Monday April 21, 2008

ChronicleMONDAY

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

TAKING IT TO THE STREETS

ATTENTION, PHARMA MARKETING TEAMS. Why are you sitting around on your duffs drinking lattés this morning, when you could be outdoors doing something useful to promote your product: say, stapling posters to hydro-poles? No joke. That’s what it’s come to at Johnson & Johnson’s stateside McNeil consumer division, where they’re busy engaging in so-called guerrilla marketing tactics to peddle antihistamine cetirizine (Zyrtec.) Unusual Zyrtec ads currently appearing in US consumer magazines are designed to look like the lost-cat posters desperate pet-owners affix to Laundromat bulletin boards, and the ad copy is equally out-of-the-box: “MISSING 2 HOURS. Last seen while waiting for Claritin to start working. If found please call 1-800-4-ZYRTEC.” Pushing the envelope even further, McNeil’s agents last week began placing similar posters on lampposts and construction site hoardings around major US metropolitan areas. (Dial the phone number and you get a cheery recorded message dissing loratadine [Claritin, Schering-Plough] and promising more shenanigans on the Zyrtec web site.) This type of semi-delightful stunt seems like a homage to Paul Lavoie, the Montreal ad mastermind who once glued pennies to the floor of a Toronto discount bookstore in an effort to demonstrate something or other to a slack-jawed public. However, not every-one is thrilled by the Zyrtec hi-jinx. Opines John Mack, a close observer of drugbiz promotion: “Wasted guerrilla marketing. Who has time to walk around noticing flyers posted to telephone poles!” Yes, who? Hey, look, here’s an offer to clean all our household ducts for only $75.

HERE’S YOUR REFERENCE: NO REFERENCE

A STUDY JUST PUBLISHED in The Journal of Nervous and Mental Disease poses serious questions about the veracity of ads for psychotropic Txs placed in leading US medical journals, including JAMA and NEJM. Researchers analyzing 69 ads found no reference for half the claims made, while in some cases the citations provided were inaccurate or contracted the claim. Moreover, according to lead author Glen Spielmans: “Attempts to obtain cited data on file from sponsoring drug companies were rarely successful.” Only three of nine drugmakers he contacted bothered to respond, during his attempt to receive substantiation for the ad claims. Says he: “It’s possible that the claims are true, but because data wasn’t reported and isn’t easily obtained or verified, we don’t really know.” In a commentary accompanying the article, an editor writes: “The FDA needs to step up to the plate but the journals themselves should develop standards and criteria for some of the advertising and reject ads that are clearly misleading. The doctor-patient relationship should not be a market-driven phenomenon.” 􀁘 Elsewhere, JAMA took another hit from critics last week following the revelation that several articles published in the peer-reviewed journal were written by employees of Merck or suppliers contracted by the company, with author’s credits given to academic physicians. Merck was also accused of misrepresented study results in an article examining the efficacy of rofecoxib (Vioxx) in Alzheimer’s patients. The company denies the latter charge, which R&D prexy Peter Kim calls “just plain wrong.” JAMA editors Catherine DeAngelis and Phil Fontanarosa say “public trust in research is jeopardized” as a result of interventions by commercial interests in the publishing of scientific knowledge.

PAYING FOR SIGNPAINTERS’ PORSCHES

MILLENNIUM PHARMACEUTICALS, the 15-year-old oncology and GI outfit, will be acquired by Japan’s Takeda Pharmaceutical for $8.8 billion. Some observers think Takeda overpaid for Massachusetts-based Mil, which brought in revenues of $500 million last year. However, the Japanese company last month ended its stateside joint venture with Abbott (see ChroMo passim) and gave up US rights to leuprolide (Lupron,) suggesting a need to fill its Ca portfolio. Analysts say the weak Yankee dollar makes US-based drugmakers attractive takeover tar-gets for overseas firms. 􀁘 Hoffmann-La Roche last week paid $160 million for Piramed, a five-year-old privately-owned UK outfit noodling out Ca and anti-inflammatory Txs. Said Pira CEO Michael Moore: “With Roche’s undisputed excellence in oncology and inflammatory disease, Piramed has found a secure long term home for some world class science.” Wait a minute. Was that guy’s name actually Michael Moore? 􀁘 While Novartis plans to acquire ophthalmic drugmaker Alcon from chocolatier Nestlé (see ChroMo passim,) another Nestlé-controlled pharma unit last week made an acquisition of its own. Galderma Laboratories, the skincare outfit, bought publicly traded CollaGenex Pharmaceuticals of Pennsylvannia for around $420 million. Colla is developing Tx candidates for erythema and psoriasis. Says Gal kingpin Humberto Antunes: “The two companies’ development pipelines have innovative compounds that have the potential to improve therapy and meet unmet needs.”

LONELY HEARTS CLUB

ASTRAZENECA R&D boss John Patterson says AZ’s current joint development deal with Bristol-Myers Squibb for diabetes Txs is going so well that he’s willing to explore partnerships with other drugmakers. He explains to CBS Marketwatch that it’s only smart business to divide risky development projects.

IT WAS A GOOD WEEK FOR…

MARIJUANA GROWERS. Health Canada says it will seek competitive bids from commercial suppliers of cannabis, as the agency plans revisions to its regulations on the use of medical marijuana. Ottawa currently exclusively contracts Flin Flon, Man.-bas-ed Prairie Plant Systems to provide the substance.

IT WAS A BAD WEEK FOR…

HEALTH CANADA, which is struggling to collect $554,255 in unpaid bills from 462 users of (wait for it) medical marijuana. Two out of three of the nation’s 739 licensed users of medicinal cannabis simply ignore their invoices from the regulator, according to Canadian Press. The Tx arrives at patients’ homes in a 30-gram package at a cost of $150, which some consumers complain is a 1,500 per cent mark-up over what the agency pays its supplier, Prairie Plant Systems. Ottawa’s usual price-gouging aside, how totally unexpected is it for a pothead to also be a deadbeat? To quote George Carlin, “Why do you think they call it dope?”

QUOTE OF THE WEEK

“HORMONES MAY ALSO BE IMPORTANT for determining how well an individual trader performs in the highly stressful and competitive world of the market. We are now exploring this in much more detail.” —Professor Joe Herbert of Cambridge University, commenting on a study relating high morning testosterone levels of London stock-market traders to higher average profits for the trading day.

(c) 2008 Chronicle Information Resources Ltd. Not for redistribution.
ChronicleMONDAY is published by Chronicle Information Resources Ltd, 555 Burnhamthorpe Road Ste. 602, Toronto, Ont. M9C 2Y3. Tel 416.916.CHROn (2476); Toll-free 866.63.CHRON (24766); Fax 416.352-6199; E-mail: health@chronicle.org

Wednesday April 16, 2008

Monday April 14, 2008

Wednesday April 9, 2008

Monday April 7, 2008

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 =>

(c) 2008 Chronicle Information Resources Ltd. Not for redistribution.
ChronicleMIDWEEK is published by Chronicle Information Resources Ltd, 555 Burnhamthorpe Road Ste. 602, Toronto, Ont. M9C 2Y3. Tel 416.916.CHROn (2476); Toll-free 866.63.CHRON (24766); Fax 416.352-6199; E-mail: health@chronicle.org

Monday March 31, 2008

ChronicleMONDAY

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

FINGER-POINTING TIME

REGULATORS last week began probing possible side-effects of two widely-prescribed Txs. Health Canada and the FDA said they were investigating reports associating blockbuster allergy Tx montelukast (Singulair, Merck Frosst) with psychiatric incidents, including suicide. Said Merck R&D boss George Philip: “We have no indication that anything about the mechanism of Singulair is consistent with these events.” The Rx rang up $4.3 billion in stateside sales last year. Elsewhere, US regulators said patients using topical wound-care Tx becaplermin (Regranex, Ethicon) may have a higher incidence of cancer. A spokesman for the company’s parent, Johnson & Johnson, tells Reuters news agency the product is safe.

THOSE BLOVIATING BIOVAILERS

APRIL 14th, which sadly happens to be the date the Titanic sank, will also mark the day Biovail founder Eugene Melnyk heads to an Ontario court to tell the judge bad things about the CEO he hired, Doug Squires. Mr. Melnyk contends that Mr. Squires contravened Canadian laws a couple of weeks back, when he groused to the media about Mr. M.’s plan to replace Biovail’s board (see ChroMo passim.) The dust-up between the two may determine the company’s future as an independent entity, according to observers. Biovail and its principals are far from strangers to the court-room, having logged $104.4 million in legal costs last quarter. Only last week, the company settled US SEC claims of accounting fraud at a further cost of $10 million (see Chronicle Midweek 03-26.) Mr. Melnyk and three other Biovail officers are also alleged by the SEC and its Ontario counterpart of individually participating in the fraud. He denies all wrongdoing and plans to fight the charges.

INCREDIBLE SHRINKING DRUGBIZ

WYETH last week revealed the meaning of the company’s mysterious new “Project Impact” to 1,200 of the company’s stateside reps, explaining, “Don’t let the door Impact you on the way out.” The pink-slips came as the first wave of company-wide job cuts, with another 800 to 1,800 global positions expected to be eliminated this year. Project Impact was announced in January as a corporate restructuring.

GIVING IT UP FOR THE ABACUS-FLICKER

WHO ARE BIG PHARMA’S new rock stars? Not the CEOs. Those guys have been keeping a low profile lately, understandably. Not the lab bosses: That bunch of sad-sacks hasn’t come up with anything good in years. Not the sales and marketing chiefs. Bunch of lazy, pampered so-and-sos. No, according to a new report from the Ernst & Young consultancy, the power in the drugbiz executive suites is shifting to the new golden boys and girls, namely, the CFOs. According to the study, drugmakers are increasingly relying on their head bean-counter to “take a greater hand in serving as business partner to the CEO and board of directors in shaping their company’s strategic plans.” (Translation: When cost-cutting becomes your company’s preoccupation, why not make the kid with the sharpest switch-blade your new best friend?) Says the report: “In an era when pipelines are erratic, patents are expiring, pricing is under pressure, and payers are pushing back, the role of the CFO and finance function will become pivotal in achieving improved returns and enhanced reputation.” 􀁘 Right on cue, Barr Pharmaceuticals last week announced an expanded role for Bill McKee, the outfit’s CFO. In other corner-office developments, Barr tapped G. Frederick Wilkinson as CEO of its Duramed unit.

COMPELLING BUSINESS CASES

DATA RELEASED LAST WEEK showed slightly less than half the Rxs filled in Canada last year were generics, compared to around two-thirds of those dispensed in the US. Fitting the textbook description of the man living in a glass house who enjoys throwing stones, Jim Keon, prexy of the Canadian Generic Pharmaceutical Association, took the opportunity to proclaim: “Increasing the use of lower-cost generic medicines is a far better way to save money on prescription drugs than cutting benefits or asking patients, particularly seniors and those on fixed in-comes, to pay more for the medicines they need.” Does that mean Mr. Keon’s group might be prepared to reduce Canadian pricing on their generic Rxs down to, say, parity with US costs, as a patriotic gesture? No, we didn’t think so.

COMPELLING BUSINESS CASES

THE GERMANS ARE BUYING, but the question is, who’s selling? Last week both Merck KGaA and Stada Arzneimittel AG confirmed they’re in the hunt for drugbiz acquisitions. Karl-Ludwig Kley, kingpin of German Merck, tells a reporter he isn’t eyeing as large a target as Serono, which he bought two years ago. Says he: “We are not looking for acquisitions in Serono’s order of magnitude, but smaller takeovers. We will measure them with… good judgment.” Mr. Kley says Japan is a market of potential interest. Meanwhile, Stada, a fast-growing generics-maker, said last week it plans to continue its string of acquisitions, and is considering several targets. 􀁘 A commentary from Standard & Poor’s distributed last week says Bristol-Myers Squibb “could offer significant value in a merger with the right partner.” Zacks Investment Research added: “The company is an attractive takeover candidate for a larger pharma such as Pfizer or France’s Sanofi-Aventis, both of which have been partners with Bristol on some of its products.”

IT WAS A GOOD WEEK FOR…

THE US FDA, which identified not one, but two nutriceuticals that it says the public shouldn’t be taking. That would be your “Total Body Mega Formula,” distributed by a Georgia company. According to the G-men, 23 reports have been registered associating the product with “significant hair loss.” Then you’ve got your “Blue Steel” and “Hero” dietary supplements, advertised on the Internet as all-natural Txs for erectile dysfunction. The feds say the products contain undisclosed quantities of sildenafil (Viagra, Pfizer.)

IT WAS A BAD WEEK FOR…

PFIZER’s vice-president and global head of patents, Alan Hesketh. He was arrested last week in New York and charged with distributing child pornography over the Internet. Authorities claim he may have used various computers during the alleged acts, which could result in fines of $500,000 and up to 20 years in the stony lonesome. A company spokesman said: “Pfizer will cooperate with authorities in any investigation.” The company has faced a number of issues in its IT department recently, including the hi-jacking of corporate IP addresses for the distribution of spam e-mails.

QUOTE OF THE WEEK

“ALL I’M GETTING is ‘We can’t do it, we can’t do it, it’s too expensive.’ And I ask, ‘What value do you folks put on a life?’”—D. Timothy Dazé of the California State Board of Pharmacy, which last week agreed to postpone until 2011 a new requirement that all Rxs in the state be tracked electronically

(c) 2008 Chronicle Information Resources Ltd. Not for redistribution.
ChronicleMONDAY is published by Chronicle Information Resources Ltd, 555 Burnhamthorpe Road Ste. 602, Toronto, Ont. M9C 2Y3. Tel 416.916.CHROn (2476); Toll-free 866.63.CHRON (24766); Fax 416.352-6199; E-mail: health@chronicle.org

Wednesday March 26, 2008

Monday March 24, 2008

Wednesday March 19, 2008