OncBioMune acquires Mexican rights to norepinefrine from Teva
BATON ROUGE, La. — OncBioMune Pharmaceuticals signed a non-binding term sheet with Teva Pharmaceuticals to acquire norepinefrine in Mexico. This agreement can also extend to other Latin American countries.
“Mexico is one of the top five emerging markets globally, principally with generics. Teva has a broad portfolio of generics that are overlapping in some strategic markets, which presented an opportunity for us to acquire another revenue-generating drug,” said Jonathan Head, Ph. D., Chief Executive Officer at OncBioMune. “We intend to remain aggressive in our acquisition strategy to grow our high specialty footprint in Mexico and across all of Central and South America to capitalize on the burgeoning markets. Pending the unexpected, I anticipate a definitive agreement and our acquisition of Norepinefrine during the second quarter of 2017, with commercialization efforts to commence shortly thereafter.”
The term sheet confirms mutual interest and sets forth guidelines for OncBioMune to acquire the sanitary registration and intellectual property rights of Norepinefrine currently owned by Teva. Norepinefrine is approved in Mexico as indicated for the treatment of low blood pressure and heart failure.
Baton Rouge-based OncBioMune is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient.
Analysis: Entresto improves glycemic control
EAST HANOVER, N.J. — A post-hoc analysis in a subgroup of patients with reduced ejection fraction heart failure (HFrEF) and diabetes suggest that Entresto (sacubitril/valsartan) tablets improved glycemic control, as assessed by hemoglobin A1c (HbA1c) testing, compared to ACE-inhibitor enalapril.
According to Novartis, which funded the study, FDA-approved Entresto lowered HbA1c levels — a measure of average blood glucose levels for the past two to three months — after one year of treatment for heart failure, and this effect was sustained over three years of study follow-up. In the analysis, new use of insulin therapy or oral diabetes agents was also reduced in the Entresto group. The analysis was presented at the American College of Cardiology 66th Annual Scientific Session & Expo in Washington, D.C. and published in The Lancet Diabetes & Endocrinology.
"Diabetes is a major risk factor in heart failure and is strongly linked to progression of the disease, putting heart failure patients at increased risk of hospitalization and death," said Scott Solomon, MD, Director of Noninvasive Cardiology, Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and senior author of the publication. "This analysis suggests that, in addition to the proven heart failure benefits demonstrated in PARADIGM-HF, Entresto may also help tighten glycemic control among heart failure patients with diabetes."
An analysis was conducted of 3,778 HFrEF patients in the PARADIGM-HF trial who were diagnosed with diabetes or had a baseline HbA1c ≥ 6.5% without a reported diagnosis at screening (98% of patients assessed had type 2 diabetes). The investigators compared the effects of Entresto vs. enalapril on glycemic control by measuring patients' HbA1c levels at screening and at one-, two-, and three-year follow-up visits, and by evaluating patients' initiation of oral antihyperglycemic or insulin therapy during the study.
This post-hoc analysis found that Entresto decreased HbA1c levels by 0.26% during the first year of follow-up, compared to a 0.16% reduction with enalapril (p=0.0023)
"On top of the already well-demonstrated clinical benefits of Entresto, a reduction in HbA1c levels in these type 2 diabetes patients is of great interest and shows us that further research is needed to better understand this metabolic effect of the drug," said Fabrice Chouraqui, President of Novartis. "Novartis is committed to exploring the full potential of this important medication to maximize its value for heart failure patients managing their chronic condition."
Heart failure is a debilitating and life-threatening condition, which impacts 6.5 million Americans and is the leading cause of hospitalization among Americans over the age of 65.