is...wondering why God loves us so much?
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Earning tomorrow Premartket - GO! C!
Good Morning SSS!!!
FRDM looks great. Nice call Glass.
Cumberland Pharmaceuticals Receives FDA Approval for New Formulation of Acetadote
- Company commences launch of the next generation product
- Product shelf life extended from 24 to 30 months
NASHVILLE, Tenn., Jan. 13, 2011 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Acetadote® (acetylcysteine) Injection, the Company's product used to treat acetaminophen poisoning. The proprietary new formulation, which does not contain Ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives, will replace the currently marketed product. Cumberland is immediately commencing U.S. launch activities for this next generation Acetadote product and will no longer manufacture the previously approved formulation.
Acetadote, which has been available in the United States since Cumberland's 2004 introduction of the product, is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States, and Acetadote has become a standard of care for treating this potentially life-threatening condition.
"We are committed to further developing our products, whether to expand into new patient populations or to improve upon an existing formulation, and worked with the FDA to develop this new formulation of Acetadote," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We look forward to introducing this next generation product to the hospital community and the growing number of patients who will benefit from it."
The new formulation of Acetadote is the result of a phase IV commitment Cumberland made to the FDA upon receipt of initial marketing approval of the product. Cumberland initiated a program to develop the new formulation and determined that it could be prepared and scaled in a commercial manufacturing setting without compromising the potency, solubility or stability of the product. The Company obtained approval for an extended shelf life with the new product, up from 24 months for the original formulation to 30 months.
About Acetadote
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. For full prescribing information, visit www.acetadote.net.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States, and Kristalose® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information, please visit the company website at www.cumberlandpharma.com.
Important Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that reflect Cumberland's current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of operations are subject to influences outside of the Company's control. Risk factors that could materially affect results of operations include, among other things, market conditions, intense competition from existing and new products, an inability of manufacturers to produce Acetadote on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to drug manufacturers, maintaining and building an effective sales and marketing infrastructure, government regulation, the possibility that marketing exclusivity and patent rights may provide only limited protection from competition, and other factors related to the Company including those under the headings "Risk factors" and "Management's discussion and analysis of financial condition and results of operations" in Cumberland's Form 10-K filed with the SEC on March 19, 2010. There can be no assurance that the results or developments anticipated by Cumberland will be realized or, if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof.
SOURCE Cumberland Pharmaceuticals Inc.
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RELATED LINKS
http://www.cumberlandpharma.com
Cumberland Pharmaceuticals Receives FDA Approval for New Formulation of Acetadote
- Company commences launch of the next generation product
- Product shelf life extended from 24 to 30 months
NASHVILLE, Tenn., Jan. 13, 2011 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Acetadote® (acetylcysteine) Injection, the Company's product used to treat acetaminophen poisoning. The proprietary new formulation, which does not contain Ethylene diamine tetracetic acid or any other stabilization and chelating agents and is free of preservatives, will replace the currently marketed product. Cumberland is immediately commencing U.S. launch activities for this next generation Acetadote product and will no longer manufacture the previously approved formulation.
Acetadote, which has been available in the United States since Cumberland's 2004 introduction of the product, is currently used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States, and Acetadote has become a standard of care for treating this potentially life-threatening condition.
"We are committed to further developing our products, whether to expand into new patient populations or to improve upon an existing formulation, and worked with the FDA to develop this new formulation of Acetadote," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We look forward to introducing this next generation product to the hospital community and the growing number of patients who will benefit from it."
The new formulation of Acetadote is the result of a phase IV commitment Cumberland made to the FDA upon receipt of initial marketing approval of the product. Cumberland initiated a program to develop the new formulation and determined that it could be prepared and scaled in a commercial manufacturing setting without compromising the potency, solubility or stability of the product. The Company obtained approval for an extended shelf life with the new product, up from 24 months for the original formulation to 30 months.
About Acetadote
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. For full prescribing information, visit www.acetadote.net.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States, and Kristalose® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information, please visit the company website at www.cumberlandpharma.com.
Important Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that reflect Cumberland's current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of operations are subject to influences outside of the Company's control. Risk factors that could materially affect results of operations include, among other things, market conditions, intense competition from existing and new products, an inability of manufacturers to produce Acetadote on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to drug manufacturers, maintaining and building an effective sales and marketing infrastructure, government regulation, the possibility that marketing exclusivity and patent rights may provide only limited protection from competition, and other factors related to the Company including those under the headings "Risk factors" and "Management's discussion and analysis of financial condition and results of operations" in Cumberland's Form 10-K filed with the SEC on March 19, 2010. There can be no assurance that the results or developments anticipated by Cumberland will be realized or, if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof.
SOURCE Cumberland Pharmaceuticals Inc.
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RELATED LINKS
http://www.cumberlandpharma.com
I was just about to reply to that post lol - GOOD MORNING SSS!!!!
Well said Chevy - this is an 8K posted from back in Dec.
Form 8-K for CALIFORNIA COASTAL COMMUNITIES INC
8-Dec-2010
Bankruptcy or Receivership, Financial Statements and Exhibits
Item 1.03. Bankruptcy or Receivership.
On December 7, 2010, California Coastal Communities, Inc. (the "Company") and certain of its direct and indirect wholly-owned subsidiaries (collectively with the Company, the "Debtors") filed a motion for authority to enter into a Plan Support Agreement with a majority of its senior lenders comprising 81% of the senior revolving loan and 88 % of the senior term loan (the "Lenders") that will enable the Company to proceed with a consensual plan of reorganization (the "Plan") with respect to its Chapter 11 bankruptcy cases (the "Chapter 11 Cases"). The Chapter 11 Cases are being jointly administered in the United States Bankruptcy Court for the Central District of California (the "Bankruptcy Court"), Case No. 09-21712-TA. The Plan will be subject to approval by the Bankruptcy Court following Bankruptcy Court approval of the Debtors disclosure statement and solicitation of votes from creditors, and there can be no assurance that Bankruptcy Court approval will be obtained.
Under the proposed Plan:
(i) There will be no recovery by the holders of the Company's outstanding common stock.
(ii) Certain of the Lenders will enter into a debtor-in-possession term loan agreement (the "DIP Credit Agreement"), pursuant to which they will lend an aggregate of $15 million, in the form of senior secured super-priority loan advances, as follows:
$5.0 million upon the Bankruptcy Court's interim approval of the DIP Credit Agreement; and
$10.0 million upon final approval of the DIP Credit Agreement by the Bankruptcy Court.
(iii) Lenders under the DIP Credit Agreement will have an option to be converted into a first lien position in the principal amount of $15.0 million with an expected maturity date of March 1, 2013 and will be paid interest at an annual rate of Libor + 750 basis points with a Libor floor of 250 basis points (resulting in a current rate of 10.0%).
(iv) The $81.7 million existing senior revolving loan will be converted into a new second lien position loan, with an expected maturity date of March 1, 2016 and will be paid interest at the same rate as the DIP Credit Agreement.
(v) The existing $99.8 million senior term loan holders will receive a pro rata share of (a) a new third lien position loan in the principal amount of $44.0 million, with an expected maturity date of March 1, 2017 without any amortization required until the first and second lien loans are fully repaid and bearing interest at an annual fixed rate of 15%, with all of such interest accruing and being added to the principal balance until the first and second lien loans are fully repaid; and (b) 100% of the equity in the reorganized Company.
(vi) General unsecured creditors will share on a pro rata basis, based on the face amount of allowed claims, in a $2 to 3 million trust for general unsecured claims.
A copy of the press release dated December 7, 2010 announcing, among other things, the filing of the motion for authority to enter into the Plan Support Agreement for implementation of the proposed Plan and the DIP Credit Agreement is attached hereto as Exhibit 99.1.
This Form 8-K contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The most significant among these risks and uncertainties are: (i) the ability of the Company to continue as a going concern; (ii) the Company's ability to obtain Bankruptcy Court approval with respect to the DIP Credit Agreement, the Plan Support Agreement and the Plan, and other motions in the Chapter 11 Cases; (iii) risks associated with third party motions in the Chapter 11 Cases which may interfere with the Company's ability to consummate the Plan; (iv) the ability to execute the Company's business and restructuring plan; (v) the Company's ability to maintain contracts that are critical to its operation and to retain key executives, managers and employees. The cautionary statements provided above are being made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 (the "Act") and with the intention of obtaining the benefits of the "safe harbor" provisions of the Act for any such forward-looking information. Additional risks that may affect the Company's future performance are detailed in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Exhibit Description
99.1 Press Release dated December 7, 2010
GM YAK & SSS!!!!
Good Morning VVV!
GM YAK - Good Morning SSS!
you make me laugh
Happy New Year Z!! Sana Sa3eeda :)
Happy New Year Yak!!
Happy New Year Soto!!!
my doors will be open :)
MERRY NEW YEAR MM AND ALL OF VVV!
Happy new year SSS!!!!!!!!!!!!
land - less supply more demand?
you blow my mind - rationale = logic!
A float like this - dangerous to short?
sure anytime :)
do you want it in pennies, nickels, dimes, quarters, half dollars, Sacagawea coin or green paper dollar bill......anything for you glass.
Pacific Capital Bancorp Reverse Stock Split Effective Today
4:00p ET December 28, 2010 (Business Wire)
Pacific Capital Bancorp (Nasdaq: PCBC) announced today that its previously disclosed 1-for-100 reverse stock split of its common stock became effective at 1:00 p.m. California time today. Commencing December 29, 2010, the Company's shares will trade on the NASDAQ Global Select Market under the symbol "PCBCD" for a period of 20 trading days as a result of the reverse stock split. The Company's symbol will revert back to its original symbol "PCBC" on January 27, 2010. The Company's common stock has been assigned a new CUSIP number 69404P 200.
The reverse stock split applies to all of the Company's outstanding common stock, reducing the current number of outstanding shares from approximately 3.29 billion to approximately 32.9 million (without giving effect to the treatment of fractional shares). Shareholders will receive cash in lieu of fractional shares. In connection with the reverse stock split, the Company also proportionately reduced the number of its authorized shares of common stock from 5 billion to 50 million.
The Company's shareholders of record will receive a letter of transmittal and instructions from the Company's exchange agent, BNY Mellon Shareowner Services, regarding the procedures for submitting their stock certificates in connection with the reverse stock split. Those shareholders holding the Company's common stock in "street name" will receive instructions from their broker if they need to take any action in connection with the reverse stock split.
The Company also announced that its previously disclosed reincorporation from California to Delaware is expected to be effected on December 30, 2010.
Additional information about the reverse stock split and the reincorporation is available in the Company's definitive information statement on Schedule 14C filed with the Securities and Exchange Commission on December 6, 2010.
About Pacific Capital Bancorp
Pacific Capital Bancorp, with $6.3 billion in assets, is the parent company of Pacific Capital Bank, N.A., a nationally chartered bank that operates 47 branches under the local brand names of Santa Barbara Bank & Trust, First National Bank of Central California, South Valley National Bank, San Benito Bank and First Bank of San Luis Obispo. The Company's website is www.pcbancorp.com.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, but not limited to, statements regarding the reverse stock split and the reincorporation. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements in these provisions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. The Company cautions you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are detailed in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2009 and the Company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010, June 30, 2010 and September 30, 2010. The Company cautions that the foregoing factors are not exclusive.
SOURCE: Pacific Capital Bancorp
Pacific Capital Bancorp
Debbie Whiteley, Investor Relations
805-884-6680
Debbie.Whiteley@pcbancorp.com
Pacific Capital Bancorp Reverse Stock Split Effective Today
4:00p ET December 28, 2010 (Business Wire)
Pacific Capital Bancorp (Nasdaq: PCBC) announced today that its previously disclosed 1-for-100 reverse stock split of its common stock became effective at 1:00 p.m. California time today. Commencing December 29, 2010, the Company's shares will trade on the NASDAQ Global Select Market under the symbol "PCBCD" for a period of 20 trading days as a result of the reverse stock split. The Company's symbol will revert back to its original symbol "PCBC" on January 27, 2010. The Company's common stock has been assigned a new CUSIP number 69404P 200.
The reverse stock split applies to all of the Company's outstanding common stock, reducing the current number of outstanding shares from approximately 3.29 billion to approximately 32.9 million (without giving effect to the treatment of fractional shares). Shareholders will receive cash in lieu of fractional shares. In connection with the reverse stock split, the Company also proportionately reduced the number of its authorized shares of common stock from 5 billion to 50 million.
The Company's shareholders of record will receive a letter of transmittal and instructions from the Company's exchange agent, BNY Mellon Shareowner Services, regarding the procedures for submitting their stock certificates in connection with the reverse stock split. Those shareholders holding the Company's common stock in "street name" will receive instructions from their broker if they need to take any action in connection with the reverse stock split.
The Company also announced that its previously disclosed reincorporation from California to Delaware is expected to be effected on December 30, 2010.
Additional information about the reverse stock split and the reincorporation is available in the Company's definitive information statement on Schedule 14C filed with the Securities and Exchange Commission on December 6, 2010.
About Pacific Capital Bancorp
Pacific Capital Bancorp, with $6.3 billion in assets, is the parent company of Pacific Capital Bank, N.A., a nationally chartered bank that operates 47 branches under the local brand names of Santa Barbara Bank & Trust, First National Bank of Central California, South Valley National Bank, San Benito Bank and First Bank of San Luis Obispo. The Company's website is www.pcbancorp.com.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, but not limited to, statements regarding the reverse stock split and the reincorporation. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements in these provisions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. The Company cautions you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are detailed in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2009 and the Company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010, June 30, 2010 and September 30, 2010. The Company cautions that the foregoing factors are not exclusive.
SOURCE: Pacific Capital Bancorp
Pacific Capital Bancorp
Debbie Whiteley, Investor Relations
805-884-6680
Debbie.Whiteley@pcbancorp.com
Pacific Capital Bancorp Reverse Stock Split Effective Today
4:00p ET December 28, 2010 (Business Wire)
Pacific Capital Bancorp (Nasdaq: PCBC) announced today that its previously disclosed 1-for-100 reverse stock split of its common stock became effective at 1:00 p.m. California time today. Commencing December 29, 2010, the Company's shares will trade on the NASDAQ Global Select Market under the symbol "PCBCD" for a period of 20 trading days as a result of the reverse stock split. The Company's symbol will revert back to its original symbol "PCBC" on January 27, 2010. The Company's common stock has been assigned a new CUSIP number 69404P 200.
The reverse stock split applies to all of the Company's outstanding common stock, reducing the current number of outstanding shares from approximately 3.29 billion to approximately 32.9 million (without giving effect to the treatment of fractional shares). Shareholders will receive cash in lieu of fractional shares. In connection with the reverse stock split, the Company also proportionately reduced the number of its authorized shares of common stock from 5 billion to 50 million.
The Company's shareholders of record will receive a letter of transmittal and instructions from the Company's exchange agent, BNY Mellon Shareowner Services, regarding the procedures for submitting their stock certificates in connection with the reverse stock split. Those shareholders holding the Company's common stock in "street name" will receive instructions from their broker if they need to take any action in connection with the reverse stock split.
The Company also announced that its previously disclosed reincorporation from California to Delaware is expected to be effected on December 30, 2010.
Additional information about the reverse stock split and the reincorporation is available in the Company's definitive information statement on Schedule 14C filed with the Securities and Exchange Commission on December 6, 2010.
About Pacific Capital Bancorp
Pacific Capital Bancorp, with $6.3 billion in assets, is the parent company of Pacific Capital Bank, N.A., a nationally chartered bank that operates 47 branches under the local brand names of Santa Barbara Bank & Trust, First National Bank of Central California, South Valley National Bank, San Benito Bank and First Bank of San Luis Obispo. The Company's website is www.pcbancorp.com.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, but not limited to, statements regarding the reverse stock split and the reincorporation. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements in these provisions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. The Company cautions you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are detailed in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2009 and the Company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010, June 30, 2010 and September 30, 2010. The Company cautions that the foregoing factors are not exclusive.
SOURCE: Pacific Capital Bancorp
Pacific Capital Bancorp
Debbie Whiteley, Investor Relations
805-884-6680
Debbie.Whiteley@pcbancorp.com
Good Morning YAK!
Especially, if they rally into the split to higher their pps - Extremely shady!!!
Discovery Labs Announces Reverse Stock Split
Posted on: Mon, 27 Dec 2010 17:00:04 EST
Symbols: DSCO
WARRINGTON, Pa., Dec 27, 2010 (GlobeNewswire via COMTEX) --
Discovery Laboratories, Inc. (Nasdaq: DSCO | PowerRating) 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(R) ("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(R), 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.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our 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, including with respect to the potential continued listing of the Company's common stock on the Nasdaq Capital Market, the potential approval in the United States of Surfaxin for the prevention of RDS in premature infants, and the ability of the Company to fund its activities through strategic and financing transactions or otherwise, 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 are described in the Company's filings with the Securities and Exchange Commission including the Company's proxy statement on Schedule 14A and the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Discovery Laboratories, Inc.
CONTACT: Discovery Laboratories, Inc.
Investor relations:
John G. Cooper, President and Chief Financial Officer
215-488-9490
For full details on Discovery Labs Inc (DSCO) DSCO. Discovery Labs Inc (DSCO) has Short Term PowerRatings at TradingMarkets. Details on Discovery Labs Inc (DSCO) Short Term PowerRatings is available at This Link.
Discovery Labs Announces Reverse Stock Split
Posted on: Mon, 27 Dec 2010 17:00:04 EST
Symbols: DSCO
WARRINGTON, Pa., Dec 27, 2010 (GlobeNewswire via COMTEX) --
Discovery Laboratories, Inc. (Nasdaq: DSCO | PowerRating) 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(R) ("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(R), 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.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our 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, including with respect to the potential continued listing of the Company's common stock on the Nasdaq Capital Market, the potential approval in the United States of Surfaxin for the prevention of RDS in premature infants, and the ability of the Company to fund its activities through strategic and financing transactions or otherwise, 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 are described in the Company's filings with the Securities and Exchange Commission including the Company's proxy statement on Schedule 14A and the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Discovery Laboratories, Inc.
CONTACT: Discovery Laboratories, Inc.
Investor relations:
John G. Cooper, President and Chief Financial Officer
215-488-9490
For full details on Discovery Labs Inc (DSCO) DSCO. Discovery Labs Inc (DSCO) has Short Term PowerRatings at TradingMarkets. Details on Discovery Labs Inc (DSCO) Short Term PowerRatings is available at This Link.
Discovery Labs Announces Reverse Stock Split
Posted on: Mon, 27 Dec 2010 17:00:04 EST
Symbols: DSCO
WARRINGTON, Pa., Dec 27, 2010 (GlobeNewswire via COMTEX) --
Discovery Laboratories, Inc. (Nasdaq: DSCO | PowerRating) 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(R) ("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(R), 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.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our 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, including with respect to the potential continued listing of the Company's common stock on the Nasdaq Capital Market, the potential approval in the United States of Surfaxin for the prevention of RDS in premature infants, and the ability of the Company to fund its activities through strategic and financing transactions or otherwise, 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 are described in the Company's filings with the Securities and Exchange Commission including the Company's proxy statement on Schedule 14A and the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Discovery Laboratories, Inc.
CONTACT: Discovery Laboratories, Inc.
Investor relations:
John G. Cooper, President and Chief Financial Officer
215-488-9490
For full details on Discovery Labs Inc (DSCO) DSCO. Discovery Labs Inc (DSCO) has Short Term PowerRatings at TradingMarkets. Details on Discovery Labs Inc (DSCO) Short Term PowerRatings is available at This Link.
EpiCept Announces Initiation of Phase 2B Study of Azixa(TM) for Front-Line Treatment of Glioblastoma Multiforme by Myrexis
12:01a ET December 28, 2010 (Business Wire)
Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today reported that Myrexis, Inc. has initiated a controlled two-arm Phase 2b clinical study of Azixa(TM) as a front-line treatment for glioblastoma multiforme (GBM). Azixa(TM), a vascular disruption agent with potent anti-cancer activity, was discovered by EpiCept as part of its ASAP technology platform and licensed to Myrexis.
The study will enroll up to 120 newly-diagnosed GBM patients at treatment centers in the United States and India in order to evaluate Azixa(TM) combination therapy as a first-line GBM treatment. The trial will compare standard of care in this disease with standard of care in combination with Azixa(TM).
"We are pleased that Myrexis is continuing to evaluate Azixa and that they continue to see promise for the compound in a devastating disease for which current therapy is inadequate," said Jack Talley, President and Chief Executive Officer of EpiCept. "We expect them to continue to move the product candidate forward towards registration in the United States."
Azixa(TM) is currently being evaluated in other Phase II trials. In June 2010, Myrexis reported results from two of the Phase II trials, in metastatic melanoma in combination with temozolomide and in recurrent glioblastoma in combination with carboplatin, at the annual meeting of the American Society for Clinical Oncology (ASCO). Updated results from an ongoing, open-label Phase 2a monotherapy study of Azixa(TM) in treatment-experienced patients with glioblastoma multiforme (GBM) were presented in November 2010, and data from a sub-group of patients with recurrent GBM who are naive to Avastin is expected to be reported in the first half of 2011.
As one of the molecules within the EpiCept EP90745 series of apoptosis inducer compounds intended for the treatment of cancer, Azixa(TM) was discovered through the Company's Anti-cancer Screening Apoptosis Platform (ASAP). In December 2003, EpiCept granted an exclusive, worldwide development and commercialization agreement for the EP90745 series (which includes Azixa(TM)) to Myrexis, which assumed responsibility for the clinical development and commercialization of this series of compounds. The license agreement requires Myrexis to make milestone payments and pay license fees as well as a royalty to EpiCept on sales of EP90745-related products, assuming successful commercialization of any compound within the EP90745 series. The dosing of the first patient in a Phase III or equivalent trial intended to be used for registration purposes for Azixa(TM) triggers a milestone payment to EpiCept.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene(R), approved in the EU for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. In the U.S., a pivotal trial is scheduled to commence in 2011. The Company has two other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCept(TM) NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that Azixa(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myrexis, the risk that the development of our other apoptosis product candidates will not be successful; the risk that Ceplene(R) will not receive regulatory approval or marketing authorization in the United States, the risk that Ceplene(R) will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene(R) will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene(R), the risk that future financing will not successfully close or that the proceeds thereof will be materially less than anticipated, the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that clinical trials for EpiCept(TM) NP-1 or crolibulin(TM) will not be successful, the risk that EpiCept(TM) NP-1 or crolibulin(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for EpiCept(TM) NP-1 on attractive terms, a timely basis or at all, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; the risk that our securities may be delisted from Nasdaq; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
EPCT-GEN
SOURCE: EpiCept Corporation
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
EpiCept Announces Initiation of Phase 2B Study of Azixa(TM) for Front-Line Treatment of Glioblastoma Multiforme by Myrexis
12:01a ET December 28, 2010 (Business Wire)
Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today reported that Myrexis, Inc. has initiated a controlled two-arm Phase 2b clinical study of Azixa(TM) as a front-line treatment for glioblastoma multiforme (GBM). Azixa(TM), a vascular disruption agent with potent anti-cancer activity, was discovered by EpiCept as part of its ASAP technology platform and licensed to Myrexis.
The study will enroll up to 120 newly-diagnosed GBM patients at treatment centers in the United States and India in order to evaluate Azixa(TM) combination therapy as a first-line GBM treatment. The trial will compare standard of care in this disease with standard of care in combination with Azixa(TM).
"We are pleased that Myrexis is continuing to evaluate Azixa and that they continue to see promise for the compound in a devastating disease for which current therapy is inadequate," said Jack Talley, President and Chief Executive Officer of EpiCept. "We expect them to continue to move the product candidate forward towards registration in the United States."
Azixa(TM) is currently being evaluated in other Phase II trials. In June 2010, Myrexis reported results from two of the Phase II trials, in metastatic melanoma in combination with temozolomide and in recurrent glioblastoma in combination with carboplatin, at the annual meeting of the American Society for Clinical Oncology (ASCO). Updated results from an ongoing, open-label Phase 2a monotherapy study of Azixa(TM) in treatment-experienced patients with glioblastoma multiforme (GBM) were presented in November 2010, and data from a sub-group of patients with recurrent GBM who are naive to Avastin is expected to be reported in the first half of 2011.
As one of the molecules within the EpiCept EP90745 series of apoptosis inducer compounds intended for the treatment of cancer, Azixa(TM) was discovered through the Company's Anti-cancer Screening Apoptosis Platform (ASAP). In December 2003, EpiCept granted an exclusive, worldwide development and commercialization agreement for the EP90745 series (which includes Azixa(TM)) to Myrexis, which assumed responsibility for the clinical development and commercialization of this series of compounds. The license agreement requires Myrexis to make milestone payments and pay license fees as well as a royalty to EpiCept on sales of EP90745-related products, assuming successful commercialization of any compound within the EP90745 series. The dosing of the first patient in a Phase III or equivalent trial intended to be used for registration purposes for Azixa(TM) triggers a milestone payment to EpiCept.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene(R), approved in the EU for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. In the U.S., a pivotal trial is scheduled to commence in 2011. The Company has two other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCept(TM) NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that Azixa(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myrexis, the risk that the development of our other apoptosis product candidates will not be successful; the risk that Ceplene(R) will not receive regulatory approval or marketing authorization in the United States, the risk that Ceplene(R) will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene(R) will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene(R), the risk that future financing will not successfully close or that the proceeds thereof will be materially less than anticipated, the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that clinical trials for EpiCept(TM) NP-1 or crolibulin(TM) will not be successful, the risk that EpiCept(TM) NP-1 or crolibulin(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for EpiCept(TM) NP-1 on attractive terms, a timely basis or at all, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; the risk that our securities may be delisted from Nasdaq; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
EPCT-GEN
SOURCE: EpiCept Corporation
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
EpiCept Announces Initiation of Phase 2B Study of Azixa(TM) for Front-Line Treatment of Glioblastoma Multiforme by Myrexis
12:01a ET December 28, 2010 (Business Wire)
Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today reported that Myrexis, Inc. has initiated a controlled two-arm Phase 2b clinical study of Azixa(TM) as a front-line treatment for glioblastoma multiforme (GBM). Azixa(TM), a vascular disruption agent with potent anti-cancer activity, was discovered by EpiCept as part of its ASAP technology platform and licensed to Myrexis.
The study will enroll up to 120 newly-diagnosed GBM patients at treatment centers in the United States and India in order to evaluate Azixa(TM) combination therapy as a first-line GBM treatment. The trial will compare standard of care in this disease with standard of care in combination with Azixa(TM).
"We are pleased that Myrexis is continuing to evaluate Azixa and that they continue to see promise for the compound in a devastating disease for which current therapy is inadequate," said Jack Talley, President and Chief Executive Officer of EpiCept. "We expect them to continue to move the product candidate forward towards registration in the United States."
Azixa(TM) is currently being evaluated in other Phase II trials. In June 2010, Myrexis reported results from two of the Phase II trials, in metastatic melanoma in combination with temozolomide and in recurrent glioblastoma in combination with carboplatin, at the annual meeting of the American Society for Clinical Oncology (ASCO). Updated results from an ongoing, open-label Phase 2a monotherapy study of Azixa(TM) in treatment-experienced patients with glioblastoma multiforme (GBM) were presented in November 2010, and data from a sub-group of patients with recurrent GBM who are naive to Avastin is expected to be reported in the first half of 2011.
As one of the molecules within the EpiCept EP90745 series of apoptosis inducer compounds intended for the treatment of cancer, Azixa(TM) was discovered through the Company's Anti-cancer Screening Apoptosis Platform (ASAP). In December 2003, EpiCept granted an exclusive, worldwide development and commercialization agreement for the EP90745 series (which includes Azixa(TM)) to Myrexis, which assumed responsibility for the clinical development and commercialization of this series of compounds. The license agreement requires Myrexis to make milestone payments and pay license fees as well as a royalty to EpiCept on sales of EP90745-related products, assuming successful commercialization of any compound within the EP90745 series. The dosing of the first patient in a Phase III or equivalent trial intended to be used for registration purposes for Azixa(TM) triggers a milestone payment to EpiCept.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene(R), approved in the EU for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. In the U.S., a pivotal trial is scheduled to commence in 2011. The Company has two other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCept(TM) NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that Azixa(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myrexis, the risk that the development of our other apoptosis product candidates will not be successful; the risk that Ceplene(R) will not receive regulatory approval or marketing authorization in the United States, the risk that Ceplene(R) will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene(R) will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene(R), the risk that future financing will not successfully close or that the proceeds thereof will be materially less than anticipated, the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that clinical trials for EpiCept(TM) NP-1 or crolibulin(TM) will not be successful, the risk that EpiCept(TM) NP-1 or crolibulin(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for EpiCept(TM) NP-1 on attractive terms, a timely basis or at all, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; the risk that our securities may be delisted from Nasdaq; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
EPCT-GEN
SOURCE: EpiCept Corporation
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
is it similar to hybrid cars? generating heat from the wheels etc...storing it for later use?
Happy Monday SSS - Wish i was here earlier :(
lol I KNOW!!!!!! it was the first thing i looked for !!!! LOOOL
And the follow-up:
Ceiling lights in Minn. send coded Internet data
saw this the other day - NO FOAM! lol More liquid piss!!!
Merry Christmas VVV board. MM, tina, glass, kommando.