Latebreakers: February 5, 2007

February 5, 2007

According to the FDA Web site (www.fda.gov), 18 new molecular entities (NMEs) were approved in 2006, the lowest number to be given the nod by the agency since 2002 when only 17 drugs were approved.

2006 a slow year for NMEs

According to the FDA Web site ( http://www.fda.gov/), 18 new molecular entities (NMEs) were approved in 2006, the lowest number to be given the nod by the agency since 2002 when only 17 drugs were approved. The new agents given the green light included Amitiza (lubiprostone, Sucampo), Ranexa (ranolazine, CV Therapeutics), Sutent (sunitinib, Pfizer), Eraxis (anidulafungin, Vicuron), Azilect (rasagiline, Teva), Chantix (varenicline, Pfizer), Dacogen (decitabine, MGI Pharma), Sprycel (dasatinib, Bristol-Myers Squibb), Prezista (darunavir, Tibotec), Anthelios SX (avobenzone/ecamsule/octocrylene, L'Oreal), Pylera (biskalcitrate/metronidazole/tetracycline, Axcan), Noxafil (posaconazole, Schering), Veregen (kunecatechins, Medigene), Tyzeka (telbivudine, Idenix/Novartis), Omnaris (ciclesonide, Altana), Januvia (sitagliptin, Merck), Zolinza (vorinostat, Merck), and Invega (paliperidone, Janssen).

Caremark shareholders to consider risk posed by Express Scripts' offer

GAO finds AMP reimbursement 36% below acquisition cost

GAO has concluded that pharmacy reimbursement for generics under Medicaid would be less than their acquisition costs by an average of 36% under the planned switch to average manufacturers price (AMP). GAO reached its conclusions by looking at AMP data from CMS that have not been made publicly available for a list of 77 of the most commonly prescribed and most expensive drugs. For 59 of the 77 drugs, the AMP was lower than the estimated acquisition cost. The Deficit Reduction Act of 2005 required Medicaid to begin to use 250% of AMP as the reimbursement rate for generic drugs, and in late December, CMS released the details on how it proposes to implement the provision. CMS is accepting comments through Feb. 20 at http://www.cms.gov/erulemaking/. Officials at NCPA and NACDS were quick to point out that the GAO study confirmed their dire predictions. "This is more disastrous than we thought," lamented Charlie Sewell, VP of government affairs at NCPA. "Having the documentation makes the case that this proposed reimbursement system clearly is in need of major changes."

AmerisourceBergen, Kindred name Greg Weishar CEO

AmerisourceBergen Corp. and Kindred Healthcare announced that Gregory S. Weishar has agreed to become CEO of a new company to be formed by the proposed combination of their respective institutional pharmacy businesses, PharMerica Long-term Care and Kindred Pharmacy Services. Weishar is currently CEO and president of PharmaCare Management Services, a subsidiary of CVS Corp. The new company will be named PharMerica Corp. and will be headquartered in Louisville, Ky.

Tyco Healthcare to become Covidien

Tyco Healthcare has announced that it will change its name to Covidien following its separation from parent company Tyco International. The new company is expected to complete the separation this spring and will be independent and publicly traded. Tyco Healthcare is a manufacturer and distributor of disposable medical supplies, monitoring equipment, medical instruments, and bulk analgesic pharmaceuticals, with annual sales of nearly $10 billion.

USP collaboration helps identify high-quality dietary supplements