27.05.2008 04:01:00
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Emergent BioSolutions to Acquire Protein Sciences' Phase III Recombinant Flu Vaccine Candidate, FluBlok(R), and Related Novel Platform Technology
Emergent BioSolutions Inc. (NYSE:EBS) and Protein Sciences Corporation
(PSC), based in Meriden, Connecticut, announced today that the two
companies have entered into an asset purchase agreement under which
Emergent will acquire PSC’s ongoing
operations, including FluBlok, a Phase III recombinant influenza vaccine
candidate, and certain other assets. This agreement achieves a key
component of Emergent’s stated strategy for
growth through acquisition of late-stage product candidates.
Under the terms of the agreement, Emergent will acquire substantially
all assets of PSC, including:
FluBlok® (trivalent
recombinant hemagglutinin vaccine). FluBlok is a Phase III influenza
vaccine candidate that, if approved, would be the first recombinant
cell culture influenza vaccine. FluBlok has potential for use in both
seasonal and pandemic settings. The clinical program for FluBlok,
which includes four trials and more than 6,000 participants, has
demonstrated promising immunogenicity, including in the elderly.
FluBlok has been granted both fast track status and priority review by
FDA.
Baculovirus Expression Vector System (BEVS) technology. BEVS is a cell
culture-based manufacturing platform used to manufacture FluBlok. The
BEVS technology can be applied to develop vaccines and therapeutic
candidates to prevent or treat a wide range of diseases.
Other product candidates. PSC’s other
product candidates are based on the BEVS platform and include a SARS
vaccine in preclinical development.
A vaccine manufacturing facility. This facility is located in Meriden,
Connecticut and includes a 600-liter bioreactor and related upstream
and downstream capabilities.
Emergent intends to retain all of the approximately 50 PSC employees and
anticipates continuing production of FluBlok in the Meriden, Connecticut
facility. Emergent expects to launch out of this location. In parallel,
Emergent is evaluating plans for future large-scale manufacturing of
FluBlok and is considering Meriden as a site for the facility.
In April 2008, PSC submitted to FDA a Biologics License Application
(BLA) for FluBlok, including data from the Phase III clinical program.
The next steps in the BLA process include readiness preparations for the
upcoming FDA pre-approval inspection. In addition, late last year, PSC
applied for a research and development grant in response to a Biomedical
Advanced Research and Development Authority (BARDA) RFP, "Advanced
Development of Recombinant Influenza Virus Vaccines.”
BARDA has indicated its intention to issue one or more awards under this
RFP in late 2008.
"We are delighted about the opportunity to
commercialize the first recombinant cell culture influenza vaccine. We
believe that FluBlok will become a strong competitive product in the
sizeable and growing seasonal influenza market and that BEVS will
provide a unique platform for the development of a novel pandemic
influenza candidate. We congratulate the management of PSC in building a
manufacturing operation and for bringing FluBlok through a Phase III
clinical trial to the point of a BLA submission. Emergent, with the
combined resources of PSC, is well positioned to bring this exciting
product to the market successfully, based on our product development,
regulatory and manufacturing experience,”
said Fuad El-Hibri, chairman and chief executive officer of Emergent
BioSolutions. "The acquisition of FluBlok is
consistent with Emergent’s strategy of
expanding its product portfolio with a vaccine candidate focused on a
major infectious disease.”
Daniel D. Adams, president and chief executive officer of Protein
Sciences Corporation, said, "We are grateful
that Emergent recognized the value of our lead product, FluBlok, and our
proprietary BEVS technology and is providing financial and operational
assistance to assist us in bringing FluBlok through regulatory approval.
Combining our expertises should help to ensure the continued success of
FluBlok and our other strategic assets.”
William H. Narwold, chairman of the board of directors of Protein
Sciences Corporation, commented, "Emergent
enhances our regulatory, manufacturing and process development
capabilities and brings a proven track record of working with the United
States Government to deliver critical infectious disease products. It is
for these reasons that the Board of Directors of Protein Sciences has
approved this transaction and believes that our shareholders will have
the opportunity to benefit from the continued growth and success of
Emergent BioSolutions.” Terms of Acquisition
Under the terms of the asset purchase agreement, the consideration paid
by Emergent will include:
Up to $28 million in cash and the assumption of PSC liabilities,
including trade payables associated with the Phase III clinical trials
of FluBlok;
A $20 million, 4.75%, 5-year note, convertible into Emergent common
stock at a conversion price of $12.50 per share;
Up to $30 million in future payments based on the achievement of
FluBlok commercialization milestones and net sales of FluBlok;
A percentage of net sales of FluBlok.
The closing of this transaction, anticipated by the end of the second
quarter of this year, is subject to the approval of the stockholders of
PSC, the receipt of regulatory approvals and the satisfaction of certain
conditions of closing. Emergent BioSolutions’
financial advisor on this transaction was Jefferies & Company, with
Thelen Reid Brown Raysman & Steiner LLP as primary legal counsel. PSC’s
financial advisor on this transaction was BMO Capital Markets, with
Brenner, Saltzman & Wallman, LLP as legal counsel.
Update on Emergent BioSolutions 2008 Financial Guidance
As Emergent evaluates the impact of this acquisition on current year
financial guidance, management expects revenue for 2008 to remain
unchanged, between $180 and $195 million. With respect to net income,
management is still evaluating current forecasts related to PSC’s
anticipated operating costs as well as the appropriate accounting
treatment for the acquisition. Management expects to be in a position to
update guidance for 2008 net income when the company reports financial
results for the second quarter of 2008, anticipated during early August.
About the Influenza Market
According to industry reports, there are 1 billion cases of influenza
each year, resulting in 250,000 to 500,000 deaths, world-wide. In the US
alone, there are an estimated 15 million to 60 million cases and 30,000
to 40,000 deaths annually, making influenza a major public health
concern. Young children and the elderly are at a particularly high risk
of infection and complications.
About FluBlok®
FluBlok is a novel recombinant subunit influenza vaccine manufactured in
a cell culture medium, which represents the next-generation in flu
vaccine technology. The currently licensed flu vaccines are manufactured
through egg-based technology, which presents numerous operational and
market challenges. FluBlok consists of three recombinant hemagglutinin
(rHA) proteins derived from the flu strains selected by the World Health
Organization and the U.S. Centers for Disease Control and Prevention for
each year’s seasonal flu vaccine. These
proteins are produced in a proprietary cell culture and formulated
without preservatives, adjuvants, or antibiotics. FluBlok has been
developed as a single-dose vaccine to be administered intramuscularly.
In clinical trials, FluBlok has demonstrated promising immunogenicity in
both healthy adults and the elderly, with a positive safety profile.
Preliminary evidence of protection against influenza disease has been
observed in adults, as published in the April 2007 issue of JAMA® (The Journal of the American Medical Association).
About BEVS
The Baculovirus Expression Vector System (BEVS) is recognized as a
robust and versatile tool for producing a variety of functional
recombinant proteins. The BEVS manufacturing process begins by cloning
the gene for the desired target protein into a virus capable of
infecting insect cells (baculovirus). When these genetically engineered
baculoviruses are used to infect insect cell cultures, these cells are "programmed”
to manufacture the desired proteins.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a profitable biopharmaceutical company
dedicated to one simple mission—to protect
life. We develop, manufacture and commercialize vaccines and
therapeutics that assist the body’s immune
system to prevent or treat disease. Our products target infectious
diseases and other medical conditions that have resulted in significant
unmet or underserved public health needs. Our marketed product, BioThrax®
(Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S.
Food and Drug Administration for the prevention of anthrax infection.
More information on the company is available at www.emergentbiosolutions.com.
Conference Call & Webcast
Emergent management will host a conference call at 9:00 am Eastern this
morning to discuss this transaction. The conference call will be webcast
and can be accessed from the Investor Relations section of the company’s
website at www.emergentbiosolutions.com,
under "Investors”.
Participants can also access the call by dialing 866/383-8003 or
617/597-5330 (international) and providing the passcode EMERGENT.
The conference call, replay and webcast will be open to all interested
parties. A replay of the teleconference will be available approximately
one hour following its conclusion by dialing 888/286-8010 or
617/801-6888 and using the passcode 25871111. The replay will be
available through June 10, 2008. In addition, the webcast will be
archived at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including our expected revenue growth and net
earnings for 2008, and any other statements containing the words "believes”,
"expects”, "anticipates”,
"plans”, "estimates”
and similar expressions, are forward-looking statements. There are a
number of important factors that could cause the company’s
actual results to differ materially from those indicated by such
forward-looking statements, including the timing of, and our ability to
obtain and maintain, regulatory approval for FluBlok; our plans for
future manufacture and sale of FluBlok; our ability to obtain new
BioThrax sales contracts with the U.S. government; our plans for future
sales of BioThrax; our plans to pursue label expansions and improvements
for BioThrax; our plans to expand our manufacturing facilities and
capabilities; the rate and degree of market acceptance and clinical
utility of our products; our ongoing and planned development programs,
preclinical studies and clinical trials; our ability to identify and
acquire or in license products and product candidates that satisfy our
selection criteria; the potential benefits of our existing collaboration
agreements and our ability to enter into selective additional
collaboration arrangements; the timing of and our ability to obtain and
maintain regulatory approvals for our other product candidates; our
commercialization, marketing and manufacturing capabilities and
strategy; our intellectual property portfolio; our estimates regarding
expenses, future revenue, capital requirements and needs for additional
financing; and other factors identified in the company’s
current report on Form 10-Q for the quarter ended March 31, 2008 and
subsequent reports filed with the SEC. The company disclaims any
intention or obligation to update any forward-looking statements as a
result of developments occurring after the date of this press release.
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