Japan related Press Releases

PerkinElmer and Leading Japan Universities Announce Results of Collaboration to Detect Contamination from Nuclear Crisis

Wed, 25 Jan 2012 08:20:46 -0500

Global leader in detection technologies helps researchers create new tests for radiation in water, soil and food, for safety and decontamination

WALTHAM, Mass.--(BUSINESS WIRE)-- PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today announced the results of collaborations with Fukushima University and the University of Tokyo, to develop new radiation detection tests in support of ongoing nuclear crisis response efforts in Japan.

Immediately after the March earthquake that triggered the radiation contamination event in Fukushima prefecture, PerkinElmer assembled and deployed a loan package of sophisticated radiometric detection instruments and expertise for use by front-line researchers in Japan. The company provided research teams with critical application knowledge and technology platforms including Liquid Scintillation Counters, Gamma Ray Counters, and Mass Spectrometers, for measuring uranium, plutonium, iodine, cesium and strontium isotopes in soil, water supplies, fish, vegetables and other produce in affected areas.

In response to concerns from the local community of Fukushima prefecture, Fukushima University researchers developed the first map of radioactive contamination immediately after the accident. PerkinElmer worked closely with Dr. Yoshitaka Takagai, Associate Professor of Analytical Chemistry in the Division of Environmental System Management, Faculty of Symbiotic Systems Science, Fukushima University.

According to Dr. Takagai, “Our research team took the initiative to build the first map of radioactive fallout in response to urgent local anxiety and demands for assurance, as well as taking on the additional vital task of detecting soil contamination to guide cleanup efforts. PerkinElmer technology was instrumental in speeding up the formerly labor-intensive radiation screening of large volumes of soil samples. The sensitivity of the instruments also helped in developing protocols for removing topsoil to ensure effective decontamination of public areas such as schoolyards and playgrounds.”

The Radioisotope Center of University of Tokyo also participated in the urgent task of determining the scope of contamination in the affected areas, as well as devising new methods for detecting radiation in soil, water, and food, to determine their safety and to guide development of decontamination methods, using PerkinElmer equipment.

Toshiyuki Tadenuma, radiation detector group leader, PerkinElmer, commented, "PerkinElmer has also deployed these technologies in collaboration with the National Institute of Health Sciences in Japan, to create screening methods for testing radiation levels in beef products in the affected areas, which will be expanded into other food ingredients."

Robert F. Friel, chairman and chief executive officer of PerkinElmer, said, “As soon as the crisis became known, we felt a unique responsibility to offer all possible assistance, as our company has long been a leader in the specific field of radiometric detection, a technology that enables critical applications needed by the Japanese crisis monitoring and remediation teams. We quickly identified the technologies and applications that would be required, and rapidly mobilized the needed solutions and expertise to support response efforts, by offering our people and technologies to aid researchers leading contamination detection and cleanup activities.”

Friel added, “Over the course of the last several months, due to the strong efforts by the PerkinElmer Japan team and their global colleagues, we are proud to have been able to assist Fukushima University and the University of Tokyo in their mission to find and reduce the effects of radiation and other contaminants resulting from the March earthquake and tsunami. We look forward to continuing our support for as long as necessary to help the people of Japan in their efforts to recover from the crisis.”

Directly and indirectly, the use of PerkinElmer equipment by Japanese researchers in response to the nuclear crisis led to such discoveries as:

Determining that uranium and plutonium contamination was extremely limited, in the vicinity of the reactors, and not widespread
While radioactive iodine is completely gone from affected sites, the bulk of remaining contamination comprises long half-life cesium-134 and -137
Cleaning up radioactive soil depends on varied terrain – and requires different protocols depending on variables such as abundance of site vegetation, and other related factors

Specific PerkinElmer technology platforms used by the university teams included:

Liquid scintillation counter technology (Tri-Carb^®) used for measurement of radioactive strontium and radioactive hydrogen (tritium), to locate contamination patterns as well as testing environmental water samples.
Automatic gamma counter technology (WIZARD^2®) used for 270 sample sequential measurement of gamma-ray nuclear species such as radioactive cesium and iodine, to determine the scope of contamination in the affected areas, as well as devise new methods for detecting radiation in soil, water, and food, to determine their safety as well as to guide development of decontamination methods.
Inorganic technology (ELAN^® DRC II ICP-MS) with the necessary broad range of detection limits required for metal contamination (as well as the presence of uranium and plutonium) in drinking water, soil, wastewater and food.

To learn more about PerkinElmer’s Japan Rapid Response efforts, please visit www.perkinelmer.com.

About PerkinElmer, Inc.

PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The Company reported revenue of approximately $1.7 billion in 2010, has about 7,000 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.

CONTACT:

PerkinElmer, Inc.
Mario Fante, 781-663-5602
Corporate Public Relations Manager
mario.fante@perkinelmer.com
or
Edelman (on behalf of PerkinElmer, Inc.)
Amanda L. Connolly, 404-832-6785
amanda.connolly@edelman.com

KEYWORDS: United States Asia Pacific North America Massachusetts Japan

INDUSTRY KEYWORDS: Women Other Consumer Education University Energy Technology Consumer Electronics Hardware Health Biotechnology Medical Devices Pharmaceutical Manufacturing Chemicals/Plastics Engineering Natural Resources Other Natural Resources Environment Nuclear Consumer Family General Health Men

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Ono Pharmaceutical Company Selects Medidata Rave as Enterprise EDC/CDM Solution

Wed, 18 Jan 2012 16:20:51 -0500

Standard Use of Rave by Japanese Specialty Pharma Across All Trials Will Streamline Research, Accelerate Decision Making and Help Expand Global Network

NEW YORK & OSAKA, Japan--(BUSINESS WIRE)-- Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced Japanese-based Ono Pharmaceutical Co., Ltd. has selected Medidata Rave® as its electronic data capture (EDC) and clinical data management (CDM) solution. The innovation-focused Ono will use Rave as a first preference for all clinical trials in Japan.

Specializing in Phase II and III clinical trials in oncology, carpal tunnel syndrome, diabetes and other therapeutic areas, Ono was impressed with Rave’s ability to improve operational efficiency and enhance workflow throughout the clinical trial process. Beyond functional requirements, Ono also selected Medidata for its strong global presence and reputation for dependability as the company seeks to develop candidate compounds for new drugs and actively conduct trials outside of Japan. During the evaluation phase, Ono deployed Rave in trials across several therapeutic areas and valued the system’s advantages.

“Not only does Rave deliver most of the functionality we were seeking in an EDC solution, but Medidata’s strong global footprint – especially in Japan – offers us an unmatched resource in the industry,” said Satoru Fukinbara, Ph.D., director of data science at Ono’s development headquarters. “Medidata’s established network of satisfied and successful sponsors, in addition to a strong support team, gives us access to a wealth of knowledge and best practices that can help guide our efforts in our global expansion.”

Ono is examining its standardization process using EDC and anticipates immediate benefits for both site users and sponsors, particularly real-time access to clinical data. Ono has already participated in the Japan Medidata User Group (J-MUG), a collaborative forum of more than 40 companies in which Medidata customers share knowledge, experiences and best practices, and plans to actively participate in the 2012 J-MUG.

“Ono is one of Japan’s leading specialty pharmaceutical companies, and we’re excited to play a role in helping them drive continued innovation,” said Tarek Sherif, CEO, Medidata Solutions. “Our leadership in clinical research in the Asia-Pacific region and broad global network enhance our ability to help Ono achieve its goal of streamlining trials and strengthening global alliances.”

About Ono Pharmaceutical Co., Ltd.

In keeping with its philosophy of “Dedicated to Man’s Fight against Disease and Pain” Ono Pharmaceutical Co. Ltd. has always strived to achieve its goal of serving as an R&D-oriented global specialty pharmaceuticals, aiming to develop innovative and globally recognized drugs. To do this, Ono has been engaged in drug discovery research based on accumulated technologies and know-how in areas where Ono’s strengths can be fully exploited (i.e. bioactive lipid agonists and enzyme inhibitors such as proteases and kinases). In addition, modulators of membrane transport system such as ion-channels and transporters as well as biotechnology based medicines are also the areas of our focus where we drive forward our research effectively deploying our research know-how together with the latest information acquired from global research institutions on drug discovery targets and the cutting-edge drug discovery technologies that biopharmaceutical companies can offer. For additional information please go to www.ono.co.jp.

About Medidata Solutions Worldwide

Medidata Solutions is a leading global provider of SaaS clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced solutions lower the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics. Connect with Medidata online by following us on Twitter (@Medidata) or visiting us on LinkedIn.

CONTACT:

Lois Paul & Partners
Susan McCarron, 617-986-5767
Susan_McCarron@lpp.com

KEYWORDS: United States Asia Pacific North America Canada New York Japan

INDUSTRY KEYWORDS: Technology Software Health Biotechnology Medical Devices Pharmaceutical

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Nuron Biotech Licenses HibTITER® Vaccine to Mitsubishi Tanabe Pharma Corporation for Japanese Market

Fri, 13 Jan 2012 08:21:03 -0500

EXTON, Pa.--(BUSINESS WIRE)-- Nuron Biotech Inc., a specialty biologics and vaccines company, today announced that it has licensed its HibTITER® vaccine to Mitsubishi Tanabe Pharma Corporation (Head Office: Osaka, Japan; “MTPC”) for commercialization in the Japanese market for both the single entity and for combination product use. Under the terms of the agreement MTPC will be responsible for any necessary development and regulatory approval costs, pay undisclosed upfront, pre-commercial milestones and pay Nuron Biotech significant royalties on commercial sales in Japan.

“The HibTITER® vaccine still represents a considerable global opportunity, especially in markets like Japan, where there is only one approved vaccine for Haemophilus influenza type b (Hib) bacteria, which is a potential life-threatening illness,” commented Shankar Musunuri, Ph.D., MBA, Chief Executive Officer and Founder of Nuron Biotech. “This agreement provides us with additional resources to accelerate our re-launch strategy of this first-in-class vaccine in the U.S. market.”

“HibTITER®’s easy to use liquid formulation, adjuvant free, with a track record of success in virtually eliminating Haemophilus in the United States makes it a great addition to our pediatric vaccine franchise,” said Masayuki Mitsuka, Ph.D., Board Director, Executive Officer, Global Product Strategy at MTPC.

Richard Dinovitz, Vice President, Marketing and Business Development at Nuron Biotech continued, “MTPC is one of Japan’s largest and most respected pharmaceutical companies, and we believe they have both the experience and market access to bring HibTITER® to patients and clinicians across Japan.”

Nuron acquired HibTITER® (Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate)) from Wyeth LLC, a wholly owned subsidiary of Pfizer Inc., for the U.S. and many other markets, including Japan and Korea. HibTITER® was one of the first glycoconjugate technology vaccines for humans on the market and was responsible for greatly reducing the incidence of Hib disease in children^[1]. Hib vaccines are now part of the CDC Recommended Childhood and Adolescent Immunization Schedule with over 10 million annual doses administered each year in the U.S. alone. Nuron is currently executing the re-launch strategy to launch this vaccine in the U.S.

About Nuron Biotech

Nuron Biotech’s vision is to bring innovative and improved biologics to market for the better health of patients. Nuron’s management team consists of proven veteran industry executives who have made significant contributions in developing, launching and managing the life cycle of various biologics.

Nuron is currently working on products in several disease areas including central nervous system (CNS) and vaccines. www.nuronbiotech.com

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation is a research-driven pharmaceutical company based in Japan, specializing in research, development and marketing of globally competitive pharmaceutical products focused on autoimmune diseases, diabetes, kidney diseases, and other disease areas that respond to unmet medical needs. Mitsubishi Tanabe Pharma contributes to the healthier lives of people around the world through the creation of pharmaceuticals. www.mt-pharma.co.jp/e

[1] Peltola H, Kilpi T, Anttila M. Rapid disappearance of Haemophilus influenzae type b meningitis after routine childhood immunisation with conjugate vaccines. Lancet. 1992; 340:592–4. [PubMed]

CONTACT:

Nuron Biotech, Inc.
Richard Dinovitz, 610-968-6704
Vice President, Marketing and Business Development
or
Media:
MacDougall Biomedical Communications
Charles Liles, 781-235-3060

KEYWORDS: United States Asia Pacific North America Pennsylvania Japan

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Other Health Children Consumer General Health

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9th Annual BIO Asia International Conference to Feature New Deal Models and Discuss the Future of Innovation in Asia

Thu, 12 Jan 2012 14:21:05 -0500

Biotechnology Industry Organization (BIO) Announces Programming for 2012 Event, to Be Held in Osaka, Japan

WASHINGTON--(BUSINESS WIRE)-- The BIO Asia International Conference will feature industry leaders discussing the future of the Asian biotechnology industry and new deal models between Western and Asian companies. BIO Asia is the longest running biotechnology partnering conference in Asia. The conference, produced by the Biotechnology Industry Organization (BIO), will be held January 31 – February 1, 2012 in Osaka, Japan for the first time.

“BIO Asia provides a unique forum for leaders of Western and Japanese biotechnology and pharmaceutical companies to engage in high level discussions about several new deal models, as well as exchange their vision of how innovation will evolve in Asia. This conference will explore what the future holds for investors and executives alike," said Alan Eisenberg, Executive Vice President, Emerging Companies and Business Development.

The biotechnology market in Japan was estimated at 1.76 trillion yen (approximately 22.6 billion U.S. dollars) in 2005, second only to that of the United States. The market has grown considerably since then and could represent a significant opportunity for Western companies looking to do business in Asia.

Based on this growth and a potentially promising outlook, BIO Asia’s Opening Plenary session will feature an in-depth look at the Takeda/Nycomed deal, which was the largest cross-border transaction by a Japanese company in 2011.

Cross-Border M&A – Takeda/Nycomed

Nominated to be the IN VIVO Blog’s M&A Deal of the Year for 2011, Takeda’s $13.7B acquisition of Nycomed is the largest cross-border transaction by a Japanese company and provided Takeda with greater infrastructure in Europe, an immediate entry into emerging markets, and an immediate increase in cash flow. The deal provided a hefty return to Nycomed investors, and even yielded a coveted “Private Equity Deal of the Year” award at the European M&A awards for primary investor Nordic Capital. This deal both expands Takeda’s global footprint and reinforces Japan’s global leadership in the biopharma industry. Senior executives crucial to the execution of this stellar deal will conduct a deep-dive on the deal terms and integration process.

Moderator:

David Low, Managing Director, Life Sciences Group, Lazard

Panelists:

Ken Araki, Vice President, Head of Global Corporate Development and Japan BD Group Global Business Development, Takeda Pharmaceuticals International
Gunnar Gårdemyr, VP, Head of Global Licensing Business Development Operations, Takeda Pharmaceuticals International

Other sessions include:

The Next Frontier—Asia in 5-10 Years

Asia has long been thought of as the next frontier for the biotech industry with large pharma and investors staking their claim over the last decade in Japan and more recently, in China. Korean biotech is rapidly becoming a real player as well, so what can we expect to see from this growing market in the next 5-10 years? Will the landscape evolve similar to that of Europe and the US, with biotech epicenters, such as Boston and San Francisco? When will home-grown novel products reach market and which parts of Asia will they come from? Will sufficient capital markets exist to grow and sustain life sciences companies? Pharma executives, investors and other industry leaders will convene to discuss how the biotech landscape will evolve in Asia in the next 5-10 years.

Moderator:

David Flores, Co-Founder, President & CEO, BioCentury Publications, Inc.

Panelists:

Paul B. Bolno, MD, MBA , Vice President, Worldwide Business Development, Head of Asia, GlaxoSmithKline PLC
Paul Hudson, President, AstraZeneca KK
Kewen Jin, Managing Director, Nimbus Innoworks
Joong Myung Cho, PhD, President & CEO, CrystalGenomics, Inc

The New World of Pharma Collaborations

This panel will illustrate a set of new types of collaborations that bring together funding and know-how to address pharma’s needs in the world of patent expirations, lower R&D productivity, and other pipeline challenges. This unique panel will feature three parties and three separate deals that have been completed among them. Two of these deals are very recent, and BIO Asia will be the first public platform in which this new development model and two of these deals will be discussed. More details will be announced in coming weeks prior to BIO Asia.

Moderator:

Alan Eisenberg, Executive Vice President, Emerging Companies and Business Development, Biotechnology Industry Organization

Panelists:

Robert DeBenedetto, CPA, President & CEO, SFJ Pharmaceuticals
Rami Suzuki Ph.D., Senior Director of Business Development Department, Eisai Co, Ltd.
Johan Westblad, M.Sc., MBA, Associate Director, Business Development at Quintiles Japan

The BIO Asia International Conference is an exclusive, customized partnering forum that brings together U.S. and European drug development companies with Asian biotech and pharmaceutical companies interested in research collaborations and licensing agreements.

To learn more about the BIO Asia International Conference, registration and up-to-date program information, please visit the web site here. Advance media registration is available here. Registration is complimentary for credentialed members of the media.

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtechNOW, a multiblog platform and monthly newsletter that aims to create an online biotech community where the the industry can connect to discuss the latest news. Subscribe to BIOtechNOW.

For more information:
Visit http://www.bio.org
Follow us on Twitter @IAmBiotech
Join us on LinkedIn/MyBio
Become a fan at facebook.com/IAmBiotech

Upcoming BIO Events

BIO Asia International Partnering Conference
January 31 – February 1, 2012
Osaka, Japan

BIO CEO & Investor Conference
February 13-14, 2012
New York, NY

World Congress on Industrial Biotechnology & Bioprocessing
April 29-May 2, 2012
Orlando, FL

2012 BIO International Convention
June 18-21, 2012
Boston, MA

CONTACT:

BIO
Tracy Cooley, APR
202-312-9274
tcooley@bio.org

KEYWORDS: United States Asia Pacific North America District of Columbia Japan

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

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QIAGEN Receives Regulatory Approval in Japan for EGFR Companion Diagnostic to Guide Cancer Treatments

Tue, 10 Jan 2012 02:20:48 -0500

-- therascreen® EGFR Mutation Detection Kit RGQ approved in Japan, one of the leading markets for pairing diagnostics with drug therapies in personalized healthcare

TOKYO and HILDEN, Germany, Jan. 10, 2012 /PRNewswire-Asia/ -- QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced the regulatory approval of its therascreen^® EGFR Mutation Detection Kit RGQ in Japan. EGFR, the epidermal growth factor receptor, has been shown to play an important role in certain cancers and is the target of many new anticancer drugs.

The approval is a milestone in QIAGEN's Personalized Healthcare strategy, as Japan is one of the world's largest markets for companion diagnostic tests. In April 2011, QIAGEN's therascreen^® KRAS Mutation Detection Kit was approved in Japan, targeting a different biomarker that is also used to guide cancer treatment decisions. The potential patient population alone in Japan for EGFR and KRAS testing is estimated at approximately 100,000 per year.

"Greater use of companion diagnostic tests such as our EGFR and KRAS assays may help overcome significant challenges by maximizing the efficacy and safety of therapies and improving patient outcomes," said Dr. Stephen Little, Vice President Global Personalized Healthcare at QIAGEN. "Japanese and other East Asian populations generally have a higher rate of EGFR mutations than other groups, and non-smoking East Asian women are the largest potential market for EGFR-inhibitor anticancer drugs. This approval allows QIAGEN to market our companion diagnostic along with major pharmaceutical companies offering certain EGFR-inhibitor drugs. The approval of therascreen EGFR exemplifies our strategy of driving dissemination of molecular technologies by creating innovative test content and providing efficient, automated platforms for hospitals and laboratories to use these tests."

Companion diagnostic tests targeting EGFR, like QIAGEN's therascreen EGFR Mutation Detection Kit RGQ, determine the presence or absence of an EGFR mutation in a patient's tumor. Individuals, for whom treatment decisions are made following determination of EGFR mutation status, can experience 60% response rates to EGFR-inhibitor drugs, a much higher success rate than with traditional chemotherapy, studies show. Conversely, other patients can be unresponsive to EGFR-inhibitor drugs. Using the companion diagnostic not only may improve therapeutic outcomes, but also save patients and healthcare systems a significant amount of money since the newer classes of drugs can cost tens of thousands of dollars. By determining EGFR mutation status, doctors can prescribe the relevant drugs only to patients who are expected to benefit from them.

QIAGEN is the world's leading independent provider of molecular technologies for personalized healthcare, currently offering more than 30 assays that include tests for the biomarkers KRAS, BRAF and PI3K. QIAGEN is expanding its presence in the personalized healthcare field through regulatory submissions, such as two completed in mid-2011 in the U.S. for the KRAS biomarker, that are the result of an extensive range of research and development partnerships. In 2011, QIAGEN also acquired the French diagnostics company Ipsogen, gaining rights to a portfolio of biomarkers, including JAK2 and BCR-ABL, that are believed to play a role in various blood cancers.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. As of September 30, 2011, QIAGEN employed nearly 3,800 people in over 35 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.

Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Contacts:
Investor Relations		Public Relations
John Gilardi	+49 2103 29 11711 +1 240 686 2222	Dr. Thomas Theuringer	+49 2103 29 11826 +1 240 686 7425
Albert F. Fleury	+1 301 944 7028 IR@qiagen.com	Brendan Green	+86 21 3865 3824 PR@qiagen.com
www.qiagen.com/about/investorrelation		www.qiagen.com/about/press

SOURCE QIAGEN

Aeterna Zentaris Partner, Yakult Honsha, Initiates Phase 1/2 Trial with Perifosine in Colorectal Cancer in Japan

Tue, 03 Jan 2012 08:20:27 -0500

Trial initiation to trigger milestone payment to Aeterna Zentaris

QUÉBEC CITY, Jan. 3, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that its Japanese partner, Yakult Honsha ("Yakult"), has initiated a Phase 1/2 trial in Japan to assess the safety and efficacy of the Company's PI3K/Akt inhibitor, perifosine, in combination with chemotherapeutic agent, capecitabine, in patients with refractory advanced colorectal cancer ("CRC"). The initiation of this trial will trigger a milestone payment of an undisclosed amount from Yakult to Aeterna Zentaris under the partnership agreement signed with Yakult in March 2011 for perifosine in Japan.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "We would like to thank our partner Yakult for the swift initiation of this trial in Japan, a first in the clinical development of perifosine in Japan. The trial is also part of our worldwide clinical development and registration strategy for perifosine in colorectal cancer, as we await the completion of the Phase 3 trial in this indication in the United States during the first quarter of 2012."

The Phase 1/2 Trial in CRC

The Phase 1/2 trial is being conducted in patients with refractory advanced CRC. The primary endpoint of the Phase 1 portion of the trial is the safety profile of perifosine in combination with capecitabine. The primary endpoint of the Phase 2 portion is efficacy (Disease Control Rate).

About Perifosine

Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival. Perifosine, in combination with chemotherapeutic agents, is currently being studied for the treatment of colorectal cancer, multiple myeloma and other cancers, and is the most advanced anticancer agent of its class. Perifosine, as monotherapy, is being explored in other indications. The FDA has granted perifosine orphan-drug designation in multiple myeloma and neuroblastoma, and Fast Track designations in both multiple myeloma and refractory advanced colorectal cancer. Additionally, an agreement was reached with the FDA to conduct the Phase 3 trials in both of these indications under a Special Protocol Assessment. Perifosine has also been granted orphan medicinal product designation from the European Medicines Agency (EMA) in multiple myeloma. Furthermore, perifosine has received positive Scientific Advice from the EMA for both the multiple myeloma and advanced colorectal cancer programs, with ongoing Phase 3 trials for these indications expected to be sufficient for registration in Europe. Perifosine rights have been licensed to Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) for North America, to Yakult for Japan, to Handok for Korea and to Hikma Pharmaceuticals for the MENA (Middle East and North Africa) region.

About Yakult Honsha Co., Ltd.

Yakult is a leading Japanese company focused on the development and marketing of pharmaceuticals, foods, beverages, and cosmetics. As for pharmaceutical business, Yakult has an emerging presence in oncology. For more information on Yakult, visit: www.yakult.co.jp/english/index.html or view the following company profile: www.yakult.co.jp/english/pdf/profile2010-2011.pdf

About Aeterna Zentaris Inc.

Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers including colorectal, multiple myeloma, endometrial, ovarian, prostate and bladder cancer. The Company's innovative approach of "personalized medicine" means tailoring treatments to a patient's specific condition and to unmet medical needs. Aeterna Zentaris' deep pipeline is drawn from its proprietary discovery unit providing the Company with constant and long-term access to state-of-the-art therapeutic options. For more information please visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.

SOURCE AETERNA ZENTARIS INC.

Takeda and Affymax Provide Update on Peginesatide Commercialization Rights in Japan

Thu, 15 Dec 2011 16:21:12 -0500

OSAKA, Japan & PALO ALTO, Calif.--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502) and Affymax, Inc. (Nasdaq:AFFY) today announced that Takeda has decided not to commercialize peginesatide in Japan. Peginesatide is an investigational therapy for use in the treatment of patients with anemia due to chronic kidney disease (CKD). Takeda and Affymax will explore other options for the commercialization rights for this product in the Japanese market, including potentially licensing it out to a third party.

Takeda had been reviewing the business opportunity for peginesatide in Japan in view of its product portfolio and also further concentration into its core therapeutic areas and reached the conclusion that commercialization in the territory is not strategically optimal. Takeda and Affymax will continue closely collaborating in the development and commercialization of peginesatide outside Japan, including preparing for potential U.S. approval and launch and regulatory filing in Europe.

In Japan, the majority of phase 2 and phase 3 clinical trials are completed, and the findings to date suggest that peginesatide can become a promising treatment option for Japanese renal anemia patients. Accordingly, the companies are pursuing options that will take the program forward with a regulatory submission and commercialization in Japan.

Takeda and Affymax entered into two agreements signed in 2006 for development and commercialization of peginesatide, one for Japan and another for the rest of the world. In the U.S., a New Drug Application of peginesatide is under FDA review with a scheduled action date of March 27, 2012. In the European Union, Takeda expects to submit a Marketing Authorization Application during the first quarter of calendar year 2012.

About Peginesatide

Peginesatide is a synthetic PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The peginesatide Phase 3 clinical program was the largest to support the new drug application of an ESA in the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events. The compound was discovered by Affymax and is being co-developed by Affymax and Takeda. If approved, peginesatide may be the first once-monthly product for anemia in CKD for dialysis patients available in the United States.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding the timing and potential for FDA approval of peginesatide following the ODAC recommendation, continuation and success of Affymax's collaboration with Takeda, timing for identification of a collaborative partner in Japan, if any, milestones expected to be accomplished, timing, design and progress of the peginesatide development program and the timing and potential regulatory filing of the MAA and commercialization of peginesatide in Europe. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the approvability of the New Drug Application (NDA) filing, risks relating to regulatory requirements and approvals, including pre-or post-marketing studies and Risk Evaluation and Mitigation Strategy (REMS), in particular the FDA's interpretation of the ODAC recommendations and its interpretation and review of the data in the NDA including issues related to the subgroup analyses in non-dialysis, study design, the completeness of the NDA, including data quality and integrity in our non-inferiority designed trials, the continued safety and efficacy of peginesatide in clinical development, the timing of patient accrual in ongoing and planned clinical studies, research and development efforts, industry and competitive environment, potential delays or additional studies that may be required by the FDA or other regulatory authorities, financing requirements and our ability to access capital and other matters that are described in Affymax's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," “assume,” "continue," "seek," "pro forma," "potential," "target," "forecast," “guidance,” “outlook” or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50108747&lang=en

CONTACT:

Takeda Pharmaceutical Company Limited
Seizo Masuda, +81-3-3278-2037
Corporate Communications Dept. (PR/IR)
or
Affymax, Inc.
Sylvia Wheeler, +1-650-812-8861
Vice President, Corporate Communications

KEYWORDS: United States Asia Pacific North America California Japan

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical

MEDIA:

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Celgene Announces New Drug Application Filing for REVLIMID in Japan

Calisha Myers — Tue, 07 Jul 2009 11:44:10 -0400

Celgene Announces New Drug Application Filing for REVLIMID^® in Japan

REVLIMID filing based on safety and efficacy results of two large, randomised pivotal Phase III trials, as well as specific Japanese studies

NDA is for REVLIMID in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy

BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Sàrl (NASDAQ:CELG) today announced it has filed a New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare (MHLW) for REVLIMID (lenalidomide) in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approximately 11,000 people in Japan suffer from multiple myeloma and around 4,000 patients are diagnosed each year.

"The filing of an NDA in Japan for multiple myeloma represents an important step towards achieving our goal of delivering REVLIMID to patients in need in one of the world's largest oncology populations," said Joseph Melillo, General Manager of Celgene KK.

The filing with the MHLW is based upon the safety and efficacy results of two large, randomised pivotal Phase III special protocol assessment trials: North American Trial MM-009 and International Trial MM-010 evaluating REVLIMID plus dexamethasone in multiple myeloma patients who have received at least one prior therapy. Both studies were published in the New England Journal of Medicine in November 2007. Phase I clinical results with Japanese patients, including those from MM-017, confirm similar efficacy and further support the filing.

REVLIMID was granted orphan drug status in February 2008 by the MHLW in Japan for two indications - the treatment of anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without other cytogenic abnormalities, and in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID^® is also approved in the United States, Canada and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorisation Applications are currently being evaluated in a number of other countries.

About REVLIMID

REVLIMID is an IMiDs^® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications including composition-of-matter and use patents.

About Multiple Myeloma

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.

REVLIMID^® is a registered trademark of Celgene Corporation.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.

Shire Announces Opening of Office in Japan

Fri, 20 Feb 2009 17:23:49 -0500

Shire Announces Opening of Office in Japan

TOKYO, Japan and CAMBRIDGE, Massachusetts, February 20 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it has officially opened a new representative office in Japan and has appointed Soh Fujiwara as Managing Director for Japanese operations.

Shire's new office in Shinkujuku Ward, Tokyo, will serve as the base for preparations for the future commercialization of its pipeline products in Japan, the second largest biopharmaceutical market in the world.[1] Shire currently focuses its business on the areas of attention deficit and hyperactivity disorder (ADHD), gastrointestinal (GI) and human genetic therapies, and markets products in pharmaceutical markets worldwide.

"The unique regulatory, clinical and cultural characteristics of the Japanese market require an early investment in infrastructure to maximize the potential in this strategically important region," said Sylvie Gregoire, President of Shire Human Genetic Therapies, the business unit focusing on treating rare diseases. "Through the opening of this new office, we have taken a significant step toward increasing our presence in this market. Soh Fujiwara joins Shire at a critical time in our global expansion, and we look forward to working closely with him and his team to build an infrastructure that will enable us to bring additional therapies to Japanese patients."

Mr. Fujiwara joins Shire as Managing Director for Japanese operations after spending more than 20 years in the pharmaceutical industry. During his career, Mr. Fujiwara has spent a significant amount of time working on the development of products for rare diseases. In his new role, Mr. Fujiwara will oversee the implementation and development of clinical and regulatory strategies for the commercialization of products in the Human Genetic Therapies pipeline, as well as identify potential future opportunities for growth in this market. He will also work closely with Japanese physicians and regulatory authorities to ensure the needs of affected patients and their families are being met.

Shire currently has numerous therapies available in Japan through strategic partnerships. In addition to the Japan representative office, Shire has offices in Singapore and Australia, and plans to continue exploring additional opportunities for growth throughout the Asia Pacific region.

Notes to Editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

SOURCE Shire Plc

Bristol-Myers Squibb and AstraZeneca Announce Expansion of Worldwide Collaboration to Develop and Commercialize Dapagliflozin

Calisha Myers — Mon, 08 Dec 2008 09:56:40 -0500

Bristol-Myers Squibb and AstraZeneca Announce Expansion of Worldwide Collaboration to Develop and Commercialize Dapagliflozin in Japan

PRINCETON, N.J. & LONDON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced expansion of their worldwide collaboration to include the development and commercialization of dapagliflozin in Japan. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in Phase III clinical trials in several countries, including the U.S., to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.

In January 2007, Bristol-Myers Squibb and AstraZeneca entered into a global collaboration, excluding Japan, to enable the companies to research, develop and commercialize dapagliflozin. The companies now have agreed to co-develop dapagliflozin in Japan with AstraZeneca having operational and cost responsibility for all development and regulatory activities on behalf of the collaboration. The two companies will jointly market the product in Japan, sharing all commercialization expenses and activities and splitting profits/losses equally. Bristol-Myers Squibb will manufacture dapagliflozin and also book sales. Dapagliflozin is currently being studied in Phase II clinical trials in Japan.

"Bristol-Myers Squibb and AstraZeneca have been working together to develop dapagliflozin for type 2 diabetes for nearly two years - this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship," said Lamberto Andreotti, Executive Vice President and Chief Operating Officer, Bristol-Myers Squibb. "Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than 6 million people in Japan living with type 2 diabetes."

"Last year, the cost of treating and preventing type 2 diabetes and its complications in Japan was more than USD 18.4 billion, which is a significant cost to Japanese society," said Bruno Angelici, Executive Vice President, International Sales and Marketing Organization, AstraZeneca. "We have a long-standing presence in Japan, and our agreement with Bristol-Myers Squibb to bring a potentially important type 2 diabetes treatment to market in the region will not only help reduce this cost burden, but also reduce the impact this disease has on the country's health."

About Dapagliflozin

Dapagliflozin was specifically designed to be a novel, selective inhibitor of sodium glucose cotransporter 2 (SGLT2), which regulates the reabsorption of glucose in the kidney. It has a C-glucoside chemical structure, which prolongs the pharmacokinetic half-life and duration of action. Dapagliflozin is metabolized through the liver and excreted in the urine. Phase IIB data for Dapagliflozin were presented at the 2008 American Diabetes Association Annual Meeting and the 2008 European Association for the Study of Diabetes Annual Meeting.

About ONGLYZATM (saxagliptin)

In addition to the companies' collaboration on dapagliflozin, Bristol-Myers Squibb and AstraZeneca have been working together to develop another potential treatment for type 2 diabetes -- ONGLYZATM (saxagliptin) -- globally, excluding Japan.

ONGLYZA, the proposed tradename for saxagliptin, is an investigational DPP-4 inhibitor being studied in clinical trials as a once-daily therapy to determine its efficacy and safety. Saxagliptin was specifically designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance. The companies submitted a New Drug Application to the U.S. Food & Drug Administration (FDA) on June 30, which has been officially filed by the FDA, and a Marketing Authorization Application to the European Medicines Agency (EMEA) on July 1, which has been accepted for review by the Agency. The name ONGLYZA, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.

Saxagliptin Phase III data have previously been presented as a monotherapy, as well as in combination with metformin, sulfonylureas and thiazolidinediones, commonly prescribed oral anti-diabetic medications. The overall clinical development program included over 5,000 individuals -- more than 4,000 of whom were given saxagliptin. The worldwide collaboration for the development and commercialization of saxagliptin will continue to exclude Japan. On December 27, 2006, Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. announced an exclusive licensing agreement for saxagliptin in Japan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the products described in this release will receive regulatory approval. There can be no assurance that if approved, the products will be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2007, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

AstraZeneca Forward-Looking Statement

The statements contain herein include forward-looking statements. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of the preparation of this press release and the Company undertakes no obligation to update these forward-looking statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things, those risk factors identified in the Company's Annual Report/Form 20-F for 2007. Nothing contained herein should be construed as a profit forecast.