Monday September 19, 2005

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

ALL VIOXX, ALL THE TIME

MERCK’s attorney Diane Sullivan, leading the com­pany’s defense against the latest rofecoxib (Vioxx) lawsuit (see ChroMo passim), had a rough couple of days in a New Jersey courtroom last week. Sulli­van got off on a shaky start by drawing the jury’s attention to the plaintiff, Frederick Humeston, being “surrounded” by his attorneys. That irritated the judge, who threatened a mistrial. Judge Carol Hig­bee advised Sullivan against repeating the tactic, sug­gest­ing: “Don’t do it [again.] If you do it, you will regret it.” Later, Sullivan said she might ask for a mistrial, following the judge’s ruling that Merck couldn’t refer to its voluntary recall of Vioxx, or to an April 2005 FDA memo the lawyer wanted to en­ter as evidence. “This is unfair, this is really unfair,” Sullivan said. Merck’s lawyer was later denied an­other decision by Judge Higbee, who ruled that the prominent cardiologist Dr. Benedict Lucchesi could offer testimony on behalf of the plaintiff. The trial, which is the second of approximately 5,000 cases Merck plans to fight, continues this week, and is expected to continue through the beginning of November. u Meanwhile, researchers at Duke University in North Carolina last week published research in the journal Cell Metabolism that suggested the CV side-effects of COX-2 inhibitors, such as Vioxx, could be counter­ed with low-dose ASA. Says investigator Dr. Thomas Coffman: “Low doses of aspirin… might protect against end-organ damage without affecting blood pressure in patients taking COX-2 inhibitors.”

WHO NEEDS LANCE ARMSTRONG?

ON A DULL DAY, who would blame a pharmaceutical marketer for looking out the window and fantasizing about bicycling? So, perhaps it’s only recip­rocal that a bicycle manufacturer would dream of entering the drug business. That’s precisely what the Kapur fam­ily of India, which owns the Atlas Cycles con­cern, plans to do. Salil Kapur, who runs a div­ision of the company, tells the Financial Express newspaper of New Delhi: “Our group has decided to diversify into pharmaceutical industry as we anti­cipate the sector will accelerate in the next 10 to 15 years.” He adds: “We plan to contract manufacture for big pharma companies with whom we are in talks. I am ex­plor[ing] alliances with global pharma majors as well.” The newspaper reports per-capita consumpt­ion of Rxs in India has increased by more than 250 per cent during the last two years, on a revenue bas­is. That’s enough growth to make any­one want to ped­dle a little faster.

GLAD ZOOKS

ASTRAZENECA last week tapped Tony Zook as prexy and CEO for the outfit’s stateside unit, effective in the new year. He was vee-pee of commercial oper­ations, and previously sales vee-pee for AZ. He suc­ceeds David Brennan, who in turn will step in to fill Sir Tom McKillop’s job as CEO of the London-based parent company, when McKillop retires in January. Says Brennan: “Tony possesses the leadership skills to grow AstraZeneca’s US business in the years to come. With over 20 years in the pharmaceutical industry, he is well-suited for this important post at a critical time in our industry.”

NOCs OF NOTE

HEALTH CANADA last week okayed injectable cetuximab (Erbitux, Bristol-Myers Squibb) as Tx for metastatic colorectal Ca. The Rx, developed by ImClone Systems, was approved for use in combo with irinotecan for patients with epidermal growth factor receptor-expressing, metastatic colorectal Ca who are refractory to other irinotecan-based chemo­therapy, and as single-agent Tx for patients who are intolerant to irinotecan-based chemo­ther­apy. Judy Robertson, gee-em of BMS Canada, says BMS “will work closely with health authorities to provide rapid access for Canadian patients to this innovative cancer therapy.”

M&A ACTION

ZENTIVA, the Czech drugmaker, last week bought a con­trolling stake in the largest Romanian generics outfit, Sicomed, for around Cdn$122 million. Zent­iva plans buy remaining minority shares in Sicomed. Zentiva boss Jiri Michal says the takeover “will en­able us to capitalize on our modern branded generic portfolio and deep product pipeline to build rapidly a clear leadership position in the primary care market.” u Elsewhere, E. Merck, the German drug­maker, said its Spanish generics subsidiary last week purchased Prasfarma, a uro-oncology specialty house based in Barcelona. Price of the transaction was Cdn$29 million. Says Alberto Bueno, who runs Merck’s Spanish generics business: “Prasfarma, with its respected name, an established product port­folio and well-trained staff, will provide immediate resources to fund the launch of Merck products in Spain.”

DERMAL DOINGS

NEXMED, the New Jersey developer of transdermal Txs last week out-licensed its proprietary nail lac­quer Tx for onychomycosis to Novartis. The com­pound, NM100060, is in Phase I development. The Rx incorporates terbinafine (Lamisil, Novartis.) Says NexMed helmer Dr. Joseph Mo: “Novartis is a lead­er in the treatment of onychomycosis and we are de­light­ed by the opportunity.” u In other derm­ato­l­og­ic de­v­el­opments, Helix Biomedix, the Wash­ing­ton state-based developer of delivery system oligo­peptide-10, last week out-licensed its product to Levlad, maker of a so-called natural acne Tx. Says Helix prexy H. Stephen Beatty: “We are excited that Lev­lad has chosen to incorporate our proprietary pep­tide technology as a key feature of their new anti-acne product.” Agrees Levlad kingpin Paddy Spence: “Oligopeptide-10, combined with salicylic acid, is clearly the new ‘superpower’ in acne con­trol.”

(c) 2005 Chronicle Information Resources Ltd. Not for redistribution.
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