Baxter Receives EMEA Positive Opinion For CELVAPAN H1N1 Pandemic Influenza Vaccine!

Baxter International Inc. (NYSE:BAX) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its "positive opinion" for CELVAPAN H1N1pandemic vaccine using Baxter's Vero cell technology. This positive opinion confirms the acceptability of Baxter's regulatory submission to obtain final marketing authorization and licensure of the product.

CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted vaccine to receive a positive opinion in the European Union. Initial quantities of vaccine have already been delivered to a number of countries, including the UK and Ireland, for use in their national vaccination programs, and are awaiting product release subject to final marketing authorization being granted by the European Commission.

Presently, Baxter is confirming the safety and immunogenicity of CELVAPAN H1N1 in clinical trials. The company is conducting two randomized trials in 400 healthy adults age 18 and over and in 400 children and adolescents to supplement the licensure post-approval with appropriate clinical data. These trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5µg and 3.75µg. Once countries initiate national vaccination programs using CELVAPAN H1N1, Baxter will also conduct a large-scale observational study with CELVAPAN in 9,000 people of different age groups, including children.

Preliminary safety data in adults and the elderly indicate that the vaccine is well tolerated in these age groups. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenzavaccines. Immunogenicity data from the first vaccination in adults are due later this month. The current dosing schedule, as specified in the EMEA mock-up licensure for CELVAPAN using another virus strain, calls for two 7.5 µg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for CELVAPAN H1N1. This study will also determine whether a lower dose, 3.75µg, is sufficient to induce the necessary immune response.

"We are pleased that the regulatory submission and the preliminary clinical trial data uphold the extensive work done by Baxter and the support received from key Ministries of Health in developing a pandemic vaccine," said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. "We are looking forward to analyzing the immunogenicity data for our cell culture-derived, non-adjuvanted vaccine to assess the potential of a one dose regimen."

About Baxter's Pandemic Vaccine Development

Earlier this year, the EMEA granted mock-up licensure for CELVAPAN using a different strain with pandemic potential, which was tested in five completed clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004. This pathway allows for the development, evaluation and licensure of a company's pandemic candidate vaccine using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain.

Baxter received the H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics in the company's proprietary Vero cell culture technology.

Baxter initiated commercial production in early June, and made its first commercial product within 12 weeks of receipt of the virus. The company produces bulk CELVAPAN H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and finish before distribution. Baxter completed production of the first batches of CELVAPAN H1N1 vaccine in late July and initiated its first delivery within two weeks. The company continues to deliver vaccine on an ongoing basis to national public health authorities.

Baxter initiated its license application for CELVAPAN H1N1 in July based on the EMEA published guidelines for pandemic vaccine marketing authorization. The company conducted rigorous testing of the H1N1 based vaccine and submitted additional data for vaccine development, product quality and manufacturing processes specific to that strain. Other non-E.U. countries may choose to evaluate the company's EMEA submission and licensure as the basis for their national health authority's authorization for use of the vaccine.

More information on CELVAPAN H1N1 clinical trials is available here.