IN DEPTH: PEOPLE & ISSUES 2005
From the December 31, 2004 print edition
Discovery awaits FDA review of flagship drug product
John George
Staff Writer
WARRINGTON -- Sometime between Groundhog's Day and Valentine's Day, Discovery Laboratories Inc. should learn the fate of its flagship product, now under review by the Food and Drug Administration.
The Bucks County biopharmaceutical company is seeking approval for its new drug candidate, called Surfaxin, initially as a treatment for respiratory distress syndrome in premature infants.
"After all the work we've done, including multination clinical trials, everybody is very excited and very positive," said Christopher J. Schaber, Discovery's executive vice president and chief operating officer. "This is a very positive time. Morale is high."
Citing Securities and Exchange Commission regulations, Schaber said he can't say too much about the company's discussions with the FDA other than to say those talks are "ongoing and according to plan."
Surfaxin is a bioengineered version of natural human lung surfactants, soap-like substances essential for breathing that lubricate the lining of the lungs and keep them from collapsing.
The estimated 40,000 infants born prematurely with respiratory distress syndrome each year are now treated primarily with animal-derived pig or cow surfactants, which are costly and in limited supply. Surfaxin is designed to closely mimic the essential properties of human lung surfactant.
Discovery submitted its new drug application for Surfaxin in April.
Recently, Schaber said, the company has restructured two deals to enable Discovery to keep "the lion's share" of Surfaxin revenue -- should the product get regulatory approval in the United States as well as Europe, where a decision is expected in late 2005.
Last month, the company terminated a commercialization arrangement it has with Quintiles Transnational Corp. in favor of forming its own sales and marketing team to promote the product to physicians in hospital neonatal intensive-care units (NICUs).
Earlier this month, Discovery amended its collaboration agreement with Laboratories del Dr. Esteve of Spain to regain full commercialization rights for its surfactant replacement therapy products, including Surfaxin, for respiratory distress syndrome and acute respiratory distress syndrome in Central America, South America and most countries in Europe.
As a result of the changes, the company expects to grow from 90 employees to about 150 by mid-2005.
Discovery was founded in 1996 to commercialize the invention of a synthetic surfactant made in the laboratories of Dr. Charles G. Cochrane, the founder of Scripps Research Institute in La Jolla, Calif.
Cochrane invented Surfaxin, for which Johnson & Johnson initially held the rights, to treat patients who suffered from damaged, absent or otherwise ineffective lung surfactants.
Discovery Laboratories obtained the worldwide licensing rights to Surfaxin in 1996 from J&J, where Robert Capetola -- Discovery's president and CEO -- previously worked as director of experimental therapeutics.
"Our proprietary surfactant technology represents a new paradigm that we believe will revolutionize the treatment of respiratory diseases," Capetola said. "We believe our NICU pipeline could serve an addressable market estimated to be in excess of $500 million per year in potential revenue to the company."
Discovery's long-range plans call for applying its surfactant technology to treat a broad range of other respiratory diseases including bronchopulmonary dysplasia, a serious form of chronic lung disease; meconimium aspiration syndrome in premature infants; asthma; chronic obstructive pulmonary disease, a chronic condition of the lung that prevents enough oxygen from reaching the blood; acute lung injury; and upper airway disorders such as sinusitis and sleep apnea.
Schaber said Discovery intends to stay committed to neonatal care.
"Other companies, in the past, have gotten one drug approved and moved on to larger patient populations," he said.
Schaber said one of Discovery's major areas of focus in 2005 will be further developing its technology to keep infants from going on mechanical ventilators. He said scientists at the company's Northern California research facility are working on an aerosolized formulation of its synthetic surfactant replacement product that can be delivered through a process known as nasal continuous airway pressure, or CPAP.
A phase-II clinical trial of the technology for neonatal respiratory failures was scheduled to begin by the end of this month.
"We are the first company embarking and traveling down this road," Schaber said.
jgeorge@bizjournals.com | 215-238-5137
bizjournals.com |
