Iomai Corp - Additional Proxy Soliciting Materials (definitive) (DEFA14A)
12 6월 2008 - 7:00PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of the Securities
Exchange Act of 1934 (Amendment No. )
Filed by the Registrant
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Preliminary Proxy Statement
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Confidential, for Use of the Commission Only (as permitted by Rule 14a-
6(e)(2)
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Definitive Proxy Statement
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Definitive Additional Materials
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Soliciting Material Pursuant to §240.14a-12
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IOMAI CORPORATION
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
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Iomai Announces Publication in
The Lancet
of Phase II Study Demonstrating Significant Efficacy of Travelers Diarrhea Vaccine
GAITHERSBURG, Md., and VIENNA, June 11, 2008
Iomai Corporation (Nasdaq: IOMI) today
announced the publication of data from the companys positive Phase II field study of its
travelers diarrhea vaccine in
The Lancet
. The study, which analyzed data from 170 travelers, found
that those who received the Iomai patch-based vaccine were statistically significantly less likely
to suffer from clinically significant diarrhea than their counterparts who received a
placebo.
The study, available online today and to be published in the June 14 edition of
The Lancet
, found
that of the 59 individuals who received the novel, patch-based vaccine, only three suffered from
moderate or severe diarrhea, while 23 of the 111 who received a placebo suffered from moderate or
severe diarrhea, a 75 percent reduction (p=0.007). One of the 59 volunteers in the vaccine group
reported severe diarrhea, compared with 12 of the 111 in the placebo group, an 84 percent reduction
(p=0.033).
These results suggest that the Iomai patch has the potential to fundamentally change the way we
approach prevention of this disease, an ailment against which we now have very few weapons, said
Herbert L. DuPont, M.D., professor and director of the Center for Infectious Diseases at The
University of Texas School of Public Health and the principal investigator on the trial. If these
results are replicated, the Iomai vaccine will have the potential to not only mitigate a disease
that sickens millions each year but also keep some patients from going on to develop the chronic
symptoms of irritable bowel syndrome.
As previously announced, Iomai and Intercell AG (VSE: ICLL) have entered into an agreement whereby
Iomai has agreed to be acquired by Intercell AG.
In addition to the acute symptoms of travelers diarrhea, which include severe diarrhea, abdominal
cramps and dehydration, patients who suffer a bout of travelers diarrhea are also at higher risk
of developing irritable bowel syndrome, a chronic condition characterized by pain, bloating,
diarrhea or constipation.
Diarrheal disease also exacts a significant toll on children in the developing world, where
diarrhea linked to enterotoxigenic E. coli the most common causes of travelers diarrhea
sickens 210 million children each year, killing more than 350,000 annually.
Bacterial diarrheal disease is a significant medical problem for children and travelers, and our
technology represents an advance in vaccine delivery and a breakthrough in the field of infectious
disease. We look forward to targeting both the significant travelers market and developing the
vaccine for the children in the developing world who still suffer serious morbidity and mortality
from this disease, said Gregory Glenn, M.D., Iomais Chief Scientific Officer.
Iomai plans to initiate a Phase III program for the needle-free vaccine patch in 2009.
The research was conducted in collaboration with researchers from the Johns Hopkins Bloomberg
School of Public Health and the University of Texas School of Public Health.
The Lancet
, which has been published since 1823, is an independent and authoritative voice in
global medicine that seeks to publish high-quality clinical trials that will alter medical
practice.
The Lancet
delivers in-depth knowledge in key medical disciplines.
(www.thelancet.com)
About the Phase II Trek Study
The Trek Study followed travelers to Mexico and Guatemala. Volunteers received either two doses of
the Iomai vaccine patch or a placebo, 2 to 3 weeks apart, with the last dose administered at least
a week before travel. Travelers kept detailed diaries and received in-country checkups. The study
met its primary endpoints, which were designed to evaluate the safety of the vaccine and the
incidence of enterotoxigenic E. coli (ETEC) bacteria the most common cause of travelers
diarrhea. No vaccine-related serious adverse events were reported.
Of the few vaccinated patients who were sickened, the diarrhea lasted only half a day on average,
while those in the placebo group endured two days of illness and more than twice as many loose
stools. Although not statistically significant, the frequency of new-onset irritable bowel
syndrome, a long-term consequence of travelers diarrhea, was three times greater in placebo than
vaccine recipients.
Iomais vaccine uses an ETEC toxin delivered via a skin patch using the companys novel
transcutaneous immunization (TCI) technology. ETEC causes illness through the toxins it produces,
including one known as heat-labile toxin or LT. Iomais unique patch-based vaccine enables the safe
administration of this potent immunogen into the skin to stimulate the immune response.
About Travelers Diarrhea
This year, approximately 55 million international travelers will visit countries where bacteria
that cause travelers diarrhea are endemic, particularly Africa, Asia and Latin America, and about
20 million of those travelers will develop travelers diarrhea.
A recently completed market study suggested that there is a large market for an effective
travelers diarrhea vaccine, potentially exceeding $750 million annually. If approved, the Iomai
vaccine would be the first vaccine for travelers diarrhea available in the United States.
ETECs impact goes beyond travelers. The World Health Organization estimates that children in the
developing world suffer 210 million episodes of diarrhea caused by ETEC annually, causing 380,000
deaths each year.
About Iomai Cooperation
Iomai Corporation 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 (Langerhans cells) 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: three
targeting influenza and pandemic flu and one to prevent travelers diarrhea. For more information
on Iomai, please visit
www.iomai.com.
Iomai announced on May 12 that it has entered into an agreement with Intercell AG in which
Intercell will acquire Iomai for $6.60 a share.
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 patch vaccine being a prophylaxis for travelers diarrhea,
the timing for commencing Phase III studies, and bringing the product candidate to market; the
potential size of the market for a travelers diarrhea vaccine; the applicability of TCI technology
to other pathogens; that, if approved, Iomais vaccine would be the first available in the U.S.;
and about the anticipated acquisition of Iomai by Intercell. Applicable risks and uncertainties
include, among others, that Iomai may not be able to enroll sufficient numbers of patients in
future clinical trials; that future clinical trials may not replicate results seen in the trial
described in this press release; that Iomai may be unable to obtain the regulatory approvals
necessary to conduct additional clinical trials or to market any product for travelers diarrhea;
that estimates of market size overstate the number of travelers who would use such a product, if it
were approved; that competitors may develop products that are safer, more effective, or more
convenient to use; that the proposed acquisition of Iomai by Intercell 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, Iomais business suffers due to uncertainty; that the
companies are unable to successfully execute their integration strategies, or achieve planned
synergies; and the risks identified under the heading Factors That May Impact Future Results in
Managements Discussion and Analysis of Financial Condition and Results of Operations in Iomais
Quarterly Report on Form 10-Q for the three months ended March 31, 2008, and filed with the
Securities and Exchange Commission. Iomai cautions investors and others not to place undue reliance
on the forward-looking statements contained in this press release. Iomais business is subject to
many risks. For a discussion of such risks, you are encouraged to read the documents the Company
files with the U.S. Securities and Exchange Commission, available at http://www.sec.gov. The
statements in this press release speak only as of the date of this
document.
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 Companys leading product, a prophylactic vaccine against Japanese Encephalitis, successfully
concluded pivotal Phase III clinical trials in 2006. The Market Authorization Application (MAA) in
Europe as well as the Biological License Application (BLA) with the US Food and Drug Administration
(FDA) for the use of the vaccine to prevent Japanese Encephalitis were submitted in December of
2007. The licensure application to TGA (Therapeutic Goods Administration) in Australia was
submitted in February of 2008.
The Companys 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:
www.intercell.com
Important Additional Information Regarding the Proposed Merger
In connection with the proposed transaction, on May 14, 2008, Iomai Corporation filed a preliminary
proxy statement for its stockholders with the Securities and Exchange Commission (SEC). Iomai
Corporation will be filing a definitive proxy statement for its stockholders and other documents
regarding the proposed transaction with the SEC. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION,
IOMAI STOCKHOLDERS AND INVESTORS ARE URGED TO CAREFULLY READ THE PRELIMINARY PROXY STATEMENT AND,
WHEN IT BECOMES AVAILABLE, THE DEFINITIVE PROXY STATEMENT AS WELL AS ANY OTHER RELEVANT MATERIALS,
IN THEIR ENTIRETY BECAUSE THE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION AND IOMAI. Investors and stockholders may obtain copies of the proxy statements and
other relevant documents filed with the SEC by Iomai free of charge at the SECs web site at
www.sec.gov. In addition, investors and stockholders may obtain copies of the proxy statements and
other relevant documents filed with the SEC by Iomai free of charge (when they are available) by
going to Iomais Investor Relations page on its corporate website at
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 Iomais stockholders with respect to the proposed
transaction. Information regarding the interests of such potential participants in the proxy
solicitation is contained in the preliminary proxy statement and will be contained in the
definitive proxy statement and other relevant materials to be filed with the SEC when they become
available.
Contact Iomai Corporation:
Russell P. Wilson
SVP, Chief Financial Officer and General Counsel of Iomai Corporation
P: +1-301-556-4478
Mail to: investors@iomai.com
Brian Reid
WeissComm Partners, Inc.
703-402-3626
breid@wcpglobal.com
Contact Intercell AG:
Lucia Malfent
Head of Corporate Communications
Campus Vienna Biocenter 2, A-1030 Vienna
P: +43-1-20620-303
Mail to: LMalfent@intercell.com
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.
Iomai Corp (MM) (NASDAQ:IOMI)
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