The Pharm Exec Pipeline Report 2007 - Pharmaceutical Executive


The Pharm Exec Pipeline Report 2007

Pharmaceutical Executive

Takeda and Forest Labs are working on ceftaroline fosamil, a cephalosporin that should hit the market in late 2010. Also delivered as a prodrug for solubility reasons, ceftaroline fosamil promises most of the advantages of J&J's compound. Even so, J&J and Pfizer will have a strong marketing advantage in hospitals, since they can bundle two or three antibiotics in a single-price package, Drayton says.

Oritavancin has bounced from company to company. Lilly originated development in 1995 and licensed it to InterMune in 2001. Targanta Therapeutics acquired world rights in 2005. The long half-life of the compound may allow once-daily dosing, but it otherwise has a profile similar to vancomycin. "It's an incremental improvement over the current standard of care, at best," said Kevin Richard, a managing director at investment banking firm Leerink Swann.

Telavancin has two mechanisms of action. "Having a dual mechanism of action theoretically has a potential to keep resistance development low," Drayton says. However, she notes that vancomycin has retained almost miraculously low resistance against MRSA. Only 10 patients in 50 years have been reported with complete vancomycin resistance, although "intermediate resistance" has become increasingly common. Telavancin set out to prove superiority to vancomycin in clinical trials but achieved only non-inferiority, according to Drayton.

All these drugs can be expected to move through clinical trials again to determine efficacy against "community MRSA," which is genetically different from the hospital-acquired strain.

A Pain in the Leg
Peripheral Arterial Disease: Growing Blood Vessels

People with peripheral arterial disease endure intense pain. Frequently, they can't walk. In severe cases, they die from a huge clot in the leg that stops blood flow.

Two new drugs for PAD are angiogenic gene therapies that build blood vessels in ischemic limbs. "NV1FGF is a plasmin-based gene expression vector," explains Donny Wong, a senior analyst at Decision Resources. "Basically it's DNA that you inject into the patient's leg to cause the expression of FGF1, which is Fibroblast Growth Factor."

Genzyme has a similar gene therapy for this vascular disease: HIF-1 alfa, which stands for hypoxia inducible factor-1-alpha.

"It's kind of a high-risk therapy," Wong says, noting that the drugs could feed an undetected tumor. "But if it's successful, these drugs are potentially billion-dollar earners."

Acomplia Forever?
Obesity: Losers Are Gainers

Rimonabant (Zimulti), which remains better known as Acomplia, has fallen from an odds-on blockbuster four years ago to the Great American Longshot. Sanofi-Aventis, undaunted by FDA’s safety concerns, may submit an NDA for diabetes indications as early as next year. Both Merck (taranabant) and Pfizer (CP 945598) remain committed to similar cannabinoid receptor antagonists, despite fears that their products may also produce depression and suicidal ideation, the side effects that hamstrung rimonabant.

The expected payoff is huge if FDA smiles on one of these compounds. Lehman Brothers estimates $3 billion in peak sales for Pfizer's obesity candidate in 2018—but gives it only a 20 percent chance of success. Merck, which aims to file an NDA for taranabant in 2008, can expect a similar risk-to-payoff ratio.


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