Sept. 26, 2013
Betta Pharma and Amgen Announce Approval to Establish Planned Joint Venture
ZHEJIANG, CHINA (September 26, 2013) -- Betta Pharmaceuticals Co., Ltd (Betta Pharma) and Amgen today announced that the companies have received the approval of relevant government authorities in China to create the joint venture that was initially announced in May 2013.
The Hangzhou-based joint venture, which will operate under the name Amgen-Betta Pharmaceuticals Co., Ltd. (贝达安进制药有限公司), will be responsible for the introduction of Amgen’s Vectibix® (panitumumab) in the Chinese market. Together, Amgen and Betta Pharma aim to quickly and efficiently deliver Vectibix to patients in China, following regulatory approval of the medicine in China. Vectibix has been approved in approximately 40 countries for colorectal cancer treatment and is in late-stage clinical development in China. Betta Pharma owns 51 percent and Amgen, through its affiliate Amgen Greater China Limited, owns the remaining 49 percent interest in the joint venture.
Dr. Lieming Ding, chairman and CEO of Betta Pharma, will serve as chairman of the Amgen-Betta Pharmaceuticals board of directors and James Li, vice president and general manager, Amgen Greater China, will serve as vice-chairman of the board. Dr. Yinxiang Wang, president and chief scientific officer of Betta Pharma, will serve as general manager of the joint venture. Additional management roles will be jointly appointed by Amgen and Betta Pharma. The joint venture will be staffed by seconded employees from Betta Pharma, transferred employees from Amgen and newly hired employees. The joint venture will start operations, effective immediately and has opened its offices in Hangzhou City, Yuhang District, Zhejiang Province.
"Today, we are delighted to witness the grand opening of the Amgen-Betta Pharma joint venture, which has been made possible thanks to the support of many parties," said Dr. Lieming Ding, chairman and CEO of Betta Pharma. "This is a major step forward in Betta Pharma’s innovative history and marks a new chapter in Betta Pharma’s development. In line with our philosophy of ‘Sincere Collaboration, Innovation for People’, we will strive to make new contributions to China’s biotech industry and to the well-being of Chinese people."
"We are extremely pleased with the creation of this exciting joint venture," said Anthony C. Hooper, executive vice president at Amgen. "The new company visibly demonstrates Amgen’s commitment to expanding into key, fast-growing markets, such as China, and will enable us to efficiently deliver Amgen’s leading medicines to Chinese patients. We are truly delighted to be working with the Betta Pharma team who clearly share the Amgen goal of making a new treatment option available to colorectal cancer patients in China."
"We look forward to working with Amgen,” said Dr. Yinxiang Wang, president and CSO of Betta Pharma. “We are confident that this win-win collaboration will deliver scientific and technological developments, which will benefit Chinese society and the health of Chinese people."
"The creation of Amgen-Betta Pharmaceuticals is an important milestone for Amgen in China," said James Li, vice president and general manager, Amgen Greater China. "Betta Pharma’s expertise in the development and commercialization of molecularly targeted therapies makes it an ideal partner for Amgen. We look forward to sharing our global expertise in the development and manufacturing of human therapeutics through the joint venture, to serving Chinese patients and ultimately to supporting the development of China’s biotech sector."
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit http://wwwext.amgen.com and follow us on www.twitter.com/amgen.
About Betta Pharmaceuticals Co., Ltd
Betta Pharmaceuticals Co., Ltd is a leading innovative pharmaceutical company in China with fully integrated capabilities that include R&D, GMP manufacture, sales and marketing. Betta Pharma was founded in 2003 and is headquartered in Hangzhou with R&D operations in Beijing. Over the last 10 years, Betta Pharma has been dedicated to the development of novel therapeutics and launched Icotinib in 2011 for the treatment of NSCLC patients in China. Going forward, Betta Pharma will continue to focus on pharmaceutical innovation so that it can benefit many more patients. For more information, visit www.betapharma.com.cn.
Vectibix is the first fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC). Vectibix is approved in more than 40 countries and is in late-stage clinical development in China. Retrospective subset analyses of mCRC trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of mCRC with these mutations.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on Amgen’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen’s most recent Form 10-K and any subsequent Forms 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen’s business. Unless otherwise noted, Amgen is providing this information as of September 26, 2013, and expressly disclaims any duty to update information contained in this news release. No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and product liability claims. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, sales of Amgen’s products are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations. The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the China Food and Drug Administration of the People’s Republic of China (CFDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
Brunswick (Representing Amgen in China)
Tel: +86 (10) 5960-8600
Betta Pharma, Zhejiang, China
Lina Huang (media)
Tel: + 86 (10)-6786-9692 # 610