Cadence Pharmaceuticals shares jumped more than 60 percent yesterday after the San Diego startup said it won't have to conduct any additional clinical trials of its developmental drug, Acetavance.
Cadence stock rose $3.87 to close at $10.29 a share in Nasdaq trading of almost 1.4 million shares. The company's recent average daily volume is 122,295 shares.
The company, which plans to complete three studies now under way, asked the Food and Drug Administration to waive requirements for additional studies because Acetavance is a reformulation of a well-known drug. The FDA agreed.
As a result, Cadence plans to seek FDA approval for the drug during the first three months of 2009.
“This news removes a major overhang on the stock,” Cowen analyst Leland Gershell wrote in a research note yesterday.
Acetavance is an injectable form of acetaminophen, the active ingredient in Tylenol. Acetaminophen was introduced in the United States in 1955 as an alternative to aspirin and has become the country's most widely used drug for pain relief and fever reduction.
“It's the exact same molecule,” Cadence Chief Executive Officer Ted Schroeder said. “It's just a different method of delivery through an IV (intravenous) preparation.”
But the difference is significant because researchers were unable to develop an injectable form of acetaminophen for almost 50 years.
“Until this formulation, it's been difficult to stabilize acetaminophen in solution,” Schroeder said. The molecule is degraded by oxygen in the water.
In 2002 an IV form of acetaminophen, Perfalga, was introduced in Europe and other countries. Cadence acquired exclusive rights to the drug, which was renamed Acetavance, for use in the United States and Canada.
The injectable form of the drug is intended for use by patients who are unable to take oral medications, Schroeder said. Usually that means post-surgical hospital patients who are unconscious or nauseated, or other patients who have difficulty swallowing.
While the market is not as big as the market for acetaminophen, Schroeder said about 50 million surgeries are done each year in the United States.
Reuters contributed to this report.
Bruce Bigelow: (619) 293-1314; bruce.bigelow@uniontrib.com
