PHARMACY

Bayer Diabetes Care launches A1C monitor

BY Allison Cerra

TARRYTOWN, N.Y. Bayer Diabetes Care announced the launch of A1CNow SelfCheck, a new A1C monitor that enables people with diabetes to check their A1C level at home.

Measurement of A1C provides an average assessment of blood sugar levels over the past three months, and is an indicator of how well diabetes is being managed. The Food and Drug Administration recently cleared Bayer’s A1CNow SelfCheck, which enables patients to more closely watch their A1C levels in between healthcare provider visits so they may modify their diet and exercise, or have a more informed discussion with their healthcare providers based on the results.

“A1C testing is an important measure of long-term diabetes management, however, some patients will skip having their A1C tested because they’re worried about what their healthcare provider will say if their A1C levels are not good,” said Steve Edelman, MD, founder and director, Taking Control of Your Diabetes. “A1CNow SelfCheck is a new tool that allows people with diabetes to test their A1C level in the comfort and privacy of their own home, to get the information they need to manage their disease in-between healthcare provider visits.”

The monitor, which is now available without a prescription and through leading online pharmacies, provides at-home results within five minutes, has an easy-to-use design and delivers lab accuracy. Measuring A1C levels is important for consistent diabetes management, as even a one-percent reduction in A1C reduces the risk of serious complications by 40%, Bayer Diabetes Care said.

“Bayer’s A1CNow SelfCheck provides patients with a new way to partner with their healthcare providers to better achieve good blood sugar control on both a daily basis and over the long-term,” said Sandra Peterson, president of Bayer Diabetes Care. “This new product builds on our history of innovation, which began with Bayer’s invention of the first portable blood glucose meter 40 years ago, and represents a significant step forward in helping patients simplify life with diabetes.”

A1CNow SelfCheck, available for purchase through leading online pharmacies, comes as a 2-test-kit for a suggested sale price of $29.99.

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Pfizer presents investigational cancer drug results at conference

BY Alaric DeArment

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.

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FDA accepts NDA for epilepsy treatment

BY Allison Cerra

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.

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