Wednesday, August 22, 2007

U.S. FDA Approves GE Healthcare’s Newest Mobile Mammography System for Improved Access to Breast Care

GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced that it has received U.S. Food and Drug Administration (FDA) approval for its new mobile mammography product that will improve access to breast cancer screening for millions of women around the world. The mobile Senographe® Essential is built on the company’s Senographe Essential platform, the next-generation of GE’s proven Senographe Full Field Digital Mammography systems.

As medical organizations continue to offer full-field digital mammography in a mobile setting, GE Healthcare’s newest mobile unit will feature the largest digital detector in the mammography market, advanced ergonomic design for the technologist, optimized patient comfort and seamless workflow connectivity. The foundation of the Senographe Essential imaging excellence is GE’s advanced digital detector, which delivers the industry's highest Detective Quantum Efficiency (DQE) - the standard for quantifying digital X-ray image quality - at low doses.

“GE’s goal is to enhance breast care for women worldwide and bring this technology to those who otherwise would not have access to it,” said David Caumartin, general manager of Global Mammography for GE Healthcare. “GE offers customers the broadest portfolio when it comes to breast imaging and the new mobile Essential will be the top of the line mobile product in the market featuring all the proven advantages of our Senographe platform.”

First Mobile Essential in Seattle

A study published in May 2007 by the National Cancer Institute found that use of mammography screening had dropped four percent from 2000 to 2005. In 2005, only 70 percent of women surveyed for the study reported getting an annual mammogram. During the same timeframe, among women 50-64, the group most at risk for breast cancer, screening was down 7 percent, from 79 percent to 72 percent.

According to the American Cancer Society, mammography rates in Washington state are also below the national average. In a 2005-2006 study, only 56.3 percent of women 40-64, who are most at risk for breast cancer, were screened. The national average was 60.5 percent. To combat the low numbers and to improve the overall health of women in the area, Connie Lehman, M.D., Ph.D., director of radiology at the Seattle Cancer Care Alliance and professor and vice chair of radiology, section head of breast imaging, at the University of Washington School of Medicine, will take an active approach toward improving breast cancer screening rates.

Courtesy of a month-long fundraising campaign sponsored by the Seattle Division of Safeway Inc. and supported by its employees and customers along with a corporate grant from the Safeway Foundation to acquire a van for the mobile Essential unit, Lehman will be able to hold breast-screening clinics at locations around the Seattle region. Eventually Lehman will be scheduling visits to cities throughout western Washington.

“Women living in the state of Washington have higher rates of breast cancer compared to the rest of the country,” said Lehman. “And yet, compared to the rest of the country, we also have fewer women receiving regular screening mammography. We have an opportunity with this program to provide more women the opportunity to be screened with the latest technology for early detection of breast cancer. This is our way of removing some of the barriers preventing women from having screening mammograms. We are delighted to partner with GE and Safeway to make a difference for women and their families in our community.”

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

Tuesday, August 14, 2007

GE Healthcare and Sprint Deliver Enhanced Wireless Connectivity to Hospitals Across North America

Uninterrupted communication within a hospital is a requirement for physicians, patients and visitors and is essential to quality care. Sprint (NYSE: S) and GE Healthcare announced today their collaboration to provide in-building wireless communications services to hospitals in North America. Patients, clinicians and hospital visitors will benefit from secure, reliable voice and data communications, supporting an environment conducive to higher levels of patient care.

Historically, the use of mobile phones in hospitals has been limited due to unreliable wireless support and the risk of interference between wireless phones and medical equipment. Using the new combined offering, physicians and caregivers will be able to communicate amongst each other and securely access patient information from almost anywhere in the facility.

The new in-building cellular communications network from GE Healthcare and Sprint’s Custom Network Solution (CNS) team leverages GE’s CARESCAPE™ Enterprise Access™, a single, universal wireless platform powered by MobileAccess, and includes Sprint handsets. This solution will provide hospitals with a comprehensive platform for voice and data communications over secure cellular, Wi-Fi and telemetry infrastructure that requires only one installation. Using the combined offering, clinicians, patients and hospital visitors can communicate more efficiently and with ease.

“Sprint CNS provides scalable coverage and a high-capacity platform for wireless voice and data services on the Sprint National Network and Nextel National Network, enhancing the mobility and productivity of staff at hospitals and other businesses,” says Darlene Braunschweig, vice president of CNS at Sprint. “We are very excited to partner with GE Healthcare to provide differentiated and innovative mobile solutions that are critical for every business. This new solution facilitates constant communication of secure information amongst hospital staff; an aspect very critical to patient care.”

GE CARESCAPE Enterprise Access, built on the MobileAccess technology platform, enables critical patient data to be securely coordinated, managed and distributed without the type of communications failures, interference or interruptions that can be caused by un-integrated systems. It is designed to transparently incorporate new systems and services without the need to install parallel, standalone infrastructures. CARESCAPE Enterprise Access is part of GE Healthcare’s CARESCAPE portfolio, an integrated suite of patient monitoring devices, communications networks and IT systems designed to transform traditional patient monitoring data into clinical intelligence. The CARESCAPE portfolio, released in May 2007, reflects a new approach to patient monitoring that provides clinicians with the opportunity to act earlier in the care process when compared to traditional patient monitoring and communication methods.

“The CARESCAPE portfolio represents our commitment to providing customers with a wide range of products and services that work together to help clinicians improve patient care,” said Munesh Makhija, General Manager of Systems and Wireless for GE Healthcare’s Monitoring Solutions business. “Our agreement with Sprint reflects this commitment. By harnessing the power of in-building cellular communications, hospitals will be able to offer secure, reliable voice and data communications throughout a campus, which can support improved communication and ultimately, patient outcomes.”

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

ABOUT SPRINT NEXTEL

Sprint CNS is a leader in providing enhanced in-building and campus-wide network consulting, integration and fixed mobile convergence solutions. Sprint designs, deploys and maintains wireless networks and mobility solutions that deliver the productivity and efficiency of voice and data communications to virtually anywhere a business and their employees need them. Sprint’s CNS team offers 24/7 technical support and manages all stages of the customer deployment process, from the initial requirements assessment through installation and deployment with consultant-grade methods, procedures and tools. For more information about Sprint CNS, please visit www.sprint.com/cns.

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 54 million customers at the end of the second quarter 2007; industry-leading mobile data services; instant national and international walkie-talkie capabilities; and a global Tier 1 Internet backbone. For more information, visit www.sprint.com.

Invitrogen Launches Breakthrough Media for Human Embryonic Stem Cells

Invitrogen, a provider of essential life science technologies for research, production and diagnostics, and Novocell Inc., a stem cell engineering company, today announced the launch of a new fully-defined, serum- and feeder-free media specifically formulated for the growth and expansion of human embryonic stem cells (hESCs). The product, known as STEMPRO(R) hESC SFM, will be sold by Invitrogen under a licensing agreement with Novocell.
STEMPRO(R) hESC SFM is the first serum- and feeder-free media for hESCs that has been shown to maintain these cells in a genetically normal state. Unlike other defined media, which have been tested only in one or two hESC lines, STEMPRO(R) hESC SFM has been extensively tested and proven to keep the cells pluripotent in a number of lines, including BG01, BG02, BG03, HUES9, H1 and H9. Pluripotency, the ability of hESCs to develop into cells of all three major lineages in the body, is a key characteristic of embryonic stem cells, and one reason they hold such promise for therapeutic uses.

Currently, researchers working with hESCs grow them in serum-containing undefined media using mouse or human embryonic fibroblast feeder cells. These culture methods not only make it difficult to keep cells pluripotent, they are also labor-intensive and lead to challenges in scaling up cell production. Also, the undefined nature of these cultures means scientists have a harder time controlling culture conditions and comparing results from experiment to experiment.

"STEMPRO(R) hESC SFM represents a major breakthrough in the field of embryonic stem cell research," said Joydeep Goswami, Vice President, Stem Cells and Regenerative Medicine. "Researchers today face major challenges when culturing hESCs, including difficulties in maintaining pluripotency, lack of definition in current culture systems and consistency in their experiments. This revolutionary product addresses these challenges and allows for more ideal cell culture conditions to keep hESCs genetically normal and in an undifferentiated state."

"We are pleased to collaborate with Invitrogen in bringing our defined media for hESCs to market," said Alan Lewis, Ph.D., President and CEO of Novocell. "We anticipate this product will accelerate the important work of stem cell research. The commercialization of our defined media is especially motivating for Novocell as we continue to advance and develop our cell therapy for diabetes."

Invitrogen is the premier supplier of tools and reagents for stem cell research. The company offers more than 1,200 products tailored to various parts of the stem cell research workflow for embryonic and adult stem cell populations, including Dynabeads(R) for cell separation; pre-conjugated stem cell antibodies from Molecular Probes; and gold standard media from GIBCO such as KNOCKOUT(TM) Serum Replacement and MesenPRO(TM) RS reduced serum medium for mesenchymal stem cells. The company recently announced the launch of the BG01v/hOG engineered stem cell line, which allows scientists to monitor the pluripotency of hESCs without sacrificing those cells, and the STEMPRO(R) EZPassage(TM) tool for stem cell passaging.

About Invitrogen

Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,300 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About Novocell

Novocell Inc. is a stem cell engineering company with research operations in San Diego, CA, and Athens, GA, dedicated to creating, delivering, and commercializing cell and drug therapies for diabetes and other chronic diseases. Novocell is the first company to efficiently engineer human embryonic stem cells into definitive endoderm, the gatekeeper cells that differentiate into many other cells and tissues of the endoderm lineage. Novocell has three primary technologies: stem cell engineering, cell encapsulation, and drug discovery. The company was founded in 1999, merged with CyThera and BresaGen in 2004 and completed a $25M Series C financing in July 2007. For more information, visit www.novocell.com.

Thursday, August 9, 2007

WuXi PharmaTech Celebrates IPO on NYSE

WuXi PharmaTech, a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today opened for trading on the New York Stock Exchange under the ticker symbol “WX” after its successful IPO in which it raised $185 million.

E-House (China ) Holdings Ltd., a leading provider of real estate services in China , yesterday opened for trading on the New York Stock Exchange under the ticker symbol “EJ” after its successful IPO raised $201 million.

"With the additions of Wuxi PharmaTech and E-House to our growing family of world-class listed companies, the New York Stock Exchange is now privileged to list 40 companies from Greater China," said NYSE Euronext John A. Thain. "We welcome the opportunity to offer Wuxi PharmaTech and E-House access to the U.S. capital marketplace and the world's largest pool of investors, and are committed to growing our partnership with the people and business community of China . NYSE Euronext also looks forward to providing these outstanding companies and their shareholders with the superior service, market quality and brand visibility that come with listing on NYSE Euronext markets."

The combined global market capitalization of the 40 NYSE-listed companies from Greater China listed on the NYSE is $1 trillion (July 31, 2007 ). The NYSE roster of companies from Greater China includes 28 from Mainland China , 7 from Hong Kong and 5 from Taiwan .

To celebrate today’s special occasion, WuXi PharmaTech Chairman and CEO Ge Li, joined by company executives and NYSE Euronext CEO John A. Thain, rang the opening bell.

View listed companies from Mainland China.
View listed companies from Hong Kong.
View listed companies from Taiwan.


About WuXi PharmaTech (NYSE: WX)

Founded in 2000, Shanghai-based WuXi PharmaTech is the leading China-based pharmaceutical and biotechnology R&D outsourcing company. As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical and biotechnology companies a broad and integrated portfolio of laboratory and manufacturing services throughout the drug discovery and development process. WuXi PharmaTech’s services are designed to assist its global partners in shortening the cycle and lowering the cost of drug discovery and development by providing cost-effective and efficient outsourcing solutions that save its customers both time and money. Its operations are grouped into two segments: laboratory services, consisting of discovery chemistry, service biology, analytical, pharmaceutical development and process development services, and manufacturing, focusing on manufacturing of advanced intermediates and active pharmaceutical ingredients for R&D use. In 2006, WuXi PharmaTech provided services to 70 pharmaceutical and biotechnology customers, including nine of the top 10 pharmaceutical companies in the world, as measured by 2006 total revenues.

About E-House (NYSE: EJ)

E-House (China ) Holdings Limited (“E-House”) is a leading real estate services company in China based on scope of services, brand recognition and geographical presence. Since its inception in 2000, E-House has experienced rapid growth and has become the largest real estate agency and consulting services company in China . E-House provides primary real estate agency services, secondary real estate brokerage services and real estate consulting and information services, and has received numerous awards and accolades for its innovation and quality, including “China ’s Best Company” from the National Association of Real Estate Brokerage and Appraisal Companies in 2006. E-House believes it has the largest and most comprehensive real estate database system in China , providing up-to-date and in-depth information covering residential and commercial real estate properties in all major regions in China .

About NYSE Euronext (NYSE: NYX)

NYSE Euronext, a holding company created by the combination of NYSE Group, Inc. and Euronext N.V., commenced trading on April 4, 2007 . NYSE Euronext (NYSE Euronext: NYX) operates the world’s largest and most liquid exchange group and offers the most diverse array of financial products and services. NYSE Euronext, which brings together six cash equities exchanges in five countries and six derivatives exchanges in six countries, is a world leader for listings, trading in cash equities, equity and interest rate derivatives, bonds and the distribution of market data. Representing a combined €21.7/$29.6 trillion total market capitalization of listed companies and average daily trading value of approximately €85/$115 billion (as of April 30, 2007), NYSE Euronext seeks to provide the highest standards of market quality and integrity, innovative products and services to investors, issuers, and all users of its markets.

Wednesday, August 8, 2007

GSK receives decision from FDA on Advair 500/50 for COPD

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).


The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request in more detail and determine next steps, including discussion of data GSK has recently generated on the reduction of exacerbations with the Advair 250/50 strength.


“We are very surprised and disappointed by this FDA decision particularly given the outcome of the FDA advisory committee meeting earlier this year,” said Katharine Knobil, M.D., Vice-President of Respiratory Clinical Development for COPD at GSK. “The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward.”


About Advair in COPD

Advair 250/50 is currently indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. Advair does not replace fast-acting inhalers to treat sudden symptoms. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including fluticasone propionate and Advair Diskus. Patients with COPD often have multiple risk factors for reduced bone mineral density. Advair Diskus may increase this risk, therefore, bone mineral density assessment is recommended prior to starting Advair Diskus and periodically thereafter. Long-term use of inhaled corticosteroids, including Advair Diskus, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered.

For more information about Advair please visit www.gsk-us.com

About GlaxoSmithKline

Advair was developed and is marketed by GlaxoSmithKline, a research based pharmaceutical company and a world leader in respiratory care. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information please visit www.gsk.com.

GSK gives consent under Canada’s Access to Medicines Regime for generic version of HIV/AIDS medicine for use in Rwanda

As part of its broad commitment to improving access to medicines, GlaxoSmithKline today announced it has given consent through Canada’s Access to Medicines Regime to enable a Canadian company (Apotex) to manufacture a generic fixed dose combination (FDC) antiretroviral (ARV), containing two molecules over which GSK has patent rights (zidovudine and lamivudine) for the treatment of HIV/AIDS in Rwanda.


Canada’s Access to Medicines Regime reflects the WTO “31f” agreement of August 2003 and enables the government to authorise the production of certain patented medicines for export. The legislation includes controls which are designed to ensure that these essential medicines reach the patients for whom they are intended and the authorisation to be granted will be subject to these controls. GSK has agreed to waive royalties on the basis that Apotex’s triple combination generic ARV will be supplied on a no profit basis.


Paul Lucas, President and CEO, GSK Canadasaid, “Tackling the AIDS crisis is one of the greatest challenges the world faces. GSK continues to play its part to tackle this crisis through research and development, not-for-profit pricing and ongoing investment in dedicated community programmes. Our decision to allow Apotex to manufacture an FDC containing two GSK molecules is part of this broad commitment. It also shows that Canada’s Access to Medicines Regime operates effectively to enable supply of medicines from Canadaas envisaged under the 31f Agreement.”


About GlaxoSmithKline

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and health-care companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.


GSK has issued eight previously announced voluntary licences to produce generic versions of GSK’s patented HIV/AIDS medicines for patients across Sub-Saharan Africa. In 2006 alone, GSK supplied 86 million tablets of preferentially priced ARVs to developing countries, while over 120 million ARV generic tablets were supplied by companies licensed by GSK.

Monday, August 6, 2007

Survey Indicates Meniett Therapy Is Preferred Treatment, After Diet Modification, for Management of Meniere's Disease

Results of a survey published in the August 2007 issue of Otology & Neurotology indicates that the Meniett® Low Pressure Pulse Generator manufactured by Medtronic, Inc. (NYSE: MDT) is the preferred treatment method after diet modification for patients diagnosed with Ménière's Disease in an only hearing ear. The survey was conducted among a nonrandom sample of clinically active members of the American Otological Society and the American Neurotology Society by researchers from the Division of Otolaryngology – Head and Neck Surgery at Penn State Milton S. Hershey Medical Center.


Dietary modification was recommended as first-line therapy by 99 percent of the survey respondents, including moderate to strict salt restriction, decreased caffeine intake and avoidance of alcohol. A diuretic was also recommended by 96 percent of respondents.

When asked what they would offer if initial treatment failed, respondents chose the Meniett® device first and most frequently over therapies such as intratympanic corticosteroids, endolymphatic sac mastoid shunt, intratympanic gentamicin perfusion and endolymphatic sac vein decompression.

“We agree that the Meniett® makes the most sense as the second-line treatment of choice for this difficult problem. It has demonstrative efficacy and a low-risk profile,” stated Jon Isaacson, M.D., associate professor of Surgery and director of Otology/Neurotology at Penn State Milton S. Hershey Medical Center and co-conductor of the survey.

Approximately 2.6 million people in the United States and Europe1 suffer from Ménière’s disease, a disorder associated with excess fluid in the inner ear. This complex disease is characterized by vertigo in combination with hearing loss, tinnitus (ringing in the ear) and pressure in the ear. The origin is unknown and there is no cure, which makes managing the disease difficult when symptoms are severe. Unpredictable vertigo attacks with nausea and vomiting can be very debilitating, with patients unable to work or perform routine activities.2


About the ENT Business at Medtronic

Located in Jacksonville, Fla., the ENT business at Medtronic (www.MedtronicENT.com) is a leading developer and manufacturer of products to treat diseases of the ear, nose and throat (ENT). Patients seeking additional information about Ménière’s disease and the Meniett device should visit www.meniett.com.


About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

1. Stahle J, Stahle C, Arenberg IK. The incidence of Ménière’s disease. Arch Otolaryngol Head Neck Surg. 1978;104:99-102.

2. Anderson JP and Harris JP. Impact of Ménière’s disease on quality of life. Otol Neurotol. 2001;22:888-894.

Thursday, August 2, 2007

FDA issues second approvable letter for Trexima

GlaxoSmithKline (LSE & NYSE: GSK) and POZEN Inc. (NASDAQ: POZN) today announced that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for Trexima™ (sumatriptan/naproxen sodium). An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S.marketing approval.


In January 2007, POZEN and GSK responded to the FDA’s first approvable letter, submitting additional safety data from clinical trials, data from GSK’s database, and additional in vitro preclinical data. In the second approvable letter, no additional information regarding the cardiovascular safety of Trexima was requested. The companies agreed to conduct a prospective study after approval to evaluate the effects on blood pressure during chronic, intermittent treatment.


The FDA has requested that POZEN further address the Agency’s concern, prior to approval, about the potential implications from one preclinical in vitro chromosomal aberration study (one of four standard genotoxicity assays) in which genotoxicity was seen for the combination of naproxen sodium and sumatriptan, but not with either component alone. None of the other three standard genotoxicity studies (Ames test, mouse lymphoma TK assay, in vivo mouse micronucleus assay) demonstrated any genotoxicity for the combination of naproxen sodium and sumatriptan.


The companies intend to request a meeting with the FDA as quickly as possible to discuss the necessary steps to address the Agency’s concerns.


Trexima was the proposed brand name for the product candidate combining sumatriptan 85 mg, as the succinate salt, formulated with RT Technology™ and naproxen sodium 500 mg in a single tablet. Several new names are under consideration at FDA, but pending a final decision on a new name the product will still be referred to as Trexima.


The FDA had previously determined that Trexima is effective as an acute treatment for migraine headaches. POZEN and GSK will continue to work with the FDA on revisions to the proposed package insert and the proposed trade name.

About Imitrex® (sumatriptan succinate) Tablets

Imitrexis a prescription medication indicated for the acute treatment of migraine in adults. Imitrex should only be used when a clear diagnosis of migraine has been established. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.

About Naproxen sodium

Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox®, Anaprox DS®, Naprelan®, Aleve® and in a number of over-the-counter medications. Naproxen sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendinitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. Naproxen-containing products should not be used by patients who have had allergic reactions to any product containing naproxen, nor in patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasal polyps. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing medications. NSAIDs may cause increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors for cardiovascular disease. Serious gastrointestinal toxicity such as bleeding, ulceration and perforation can occur at any time in patients treated chronically with NSAID therapy and physicians should remain alert for such effects even in the absence of previous GI tract symptoms. Patients who are pregnant or are nursing should consult a physician before use of a naproxen-containing medication.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline's website: www.gsk.com