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Intercell will gain full rights to Iomai's late stage Travelers' Diarrhea
vaccine which is based on Iomai's proprietary needle-free patch delivery
vaccine technology and has shown positive interim Phase II efficacy data. The
Travelers' Diarrhea vaccine is expected to enter pivotal Phase III trials in
the first half of 2009. If approved, the medical use of Iomai's Travelers'
Diarrhea vaccine will be highly complementary with Intercell's Japanese
Encephalitis vaccine for which a Biologics License Application was
successfully submitted to the US Food and Drug Administration in
Commenting on the transaction, Gerd Zettlmeissl, CEO of Intercell, said: "This transaction further expands our leadership in vaccine innovation, greatly enhances Intercell's R&D technology base and further strengthens our late stage vaccine portfolio. Building on our proven experience in industrialization and in moving novel products to the market, Intercell is fully committed to becoming the leading pure play vaccine company globally. We look forward to welcoming Iomai's employees to Intercell and are excited by the potential of the combined group to create significant value for all stakeholders."
Intercell will also gain full rights to two additional clinical and three preclinical programs under development, the most advanced being an immunostimulant vaccine patch in Phase II for pandemic influenza. This patch is designed to enhance the immune response compared to injected pandemic influenza vaccines. If successful, it would have the effect of expanding limited vaccine supplies by allowing public health officials to use fewer or lower doses of the vaccine. The vaccine patch has recently generated positive interim immunogenicity data in a 500-subject Phase I/II study with a one-dose application. The program is funded by a grant from the United States Department of Health and Human Services.
Iomai's pioneering work in transcutaneous immunization (TCI) technology has led to the development of a simple and promising needle-free vaccine patch. This highly innovative vaccine delivery system provides a potential future alternative to current injected vaccines. TCI technology has the potential to enhance the efficacy of existing vaccines, replace current vaccines that have a cumbersome mode of administration and enable the development of new vaccines that are not viable to be delivered via an injection.
Iomai's TCI technology strengthens Intercell's position as an innovative vaccine company and is highly complementary with its proprietary antigen identification and adjuvant vaccine technology platforms (AIP(R) and IC31(R)). TCI adds an important third arm to Intercell's leading vaccine technologies, specifically a delivery platform for antigens and adjuvants that can facilitate the development of a broad range of in-house and partnered vaccine products. Both companies have already partnered technologies with Merck & Co., Inc., the most recent one being Iomai's agreement to conduct proof-of-principle preclinical studies evaluating the use of its needle-free immunostimulant patch. Intercell plans to further leverage the TCI technology by applying it to other vaccines in its development pipeline, such as its Pneumococcus vaccine candidate.
Furthermore, Iomai's vaccine patch has the potential to provide cheaper
and more effective medication to those living in endemic areas, in particular
high risk groups such as children and the elderly located in developing
countries in
Transaction Terms:
Under the terms of the merger agreement, Intercell will acquire Iomai for
The combination is structured as a share exchange together with a merger of Iomai and a US subsidiary of Intercell. Certain of Iomai's largest shareholders (and their affiliates), which together represent over 50 percent of Iomai's outstanding common stock, have agreed pursuant to a voting agreement with Intercell that they will vote their shares in favour of the merger.
The transaction has been unanimously approved by the Boards of Directors
of both companies and is subject to customary closing conditions, including
the approval of the merger by a majority of shareholders of Iomai at a special
shareholder meeting to be held as soon as practical, receipt of antitrust
clearances and clearance by the Committee on Foreign Investment in
Based on Intercell's closing share price as of
Merrill Lynch International acted as exclusive financial adviser to Intercell and Cowen and Company provided a financial fairness opinion to Iomai's Board of Directors.
Analyst/Shareholder Conference Call:
A conference call on the transaction together with Intercell's Q1 2008
results will be held by Intercell and Iomai's senior managements on
Ad-hoc Information
About Travelers' Diarrhea:
This year, approximately 55 million international travelers will visit
countries where bacteria that cause travelers' diarrhea are endemic,
particularly
Because of the extent of the problem and the lack of safe and effective
prophylaxis, market studies suggest that there is a large market for an
effective travelers' diarrhea vaccine, potentially exceeding
About Pandemic Influenza:
Three influenza pandemics have occurred in the 20th century leading to the
death of more than 50 million people globally. By US government estimates,
pandemic influenza has a greater potential to cause deaths and illnesses than
virtually any other natural health threat. Signs of a pandemic influenza have
emerged in
In
About Japanese Encephalitis:
With over three billion people living in endemic areas, Japanese
Encephalitis, a mosquito-borne flaviviral infection, is the leading cause of
childhood encephalitis and viral encephalitis in
About Intercell AG:
Intercell AG is a growing biotechnology company which focuses on the design and development of novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical need. The Company develops antigens and adjuvants which are derived from its proprietary technology platforms and has in-house GMP manufacturing capabilities. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, Sanofi Pasteur, Kirin, and the Statens Serum Institut.
The Company's leading product, a prophylactic vaccine against Japanese
Encephalitis, successfully concluded pivotal Phase III clinical trials in
2006. The Market Authorization Application (MAA) in
The Company's broad development pipeline includes a partnered S. aureus vaccine in Phase II, a therapeutic vaccine against Hepatitis C in Phase II, a Pseudomonas vaccine in Phase II, a partnered Tuberculosis vaccine (Phase I/II), and five products focused on infectious diseases in preclinical development.
Intercell is listed on the Prime Market of the Vienna Stock Exchange under the symbol "ICLL".
ISIN: AT0000612601 For more information on Intercell, please visit: http://www.intercell.com
About Iomai Corporation:
Iomai Corporation has approximately 110 employees and discovers and develops vaccines and immune system stimulants, delivered via a novel, needle-free technology called transcutaneous immunization (TCI). TCI, discovered by researchers at the Walter Reed Army Institute of Research, taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, develop new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: one to prevent traveler's diarrhea and three targeting influenza and pandemic flu.
Iomai is listed on the NASDAQ Global Market under the symbol "IOMI". For more information on Iomai, please visit: http://www.Iomai.com
Additional Information and Where to Find It:
In connection with the proposed transaction, Iomai Corporation will be filing a proxy statement for its stockholders and other documents regarding the proposed transaction with the Securities and Exchange Commission (SEC). BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, IOMAI STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT MATERIALS CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND IOMAI. Investors and stockholders may obtain copies of the proxy statement and other relevant documents filed with the SEC by Iomai free of charge at the SEC's web site at http://www.sec.gov. In addition, investors and stockholders may obtain copies of the proxy statement and other relevant documents filed with the SEC by Iomai (when they are available) by going to Iomai's Investor Relations page on its corporate website at http://www.iomai.com.
Iomai and its directors, executive officers and other members of
management may be deemed to be participants in the solicitation of proxies
from Iomai's stockholders with respect to the proposed transaction.
Information regarding Iomai's executive officers and directors, and their
beneficial ownership of Iomai's common stock as of
Forward Looking Statements for Intercell AG:
This communication expressly or implicitly contains certain advance statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such advance statements. Intercell AG is providing this communication as of this date and does not update any advance statements contained herein as a result of new information, future events or otherwise.
Forward Looking Statements for Iomai Corporation:
Some matters discussed in this press release constitute "forward-looking
statements" that involve known and unknown risks and uncertainties that could
cause actual results to differ materially from those expressed or implied by
the forward-looking statements. Such forward-looking statements include
statements about the anticipated acquisition of Iomai by Intercell and timing
of and potential benefits of the anticipated acquisition; the potential
synergies between the combination of Iomai and Intercell's product
technologies; expectations regarding the timing of clinical trials and product
development; the ability of Iomai's adjuvant patches to provide protective
immune responses; the significance of clinical results described in this press
release; expectations that the clinical trial data from a clinical trial will
be sufficient to proceed with future clinical trials; estimates of potential
markets for Iomai's product candidates; the potential for Iomai's product
candidates to be lower cost or more effective for specific patient
populations; expectations that the characteristics of Iomai's adjuvant patch
for pandemic influenza would make the product ideal for stockpile and rapid
distribution; expectations that TCI technology will enhance the efficacy of or
replace or be an alternative to current injected vaccines, expectations that
TCI technology can facilitate development of a broad range of vaccine
products; and expectations for further collaboration with Merck & Co., Inc. or
any other potential collaborations. These statements are subject to risks and
uncertainties that could cause actual results to differ materially from those
projected in these forward-looking statements. Applicable risks and
uncertainties include, among others, that the proposed acquisition does not
close or that the companies may be required to modify aspects of the
transaction to achieve regulatory approval; that prior to the closing of the
acquisition, Iomai's business suffers due to uncertainty; that the companies
are unable to successfully execute their integration strategies, or achieve
planned synergies; that future clinical trials may not replicate results seen
in the trials described in this press release; that the U.S. Food and Drug
Administration or other regulatory authorities may not concur with Iomai's
analysis of the trial results described in this press release; that Iomai may
not be able to enroll sufficient numbers of subjects in future clinical
trials; that Iomai may be unable to obtain the regulatory approvals or
financing necessary to conduct additional clinical trials; that competitors
may develop products that are safer, more effective, or more convenient to
use; that future clinical results may not support regulatory approval to
commercialize Iomai's product candidates, which will depend on the outcome of
additional clinical trials and analysis by regulatory authorities of data
Iomai submits; that development costs may exceed expectations; that Iomai may
fail to adequately protect its intellectual property or may be determined to
infringe on the intellectual property of others; and the risks identified
under the heading "Risk Factors" in our Annual Report on Form 10-K for the
year ended
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