Par ships first generic version of J&J drug
WOODCLIFF LAKE, N.J. Par Pharmaceutical Cos. has begun shipping its generic version of a drug used to treat schizophrenia and bipolar disorder.
The company announced Tuesday the shipment of risperidone ODT in the 0.25-mg, 3-mg and 4-mg strengths. The drug is used in adults as a stand-alone treatment for schizophrenia and as a combination, with lithium or valproate, for the treatment of manic and mixed episodes in bipolar I disorder.
The drug is a generic version of Johnson & Johnson’s Risperdal M-TAB, which had sales of $89 million last year, according to IMS Health data. As the first company to file an approval application with a paragraph IV certification, Par has six months of market exclusivity, though J&J retains exclusivity for the use of the drug in children.
Pfizer presents investigational cancer drug results at conference
ORLANDO Data from a phase 2 study of an investigational lung cancer drug identify patients who may benefit from treatment with the drug, according to abstracts presented at a cancer conference.
Drug maker Pfizer presented three abstracts of a study on figitumumab (CP-751,871) at the 45th annual meeting of the American Society of Clinical Oncology in Orlando, Fla. The study showed a response rate of more than 60% in a single-arm extension cohort of 56 patients conducted to confirm preliminary findings from a 156-patient phase 2 study evaluating overall response with figitumumab when combined with carboplatin and paclitaxel in patients with non-small cell lung cancer.
“As we try to find the right drug to use in the right setting for each patient, we are encouraged by these data, suggesting a relationship between tumor histology and response to figitumumab,” Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said in a statement. “Given that patients with advanced NSCLC face a poor prognosis, it is important to be able to identify specific patients who may benefit most from different treatment options.”
The company recently started a phase 3 trial of the drug, an anti-insulin growth factor type 1 receptor antibody.
FDA accepts NDA for epilepsy treatment
MARLBOROUGH, Mass. Sepracor announced Monday that the Food and Drug Administration has accepted the new drug application for its epilepsy treatment.
Stedesa (eslicarbazepine acetate) has been accepted for filing and is now under formal review. The NDA was submitted Mar. 31 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Meanwhile, the Prescription Drug User Fee Act date for Stedesa is expected to be Jan. 30, 2010, subject to written confirmation, the drug maker said.
Sepracor is seeking approval of Stedesa for adjunctive therapy with once-daily doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.
“We are very pleased to continue the advancement of Stedesa as a potential new adjunctive treatment for partial-onset epilepsy,” said Adrian Adams, president and CEO Sepracor. “Stedesa represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline.”
Stedesa, Sepracor said, was studied in three Phase III trials involving more than 1,000 patients in 23 countries. Sepracor acquired the rights to commercialize eslicarbazepine acetate in the U.S. and Canadian markets from BIAL, a privately-held Portuguese pharmaceutical company, in late 2007.