Merck said Wednesday that its big outcomes study of cholesterol drugs Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) will be extended. The IMPROVE-IT trial has met 75% of clinical endpoints, but has yet to yield results, and the Data Safety Monitoring Board recommended that the study continue without change, saying it plans to review data again in about nine months. It's known that Vytorin lowers cholesterol more than simvastatin alone. The study, which has 18,141 participants, is meant to assess whether the cholesterol-lowering cocktail in Vytorin does a better job preventing heart attacks and strokes than the statin alone. The two drugs that make up Vytrorin work in different ways: ezetimibe absorbs cholesterol in the intestine, while the statin inhibits uptake by the liver. Merck said the projected 2013 end date for the study may change and that it will update the timeline if appropriate. If Vytorin beats Zetia, the study could finish early. More data from the trial could become available this week.
IMPROVE-IT is yet one more chapter in Merck's cholesterol business. The FDA rejected the pharma co's drug MK-0653C earlier this month, saying it wants more data. The drug is a mixture of Zetia and atorvastatin, the active ingredient in the financial powerhouse that once was Lipitor. Just four years ago, the agency shot down Merck's MK-0524A, which combined niacin and a flushing inhibitor called laropiprant. The compound was intended to lower “bad” cholesterol, or LDL levels, while boosting “good” cholesterol, or HDL levels and also lowering triglycerides. The FDA wanted more info, and Merck said in its 2011 annual report that HPS2-THRIVE, a study designed to look at CV outcomes in relation to HDL increases, is expected to close this year. Even with Vytorin and Zetia sales flagging since 2008, the drugs still managed $1.9 billion and $2.4 billion in sales, respectively, in 2011. The company's worldwide sales hit $48 billion last year, a 4% jump.
The first new anemia drug on the market in 10 years also has a brand new patient category: patients suffering from chronic kidney disease (CKD), as opposed to the patients with chemotherapy-induced anemia who were the focus of older anemia drugs. The FDA approved Affymax's Omontys, a monthly injection. Dosing is another point of departure in the anemia therapy category, as current drugs require weekly, if not more frequent, dosing. The new drug also takes on Amgen, which controls the anemia treatment market with its drugs Aranesp and Epogen. Omontys works by stimulating bone marrow to produce more blood cells. Affymax expects a second-quarter launch and is still working on final post-marketing requirements with the FDA, according to a research note by ISI analyst Mark Schoenebaum. The analyst notes that dialysis centers pay a wholesale cost of $904 a month for Epogen, and Omontys may run $864 for the same period.
Generic drugmakers Teva and Mylan Pharmaceuticals have started selling copycat versions of AstraZeneca's antipsychotic Seroquel. The launches come days after a US district court dismissed a suit by AZ to block the lower-cost versions of the drug, which was among the company's top-selling medicines last year. AstraZeneca had sought to extend patent protection on the active ingredient quetiapine and on the extended-release version, Seroquel XR, until December, on the basis of differences in labeling between the branded and generic. Citizens petitions filed with the FDA had also been rejected. The US decisions were part of an international trend: the UK High Court also deemed the patent for Seroquel XR to be invalid. The High Court decision is limited to the UK, AZ stressed in a statement, adding that it's engaged in numerous other proceedings regarding Seroquel XR-related patents and regulatory exclusivity. Total franchise sales were $5.8 billion last year, up 8% from the year before.