Wednesday April 2, 2008

ChronicleMIDWEEK

From the publishers of THE CHRONICLE OF CANCER THERAPY, THE CHRONICLE OF CARDIOVASCULAR & INTERNAL MEDICINE, THE CHRONICLE OF NEUROLOGY & PSYCHIATY, THE CHRONICLE OF SKIN & ALLERGY, THE CHRONICLE OF UROLOGY & SEXUAL MEDICINE, PHYSICIANS’ CHRONICLE, THE CHRONICLE OF HEALTHCARE MARKETING, LINACRE’S BOOKS, and chronicl*e group

PRESIDENT GOES VAMOOSE FROM VALEANT, STAFF DOWNSIZING LIKELY TO FOLLOW

VALEANT PHARMACEUTICALS, the struggling California-based maker of anti-infectives, CNS and skin Txs, announced yesterday its prexy, Charles Bramlage, has ankled. CEO J. Michael Pearson said Bramlage will hang around long enough “to assist the company with transition matters over the coming weeks.” That means staff cuts, product divstures, and the likely exit of Valeant from several countries. The company was formerly known as ICN Pharma.  More info =>

INVESTORS FLEE AS ENHANCE RESULTS DEFLATE MERCK, SCHERING-PLOUGH

BAD NEWS COMES AT A PRICE: 14 billion for Merck, and $8 billion for Schering-Plough. That’s how much market capital was erased from the companies after Sunday’s recommendation by an expert panel at the American College of Cardiology meetings that physicians cut back on prescribing ezetimibe/simvastatin combo (Vytorin) and ezetimibe (Zetia, Ezetrol.) Merck and Scher have a joint venture to sell the Rxs, the future of which seems questionable in the wake of disappointing data from the ENHANCE trial. One more consequence for Scher is the revival of rumors that the outfit is an acquisition target. With the company’s value to Wall Street now knocked down to a bargain-basement $23.6 billion, analysts say Scher’s exposed to a takeover. (See next item.) More info =>

MERCK, SCHER SUSPECTED BY LEGISLATOR OF KEEPING MUM ON TRIAL DATA

MERCK AND SCHERING-PLOUGH will face close scrutiny during the coming months as a result of their aggressive promotion of Vytorin and Zetia, according to reports. Worldwide sales of the two Rxs topped $5 billion last year, driven by extensive DTC advertising. Now the US Congress is considering the thorny issue of whether the companies may have kept up the marketing ballyhoo in spite of negative unreleased trial data. Sen. Chuck Grassley, a critic of the drugbiz, last week said any delay in revealing data from the two-year-old ENHANCE trial cost payers “hundreds of millions of dollars.” The companies deny withholding data. Meanwhile, a new study by the the Institute for Clinical Evaluative Sciences suggests Canadians probably would have been prescribed an additional $150 million worth of Vytorin and Zetia if this country allowed DTC advertising. The Rxs have 3.4 per cent of the anti-lipemic market here, compared with 15.2 per cent in the US, where the product’s DTC ad budget was $200 million annually. More info => Editorial from the New York Times

WITH ITS BLOCKBUSTER IMPREILED, MERCK COUNTS ON SWIFT APPROVALS FOR CORDAPTIVE

WITH SCRIPS FROM VYOTRIN getting all vy-torn up, Merck may need a smooth approval process for its anti-lipemic candidate niacin/laropiprant (Cordaptive.) The product will compete with Abbott’s extended-release niacin (Niaspan, SimCor), but data presented at the American College of Cardiology meetings suggests Cordaptive offers a better profile for reducing skin-flushing. There was a downside to the Cordaptive data: elevated glucose levels in diabetics, and increased liver enzymees. More info=>

STATESIDE REGULATORS RAP KING FOR ‘UNSUBTANTIATED’ AVINZA MARKETING

KING PHARMACEUTICALS this week received a bad-boy letter from the US FDA, which doesn’t care for the recent promotion for King’s analgesic morphine (Avinza.) According to the G-men, “The combination of such broad and unsubstantiated efficacy claims about the benefits of Avinza and the omission of the serious, potentially fatal risks associated with its use, as well as its potential for abuse, is especially egregious and alarming in its potential impact on the public health.” King bought the controlled-substance Tx last year from Ligand Pharmaceuticals. More info =>

Bentley Pharmaceuticals, big in Spain, bought by Israel’s Teva for $360 million

BENTLEY PHARMACEUTICALS, BIG IN SPAIN, BOUGHT BY ISRAEL’S TEVA FOR $360 MILLION

TEVA, parent of Toronto-based Novopharm, Monday (03/31) paid US$360 million for publicly traded Bentley Pharmaceuticals, which markets generics in the EU. Bentley, which is divesting its Rx delivery system separately, has a strong presence in Spain, described by Teva kingpin Shlomo Yanai as a “fast-growing… generic pharmaceutical market.”  More info=>

DEL PHARMACEUTICALS SOLD TO OTC GIANT CHURCH & DWIGHT FOR $380 MILLION

CHURCH & DWIGHT, the consumer products outfit, this week paid $380 million for the brands of Del Pharmaceuticals, which include oral analgesic Orajel. Del, which rang up $100 million in total revenues last year, was acquired by Coty, the beauty products marketer, late in 2007. More info =>

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