Sluggish Day for Healthcare and the rest of market's sectors Print E-mail
By Staff and Wire Reports   
Tuesday, 30 August 2011 12:11
The U.S. Food and Drug Administration has agreed to review and consider additional uses for an anti-constipation drug made by Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP, the company said in a written statement Tuesday morning.
Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) joined Salix in announcing the news of the filed supplemental New Drug Application (sNDA) for RELISTOR® Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain. The FDA has issued an action date of April 27, 2012 under the Prescription Drug User Fee Act (PDUFA). Progenics’ first commercialized therapy is RELISTOR®, a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness. Progenics has exclusively licensed Salix Pharmaceuticals, Ltd. to continue development and commercialization of RELISTOR in worldwide markets other than Japan, where Ono Pharmaceutical Co., Ltd. has an exclusive license to develop and commercialize subcutaneous RELISTOR.

Bill Forbes, Pharm.D., executive vice president, research and development, and chief development officer at Salix said, “Acceptance of this filing for FDA review is a significant step toward gaining approval for RELISTOR to treat the underlying cause of OIC experienced by the millions of patients taking opioids for non-cancer pain.”

Robert J. Israel, senior vice president of medical affairs for Progenics, added, “This sNDA includes results from 31 studies involving more than 4,000 patients. We are pleased to have the FDA review these data in support of RELISTOR’s safety and efficacy in a new indication.”

In other news, shares of Aeterna Zentaris Inc. (NASDAQ:AEZS) rose over 9% after the company announced that a poster on its novel orally active anticancer Erk inhibitor, which includes AEZS-131, was presented at the 242nd American Chemical Society National Meeting held at the Colorado Convention Center in Denver, Colorado. The poster was presented by Matthias Gerlach, Ph.D., Senior Director of Medicinal Chemistry for the company which has identified small molecular compounds that selectively inhibit Erk 1/2, among them AEZS-131, which has been shown to significantly inhibit tumor growth in in vivo studies. Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers including colorectal, multiple myeloma, endometrial, ovarian, prostate and bladder cancer.

The Canadian drugmaker, over the coming months, will look to file a new drug application with the U.S. Food and Drug Administration, the company said on Tuesday.

The U.S. economy expanded less than previously estimated in the second quarter, underscoring the weakness that has prompted the Federal Reserve to mark down its growth forecasts. The global economic crisis is leading to a possible “developed economy” recession in the U.S. and Europe, which may be hard to alleviate, according to Pacific Investment Management Co.’s Bill Gross. Treasuries and gold rose after consumer confidence sank to a 28-month low, while U.S. stocks fell as banks’ losses offset gains by companies most-linked to economic growth. Almost $5 trillion has been wiped off the value of equities worldwide this month amid concerns that the global recovery is faltering.

Here is a snapshot of the trading action at mid-day on Tuesday:

Gainers (% price change)
AEterna Zentaris Inc
AEZS 2.07 +0.18 (9.26%) 200.49M
Hansen Medical, Inc. HNSN 3.57 +0.27 (8.18%) 195.93M
BioCryst Pharmaceuticals BCRX 3.35 +0.24 (7.72%) 151.25M
Sun Healthcare Group Inc SUNH 4.29 +0.26 (6.45%) 107.84M
Optimer Pharmaceuticals OPTR 9.21 +0.48 (5.50%) 429.21M
Losers (% price change)
Progenics Pharmaceuticals PGNX 6.15 -0.41 (-6.25%) 207.31M
Palomar Medical Tech PMTI 8.07 -0.43 (-5.06%) 153.58M
Senomyx Inc. SNMX 4.25 -0.22 (-4.92%) 168.46M
Array BioPharma Inc. ARRY 2.18 -0.11 (-4.80%) 124.30M
Infinity Pharmaceuticals INFI 6.83 -0.34 (-4.74%) 181.70M
Most Actives (dollar volume)
Pfizer Inc. PFE 18.79 -0.09 (-0.48%) 146.60B
Johnson & Johnson JNJ 65.51 -0.35 (-0.53%) 179.52B
Bristol Myers Squibb Co. BMY 28.93 -0.36 (-1.23%) 49.34B
Cephalon, Inc. CEPH 80.63 -0.01 (-0.01%) 6.28B
Merck & Co., Inc. MRK 32.47 +0.01 (0.03%) 100.03B




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