May 22

Emergent BioSolutions Signs Agreement With sanofi pasteur for Development of Novel Meningitis B Vaccine
Monday June 5, 9:33 am ET

Sanofi pasteur Receives Exclusive Rights to Emergent BioSolutions' Technology; Emergent BioSolutions to Lead Early Development and Receive Fees and Milestone Payments

GAITHERSBURG, Md., June 5 /PRNewswire/ -- Emergent BioSolutions Inc, a privately-held biopharmaceutical company, today announced it has signed an agreement with sanofi pasteur, the vaccines business of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY). The agreement gives sanofi pasteur exclusive, world-wide rights to Emergent BioSolutions' proprietary proteins and related technology for the development of a novel vaccine to protect against Neisseria meningitidis serogroup B bacterial infections. In addition, the agreement provides that the parties will collaborate in all aspects of product development through to regulatory approval. The companies are targeting a major unmet public health need as current vaccines do not provide protection against serogroup B meningitis.

Under the terms of the agreement, the parties will jointly evaluate and develop a pool of Emergent BioSolution's proprietary antigens as the basis of a multivalent subunit vaccine against Neisseria meningitidis infection. Emergent BioSolutions identified these protein candidates using its patented Signature-Tagged Mutagenesis (STM(TM)) functional genomics technology in combination with functional proteomics techniques. Emergent BioSolutions will have primary responsibility for product development activities through Phase I clinical trials. Sanofi pasteur will have primary responsibility for product development activities from initiation of Phase II studies through to regulatory approval, and for all commercialization activities including world- wide sales and marketing.

Upon agreement sanofi pasteur paid Emergent BioSolutions an up-front license fee of euro 3 million. Agreement terms also provide for payments to Emergent BioSolutions for all development services provided in advancing a vaccine through Phase I clinical trials with a retrospective payment for work performed from January 1, 2006 until agreement, significant milestone payments along the development cycle and royalties on eventual products sales.

"We are pleased at the opportunity to collaborate with Emergent BioSolutions, as part of our overall strategy to develop and commercialize a successful vaccine for protection against meninge B infections," said Michel DeWilde, Sr. Vice President of Research & Development, sanofi pasteur. "Now, more than ever, it is clear that creative partnerships between academia, biotechnology companies, research foundations, government agencies, and the pharmaceutical industry are necessary to meet the demand for new, more technologically challenging vaccines. Emergent BioSolutions' performance and values are aligned with our own, making them a good partner for us."

"Our agreement with sanofi pasteur is an important step forward in the development of a critically-needed vaccine to prevent one of the world's deadliest childhood diseases," said Fuad El-Hibri, Chairman and Chief Executive Officer, of Emergent BioSolutions. "This agreement is also consistent with our strategy of selectively establishing relationships with leading pharmaceutical and biotechnology companies for the commercialization of certain of our product candidates. We believe the program established with sanofi pasteur creates a powerful, best-in-class team charged with the mission of developing our novel technology to address a substantial unmet medical need."

About Meningitis B

Meningococcal disease is a life threatening infection capable of causing both meningitis and septicemia. Children aged 6 months to 2 years are at the highest risk of serogroup B meningococcal infection (meningitis B), with teenagers also at enhanced risk. While there are effective purified polysaccharide and conjugate vaccines available to protect against the other major meningococcal serogroups, there is no preventive vaccine currently available to protect against Neisseria meningitides serogroup B infections. Even with intensive medical treatment, meningococcal infection has a fatality rate of up to 10 percent and can rapidly develop, causing death within 24 hours of the onset of symptoms. Approximately 15 percent of survivors are left with serious disability, such as loss of limbs, deafness, or brain damag

May 22, 2006
ACIP RECOMMENDS DEFERRING MENINGOCOCCAL CONJUGATE VACCINATION FOR PERSONS AGES 11to 12 YEARS BECAUSE OF LIMITED SUPPLY

On May 19, CDC published "Notice to readers: Limited supply of
meningococcal conjugate vaccine, recommendation to defer
vaccination of persons aged 11to 12 years" in the MMWR Dispatch.
It is reprinted below in its entirety, excluding a reference.

In January 2005, a tetravalent meningococcal polysaccharide-
protein conjugate vaccine ([MCV4] Menactra, manufactured by
Sanofi Pasteur, Inc., Swiftwater, Pennsylvania), was licensed
for use among persons aged 11�55 years. The Advisory Committee
on Immunization Practices (ACIP) recommends routine vaccination
with MCV4 of persons aged 11�12 years, of adolescents at high
school entry (i.e., at approximately age 15 years) if not
previously vaccinated with MCV4, and of college freshmen living
in dormitories. Vaccination also is recommended for other
persons at increased risk for meningococcal disease (i.e.,
military recruits, travelers to areas where meningococcal
disease is hyperendemic or epidemic, microbiologists who are
routinely exposed to isolates of Neisseria meningitidis, persons
with anatomic or functional asplenia, and persons with terminal
complement deficiency).

Sanofi Pasteur anticipates that MCV4 demand will outpace supply
at least through summer 2006. CDC, in consultation with ACIP,
the American Academy of Pediatrics, American Academy of Family
Physicians, American College Health Association, and Society for
Adolescent Medicine, recommends that providers continue to
vaccinate adolescents at high school entry who have not
previously received MCV4 and college freshmen living in
dormitories. Current supply projections from Sanofi Pasteur
suggest that enough MCV4 will be available to meet vaccine
demand for these groups. Until further notice, administration of
MCV4 to persons aged 11�12 years should be deferred. If
possible, providers should track persons aged 11�12 years for
whom MCV4 has been deferred and recall them for vaccination when
supply improves. Other persons at high risk for meningococcal
disease (i.e., military recruits, travelers to areas where
meningococcal disease is hyperendemic or epidemic,
microbiologists who are routinely exposed to isolates of N.
meningitidis, persons with anatomic or functional asplenia, and
persons with terminal complement deficiency) also should be
vaccinated.

For vaccination of most persons, MCV4 is preferable to
tetravalent meningococcal polysaccharide vaccine ([MPSV4]
Menomune-A,C,Y,W-135, manufactured by sanofi pasteur). MPSV4 is
highly effective in preventing meningococcal disease caused by
serogroups A, C, Y, and W-135 and is an acceptable alternative
to MCV4, particularly in persons who have brief elevations in
their risk for meningococcal disease (e.g., travelers to areas
where meningococcal disease is hyperendemic or epidemic);
however, availability of MPSV4 also is limited.

Periodic updates of vaccine supply will be available at
http://www.cdc.gov/nip/news/shortages/default.htm or you can check back here.