If you are having trouble viewing this message, please go to http://community.icontact.com/p/stockshaven/newsletters/distributionlistpublic/posts/disovery-labs-riding-on-major-pending-fda-news [1][2] Breaking News and Insider Scoops May 11, 2010 Major Clinical Pipeline Updates For (
DSCO) Could Bring A Major Rebound In The Short Term There are also rumours swirling the company is looking for a partnership /
buyout Dear Readers, Discovery Labs could be on the verge of releasing some major news in order to help the company relieve the price per share back to its normal $1.00+ range, in order to meet the NASDAQ listing requirements (May 17th deadline). Rumours are swirling around the investment community that they are currently engaged in discussions with potential strategic and financial partners that, if successful, will provide the financial resources needed to potentially advance our development programs. Currently shares reside near strong support at $0.50 a share, and if broken, expect them to rise a quick 30%+ right off the bat.
* FDA Submission of Flagship product in 1Q11 * Phase 2 Results for Acute Respiratory Failure in June 2010 * Initiation of Phase 2a trial for Cystic Fibrosis in 3Q10 About Flagship Product, Surfaxin
ARDS/ALI afflicts approximately 220,000 patients annually. The company believes that it represents a $1.8 billion market opportunity in theUS alone (with a market of similar size in Europe). There are currently no drugsapproved to treat
ARDS/ALI, which has a mortality rate of approximately 50%. Discovery has the capability to produce Surfaxin(TM) in the commercial quantities required for the adult market.
On top of that there is also a handful of FDA news that is expected, as well as positive news which was released for its 2010 1st Quarter Financials. If we look at pervious quarters the Discovery laboratories have reduced their operating expenses gradually which were actually standing around $8.70 million for the quarter ended March 31^st, 2009 till than the company has reduced its operating expenses by 32 percent As per its balance sheet ending December 31^st, 2009 the companys total assets stood at $21.40 million with current assets having the highest proportion standing at $15.97 million. Further the most promising financial aspect of Discover Laboratories is that cash and cash equivalents happen to have the proportion of more than 98 percent in total figure of current assets which depicts the companys high liquidity positions and its ability to lay off its current liabilities any time.
The company has no long term debt at all whereas its long term capital lease obligations stand at $0.43 million ending up in total liabilities of $16.92 million.
FDA Update On 2/16/10,
DSCO announced that in response to written guidance recently received from FDA, it will now focus on a pathway that would entail solely performing additional preclinical work, instead of conducting a limited clinical trial to potentially gain FDA marketing approval for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Based on prior guidance received from the FDA,
DSCO expected that a limited, pharmaco-dynamic (PD) based on study in preterm infacts would be required to address the sole remaining Chemistry, Manufacturing & Control (CMC) issue regarding the final validation of a fetal rabbit Biological Activity Test (BAT, an important quality control release and stability test) necessary for Surfaxin approval.
DSCO believes a Complete Response coudl be submitted to the FDA during 1Q11.
DSCO stated that the safety and efficacy of Surfaxin for RDS has previously been demonstrated in a comprehensive phase 3 clinical program and consistent with previous communications from the FDA there continues to be no noquestions regarding clinical trial data and no indication that the FDA has any concerns related to other quality assurance tests or the manufacturing process for Surfaxin.
Other Key Pipeline Programs Discovery Labs is conducting a Phase 2 clinical trial to determine whether Surfaxin improves lung function and reduces the duration and related risk-exposure of mechanical ventilation in children up to two years of age diagnosed with Acute Respiratory Failure (ARF). ARF is a severe respiratory disorder associated with lung injury, often entailing surfactant dysfunction.
ARF occurs after patients have been exposed to serious respiratory infections, such as influenza (including the type A serotype referred to as H1N1) or respiratory syncytial virus (RSV). Hospitalization following influenza or other viral infection is associated with high morbidity and significant healthcare costs. Enrollment is now completed and top-line results are expected to be available in June 2010.
Surfaxin LS(TM) (lyophilized dry powder formulation of KL4 surfactant) and Aerosurf^(R) (aerosolized formulation of KL4 surfactant) have the potential to greatly improve the management of RDS and represent the opportunity, over time, to expand the current RDS estimated worldwide annual market of $200 million to a $1 billion opportunity. Surfaxin LS is intended to improve product ease of use for healthcare practitioners, eliminate the need for cold-chain storage, and potentially further improve product clinical performance. Aerosurf holds the promise to significantly expand the use of surfactant therapy in pediatric respiratory medicine by providing neonatologists with a means of delivering KL4 surfactant while potentially avoiding the risks associated with invasive endotracheal intubation and mechanical ventilation.
The Company is currently conducting important preclinical activities for both Surfaxin LS and Aerosurf as well as advancing development of its capillary aerosolization device to support regulatory requirements for its planned clinical programs. The Company is preparing to further engage the FDA and international regulatory agencies with respect to its planned Phase 3 clinical program for Surfaxin LS and Phase 2 clinical program for Aerosurf. The Company intends to initiate these clinical programs upon determining final regulatory strategy and after securing appropriate strategic alliances and necessary capital.
Aerosolized KL4 surfactant is being evaluated in an investigator-initiated Phase 2a clinical trial in Cystic Fibrosis (CF) patients. The trial is being conducted at a leading research center, The University of North Carolina, and is further supported by the Cystic Fibrosis Foundation. The trial has been designed to assess the safety, tolerability and short-term effectiveness (via improvement in mucociliary clearance) of aerosolized KL4 surfactant in CF patients. Enrollment is approximately 70% complete and top-line results are now expected in the third quarter of 2010.
The full report is available here:
[3]http://www.themarketfinancial.com/discovery-laboratories-small-biotech-compa ny-with-multiple-prime-time-catalysts/2544 Regards, TMF Staff Latest Updates ___________________________________________________________________________ *
DSCO is awaiting major pipepeline updates which could send shares significantly higher [4] [5]Disclaimer | [6]Terms of Use | [7]Contact Us | [8]About Us | [9]Become an Author |
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