AMGEN AND ZHEJIANG BETA PHARMA ANNOUNCE PLANNED JOINT VENTURE IN CHINA
Goal is to bring Amgen’s Vectibix(panitumumab) to Chinese patients
THOUSAND OAKS, Calif., and Zhejiang, China (May 7, 2013) – Amgen (NASDAQ:AMGN), the world’s largest biotechnology company, and Zhejiang Beta Pharma, Inc. (Zhejiang Beta Pharma), a leading innovative pharmaceutical company in China, today announced that the companies have signed an agreement to form a joint venture. The joint venture is a long-term partnership which aims to commercialize Amgen’s Vectibix(panitumumab) in the China market. Together, Amgen and Zhejiang Beta Pharma aim to quickly and efficiently deliver Vectibix to Chinese patients.
The joint venture will benefit from Zhejiang Beta Pharma’s strong expertise in the development and commercialization of molecularly targeted therapy as well as Zhejiang Beta Pharma’s industry leading oncology sales network in China. Zhejiang Beta Pharma’s China capabilities are complimentary to Amgen’s global expertise in the development and manufacturing of human therapeutics.
“This joint venture brings us one step closer to providing Chinese patients with Amgen’s medicines,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. “We are pleased to have the opportunity to join forces with Zhejiang Beta Pharma, a leader in developing and commercializing innovative medicines that shares our goal of making a new treatment option available to colorectal cancer patients in China.”
“Amgen is a pioneer and a global leader in the biotech industry,” said Lieming Ding, Chairman of Zhejiang Beta Pharma.“Our partnership with Amgen will be of long term strategic significance not only for Zhejiang Province, but also for the whole medical community in China.” We share with Amgen passion for developing molecularly targeted therapies for unmet medical needs, and are confident that together we can help many Chinese patients who suffer from colorectal cancer. “
“This is an important step forward in Amgen’s commitment to the China market,” said James Li, vice president and general manager, Amgen Greater China. “We are excited about the formation of our partnership with Zhejiang Beta Pharma and look forward to bringing Vectibix to Chinese patients within the coming years. Amgen’s 30-year track record of developing innovative medicines means we are well positioned to support the development of China’s biotech sector. We see this as a clear step that enables Amgen to help China achieve its goals for the biotech industry.”
“This is certainly a ground breaking event for the biotech industry in China,” said Yinxiang Wang, the CEO of Zhejiang Beta Pharma. “We are pleased to be joining forces with Amgen in the war against cancer.”
According to the agreement, the new joint venture will be named Amgen-Beta Pharmaceuticals Co., Ltd. Zhejiang Beta Pharma would own 51 percent and Amgen would own the remaining 49 percent interest in the joint venture. The joint venture is subject to the satisfaction of certain closing conditions, including the approval of relevant government authorities in China.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Vectibix is a prescription medicine used for the treatment of metastatic colorectal cancer (mCRC). It is grouped within a class of medications called biologics, which are therapies derived from human cells. Vectibix is approved in more than 40 countries.
Vectibixis 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). Vectibixwas approved in the U.S. in September 2006 as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Retrospective subset analyses of metastatic colorectal cancer 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 colorectal cancer (CRC) with these mutations.
Important U.S. Product Safety Information
Vectibixis indicated as a single agent for the treatment of EGFR-expressing, mCRC with disease progression on or following fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing mCRC is based on progression-free survival. Currently, no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Vectibixis not indicated for the treatment of patients with KRAS mutation-positive mCRC or for whom KRAS mCRC status is unknown. Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibixin patients whose tumors had KRAS mutations in codon 12 or 13.
WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients receiving Vectibixmonotherapy. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
Infusion Reactions: Severe infusion reactions occurred in approximately one percent of patients. Fatal infusion reactions occurred in postmarketing experience. [See Dosage and Administration (2.1), Warnings and Precautions (5.2), and Adverse Reactions (6.1, 6.3)].
The most common adverse reactions (≥ 20%) of Vectibixare skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, diarrhea, including diarrhea resulting in dehydration.
The most serious adverse reactions of Vectibixare pulmonary fibrosis, pulmonary embolism, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.
To see the US VectibixPrescribing Information, visit：www.Vectibix.com
Amgen Forward-Looking Statements
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2012, and in any subsequent periodic reports on Form 10-Q and Form 8-K.Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project.The Company’s results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign), difficulties or delays in manufacturing our products.
In addition, sales of our products are affected by reimbursement policies imposed by third-party payors, 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 our products.Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.We or others could identify safety, side effects or manufacturing problems with our products after they are on the market.Our business may be impacted by government investigations, litigation and products liability claims.If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions.Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors.We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products.Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product.Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers.Our business performance could affect or limit our ability to repurchase our common stock or the ability of the Amgen Inc. Board of Directors to declare a dividend.
Xcovery Raised $20M through Equity Investment from China’s Betta Pharmaceuticals for Development of ALK Inhibitor
West Palm Beach, Fla.,October 27, 2014–Xcovery, a developer of next-generation targeted therapeutics for cancer, today announced a $20 million equity investment from Betta Pharmaceuticals Co., a leading Chinese pharmaceuticalcompany focused on discovering, developing and delivering innovative medicines. In addition to the equity investment in Xcovery, Bettagains Chinese rights to X-396, a potent small molecule anaplastic lymphoma kinase (ALK) inhibitorcurrently in a Phase 1/2 expansion cohort.
Xcovery also announced that it will be presenting Phase 1 data on X-396 at the 2014 Multidisciplinary Symposium in Thoracic Oncology on Oct. 30 in Chicago. Preliminary Phase 1 data that showed X-396 is generally well-tolerated and has anti-tumor activity in patients with ALK-positive non-small cell lung cancer (NSCLC) was presented in June at the American Society for Clinical Oncology (ASCO) annual meeting.
“This significant investment from Betta Pharmaceuticals, a company that has demonstrated success in research and development as well as commercializing drugs in China, will benefit the Chinese patients as well as advance the development of X-396,” said Dr. Chris Liang, Executive Vice President and Chief Scientific Officerat Xcovery.
The investment with Xcovery will be the first U.S. investment for Betta, whose portfolio of products and pipeline of investigational drugs include treatments for cancer, cardiovascular disease and metabolic disease. Recently, Betta announced a commercial partnership with Amgen to market Vactibix? in China through a joint venture, Amgen-Betta Pharmaceuticals Co., Ltd.
“Xcovery has developed a molecule that potentially has significant anti-tumor activity as well a favorable tolerability profile when compared to other ALK inhibitors,” said Larry Zhu, PhD, MBA, vice president of business development at Betta Pharmaceuticals. “We look forward to working with Xcovery to bring X-396 through the next phase of development and to patients in the U.S., China and the rest of the world.”
Xcoveryisnow enrolling patients in the expansion cohort portion of a Phase 1/2 study of X-396 for the treatment of non-small cell lung cancer where ALK is deregulated, with plans to kick off a Phase 3 registration study in early 2015.
Xcovery is a clinical-stage company focused on the development of next-generation targeted therapeutics for cancer. Founded by Sheridan G. Snyder and Chris Liang, Ph.D., Xcovery’s vision is to successfully develop innovative oncology therapies to optimize patient outcomes. Through innovative drug design, Xcovery has developed a comprehensive pipeline of oncology therapies that target a wide range of advanced tumors. For more information, please visit www.xcovery.com.
The Company Web Site：www.xcovery.com.