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
WANTED DEAD OR ALIVE IN DOGPATCH
THE STATE OF ARKANSAS last week accused Janssen Pharmaceutica of being “engaged in a direct, illegal, nationwide program of promotion of the use of Risperdal (risperidone) for non-medically necessary uses.” Attorney-General Dustin McDaniel is suing the drugmaker to recover funds spent by the state formulary on scrips he claims weren’t required medically. The Razorback State spent $200 million over an eight-year period for atypical anti-psychotics olanzapine (Zyprexa, Eli Lilly), quetiapine (Seroquel, AstraZeneca) and Risperdal. The company denies wrongdoing. A spokesman tells Associated Press: “Janssen has always been committed to the highest ethical standards and ethical behavior. We’re prepared to vigorously defend ourselves against these claims.”
SMOKE GETS IN PFIZER’S EYES
PFIZER’s smoking-cessation Tx varenicline (Chantix) last week became the subject of what the US FDA calls an “early communication” last week. The agency advised physicians of behavioral problems, including depression, in some patients taking the Rx. Says the FDA’s Rita Chappelle: “We’re beginning to look at this as an emerging safety issue. We’re requesting information from physicians, patients, nurses, and family members. This is an effort to let everyone know we’re looking at the adverse events.” That’s disappointing news for Pfizer, which launched Chantix in May 2006, and just ramped up a stateside DTC campaign this September. The Rx rang up US$101 million in revenues last year, and Pfizer assumed a strong marketing push would move Chantix into blockbuster status. However, publicity from a bizarre incident preceded the FDA’s recent advisory. Musician Carter Albrecht, who performed with the group Edie Brickell and the New Bohemians, reportedly became erratic and incoherent while on a Chantix regimen. His unusual behavior evidently led to his being shot and killed by a frightened neighbor. Researchers at the National Taiwan University in Taipei last week added one more item to the list of reasons why it’s a bad idea to smoke cigarettes. The coffin-nails not only promote lung and oral tumors, but it now seems they also make your hair fall out. Dr. Tony Hsiu-Hsi Chen explains tobacco destroys hair follicles and may also increase estrogen production—making it clear why the Marlboro Man always wore that nice Stetson.
UNDONE
PIERRE FABRE MEDICAMENT, the privately held French drugmaker, last week said Bristol-Myers Squibb returned rights to develop vinflunine, a candidate for bladder tumors. BMS in-licensed the compound three years ago. Fabre will go forward and plans to begin trials in Q1 next year.
PIPELINE PROGRESS
ASTRAZENECA responded last week to accusations made by investment bank Dresdner Kleinwort and other analysts, that the company’s prospects are not great (see CHROMO #482.) AZ sent their development director out to settle the ruckus among investors, who recently pushed the company’s publicly traded shares down to a 12-month low. Says Dr. John Patterson: “I believe we’re going to prove analysts wrong. They’re entitled to their opinion of our pipeline, but it’s hard to say AstraZeneca’s pipeline is empty.” He concedes, however, that AZ has been forced to react to the failure of several promising Tx candidates. Says he: “We realized our pipeline just wasn’t good enough. We had to turn things around.”
INDIA-CANADA Rx LINKS – I
RANBAXY PHARMACEUTICALS of Mississauga, Ont. last week got Health Canada okay to peddle BPH Tx tamsulosin, a generic version of Boehringer-Ingelheim’s Flomax. Ranbaxy says the total market for both branded and generic tamsulosin in Canada is $22 million. Says Ran prexy Paul Drake: “[Our] sales team will be offering Ran-Tamsulosin immediately under the Ranbaxy label in all Canadian provinces. That now provides another option to [the] pharmacist for this molecule, [which] will be of benefit to both patients and the Canadian healthcare system.” The company is a unit of the largest Indian drugmaker. Cadila Healthcare, the number five Indian drugmaker, is in the hunt for skincare brands. The company currently markets a line of dermatologics under the EverYuth tradename, and senior vee-pee Anand G. Deo tells the Economic Times newspaper he’s shopping for skin and hair brands: “Inorganic growth is an integral part of the game-plan, and we wish to acquire skin care brands [...] which will suit the Indian consumer’s skin.”
INDIA-CANADA Rx LINKS – II
HEALTH CANADA’s stepping up its Mutual Recognition Agreements with foreign drug regulatory bodies, adding India and the European Agency for the Evaluation of Medicinal Products to a list that already includes the US FDA, and the regulatory agencies of Australia, China, Singapore and Switzerland. Supriya Sharma, Health Canada’s director general of the Tx directorate tells the Business Standard newspaper of India: “India has inherent strength in providing drugs at affordable costs and has immense knowhow in process chemistry and development of generic products. The initiative is to facilitate trade of quality affordable drugs and pharmaceutical products between the two countries.” Could competition from Indian generics imports be one reason Apotex kingpin Barry Sherman is branching out into the beer business? Wasanda Enterprises, a family company controlled by Mr. Sherman, recently took over the management of Steelback Brewery of Tiverton, Ont., reportedly after Steelback’s founder burned through more than $120 million of Wasanda’s capital. Mr. Sherman abruptly installed his son Jonathon as CEO of Steelback, which previously sold its suds using the truly unfortunate slogan, “It Is What It Is.” ChronicleMONDAY readers, who have always demonstrated both great creative flair and tremendous empathy toward Mr. Sherman, are invited to submit suggestions for a more fitting phrase for Barry’s Brew. We’ll kick things off with “Steelback: Biologically Equivalent to Budweiser.” Or, “Steelback: The One Beer to Have, If You Aren’t Having Apo-Prochlorazine.” Send your suggestions to health@chronicle.org, with a subject line “Contest,” before Nov. 30. Best entries will receive something nice from our Prize Drawer, and maybe we’ll also throw in a beer. Not Steelback.
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