Hyperion buys rights to drug for rare genetic diseases
SOUTH SAN FRANCISCO, Calif. — Hyperion Therapeutics has purchased rights to a drug for treating genetic metabolic disorders, the company said.
Hyperion announced the purchase of Ravicti (glycerol phenylbutyrate) from Ucyclyd Pharma, a subsidiary of Medicis Pharmaceutical.
The drug is awaiting Food and Drug Administration approval for the treatment of urea cycle disorders, a class of genetic disorders that affects 1-in-10,000 births and result from deficiency in enzymes involved in the urea cycle, the body’s primary means of removing ammonia from the bloodstream. Left untreated, the conditions can result in brain damage, coma and death.
Financial terms of the deal were not disclosed. Hyperion also has the option of buying rights to two other drugs in 2013.
FDA approves J&J HIV drug in children
TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.
J&J’s Janssen Therapeutics division announced Tuesday the FDA approval of Intelence (etravirine) in patients ages 6 years to younger than 18 years with HIV-1 who have taken other therapies but whose infection has become resistant to treatment. The drug already was approved for adults.
"This indication fulfills an important need in the U.S. among treatment-experienced young children and adolescents living with HIV," Janssen Therapeutics medical director David Anderson said. "This approval also expands the treatment options Intelence offers and reinforces our company’s commitment to serving the diverse needs of the HIV treatment community."
ReportersNotebook — Chain Pharmacy, 4/2/12
SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.
A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said. The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The FDA approved the drug on Jan. 30.
The companies developed the drug under a partnership started last year that resulted in a dispute between Lilly and Amylin Pharmaceuticals, with which Lilly had developed the injected Type 2 diabetes drugs Byetta (exenatide) and its long-acting version, Bydureon, which the FDA also approved on Jan. 30. Lilly and Amylin terminated their agreement in November.
The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said. Eisai said the FDA delivered a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about a regulatory application that preclude approval.
The drug maker said the FDA’s decision was due to the primary study not providing convincing evidence of safety and effectiveness for AML. The drug already is approved for treating myelodysplastic syndromes, a group of cancers that result from damage to the cells in the bone marrow that form blood cells.