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Dragon Commences Shipment of Erythropoietin (EPO) to Three New International Markets : Dominican Republic, Trinidad-Tobago and Kosovo
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD; BBSE:DRP) is pleased to announce that Dragon’s recombinant Erythropoietin (EPO) products have been granted market approvals in the Dominican Republic and Trinidad-Tobago as advised by Dragon’s licensees. In addition, the health authority of Kosovo has accepted our licensee’s application for the market approval and under such a circumstance, Dragon’s licensee is allowed to bid for government tender and has since won such a tender. Initial shipment of our EPO products to all three new international markets has started during the fourth quarter of 2004. Together with the already approved markets in China, Brazil, India, Egypt, Peru and Ecuador, Dragon’s EPO products are being marketed in a total of 9 countries across Asia, Central and South America, the Middle East and Eastern Europe.
“Even though these three new markets do not represent a large market size, it is important and encouraging to Dragon that our EPO is being approved and becomes available in ever more countries around the globe. This represents a most valuable confirmation of the quality and the acceptability of our EPO. It further validates our international strategy and rewards the efforts made by Dragon and our licensees. We consider this especially important since we plan to leverage our combined international regulatory and marketing expertise to commercialize other pharmaceutical products coming from the proposed and actively pursued acquisition of Oriental Wave” said Dr. Alexander Wick, President and CEO of Dragon.
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Dragon Appoints International Professionals as Independent Directors to the Board
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD; BBSE: DRP) (“the Company”) is pleased to announce the appointment of Mr. Peter Mak, Mr. Heinz Frey, and Mr. Jin Li as additional independent directors to the board. The appointments were the result of discussions with potential candidates in North America, Europe and Asia, with industry, accounting, and legal expertise who share the same vision as the Company. Our efforts turned out to be very rewarding and we are pleased to announce the appointment of the following three additional directors.
Mr. Peter Mak, age 44, is a fellow of the Chartered Association of Certified Accountants in UK as well as a fellow of the Hong Kong Institute of Certified Public Accountant. Mr. Mak was formerly the Managing Partner of Arthur Andersen Southern China and also a partner of Arthur Andersen Worldwide. Through his twenty years of accounting and financial practices, Mr. Mak has extensive knowledge and experience in Chinese and international accounting standards. He is also the independent director or financial advisor for several public companies listed in United States and Hong Kong.
Mr. Heinz Frey, age 67, graduated from University of Berne/Switzerland in 1966, has 30 years of experience in the telecommunication industry, security manufacturing and service industry. He has broad experience in the management of various sizes of companies with global presence, financing and controlling of international companies, leading development, production, sales and finance departments. He is also a board member of various companies.
Mr. Jin Li, age 38, is currently a senior advisor of Phycos International Co., Ltd. Prior to joining Phycos, he was a partner at the international law firm, Linklaters. Mr. Li studied biochemistry at Peking University in China and received his Master of Science degree in Biochemistry from the University of Michigan and his doctoral degree from Law School of University of Columbia. He has more than ten years?of experience in international IPOs, M&A and business transactions.
As a result of the appointment, the number of Dragon directors is now established at eight, with Messrs. Mak, Frey, and Li, along with current directors Dr Yiukwong Sun and Ms. Xuemei Liu, serving as independent directors. Concurrent upon the appointment of the three new independent directors, the Board of directors established an Audit Committee and Compensation Committee. Mr. Peter Mak was elected as the Chairman of Audit Committee with Mr. Heinz Frey and Mr. Jin Li as members. Ms. Xuemei Liu was elected as the Chairman of the Compensation Committee with Dr. Yiukwong Sun and Jin Li as members.
“I appreciate the Board’s confidence in me,” said Peter Mak, the newly elected Audit Committee Chairman, “After discussions with Chairman Han and management, I have had an opportunity to review the Company’s history, strategy and business potential and I am confident that it will move forward toward success.”
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Date Set for Dragon Stockholder Meeting on Acquisition of Oriental Wave Holdings
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD; BBSE: DRP) (“the Company”) is pleased to announce that January 11, 2005 has been set as the date for the annual stockholder meeting of the Company to vote on the proposed acquisition of Oriental Wave Holdings Ltd., among a series of important proposals. The annual meeting of Dragon stockholders will be held at Dragon’s corporate offices at Suite 1900, 1055 West Hastings Street, Vancouver, Canada at 10:00 A.M. Pacific Time.
Stockholders of Dragon of record as of the close of business on November 29, 2004 will be entitled to vote at the meeting. On or about December 8, 2004, the Company will send to these stockholders a copy of the definitive proxy statement in connection to the annual meeting. If the acquisition is approved by a simple majority of the outstanding shares voted at the meeting, Dragon and Oriental Wave management teams currently anticipate to close the transaction by mid-January 2005.
“We are delighted to present this proposal and other proposals to our shareholders“ said Dr. Alexander Wick, President and CEO of Dragon. “The Company and Oriental Wave have worked diligently together in preparing the document and addressing comments from the SEC and other regulatory agencies and are proud to provide the extensive proxy statement being sent to shareholders. In view of the bright future, the proposed acquisition of Oriental Wave merits positive considerations by all Dragon shareholders. All shareholders should read the proxy statement carefully.”
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Financial Results for the Third Quarter of 2005
Dragon Pharmaceutical Inc. (“Dragon”or the “Company” (TSX: DDD; OTC BB: DRUG) today announced the financial results for the quarter ended September 30, 2005.
Dragon reported sales of $13.34 million for the third quarter ended September 30, 2005, an increase of 82% compared to the third quarter of 2004, and 18% increase sequentially from the last quarter. For the nine months ended September 30, 2005, Dragon reported sales of $36.52 million, an increase of 68% compared to the same period of 2004. The increase in sales was due to the continued growth of sales from the Chemical Division and the inclusion of the sales from the Biotech Division during 2005. A summary of other key financials is as follows:
- Gross profit and gross margin were $3.08 million and 23% for the three months ended September 30, 2005 compared to $3.69 million and 50% for the same period in 2004.
- A net loss of $0.19 million or $0.00 per share have been recorded for the three months ended September 30, 2005 compared to the net income of $1.83 million, or $0.04 per share for the same period in 2004.
- Gross profit and gross margin were $9.47 million and 26% compared to $10.92 million and 50% for the nine months ended September 30, 2005 and 2004, respectively.
- Net income was $1.05 million or $0.02 per share compared to the net income of $6.11 million or $0.14 per share for the nine months ended September 30, 2005 and 2004, respectively.
Gross profit and net income was lower than the same period of 2004 because of the change in product mix especially with the significant increase in sales of the Chemical Division whose facilities were constructed and completed in 2004 and is currently at the ramp-up stage of production which incurs higher per unit production and operation cost, especially depreciation expenses.
The contribution of sales from the international markets has been increasing and is expected to continue as the Company keeps on increasing commercialization of its products outside of China. Compared to the third quarter of 2004, of which 100% of total sales were generated from the Chinese market, 80% of the sales for the same period in 2005 were generated from the Chinese market and 20% of the total sales were generated from the international markets with the addition of the international sales from the Biotech Division, and the export of products from the Chemical Division during the third quarter of 2005.
During the third quarter of 2005, the sales from Pharma Division, Chemical Division and Biotech Division contributed $6.06 million or 45% of total sales, $5.98 million or 45% of total sales and $1.30 million or 10% of total sales, respectively, compared to $6.24 million or 85% of total sales for Pharma Division, and $1.08 million or 15% of total sales for Chemical Division, for the same period of 2004. The significant increase in the sales from Chemical Division and including sales from Biotech Division product changed the product segment of the Company.
“During the third quarter, we achieved 82% year-over-year growth in revenues and 18% sequentially from the second quarter. The growth was mainly driven by the increase in revenues from our Chemical Division, which grew over 4.5 times (or 450%) year-over-year and 23% sequentially from the second quarter. We do expect the revenues from the Chemical Division will continue to grow as we continue to maintain at a high production level. Such trend will be even more obvious during the fourth quarter than the third quarter because the Company only started the ramp up of the 7-ACA production level in late July this year. We already managed to produce at more than 80% of the original full production capacity (400-tons per year) for our 7-ACA production facility” said, Mr. Yanlin Han, Chief Executive Officer of Dragon. “The Company also participated the Convention for Pharmaceutical Ingredients (CPHI) in Madrid, Spain earlier this month. We’ll continue to participate in more international events in order to gain valuable access and exposure to more and more potential customers outside of China with our quality and competitive products.”
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Dragon Retains Renmark Financial to Serve the Professional Investment Community
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD; BBSE: DRP) announces that it has retained the services of Renmark Financial Communications Inc. to handle its investor relations activities for investment brokers and advisors across the U.S. and Canada.
Renmark Financial will proactively articulate Dragon’s corporate messages and growth potential to professional investment brokers and advisors across U.S. and Canada. In addition, Dragon’s management team will also attend presentation sessions organized by Renmark Financials across North America to address the target audience upon the completion of the proposed acquisition of Oriental Wave.
“We are pleased to announce that we have selected Renmark to strengthen Dragon’s profile amongst the North American financial community. We will continue to participate in additional investor relations functions to increase the visibility of our company. We believe that Renmark Financial will be able to do so with its unique investor relations strategies and approach.” commented Dr. Alexander Wick, President and Chief Executive Officer of Dragon Pharmaceutical.
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Dragon Pharma Sells Polymun Development
Dragon Pharmaceutical Inc. (OTC BB: DRUG; TSX: DDD) (“the Company”) announced today that the Company has sold its Development and Manufacturing Agreement with Polymun Scientific Immunbiologische Forschung GmBh (“Polymun”) to AS Biotech AG, a Swiss company, for US$1 million.
Prior to the acquisition of Oriental Wave Holding Limited in early 2005, Dragon entered into a Development and Manufacturing Agreement with Polymun to develop a new cell line of EPO for the European market. At that time, EPO was the only focus of the Company and development of the European EPO market was originally based on the assumption that EMEA (European Medicines Evaluation Agency), also known as European Medicines Agency, the centralized European medicinal products authorization authority, would issue a relatively less stringent clinical requirements guideline for the registration of recombinant human EPO that allowed the approval of Dragon’s recombinant EPO be commercialized in 2006 or 2007. Under the assumed process time, the Company believed that it could fulfill the up-coming Euro 3.2 million (or approximately US$ 3.84 million) minimum purchase commitment of EPO from Polymun in 2006 and 2007.
However, in light of EMEA’s much delayed and more stringent clinical requirements for human recombinant EPO and the cautious regulatory approach to biosimilars by the EMEA, such as rejecting CPMP’s recommendation to approve Sandoz’s biosimilar version of human growth hormone, Dragon’s Board of Directors revaluated its current and future financial investment in this project. Based on the latest EMEA approval guidelines, the Company estimated that it would have to spend over US$ 20 million and would require a minimum of another 3 to 4 years to commercialize EPO in the European market. As a result, the Board of Directors has determined that the potential return of the project does not justify its risk profile and uncertainties. Therefore the Company’s Board of Directors, with Dr. Wick abstaining, approved the sale of the Polymun agreement, including the remaining milestone payment, minimum purchase commitment, and other obligations to AS Biotech AG, a Swiss company owned by Dr. Wick who also served as its Chairman, for US$ 1 million. Further, Dr. Wick has resigned as the President of the Company effective immediately but would remain as a Director. In addition, Dragon also terminated the consulting agreements with Dr. Rene Fricker and James Harris who were focusing mainly on this project during last year.
Prior to the sale, Dragon paid Euro 200,000 (or approximately US$ 235,000) to Polymun for two development milestone payments and incurred nominal travel and other expenses for this project. The milestone payments were expensed during 2003 and 2005. As a result, the Company expects to recognize an extraordinary gain for the project with the US$1 million cash payment received from the buyer.
“We believe our shareholders will share the same view with us on this project” said Mr. Yanlin Han, Chairman and CEO of Dragon, “The Company can now focus on developing its other growth areas especially the Chemical business which, through our world class facilities, could be very competitive and successful in both the Chinese and international markets.”
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Dragon Receives $1.8 Million Additional EPO Order From Itaca Laboratorios
Dragon Pharmaceuticals (OTCBB: DRUG) is pleased to announce that it’s Brazilian partner, Itaca Laboratorios Ltda., has placed an additional order for $1.8 million worth of Dragon’s EPO for delivery in 4Q 2001.
This is in addition to a previous order for $1.4 million placed in January of this year, and brings Dragon Pharmaceuticals’ total orders from Itaca to $3.2 million for 2001. Additionally, Itaca has spun-off a new business, Biolotus, which will handle Dragon’s current and pipeline products, as well as collaborate with Dragon on new drug development.
Biolotus, headed by CEO Dr. Joao Transmontano, is in the process of aggressively seeking registration for Dragon’s EPO throughout the remainder of Latin America. This region represents a largely under-served market for biotech products, and only a few countries, such as Brazil and Mexico, have universal healthcare systems that offer reimbursement for EPO therapy. In the poorest countries of the region, such as Nicaragua, Peru, and Ecuador, only a fraction of eligible patients can afford treatment with EPO and other biotech drugs.
According to Dragon’s CEO and President, Dr. Longbin Liu, “We appreciate the chance that Biolotus has given us to bring a high-quality and truly low-cost EPO to the patient populations in the most need.” Making EPO “is not exactly rocket science,” quipped Dr. Liu, “but knowing how to make it right and make it so average people can afford it is as close as it gets—and by showing we can do it, we validate our business model.”
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Dragon Acquires Rights to Novel Slow Release EPO Formulation
Dragon Pharmaceuticals Inc. (OTC BB: DRUG) is pleased to announce that it has entered into an agreement related to a novel, slow-release formulation for Erythropoietin (EPO) with Transworld Pharmaceuticals Corp. of Portugal and Renapharm AB of Sweden. 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 $4.8 billion in 2000.
The agreement provides Dragon with sole worldwide manufacturing rights as well as exclusive marketing rights to Asia, including China, Japan, Korea, and SE Asia. Transworld Pharmaceuticals, a leading international distributor of blood related products and biotechnology drugs, will have exclusive marketing rights to all markets outside Asia.
“We are extremely pleased to have completed this agreement,” said Dr. Longbin Liu, President and Chief Executive Officer of Dragon. “We are one of only two companies worldwide developing a sustained release formulation for EPO. This agreement is a key development which will support our goal of developing a leading competitive position in the worldwide EPO market by offering premium quality generic product at significantly lower prices than branded product.”
A pilot clinical trial conducted in 101 patients at the University Hospital, Uppsala University of Sweden, assessed the monthly administration of EPO in this slow release formulation compared to the four times per week administration of conventional EPO. The total dose of each form of EPO was identical. The results of the study showed that monthly administration of the slow release formulation had the same therapeutic effect as four times per week conventional EPO with the added advantage of requiring less frequent injections.
According to the agreement, each partner will participate in the final development of this formulation. Dr. Bo Danielson MD PhD, Managing Director of Renapharm and developer of the slow-release formulation, will serve as lead clinical and technical advisor to the project. Dr. Danielson is recognized as a world expert on EPO, having participated in over 75 published clinical studies involving EPO.
The potential market for slow-release EPO is estimated at US$5 billion per year, with application in the treatment of anemia in patients with kidney failure and cancer patients undergoing chemotherapy.
Prior to the 2004 expiry of the EPO gene patent, generic forms of EPO may only be sold in developing world markets outside of North America, the European Union, Japan, Australia, and New Zealand. Given that Dragon’s slow release formulation includes the Company’s generic form of EPO, initial sales will focus on those markets not protected by the EPO gene patent. After 2004, Dragon’s new formulation would not be restricted by any existing patents and would be eligible for marketing throughout the world.
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Dragon Announces Acquisition of Hepatitis B Vaccine Technology and First Quarter Financial Results
Dragon Pharmaceuticals Inc. (“Dragon”) is pleased to announce that it has acquired the rights and technology relating to the production of a Hepatitis B vaccine from Alphatech Bioengineering Limited, a Hong Kong corporation.
The technology acquired from Alphatech involves the application of genetic techniques for the expression and purification of recombinant Hepatitis B vaccine protein using Chinese Hamster Ovary (CHO) cells. Dragon’s management believes that this technology will enable the company to develop a significantly higher yield and lower cost Hepatitis B production process compared to the processes used by competing producers of CHO-cell based Hepatitis B vaccines.
Under the terms of the acquisition agreement and a subsequent amendment, the purchase price for the rights and technology is USD 4 million. Rather than finalize development and commercial production of the vaccine in-house, Dragon intends to pursue potential joint venture development and/or commercial production partnerships. In the event that Dragon is unable to establish suitable partnerships by March 5, 2002, the agreement provides Alphatech and its principals the right to repurchase the project from Dragon at the original purchase price of USD 4 million. Alphatech is jointly owned by Dr. Longbin Liu and Mr. Philip Yuen, the President and Director of Dragon, respectively. The Hepatitis B project was initiated prior to the formation of Dragon and the purchase price represents the actual out-of-pocket development costs related to the project.
Hepatitis B is a viral disease that causes both acute and chronic hepatitis (inflammation of the liver). According to IMS data, the 1999 world market for Hepatitis B vaccine was $708 million – over 90% of which was accounted for by sales in North America and the European Union. Despite the high level of need in the developing regions of the world, these regions continue to account for less than 10% of world sales of Hepatitis B vaccine in large part due to the high cost of currently available products.
Dragon is pleased to announce Erythropoietin (EPO) sales of 116,190 doses (standard reference dosage of 2,000 IU) for the first quarter of 2001, representing an increase of 56% over sales of 74,354 doses during the first quarter of 2000. Revenues for the first quarter of 2001 were US$664,414 compared to US$661,785 for the same period last year. Revenues did not increase proportionately to sales volumes due to EPO price reductions in China over the past year.
The Company incurred a net loss of US$856,183 ($0.05 per common share) during the first quarter of 2001, compared with US$234,780 ($0.02 per common share) for the same quarter in 2000, as a result of increased production of EPO to build inventories for anticipated international sales orders. At the end of the first quarter, the Company’s cash and short-term investments totaled US$7,245,107 compared with US$8,078,166 at March 31, 2000.
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DRAGON ANNOUNCES US$8 MILLION PRIVATE PLACEMENT
Dragon Pharmaceuticals Inc. announced today that it will proceed with a private placement of up to 4,000,000 units at US$2.00 per unit for total gross proceeds of up to US$8.0 million. Each unit consists of one Common Share in the Company and one Warrant to purchase an additional one-half Common Share at US$2.00 for a period of two years. A finder’s fee will be payable in conjunction with this financing.
The proceeds of this financing will be used to provide working capital and to expand the production capacity of the Company’s EPO manufacturing facility in Nanjing, China. This additional capacity will be required to meet anticipated product orders resulting from registrations of the Company’s lead product, EPO, in a number of international territories. The proceeds will also be used to fund the development of Dragon’s follow-on generic products, which include TPO, G-CSF and Insulin.
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ragon Pharmaceuticals Inc. is an international biopharmaceutical corporation engaged in the discovery, development and commercialization of genetically engineered human proteins for therapeutic use. Based on its proprietary protein expression technology, Dragon has become one of the world’s lowest cost producers of Erythropoietin (EPO) – a breakthrough drug that has revolutionized the treatment of anemia. Dragon is now applying its platform technology to the development of other generic therapeutic proteins as well as to novel protein drugs with worldwide patent potential.
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