Dragon Announces Worldwide Licensing Rights, excluding China, For Recombinant Human Granulocyte Colony Stimulating Factor (rhG-C
April 22 2004 - 5:12PM
PR Newswire (US)
Dragon Announces Worldwide Licensing Rights, excluding China, For
Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)
VANCOUVER, April 22 /PRNewswire-FirstCall/ -- Dragon Pharmaceutical
Inc. (TSX: DDD; OTC BB: DRUG) today announced that it has entered
into an agreement with Suzhou Zhongkai Bio-Pharmaceuticals Company
Limited ("Zhongkai") to in- license the exclusive right to
commercialize its Recombinant Human Granulocyte Colony Stimulating
Factor ("rhG-CSF") product worldwide, excluding the People's
Republic of China (the "Agreement"). Using a non-mammalian cell
fermentation technique (e.coli) with an in-house developed and
patented purification process in the 6000m(2) Chinese State Food
and Drug Administration ("SFD&A") cGMP-approved manufacturing
facility in Suzhou, China, Zhongkai is one of the leading producers
of rhG-CSF product, with approximately 16% market share in China,
where competition is fierce with at least 20 other domestic
producers. Dragon chose to in-license Zhongkai's rhG-CSF based on
the company's evident superiority in compliance with cGMP, its
well-documented processes, and the purity, safety, and efficacy of
its product. Zhongkai's rhG-CSF is currently approved in China for
oncology indication. Human G-CSF is a glycoprotein which regulates
the production and release of functional neutrophils from the bone
marrow. Myelosuppressive chemotherapy often upsets the patient's
white blood cell count, leading to febrile neutropenia. The primary
indications for rhG-CSF are in chemotherapy associated with the
treatment of various cancers. Zhongkai's product containing rhG-CSF
causes marked increases in peripheral blood neutrophil counts
within twenty four to thirty six hours. rhG-CSF functions within
the body to stimulate production of more white blood cells, helping
to reverse neutropenia so that cancer patients undergoing
chemotherapy can continue with as near to normal white blood cell
counts as possible. In some cancer patients, chemotherapy must
actually be interrupted until neutropenia has been separately
managed and brought under control, and in the case of certain tumor
types, successful chemotherapy must be given according to a correct
dosage and schedule. "The competition is fierce in China with about
20 G-CSF products already in the market. As a result, we decided to
partner with a leading producer in the market and focusing on
developing the international market outside of China. This will
bring much better economic value to Dragon without incurring
significant risk in research and developing and the high investment
to bring the drug into production" said Dr. Alexander Wick,
President and CEO of Dragon. "This is an excellent opportunity for
both Dragon and Zhongkai. Under the agreement, Dragon will leverage
its regulatory approval knowledge and expertise from launching its
own rh-Erythropoietin ("EPO") business internationally and will
also utilize its existing licensing partnerships developed over
time around the world to bring Zhongkai's rhG-CSF to the
international market. A good quality, competitive bio-generic drug
from China, like Zhongkai's rhG-CSF product, warrants the market
exposure opportunities from both developing and developed
countries. As a matter of fact, our international marketing and
distribution partners have been quite keenly awaiting this product.
Similar to Dragon's current strategy for the EPO product which has
been approved in a number of developing countries and is in
preparation to enter the European market, Dragon intends to
commercialize the rhG-CSF initially in non-patented developing
countries and will eventually extend the market coverage to
developed countries upon expiry of the relevant patents. In the
case of the European Union market, we believe that the relevant
patents will expire in 2006 and by that time, we'll have an
infrastructure, partnership and invaluable experience from
launching our EPO product in the European Union market." "This
partnership with Zhongkai is part of our continued initiative to
utilize our strengths and expertise in commercializing other
in-house or in-licensed pharmaceutical products internationally. We
have just announced entering into a letter of intent to merge with
Oriental Wave Holding Ltd., on March 24, 2004, which would create a
company that offers biotech generic drugs, chemical generic drugs
and chemical intermediate produced in China competitively and
marketed in China and international markets." said Dr. Wick. "We
believe that the combined company will be ready to fully leverage
the production infrastructure and sales network in China, diverse
and proven product lines and distribution partnership around the
world to make the combined company a serious player in the global
pharmaceutical industry." About Suzhou Zhongkai Bio-Pharmaceuticals
Company Limited
--------------------------------------------------------- Founded
in 1996, Suzhou Zhongkai Bio-Pharmaceuticals Co. Ltd is a wholly
owned subsidiary of Jiangsu Wuzhong Industrial Co. Limited.
Zhongkai is currently engaged in research and development for two
additional therapeutics: one recombinant drug, and the other with
the development & refinement of an existing therapeutic based
on Traditional Chinese Medicine. About Dragon Pharmaceutical Inc.
-------------------------------- Dragon Pharmaceutical Inc. is an
international biopharmaceutical company headquartered in Vancouver,
Canada, with a GMP production facility in Nanjing, China. Dragon's
EPO is currently approved to treat anemia due to renal failure and
for surgery patients in China, India, Brazil, Egypt and Peru.
Additional regulatory submissions are in progress throughout
Central and Eastern Europe, Asia, Latin America, the Middle East
and Africa. Dragon Pharmaceutical Inc. announced entering into a
letter of intent to merge with Oriental Wave Holdings, Ltd. The
proposed merger is subject to a number of conditions, including
entering into a definitive agreement. If the merger is consummated,
Dragon will be the surviving company and will be organized in three
divisions: Chemical Drug division, Chemical Intermediate division
and Biotech division with 3 existing cGMP manufacturing facilities
and 1 under final construction. For details, please refer to the
press releases on March 24, 2004 - "Dragon Announces a Proposed
Merger with a Profitable, Fully-integrated Pharmaceutical Company"
and on April 13, 2004 - "Dragon Announces Update on the Letter of
Intent to Merge with Oriental Wave Holding Ltd." For further
information, please contact Garry Wong (email: ) at (604) 669-8817
or North American toll free at 1-877-388-3784 or visit our web site
at http://www.dragonbiotech.com/ Forward Looking Statement:
Cautionary Statement for Purposes of the "Safe Harbor" Provisions
of the Private Securities Litigation Reform Act of 1995: All
statements, other than historical facts, included in the foregoing
press release are forward-looking statements. These forward looking
statements include, but are not limited to management's belief that
the Company can successfully market in Europe and elsewhere the
product licensed from Zhongkai, that the Company will become a
serious player in the global pharmaceutical industry and that the
Company and Oriental Wave will enter into a definitive merger
agreement and the proposed merger will be consummated.
Forward-looking statements are not guarantees of future
performance. They involve risk, uncertainties and assumptions
including risks discussed under "Risks Associated With Dragon
Pharmaceuticals" in the Company's annual report on Form 10-KSB, SEC
File No.: 0-27937 and other documents filed with the SEC. The
Company does not undertake the obligation to publicly revise these
forward-looking statements to reflect subsequent events or
circumstances. The foregoing may be deemed to be soliciting
materials of Dragon in connection with its Letter of Intent to
merge with Oriental Wave announced on March 24, 2004. This
disclosure is being made in connection with Regulation of Takeovers
and Security Holder Communications (Release Nos. 33-7760 and
34-42055) adopted by the Securities and Exchange Commission ("SEC")
and Rule 14a-12 under the Securities Exchange Act of 1934, as
amended. If a definitive agreement is entered into, Dragon
shareholders and other investors are urged to read the proxy
statement that Dragon will file with the SEC in connection with the
proposed merger because it will contain important information about
Dragon, Oriental Wave and related matters. Dragon and its directors
and executive officers may be deemed to be participants in Dragon's
solicitation of proxies from Dragon shareholders in connection with
the proposed merger. Information regarding the participants and
their security holdings can be found in each of Dragon's most
recent proxy statement filed with and Form 10-KSB to be filed with
the SEC, which are or will be available from the SEC and Dragon as
described below, and the proxy statement when it is filed with the
SEC. After it is filed with the SEC, the proxy statement will be
available for free, both on the SEC web site (http://www.sec.gov/)
and from Dragon as follows: Garry Wong Dragon Pharmaceutical, Inc
1900 - 1055 West Hastings Street Vancouver, British Columbia V6E
2E9 Tel: 604-669-8817 Fax: 604-669-4243 Email: In addition to the
proposed proxy statement, Dragon files annual, quarterly and
special reports, proxy statements and other information with the
SEC. You may read and copy any reports, statements or other
information filed by Dragon at the SEC's public reference rooms at
450 Fifth Street, N.W., Washington, D.C. 20549 or at the SEC's
other public reference rooms in New York and Chicago. Please call
the SEC at 1-800-SEC-0330 for further information on the public
reference rooms. Dragon filings with the SEC are also available to
the public from commercial document-retrieval services and on the
SEC's web site at http://www.sec.gov/. DATASOURCE: Dragon
Pharmaceuticals Inc. CONTACT: Garry Wong (email: ) at (604)
669-8817 or North American toll free at 1-877-388-3784 or visit our
web site at http://www.dragonbiotech.com/
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