GSK files new formulation application with FDA as per $42 million Eurand agreement
PHILADELPHIA GlaxoSmithKline has filed an application with the Food and Drug Administration for an orally disintegrating tablet formulation of a product co-developed with Eurand using its Microcaps taste-masking and AdvaTab technologies, according to CNN.
The companies had signed an agreement in October 2006, in which GSK would fund the development of a new product using Eurand’s technologies to develop a new formulation for the product. Under the agreement, GSK would have exclusive rights in the U.S. to commercialize the new product, and GSK and Eurand would each have certain rights to commercialize the product outside of the U.S. Eurand would retain exclusive, worldwide manufacturing rights. GSK would pay Eurand up to $42 million based upon achievement of certain development, regulatory and sales milestones.
GSK expects to launch the product in late 2008. Eurand is entitled to a milestone payment upon FDA acceptance for review of the application.
Gearoid Faherty, chief executive officer of Eurand, commented, “We are pleased that GSK continues to steadily progress this product towards commercialization and look forward to the anticipated launch in 2008.”
Mylan, Forest get FDA approval of Bystolic for hypertension
WASHINGTON The Food and Drug Administration has approved Mylan and Forest Labs’ new drug, nebivolol, for the treatment of high blood pressure. Forest will market the drug under the prescription name Bystolic.
Nearly 1-in-3 adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack and kidney failure. “High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” said Douglas Throckmorton, the FDA’s deputy director of the Center for Drug Evaluation and Research. “Bystolic offers a new treatment option for people who need to control their high blood pressure.”
More than 2,000 people received Bystolic during clinical trials. The drug’s efficacy was similar to that of other approved beta blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.
On Dec. 2 of this year, Forest and Mylan had said that final approval was contingent upon resolution of manufacturing deficiencies at a plant in Belgium.
Genzyme gets expanded approval for Thyrogen from FDA
CAMBRIDGE, Mass. The Food and Drug Administration has granted expanded approval for Genzyme’s thyroid cancer drug Thyrogen, according to published reports.
The new indication allows for Thyrogen (thyrotrophin) to be used in combination with radioiodine, a radioactive iodine used to treat thyroid cancer, to destroy the remaining thyroid tissue in patients who have had their cancerous thyroids removed.
Thyrogen was initially approved in the U.S. in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The drug helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal.
“This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence,” said Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business.