FDA approves Genzyme’s Renvela
WASHINGTON Genzyme’s phosphate binder Renvela, used to control serum phosphorus in patients with chronic kidney disease (CKD), has been approved by the Food and Drug Administration.
Renvela (sevelamer carbonate) will be used for both peritoneal dialysis and hemodialysis. The company said it plans to file for approval of Renvela in earlier stages of CKD as it prepares to launch the drug during the first quarter of 2008.
The drug has the same active ingredient as Renagel, which is the most prescribed phosphate binder in the U.S. Both products share the same indications as well. Renagel’s approved uses were expanded recently to include patients on peritoneal dialysis.
Both drugs control serum phosphorus, considered a biomarker for treatment of patients with CKD. However, patients on Renvela are more likely to maintain bicarbonate levels within recommended ranges and have lower incidences of gastrointestinal adverse events.
Renagel had sales of $145 million during the second quarter of 2007, the company said.
Sandoz completes $10 million expansion of N.C. facility
WILSON, N.C. Sandoz recently completed the major phase of its Wilson, North Carolina expansion when over 50 employees moved into a new 30,000 square foot building.
Over 65 new jobs are expected to be created in Wilson as a result of the $10 million expansion. The positions will be filled by pharmaceutical scientists and analytical chemists and will bring the total of employees at the site to almost 480.
“The new laboratories present an excellent workplace and opportunity for top scientists to help us continue to growth in the U.S.,” said Bernhard Hampl, president and chief executive officer of Sandoz. “The new products developed at the site will be the basis for the future growth of the Wilson site.”
Pfizer, Taisho sign letter of intent over schizophrenia drug candidate
TOKYO and NEW YORK Taisho Pharmaceuticals and Pfizer have concluded on a letter of intent with regard to Taisho’s new drug candidate for schizophrenia, TS-032.
The drug is currently in the pre-clinical stage and the letter of intent relates to a proposed license agreement regarding rights for development and commercialization.
Through the agreement, Taisho will grant exclusive development and commercialization rights outside Japan for the drug to Pfizer. Once the agreement is signed, Taisho will receive an initial payment of $22 million as well as milestone and royalties linked to the development and sales of the drug.