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Dragon Files Application for Use of EPO in Surgery
Dragon Pharmaceuticals Inc. today announced that it has submitted a New Drug Licence application to the Chinese State Drug Administration (SDA) for the use of recombinant human erythropoietin (EPO) in surgical patients. Dragon’s EPO is currently approved and marketed for use in the treatment of anemia related to chronic renal failure in China as well as in India, Egypt and Peru.
Dragon’s regulatory submission is based on the Company’s successful completion of a pivotal Phase II/III clinical trial. This multi-centre, randomized, open-label and blank-control study involved a total of 120 patients undergoing elective surgery, with 60 patients in the EPO group and 60 in the blank-control group. The primary objectives of the study were to evaluate the efficacy of EPO on increasing the production of red blood cells and correcting anemia in pre-operative and post-operative patients.
“Use of EPO for surgical indications is a key step in the development and marketing of our lead product,” said Dr. Longbin Liu, President and CEO. “With approximately 20 million surgeries performed on an annual basis in China alone, we expect the surgical indication to significantly expand our potential market in China, and eventually worldwide.”
Study results showed that Dragon’s EPO resulted in red blood cell mobilization in pre-operative patients. In post-operative patients, the product increases hemoglobin, hematocrit, and red blood cell levels, thus markedly rectifying blood loss resulting from surgery. The study established that EPO is safe when used in surgical patients for red blood cell mobilization and recovery; patients experienced no increase in platelet counts or blood pressure and no changes in liver or kidney function.
In addition to seeking approval in China, Dragon plans to obtain marketing approval for the use of EPO in surgical patients throughout its licensed territories, which include over 90 countries in Central and Eastern Europe, Southeast Asia, Latin America and the Middle East. Regulatory applications for the use of EPO in anemia related to chronic renal failure are currently underway in these markets, with approvals granted to date in Egypt, India, and Peru.
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Dragon Signs Licensing Agreement for Korea
Dragon Pharmaceuticals Inc. (OTCBB – DRUG.OB) today announced that it has entered into a marketing and licensing agreement with Boryung Biopharma Company, Ltd. of Seoul, Korea for the distribution of recombinant Erythropoietin (EPO) in North and South Korea. According to the agreement, Boryung Biopharma will also be responsible for obtaining marketing for EPO from the Korean Ministry of Health.
Established in 1991, Boryung Biopharma, a subsidiary of Boryung Pharmaceutical Co., Ltd., has developed and now markets vaccines for influenza, typhoid fever, and hepatitis B. Boryung Pharmaceutical, a public company with year 2000 revenues in excess of US$220 million, is a major provider of dialysis fluids in Korea and plans to establish a nationwide chain of approximately 50 dialysis centers by 2006.
The Boryung Biopharma agreement is an important addition to the international marketing agreements that Dragon has established with regional pharmaceutical distributors during 2001. Dragon’s EPO has been approved to date in China, India, Egypt and Peru for use in the treatment of anemia related to chronic renal failure. Additional product registrations are in progress throughout Central and Eastern Europe, Southeast Asia, Latin America and the Middle East. Assuming that Dragon receives marketing approvals in some of these territories as anticipated and that EPO market conditions remain the same, the company anticipates sales of between US$15-20 million during 2002. However, no assurances can be given that these anticipated revenues will be achieved and Dragon makes no undertaking to update this revenue estimate in the future.
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Dragon Releases Third Quarter 2001 results
Dragon Pharmaceuticals Inc. announced results for the three months and nine months ending September 30, 2001. All dollar amounts are expressed in US currency.
Revenues for the quarter totalled $787,682, an increase of 6.5% over the same period in 2000. Revenues comprise sales of the company’s sole current product, Erythropoietin (EPO), which increased 115% to 157,067 doses compared to the same period last year. Revenues did not increase proportionately to sales volumes due to competitive EPO price reductions in China over the past year.
The third quarter represents the first sales revenue generated from outside China as the company delivered two shipments of vialed EPO to Egypt as well as a large order of purified bulk to Malaysia.
“We are in the product registration process for EPO throughout non-patent protected countries in Central and Eastern Europe, Southeast Asia, Latin America and the Middle East,” said Dr. Longbin Liu, President and Chief Executive Officer. “Our distribution partners have estimated the current market size in these areas at $310 million, which is expected to double by 2005.”
The loss for the quarter was $737,782 or $0.04 per share, compared to a loss of $362,975 or $0.03 per share in the third quarter 2000. The change was due to increased marketing and administration costs, and greater production of EPO to build inventories, in anticipation of international sales orders.
The company ended the quarter with cash and short-term investments of $9,372,683, compared with $6,340,315 at December 31, 2000.
For the first nine months of 2001, revenues totalled $2,054,437, a 6.5% decrease from the same period last year. This was in spite of a 66% increase in EPO sales to 400,222 doses. As with quarterly results, increased sales volumes did not translate into a proportionate revenue gain because of price erosion.
The company incurred a net loss of $2,566,678 ($0.15 per share) during the nine months, compared with $766,752 ($0.06 per share) for the same period in 2000.
Note: The term “dose” refers to the standard reference dosage of 2,000 IU.
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Dragon Receives EPO Product Registration and Signs Licensing Agreement for India
Dragon Pharmaceuticals Inc. (OTCBB – DRUG.OB) is pleased to announce that the Drug Controller General of India has issued regulatory clearance for the import and sale of Dragon’s recombinant Erythropoietin (EPO) to India. Dragon has previously also received regulatory approval for sale of its EPO in China, Egypt, and Peru for use in anemia associated with chronic renal failure.
EPO is ranked by IMS Health as the world’s fastest growing drug by annual sales, with estimated worldwide sales of US$4.8 billion in 2000. India’s current market for the use of EPO in the treatment of patients with chronic renal failure alone is estimated at US$55 million.
Dragon is also pleased to announce that it has entered into a marketing and licensing agreement with Emcure Pharmaceuticals, Ltd. of Pune, India for the distribution of Dragon’s recombinant Erythropoietin (EPO) in India. The agreement provides Emcure, a leading Indian pharmaceutical manufacturer, with rights to distribute EPO in India and throughout the entire South Asian subcontinent, as well as in selected markets in sub-Saharan Africa where Emcure has an established presence and sales force.
Emcure Pharmaceuticals, established in 1983, is a privately held ISO-9002 certified pharmaceutical company with revenues of approximately US$76 million in 2000. Until 1995, Emcure was primarily a contract manufacturer for multinational pharmaceutical companies including Parke Davis, Warner Lambert, and Glaxo SmithKline. In addition to this contract manufacturing business unit, Emcure now also carries its own line of branded products based on its proprietary drug delivery systems. The company’s current operations include 5 major manufacturing arms, an R&D center focusing on new drug delivery systems, and an Information Technology (IT) business. Emcure fields over 900 sales representatives throughout India, with distribution centers in all major cities.
The Emcure agreement is an important addition to the international marketing agreements for EPO that Dragon has established with major regional pharmaceutical distributors during this fiscal year. Dragon’s EPO licensing agreements cover Asia, the Middle East, Central and South America, Central and Eastern Europe and Africa.
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Dragon Announces Participation at Biopartnering Europe 2001
Dragon Pharmaceuticals Inc. (OTC BB – DRUG.OB) is pleased to announce that it has been invited to present at the BioPartnering Europe 2001 conference to be held at the Queen Elizabeth II Conference Centre in London, England from October 14th to 16th, 2001.
BioPartnering Europe is the premier European venue for showcasing innovative biopharmaceutical and diagnostics companies from Europe, North America, and the rest of the world. The conference focuses on the development of corporate partnerships for both biotechnology and pharmaceutical companies.
Dragon will be participating at the conference with the goal of meeting with potential pharmaceutical industry partners for the marketing and co-development of the Company’s products, including EPO, Slow-Release EPO, TPO, G-CSF, Human Insulin and Hepatitis B Vaccine.
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Dragon Signs EPO Marketing and Licensing Agreement for Taiwan
Dragon Pharmaceuticals Inc. (OTCBB – DRUG.OB) is pleased to announce that it has entered into a marketing and licensing agreement with Standard Chemical & Pharmaceutical Co., Ltd. (“Standard”) of Taiwan for the distribution of Dragon’s recombinant Erythropoietin (EPO). EPO has been the most effective drug for the treatment of severe anemia since its introduction in 1989 and is ranked by IMS Health as the world’s fastest growing drug by annual sales, with estimated worldwide sales of US$4.8 billion in 2000.
The agreement provides Standard, a leading Taiwanese pharmaceutical manufacturer, with an exclusive license to sell Dragon’s EPO in Taiwan. Taiwan’s current market for the use of EPO in the treatment of patients with chronic renal failure is estimated at US$30 million.
According to the agreement, Dragon will manufacture and ship bulk EPO to Standard, who will vial, label, and distribute the product in Taiwan. Standard will also be responsible for obtaining product registration and marketing approval for EPO in Taiwan. Dragon and Standard management anticipate that the regulatory submission to the Taiwanese Department of Health will be filed during the second quarter of 2002.
Standard Chemical & Pharmaceutical Co., Ltd. is a fully integrated pharmaceutical developer, manufacturer and distributor based in Taiwan. Established in 1967, the company has over 450 employees and earned revenues of US$31.5 million in 2000. Standard was the first Taiwanese pharmaceutical plant to obtain ISO 9001 quality certification and its manufacturing facilities were endorsed by the U.S. Food & Drug Administration in 2000. Standard has established numerous contract manufacturing or co-marketing relationships with major international pharmaceutical companies, including Switzerland’s Novartis, France’s Rhone-Poulenc Rorer, Germany’s Bayer and Japan’s Kyoto Daiichi.
Dragon has, to date, established international licensing and distribution agreements with major regional pharmaceutical partners which cover over 90 countries throughout the ASEAN member nations, the Middle East, Latin America, Central and Eastern Europe, Africa, Scandinavia, and Taiwan.
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Dragon Announces Completion of US$7.0 Million Private Placement
Dragon Pharmaceuticals Inc. (“Dragon”) is pleased to announce the completion of its recent private placement of 3,500,000 units (the “Units”) at a price of US$2.00 per unit. Each Unit consists of one common share and one non-transferable share purchase warrant (the “Warrant”). Each Warrant entitles the holder to purchase one half common share at a price of US$2.00 per share for a period of two years. The Company has received cash and subscriptions for gross proceeds of US$7,000,000 and net proceeds, after finders’ fees and expenses, of approximately US$6,500,000.
Dragon also announces Erythropoietin (EPO) sales of 243,155 doses (standard reference dosage of 2,000 IU) for the first half of 2001, representing an increase of 45% over sales of 168,218 doses during the first half of 2000. Revenues for the first half of 2001 were US$1,266,755 compared to US$1,458,912 for the same period last year. Revenues did not increase proportionately to sales volumes due to competitive EPO price reductions in China over the past year. Sales for the three months ended June 30, 2001 were 126,965 doses for $602,341 compared to 93,864 doses for $797,127 for the three months ended June 30, 2000.
The Company incurred a net loss of US$1,828,896 (US$0.11 per common share) during the first half of 2001, compared with US$403,777 (US$0.03 per common share) for the same half in 2000, as a result of increased production of EPO to build inventories for anticipated international sales orders. The loss for the three months ended June 30, 2001 was US$972,713 or US$0.06 per share compared to US$168,997 or US$0.01 per share for the three months ended June 30, 2000. At the end of the second quarter, the Company’s cash and short-term investments totaled US$5,215,107 compared with US$6,340,315 at December 31, 2000.
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Dragon and Oriental Wave Extend the Share Purchase Agreement in Connection with the Proposed Acquisition
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD; BBSE: DRP) announces that the Company and Oriental Wave Holding Limited have agreed to extend the Share Purchase Agreement to February 28, 2005 in connection with the proposed acquisition of Oriental Wave. Under the original terms of the Share Purchase Agreement, the acquisition was to be completed by December 31, 2004, or the agreement could be terminated. As previously announced, Dragon’s stockholders’ meeting has been scheduled for January 11, 2005.
“We believe that the acquisition represents an important strategic step for us that will strengthen our competitive position. Combining the businesses of Dragon and Oriental Wave into one unified organization will expand our range of products, allow us to leverage the marketing network built over the years in China and international markets by both companies and improve our ability to execute our combined business strategy. These benefits will enable us to better capitalize on attractive global market opportunities in the generic pharmaceutical sector as well as the bulk pharmaceutical chemical sector and position us for increased revenue and growth. I urge all our stockholders to vote in favour of the proposed acquisitions together with other proposals.” said, Dr. Alexander Wick, President and CEO.
Each Dragon stockholder as of the record date of November 29, 2004 has been sent a copy of the Definitive Proxy Statement. Dragon Stockholders are strongly encouraged to read the Definitive Proxy Statement and vote on the proposed acquisition among other proposals. Any Dragon stockholder who has not received the Definitive Proxy Statement or has any questions regarding the Definitive Proxy Statement, the Annual General Meeting or the voting process can contact Garry Wong directly at the Vancouver office of the Company.
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Dragon Receives Approval from Shareholders in Connection with the Acquisition of Oriental Wave Holding Ltd.
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD; BBSE: DRP) (“the Company”) is pleased to announce that at the Annual Meeting of Shareholders held on January 11, 2005, the shareholders approved the acquisition by Dragon of Oriental Wave by accepting all the proposals in over 99% of the shares represented and voting. Over 82% of the outstanding shares were represented at the meeting. In addition, Dr. Sun and Dr. Wick were re-elected to the Board, and Moore Stephen Ellis Foster were ratified to audit the Company’s financial statements for the year ended December 31, 2004.
“We, at Dragon, are delighted that this acquisition of Oriental Wave on which we have worked hard for an extended period of time has been approved by an overwhelming majority of our shareholders. This demonstration of unity will provide an excellent basis to successfully face the challenges of the future” said Dr. Alexander Wick, President and CEO of Dragon. “Both the physical presence of individual Dragon shareholders and the owners of Oriental Wave at the meeting have been highly appreciated.”
The Company also wishes to announce that the Toronto Stock Exchange has conditionally approved the issue of shares in connection with the acquisition of Oriental Wave, subject to the filing of customary documentation. The Company and Oriental Wave expect the acquisition to close within the next couple of days.
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Dragon Completes Acquisition of Oriental Wave Holding Ltd. and Announces Appointment of Key Management Team
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD; BBSE: DRP) (“the Company”) is pleased to announce that it has completed the acquisition of Oriental Wave Holding Ltd. At closing, and as described in Dragon’s proxy statement dated December 8, 2004, Mr. Yanlin Han, Mr. Zhanguo Weng and Ms. Xuemei Liu were appointed to the Board of Directors that now consists of five members including Dr. Wick and Dr. Sun who were re-elected at the Company’s annual meeting of shareholders. The Board of Directors also appointed the following individuals as the key management team:
- Mr. Yanlin Han as the Chief Executive Officer
- Dr. Alexander Wick as the President
- Mr. Zhanguo Weng as the Vice President, China Operation
- Mr. Garry Wong, CFA as the Chief Financial Officer
- Ms. Maggie Deng as the Chief Operating Officer
“The first practical step to integrate the original Dragon and Oriental Wave into a new and efficient organization has already been started” said, Dr. Alexander Wick, President of Dragon. “A new and state-of-the-art production facility for EPO (Erythropoietin) using the proven cell-line and technology of Nanjing Huaxin Bio-pharmaceutical Co. Ltd., the Company’s subsidiary in Nanjing, is being set up on Dragon’s Chemical division campus in Datong, sharing the existing energy and administrative infrastructure. This campus will also house a new workshop for the freeze-drying of temperature sensitive pharmaceutical products, among them, Levofloxacin, a currently marketed product of the Company.”
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