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Vaccine Portfolio
Independent vaccine companies:  Crucell NV (NasdaqNM: CRXL) www.crucell.com
Current products: Crucell's fully liquid pentavalent vaccine Quinvaxem™ (co-developed with Chiron) has been licensed by the Korea FDA. The vaccine combines antigens for protection against the major childhood diseases diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and Haemophilus influenzae type b, one of the leading causes of bacterial meningitis in children. Quinvaxem is the first internationally available fully liquid vaccine containing all five antigens to reach the market. Products in development: Classical vaccines currently being developed by Crucell include an inactivated split virus influenza vaccine for epidemic and pandemic flu (in preclinical stage; being co-developed with Aventis) and an inactivated whole virus West Nile vaccine (in Phase I). Recombinant vaccines based on Crucell's PER.C6® and AdVac® technologies that are currently being developed by Crucell include an Ebola vaccine and a malaria vaccine. Both are in the preclinical stage. Crucell is also developing a monoclonal antibody product for protection against rabies. Discovered using Crucell's Mabstract® technology and produced on its PER.C6® technology, the product is a combination of two human anti-rabies antibodies. Crucell plans to initiate Phase I clinical testing of the rabies antibody product late in 2006.
 Baxter International Inc. (NYSE: BAX) www.baxter.com
Current products: Baxter produces a range of vaccines for infectious diseases, including vaccines for the prevention of meningitis C; tick-borne encephalitis (a potentially fatal disease common in Europe); and smallpox. Products in development: Baxter has developed a H5N1 candidate influenza vaccine based on an avian strain and is also developing a cell culture-based H5N1 candidate pandemic influenza vaccine. Other vaccines in the pipeline target SARS, Lyme disease and other infectious diseases.
 Acambis plc (NasdaqNM: ACAM) www.acambis.com
Current products: Acambis' product portfolio includes Vivotif®, its oral typhoid vaccine, and two unlicensed smallpox-related vaccines that the company supplies to governments under a unique arrangement with the US FDA - ACAM2000 and C-VIG (Vaccinia Immune Globulin), Acambis' co-venture with Cangene Corp. Products in development: Acambis is developing another smallpox vaccine, Modified Vaccinia Ankara (MVA), under contracts with the US Government. Acambis has US sales and marketing rights to ARILVAX™, a yellow fever vaccine, from its owner and manufacturer, Chiron Vaccines. A Phase III safety trial was completed in the UK in 2001, and a pediatric trial was completed in Peru in 2003. Acambis is developing an investigational vaccine, ChimeriVax-JE, for Japanese Encephalitis; in November 2005 pivotal Phase III trials were initiated in Australia and the US, and concurrent clinical trials are also being conducted in India. In May 2005, Acambis became the first company to present completed Phase I results of a West Nile virus vaccine with its candidate ChimeriVax-West Nile. Phase II testing of the vaccine began in December 2005. Acambis has constructed a chimeric vaccine against all four dengue virus serotypes. A Phase I trial of its tetravalent vaccine ChimeriVax-DEN2 is ongoing. The condition CDAD is caused by Clostridium difficile (C. difficile), a bacterium that causes inflammation of the colon (colitis) and diarrhea in humans; CDAD occurs in susceptible individuals following antibiotic therapy. Acambis has successfully produced and tested a batch of an injectable vaccine containing inactivated C. difficile toxins A and B for treating CDAD. Four doses of the vaccine were shown to be immunogenic and well tolerated in a Phase I clinical study on healthy young adults, and a Phase I trial in healthy elderly adults was initiated at the end of 2005.
 CSL Ltd. (ASX: CSL) Trades on Australian exchange www.csl.com.au
Current products: CSL's adult vaccines include ADT® for the immunization of adults and children over eight years against diphtheria and tetanus; H-B-VAX II® for immunization against Hepatitis B infection; Menjugate® for immunization against meningococcal group C infection; Q Vax® for immunization against Q fever; Tet-Tox® for active immunization against tetanus in adults and children two months of age or older; and Varivax® for immunization against chicken pox. CSL's pediatric vaccines include vaccines to protect children against Hepatitis B, hemophilus influenza type B, meningococcal group C infection, rubella, measles/mumps/rubella, and varicella (chicken pox). The company's respiratory vaccines include PNEUMOVAX® 23 to prevent pneumococcal infections, and Fluvax® for immunization against influenza. CSL's travel vaccines include a Plague Vaccine to prevent plague occurring in humans, and VAQTA® for active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 12 months of age and older. Products in development: CSL's pipeline products include vaccines to prevent cervical cancer and genital warts (in Phase III), to treat Hepatitis C (co-developing with Chiron - in Phase II), to treat Human papilloma virus (in Phase Ib), and to treat melanoma (in Phase II).
 Solvay Pharmaceuticals (Brussels: SOLB.BR) Trades on Brussels exchange www.solvay.com
Current products: Solvay's INFLUVAC® vaccine for influenza is currently marketed in more than 40 countries worldwide. Solvay has also acquired the rights for the production of INVIVAC®, a virsomal influenza vaccine, which is designed to give an even better protection against the influenza virus. Products in development: Solvay continues to improve its influenza vaccine and has planned the introduction of INFLUVAC®TC within 2 years from now. This new product will be manufactured using MDCK cells instead of chicken eggs.

Bavarian Nordic A/S (Copenhagen: BAVA.CO) Trades on Copenhagen exchange www.bavarian-nordic.com Products in development: The company's third-generation smallpox vaccine IMAVUNE® is currently in three Phase II studies in both healthy and high-risk subjects. The company's second-generation smallpox vaccine Elstree-BN® has completed a Phase I study in 2004, and the subjects of the study were monitored for a one-year follow-up. The company is pursuing a three-path approach to develop a prophylactic and therapeutic HIV vaccine. The first path (MVA nef) combines the MVA vector with the HIV Nef antigen, and is in an ongoing Phase II study. The second path (MVA-BN® polytope) is to use MVA-BN® to express a large number of killer T-cells and helper T-cell epitopes in one construct (HIV polytope). Bavarian Nordic is pursuing this approach independently and in collaboration with IDM Pharma (formerly known as Epimmune). Currently pre-clinical, a total of 4 studies (2 Phase I and 2 Phase I/II) are planned in 2006 - 2 in Europe and 2 in the US. The third path (MVA-BN® multiantigen) is based on the expression of multiple HIV antigens. The MVA-BN® multiantigen vaccine has been cloned and preclinical activities have started. The vaccine will be ready for clinical trials in 2006. The company's MVA-BN® Dengue Fever vaccine is in pre-clinical studies. The company's MVA-BN® JE vaccine for Japanese Encephalitis commenced a Phase I clinical trial in healthy volunteers in 2005. Bavarian Nordic has also created a new subsidiary to conduct research, preclinical and clinical development activities on MVA-BN®-based vaccines primarily against breast, prostate and colon cancer. Bavarian Nordic has cloned a measles vaccine, MVA-BN® Measles, and early clinical trial materials are expected to be released in first quarter of 2006. MVA-BN® RSV for Respiratory Syncytial Virus is in the pre-clinical stage.
 VaxGen, Inc. (OTC:VXGN.PK) www.vaxgen.com
Current products: VaxGen's LC16m8 Attenuated Smallpox Vaccine is being manufactured by KAKETSUKEN in Japan, and the vaccine has been licensed for use in Japan. VaxGen initiated a Phase I/II clinical trial of LC16m8 in October 2004. Products in development: VaxGen is developing its RPA102 vaccine against anthrax. Phase II trials were initiated in 2004, with animal studies planned as well. In May 2005, VaxGen, Inc. and EndoBiologics International Corp. announced a collaboration to pursue research of a vaccine against Neisseria meningitidis serogroup B (Meningitis B). Under the collaboration, VaxGen intends to fund proof-of concept studies and continue product development if the studies yield promising results.
 Intercell AG (VSE: ICLL) Trades on Vienna exchange www.intercell.com
Products in development: Intercell has two vaccine candidates in late-stage development. The first is a prophylactic vaccine against Japanese Encephalitis. Intercell will file for US approval for the vaccine later in 2006, with licensure expected in 2007. Intercell's second candidate is a therapeutic vaccine against hepatitis C. The product is currently in Phase II trials that are scheduled to be completed by mid-2007. The company's third product is a prophylactic vaccine candidate against tuberculosis that entered Phase I clinical trials in the fall of 2005. Other early-stage pipeline programs include vaccines against pneumonia, Group A Streptococcus, and travelers' diarrhea.
 Vical Inc. (Nasdaq NM: VICL) www.vical.com
Products in development: Vical is developing or co-developing numerous vaccines to treat cancer and infectious diseases. The company's DNA vaccines for infectious diseases in development include vaccines for Cytomegalovirus - Phase I; Bacillus anthracis (anthrax) - Phase I; Ebola - Phase I; WNV - Phase I; SARS - Phase I; HIV - Phase II (w/NIH); HIV (Phase I (w/Merck); and preclinical research with vaccines for avian flu, HIV EP, Hepatitis B, and Hepatitis C. Vical is also developing several cancer immunotherapy vaccines. The company's product Allovectin-7® is in Phase II, and a second vaccine IL-2/EP is in Phase I. Vical is co-developing a tumor-associated antigen therapeutic vaccine with Merck. |