Filing
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): October 27, 2008
ADVENTRX Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | 001-32157 | 84-1318182 | ||
(State or Other Jurisdiction of | (Commission File No.) | (IRS Employer Identification No.) | ||
Incorporation) |
6725 Mesa Ridge Road, Suite 100
San Diego, CA 92121
(Address of Principal Executive Offices and Zip Code)
San Diego, CA 92121
(Address of Principal Executive Offices and Zip Code)
N/A
(Former name or former address if changed since last report)
(Former name or former address if changed since last report)
Registrants telephone number, including area code: (858) 552-0866
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:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
o | 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 27, 2008, ADVENTRX Pharmaceuticals, Inc. (ADVENTRX) revised its corporate
presentation. Certain portions of the revised presentation are reflected in the slides attached as
Exhibit 99.1 and are incorporated herein by reference.
Forward Looking Statements
ADVENTRX cautions you that statements information included in this report and the slides attached
hereto as Exhibit 99.1 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 ADVENTRXs 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 capital to fund
the projects necessary to meet its goals; the risk that preclinical results are not indicative of
the success of subsequent clinical trials and the results of pending clinical trials; the risk the
FDA determines ADVENTRXs product candidates are not bioequivalent to the applicable reference
product; difficulties or delays in developing, manufacturing, obtaining regulatory approval for and
marketing ADVENTRXs product candidates; the potential for regulatory authorities to require
additional preclinical work or other clinical requirements to support regulatory filings; the scope
and validity of patent protection for ADVENTRXs product candidates; patent and non-patent
exclusivity covering Navelbine® and Taxotere®; 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
http://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 included
in this report or the slides attached hereto as Exhibit 99.1 to reflect events or circumstances
arising after the date on which it was made. This caution is made under the safe harbor provisions
of Section 21E of the Securities Exchange Act of 1934.
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.
SIGNATURE
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. |
||||
Dated: October 27, 2008 | By: | /s/ Patrick L. Keran | ||
Name: | Patrick L. Keran | |||
Title: | Vice President, Legal |
EXHIBIT INDEX
99.1 | Select presentation slides |
ADVENTRX ANX-530 Pricing Evaluation: Oct. 2008 Vinorelbine Conjoint derived (N = 70) ANX-530 Market Research & Forecast Third Party Conjoint Study of 70 U.S.-Based Medical Oncologists NSCLC Preference Share NSCLC Preference Share NSCLC Preference Share NSCLC Preference Share Therapy Misc. J-code WAC +6% Unique J-code ASP+6%, 0% disc. ^ ANX-530 74.6% +-9.3 70.9% +-9.3 +1.3% Vinorelbine 25.4% +-9.3 29.1% +-9.3 -1.3% Share preference unaffected by reimbursement code even at 10x generic pricing Oncologist Preference for ANX-530 at 10x Generic Pricing Prior to J-code Assignment ANX-530 75% 71% 29% 25% |
ADVENTRX ANX-514 Web-based Survey of 100 Oncologists: Oct. 2008 ANX-514 Market Research & Forecasting Oncologist's Willingness to Switch Patients to ANX-514 Prior to J-code Assignment "Upon launch of ANX-514, and prior to assignment of the product J-code, you estimate that you would begin using ANX-514 instead of Taxotere for what portion of your planned docetaxel patients?" |
ADVENTRX ANX-514 Web-based Survey of 100 Oncologists: Oct. 2008 ANX-514 Market Research & Forecasting Oncologist's Willingness to Remain with Premium-Priced ANX-514 After Generic Availability "In 2012, once generic Taxotere is available, assume that for a year there is a large spread between the quickly-falling acquisition price of generic Taxotere, being driven down by competing generic manufacturers and the payor reimbursement rates due to the lag time (assume that ANX-514 pricing and reimbursement remains the same with no impact due to generics), what would your planned use of ANX-514 be?" |
Q1 2009 Complete enrollment in BE study of ANX-514 (docetaxel emulsion) Q2 2009 Submit New Drug Application for ANX-530 (vinorelbine emulsion) Announce results from BE study of ANX-514 (docetaxel emulsion) Q3 2009 Submit New Drug Application for ANX-514 (docetaxel emulsion) Near Term Regulatory Milestones |
Mark N. K. Bagnall, Executive Vice President & Chief Financial Officer Metabolex Inc.; Metrika, Inc.; Progenitor, Inc.; Somatix Therapy Corp.; Hana Biologics, Inc. Brian M. Culley, M.S., M.B.A., Chief Business Officer & SVP Business Development Immusol; UCSD Technology Transfer and Intellectual Property Dept.; Neurocrine Biosciences Mark Erwin, Senior Vice President, Operations Centric Health Finance, LLC ;Ligand Pharmaceuticals; IDEC Pharmaceuticals; Eli Lilly & Co. Michele L. Yelmene, Vice President, Regulatory Affairs & Quality Assurance Perlan Therapeutics, Genzyme Corp., Mallinckrodt Jose R. Hechavarria, Vice President, Manufacturing HechTech Pharma Consult; Bristol Myers Squibb; DuPont Pharmaceuticals Patrick L. Keran, J.D., General Counsel Isis Pharmaceuticals; Heller Ehrman; Brobeck, Phleger & Harrison Brandi Roberts, C.P.A., M.B.A., Vice President, Finance Artes Medical; Strategene; Pfizer, Inc. ADVENTRX Team |