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Filing
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): | October 6, 2010 |
ADVENTRX Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware | 001-32157 | 84-1318182 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
6725 Mesa Ridge Road, Suite 100, San Diego, California | 92121 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | 858-552-0866 |
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On October 6, 2010, ADVENTRX Pharmaceuticals, Inc. issued a press release announcing that it has received a Notice of Allowance from the United States Patent and Trademark Office for its U.S. Patent Application No. 10/889,226, entitled "Compositions for Delivering Highly Water Soluble Drugs." The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The list of exhibits called for by this Item is incorporated by reference to the Exhibit Index filed with this report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ADVENTRX Pharmaceuticals, Inc. | ||||
October 6, 2010 | By: |
/s/ Patrick L. Keran
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Name: Patrick L. Keran | ||||
Title: President and Chief Operating Officer |
Exhibit Index
Exhibit No. | Description | |
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99.1
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Press release, dated October 6, 2010 |
ADVENTRX PHARMACEUTICALS RECEIVES NOTICE OF ALLOWANCE FOR PATENT CLAIMS FOR EXELBINE (ANX-530)
SAN DIEGO October 6, 2010 ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its U.S. patent application entitled Compositions for Delivering Highly Water Soluble Drugs. The patent claims are directed to formulations of vinorelbine bitartrate and provide protection for the Companys lead product candidate, ANX-530 (vinorelbine injectable emulsion), or Exelbine. The Notice of Allowance is the USPTOs official communication that the examination of the patent application has been successfully completed and that, upon timely payment of applicable fees, a patent will be issued. Once issued, before taking into account patent term extension, the patent will provide coverage for Exelbine until July 2024.
The notice of allowance is a positive step toward the future commercialization of Exelbine and we remain on track to submit a New Drug Application for Exelbine this quarter, stated Brian M. Culley, Chief Executive Officer of ADVENTRX.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being
developed to improve the performance of existing anti-cancer drugs by addressing limitations
associated principally with their safety and use. More information can be found on the Companys
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 are based on ADVENTRXs current expectations and assumptions. Examples of forward-looking statements include, but are not limited to, statements regarding the issuance of, and the protection expected to be provided by, a patent based on ADVENTRXs U.S. patent application entitled Compositions for Delivering Highly Water Soluble Drugs and ADVENTRXs submission of an Exelbine NDA. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: whether the patent issued based on the U.S. patent application entitled Compositions for Delivering Highly Water Soluble Drugs will provide sufficient protection and market exclusivity; the risk that any patent issued to ADVENTRX may be challenged, invalidated, infringed or circumvented by third parties, including by ADVENTRXs competitors; the risk that ADVENTRX may become involved in complex infringement and other intellectual property litigation matters regarding any issued patent, which could be costly and time consuming and may delay development and/or commercialization of Exelbine; the risk that ADVENTRX does not make timely payment of the fees required by the USPTO for issuance of the patent and the patent application is regarded as abandoned; the risk that the FDA does not accept a submitted Exelbine NDA for review, including as a result of identifying clinical or nonclinical reasons for a refusal-to-file or identifying CMC reasons that were not identified in the refusal-to-file of the previously submitted Exelbine NDA; the potential that changes made in transferring the manufacturing process for Exelbine may result in a lack of comparability between the commercial product and the material used in the bioequivalence trial, and that the FDA may require ADVENTRX to perform additional nonclinical, bioequivalence or clinical studies; the potential for the FDA to impose other requirements to be completed before or after approval of an Exelbine NDA; the risk that ADVENTRXs financial resources will not be sufficient to meet its business objectives and operational requirements; and other risks and uncertainties more fully described in ADVENTRXs press releases and periodic filings with the Securities and Exchange Commission. ADVENTRXs public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
Company Contact:
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Investor Contact: | |
ADVENTRX Pharmaceuticals Ioana C. Hone (ir@adventrx.com) |
Lippert/Heilshorn & Associates, Inc. Don Markley (dmarkley@lhai.com) |
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858-552-0866 Ext. 303
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310-691-7100 |
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