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
NOTES FROM TUNNEY’S PASTURE
HEALTH CANADA issued its strangest advisory of all time last week, urging consumers not to eat something called Royal Medic No. 1 Chinese Caterpillar Fungus. It seems that three shipments of the product, which apparently is available through the Internet, may contain microbes—but let’s pause for just a moment. Does anyone really think it might ever be necessary to actually have to explain to people that it’s not a good idea to ingest Royal Medic No. 1 Chinese Caterpillar Fungus?
WHERE IT ALL STARTED TO GO BAD
BIG PHARMA CONTINUES TO PAY DEARLY for its doomed strategy of exclusively pursuing blockbusters. Most of the mega-products conceived during this current generation—the statins, PPIs, and SSRIs—are due to expire within just five years. Meanwhile, not much is emerging from the lab: this, in spite of absurdly large R&D budgets. A Merrill Lynch analysis shows three per cent fewer compounds have been devised annually for the past decade, while during the same period, R&D budgets were increasing by seven per cent each year. The decreasing number of Tx candidates that make it out of the lab are finding the regulatory climate more challenging. A PriceWaterhouseCoopers expert tells Reuters newswire that the agencies’ philosophy has shifted to one of “risk aversion [from] risk management.” Those threatening circumstances provide the backdrop for most of the developments during what may have been the most discouraging week ever in the drugbiz.
CARRYING THE WEIGHT OF THE WORLD
IT WAS NOTHING BUT BAD NEWS for Sanofi-Aventis, where new studies appeared to further dim the prospects for anti-obesity Rx rimonabant (Acomplia, Zumulti), which the FDA declined to approve in June. Trials by University of Copenhagen researchers published in the Lancet showed patients taking Acomplia had a 40 per cent greater risk of adverse events, notably anxiety and depression. A separate University of Alberta study published in last week’s British Medical Journal demonstrated rimonabant was only slightly more effective than sibutramine (Meridia, Abbott) and orlistat (Xenical, Hoffmann-La Roche,) and noted that all three Txs are associated with serious side-effects. Says lead author Dr. Raj Padwal: “These are definitely not magic pills.” Huh, replied the litigation team at the Coughlin Stoia Geller Rudman & Robbins law firm, we tink youse did claim dey was magic pills! The lawyers said last week they’ll represent investors in a class-action suit against Sanofi, charging the drugmaker “concealed data concerning Zumulti’s propensity to cause depression.” That may have been too much for L’Oreal, the cosmetics outfit that owned 10.5 per cent of Sanofi equity. L’Oreal last week unloaded $2.2 billion worth of Sanofi shares, prompting speculation that other investors, including petroleum giant Total, will soon follow. San is still rumoured to be in merger discussions with Bristol-Myers Squibb.
I’VE GOT IT! LET’S GO BUY SOMEBODY!
PFIZER, famous for recently paying Sanofi $1.4 billion for half of a worthless insulin formulation, last week made a more cautious wager, shelling out $164 million for publicly traded Coley Pharmaceutical of Massachusetts. Coley is noodling out vaccine adjuvant technology and immunomodulatory Rx candidates as potential Txs for Ca, anti-allergy, asthma, autoimmune disorders and Alzheimer’s. Pfizer kingpin Jeffrey Kindler indicates he now plans to duke it out with Merck in a quest to dominate the emerging vaccines market. He says the deal “reflects our commitment to research new and more effective vaccines to prevent infectious diseases and to treat cancers and other debilitating conditions.”
BEATEN-UP IN BRUSSELS
BELGIAN DRUGMAKER UCB last week lost one-sixth of its stock-market capitalization after the European Medicines Agency unexpectedly turned thumbs down on Crohn’s disease Tx certolizumab (Cimzia.) The agency said it had problems with the data submitted, a similar conclusion to that offered by stateside regulators in March. UCB’s Antje Witte tells PharmaTimes World News, “There is nothing wrong with the product,“ adding that the company plans to appeal the verdict. Patents for the company’s current blockbusters, cetirizine (Zyrtec) and levetiracetam (Keppra) will both expire by 2009.
STAY AWAY, JOE
JOHNSON & JOHNSON, parent to Janssen Ortho and Ortho Biotech, last week said its global head of pharma, Joseph Scodari, will retire early next year. J&J will use the occasion to shake up its operation, splitting off a Comprehensive Care unit that will, in the words of a press release, “address some of the world’s most chronic and pervasive conditions, such as metabolic disorders, through the convergence of technologies, products and services.” Current vice-chair Christine Poon will get Scodari’s corner office. According to board chair William Weldon, “This allows Chris to focus on the pharma business.” He adds: “The whole health-care arena is being reshaped. Ten years from now it will look very different.”
LOOK AT ME, I’M MULTI-TASKING
BIOVAIL boss Doug Squires, who helms the biggest publicly traded Canadian integrated drugmaker, last week noted that the drugbiz is in “a state of significant uncertainty.” Announcing his Q3 results, Squires said the 10 candidates in his lab will compensate for lost sales of Wellbutrin XL, which are in accelerated freefall. He plans to continue paying shareholders a dividend currently worth around nine per cent annually, keep funding “high-priority pipeline programs,” and will wait for the outcome of the US Securities and Exchange Commission investigation of alleged stock-trading violations.
FACING RELEGATION?
EVEN AMONG THE GROUP OF SAD-SACKS that Big Pharma has seemingly become, there has to be one Ralphie Wiggum. Analysts at Dresdner Kleinwort, the German investment bank, last week fingered one company as the “worst performer [of the major names] in [the] entire sector” between now and 2015, and that lucky outfit is AstraZeneca. Desdner says AZ, which has eight patents expiring during the coming eight years, has a 50 per cent likelihood of negative sales growth at the end of the cycle, describing the situation as “serious trouble.” A spokesman for AZ is unperturbed by the report, offering: “They are entitled to their opinion and we will have to wait and see.” AZ supremo David Brennan, meanwhile, sees a silver lining in last week’s FDA approval of rosuvastatin (Crestor) for the new indication of atherosclerosis. He tells Reuters reporter Ben Hirschler: “I believe that this will have a positive impact on Crestor and get us back on a growth trajectory.” He adds: “The market is going through a transformation. There is clearly a bifurcation to the generic segment, which is growing substantially.”
UNNECESSARY PILING ON
ONE WEEK AFTER HEALTH CANADA withdrew approval of rosiglitazone (Avandia, GlaxoSmithKline) as monotherapy for Type 2 diabetes in most patients, regulators in other jurisdictions required the Rx to carry black box labelling. Australia’s Therapeutic Goods Administration said Avandia is “associated with an increased risk of myocardial ischemia,” while the US FDA wording was less conclusive. The Rx was GSK’s number two seller last year, with revenues of $3 billion. Stateside sales fell 48 per cent in Q3, following publicity from a New England Journal of Medicine article. Takeda Pharmaceutical seized the moment last week, announcing it would immediately begin a stateside DTC campaign for its pioglitazone (Actos), proclaiming: “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke.”
(c) 2007 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
