Magazine article Drug Topics

A Mixed Bag

Magazine article Drug Topics

A Mixed Bag

Article excerpt

The 2007 pipeline promises novel therapeutic classes for some diseases but no new drugs in others

When it comes to impending drug approvals, these appear to be the worst of times and the best of times. While some therapeutic areas like oncology continue to draw lots of research and development activity, other areas such as infectious disease seem to be left out of the progress of modern medicine. "Essentially, we have plenty of bad bugs but no drugs," remarked Robert Adamson, Pharm.D., director of clinical services and infectious disease specialist at the Saint Barnabas Healthcare System of New Jersey.

In summarizing the current state of affairs, Adamson referred to an increasing incidence of extended-spectrum beta-lactamase (ESBL)-producing bacteria, the emergence of multidrug-resistant Pseudomonas and Acinetobacter species, and the declining bacterial sensitivity to beta-lactam agents.

"Yet there are no new antibacterials in the pipeline with activity against gram-negative organisms. And there are only five antibacterials out of the more than 500 drugs in research and development," disclosed Adamson. One of these rare commodities is dalbavancin, a lipoglycopeptide agent possessing in vitro activity against various gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. Based on phase II and III clinical trials, dalbavancin appears comparable to vancomycin, linezolid (Zyvox, Pfizer), and various beta-lactam agents in the treatment of skin and soft-tissue infections and catheter-related bloodstream infections.

According to Raulo S. Frear, Pharm.D., dalbavancin, which is under development by Pfizer, is expected to emerge next year and be used mostly to treat multidrug-resistant gram-positive infections. Frear is VP of clinical evaluation and policy and is responsible for drug pipeline review at Express Scripts.

Blockbusters on horizon?

Looking at what other drugs are in the offing for next year, market forecasters such as IMS Health are predicting 25 to 35 product launches, a number that is comparable to this year's expected 30 launches. The total number of blockbuster products continues to grow and is expected to reach 112 in 2007, up from 94 in 2005.

Among the predicted blockbusters for 2007 are two oral agents from a new class of drugs being developed for Type 2 diabetes. Both Galvus (vildagliptin; Novartis), currently under Food & Drug Administration review, and Januvia (sitagliptin phosphate, Merck), just approved, are dipeptidyl peptidase (DPP)-4 inhibitors that appear to increase levels of incretin hormones, which help regulate glucose by affecting the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, these agents generally act only when blood glucose levels are elevated to address diminished insulin production (due to beta-cell dysfunction) and uncontrolled hepatic glucose production (due to alpha- and beta-cell dysfunction).

"Most of the treatments that we use today focus primarily on stimulating insulin secretion or lowering resistance," noted Vivian Fonseca, M.D., professor of medicine and pharmacology and chief of endocrinology and metabolism at Tulane University Health Sciences Center in New Orleans. "The positive clinical results we've seen to date with vildagliptin underscore the importance and promise of addressing the dysfunction of both the pancreatic beta and alpha cells." Both drugs are suitable for once-daily dosing and have not been associated with weight gain.

Paliperidone (Invega) extended-release is another agent predicted by IMS Health to be a potential blockbuster in 2007. Manufactured by Johnson & Johnson Pharmaceutical Research & Development, the product is an active metabolite of the atypical antipsychotic risperidone (Risperdal, Janssen). Through extended-release technology, paliperidone provides a steady release of medication over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations and allowing for once-daily administration. …

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