulinemia, hypoinsulinemia, increased percentage of body fat, hypertension, obesity, osteoporosis, osteopenia, vaginal dryness, thinning of the vaginal wall, menopausal symptoms and hot flashes, cognitive dysfunction, cardiovascular disease, central nervous system disorders, Alzheimer's disease, dementia, cataracts, and cervical cancer uterine cancer or breast cancer.


[0065] A "testosterone deficient disorder effect" or "testosterone deficient disorder-effective amount" is intended to qualify the amount of testosterone required to treat or prevent a testosterone deficient disorder in a mammal, or relieve to some extent one or more of the symptoms associated with, or related to, a testosterone deficient disorder in a mammal. In a woman, this includes, but is not limited to, normalizing hypogonadism; improving sexual dysfunction; increasing libido; normalizing cholesterol levels; normalizing abnormal electrocardiograms of patients and improving vasomotor symptoms; improving diabetic retinopathy as well as lowering the insulin requirements of diabetic patients; decreasing the percentage of body fat; normalizing glucose levels; decreasing the risk factors for cardiovascular disease, including normalizing hypertension, and treating obesity; preventing osteoporosis, osteopenia, vaginal dryness, and thinning of the vaginal wall; relieving menopausal symptoms and hot flashes; improving cognitive dysfunction; treating, preventing or reducing the onset of cardiovascular disease, Alzheimer's disease, dementia, and cataracts; and treating, preventing or reducing the risk of cervical, uterine or breast cancer.

Wherein ANI's claims now reduce the number of cardiovascular events even if you already had cardiovascular disease. This should be enough to differentiate it from Dudley's claim that it reduces prevents or reduces the onset of Cardiovascular disease. The same probably applies to Breast Cancer. They appear to be moving away from prevention to treating as well.

Libigels patient population included

1. Postmenopausal women at least 50 y of age with a clinical diagnosis of HSDD (DSM-IV)

2. CV disease risk score if =2(adapted from Barett-Connor et al7) using the following point scale:

a. Age, 60 to <70 y (1 point) or =70 y (2 points)
b. Diabetes mellitus (2 points)
c. Peripheral vascular disease with ankle-brachial index <0.6 (2 points)
d. Documented CV disease (myocardial infarction, stroke, hospitalization for unstable angina/acute coronary syndrome, revascularization of the coronary or peripheral circulations) (2 points)
e. Present smoker of at least 10 cigarettes per day (or the equivalent) (1 point)
f. Hypertension—defined as seated systolic blood pressure =150 mm Hg and/or diastolic blood pressure =95 mm Hg and/or taking antihypertensive medications (for treatment of hypertension)—(1 point)
g. Dyslipidemia—low-density lipoprotein >160 mg/dL and/or high-density liproprotein <45 mg/dL with triglycerides >250 mg/dL and/or taking prescribed lipid-lowering medication (1 point)
DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.



JMHO