The Pharm Exec Pipeline Report 2007 - Pharmaceutical Executive


The Pharm Exec Pipeline Report 2007

Pharmaceutical Executive

"I'm impressed by rimonabant as a drug that can lower weight by 4 to 5 percent below placebo," said Dr. Robert Eckel, professor of medicine, division of endocrinology, metabolism and diabetes, at the University of Colorado. "But if you think about it conceptually, a drug that modifies endorphins and opiate neurochemistry may, in fact, modify mood. I thought from the beginning that it might be a limitation, and I'm sorry to see that it is."

The Uncommon Cold
RSV: Attacking a Baby Killer

Respiratory syncytial virus (RSV) is the most common cause of bronchiolitis and pneumonia among children under 12 months. As few as one in 200 of those infected require hospitalization, but these cases account for 50,000 to 80,000 hospitalizations in the United States, according to the Centers for Disease Control and Prevention. RSV, fatal in some cases, causes repeated cold-like infections later in life and leads to severe lower-respiratory-tract disease, especially among the elderly or among those with compromised cardiac, pulmonary, or immune systems.

Motavizumab, developed by MedImmune before the company was sold to AstraZeneca earlier this year, is a monoclonal antibody aimed at preventing RSV infection in full-term infants. "It's significant breakthrough," says Murray Aitken, an analyst at IMS Health. In Phase II and III trials, motavizumab has proved more efficacious than its primary rival, palivizumab, a similar MedImmune drug.

ALN RSV01 is a small interfering RNA (siRNA) drug delivered to the RSV infection in the lungs, where it silences a key viral gene. Clinical studies on adult volunteers delivered the therapy using intranasal spray or a neubulized formula appropriate for hospitalized infants.

Still Waiting to Inhale?
Diabetes: After Exubera

Three inhaled-insulin therapies remain standing after Pfizer's spectacular failure with Exubera. Only one, MannKind's technosphere product, has a realistic chance of competing as a diabetes treatment. MannKind's powdered insulin is not just convenient but it reaches the bloodstream faster than subcutaneously injected insulin.

"MannKind's product has a much more rapid-acting profile," said Jay Skyler, MD professor, division of endocrinology, diabetes, and metabolism, University of Miami Miller School of Medicine. "The Lilly and Novo products, just like Exubera, have an onset similar to the existing rapid-acting insulin analogues. No question that both the Novo and Lilly delivery systems have advantages over Pfizer's."

But the market has changed. "Injections are no longer as difficult as Pfizer projected" when the Nektar/Pfizer project began in 1996, added Skyler. According to Barbara Ryan, pharmaceutical analyst at Deutsche Bank, the injection pen beat inhaled insulin to the convenience market. "Longer term, unless you show some real clinical benefit beyond convenience," she said, "inhaled insulin will have a pretty difficult mountain to climb."


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