Discovery Laboratories Inc ...nach dem 1:15 R/S

Discovery Labs Announces Reverse Stock Split  
 
Date : 12/27/2010 @ 5:00PM  
Source : GlobeNewswire  Inc.  
Stock : Discovery Laboratories, Inc. (DSCO)  
 
 
 http://ih.advfn.com/...pid=nmona&article=45796169&symbol=DSCO  
 
Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced  that it has filed a Certificate of Amendment to its Amended and Restated  Certificate of Incorporation (the "Amendment") to effect a 1-for-15  share consolidation, or reverse stock split ("reverse split"), effective  at 12:01 a.m. on December 28, 2010 (the "Effective Time"). In  addition, the Amendment reduces the number of shares of common stock,  par value $0.001 per share, authorized under the Certificate of  Incorporation from 380 million to 50 million. Because the  Amendment does not reduce the number of authorized shares of common  stock in the same proportion as the reverse split, the effect of the  Amendment is to increase the number of shares of common stock available  for issuance relative to the number of shares issued and outstanding.  The stockholders of Discovery Labs approved proposals authorizing the  Board of Directors, in its discretion, to implement the reverse split  and reduce the number of authorized shares of common stock at the Annual  Meeting of Stockholders held on December 21, 2010.
 
The Board  of Directors of Discovery Labs has determined to implement the reverse  split at this time to enable the market price per-share of its common  stock to close above $1.00, which is a continued listing requirement of  The NASDAQ Capital Market® ("Nasdaq").  On November 30, 2010, Discovery  Labs received a Staff Determination letter from Nasdaq indicating that  it had not established compliance with Nasdaq Listing Rule 5550(a)(2)  ("Minimum Bid Price Rule") because its common stock had not closed above  $1.00 per share over a period of 10 consecutive business days ending on  or prior to November 29, 2010, and that its stock is subject to  delisting. Discovery Labs has requested a hearing with Nasdaq to review  the Staff Determination and believes that implementation of the reverse  split will support its continued listing on Nasdaq. Discovery Labs  believes that continued listing on Nasdaq, combined with the increase in  shares available for issuance, will enhance its ability to secure  necessary capital from potential strategic partners and prospective  investors to achieve its key business objectives, including potentially  gaining U.S. Food and Drug Administration (FDA) approval for its lead  product, Surfaxin®, for the prevention of respiratory distress syndrome  (RDS) in premature infants.
 
Details of the Reverse Split
 
At the Effective Time, immediately and without further action by  Discovery Labs' stockholders, every 15 shares of Discovery Labs'  pre-split common stock, par value $0.001 per share, will automatically  be converted into one share of post-split common stock, par value $0.001  per share. In lieu of fractional shares, stockholders will receive cash  in an amount equal to the product obtained by multiplying (i) the  closing sale price per share on the business day immediately preceding  the Effective Time as reported on Nasdaq by (ii) the number of shares of  common stock held by the stockholder that would otherwise have been  exchanged for the fractional share interest.
 
The immediate  effect of the reverse split will be to reduce the number of shares of  Discovery Labs' common stock that are issued and outstanding to  approximately 13.8 million shares (excluding shares reserved for  stock options and unexercised warrants), adjusted for fractional  interests. The reverse split will affect all stockholders uniformly and  will have no effect on the proportionate holdings of any individual  stockholder, with the exception of adjustments related to fractional  shares. There will be no change in the number of stockholders of record  as a result of the reverse split. Following the reverse split, all  shares will remain fully paid and non-assessable.
 
To inform  the market of the reverse split, Discovery Labs expects that Nasdaq will  append a suffix character, "D," to the Company's trading symbol (DSCO)  for approximately 20 days after the Effective Time.  After the ~20  trading-day period, the ticker symbol will revert to "DSCO".  In  addition, Discovery Labs' common stock will also trade under a new CUSIP  number beginning on December 28, 2010.
 
Additional  information can be found in Discovery Labs' definitive proxy statement,  which was filed with the SEC on November 15, 2010 and is available on  the Company's website at www.Discoverylabs.com.

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Under terms of the facility, Deerfield committed to advance $30 million in 2013: $10 million immediately following execution of the facility agreement and $20 million upon the first commercial sale of SURFAXIN.  The loan matures six years from the date of the facility agreement and may be prepaid in whole or in part without penalty at any time.  The principal amount of the loan is payable in three equal annual installments on the fourth, fifth and sixth anniversaries of the facility agreement, except that, if Discovery Labs achieves certain revenue or market capitalization targets, the principal payments due on the fourth and fifth anniversaries could be deferred for one year.  Accordingly, if the milestones are achieved, payment of the principal amount could be deferred until the maturity date of the loan in 2019.  The outstanding principal amount of the loan at any time will accrue interest at a rate of 8.75% per annum, payable quarterly in cash.  The facility agreement contains customary terms and conditions but does not require Discovery Labs to meet minimum financial and revenue performance covenants.  In connection with each advance, Deerfield will receive a transaction fee equal to 1.5% of the amount disbursed.  In connection with the initial advance, Deerfield will receive warrants to purchase 2.3 million shares of common stock, par value $.001 per share (Common Stock), at an exercise price of $2.81 per share, which represents a premium of 24% over the closing price of the Company's common stock preceding the execution of the facility agreement.  Upon disbursement of the $20 million advance, Deerfield will receive warrants to purchase an additional 4.7 million shares of Common Stock at the same exercise price per share of Common Stock.  All of the warrants will expire on the sixth anniversary date of the facility agreement.

Additional information about the facility and the terms of the related agreements is included in a Current Report on Form 8-K that is expected to be filed today with the Securities and Exchange Commission.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of the securities discussed herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any state.  

ABOUT DISCOVERY LABS

Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to advance a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant.  Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  

Discovery Labs' strategy is initially focused on the development of its technologies to improve the management of respiratory distress syndrome (RDS) in premature infants.  SURFAXIN is the first synthetic, peptide-containing (KL4) surfactant approved by the FDA and the only alternative to animal-derived surfactants.  

AEROSURF is a drug/device combination product being developed to enable efficient delivery of aerosolized KL4 surfactant.  If approved, AEROSURF potentially will provide neonatologists with the ability to deliver surfactant therapy using a less-invasive method and thereby enable the treatment of premature infants who could benefit from surfactant therapy but who are currently not treated.  Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, to significantly expand the current worldwide RDS market.

For more information, please visit www.Discoverylabs.com.

ABOUT DEERFIELD

Deerfield is committed to advancing healthcare through investment, information and philanthropy.

For more information about Deerfield, please visit www.deerfield.com

IMPORTANT SAFETY INFORMATION

SURFAXIN (lucinactant) intratracheal suspension is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.

Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.  During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized.  SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).

For more information about SURFAXIN, please visit www.surfaxin.com

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including without limitation those related to the terms and conditions of the Deerfield agreements, including the security agreement, the warrants, the related registration rights agreement ("Transaction Documents"), Discovery Labs' ability to comply with the terms and conditions of the Transaction Documents, the anticipated U.S. commercial introduction of SURFAXIN, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.  Any forward-looking statement in this release speaks only as of the date on which it is made. The Company assumes no obligation to update or revise any forward-looking statements.

SOURCE Discovery Laboratories, Inc.


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The U.S. Food and Drug Administration (FDA) approved SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants who are at high risk for RDS.  SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants.
IMPORTANT SAFETY INFORMATION
SURFAXIN is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.  During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized.  
SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).
For more information about SURFAXIN, please visit www.surfaxin.com.
ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant.  Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  Discovery Labs' strategy is initially focused on neonatology and improving the management of respiratory distress syndrome (RDS) in premature infants.  Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, significantly expand the current worldwide RDS market.
For more information, please visit the Company's website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties, including those related to Discovery Labs' plans to manufacture commercial lots of SURFAXIN and the timing of the commercial launch and market acceptance of SURFAXIN, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.  Any forward-looking statement in this release speaks only as of the date on which it is made.  The Company assumes no obligation to update or revise any forward-looking statements.
SOURCE Discovery Laboratories, Inc.

Copyright 2013 PR Newswire

AEROSURF is a novel investigational drug-device combination product being developed to deliver Discovery Labs' KL4 surfactant in aerosolized form to premature infants with respiratory distress syndrome (RDS).  AEROSURF could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
About Respiratory Distress Syndrome (RDS)
RDS is a condition in which premature infants are born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen.  Premature infants born prior to 37 weeks gestation have not fully developed their own natural lung surfactant and therefore need treatment to sustain life.  RDS is experienced in approximately half of the babies born between 26 and 32 weeks gestational age.  The incidence of RDS approaches 100 percent in babies born less than 26 weeks gestational age.  RDS can result in long-term respiratory problems and death.
Premature infants with RDS currently are treated with surfactants that can only be administered by endotracheal intubation supported with mechanical ventilation, both invasive procedures that may result in serious respiratory conditions and complications.  To avoid such adverse results, neonatologists generally provide surfactants as initial therapy only to premature infants with severe RDS where the potential benefits of surfactant therapy outweigh the risks associated with endotracheal intubation and mechanical ventilation.  For infants with less severe RDS, neonatologists will first attempt to provide respiratory support using a less invasive means, such as nasal continuous positive airway pressure (nCPAP).  Unfortunately, a significant number of these infants do not respond adequately to nCPAP, an outcome referred to as nCPAP failure, and require subsequent surfactant administration via intubation and mechanical ventilation.  As it is not possible to ascertain in advance which infants will experience nCPAP failure, neonatologists are faced with a dilemma, because the outcome for those infants who experience nCPAP failure and receive delayed surfactant therapy may not be as favorable as the outcome for those infants who receive surfactant therapy as initial therapy.
Discovery Labs estimates that, on an annual basis, approximately 160,000 premature infants in the U.S. could potentially benefit from early surfactant therapy to address surfactant deficiency or insufficiency.  However, only approximately 45,000 will receive surfactants as an initial therapy.  More than 70 percent of surfactant deficient infants (approximately 115,000) do not receive first-line surfactant therapy and instead receive nCPAP alone.
Discovery Labs believes that the neonatal medical community increasingly recognizes the potential of a synthetic, peptide-containing surfactant, such as SURFAXIN® and, importantly, a less-invasive method of delivering surfactant, such as AEROSURF, to treat premature infants at risk of suffering from respiratory disorders.  
About Discovery Labs
Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care.  Discovery Labs' technology platforms include a novel proprietary KL4 surfactant, a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant, and proprietary drug delivery technologies being developed to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.  Discovery Labs' strategy is initially focused on neonatology and improving the management of respiratory distress syndrome (RDS) in premature infants.  Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
About SURFAXIN®
The U.S. Food and Drug Administration (FDA) approved SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants who are at high risk for RDS.  SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants.
IMPORTANT SAFETY INFORMATION
SURFAXIN is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting.  Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.  During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized.  SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).
For more information about SURFAXIN, please visit www.surfaxin.com.
Disclosure Note: The RDS population estimates and data included in the discussion above have been derived from the following sources, among others: IMS MIDAS data (MAT Sept 2008); CDC National Vital Statistics, 2005, Births by birth weight (CDC Website); "Annual Summary of Vital Statistics: 2006", Pediatrics, Martin et al.; Vermont Oxford Network (VON) data, 2006; UNICEF data, 2005 (website); and our primary market research (2010).  Discovery Labs' estimate of the number of premature infants that could potentially benefit from early surfactant therapy is derived from data from the foregoing sources, taking into account several factors, including without limitation, gestational age of premature infants, treatment rates for nCPAP, rates of nCPAP failure, and incidence of RDS.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties include those related to Discovery Labs' research and development activities generally and, in particular, Discovery Labs' AEROSURF development program, including, among other things, (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or failure, and (ii) regulatory requirements relating to development and manufacture of the drug and aerosol delivery components of Discovery Labs' combination drug/device products, as well as those risks and uncertainties described in Discovery Labs' filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.  Any forward-looking statement in this release speaks only as of the date on which it is made.  Discovery Labs assumes no obligation to update or revise any forward-looking statements.

SOURCE Discovery Laboratories, Inc.

Copyright 2013 PR Newswire