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.
Contact:
Celgene Corporation
Head of Regulatory Affairs
Europe
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.
Contact:
Media Relations:
Ed Tan
Cisco Systems, Inc.
408 421 5132
edgtan@cisco.com
Industry Analyst Relations:
Laura Irwin
Cisco Systems, Inc.
408 853 8876
lirwin@cisco.com
Investor Relations:
Marilyn Mora
Cisco Systems, Inc.
408 527 7452
marilmor@cisco.com
Source: Cisco Systems, Inc.
Four Most Important Questions To Check If Your Business Is Properly Insured
NEW YORK, February 19, 2008 — Today, businesses face greater risks than ever before. In addition to such typical risks as theft and fire, there are a host of other risks that are unique to each particular type of business. That’s why it is essential that businessowners make sure they buy the right type and amount of insurance and update their policies annually to include improvements, major purchases and increased rebuilding costs as well as any liability risks, according to the Insurance Information Institute (I.I.I.).
“One of the biggest mistakes businessowners make is that they don’t buy the right type of insurance and often have gaps in their coverage, “ said Loretta Worters, vice president, I.I.I. “Businessowners should contact their insurance agent or company representative annually to make sure that their insurance is adequate.”
A Businessowner’s Policy (BOP) is recommended for most small businesses (usually 100 employees or less), as it is often the most affordable way to obtain broad coverage. Combining both property and liability insurance, a BOP will cover your business in the event of property damage, suspended operations, lawsuits resulting from bodily injury or property damage to others, etc.
BOPs do NOT cover professional liability, auto insurance, workers compensation or health and disability insurance, however. You’ll need separate insurance policies to cover professional services, vehicles and your employees.
For medium and larger businesses, there are more comprehensive commercial policies. To properly insure your business, the I.I.I. suggests that you ask your agent or company representative these four important questions:
1. Do I have enough insurance to rebuild my business property and replace all of my merchandise and possessions?
A Building and Personal Property Coverage (BPP) policy is commonly used to cover any combination of the following three broad categories: the building, your business personal property and the personal property of others. Usually the covered building is owned by the insured. However, a lessee might insure a leased building when required to do so by the terms of the lease.
Your Business Personal Property includes seven specific categories:
- Furniture and fixtures
- Machinery and equipment
- Stock (i.e., merchandise held in storage, including raw materials, work in-progress and finished goods)
- All other personal property owned by you and used in your business
- Labor, materials or services furnished or arranged by you on the personal property of others
- If a tenant, the improvements or betterments you have made
- Leased personal property for which you have a contractual responsibility to insure
It is vital that the values of property are accurately reported and updated annually to reflect inflation and other increases in cost.
2. Do I have enough insurance to protect the personal property of my employees?
You will need to add Personal Effects and Property of Others coverage to your policy. This coverage permits the insured to extend up to $2,500 worth of its business personal property coverage to personal effects of the insured and its officers, partners or employees and personal property of others in the insured’s care, custody or control. The personal effects coverage does not include theft, even if theft is a covered cause of loss under the policy.
If the $2,500 limit is inadequate to cover personal property to others in the insured’s possession, a higher limit can be purchased.
3. Do I have enough insurance to keep my business open?
A business that has to close down completely while the premises are being repaired may lose out to competitors. A quick resumption of business after a disaster is essential. That’s why business interruption insurance is so important.
“Make sure the policy limits are sufficient to cover your company for more than a few days,” said Worters. “After a major disaster, it can take more time than many people anticipate to get a business back on track. There is generally a 48-hour waiting period before business interruption coverage kicks in,” she added. “Too many businessowners fail to think about how they would manage if a fire or other disaster damaged their business premises so that it was temporarily unusable.”
The price of the policy is related to the risk of a fire or other disaster damaging your premises. All other things being equal, the price would probably be higher for a restaurant than a real estate agency, for example, because of the greater risk of fire. Also a real estate agency can more easily operate out of another location.
There are typically four types of business interruption insurance. You can purchase any one of these or any combination of them that would make sense for your business:
- Business income coverage – Compensates you for lost income if your company has to vacate its premises due to disaster-related damage that is covered under your property insurance policy. Business income insurance covers the profits you would have earned, based on your financial records, had the disaster not occurred. The policy also covers operating expenses, such as electricity, that continue even though business activities have come to a temporary halt.
Review your annual financial records with your accountant to determine your annual net profit (total revenue minus total expenses). You should also have an approximate idea of how much profit you make (and would therefore lose) during a typical year. Purchase enough business income coverage to cover at least this amount of revenue.)
- Extra Income Coverage – Reimburses your company for a reasonable sum of money that it spends, over and above normal operating expenses, to avoid having to shut down during the restoration period.
In order to calculate how much extra expense coverage you will need, an appraisal of your office building or any other operating locations should be made as well as a detailed inventory, not only of your product stock but also of your existing office equipment.
- Contingent business interruption insurance – Protects a businessowner’s earnings following physical loss or damage to the property of the insured’s suppliers or customers, as opposed to its own property. Companies today are heavily dependent on raw materials from key suppliers to make the products they sell. What happens if the supplier suffers a loss and cannot continue to deliver the product?
Make sure to determine how much revenue would be lost if you were unable to receive your product from your main supplier or if your main customers were unable to buy from you.
4. Do I have enough insurance to protect my assets from a lawsuit?
The only way to protect your assets is to carry adequate business liability insurance. A Commercial
General Liability (CGL) insurance policy is the first line of defense against many common claims. CGL policies cover claims in four basic categories of business liability:
- Bodily injury
- Property damage
- Personal injury (including slander or libel)
- Advertising injury
In addition to covering the claims listed above, Commercial General Liability policies also cover the cost to defend or settle claims.
For more information on how to properly insure your business, access the Insurance Information Institute’s Web site at www.iii.org
INSURANCE INFORMATION INSTITUTE
Contact: Press Offices
New York: 212-346-5500; media@iii.org
Washington, D.C.: 202-833-1580
Wipro Launches ”Upgrade-in-a-lab” Model to Save around 30% Cost of PeopleSoft Upgrade
BANGALORE, India, Feb 19, 2008 — Wipro Technologies, the global IT services business of Wipro Limited (NYSE:WIT), today announced that its EAS business unit has engaged with its key clients to upgrade their enterprise application environment using Wipro’s proprietary “Upgrade-in-a-lab” model, which could pave the way for the next version of global delivery in the enterprise application space.
Wipro’s innovative “Upgrade-in-a-lab” model allows complete customization and retrofitting to be done remotely, resulting in approximately 30% reduction in cost. Leveraging this unique model, Wipro is helping Analogic, a leader in North America for the design and manufacture of high-performance medical and security imaging systems, to successfully upgrade to the latest PeopleSoft 9.0 version from the currently deployed PeopleSoft 7.53 version.
The key highlights of this unique model are that it cuts down the upgrade cost by approximately 30% over the traditional model and provides approximately 60% overhead reduction (infrastructure usage, reduction in involvement of customer teams, etc.), resulting in a higher ROI from their enterprise apps upgrade initiatives.
Commenting on the success of this model, Thor Wallace, VP & CIO of Analogic, said, “We are glad that we chose Wipro as our IT partner. Their in-depth process knowledge and the innovative and cost-effective ‘Upgrade-in-lab’ delivery model are key factors in our upgrade initiative. ‘Upgrade-in-lab’ is not only helping us meet our aggressive upgrade schedule; it will also save us approximately 30% over a traditional offshore upgrade approach.”
Raja Ukil, head of PeopleSoft practice for Wipro Technologies, said, “Wipro is continuously developing innovative solutions to help drive non-linearity for our clients. The benefits accrued to our customers from ‘Upgrade-in-a-lab’ validate our efforts.”
Wipro is offering is also this “Upgrade-in-a-lab” delivery model for upgrade of Siebel and JD Edwards instances.
About Wipro
Wipro Technologies, a division of Wipro Limited (NYSE:WIT – News) is the first PCMM Level 5 and SEI CMM Level 5 certified global IT services organization. Wipro Technologies was recently assessed at Level 5 for CMMI V 1.2 across offshore and onsite development centers. Wipro is one of the largest product engineering and support service providers worldwide. Wipro provides comprehensive research and development services, IT solutions and services, including systems integration, information systems outsourcing, package implementation, software application development, and maintenance services to corporations globally.
In the Indian market, Wipro is a leader in providing IT solutions and services for the corporate segment in India, offering system integration, network integration, software solutions and IT services.
Wipro also has a profitable presence in niche market segments of consumer products and lighting. In the Asia-Pacific and Middle East markets, Wipro provides IT solutions and services for global corporations. Wipro’s ADS’ are listed on the New York Stock Exchange, and its equity shares are listed in India on the Stock Exchange — Mumbai, and the National Stock Exchange. For more information, please visit our websites at www.wipro.com and www.wiprocorporate.com.
Forward-looking and Cautionary Statements
Certain statements in this release concerning our future growth prospects are forward-looking statements, which involve a number of risks, and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding fluctuations in our earnings, revenue and profits, our ability to generate and manage growth, intense competition in IT services, our ability to maintain our cost advantage, wage increases in India, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, restrictions on immigration, our ability to manage our international operations, reduced demand for technology in our key focus areas, disruptions in telecommunication networks, our ability to successfully complete and integrate potential acquisitions, liability for damages on our service contracts, the success of the companies in which we make strategic investments, withdrawal of fiscal governmental incentives, political instability, war, legal restrictions on raising capital or acquiring companies outside India, unauthorized use of our intellectual property, and general economic conditions affecting our business and industry. Additional risks that could affect our future operating results are more fully described in our filings with the United States Securities and Exchange Commission. These filings are available at www.sec.gov. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in the company’s filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statement that may be made from time to time by us or on our behalf.
Contact:
Wipro Technologies
Radhika Mahadevan, +91-9945042606 (India)
radhika.mahadevan@wipro.com
Abhishek Mendiratta, + 1 732 789 8646 (US)
abhishek.mendiratta@wipro.com
Rahul Kadavakolu, +44 792 020 5496 (UK)
rahul.kadavakolu@wipro.com
or
Gutenberg Communications
Sonali Madbhavi, +91 9844042850 (India)
sonali@gutenbergpr.com
Shalini Siromani, +44.79.6066.3200 (UK)
shalini@gutenbergpr.com
Lavanya DJ, +212-239-8740 (US)
lavanya@gutenbergpr.com
Source: Wipro Technologies
Sprint Family Locator now available on all Web-enabled Sprint phones
Filed under: Americas, Communications, Internet, Mobile, People, Telecom
OVERLAND PARK, Kansas, USA–Sprint today announced access to its popular Sprint Family Locator service is available on all Web-enabled Sprint phones, an industry first. Parents on the go now can use any Web-enabled Sprint phone to locate their loved ones with Sprint Family Locator. In addition, more than 100 Sprint phones can be located by the service, including all currently available Sprint phones.
“Sprint has always been proud to offer Sprint Family Locator on a wider range of phones than similar services from competitors, and now we’ve expanded it even further so customers have more choice for themselves and their children,” said Kevin Packingham, vice president of wireless data for Sprint. “By offering the most open wireless family locator service with the fewest device and plan limitations, we’re allowing more families to take advantage of this valuable tool. Our customers are telling us that this is a life-saving service that can be used not only for children, but also for elderly relatives, or even just to find a lost phone.”
Launched in April 2006, Sprint Family Locator is the industry’s first family location service that enables families on the go to locate one another using GPS technology. Parents can login on their phone or a PC to locate a child on an interactive map, even when the child is using their phone to make a call or send a text. The service also gives the address, surrounding landmarks and accuracy of the child’s location within a specified radius, along with the ability to click to call or send a text to the child directly from the service. Additionally, the service enables a parent to set Safety ChecksSM at certain landmarks such as a school, home, or relative’s house, at specified times. The parent is automatically notified whether the loved one is near the specified landmark at the set time, providing “hands-off” peace of mind. Sprint Family Locator is available for $9.99 per month. Unlimited location requests for up to four phones and access to the service from a PC and any Web-enabled Sprint phone are included in the monthly charge. For more information or to sign up for and purchase service, customers can visit www.sprint.com/familylocator.
To access Sprint Family Locator on any Web-enabled Sprint phone, customers should go to the Menu on their phone, click on the Web icon and type http://SFL.sprint.com/m in the address bar. Existing customers can then enter their login information.
Casual data charges apply to customers without a Sprint data plan. Sprint Family Locator is just one of a variety of tools offered by Sprint to help parents manage their children’s phone usage and view safety information. Sprint is committed to continually enhancing and expanding these tools to meet family needs. Sprint has the longest history of providing location-based services in the wireless industry, beginning with the first location and mobility services in 2000; the first GPS-enabled phone to support E911 services in 2001; the first navigation service on wireless phones with turn-by-turn driving directions in 2003; and the first family location service in 2006. Sprint received the Frost & Sullivan Mobility Award for Location-based Services Company of the Year in 2005, 2006 and 2007.
Sprint offers more than 20 consumer GPS applications, including Sprint Navigation, Sprint Family Locator, local search, real estate, shopping and fitness services. About Sprint Nextel Sprint Nextel offers a comprehensive range of wireless and wireline communications services bringing the freedom of mobility to consumers, businesses and government users. Sprint Nextel is widely recognized for developing, engineering and deploying innovative technologies, including two robust wireless networks serving approximately 54 million customers at the end of 2007; industry-leading mobile data services; instant national and international push-to-talk capabilities; and a global Tier 1 Internet backbone. For more information, visit www.sprint.com.
Recommended
