August 4, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Horsham, Penn.-based Galleon Pharmaceuticals, Inc. announced today that Joseph Oliveto will step in as chief executive officer immediately. Oliveto replaces James Mannion, who is retiring, but will act as a strategic advisor.
Galleon Pharmaceuticals focuses on products to assist with breathing problems, such as sleep apnea. The company has three products in its pipeline. Gal-021 IV for post-surgical treatment and prevention for respiratory insufficiency in apnea and other high risk patients is just starting Phase IIa trials. The other two products, GAL-160 oral and GAL-160 oral backups, are still in preclinical development for sleep apnea.
The company has raised about $17.5 million in three venture capital rounds, the first for $1.5 million on Nov. 20, 2013, another $10 million on Nov. 23, 2010 and $6 million on Jan. 13, 2014. To date the company has raised about $50 million from investors, including TPG Biotech, Morgenthaler Ventures, and Healthcare Ventures. The company received $500,000 in seed funding in 2005 from BioAdvance, which runs the Biotechnology Greenhouse of Southeastern Pennsylvania.
Oliveto most recently was president and chief executive officer of Chelsea Therapeutics, Inc. (CHTP). During his time at Chelsea, he oversaw the company's approval for Northera by the FDA. Northera is used to treat neurogenic orthostatic hypotension. Oliveto also was involved in the sale of Chelsea to Lundbeck Inc.
"Joe's broad experience and proven track record in leading successful research and development and commercial teams will be of great value as we continue to build upon Galleon's success to date," said Thomas Dietz, chairman of Galleon in a statement. "At the same time, we want to recognize the outstanding work that Jim Mannion did since founding the company as CEO. Thanks to his leadership and vision, Galleon is well-positioned to continue clinical studies and eventually bring these investigational therapies to market."
In September 2014, Galleon published data from a double-blind, placebo-controlled clinical proof-of-concept study for GAL-021 in the journal Anesthesiology. The focus was to examine whether GAL-021 stimulated breathing in patients on opiates common to surgery whose breathing was depressed. The drug met or exceeded the study's goals.
"There is a high unmet need for an agent to help anesthesiologists and other professionals manage the growing numbers of respiratory related complications taking place post-surgery," said Albert Dahan, professor of anesthesiology at Leiden University Medical Center in Leiden, The Netherlands, and lead investigator of the study, in a statement. "These new data reinforce our belief that GAL-021 may be an important option for patients and providers to help protect these patients' airways and restore breathing control. We also believe more studies are needed to confirm these initial findings."
For most people who suffer from sleep apnea, the treatment is a mechanical breathing device, or CPAP. Approximately 40 million people in the U.S. have problems with sleep apnea, which can interrupt breathing and sleep. If Galleon's drugs were approved, they would have a lock on the market. The company has suggested that if the drugs worked in 30 to 50 percent of sleep apnea patients, that's a potential $10 billion market.