July 20, 2015

Sanofi Planning New Global Business Structure

Sanofi is restructuring into five global business units effective Jan. 1 as it simplifies its organization. Under the new structure announced last week, Sanofi will maintain Sanofi Pasteur and Merial and create three new units — General Medicines & Emerging Markets, Specialty Care, and Diabetes & Cardiovascular.

General Medicines & Emerging Markets will comprise established products, generics, consumer healthcare, and all drug businesses in emerging markets. The Specialty Care division, Sanofi Genzyme, will focus on rare diseases, multiple sclerosis, oncology and immunology, while Diabetes & Cardiovascular will cover diabetes care medicines and cardiovascular products. Sanofi Pasteur and Merial will continue to manage their portfolios of vaccines and animal health products.

FDA: Proglycem Causes Serious Lung Problem in Some Babies

The FDA is warning that infants and newborns treated for low blood sugar with Teva’s Proglycem risk developing pulmonary hypertension. The agency’s adverse event database shows 11 cases of pulmonary hypertension in infants since the drug was approved in 1973, but only includes reports submitted to the FDA, so there could be more cases. The FDA is evaluating the issue to determine if product information should be updated.

Babies developed the condition within a day to a few months after starting Proglycem, and all were hospitalized or required additional time in the neonatal intensive care unit. All recovered after the therapy was discontinued. View the drug safety communication at www.fda.gov/Drugs/DrugSafety/ucm454833.htm.

Newron’s Rett Syndrome Drug Wins FDA Orphan Designation

The FDA has granted orphan status to Italian drugmaker Newron Pharmaceuticals’ Sarizotan (EMD-128, 130) for the treatment of Rett syndrome, a severe neurodevelopmental disorder affecting women and girls. Preclinical studies of Sarizotan, a 5HT1A agonist and D2 agonist/antagonist, showed a 70 percent to 85 percent reduction of apneas and hyperventilation episodes with both chronic and acute dosing, the firm says. There currently are no treatments for the disease.

FDA Grants Orphan Status to Kevetrin for Ovarian Cancer

Beverly, Mass.-based Cellceutix received FDA orphan drug designation for its p53 promoter Kevetrin for the treatment of ovarian cancer. The designation entitles the clinical-stage biopharma company to six years added marketing exclusivity, should Kevetrin win FDA approval, and other incentives. Cellceutix CEO Leo Ehrich said the milestone is in line with the firm’s plans to initiate a Phase 2/3 trial of Kevetrin against ovarian cancers.

Patient-Focused Meetings on Huntington’s, Parkinson’s Diseases

The FDA will hold a public meeting Sept. 22 to gather input from Huntington’s disease and Parkinson’s disease patients on different treatment approaches. The meeting, part of the FDA’s Patient-Focused Drug Development initiative under PDUFA V, will be held at the White Oak campus in Bethesda, Md.

Huntington’s and Parkinson’s are among more than a dozen diseases the agency selected in April 2013 to address during PDUFA V (DID, April 10, 2013). A second round of discussions to determine disease areas for fiscal 2016 and 2017 will begin this fall. View the Federal Register notice at www.fdanews.com/07-17-15-HuntingtonParkinson.pdf.