The PharmExec 2005 Pipeline Report - Pharmaceutical Executive

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The PharmExec 2005 Pipeline Report
Dry? Not quite. Instead of 1990s-style blockbusters, pharma's new molecules are niche drugs, cancer treatments and—at last—innovative mechanisms for troublesome targets.


Pharmaceutical Executive


Effective screening is the key to identifying patients who need early cancer treatment or, if dysplasia has not begun, who would be candidates for the vaccine, Blumenthal says. While the time-honored Pap smear may give way to a more sophisticated molecular test in the developed world, Blumenthal screens patients using a cheaper test: visual inspection with acetic acid (VIA). Ordinary household vinegar turns pre-cancerous growth on the cervix white, so it can be detected with the naked eye during a speculum exam.

Deutsche Bank's Ryan compares the new vaccines to Wyeth's pneumonia vaccine, Prevenar, which sold well in the United States, but less so in other countries: "There is clearly a big market," she says. "But it is not clear what the level of penetration will be and how quickly it happens." Important commercial factors, she says, will be how quickly the Centers for Disease Control embraces the vaccine, and whether it is universally mandated for targeted age populations.

Asenapine by Organon/Pfizer

2009 SALES
$1.1 billion

Bifuprunox by Solvay/Wyeth

2009 SALES
$960 million

Desvenlafaxine DVS-23 by Wyeth

2009 SALES
$843 million

Among current pipeline products, three of the top-six money-makers in 2009 will be psychopharmacological compounds, according to data assembled by Scottish analysts Wood Mackenzie.

Asenapine functions like clozapine as a treatment for bipolar mania and schizophrenia. Wood Mackenzie sees better efficacy for "negative" symptoms, such as flattened affect.

Bifeprunox is a dopamine receptor agonist with fewer side effects than today's drugs. In particular, it makes patients gain less weight.

"Wyeth expects to launch their new antidepressant, desvenlafaxine, in 2007," says Wood Mackenzie analyst Keith Redpath, "a year ahead of Effexor's US patent expiry in 2008."

"These drugs that are being studied are really me-too drugs," says Karl Rickels, a psychiatrist at the University of Pennsylvania School of Medicine, who specializes in depression. "But not every patient responds the same way to the same drug."

VX 950 by Vertex/Eli Lilly

TARGET INDICATION
Hepatitis C
DEVELOPMENT
Phase II
LAUNCH DATE
2011

Valopicitabine [NM 283) by Idenix/Novartis

TARGET INDICATION
Hepatitis C
DEVELOPMENT
Phase II
LAUNCH DATE
Unknown

This orally-dosed small molecule is likely to compete well against interferon, the current standard treatment for the hepatitis C virus (HCV), early clinical data suggest. The HCV protease inhibitor produced no adverse effects and appears to be free of the side effects that plague many interferon patients, especially early in treatment. These include headaches, muscle and joint aches, as well as tiredness, moodiness, and depression.

"It looks as though the mechanism could avoid side effects," says David Molowa of UBS. "The preliminary Phase II data are tantalizing. It dropped the viral titer by four logs to a virtually undetectable level."

Even so, VX 950 may turn out to be a combination therapy with interferon. "This is a chronic disease, so you have to take it chronically," Molowa says. "The biggest problem that we've encountered with other compounds for hepatitis is resistance. It will take longer-term studies before we see if we encounter resistance with this drug."


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