Novavax and CPL Biologicals Break Ground on New Influenza Vaccine Manufacturing Facility in India
Wed Oct 28, 2009 8:04am EDT
[Four months seems awfully fast for this, but I'm not a construction engineer]
Novavax and CPL Biologicals Break Ground on New Influenza Vaccine
Manufacturing Facility in India
- State of the art 25,000 sq. ft. facility to be operational in 4 months
ROCKVILLE, Md., Oct. 28 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX)
announced today that CPL Biologicals Pvt. Ltd., the new joint venture between
Cadila Pharmaceuticals in India, has begun construction of a state-of-the-art
manufacturing facility that will be used to produce pandemic and seasonal
influenza vaccines. CPL Biologicals will utilize Novavax's virus-like
particle (VLP) vaccine technology to produce commercial-scale quantities of
VLP-based influenza vaccines using Novavax's innovative disposable
manufacturing solution. The CPL Biologicals facility is expected to be
operational within four months and should be capable of producing over 60
million doses annually at full capacity. This facility will also be used to
produce other novel vaccines being developed by CPL Biologicals, based on
Novavax's VLP vaccine technology.
"This new facility is being 100% supported financially by our partner, Cadila
Pharmaceuticals Ltd. We anticipate creating sufficient capacity for CPL
Biologicals to sell influenza vaccines in India and at the same time become a
potential supplier to Novavax for sale of vaccines in other markets where
Novavax maintains complete commercial rights," commented John Trizzino, Senior
Vice President, International and Government Alliances for Novavax and Interim
Chief Executive Officer of CPL Biologicals. "We believe this model will show
how an efficient and scalable vaccine platform can help address the growing
demand for pandemic and seasonal influenza vaccines. Moreover, the
construction of this manufacturing facility is consistent with Novavax's
strategy to establish regional partnerships and regional manufacturing
capabilities that allow our VLP influenza vaccines to be licensed,
manufactured and sold throughout the world."
About VLPs
Virus-like particles (VLPs) mimic the external structure of viruses but lack
the live genetic material that causes viral replication and infection. VLPs
can be designed quickly to match individual viral strains and be produced
efficiently using portable cell-culture technology. Novavax VLP-based vaccine
candidates are produced more rapidly than egg-based vaccines by using
proprietary, portable, recombinant cell-culture technology.
About Novavax
Novavax, Inc. is a clinical-stage biotechnology company, creating novel
vaccines to address a broad range of infectious diseases worldwide, including
H1N1, using advanced proprietary virus-like-particle (VLP) technology. The
company produces potent VLP-based recombinant vaccines utilizing new and
efficient manufacturing approaches. Novavax is committed to using its VLP
technology to create country-specific vaccine solutions. The Company has
formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to
develop and manufacture vaccines, biological therapeutics and diagnostics in
India. Additional information about Novavax is available on the company's
website: www.novavax.com.
About CPL Biologicals
CPL Biologicals is a newly formed company evolved from a joint venture by
Cadila Pharmaceuticals Ltd and Novavax, Inc. CPL Biologicals will be
developing and manufacturing vaccines, biological therapeutics and diagnostics
in India using technology contributed from Novavax and Cadila Pharmaceuticals.
In addition, CPL Biologicals will establish manufacturing facilities in India
and develop, produce and sell products such as seasonal influenza vaccine and
potentially other novel vaccines against dengue fever and chikungunya fever
based on Novavax's virus-like-particle (VLP) vaccine technology. CPL
Biologicals also expects to develop the pandemic H1N1 influenza vaccine
candidate in India that Novavax is developing in the United States.
About Cadila Pharmaceuticals Ltd.
Cadila Pharmaceuticals Ltd. is one of the largest privately held
pharmaceutical companies in India, headquartered at Ahmedabad, in the State of
Gujarat. Over the last five decades, it has been developing and manufacturing
pharmaceutical products and selling and distributing these in India and in
over 50 countries around the world. Cadila Pharmaceuticals is an integrated
healthcare solutions provider with a pharmaceutical product basket in
therapeutic areas that include cardiovascular, gastrointestinal, analgesics,
haematinics, anti-infectives and antibiotics, respiratory agents,
antidiabetics and immunologicals. The state-of-the-art Research and
Development (R&D) facility at Cadila Pharmaceuticals is manned by more than
three hundred and fifty scientists and engineers from various disciplines
including biology, pharmacology, clinical research, chemistry, toxicology,
phytochemistry and different disciplines of engineering. The company also
participates in Public-Private partnerships for developing preventive and
curative pharmaceutical and diagnostic products. Over the last decade, Cadila
Pharmaceuticals has focused on novel approaches to cancer management and is
the first Indian company to get multiple investigational new drug applications
(INDs) cleared by USFDA. The company has state-of-the-art manufacturing
facilities conforming to the most stringent international norms at Dholka,
Ankleshwar, Kadi and Hirapur in Gujarat; Samba in Jammu and Kashmir and Addis
Ababa in Ethiopia. Cadila Pharmaceuticals has recently emerged on the World
map with the development of Polycap - a novel and world's first drug
combination for primary prevention of Cardiovascular Heart Disease (CHD).
Forward-Looking Statements
Statements herein relating to future financial or business performance,
conditions or strategies and other financial and business matters, including
expectations regarding construction, scale-up and capacity of CPL Biologicals'
manufacturing facility, and clinical developments and anticipated milestones
are forward-looking statements within the meaning of the Private Securities
Litigation Reform Act. Novavax cautions that these forward-looking statements
are subject to numerous assumptions, risks and uncertainties, which change
over time. Factors that may cause actual results to differ materially from the
results discussed in the forward-looking statements or historical experience
include risks and uncertainties, including CPL Biologicals' ability to
progress any product candidates in clinical trials; the scope, rate and
progress of the clinical trials and other research and development activities;
clinical trial results; even if the data from preclinical studies or clinical
trials is positive, the product may not prove to be safe and efficacious; the
product candidates have not been, and may not be, approved by the appropriate
regulatory authorities; the estimated costs of the manufacturing facility may
exceed the amount budgeted; the manufacturing facility will be subject to
inspection and validation, which may result in delays; unanticipated costs and
delays during construction and scale-up of the manufacturing facility; Novavax
has a minority interest in CPL Biologicals and therefore does not control its
clinical development, manufacturing or commercialization activities; Novavax's
investment in CPL Biologicals may never produce a return, even if its clinical
development, manufacturing and commercialization activities are successful;
Novavax's ability to enter into future collaborations with industry partners
and the government and the terms, timing and success of any such
collaboration; the cost of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights; Novavax's ability to
obtain rights to technology; competition for clinical resources and patient
enrollment from drug candidates in development by other companies with greater
resources and visibility; Novavax's ability to obtain adequate financing in
the future through product licensing, co-promotional arrangements, public or
private equity or debt financing or otherwise; general business conditions;
competition; business abilities and judgment of personnel; and the
availability of qualified personnel. Further information on the factors and
risks that could affect Novavax's business, financial conditions and results
of operations, is contained in Novavax's filings with the U.S. Securities and
Exchange Commission, which are available at www.sec.gov. These forward-looking
statements speak only as of the date of this press release, and Novavax
assumes no duty to update forward-looking statements.
SOURCE Novavax, Inc.
Tricia J. Richardson, Senior Manager, Investor Relations of Novavax, Inc.,
+1-240-268-2031
© Thomson Reuters 2009 All rights reserved |
