Novavax Announces Completion of Construction of Vaccine Production Facility in India
- CPL Biologicals state-of-the-art vaccine facility operational in Dholka, India - Validation testing to begin this month - Annual bulk production capacity projected at 60 million doses of VLP influenza vaccine - Sterile filling capacity available
ROCKVILLE, Md., June 10 /PRNewswire-FirstCall/ -- CPL
Biologicals (CPLB), a joint venture of Cadila Pharmaceuticals Ltd.
and Novavax, Inc. (NASDAQ: NVAX) , today announced that it has
completed construction of its vaccine facility in Dholka, India and
will commence equipment and installation validation this month so
that the facility conforms to global standards for production of
vaccines for human use.
The new facility utilizes state-of-the-art equipment for fast
and efficient production of up to potentially 60 million doses of
novel vaccines every year. Mr. I. A. Modi, Chairman of Cadila
Pharmaceuticals, said, "This facility demonstrates our commitment
to establishing the highest-quality vaccine production facility for
our nation. It utilizes world-class design and equipment that will
be competitive with the world's leading vaccine companies."
The facility plans to produce seasonal and pandemic flu vaccines
based on Novavax's advanced virus-like particle (VLP) technology
which enables the rapid development and production of novel
vaccines without the use of live virus.
Dr. Rahul Singhvi, President and CEO of Novavax, stated: "We
congratulate our colleagues at CPL Biologicals on reaching this
important milestone in the development of a state-of-the-art
vaccine production facility. This achievement reflects our strategy
to partner with leading pharmaceutical companies around the world
to develop world-class, in-country vaccine-production capacity and
use our novel vaccine technology to solve critical public health
problems. This world class vaccine production plant in India will
be able to supply India and other countries with novel vaccines
against influenza and other infectious diseases by using an
efficient, reliable and flexible vaccine production process."
In addition to vaccine production, CPLB is also focused on the
development, manufacture and sale of biosimilars and diagnostic
kits.
About CPL Biologicals
CPL Biologicals is a joint venture between 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. CPL Biologicals has the infrastructure
ready for its state-of-the-art manufacturing facility at Dholka,
near Ahmedabad, in the state of Gujarat, India with a focus on
developing, producing and marketing seasonal and pandemic flu
vaccines based on Novavax's virus-like-particle (VLP) vaccine
technology. CPL Biologicals will also produce biosimilars and
diagnostic kits.
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).
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical 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.
Forward-Looking Statements
Statements herein relating to future performance, conditions or
strategies and other matters, including expectations regarding
continued development of vaccines and the operations of Novavax and
CPL Biologics are forward-looking statements. Novavax cautions that
any 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 forward-looking statements or historical experience
include historical and current results that may not be predictive
of future trial results for vaccines that are being developed or
may be developed; further testing is required before regulatory
approval can be applied for and the FDA or other regulatory
agencies may not approve vaccines even if the results are similar
or better than the results reported to date; uncertainties related
to the initiation, enrollment, progress and completion of clinical
trials; safety or efficacy issues not seen to date may be
encountered; inexperience on manufacturing vaccines at a commercial
scale; and the intensely competitive nature of the vaccine
industry, making it difficult for vaccines to have market success
even if approved. 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.
CONTACT: Frederick W. Driscoll, VP, Chief Financial Officer
and
Treasurer of Novavax, Inc., +1-240-268-2000
Web Site: http://www.novavax.com/
Posted: June 2010
