Watson seeks FDA approval for generic Vyvanse
PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.
Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.
Shire has filed a patent infringement suit against Watson in the U.S. District Court for the Central District of California in an attempt to prevent Watson from marketing its version of the drug. Under laws governing generic drugs, the FDA can’t approve Watson’s generic version of Vyvanse until August 2014 or until the companies resolve the matter before the court.
Hi-Tech Pharmacal reports strong sales for Q4, full year
AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal reported its fourth-quarter net sales increased 45% to $57.2 million from the year-ago period.
Net income for Hi-Tech totaled $12.7 million, or 98 cents per diluted share, compared with $6.5 million, or 50 cents per diluted share in fourth quarter 2010.
Fourth-quarter net sales of generic pharmaceutical products for the period ended April 30 increased 59% to $48 million, thanks to a spike in sales for Hi-Tech’s fluticasone propionate nasal spray, a generic version of Flonase. New product launches, such as gabapentin oral solution, also contributed to the positive results, the drug maker said.
Branded pharmaceutical sales for the fourth quarter at the drug maker, however, decreased from $6.5 million to $5.9 million.
For the fiscal year, Hi-Tech reported a 20% increase in sales to $190.8 million, compared with the same period last year. Net income also increased, totaling $41.5 million, or $3.19 per diluted share, compared with $31.1 million or $2.50 per fully diluted share for the prior year. Earnings per share from continuing operations were $3.36, which excludes the loss of approximately 17 cents per share related to the Midlothian division, reflected as discontinued operations.
Generic pharmaceutical product sales rose 22% to $157.4 million, compared with last year, while branded prescription products contributed $19.6 million in sales for the full fiscal year, up from $18.7 million for the fiscal year ended April 30, 2010.
Hi-Tech president and CEO David Seltzer said that the results were "the best [results] in the company’s history."
Merck Serono names new COO
DARMSTADT, Germany — Merck KGaA division Merck Serono has appointed Belen Garijo as COO and Annalisa Jenkins as global head of drug development and medical, effective Sept. 5.
The company, which operates under the name "EMD" in the United States and is a separate company from U.S.-based Merck, said Garijo and Jenkins will be based in Geneva and will report to president Stefan Oschmann.
Garijo previously worked for Sanofi, where he was SVP global operations for the European region, while Jenkins was SVP global medical for Bristol-Myers Squibb.