Wyeth files suit to block Sandoz’s generic Lybrel
NEW YORK Wyeth alleges that Sandoz’s generic version of the oral contraceptive Lybrel violates Wyeth’s patent.
Wyeth has filed a lawsuit in the U.S. District Court for the District of Delaware against Sandoz over its version of Lybrel (90 microgram levonorgestrel/20 microgram ethinyl estradiol tablets), alleging that Sandoz’s application to the Food and Drug Administration for a generic version of the drug infringed on the ‘814 patent.
Watson Pharmaceuticals notified Wyeth in a letter on Jan. 28 that it had filed an application for FDA approval of a generic version of Lybrel, prompting Wyeth to respond with a lawsuit. Wyeth received FDA approval for Lybrel in May 2007, and the patent for the drug expires in September 2018.
Wyeth reported first-quarter 2008 contraceptive sales of $104.35 million. Based in Holzkirchen, Germany, Sandoz is a subsidiary of Novartis.
Sen. Baucus’ pharmacy-friendly bill ‘must be enacted,’ NACDS chief urges
ALEXANDRIA, Va. The National Association of Chain Drug Stores is heaping praise on Sen. Max Baucus, D.-Mont., for his introduction today of pharmacy-friendly legislation to address Medicaid prescription payment cuts and other threats to the industry.
Baucus, who is chairman of the Senate Finance Committee, included a number of key provisions affecting pharmacy in legislation introduced on the floor of the Senate with bipartisan support. The bill, marked up as S.3101, would delay implementation of Medicaid cuts, speed up payments to pharmacies in the Medicare Part D drug benefit program and spur the rollout of electronic prescribing.
NACDS president and chief executive officer Steve Anderson is calling the Baucus bill “must-enact legislation,” and is urging its quick passage in time to head off a plan by the Bush Administration and the Centers for Medicare & Medicaid Services to cut reimbursements to pharmacies for generic drugs dispensed under Medicaid.
“Today marks an important step for the nation’s pharmacies, but we have a long road ahead,” Anderson warned. “This bill is must-enact legislation, for pharmacies’ vitality, patients’ health and the economic wellness of communities.
“The delay until September 2009 of Medicaid pharmacy reimbursement cuts will provide more time to provide a long-term solution to the pharmacy reimbursement model, which would reimburse pharmacies below cost for Medicaid prescriptions,” Anderson added. “It also removes imminent financial peril facing many pharmacies.”
NACDS’ president also commended a provision of the bill that requires prompt payments for Medicare prescriptions, which he said have been subject to “lower and slower” payments from the prescription drug plans administering the Part D program.
“We also are pleased,” Anderson noted, “that the legislation includes provisions that will encourage physician adoption of e-prescribing, a critical health information technology system that fosters secure two-way communication between pharmacies and other healthcare providers, for the enhanced medication therapy and safety of patients.”
Stephen Giroux, president of the National Community Pharmacists Association, issued a statement praising the bill, as well:
“Chairman Baucus has included two provisions in his Medicare bill that will assure access for the patients of America’s 23,000 community pharmacies. Our members and their patients are counting on these provisions to become law to assure their access to prescription drugs. The first provision ends the deliberately slow payment of Part D claims that force community pharmacies to maintain cash flow by taking out huge loans; while the second one delays the implementation of a fundamentally-flawed Medicaid reimbursement formula that forces community pharmacies to be reimbursed below actual generic prescription drug cost.”
NCPA and NACDS had filed a successful lawsuit in late 2007 that stopped the implementation of the reimbursement rule from taking effect on its original date of Jan. 30, 2008. The legal process is still ongoing.
Anderson framed the Baucus bill in stark terms. “We are facing the forced closure of pharmacies if this bill is not enacted,” he asserted. “That means health consequences, emergency room visits and catastrophic care when patients do not take their medications, and lost economic activity and jobs in communities.
“We commend Chairman Baucus for introducing this important legislation,” Anderson said. “This further demonstrates his support of pharmacy on this issue, which also was reflected in his introduction of the Fair Medicaid Drug Payment Act (S. 1951). We also thank Senators Olympia Snowe, D-Maine, Jay Rockefeller, D-W.V., and Gordon Smith, R-Ore., for their original co-sponsorship of S. 3101.
“We are committed to helping to build continued and growing support in both parties, and at both ends of Pennsylvania Avenue, for this bill. The bottom line is that it must be enacted.”
J&J, Astex ink potential $500 million deal for cancer research
LONDON Astex Therapeutics has signed a cancer drug research deal with Johnson & Johnson that can potentially be worth more than $500 million in milestone payments, according to Reuters.
Astex will receive upfront payments, cash and equity payment and research funding of $37.4 million over two years under the agreement. Total payments, excluding royalties, would be worth over $500 million to Astex, assuming one product from each program is successfully commercialized in all territories, Astex said.
The deal grants a worldwide license to J&J’s Janssen unit to develop and commercialize compounds arising from Astex’s Fibroblast Growth Factor Receptor inhibitor program and establishes a novel drug discovery program focused on two further cancer drug targets. FGFR activates a biochemical pathway that promotes cell growth and is thought to play a role in multiple myeloma, breast, prostate, colon and bladder cancers.
Astex also has deals with other big drug companies like, Novartis, AstraZeneca, Bayer and Boehringer Ingelheim.