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ADVENTRX also announced that Evan M. Levine has resigned his positions asChief Executive Officer and President, effective October 17, 2008, to pursueother opportunities. Mr. Levine will continue to serve on the Company's Boardof Directors. The Company intends to conduct a search for a replacement ChiefExecutive Officer. In the interim, consistent with the Company's CEO successionplan, ADVENTRX will be led by a committee of executive officers.
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"We thank Evan for his leadership and contributions to the Company and wishhim the best in his future endeavors," stated Jack Lief, Chair of the Company'sBoard of Directors. "While the decision to let go employees, particularly thosewho have been with the Company for many years, was difficult, the changesannounced today give the Company the opportunity to advance its lead productcandidates towards commercialization and to demonstrate their value, which webelieve has been underappreciated by the market," added Mr. Lief.
ANX-530 and ANX-514 Timelines
ADVENTRX has entered into an agreement with a new contract manufacturer toconduct process development and scale-up activities for both ANX-530 and ANX-514. Last week, the Company attended a pre-NDA meeting with the U.S. Food andDrug Administration (FDA) to discuss its NDA submission for ANX-530. The FDArequested additional information regarding the Company's new manufacturer, andas a result, ADVENTRX anticipates the submission of its NDA for ANX-530 willtake place in the second quarter of 2009.
ADVENTRX also announced that it anticipates completing patient enrollmentin its registrational bioequivalence clinical study of ANX-514 in the firstquarter of 2009. The Company expects to announce results from this study in thesecond quarter of 2009. These changes will not affect the Company's previouslyannounced plans to submit an NDA for ANX-514 in the third quarter of 2009.
Restructuring
On October 14, 2008, a total of nine employees were terminated, consistingof four in research and development, two in clinical, two in selling, generaland administrative and one in regulatory/quality assurance. After adjusting toreflect severance costs, these measures will reduce the Company's compensationexpenses in 2009 by approximately $1,500,000.
As part of the reorganization, Mark Erwin, previously the Company's VicePresident of Commercialization, was promoted to Senior Vice President,Operations. In addition, the Company ended its employment relationship with itsChief Scientific Officer, Vice President, Medical Affairs and Vice President,Research and Development.
"This restructuring balances the difficult trade-off between curtailingspending and conducting those activities that continue to demonstrate and buildthe value of ANX-530 and ANX-514, while efficiently moving towards becoming acommercial organization," said Mark Bagnall, the Company's Executive VicePresident and Chief Financial Officer. "Our cash conservation measures will cutour overall burn rate by approximately 50%," added Mr. Bagnall.
The Company discontinued active work on all product candidates other thanANX-530 and ANX-514, including its CoFactor(R) program. Patients currentlyreceiving CoFactor will continue to receive treatment. With respect to ANX-530and ANX-514, until the Company has secured additional funding, it anticipatesfocusing primarily on those activities relating to submitting NDAs and maydelay or significantly reduce spending on other work, including activitiesrelated to product launches.
Upcoming Conferences
The Company will present its updated corporate outlook at the 3rd AnnualBIOCOM Investor Conference in San Diego on October 27th, 2008 at 2:30 p.m.Pacific Time, as well as at the 7th Annual BIOInvestor Forum in San Franciscoon October 30th, 2008 at 3:15 p.m. Pacific Time. The presentations will bewebcast live via the "Investors" section of the Company's web site athttp://www.adventrx.com under "Events." The webcasts will be available forreplay for 14 days and can be accessed through the same link.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drugvinorelbine. ANX-530 emulsifies vinorelbine into a homogeneous suspension ofnanoparticles that is designed to protect the venous endothelium duringadministration into a peripheral vein. Navelbine(R), a branded formulation ofvinorelbine, is approved in the U.S. to treat advanced non-small cell lungcancer as a single agent or in combination with cisplatin, and approved in theEuropean Union to treat non-small cell lung cancer and advanced or metastaticbreast cancer.
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drugdocetaxel, which is marketed under the brand name Taxotere. ANX-514 isformulated without polysorbate 80 or other detergents and is intended to reducethe severity and/or incidence of hypersensitivity reactions. Docetaxel is ananti-cancer agent that acts by disrupting the cellular microtubular networkthat is essential for cell division. Immunosuppressant premedication isrecommended for docetaxel therapy to reduce the incidence and severity ofhypersensitivity reactions. Docetaxel is approved to treat breast, non-smallcell lung, prostate, gastric and head and neck cancers.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused onin-licensing, developing and commercializing proprietary product candidatesprimarily for the treatment of cancer and infectious disease. The Company seeksto improve the performance and commercial potential of existing treatments byaddressing problems associated with these treatment regimens. More informationcan be found on ADVENTRX's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release thatare not a description of historical facts are forward-looking statements thatinvolve risks and assumptions that, if they materialize or do not prove to beaccurate, could cause ADVENTRX's results to differ materially from historicalresults or those expressed or implied by such forward-looking statements.These risks and uncertainties include, but are not limited to: the risk thatADVENTRX will be unable to raise sufficient capital to fund the projectsnecessary to meet its goals, including funding the continued development andcommercialization of ANX-530 or ANX-514; the risk the FDA will determine thatANX-530 and Navelbine are not bioequivalent, including as a result ofperforming pharmacokinetic equivalence analysis based a patient populationother than the population on which ADVENTRX based its analysis; the risk thatthe on-going clinical study of ANX-514 does not demonstrate pharmacokineticequivalence or bioequivalence; the risk of investigator bias in reportingadverse events as a result of the open-label nature of the ANX-530bioequivalence clinical study, including bias that increased the reporting ofadverse events associated with Navelbine and/or that decreased the reporting ofadverse events associated with ANX-530; difficulties or delays inmanufacturing, obtaining regulatory approval for and marketing ANX-530 and ANX-514, including validating commercial manufacturers and suppliers and thepotential for automatic injunctions regarding FDA approval of ANX-514; thepotential for regulatory authorities to require additional preclinical work orother clinical requirements to support regulatory filings, including prior tothe submission or the approval of an NDA for ANX-530 and ANX-514; the risk thatthe performance of third parties on whom ADVENTRX relies to conduct its studiesor evaluate the data, including clinical investigators, expert data monitoringcommittees, contract laboratories and contract research organizations, may besubstandard, or they may fail to perform as expected; and other risks anduncertainties more fully described in ADVENTRX's press releases and periodicfilings with the Securities and Exchange Commission. ADVENTRX's public filingswith the Securities and Exchange Commission are available athttp://www.sec.gov.
You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date when made. ADVENTRX does notintend to revise or update any forward-looking statement set forth in thispress release to reflect events or circumstances arising after the date onwhich it was made.
SOURCE ADVENTRX Pharmaceuticals, Inc.
