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FDA Approval ??? 1-Oct-09 04:15 am Not Very Sure Any Changes On This.........
LONDON (MarketWatch) -- Biopharmaceutical research and development firm Adventrx Pharmaceuticals Inc. said Thursday that the U.S. Food and Drug Administration has granted fast track designation for ANX-510, or CoFactor injection, which is being investigated in a Phase 3 study on colorectal cancer. "The FDA's fast track designation represents a significant step towards bringing CoFactor to market as rapidly as possible," said CEO Evan Levine in a statement.
From end of October ?? - to hold on until the word comes out about their status on the FDA approval.....
FDA Approval ??? 1-Oct-09 04:15 am Not Very Sure Any Changes On This.........
LONDON (MarketWatch) -- Biopharmaceutical research and development firm Adventrx Pharmaceuticals Inc. said Thursday that the U.S. Food and Drug Administration has granted fast track designation for ANX-510, or CoFactor injection, which is being investigated in a Phase 3 study on colorectal cancer. "The FDA's fast track designation represents a significant step towards bringing CoFactor to market as rapidly as possible," said CEO Evan Levine in a statement.
From end of October ?? - to hold on until the word comes out about their status on the FDA approval.....
osinod
Banned
Submission Anticipated By Year-End 2009 SAN DIEGO--(BUSINESS WIRE)--Aug. 4, 2009-- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it intends to submit an NDA for ANX-530 (vinorelbine emulsion) by the end of 2009. The Company successfully completed the final manufacturing activities required for the NDA submission, which activities were re-started following the Company’s June 2009 equity financing.
“Our recently completed manufacturing activities represented the last major hurdle before our NDA submission,” said Brian M. Culley, Principal Executive Officer at ADVENTRX. “While we continue to evaluate the bioequivalence and preclinical data, we have begun the substantial process of compiling the information required for a submission, which we expect to take place by the end of this year.”
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin. Worldwide sales of Navelbine and its generic equivalents in 2006 were in excess of $200 million. The ANX-530 formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that may reduce exposure of the venous endothelium during administration of the drug.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company whose product candidates are designed to improve the safety of existing cancer treatments. More information can be found on the Company’s web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to submit an NDA for ANX-530, to fund operations during the FDA review period if an NDA is submitted, or to conduct pre-launch activities should an NDA for ANX-530 be submitted or launch activities should an NDA for ANX-530 be approved; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to continue as a going concern; the risk that ADVENTRX will seek protection under the provisions of the U.S. Bankruptcy Code; the risk that ADVENTRX will reassess the results of the ANX-530 bioequivalence study and determine to conduct additional bioequivalence studies of ANX-530, including in humans; the potential for regulatory authorities to require additional preclinical work and/or clinical activities to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-530, which activities may increase the cost and timeline to NDA submission or approval; the risk the FDA will determine that ANX-530 and Navelbine® are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based on a patient population other than the population on which ADVENTRX based its analysis; the risk of investigator bias in reporting adverse events as a result of the open-label nature of the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530, including validating commercial manufacturing processes and manufacturers, as well as suppliers; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; and other risks and uncertainties more fully described in ADVENTRX’s press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement as set forth in this press release to reflect events or circumstances arising after the date on which it was made.
Source: ADVENTRX Pharmaceuticals, Inc.
Company Contact:
ADVENTRX Pharmaceuticals
Brian Culley, Principal Executive Officer
858-552-0866
or
Investor Contact:
Lippert/Heilshorn & Associates, Inc.
Don Markley, 310-691-7100
[email protected]
“Our recently completed manufacturing activities represented the last major hurdle before our NDA submission,” said Brian M. Culley, Principal Executive Officer at ADVENTRX. “While we continue to evaluate the bioequivalence and preclinical data, we have begun the substantial process of compiling the information required for a submission, which we expect to take place by the end of this year.”
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin. Worldwide sales of Navelbine and its generic equivalents in 2006 were in excess of $200 million. The ANX-530 formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that may reduce exposure of the venous endothelium during administration of the drug.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company whose product candidates are designed to improve the safety of existing cancer treatments. More information can be found on the Company’s web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to submit an NDA for ANX-530, to fund operations during the FDA review period if an NDA is submitted, or to conduct pre-launch activities should an NDA for ANX-530 be submitted or launch activities should an NDA for ANX-530 be approved; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to continue as a going concern; the risk that ADVENTRX will seek protection under the provisions of the U.S. Bankruptcy Code; the risk that ADVENTRX will reassess the results of the ANX-530 bioequivalence study and determine to conduct additional bioequivalence studies of ANX-530, including in humans; the potential for regulatory authorities to require additional preclinical work and/or clinical activities to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-530, which activities may increase the cost and timeline to NDA submission or approval; the risk the FDA will determine that ANX-530 and Navelbine® are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based on a patient population other than the population on which ADVENTRX based its analysis; the risk of investigator bias in reporting adverse events as a result of the open-label nature of the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530, including validating commercial manufacturing processes and manufacturers, as well as suppliers; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; and other risks and uncertainties more fully described in ADVENTRX’s press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement as set forth in this press release to reflect events or circumstances arising after the date on which it was made.
Source: ADVENTRX Pharmaceuticals, Inc.
Company Contact:
ADVENTRX Pharmaceuticals
Brian Culley, Principal Executive Officer
858-552-0866
or
Investor Contact:
Lippert/Heilshorn & Associates, Inc.
Don Markley, 310-691-7100
[email protected]
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Banned
[FONT=arial, geneva, san-serif][SIZE=-1]Clinical and Regulatory Strategy
Our strategy initially is to demonstrate the bioequivalence of each of our emulsion formulation product candidates to the currently marketed reference product. The bioequivalence of two drugs can be demonstrated in a single clinical trial of as few as 28 patients, typically in an open-label, single-dose, cross-over comparison of the drugs. For each of ANX-530 and ANX-514, the FDA has indicated that data from a single study of approximately 28 patients that demonstrates the bioequivalence of our product candidates to the reference product may be sufficient clinical data to support a Section 505(b)(2) NDA. Accordingly, we view these bioequivalence trials as registrational clinical studies in that they have the potential to support a marketing application. If approved, the drug prescribing information, or "label," for our products may reflect clinical data generated during the bioequivalence trials, including comparative adverse event information.
The relatively low number of required patients and the single-dose treatment cycles associated with these bioequivalence trials can decrease study timelines and costs relative to typical pivotal studies. Accordingly, with relatively modest financial investment, we are able to assess in the clinic the pharmacokinetic equivalence of each of our product candidates to the reference product in as little as 12 to 18 months, which information should provide the clinical data necessary to support a Section 505(b)(2) NDA. By securing in advance FDA agreement regarding our planned regulatory pathway, as we have done for ANX-530 and ANX-514, we mitigate aspects of the clinical and regulatory risk associated with drug development. Furthermore, if and after we obtain marketing approval, we can conduct additional clinical studies while marketing our products for use of these products in new indications or to expand product labels in ways that might increase their commercial value.
Furthermore, if any new clinical studies we conduct, in addition to our bioequivalence studies, are essential to the FDA's approval of an application to use our products or product candidates to treat a new indication, or to support a label change in product use, the product may be eligible for three years of marketing exclusivity for that indication or use. Marketing exclusivity means that the FDA will not approve an abbreviated NDA, or ANDA (an ANDA is for a generic drug product) or Section 505(b)(2) NDA during the exclusivity period based on the conditions of approval of our product.[/SIZE][/FONT]
Our strategy initially is to demonstrate the bioequivalence of each of our emulsion formulation product candidates to the currently marketed reference product. The bioequivalence of two drugs can be demonstrated in a single clinical trial of as few as 28 patients, typically in an open-label, single-dose, cross-over comparison of the drugs. For each of ANX-530 and ANX-514, the FDA has indicated that data from a single study of approximately 28 patients that demonstrates the bioequivalence of our product candidates to the reference product may be sufficient clinical data to support a Section 505(b)(2) NDA. Accordingly, we view these bioequivalence trials as registrational clinical studies in that they have the potential to support a marketing application. If approved, the drug prescribing information, or "label," for our products may reflect clinical data generated during the bioequivalence trials, including comparative adverse event information.
The relatively low number of required patients and the single-dose treatment cycles associated with these bioequivalence trials can decrease study timelines and costs relative to typical pivotal studies. Accordingly, with relatively modest financial investment, we are able to assess in the clinic the pharmacokinetic equivalence of each of our product candidates to the reference product in as little as 12 to 18 months, which information should provide the clinical data necessary to support a Section 505(b)(2) NDA. By securing in advance FDA agreement regarding our planned regulatory pathway, as we have done for ANX-530 and ANX-514, we mitigate aspects of the clinical and regulatory risk associated with drug development. Furthermore, if and after we obtain marketing approval, we can conduct additional clinical studies while marketing our products for use of these products in new indications or to expand product labels in ways that might increase their commercial value.
Furthermore, if any new clinical studies we conduct, in addition to our bioequivalence studies, are essential to the FDA's approval of an application to use our products or product candidates to treat a new indication, or to support a label change in product use, the product may be eligible for three years of marketing exclusivity for that indication or use. Marketing exclusivity means that the FDA will not approve an abbreviated NDA, or ANDA (an ANDA is for a generic drug product) or Section 505(b)(2) NDA during the exclusivity period based on the conditions of approval of our product.[/SIZE][/FONT]
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[FONT=arial, geneva, san-serif][SIZE=-1]Commercialization Strategy
Group Purchasing Organizations
Our commercial strategy in the U.S. for ANX-530 and ANX-514 includes seeking to obtain Healthcare Common Procedure Coding System (HCPCS) product codes that are distinct from those for Navelbine and Taxotere, respectively. Additionally, we intend to price ANX-530 at a premium to competitive products.
In the U.S. and elsewhere, healthcare providers, including hospitals, nursing homes and physician offices, typically purchase the drugs they administer to patients and then seek reimbursement, primarily from third party payors such as Medicare, Medicaid and private insurance companies. As a result, sales of prescription pharmaceuticals are dependent in large part on the availability and rate of reimbursement to healthcare providers from third party payors.
The Healthcare Common Procedure Coding System was established to identify and provide unique codes for healthcare goods and procedures, including codes for injectable oncology drugs such as ANX-530 and ANX-514, should they be approved. Ultimately, CMS is responsible for reviewing and approving applications for new HCPCS codes for injectable oncology drugs. Generic equivalents of drugs are assigned the same HCPCS code as the original drug. Virtually all U.S. payors, including Medicare and private insurance plans, use the HCPCS, including the product codes assigned by CMS.
In determining a specific reimbursement rate for a drug, CMS publishes an average sales price for the drug based on manufacturer-reported sales data for all drugs within the same HCPCS product code, including applicable discounts and rebates, as well as a reimbursement rate, expressed as a percentage of the average sales price. Because generic equivalents of drugs are assigned the same HCPCS code as the original drug, generic competition can be expected to decrease the level of reimbursement for all drugs with the same HCPCS product code (both the original drug and its generic equivalents) until price equilibrium is reached. Most private payors use similar methods for determining reimbursement rates, sometimes based on average wholesale prices or CMS' published average sales price.
We intend to seek unique HCPCS codes for ANX-530 and ANX-514. If we obtain unique HCPCS codes for our products, they will be reimbursed based on their own sales prices, without including sales prices of the applicable reference product or its generic competition. We believe this will provide us greater freedom to price our products at a premium to competitive products, enhancing their value to us.
Group Purchasing Organizations
Group purchasing organizations, or GPOs, including distributors and provider networks, are entities that help health care providers, such as hospitals, nursing homes and physician offices, realize savings and efficiencies by aggregating purchasing volume and using that scale to negotiate discounts with manufacturers and other vendors. The U.S. healthcare industry spends more than $200 billion annually in medical and non-medical products, with more than 70% allocated through GPOs.
We believe up to 80% of the U.S. markets for ANX-530 and ANX-514 are concentrated within eight to ten GPOs and that a focused, specialized sales force may be able to effectively market and sell our products, once approved, to these organizations. As consolidation within the industry and attempts to further enhance economies of scale and marketing advantages continue, we believe these markets will concentrate further. If our products demonstrate equivalent efficacy and superior tolerability or pharmacoeconomic benefits relative to the reference product, we believe the well-established utility of the reference product should enable GPOs to enact broad and rapid shifts among their constituents from the reference product to our novel emulsion formulations.
The concentrated nature of these markets in the U.S. may warrant retaining marketing rights to ANX-530 and ANX-514 in the U.S., which may provide us better value than we could obtain through a partnering relationship. By understanding the organization of our target markets and pursuing directly only those markets we believe are sufficiently concentrated, we seek to avoid the substantial direct and indirect expense associated with large sales and marketing organizations that pursue individual physicians. However, we also remain receptive to partnering these product candidates in the U.S. if presented with terms that are sufficiently attractive.[/SIZE][/FONT]
Group Purchasing Organizations
Our commercial strategy in the U.S. for ANX-530 and ANX-514 includes seeking to obtain Healthcare Common Procedure Coding System (HCPCS) product codes that are distinct from those for Navelbine and Taxotere, respectively. Additionally, we intend to price ANX-530 at a premium to competitive products.
In the U.S. and elsewhere, healthcare providers, including hospitals, nursing homes and physician offices, typically purchase the drugs they administer to patients and then seek reimbursement, primarily from third party payors such as Medicare, Medicaid and private insurance companies. As a result, sales of prescription pharmaceuticals are dependent in large part on the availability and rate of reimbursement to healthcare providers from third party payors.
The Healthcare Common Procedure Coding System was established to identify and provide unique codes for healthcare goods and procedures, including codes for injectable oncology drugs such as ANX-530 and ANX-514, should they be approved. Ultimately, CMS is responsible for reviewing and approving applications for new HCPCS codes for injectable oncology drugs. Generic equivalents of drugs are assigned the same HCPCS code as the original drug. Virtually all U.S. payors, including Medicare and private insurance plans, use the HCPCS, including the product codes assigned by CMS.
In determining a specific reimbursement rate for a drug, CMS publishes an average sales price for the drug based on manufacturer-reported sales data for all drugs within the same HCPCS product code, including applicable discounts and rebates, as well as a reimbursement rate, expressed as a percentage of the average sales price. Because generic equivalents of drugs are assigned the same HCPCS code as the original drug, generic competition can be expected to decrease the level of reimbursement for all drugs with the same HCPCS product code (both the original drug and its generic equivalents) until price equilibrium is reached. Most private payors use similar methods for determining reimbursement rates, sometimes based on average wholesale prices or CMS' published average sales price.
We intend to seek unique HCPCS codes for ANX-530 and ANX-514. If we obtain unique HCPCS codes for our products, they will be reimbursed based on their own sales prices, without including sales prices of the applicable reference product or its generic competition. We believe this will provide us greater freedom to price our products at a premium to competitive products, enhancing their value to us.
Group Purchasing Organizations
Group purchasing organizations, or GPOs, including distributors and provider networks, are entities that help health care providers, such as hospitals, nursing homes and physician offices, realize savings and efficiencies by aggregating purchasing volume and using that scale to negotiate discounts with manufacturers and other vendors. The U.S. healthcare industry spends more than $200 billion annually in medical and non-medical products, with more than 70% allocated through GPOs.
We believe up to 80% of the U.S. markets for ANX-530 and ANX-514 are concentrated within eight to ten GPOs and that a focused, specialized sales force may be able to effectively market and sell our products, once approved, to these organizations. As consolidation within the industry and attempts to further enhance economies of scale and marketing advantages continue, we believe these markets will concentrate further. If our products demonstrate equivalent efficacy and superior tolerability or pharmacoeconomic benefits relative to the reference product, we believe the well-established utility of the reference product should enable GPOs to enact broad and rapid shifts among their constituents from the reference product to our novel emulsion formulations.
The concentrated nature of these markets in the U.S. may warrant retaining marketing rights to ANX-530 and ANX-514 in the U.S., which may provide us better value than we could obtain through a partnering relationship. By understanding the organization of our target markets and pursuing directly only those markets we believe are sufficiently concentrated, we seek to avoid the substantial direct and indirect expense associated with large sales and marketing organizations that pursue individual physicians. However, we also remain receptive to partnering these product candidates in the U.S. if presented with terms that are sufficiently attractive.[/SIZE][/FONT]
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questo credo faccia capire meglio cosa fanno :
[FONT=arial, geneva, san-serif][SIZE=-1] Lead Product Candidates
ADVENTRX is currently focused on commercializing two late-stage product candidates in the U.S., ANX-530 (vinorelbine emulsion) and ANX-514 (docetaxel emulsion), which are novel emulsion formulations of currently marketed chemotherapy drugs. The Company believes ANX-530 and ANX-514 may improve the safety of and have greater commercial potential than the currently marketed reference products, Navelbine and Taxotere, respectively, by:
[/SIZE][/FONT]
Reformulating existing pharmaceutical products is an increasingly common product lifecycle-management technique. Between 2002 and 2005, nearly 40% of the products launched by the top 50 pharmaceutical manufacturers were reformulations. Finding new markets for and ways to modify and improve existing products is often an essential element of pharmaceutical companies' efforts to maintain or grow revenues in the face of patent expirations and competitive pressures.
Navelbine and Taxotere are intravenously-injected chemotherapy drugs commonly used to treat solid tumors. We believe the current formulations of these drugs have limitations that present opportunities for improvement. We are developing novel ways to formulate the active ingredient underlying each of these drugs that we believe may improve their safety profiles without adversely affecting efficacy. In addition, we believe our formulations may provide benefits to patients and practitioners that do not manifest themselves in traditional measures of safety or efficacy.[/SIZE][/FONT]
[FONT=arial, geneva, san-serif][SIZE=-1] Lead Product Candidates
ADVENTRX is currently focused on commercializing two late-stage product candidates in the U.S., ANX-530 (vinorelbine emulsion) and ANX-514 (docetaxel emulsion), which are novel emulsion formulations of currently marketed chemotherapy drugs. The Company believes ANX-530 and ANX-514 may improve the safety of and have greater commercial potential than the currently marketed reference products, Navelbine and Taxotere, respectively, by:
[/SIZE][/FONT]
- [FONT=arial, geneva, san-serif][SIZE=-1]
[*]Improving their safety and reducing the incidence and severity of adverse effects; and
[*]Increasing their pharmacoeconomics and convenience to healthcare practitioners and patients. [/SIZE][/FONT]
Reformulating existing pharmaceutical products is an increasingly common product lifecycle-management technique. Between 2002 and 2005, nearly 40% of the products launched by the top 50 pharmaceutical manufacturers were reformulations. Finding new markets for and ways to modify and improve existing products is often an essential element of pharmaceutical companies' efforts to maintain or grow revenues in the face of patent expirations and competitive pressures.
Navelbine and Taxotere are intravenously-injected chemotherapy drugs commonly used to treat solid tumors. We believe the current formulations of these drugs have limitations that present opportunities for improvement. We are developing novel ways to formulate the active ingredient underlying each of these drugs that we believe may improve their safety profiles without adversely affecting efficacy. In addition, we believe our formulations may provide benefits to patients and practitioners that do not manifest themselves in traditional measures of safety or efficacy.[/SIZE][/FONT]
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[FONT=arial, geneva, san-serif][SIZE=-1] OTHER PRODUCT CANDIDATES AND POTENTIAL PRODUCT CANDIDATES
In addition to ANX-530, ANX-514, ADVENTRX holds rights to a number of other compounds that the Company is evaluating for future preclinical and/or clinical development. These include:
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In addition to ANX-530, ANX-514, ADVENTRX holds rights to a number of other compounds that the Company is evaluating for future preclinical and/or clinical development. These include:
- ANX-211, an anti-viral nasal spray. A patent-protected aqueous formulation of chitosan and other ingredients designed to protect users from bacterial and viral infections, including common cold, influenza, and other infections of the upper respiratory tract. ANX-211 has been shown to prevent infection of human cell lines by human influenza B virus, human rhinovirus and adenovirus, major causes of the flu and common cold;
- ANX-015, a novel formulation of clarithromycin. An intravenous formulation of clarithromycin is approved to treat mild to moderate bacterial infections (such as community-acquired pneumonia). ANX-015 is intended to reduce injection site reactions associated with intravenous delivery of clarithromycin;
- ANX-016, a novel formulation of vancomycin. An intravenous formulation of vancomycin is approved to treat Gram-positive bacterial infections. ANX-016 is intended to reduce injection site reactions associated with intravenous delivery of vancomycin;
- ANX-201, a member of a new class of reverse transcriptase inhibitor, that in preclinical studies has shown broad-spectrum antiviral activity against human immunodeficiency virus (HIV), human and avian influenza viruses and herpes simplex viruses (HSV);
- ANX-513, a novel formulation of paclitaxel. Taxol, a branded formulation of paclitaxel, is approved to treat breast, ovarian, Kaposi's sarcoma and non-small cell lung cancers. ANX-513 is intended to be non-allergenic and to reduce the need for immunosuppressant premedication associated with administration of Taxol; and
- ANX-575, a novel formulation of alpha-tocopheryl succinate, which has been shown in preclinical studies to selectively facilitate cell death in cancer cells.
[/SIZE][/FONT]
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ADVENTRX Pharmaceuticals Announces Closing of Financing SAN DIEGO, Aug. 10 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has completed the previously announced sale of shares of its 5% Series C convertible preferred stock pursuant to a registered direct offering to a single institutional investor, representing gross proceeds of approximately $0.9 million. Twelve and one-half percent, or $115,250, of the gross proceeds will be placed in an escrow account, which amounts will be released to make the dividend and other payments described below.
The preferred stock is convertible into shares of ADVENTRX's common stock at the option of the investor at a price of $0.13 per share and will accrue a 5% cumulative dividend until February 10, 2012. If the convertible preferred stock is converted at any time prior to February 10, 2012, ADVENTRX will pay the holder an amount equal to the total dividend that would accrue on the convertible preferred stock from the conversion date through February 10, 2012, or $125 per $1,000 of stated value of notes converted, less any dividend payments made with respect to the converted convertible preferred stock.
ADVENTRX plans to use the net proceeds from the offering to fund activities necessary to advance ANX-530 (vinorelbine emulsion) toward commercialization in the U.S. and to continue development of ANX-514 (docetaxel emulsion), and for general corporate purposes.
The shares were sold by ADVENTRX pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission ("SEC"). A prospectus supplement relating to the offering was filed with the SEC on August 5, 2009. Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. (NasdaqGM: RODM), acted as the exclusive placement agent for the transaction.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities may only be offered by means of a prospectus. Copies of the prospectus supplement and accompanying base prospectus can be obtained directly from ADVENTRX at 6725 Mesa Ridge Road, Suite 100, San Diego, California 92121 or from the SEC's website at www.sec.gov.
About ADVENTRX Pharmaceuticals, Inc.
ADVENTRX Pharmaceuticals is a biopharmaceutical company whose product candidates are designed to improve the safety of existing cancer treatments. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statement
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX's common stock will be delisted by the NYSE Amex, including as a result of failing to comply with applicable stockholder approval requirements or failing to maintain sufficient stockholders' equity or a sufficient stock price; the risk that the provisions of Delaware General Corporation Law will prohibit ADVENTRX from making the cumulative dividend and other payments due its 5% Series C convertible preferred stock (or to the holders thereof), which may be a breach of its certificate of incorporation or other contractual obligations and expose ADVENTRX to corresponding liability; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to submit an NDA for ANX-530, to fund operations or pre-launch activities during the FDA review period if an NDA is submitted or launch activities should an NDA for ANX-530 be approved; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to continue as a going concern; the risk that ADVENTRX will seek protection under the provisions of the U.S. Bankruptcy Code; the risk that, if ADVENTRX liquidates its assets, the capital available for distribution to stockholders, if any, will be insignificant; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530 and ANX-514, including validating commercial manufacturing processes and manufacturers, as well as suppliers, and the potential for automatic injunctions regarding FDA approval of ANX-514; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; the risk that ADVENTRX's significantly reduced workforce and leadership by officers who do not have substantial previous experience in executive leadership roles will negatively impact its ability to raise capital or maintain effective disclosure controls and procedures or internal control over financial reporting; the risk that ADVENTRX will be unable to file timely required reports with the Securities and Exchange Commission; the risk that ADVENTRX will trigger a "maintenance failure" under that certain Rights Agreement, dated July 27, 2005, as amended, and be required to pay liquidated damages, including as a result of losing its eligibility to use Form S-3 if its common stock is delisted from the NYSE Amex or ADVENTRX is not timely in its filings with the Securities and Exchange Commission; and other risks and uncertainties more fully described in ADVENTRX's press releases and in the prospectus supplement that was filed with the Securities and Exchange Commission on August 5, 2009. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement as set forth in this press release to reflect events or circumstances arising after the date on which it was made.
SOURCE ADVENTRX Pharmaceuticals, Inc. -0- 08/10/2009
CONTACT:
Brian Culley, Principal Executive Officer of ADVENTRX Pharmaceuticals, Inc., +1-858-552-0866; or
Investors, Don Markley of Lippert/Heilshorn & Associates, Inc., +1-310-691-7100, [email protected],
for ADVENTRX Pharmaceuticals, Inc.
Web Site: http://www.adventrx.com
The preferred stock is convertible into shares of ADVENTRX's common stock at the option of the investor at a price of $0.13 per share and will accrue a 5% cumulative dividend until February 10, 2012. If the convertible preferred stock is converted at any time prior to February 10, 2012, ADVENTRX will pay the holder an amount equal to the total dividend that would accrue on the convertible preferred stock from the conversion date through February 10, 2012, or $125 per $1,000 of stated value of notes converted, less any dividend payments made with respect to the converted convertible preferred stock.
ADVENTRX plans to use the net proceeds from the offering to fund activities necessary to advance ANX-530 (vinorelbine emulsion) toward commercialization in the U.S. and to continue development of ANX-514 (docetaxel emulsion), and for general corporate purposes.
The shares were sold by ADVENTRX pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission ("SEC"). A prospectus supplement relating to the offering was filed with the SEC on August 5, 2009. Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. (NasdaqGM: RODM), acted as the exclusive placement agent for the transaction.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities may only be offered by means of a prospectus. Copies of the prospectus supplement and accompanying base prospectus can be obtained directly from ADVENTRX at 6725 Mesa Ridge Road, Suite 100, San Diego, California 92121 or from the SEC's website at www.sec.gov.
About ADVENTRX Pharmaceuticals, Inc.
ADVENTRX Pharmaceuticals is a biopharmaceutical company whose product candidates are designed to improve the safety of existing cancer treatments. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statement
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX's common stock will be delisted by the NYSE Amex, including as a result of failing to comply with applicable stockholder approval requirements or failing to maintain sufficient stockholders' equity or a sufficient stock price; the risk that the provisions of Delaware General Corporation Law will prohibit ADVENTRX from making the cumulative dividend and other payments due its 5% Series C convertible preferred stock (or to the holders thereof), which may be a breach of its certificate of incorporation or other contractual obligations and expose ADVENTRX to corresponding liability; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to submit an NDA for ANX-530, to fund operations or pre-launch activities during the FDA review period if an NDA is submitted or launch activities should an NDA for ANX-530 be approved; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to continue as a going concern; the risk that ADVENTRX will seek protection under the provisions of the U.S. Bankruptcy Code; the risk that, if ADVENTRX liquidates its assets, the capital available for distribution to stockholders, if any, will be insignificant; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530 and ANX-514, including validating commercial manufacturing processes and manufacturers, as well as suppliers, and the potential for automatic injunctions regarding FDA approval of ANX-514; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; the risk that ADVENTRX's significantly reduced workforce and leadership by officers who do not have substantial previous experience in executive leadership roles will negatively impact its ability to raise capital or maintain effective disclosure controls and procedures or internal control over financial reporting; the risk that ADVENTRX will be unable to file timely required reports with the Securities and Exchange Commission; the risk that ADVENTRX will trigger a "maintenance failure" under that certain Rights Agreement, dated July 27, 2005, as amended, and be required to pay liquidated damages, including as a result of losing its eligibility to use Form S-3 if its common stock is delisted from the NYSE Amex or ADVENTRX is not timely in its filings with the Securities and Exchange Commission; and other risks and uncertainties more fully described in ADVENTRX's press releases and in the prospectus supplement that was filed with the Securities and Exchange Commission on August 5, 2009. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement as set forth in this press release to reflect events or circumstances arising after the date on which it was made.
SOURCE ADVENTRX Pharmaceuticals, Inc. -0- 08/10/2009
CONTACT:
Brian Culley, Principal Executive Officer of ADVENTRX Pharmaceuticals, Inc., +1-858-552-0866; or
Investors, Don Markley of Lippert/Heilshorn & Associates, Inc., +1-310-691-7100, [email protected],
for ADVENTRX Pharmaceuticals, Inc.
Web Site: http://www.adventrx.com
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Strategic Opportunities
ADVENTRX is seeking partners for one or both of its two late-stage oncology programs, both of which are novel reformulations of currently approved products and are designed to improve the safety profiles of the approved products without affecting efficacy. ANX-514 (docetaxel emulsion for injection) is a reformulation of the blockbuster chemotherapeutic agent, Taxotere(R). In 2007, the aggregate worldwide market for Taxotere was in excess of $3 billion. ANX-530 (vinorelbine injectable emulsion) is a reformulation of Navelbine(R) which, despite being a generic product for a number of years, still sells in excess of $200 million a year world-wide. Both of the Company's product candidates have the potential to be on the market in 2010.
ADVENTRX is seeking partners for one or both of its two late-stage oncology programs, both of which are novel reformulations of currently approved products and are designed to improve the safety profiles of the approved products without affecting efficacy. ANX-514 (docetaxel emulsion for injection) is a reformulation of the blockbuster chemotherapeutic agent, Taxotere(R). In 2007, the aggregate worldwide market for Taxotere was in excess of $3 billion. ANX-530 (vinorelbine injectable emulsion) is a reformulation of Navelbine(R) which, despite being a generic product for a number of years, still sells in excess of $200 million a year world-wide. Both of the Company's product candidates have the potential to be on the market in 2010.