Celgene Lenalidomide Receives Orphan Drug Status in Japan for both deletion 5q MDS and previously treated multiple myeloma
Boudry, Switzerland–Celgene International Sàrl (NASDAQ: CELG) announced that lenalidomide (CC-5013) has been granted orphan drug status by Japan’s Ministry of Health, Labour and Welfare (MHLW) for two different indications: the treatment of both anemia 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.
Orphan drug status is granted by the MHLW to promote development of drugs to treat rare diseases or conditions. Such designation confers multiple incentives for development, including access to a fast-track Marketing Authorization Approval procedure; financial incentives for development expenses; protocol development assistance; and a ten-year registration validity period once the product is approved.
“The decision by the MHLW to grant lenalidomide orphan drug status for both relapsed/refractory multiple myeloma and deletion 5q MDS represents a major step in our efforts to deliver REVLIMID as a therapeutic option for patients living with these conditions worldwide as quickly as possible,” said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation. “We will continue to work closely with the Japanese regulatory authorities as we move lenalidomide through the clinical development process.”
Lenalidomide (REVLIMID) has obtained orphan drug designation for MDS in the European Union (EU), United States (US), and Australia, orphan drug designation for multiple myeloma (MM) in the EU, US, Australia and Switzerland, and orphan drug designation for chronic lymphocytic leukemia (CLL) in the EU and US. REVLIMID is currently approved for use in the US and Canada for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is also approved for use in the EU, US and Switzerland for the treatment of multiple myeloma in combination with dexamethasone in patients who have received at least one prior therapy, and Australia for patients with multiple myeloma whose disease has progressed after one therapy.
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 hematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of-matter and use patents.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with MM worldwide. Multiple 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 Myelodysplastic Syndromes
Myelodysplastic syndromes are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or “blast” stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue and may develop life-threatening iron overload and/or toxicity from frequent transfusions, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms.
About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with MDS, and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in 20 percent to 30 percent of all MDS patients. The World Health Organization has also recently identified a unique subset of MDS patients with a “5q- Syndrome” where the only chromosomal abnormality is a specific portion of the 5q chromosome.
About Celgene International Sárl
Celgene International Sárl, located in Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical 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 forward-looking statements which are subject to 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 expressed or 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 other factors described in the Company’s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
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Catarina Edfjäll, +41 32 729 87 63
Duke University to Deploy World’s Largest WiFi Network
Filed under: Americas, Communications, Computing, Education, Internet, Mobile, Technology
SAN JOSE, CA–Feb 19, 2008 — Cisco® (NasdaqGS:CSCO) announced today that Duke University will deploy the next phase of its mobility transformation by deploying an expansive next-generation 802.11n wireless network across its campus, featuring more than 2,500 Cisco access points — the largest planned 802.11n wireless network in the world by any organization to date.
As a progressive leader in education and one of the first organizations to deploy 802.11n technologies, Duke will blanket more than 6 million square feet of its Durham, N.C. campus with 2,500 Wi-Fi-certified Cisco 802.11n Aironet® 1250 Series access points. The deployment will provide ubiquitous wireless coverage in academic halls, libraries, residence halls and other campus buildings.
Duke’s chief information officer, Tracy Futhey, said Cisco’s 802.11n technology — which dramatically increases the speed and reliability of traditional wireless networks — is a fundamental part of Duke’s strategy to implement innovative technologies that can enhance the quality of campus life, enable new learning spaces and provide seamless access to course materials and resources for a campus population of 45,000 students, faculty and staff.
“Wireless on our campus is absolutely critical to our 24-by-7 population. Universities are an ideal testing ground for new technologies, especially wireless uses and devices, because students are spending their entire day on campus in a mobile manner. They live, learn, work and play on campus,” said Futhey. “At Duke, we really have the opportunity to apply innovative wireless technology that can meet the demands of a diverse, mobile user base and enrich their academic and social experience as a result.”
“We expect the campus-wide 802.11n wireless network to increasingly be the primary mode of connectivity for data access and mobility applications. The value of a technology like 802.11n is about enabling new kinds of uses on our campus, giving our students new opportunities and enabling faculty to push the limits and try things that were not possible before on previous wireless technologies,” Futhey added.
During real-world tests, Duke experienced predictable and reliable wireless coverage and consistent average data throughput performance of nearly 130 Mbps per client with the Cisco Aironet 1250 Series access point. In addition, tests at Duke indicated that existing 802.11g clients such as laptops connected to a Cisco Aironet 1250 Series access point obtained almost twice the data rate achieved while connected to an older wireless network, demonstrating the benefit of 802.11n to existing Wi-Fi devices.
In addition to the current benefits for the campus population, the new Cisco 802.11n wireless network supports the Duke Digital Initiative by enabling multimodal “classrooms of tomorrow” and collaborative group study areas that are now under construction in the Perkins Library. Video applications will become more pervasive with streaming audio, video and high-definition TV (HDTV) over Wi-Fi. All course materials, including digital recordings of classes, will be available anytime, anywhere using the wireless network. In addition, inside or outside of a classroom, faculty can use network resources to enhance teaching. For example, an economics professor is planning to use real-time market data as part of the course materials, clearly demonstrating the relevancy to current events.
“802.11n is clearly ready for prime time, and Cisco continues to deliver a reliable 802.11n solution to meet mobility needs,” said Ben Gibson, Cisco’s senior director of mobility solutions. “Duke is one of the first organizations to realize the benefits of a Cisco 802.11n wireless network and what it enables them to do: transform how they learn, live and play.”
Live Broadcast: Duke University and 802.11n
Today, from 10:00 to 11:00 a.m. PST, Kevin Miller, assistant director of Duke University’s communications infrastructure, will discuss the university’s Digital Initiative, strategy, business drivers and next steps for evolving the campus network to more powerful 802.11n wireless connectivity that will help shape the future of the education experience. Go to this URL and select “Play” at 10:00 a.m. PST to watch the live presentation. http://tools.cisco.com/cmn/jsp/index.jsp?id=70969
About Cisco
Cisco (NasdaqGS:CSCO – News) is the worldwide leader in networking that transforms how people connect, communicate and collaborate. Information about Cisco can be found at http://www.cisco.com. For ongoing news, please go to http://newsroom.cisco.com.
Cisco, the Cisco logo, Aironet and Cisco Systems are registered trademarks or trademarks of Cisco Systems, Inc. and/or its affiliates in the United States and certain other countries. All other trademarks mentioned in this document are the property of their respective owners. The use of the word partner does not imply a partnership relationship between Cisco and any other company. This document is Cisco Public Information.
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Cisco Systems, Inc.
408 421 5132
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Cisco Systems, Inc.
408 853 8876
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Cisco Systems, Inc.
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Source: Cisco Systems, Inc.