The Big Day is Coming!!!!!!!!!!
The FDA classified the review of the Complete Response as a Class 2 review and established March 6, 2012 as the target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for SURFAXIN.
Discovery Laboratories, Inc., a biotechnology company, engages in developing surfactant therapies to treat respiratory disorders and diseases based on its KL4 surfactant and capillary aerosol-generating technologies. Its development stage products include Surfaxin, a synthetic, peptide-containing surfactant in phase III clinical trial for the prevention of respiratory distress syndrome in premature infants; Surfaxin LS, a Phase III trial product to improve ease of use for healthcare practitioners; and Aerosurf, an aerosolized KL4 surfactant that has completed first pilot Phase II clinical trial for the treatment of respiratory distress syndrome in premature infants.
The company has a license agreement with Philip Morris USA Inc. to use its capillary aerosolization technology for use with pulmonary surfactants for the respiratory diseases and conditions; and a strategic alliance agreement with Laboratorios del Dr. Esteve, S.A. for the development, marketing, and sale of a portfolio of potential KL4 surfactant products in Andorra, Greece, Italy, Portugal, and Spain.
Discovery Laboratories, Inc. was founded in 1992 and is headquartered in Warrington, Pennsylvania.
On May 11, 2011, the Company issued a press release highlighting the results of operations for the quarter ended March 31, 2011, and providing an update on its pipeline development as follows:
| |Surfaxin® (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants:
The Company is conducting a comprehensive preclinical program
to validate its optimized biological activity test (BAT), a key remaining issue that must be addressed to potentially gain U.S. Food and Drug Administration (FDA) marketing approval for Surfaxin in the United States. The Company has had several interactions with the FDA intended to ensure that the comprehensive preclinical program would ultimately satisfy the FDA. In January 2011, the Company announced that the FDA had provided guidance to increase the sample size of a specific data set by testing additional Surfaxin batches. To comply with the FDA's suggestion, the Company has successfully manufactured eight Surfaxin batches and presently plans to manufacture two additional Surfaxin batches for use in the comprehensive preclinical program. The Company presently plans to complete all related analytical testing and concordance studies
, and be in a position to file a Surfaxin Complete Response in the third quarter of 2011.
Surfaxin LSTM (lyophilized lucinactant) for neonatal RDS : The Company continues to advance this program. Its plans for 2011 include establishing a commercial-scale manufacturing capability at a cGMP-compliant contract manufacturer with expertise in lyophilized formulations and seeking regulatory guidance from the FDA and the European Medicines Agency (EMA) for the planned clinical development program.
| |Aerosolization Technology
: Recently, at the 2011 Pediatric Academic Societies Annual Meeting
(PAS), new data was presented including: (i) a collaborative study indicating that aerosolized KL4 surfactant significantly improved lung function and survival when treating Acute Lung Injury in a well established preclinical model of this severe respiratory condition, (ii) a dose-ranging assessment of aerosolized KL4 surfactant in a widely recognized preclinical model of RDS, demonstrating significant improvement in lung function, lung structural integrity and pulmonary inflammatory mediator profile following treatment with aerosolized KL4 surfactant versus controls, and (iii) a study highlighting the Company's novel patient interface technology intended to increase the efficiency of pulmonary aerosol drug delivery to patients requiring positive pressure ventilatory support.
Regarding the Company's lead aerosolized KL4 surfactant program, Aerosurf® (aerosolized lucinactant for neonatal RDS), data from the preclinical dose ranging assessment study presented at PAS mentioned above suggests that, out of several doses tested, KL4 surfactant delivered via the Company's proprietary capillary aerosol generator during a 20 to 30 minute dosing interval results in the most favorable physiologic outcomes. This study provides guidance for future clinical dosing strategies for this program. The Company's plans for 2011 include finalizing the clinical and potential commercial design of the capillary aerosol generator, finalizing the clinical and potential commercial design for the novel patient interface, and seeking regulatory guidance in the U.S. and Europe for the planned development program.
For the quarter ending June 30, 2011, the Company projects
cash outflow of $5.8 million.
Investor Relations Contacts
John G. Cooper
Executive Vice President, Chief Financial Officer
Discovery Laboratories, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
[email protected] As of November 8, 2011, 24,499,497 shares of the registrant's common stock, par value $0.001 per share, were outstanding
As of May 2, 2011, 24,178,502 shares of the registrant's common stock, par value $0.001 per share, were outstanding. AutAeeeeee Authorized 50 Mill
85 BM's 5-15-11
2010-11 Press Releases
May 13, 2011 10-Q http://ih.advfn.com/p.php?pid=nmona&article=47677338
May 13, 2011 http://ih.advfn.com/p.php?pid=nmona&article=47666790 A Brighter Decade Ahead for Biotech - Equity Research on Discovery Laboratories and Mylan Inc
May 11, 2011 8k http://ih.advfn.com/p.php?pid=nmona&article=47626029
May 19, 2010
Discovery Labs Achieves Key Milestone Towards Potential Surfaxin® Approval
May 17, 2010
Discovery Labs' KL4 Surfactant Demonstrates Potential Protective Role for Lung Transplantation in Established Preclinical Model
May 14, 2010
Discovery Labs' Phase 2a Aerosurf® Study Published in Journal of Aerosol Medicine and Pulmonary Drug Delivery
May 5, 2010
Surfaxin LSTM Improves Pulmonary Function and Reduces Lung Inflammation in Established Model of Respiratory Distress Syndrome
April 28, 2010
Discovery Labs' KL4 Surfactant Data to be Presented at Pediatric Academic Societies Annual Meeting and American Thoracic Society International Conference
April 27, 2010
Discovery Labs Provides Updates on Surfaxin®, Other Key Programs and First Quarter 2010 Financial Results
March 10, 2010
Discovery Labs Reports Fourth Quarter 2009 Financial Results and Provides Business Update
February 23, 2010
Discovery Labs Announces Completion of $16.5 Million Public Offering
February 18, 2010
Discovery Labs Prices $16.5 Million Public Offering of Common Stock and Warrants
February 17, 2010
Discovery Labs Announces Proposed Public Offering of Common Stock and Warrants
February 16, 2010
Discovery Labs Receives FDA Guidance Regarding Pathway to Potential SURFAXIN® Approval
January 19, 2010
POPG, a Key Component of Discovery Labs KL4 Surfactant, Identified as a Novel Anti-Viral Therapeutic Approach
Management Team View Bio
W. Thomas Amick, Interim CEO
Russell Clayton, D.O.
Vice President, Academic and Medical Affairs, Acting Head, Regulatory Affairs and Preclinical Research
Senior Vice President, Human Resources
John G. Cooper
Executive Vice President, Chief Financial Officer
David L. Lopez, C.P.A., Esq.
Executive Vice President, General Counsel
Charles F. Katzer
Senior Vice President, Manufacturing Operations
Thomas F. Miller, Ph.D., MBA
Senior Vice President, Commercialization & Corporate Development
Gerald J. Orehostky
Senior Vice President, Quality Operations
Robert Segal, M.D., F.A.C.P.
Senior Vice President, Medical & Scientific Affairs, Chief Medical Officer
Mary B. Templeton, Esq.
Senior Vice President, Deputy General Counsel
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Last update: June 03,2010