Prasco to distribute authorized generic drug for seizures, pain
CINCINNATI — Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.
Prasco announced that it had partnered with Shire to distribute carbamazepine extended-release capsules in the 100-mg, 200-mg and 300-mg strengths. The drug is an authorized generic version of Carbatrol, used to treat certain types of seizures and pain.
Authorized generics are branded drugs sold under their generic names at a reduced price.
Amylin outlines diabetes strategy for 2012
SAN DIEGO — A special focus on its diabetes franchise will define Amylin Pharmaceuticals’ corporate strategy, the company’s chief executive said at a recent conference sponsored by J.P. Morgan.
Speaking at the 30th annual J.P. Morgan Healthcare Conference in San Francisco, Amylin president and CEO Daniel Bradbury laid out the company’s plans for the launch of the injected Type 2 diabetes medication Bydureon (exenatide), a long-acting version of the drug Byetta. Amylin originally marketed Byetta and planned to market Bydureon under a partnership with Indianapolis-based Eli Lilly, but the companies terminated their agreement to develop exenatide products in November after Lilly started a diabetes drug collaboration with German drug maker Boehringer Ingelheim. Under the agreement to terminate the Amylin-Lilly collaboration, Amylin paid $250 million upfront to Lilly and agreed to share 15% of revenues from sales of exenatide products.
Bydureon is under review by the Food and Drug Administration, which is expected to decide whether or not to approve the drug by Jan. 28.
Bradbury listed Amylin’s priorities as launching Bydureon; securing a partner outside the United States to develop exenatide; maximizing the value of Byetta and Symlin (pramlintide acetate); advancing the development programs for the investigational drug metreleptin, as well as once-weekly and once-monthly formulations of exenatide; and a continued focus on financial discipline
"We have a truly extraordinary opportunity at Amylin as we embark on a year in which we are prepared to deliver the first ever once-weekly therapy in the U.S. for patients with Type 2 diabetes — which we believe could change the way people with diabetes manage their disease," Bradbury said. "With the addition of Bydureon in the U.S., we will solidify our position as a driving force in the fight against this rising global epidemic."
Sens. Conrad, Snowe raise bipartisan concerns over draft lists of Medicaid drug FULs
ALEXANDRIA, Va. — In a bipartisan effort, Sens. Kent Conrad, D-N.D., and Olympia Snowe, R-Maine, along with 12 of their colleagues, have expressed concerns with draft Federal Upper Limits lists for Medicaid generic drug reimbursement that recently have been published by the Centers for Medicare and Medicaid Services.
The National Association of Chain Drug Stores and National Community Pharmacists Association commended the Senators for the effort.
"In publishing three draft lists of Medicaid drug FULs, CMS has provided states with a potential unofficial standard for setting state maximum allowable costs. Specifically, pharmacists believe that if states were to implement MACs based on the CMS’s draft FUL lists, pharmacies could see reduced reimbursement for selected generic drugs in the range of 30% to 60% of acquisition costs. Cuts of this magnitude could create a disincentive to dispense generic drugs, which is exactly the opposite of what we should be trying to achieve as we seek to control healthcare costs," the senators wrote in a letter to CMS. Fourteen senators signed the letter to CMS.
NACDS and NCPA also have expressed concern with the draft FUL lists in written comments to CMS. “We are pleased that our arguments have been given further credibility by a large, bipartisan group of senators,” stated NACDS president and CEO Steve Anderson and NCPA CEO B. Douglas Hoey. “We want to especially thank senators Conrad and Snowe for their leadership on this important issue.”
In addition to urging CMS to cease publication of draft FUL lists until a final AMP rule is in place, the Senators also urged the agency to be mindful of comprehensive pharmacy reimbursement. “When setting pharmacy reimbursement rates, it is important that both components of reimbursement — product cost and cost to dispense — be taken into consideration to ensure pharmacies are adequately paid,” the senators wrote.
Last month, a similar bipartisan letter was sent to CMS by 40 U.S. representatives raising concerns over the flawed Medicaid pharmacy reimbursement process.