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Filing
Table of Contents
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 10, 2007
ADVENTRX Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware (State or Other Jurisdiction of Incorporation) |
001-32157 (Commission File No.) |
84-1318182 (IRS Employer Identification No.) |
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))
TABLE OF CONTENTS
Item 7.01. Regulation FD Disclosure | ||||||||
Item 9.01. Financial Statements and Exhibits | ||||||||
SIGNATURE | ||||||||
INDEX TO EXHIBITS | ||||||||
EXHIBIT 99.1 |
Table of Contents
Item 7.01. Regulation FD Disclosure.
Evan M. Levine, Chief Executive Officer of ADVENTRX Pharmaceuticals, Inc. (ADVENTRX), and other
executive officers will present the information reflected in the slides attached as Exhibit 99.1 to
this Current Report on Form 8-K (this Report) commencing October 10, 2007 at various investor
conferences and analyst meetings.
The information in this Report, including the slides attached hereto as Exhibit 99.1, is being
furnished pursuant to this Item 7.01 and shall not be deemed filed for purposes of Section 18 of
the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of
that section, and it shall not be deemed incorporated by reference in any filing under the
Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof,
except as expressly set forth by specific reference in such filing to this Report.
By filing this Report and furnishing this information, ADVENTRX makes no admission as to the
materiality of any information in this Report. The information contained in the slides is summary
information that is intended to be considered in the context of ADVENTRXs filings with the
Securities and Exchange Commission (the SEC) and other public announcements that ADVENTRX makes,
by press release or otherwise, from time to time. ADVENTRX does not intend and undertakes no duty
or obligation to publicly update or revise the information contained in this Report, although it
may do so from time to time as its management believes is appropriate. Any such updating or
revision may be made through the filing of other reports or documents with the SEC, through press
releases or through other public disclosure.
ADVENTRX cautions you that statements information included in 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 anticipated or stated goals and milestones; the risk that ADVENTRX will not continue its
Phase 3 clinical trial of CoFactor; the risk that preclinical results (including bioequivalency
results) are not indicative of the success of subsequent clinical trials (including bioequivalence
trials); difficulties or delays in developing, testing, manufacturing and marketing and obtaining
regulatory approval for ADVENTRXs product candidates, including receiving necessary regulatory
approvals for clinical trials of ANX-514 and the potential for automatic injunctions and other
challenges by patent holders during the Section 505(b)(2) process; 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,
including any information included in the slides attached hereto as Exhibit 99.1, to
Table of Contents
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 Index to
Exhibits filed with this report.
Table of Contents
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 10, 2007 | By: | /s/ Evan M. Levine | ||
Name: | Evan M. Levine | |||
Title: | Chief Executive Officer |
Table of Contents
Exhibit 99.1
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0001.gif)
? ? AMEX: ANX Refining therapies for life |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0002.gif)
Safe Harbor Statement ADVENTRX cautions you that statements included in this presentation 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 capital to fund the projects necessary to meet its anticipated or stated goals and milestones; the risk that ADVENTRX will not continue its Phase 3 clinical trial of CoFactor; the risk that preclinical results (including bioequivalency results) are not indicative of the success of subsequent clinical trials (including bioequivalence trials); difficulties or delays in developing, testing, manufacturing and marketing and obtaining regulatory approval for ADVENTRX's product candidates, including receiving necessary regulatory approvals for clinical trials of ANX- 514 and the potential for automatic injunctions and other challenges by patent holders during the Section 505(b)(2) process; 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 ADVENTRX's product candidates; patent and non-patent exclusivity covering Navelbine(r) and Taxotere(r); 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 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, including as set forth in this presentation, to reflect events or circumstances arising after the date on which it was made. |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0003.gif)
Mission ADVENTRX is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems such as drug metabolism, bioavailability, excessive toxicity and resistance. |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0004.gif)
Clinical Development Plan Three clinical trials currently ongoing: CoFactor Pivotal Phase 3 Study (colorectal cancer) Currently under evaluation Spending commitments reduced CoFactor Phase 2 Study (breast cancer) Completion of patient enrollment anticipated Q4'07 Data anticipated Q2'08 ANX-530 Marketing-enabling Bioequivalence Study Patient enrollment complete Data anticipated Nov. '07 ANX-514 Marketing-enabling Bioequivalence Study Study anticipated Q4'07, pending appropriate regulatory clearances |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0005.gif)
ADVENTRX Pipeline and 2008 Goals PROGRAMS ONCOLOGY ANX-530 (vinorelbine)* Preclinical Initiate Phase 1 Trial Market ANX-513 (paclitaxel) ANX-514 (docetaxel)* ANX-510 (CoFactor?) (mCRC) ANX-201(thiophosphonoformate) Anticipated 2008 progress Submit NDA Current status * Anticipated 505(b)(2) registration strategy (subject to FDA approval) INFECTIOUS DISEASE ANX-211 (chitosan gel) Initiate Phase 2 Trial Initiate Registration Trial ANX-510 (CoFactor?) (BC) Under Evaluation |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0006.gif)
? ? Oncology Programs |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0007.gif)
Folate-based biomodulator designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU ANX-510 (CoFactor(r)) Leucovorin (LV) Requires multiple metabolic steps to become active Global market > $500M CoFactor? Phase 2b results indicated clinical equivalence of CoFactor/5-FU to Leucovorin/5-FU utilizing an infusional administration Two clinical trials & preclinical studies have demonstrated superior efficacy & reduced toxicity against historical comparison of bolus administration of 5-FU Special Protocol Assessment agreement with FDA for U.S. pivotal Phase 3 study Fast track designation in U.S. with 5-FU and bevacizumab in initial treatment of mCRC Orphan drug designation in U.S. & E.U. for pancreatic cancer |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0008.gif)
Phase 2b mCRC Trial Clinical Design: Multi-national randomized two-armed open-label Study Population: 300 patients with mCRC (1st line) Dosing Regimen: de Gramont regimen (400mg/m2 loading dose of 5-FU followed by 600 mg/m2 5-FU via 22 hr infusion for two consecutive days every 2 weeks), with either CoFactor 60mg/m2 or leucovorin 200 mg/m2, each administered every 2 weeks for 12 cycles as a 2 hr IV bolus. Primary Endpoint: Incidence of Grade 3 or 4 hematological or gastrointestinal toxicity Secondary Endpoints: Safety, response rate, TTP and quality of life Clinical Sites: 30 (Europe and India) Data Analysis: Tumor assessment every 8 weeks, strict regulations for dose modification Principal Investigator: James Cassidy, MD, MBChB, MSc, FRCP |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0009.gif)
Phase 2b Clinical Trial Results Primary Endpoint CoFactor/5-FU did not demonstrate statistically significant improved safety in trial's primary endpoint, reduction in proportion of patients reporting at least one hematological or gastrointestinal adverse event of grade 3 or greater CoFactor/5-FU (n= 147) Leucovorin /5-FU (n= 148) P-value Patients reporting at least 1 hematological or gastrointestinal adverse event of grade 3 or greater 23 10 p< 0.05 Hematological 11 7 Gastrointestinal 12 5 |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0010.gif)
Phase 2b Clinical Trial Toxicity Profile Comparison (% Grades 3/4)* *Comparison data from Xeloda product package insert or Oxaliplatin from deGramont et al JCO Sept 2000. (nr=not reported) Grade 3-4 Adverse Events (%) Ph 2B 5-FU/ CoFactor (n=147) Ph 2B 5-FU/ LV (n=148) deGramont Regimen 5-FU/LV cntl arm OX (n=210) 5-FU/LV cntl arm Xeloda (n=593) Xeloda (n=596) Diarrhea 0 0.7 5.3 12 15 Nausea 0.7 0 2.0 3 4 Vomiting 0.7 1.4 2.0 4 4 Stomatitis 0 1.4 nr 15 2 Mucositis 0 0 1.5 nr nr Anemia 1.4 1.4 2.5 1 2 Neutropenia 2.7 2.0 5.3 21 3 Hyperbilirubinemia 2.0 0.7 nr 6 23 Neuropathy 0 0 0 nr nr Hand-Foot Syndrome 0.7 0 nr 1 17 Comparable percentage of grade 3/4 adverse events with CoFactor/5- FU compared with LV/5-FU |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0011.gif)
Phase 2b Clinical Trial Toxicity Profile Comparison (% All Grades)* Adverse Events (% ALL grades) Ph 2B 5-FU/ CoFactor (n=147) Ph 2B 5-FU/ LV (n=148) deGramont Regimen 5-FU/LV cntl arm OX (n=210) 5-FU/LV cntl arm Xeloda (n=593) Xeloda (n=596) Diarrhea 17.0 17.6 43.8 61 55 Nausea 17.7 16.9 53.5 51 43 Vomiting 15.6 12.8 29.4 30 27 Stomatitis 2.7 2.7 nr 62 25 Mucositis 0.7 0.7 35.6 nr nr Anemia 2.0 7.4 81.4 79 80 Neutropenia 4.8 3.4 30.2 46 13 Hyperbilirubinemia 6.1 3.4 nr 17 48 Neuropathy 0 0.7 12 4 10 Hand-Foot Syndrome 2.7 1.4 nr 6 54 Comparable percentage of all adverse events with CoFactor/5-FU compared with LV/5-FU *Comparison data from Xeloda product package insert or Oxaliplatin from deGramont et al JCO Sept 2000. (nr=not reported) |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0012.gif)
Phase 2b Clinical Trial Results Selected Secondary Endpoints Data from selected secondary endpoints (intent-to-treat population) CoFactor/5-FU (n= 150) Leucovorin /5-FU (n= 150) deGramont Regimen (n= 210) Objective response rate 10.7% 13.3% 21.9% Median Progression-free Survival (months) 6.3mo 6.1mo 6.0mo Preliminary Median Survival (months) 14.7mo 14.3mo 14.7mo CoFactor/5-FU arm 70 patients remain alive Leucovorin/5-FU arm 65 patients remain alive |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0013.gif)
Phase 3 mCRC Trial (Currently Under Evaluation) Trial Indication Design Phase 3 1st line CRC CoFactor/5-FU/Avastin versus LV/5-FU/Avastin Primary Endpoint: Improvement in progression free survival of > 28 days; SPA with the FDA Power of 80%, ? level of 0.05. Estimated median TTP is 9.44mo in control arm and 10.44mo in study arm. Secondary Endpoints: Response rate, duration of response, overall survival and adverse events Number of Patients: 1,200 (600 per arm) |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0014.gif)
Phase 2 Advanced Breast Cancer Trial Patient Enrollment: Completion expected Q4'07 Primary Endpoint: Objective response rate (RECIST criteria) Power of 80%, ^ level of 0.10. Estimated rate of objective response is 25% Secondary Endpoints: Duration of response, progression free survival and adverse events Number of Patients: 31 Outcome to guide design of Phase 3 Study Trial Indication Design Phase 2 Advanced breast cancer CoFactor/5-FU |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0015.gif)
New formulation of intravenous vinorelbine tartrate designed to reduce vein irritation ANX-530 (vinorelbine emulsion) Patient enrollment complete in a marketing-enabling 28-patient bioequivalency study of ANX-530 and Navelbine under 505(b)(2) Preclinical studies have demonstrated: Reduced vein irritation, redness and swelling Pharmacokinetics and antitumor activity similar to Navelbine ANX-530 (vinorelbine emulsion ) Navelbine? (vinorelbine) Indicated as single agent or in combination with cisplatin for first-line treatment of unresectable advanced NSCLC Injection site reactions in approximately one-third of patients Annual global market > $200M |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0016.gif)
Vein Irritation Edema Erythema ANX-530 Preclinical Results Lower Vein Irritation, Erythema & Edema 2nd Injection: Navelbine? (vinorelbine) ANX-530 Navelbine: Due to the severity of toxicity, animals did not receive the full set of injections but were still analyzed for toxicity after each injection period. High dose group received 1st injection only. Increasing toxicity 1st Injection: multiple of human dose multiple of human dose multiple of human dose Navelbine ANX-530 2x 4x 8x 2x 4x 8x 2x 4x 8x 2x 4x 8x 2x 4x 8x 2x 4x 8x Increasing toxicity |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0017.gif)
ANX-530 Preclinical Results Ear Vein Histopathology ANX-530 exhibited markedly less ear vein histopathological toxicity in preclinical studies Following intravenous treatment in rabbits, ear vein tissue sections were scored for severity of symptoms (0 to 3 scale = no observable event to marked severity). Toxicity score represents the summation of scores from seven separate vein sections/rabbit. |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0018.gif)
ANX-530 Preclinical Results Breast Tumor Xenograft ANX-530 exhibits equivalent antitumor activity as Navelbine in a mouse xenograft model Dose level = 8 mg/kg (24 mg/m2 human equivalent dose), qdx6 intravenous treatment n=12 (saline group); n=(Navelbine & ANX-530 groups) Day 28 Excised Tumors |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0019.gif)
ANX-530 Preclinical Results Pharmacokinetics Source: Cantwell, MJ, Robbins, JM, Chen, AX; A novel emulsion formulation of vinorelbine attenuates venous toxicity while maintaining antitumor efficacy; AACR 2006 n= 12/group Pharmacokinetics unchanged (statistically equivalent) for ANX-530 in a rat pK model |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0020.gif)
ANX-530 Bioequivalence Trial Data Expected: Nov. 2007 Patient Enrollment: Completed Oct. '07 Primary Endpoint: Pharmacokinetic equivalence of ANX-530 and Navelbine Secondary Endpoints: Safety of a single dose of ANX-530 Number of Patients: 28 Trial Design Bioequivalence Crossover comparison of ANX-530 v. Navelbine |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0021.gif)
Global Vinorelbine Market Source: IMS Health Standard units (000's) Generic Vinorelbine Sales (2004-2007) Global annual sales > $200M Unit sales CAGR of 9% (last 2 years, top 10 countries) Q1 04 Q2 04 Q3 04 Q4 04 Q1 05 Q2 05 Q3 05 Q4 05 Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 vino unit sales 553 571 599 632 612 659 659 684 658 713 704 717 811 Standard units (000's) |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0022.gif)
Vinorelbine Market Growth Opportunity Combination of vinorelbine and cisplatin significantly improves disease-free and OS following complete resection of stage IB or stage II NSCLC (up to 15% survival gain following vinorelbine/cisplatin adjuvant therapy versus observation alone) Adjuvant chemotherapy has become recommended method of care for patients with operable early stage NSCLC3 1. JBR.10 Study, New England Journal of Medicine 352:258902597, 2005 2. ANITA Study, Lancet Oncology 7:719-727, 2006 3. NCCN Clinical Practice Guidelines in Oncology V.2.2008 Adjuvant Vinorelbine/Cisplatin Prolongs Survival in Patients With Early- Stage Non-Small Cell Lung Cancer Two NSCLC clinical studies (JBR.10 and ANITA) demonstrated survival benefit with vinorelbine/cisplatin in adjuvant setting1,2 Potential for increased use of vinorelbine in the adjuvant setting |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0023.gif)
ANX-514 (docetaxel emulsion) New formulation of docetaxel formulated without polysorbate 80 or other detergents, designed to reduce the incidence and severity of hypersensitivity reactions ANX-514 (docetaxel emulsion) FDA recently affirmed a 505(b)(2) regulatory path in the U.S. Single study of approximately 28 patients that demonstrates the bioequivalence of ANX-514 & docetaxel is sufficient clinical data to support filing an NDA Preclinical results have indicated bioequivalent pharmacokinetics with a reduced risk of hypersensitivity reactions Docetaxel (Taxotere(r)) Approved for the treatment of breast, non-small cell lung, prostate, head and neck & gastric cancers Severe hypersensitivity reactions can be caused by the presence of polysorbate 80 (detergent used to solubilize docetaxel); premedication with corticosteroids recommended for patients prior to treatment with docetaxel 2006 Global Taxotere Sales = Approx. $2.2B |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0024.gif)
ANX-514 Preclinical Results Plasma Histamine Levels Day 1 Dosing Day 22 Dosing Dose Level = 1 mg/kg. Duration of Infusion = 5 minutes. Crossover Study Design. (n= 4 animals per group) ADVENTRX data on file. Lower hypersensitivity observed following ANX-514 administration over Taxotere in an animal model |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0025.gif)
ANX-514 Preclinical Results Blood Pressure Changes Systolic blood pressure drops following Taxotere treatment compared to ANX-514 in an animal model n = 4 animals per group |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0026.gif)
Taxotere induces statistically significant (p < 0.05) increase in human serum complement activation compared to ANX-514 ANX-514 Preclinical Results Complement Activation n = 10 normal human donor serum samples |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0027.gif)
ANX-514 Preclinical Results Breast Tumor Xenograft ANX-514 exhibits equivalent antitumor activity as Taxotere in a mouse xenograft model Day 25 Excised Tumors Dose level = 10 mg/kg (30 mg/m2 human equivalent dose), q3dx4 intravenous treatment; n=12 (saline group); n=6 (Taxotere & ANX-514 groups) |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0028.gif)
ANX-514 Preclinical Results Pharmacokinetics Pharmacokinetics unchanged (statistically equivalent) for ANX-514 in an animal PK model n = 4 animals per group |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0029.gif)
Total Taxane pharmaceutical market nearly $2.2 billion Taxanes Market Source: Datamonitor Taxane Global Drug Sales 1999-2006 |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0030.gif)
? ? Infectious Diseases |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0031.gif)
ANX-201 (thiophosphonoformate) Reverse transcriptase inhibitor with novel mechanism of action that re-enables NRTI use in NRTI-resistant HIV+ patients Unique mechanism of action as a pyrophosphate analog reflected in unique resistance profile Resensitizes NRTI-resistant virus Active against virus with common mutations thiophosphonoformate, TPFA Synergistic activity with NRTIs including tenofovir, zidovudine (AZT), lamivudine and abacavir Broad antiviral activity: HIV, HPV, herpes and influenza A Note: Tenofovir is a NRTI in Truvada? and Viread?, zidovudine is a NRTI in Combivir?, Trizivir?, Retrovir? , lamivudine is a NRTI in Epivir?, Combivir?, Trizivir?, and abacavir is a NRTI in Ziagen?, Trizivir?, Epzicom?. |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0032.gif)
K65R TAMs M184V tenofovir 0 50 12.5 stavudine nt 37.5 66.7 zidovudine 50 11.1 38.5 ANX-201 100 100 100 ANX-201 Preclinical Data Source: Assays performed by Monogram Biosciences. Data on file. Drug Activity Against HIV with Resistance to NRTIs ANX-201 tested against viruses resistant to common NRTIs due to virus mutations; all viruses tested were sensitive to ANX-201 nt ANX-201 % of viruses sensitive ADVENTRX data on file. n=6 n=18 n=13 |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0033.gif)
% resistant 4th Qtr nnrti-resistant virus 20.4 TDF/d4T 32.7 31.6 ZDV 27 43.9 EFV 3.7 NVP 14.8 THV 100 wt TDF/d4T 0 ZDV 0 EFV 0 NVP 20 THV 0 Source: Assays performed by Monogram Biosciences. Data on file. zidovudine ANX-201 tenofovir/ stavudine efavirenz nevirapine NNRTI-resistant virus n=27 ANX-201 Preclinical Data % of viruses sensitive ADVENTRX data on file. Drug Activity Against HIV with Resistance to NNRTIs ANX-201 tested against viruses resistant to NNRTIs due to virus mutations; all viruses tested were sensitive to ANX-201 |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0034.gif)
Sources: National Center for Health Statistics, UNAIDS/WHO, Datamonitor Pipeline Insight HIV 8/06 HIV/AIDS Market RTI SALES (US) Drugs targeting HIV reverse transcriptase generated $3.2B in U.S. sales (2006) MARKET GROWTH HIV/AIDS is a chronic disease: Goal of treatment is lifelong viral suppression. Treatment-experienced 3rd line+ patients, represent approximately one-third of all HIV+ patients in the U.S. Number of HIV cases: US - 950,000 with 40,000 new cases each year North America and Western Europe - 1.8M Global - nearly 40M Portion of total sales by drug class in the 6 major markets (2006): NRTI NNRTI PI Other 2.635 0.606 1.834 0.305 30.6 38.6 34.6 45.9 46.9 45 |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0035.gif)
Source: Incidence and prevalence database. Matrixx Initiatives, Inc. 2006 annual report. ANX-211 ANX-211 ANX-211 has demonstrated efficacy against viruses responsible for the common cold, influenza and other respiratory tract infections in preclinical studies Zicam(r) Leading competitive US product positioned for cold Zicam-branded cold remedy and multi-symptom cold/flu product line sold nearly $75M in 2006 Estimated 20-50M cases of flu and 500M cases of common cold each year in U.S. Zinc and chitosan based intranasal/topical broad spectrum antiviral designed to reduce duration and severity of cold and flu for OTC market |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0036.gif)
ANX-211 Preclinical Efficacy No antiviral added (positive control) Zinc only preparation ANX-211 HEK cells infected by adenovirus carrying ?-gal gene. Virus-infected cells are blue from X-gal staining. ANX-211 was more effective than the zinc only preparation in protecting the cells against the adenovirus infection. virus-infected cells stained blue ANX-211 has demonstrated efficacy against viruses responsible for the common cold, influenza and other respiratory tract infections in preclinical studies |
![](https://cdn.kscope.io/9d4e62f5a47fd98900d2019fbbb357f4-a34453a34453z0037.gif)
Leadership Evan M. Levine, Chief Executive Officer & Director Brown Simpson Asset Management; Dillon Read; Hambrecht & Quist James A. Merritt, M.D., President & Chief Medical Officer Imagine Pharmaceuticals; Introgen; Viagene; Idec Pharmaceuticals; Upjohn Gregory P. Hanson, C.M.A., M.B.A., Chief Financial Officer Avanir Pharmaceuticals; XXsys Technologies, L3 Communications, Caterpillar, Ford Joan M. Robbins, Ph.D., Chief Scientific Officer Immusol; Chiron; NCI/NIH Laboratory of Tumor Immunology & Biology Brian M. Culley, M.S., M.B.A., Chief Business Officer Immusol; UCSD Technology Transfer and Intellectual Property Dept.; Neurocrine Biosciences Joachim P. H. Schupp, M.D., Vice President, Medical Affairs ProSanos Corp.; Novartis AG; CIBA-GEIGY AG Patrick L. Keran, J.D., General Counsel Isis Pharmaceuticals; Heller Ehrman; Brobeck, Phleger & Harrison Mark J. Cantwell, Ph.D., Vice President, Research & Development Tragen Pharmaceuticals; UCSD Mark Erwin, Vice President, Commercialization Centric Health Finance, LLC ; Ligand Pharmaceuticals; IDEC Pharmaceuticals Michele L. Yelmene, Vice President, Regulatory Affairs Perlan Therapeutics, Genzyme Corp., Mallinckrodt |
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Board of Directors Jack Lief, Chairman President, CEO, Cofounder and Director, Arena Pharmaceuticals Evan M. Levine Chief Executive Officer, ADVENTRX Pharmaceuticals Mark N. K. Bagnall, C.P.A. Former Chief Finance and Operations Officer, Metabolex, Inc. Alex J. Denner, Ph.D. Icahn Partners LP, Icahn Partners Master Fund LP; Director, ImClone Systems Michael M. Goldberg, M.D. Partner, Montaur Capital Partners Mark J. Pykett, V.M.D., Ph.D. President and COO, Alseres Pharmaceuticals Inc.; Cofounder, Cytomatrix |
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Q4 2007 Milestones ANX-530 Marketing-Enabling Bioequivalence Study Data anticipated Nov. '07 CoFactor Phase 2 Study (breast cancer) Completion of patient enrollment anticipated Q4'07 ANX-514 Marketing-Enabling Bioequivalence Study IND filing anticipated Q4'07 Study initiation anticipated Q4'07, pending appropriate regulatory clearances |
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? ? AMEX: ANX Refining therapies for life |