Monday September 26, 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

CORNER-OFFICE ROULETTE

LAST WEEK must have been a good time for drugmakers to rearrange their organizational charts. Bristol-Myers Squibb consolidated its global pharma operations under Lamberto Andreotti, who was promoted to worldwide drug prexy. He previously ran the company’s wound care unit, ConvaTec, Mead Johnson nutritionals, and the overseas BMS pharma business. Said BMS kingpin Peter Dolan: “As our portfolio continues to evolve and we launch addit­ional new medications around the world—with one approval, two recent favorable advisory comm­ittee votes, and a potential regulatory sub­mission in 2005 alone—it makes great sense to com­bine our US and international pharmaceutical oper­ations in one group.” u Meanwhile, Eli Lilly tapp­d John Lech­leiter as prexy and COO, effective in October. He’ll continue to report directly to supremo Sidney Taurel, who said: “We want to be sure that our leadership team is in the best position to help people throughout the company deliver for the customer now and in the future. John’s new role is an important step in making that happen.” u Else­where, Florida gen­erics outfit Andrx said last week its CFO has ankled. No reason was cited for the departure of John Hanson, who took the CFO position last year. Earlier this month, Andrx lost its general counsel, when Scott Lodin resigned abruptly. The company failed an FDA inspection of its manufacturing facilities on Sept. 6.

ALL VIOXX, ALL THE TIME

ONE COMPELLING reason why companies might prefer not to have to defend themselves in court is that people get to say all these hurtful things about you, and the newspapers report the comments, and soon everyone is repeating them. That realization must be dawning on Merck, which nonetheless still plans to go to court 5,000 more times to defend itself against rofecoxib (Vioxx) litigation. Last week’s well-publicized trial in Atlantic City, N.J. included a University of Washington professor accusing the company of “scientific misconduct” for allowing patient trials of rofecoxib to continue, despite data which suggested increased mortality. Said Prof. Richard Kromnal: “They had evidence that they were potentially killing people and they let that trial go on for another two years. That trial should have been stopped.” u Earlier last week, Merck’s Edward Scolnick, who ran the company’s R&D unit, testified via video-link that he was “in minor agony” because his lab couldn’t rule out the possibility that Vioxx was associated with cardiovascular side-effects. Said he: “I continued to worry about it. I always worried about the safety of our drugs.” Law­yers for the plaintiff also introduced into evid­ence e-mails from Scolnick which described the US FDA as “devious and antagonistic… bastards.” Scolnick ex­plained that he was angry when he composed the messages. The trial is expected to continue for at least four more weeks.

PRODUCT DEALS

STIEFEL LABORATORIES, the dermatology house, last week inked what it says is the biggest deal in the company’s 158-year history, in-licensing oral anti­fungal candidate albaconazole, from Spain’s Grupo Uriach. The Rx, which is in Phase II trials, has the potential to reach blockbuster status, the companies say. Says board chair Charles Stiefel: “Our agreement with Uriach is consistent with our busi­ness strategy to maximize utilization of investi­gational agents in our portfolio as we strengthen and promote our worldwide leadership in dermatology. This is just the first of what promises to be many such partnerships.” u In other dermal devel­op­ments, Barrier Therapeutics, the New Jersey-based skincare outfit, last week announced Janssen Pharm­a­­­ceutica won’t exercise its option for rights to anti­fungal itraconazole (Hyphanox), following the Rx’s failure to reach primary regul­atory endpoint in Phase III trials.

HONORS

ASTRAZENECA won the 2005 Pharmaceutical Industry Product of the Year Award for its breast Ca Tx anastrozole (Arimidex). The award was pre­sented in London by the Frost & Sullivan con­sult­ancy.

SPEED BUMP

GENENTECH last week stopped ovarian Ca trials of its colon Ca Tx bevacizumab (Avastin), which it is co-developing with Hoffmann-La Roche, following reports of five GI perforations observed in the first 44 patients enrolled in the proposed 53-patient study. The Rx is forecast to sell Cdn$1.9 billion annually for the colon indication alone. The companies also plan to seek approvals for Avastin as Tx for lung and breast tumors.

HERE’S RANBAXY

RANBAXY PHARMACEUTICALS, the largest Ind­ian drugmaker, last week officially launched their Canadian HQ in Mississauga, Ont., which, accord­ing to the company, “will be engaged in the sale and distribution of affordable medicines.” Ran­baxy has worldwide revenues of Cdn$1.3 billion. Said Malvinder Singh, who runs the parent company: “As a result of our efficiency, as well as our highly competitive manufacturing costs and lower innovation expenses, the Canadian healthcare system—government and consumers—will benefit from more competitive prices of medicines.” The local unit is run by gee-em Bill Abboud, with Anthony DiPierdomenico heading national sales.

VACCINE SCENE

CANGENE, the Winnipeg vaccine-maker controlled by clonemeister Apotex, was last week awarded a Cdn$17 million contract to supply Vaccinia Immune Glob­u­lin Intravenous-Human (VIG) to the UK health authority. Said Cangene prexy John Lang­staff: “As countries around the world consider implementing smallpox vaccination or stockpiling programs, the market for this product could grow.” Meanwhile, the World Health Organization’s Pacific regional director called for an all-out war on avian influenza and warned of the threat of new emerging diseases. Said Dr. Shigeru Omi: “Avian influenza and the earlier outbreak of severe acute respiratory syn­drome (SARS) are not the only emerging dis­eases we can expect to confront in this new century.”

HATE MAIL

PATHEON, the Toronto-based contract manufacturing outfit, said last week the company had received a letter from the stateside FDA pointing out manu­facturing problems in a Carolina, Puerto Rico faci­ity. Patheon bought the plant last year. The G-men say they have concerns over assay, content uni­formity, and fill-weights.

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