The Pharm Exec Pipeline Report 2007 - Pharmaceutical Executive


The Pharm Exec Pipeline Report 2007

Pharmaceutical Executive

Mipomersen adds 50 percent to the power of statins. "With this drug, up to three-quarters of patients achieved LDL levels below 70 milligrams per deciliter," said Donny Wong, senior analyst at Decision Resources. "That's the lowest target for patients at the highest risk of heart attack." The weekly injectable will first target familial hypercholesterolemia, which causes very high levels of LDL cholesterol in very young people. But Wong says the drug is likely to be appropriate for the patient with an LDL cholesterol level of 200 who isn't responsive to a statin.

Butt Out
Smoking: Taking the Pleasure Out of Tobacco

Despite the early successes of Chantix (varenicline), a partial nicotinic receptor agonist that Pfizer launched last year, the smoking-withdrawal field remains wide open. "We see a number of treatment approaches but no standard of care," said David Smith, MD, an addiction specialist and past president of the American Society of Addiction Medicine.

Celtic Pharma's TA-NIC is a vaccine designed to produce antibodies to nicotine. The antibodies bind to nicotine in the bloodstream, reducing its rate of entry into the brain—and thus the positive reinforcement associated with smoking.

Dianicline, like Chantix, acts on the alpha4-beta2 nicotinic acetylcholine receptor. It allows nicotine to enter the brain, but binds preferentially to the receptors that produce pleasurable effects.

"These new approaches all help," Smith said. "But we have not seen the treatment that will reduce withdrawal and craving for every smoker."

Staph Meeting
Antibiotics: Battling MRSA

A new wave of antibiotics aims to take on two tough challenges: fighting hospital-acquired MRSA (methicillin-resistant Staphylococcus aureus) and winning patient share from vancomycin, the cheap, 50-year-old drug administered to more than half of hospitalized US patients with MRSA.

One of the biggest problems for Pfizer's dalbavancin may be avoiding direct competition with Zyvox (linezolid), the drug giant's popular IV antibiotic—a preferred pneumonia treatment, and the only product in the space with a step-down therapy that lets patients take their hospital antibiotic orally at home. Dalbavancin, designed as the first once-weekly injectable antibiotic, nearly guarantees patient compliance. People leave the hospital and do nothing but return for a second dose seven days later.

Ceftobiprole medocaril, a joint project by Basilea Pharmaceutica and subsidiaries of Johnson & Johnson, may be the most eagerly anticipated drug in the space. Formulated as a prodrug to increase its water solubility, the new compound promises to be the first cephalosporin to show activity against MRSA.

"The drug rides on a history of positivity," says Danielle Drayton, an analyst at Decision Resources. "Doctors love cephalosporins. To have a cephalosporin active against MRSA is huge. This is a drug that will have leading sales for MRSA treatment in the future." Drayton notes that ceftobiprole not only kills gram-positive bacteria, such as MRSA, but gram-negative organisms as well.


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