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.
. 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.
