Monday December 24, 2007

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

IT’S A WONDERFUL LIFE (PHARMA EDITION)

FROM READING THESE NEWSLETTERS you may have arrived at the impression that all the pharma industry news in 2007 was bad. And nearly all of it was—except for a few hopeful items, which have just popped up at year-end. Here’s one happy development: European governments have agreed to stop hating the drugbiz. The Innovative Medicines Initiative, just signed, is a $3-billion collaboration between drugmakers and the European Commission, aimed at fostering co-operation between regulators, universities and the private sector. The shared hope is to avoid ceding Rx development to India, the Far East and the US. Says Arthur Higgins, prexy of the European Federation of Pharmaceutical Industries and Associations: “This is a real attempt to remove the bottlenecks. We need to step back and find a new paradigm.” The effort will focus on noodling out CNS, Ca, inflammatory, metabolic and infectious disease Txs. u Cutbacks? What cutbacks? Hoff­mann-La Roche said last week it will give all its 9,000 Swiss employees a 2.25 per cent raise, come next April. The flourishing company also plans to extend bonuses to all in­div­idually-contracted work­ers at its Basel HQ. u South African drug manu­facturers have taken the lead in reforming marketing practices, according to sources in that country. A new code of conduct was submit­ted by an industry council to health minister Manto Tshaba­l­a­la-Msim­ang. Says a spokesman for Innovat­ive Medi­cines SA, a group of six multi­national drug­makers: “Pati­ent treatment choices must be made for the right reason and not because there is a bribe or per­versity, a motorcar or a trip to France.” u It’s a Yuletide mitzvah at McGill University, where the Depart­ment of Animal Science has successfully pro­duced three litters of cloned pigs. The university, fittingly located across the street from the now-closed Ben’s Delicatessen, says the blessed event is a Canadian first that “will eventually contribute to advancing biomedical research into human ailments such as diabetes and cardiovascular disease.” And, if not, those researchers are still going to want break­fast, just like everyone else. u Meanwhile, 175 em­ploy­ees at Pfizer’s Arnprior, Ont. manufact­uring faci­­­lity will be spared the un-merriment of an un­certain ‘08. They’ll get to keep their jobs, fol­low­ing the purchase of the plant by Keata Phar­ma, a unit of publicly traded Pharmeng of Tor­onto, which plans to maintain the business as a CMO. u We now return to our regularly scheduled bad news, al­ready in progress.

HUGGING THE TREE A LITTLE TIGHTER

FORBES MEDI-TECH, the struggling Vancouver mak­­er of CV Txs and nutritional supplements, said last week it plans to reorganize in the new year as a subsidiary of a new entity. Kingpin Charles Butt said the outfit will likely offer a four-for-one reverse stock split, in order to preserve a public listing on the Nasdaq exchange. Says he: “We are focused on building long-term shareholder value with the add­ition­al activity in our nutritional business and ad­vanc­ing our pharmaceutical development pro­gram.” Forbes was originally spun out of a BC-bas­ed forestry products concern.

CORNER-OFFICE ROTISSERIE

ELI LILLY helmer Sidney Taurel last week announced he’ll retire at the end of Q1 next year. Lil tapped COO John Lechleiter as his replacement. Says Lech­leiter, a 29-year man with the company: “My ex­per­ience equips me to meet the company’s biggest challenge, which is to bring new molecules for­ward.” Three of Lil’s blockbusters, CNS Txs Zy­prexa and Cymbalta and Ca Tx Gemzar face patent ex­piry within the next four years. Lechleiter, a chemist, is a champion of personalized medicine as the company’s future. Says he: “There’s no question we will face the biggest challenge of our history at the beginning of the next decade.” However, he adds that so-called tailored therapeutics will provide direction: “We want to make sure the right patients get the right dose of the right medicine at the right time.” u Lechleiter’s appointment continued a change of the guard in Big Pharma, as directors seek fresh management faces in an effort to appease investors. Shire Pharmaceuticals also announced a new supremo last week, promoting CFO Angus Russell to the corner-office. Russell will replace Matt Emmens, who will take over as board chair from the retiring James Cavanaugh. The changes will take place next June.

PRODUCT TRANSACTION

VALEANT PHARMACEUTICALS last week peddled Canadian and stateside rights to hepatitis C Tx inter­feron (Infergen) to Three Rivers Pharmaceuti­cals, a pri­vately held Pennsylvania drugmaker. Price-tag: up to $91 million, which includes some inventory. Says Three Rivers boss Donald Kerrish: “This ac­quisition further promotes Three Rivers’ contin­uous strat­egy to expand its product offerings through product acquisition and internal product develop­ment in highly specialized therapeutic disease cat­eg­ories like hepatitis C.” Prod­uct reven­ues have de­clin­ed following a patent loss in the EU.

DAY IN COURT

A RECENTLY UNSEALED stateside lawsuit charges Pfizer with encouraging an improper CME effort in­volving atorvastatin (Lipitor.) Former Pfizer exec­utive Jesse Polansky launched an ostensible “whistle­­blower” suit in 2004, alleging the company hired third-party educational organizations to pro­mote off-label use of the Rx, which he claims “led thousands of physicians to prescribe Lipitor for millions of patients who did not need medication.” Mr. Polan­sky was director of outcomes management strategies between 2001 and 2003, and says he was fired after objecting to certain of the company’s marketing pract­ices. In a statement, the company deni­ed wrong­doing, saying: “Pfizer does not con­done the off-label promotion of our products. We be­lieve that our sales and marketing practices are solely based on our prescription information as approved by the US Food and Drug Administrat­ion.” In a peculiarity of the US legal system, Pfizer only learned of the litigation last week, although the action was initiated by Mr. Polansky nearly four years ago. During the lag, US federal prosecutors considered the merits of the case and determined if they wished to intervene. The feds took a pass, lead­ing some observers to guess that Mr. Polansky’s evidence may not be per­suasive.

END OF THE ROAD

BAYER last week said it will stop selling implantable pros­tate Ca Tx leuprolide (Viadur) due to dim­in­ished market demand and rising manufacturing costs. The company emphasized the decision to dis­continue marketing of Viadur isn’t the result of safety or efficacy issues, but is due to a poor long-term sales forecast. Viadur is intended to block test­osterone for 12 months.

THAT’S WHAT FRIENDS ARE FOR

GLAXOSMITHKLINE last week inked a pact with Danish Rx developer Santaris Pharma to noodle out pat­ented RNA antagonist compounds as potential new antiviral Txs. The deal could eventually be worth more than $700 million to Santaris, prompting the outfit’s head scientist Henrik Ørum to say, “We are confident that the high potency and exquisite precision of RNA targeting […] has the potential to achieve clinical breakthroughs in viral infections.” u The downside of co-marketing arrangements is that if your partner does something silly, you’re likely to share the consequences. And so, Biogen Idec, which suffered badly on the stock market after placing it­self for sale and not finding any takers, also had an effect on Elan, the Irish drugmaker. The companies share MS Tx Tysabri, and investors figured Elan might gain a full stake in the product after Biogen was acquired. Biogen’s recent change of plans seems to have had a rip­ple effect, sending Elan’s stock price crashing down by 10 per cent last week.

OUR BEST TO YOU AND YOURS

HAVE A HAPPY, HEALTHY holiday break, and a peaceful, prosperous ’08. We’ll see you again on January 8, 2008.

(c) 2007 Chronicle Information Resources Ltd. Not for redistribution.
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