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FDA Licenses Sanofi Pasteur’s New Pediatric Combination Vaccine, Pentacel®

- Pentacel® vaccine is the first 5-in-1 pediatric combination for immunization against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib) -    Swiftwater, PA - Lyon, France - June 23, 2008 - Sanofi Pasteur, the vaccines division of the sanofiaventis Group, announced that the U.S. Food and Drug Administration (FDA) has licensed Pentacel®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine. Pentacel® vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b (Hib). Pentacel® vaccine is approved for use in infants and children 6 weeks through 4 years of age (prior to fifth birthday). Pentacel® vaccine is the first and only four-dose diphtheria, tetanus, and acellular pertussis (DTaP)- based combination vaccine for use in infants and young children in the U.S. that includes both poliovirus and Hib antigens.   Pentacel® vaccine is approved for administration as a four-dose series at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6 weeks of age. According to the current Recommended Childhood Immunization Schedule of the U.S. Centers for Disease Control and Prevention (CDC), up to 23 injections are needed by the time a child reaches 18 months of age with single-entity vaccines. The use of Pentacel® vaccine could reduce that number of shots by seven.   “Pentacel® vaccine will help simplify the immunization schedule by reducing the number of injections infants and young children will receive in their first two years of life,” said Wayne Pisano, President and Chief Executive Officer, sanofi pasteur. Pentacel® vaccine has been used in Canada for a decade and is licensed in seven other countries. “We are pleased that the U.S. FDA has now taken this important step, to make the convenience of Pentacel® vaccine available to health-care providers and parents in the U.S.,” Pisano added.   “The FDA approval of Pentacel® vaccine is great news for parents and pediatricians who want to reduce the stress of well-baby visits,” said Tina Q. Tan, M.D., infectious disease specialist, Children’s Memorial Hospital, Chicago. “Pertussis disease continues to remain a threat to young infants, who are at the highest risk for severe complications and death. With a four-dose primary series of Pentacel® vaccine, pediatricians can reduce the number of vaccination shots while providing protection against five diseases, including pertussis.”   Pentacel® vaccine is also the first five-component (pentavalent) pediatric combination vaccine in the U.S. to contain sanofi pasteur’s five acellular pertussis antigens, which are also used in its DTaP vaccine for children (DAPTACEL®a vaccine, licensed in 2002) and its tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for adults and adolescents (Adacel®b vaccine, licensed in 2005). Pertussis is commonly known as whooping cough because of the sound some patients—especially children—make while gasping for air during coughing spells.   The FDA licensure of Pentacel® vaccine is based on the results of multi-center clinical studies conducted in the U.S. and Canada involving more than 5,000 children who received at least one dose of Pentacel® vaccine. The immunogenicity of Pentacel® vaccine was compared to separately administered DAPTACEL, IPOL®c and ActHIB®d vaccines (studies P3T06 and M5A10), as well as to other single-entity vaccine formulations (study 494-01). The safety of Pentacel® vaccine was compared both to separately administered DAPTACEL, IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine formulations (study 494-01).   In clinical studies, local and systemic reactions following administration of Pentacel® vaccine were reported at rates consistent with those of the separately administered vaccines used in each trial. The most common local and systemic adverse reactions to Pentacel® vaccine include injection site redness, swelling and tenderness; fever, fussiness and crying. Other adverse reactions may occur.   Known systemic hypersensitivity reaction to any component of Pentacel® vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination.   The decision to give Pentacel® vaccine should be based on the potential benefits and risks; if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel® vaccine may not protect all individuals.   Before administering Pentacel® vaccine, please see accompanying full Prescribing Information. The full Prescribing Information for Pentacel® vaccine is available on www.pentacel.com  and www.vaccineshoppe.com .   More than 14 million doses of Pentacel® vaccine have been distributed in Canada since 1997. Pentacel® vaccine is expected to be available for distribution in the U.S. this summer. Sanofi Pasteur’s U.S. operations in Swiftwater, PA have long been committed to providing vaccines to prevent childhood diseases. In 1987, it licensed the first Hib conjugate vaccine. And in 1996, it was the first company to license a DTaP vaccine for use in infants (TripediaÒe vaccine).   In 2005, sanofi pasteur continued its tradition of innovation by introducing MenactraÒf vaccine to protect against meningococcal disease, and Adacel vaccine as a booster dose for protection against tetanus, diphtheria and pertussis in both adults and adolescents 11-64 years of age.   About Sanofi-aventis Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone.  Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2007, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, sanofi pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR1 million in research and development. For more information, please visit: www.sanofipasteur.com  or www.sanofipasteur.us .   Source: Sanofi-aventis Press Release

Extavia Approved in European Union for Treatment of Multiple Sclerosis, First in Planned Portfolio of Therapies from Novartis

--Extavia is Novartis brand for interferon beta-1b - an established therapy with more than 700,000 patient-years' experience to date[1]--   --Launch of Extavia for early and relapsing forms of multiple sclerosis (MS) planned for US and Europe in first half of 2009--   --Novartis committed to MS through extensive research and development programs, including novel oral therapy FTY720 currently in Phase III--   --MS, a devastating disease causing progressive disability, affects an estimated 2.5 million people worldwide, including many young adults[2]--   Basel, May 26, 2008 - The European Commission has approved Extavia® (interferon beta-1b) for the treatment of early and relapsing forms of multiple sclerosis (MS) - the first in a new portfolio of medicines from Novartis that is planned to include both established treatments and innovative therapies for patients with MS.   Extavia is the Novartis branded version of interferon beta-1b, a first-line disease-modifying therapy injected every other day for the treatment of MS. Interferon beta-1b has been available globally for more than 13 years and is supported by more than 700,000 patient-years of experience[1].   Formerly known as NVF233, Extavia is the same medicine as Betaferon®/Betaseron®, which is marketed by Bayer-Schering and was the first beta interferon treatment for MS. Novartis gained rights to its own branded version of this medicine in agreements with Bayer-Schering related to the acquisition of Chiron.   "Novartis is committed to MS and to providing effective treatments for patients with this disease," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "The approval of Extavia means we are able to offer the MS community a current standard of care while preparing for the introduction of innovative therapies such as FTY720."   Novartis also recently filed for approval of interferon beta-1b with the US Food and Drug Administration. Launches in the US and EU are planned for the first half of 2009, in line with an agreement with Bayer-Schering that established the opportunity for Novartis to introduce its own branded version of interferon beta-1b.   By the end of 2009, Novartis also plans to file for approval of the innovative oral therapy FTY720 (fingolimod). Results of an ongoing Phase II study extension presented in April show sustained benefits in patients with relapsing MS after three years of treatment with FTY720. Data showed that 68-73% of patients in the study remained free from relapses after three years' continuous treatment[3].   A number of other compounds for treating MS are also in early stage development by Novartis.   Multiple sclerosis is the most common disorder of the central nervous system in young adults. It is a progressive and debilitating disorder caused by the destruction of myelin, which helps neurons carry electrical signals in the brain. MS causes problems with muscle control and strength, vision, balance, sensation and cognitive function2. MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (or "relapses") followed by complete or partial restoration of functions[4].   In the EU, Extavia is approved for patients with relapsing-remitting MS, the most common form of the disease involving relapses followed by complete or partial restoration of function, and for a steadily worsening form of the disease known as secondary progressive MS with relapses. In addition, Extavia is approved to treat patients with early MS who:         --Have experienced a single episode involving loss of myelin (or "demyelinating event")  --Have an active inflammatory process that is severe enough to need treatment with intravenous corticosteroids, if alternative diagnoses have been excluded r--Are at high risk of developing clinically definite MS.   About Novartis Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.   References [1] Data on file. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2007. [2] Multiple Sclerosis International Federation at www.msif.org Accessed 15 May 2008. [3] Comi G et al. Oral FTY720 (fingolimod) in patients with relapsing multiple sclerosis. 3-year extension shows sustained low relapse rate and MRI activity. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago, 12-19 April 2008. [4] National Multiple Sclerosis Society at www.nationalmssociety.org, Accessed 15 May 2008.   Source: Novartis Press Release

Ortho-Clinical Diagnostics Receives FDA Approval for New HIV Test Assay Can Help Laboratories Meet New CDC HIV Testing Guidelines

Raritan, NJ (March 28, 2008) – Ortho-Clinical Diagnostics announced U.S. Food and Drug Administration approval of a new diagnostic assay for the detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti HIV-1 and anti HIV-2). The new VITROS® Anti-HIV 1+2 assay1 can be run in a fully automated, random access format on the VITROS ECi/ECiQ Immunodiagnostic System, with results readily available in less than 50 minutes. This FDA approval and availability to laboratories in the U.S., Puerto Rico and U.S. territories marks the first anti-HIV 1+2 test capable of being run in full random access with other tests and providing immediate result reporting capability upon test completion. VITROS Anti-HIV 1+2 tests can be run at any time, in any order and with other types of tests. The features of automation and random access can increase productivity and efficiency in the laboratory.   The VITROS Anti-HIV 1+2 assay can help meet the demand on laboratories created by new U.S. Centers for Disease Control and Prevention (CDC) testing recommendations. The CDC now recommends routine, voluntary HIV testing in all health care settings, including health clinics and emergency rooms, for all individuals ages 13 to 64 without written informed consent. In addition, testing is recommended at least once a year for those at high risk.2   By latest estimates, approximately 1,039,000 to 1,185,000 people in the United States are living with HIV/AIDS, with 24 to 27 percent undiagnosed and unaware of their HIV infection.3 Costs associated with unrecognized or late-recognized HIV infection are growing.   Two multicenter research teams supported in part by the National Institute on Drug Abuse, National Institutes of Health, have independently determined through the development of computer models that routine screening for HIV in health care settings is as cost effective as screening for other conditions such as breast cancer and high blood pressure, and can provide important health and survival benefits. The studies also suggest that screening that leads to a diagnosis of HIV infection may further lower health care costs by preventing high-risk practices and decreasing virus transmission.4   The VITROS Anti-HIV 1+2 Assay has been co-developed with Chiron, a business of Novartis Vaccines and Diagnostics Inc.   About the VITROS ECi/ECiQ Immunodiagnostic System  The VITROS ECi/ECiQ Immunodiagnostic System is a simple to use, flexible and fully automated laboratory testing system that provides true continuous, STAT, random access capabilities for routine and specialty immunodiagnostic testing. The system uses proprietary enhanced chemiluminescence detection technology to provide excellent assay performance including wide dynamic ranges and exceptional precision and sensitivity. The VITROS ECi/ECiQ Immunodiagnostic System also uses Intellicheck® Technology, a proprietary technology designed to verify diagnostic checks throughout automated sample and assay processing. Intellicheck serves to increase the integrity and security of reported patient results while helping to ensure greater confidence and productivity for laboratories that generate these results.   The expanding VITROS ECi/ECiQ Immunodiagnostic System test menu now includes more than 45 tests worldwide for the sensitive measurement of thyroid function, reproductive health and fertility, bone metabolism, anemia, metabolic, oncology, emergency cardiology, and infectious diseases.   About Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the company brings products to market that provide timely information and help to facilitate medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world’s blood supply. In addition, through its VITROS MicroSlide and enhanced chemiluminescence technologies, the company has transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions and services that promote effective diagnoses and enhance patient care. For more information, visit www.orthoclinical.com.   1 Refer to the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack and VITROS Products Anti-HIV 1+2 Calibrators Instructions for Use for Warnings and Limitations   2 CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006; 55 (No. RR-14):1-17.   3 Glynn M, Rhodes P. Estimated HIV prevalence in the United States at the end of 2003. National HIV Prevention Conference; June 2005; Atlanta. Abstract 595.   4 http://www.drugabuse.gov/newsroom/05/NR2-09.html   Source: J&J Press Release   Share your Favorite Biotech/Pharma/Medicine/Clinical Trials articles on Your Helix!-Professional Networking Site Designed for Biotech/Pharma Community:

Sanofi-aventis’ SoloSTAR® Disposable Insulin Injection Pen for Diabetes Patients Receives the Prestigious GOOD DESIGN Award   February 2008. The Chicago Athenaeum Museum of Architecture and Design has awarded a 2007 GOOD DESIGN™ Award for the new SoloSTAR® disposable insulin injection pen for people with type 1 and type 2 diabetes.   “LANTUS®  SoloSTAR® and APIDRA® SoloSTAR®, the results of over four years of intensive development, have been designed in dialogue with patients, nurses and doctors and meet the high standards of the industry,” said Paul Jansen, Global Head Medical Devices, Sanofi-aventis.    For some people with diabetes, self-injection can be a barrier to acceptance of insulin therapy. “SoloSTAR® is a marriage of sleek, handsome design styling with easy, but advanced sophisticated technology for dispensing insulin to people with diabetes,” says Christian K. Narkiewicz-Laine, President Chicago Athenaeum Museum of Architecture and Design.   “SoloSTAR® represents a design for social good and for humanitarian concerns”.   When choosing a specific insulin pen for an individual patient, clinicians consider the patient's insulin regimen, lifestyle, and other factors that may affect the ability to use a particular device, such as manual dexterity and visual acuity. Therefore certain characteristics of a given insulin pen may make it preferable for patients. The outstanding design of SoloSTAR® using breakthrough technology contributes to making this patients’ and clinicians’ choice easier.   SoloSTAR® provides a delivery option that may be more acceptable and more convenient to use in comparison with other delivery systems, thus may promote patient compliance, which could help achieve and maintain glycemic control.   A recent survey of LANTUS® SoloSTAR® use in everyday clinical practice, involving more than 2000 people with diabetes (16% with manual dexterity problems and 15% with poor eyesight not corrected by glasses) showed that more than 95% of participants declared to be “satisfied” or “very satisfied” with using SoloSTAR® to inject insulin, irrespective of diabetes type or previous device experience.   Healthcare professionals involved in teaching the people in this survey how to use LANTUS® SoloSTAR® found SoloSTAR® to be easy learn and easy to use for people with diabetes. SoloSTAR® also operates with a lower injection force and a recent study found that SoloSTAR® required 31% less injection force than the Novo Nordisk FlexPen® and 54% less force than the Eli Lilly Humulin/Humalog pen. “Insulin injection with SoloSTAR® brings flexibility, satisfaction for the patients, and an opportunity for earlier initiation of insulin therapy which may contribute to better long term glycaemic control”, Denis Raccah, Professor of Endocrinology, University Hospital Sainte Marguerite, France, added.   About SoloSTAR® SoloSTAR® is a new, easy-to-use disposable pen for administration of LANTUS® and APIDRA®. SoloSTAR®, allows to administer doses from 1 up to 80 units, in one unit increments, in one injection. SoloSTAR offers a 25% greater maximum capacity than other insulin pens. Consequently, the administration until 80 units of insulin can be done with only one injection. SoloSTAR uses a simple, intuitive design with easy-to-read display featured and requires only a few steps to use it properly. SoloSTAR® is small, discreet and eliminates the need for the patient to change insulin cartridges. Easy-to-use and easy-to-inject, SoloSTAR® reduces the injection force by 30% or more in comparison to other most broadly available pens in its class.   Lantus® SoloSTAR® and APIDRA® SoloSTAR® were approved by the EMEA in September 2006; LANTUS® SoloSTAR® was approved by the FDA in April 2007. LANTUS® SoloSTAR® and APIDRA® SoloSTAR® are launched in France, UK, Italy, Spain, Germany, Netherlands, Slovakia, Slovenia, Sweden, Norway, Austria, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Australia, Lithuania, Lebanon, and South Africa. LANTUS® SoloSTAR® is launched in the US, Canada and Switzerland. The preparation for launches in other countries is planned during 2008.   The elegant exterior design of Lantus® and Apidra® SoloSTAR® and its ease of use due to advanced technology is the result of the collaboration with DCA Design International Ltd. in Great Britain DCA Company.   About Sanofi-aventis’ pen portfolio Sanofi-aventis having 85 years of innovation in the diabetes is committed to offering people with diabetes an integrated system of insulin products and delivery devices. In addition to the SoloSTAR®, the pen portfolio available for LANTUS® and APIDRA® includes the OptiSet® disposable pen, the OptiClik® and OptiPen® Pro reusable pens, and the Autopen® 24 from Owen Mumford.   About LANTUS® (insulin glargine [rDNA origin]) LANTUS® is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and pediatric patients (6 years of age and older) with type 1 diabetes mellitus. LANTUS® demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours.   About APIDRA® (insulin glulisine [rDNA origin]) APIDRA® is a rapid-acting insulin analog with a unique zinc-free molecular structure that maintains a rapid onset and a short duration of action, indicated for adult patients with type 1 and type 2 diabetes. APIDRA® offers patients mealtime dosing flexibility—it can be taken 15 minutes before or within 20 minutes after starting a meal. APIDRA® is also flexible for use in patients with a variety of body types, from lean to obese.   About Diabetes Diabetes is a chronic, evaluative widespread disease in which the body reduces or does not produce or properly use insulin – the hormone needed to convert glucose (sugar) into energy. More than 240 million people worldwide are living with the disease. It is estimated that near 250 million people worldwide have diabetes, the number is expected to reach some 380 million within 20 years.   It is estimated more than 20 million Americans have diabetes, including an estimated 6.2 million who remain undiagnosed. At the same time, approximately half of those diagnosed are not achieving the general blood sugar control standard of A1C <7% recommended by the American Diabetes Association and the European Association for the Study of Diabetes (ADA/EASD). The A1C test reflects average blood glucose levels over a two- to three-month period.   Without proper insulin production and action, glucose remains in the blood, leading to chronic hyperglycaemia (raised blood sugar). This can result in short and long-term complications, many of which, if not prevented and left untreated, can be fatal. All have the potential to reduce the quality of life of people with diabetes and their families. The most common long-term complications are: - Diabetic nephropathy (kidney disease), which may result in total kidney failure and in the need for dialysis or kidney transplant. - Diabetic eye disease (retinopathy and macular oedema), damage to the retina of the eye which can lead to vision loss. - Diabetic neuropathy (nerve disease), which can ultimately lead to ulceration and amputation of the feet and lower limbs. - Cardiovascular disease, which affects the heart and blood vessels and may cause fatal - complications such as coronary heart disease (leading to a heart attack) and stroke.   Diabetes is the fourth leading cause of death by disease globally. Every year, 3.8 million people die from diabetes-related causes.   About GOOD DESIGN The Museum’s historic GOOD DESIGN program was founded in Chicago in 1950 by Edgar J.Kaufmann, Jr. with the participation of some of America’s most important designers. Every year the jury meets in New York and select products and graphics worthy of the GOOD DESIGN Award for design distinction. GOOD DESIGN remains the oldest and most important Awards program worldwide.   About Sanofi-aventis Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone.   References: For easy to inject Owens DR. Comparison of insulin pen devices reveals lower injection force of Solostar® compared with novo Flexpen® and lilly® disposable pen; Diabetes Technology Meeting 25–17 October 2007, San Francisco, CA, USA. Journal of Diabetes Science and Technology, March 2008; Abstract OWEN70184; In press.   Clarke A, Spollett G. Dose accuracy and injection force dynamics of a novel disposable insulin pen. Expert Opin. Drug Deliv. (2007) 4(2):165-174.   For easy to use and patient’s satisfaction Carter J et al. Usability, participant acceptance and safety of SoloStar in an observational survey in everyday clinical practice; Diabetes Technology Meeting 25–17 October 2007, San Francisco, CA, USA. Journal of Diabetes Science and Technology, March 2008; Abstract CART70119; In press.     Source: Sanofi-Aventis Press Release   Share your Favorite articles on the following Social Networks: Share on Facebook

Affymetrix Launches World's Most Comprehensive Solution for Clinical Drug Metabolism Studies for Pharmaceutical Research   --Drug Metabolizing Enzymes and Transporters (DMET) Early Access Solution Enables Pharmaceutical Researchers to Assess all Clinically Relevant ADME Markers in a Single Assay--   SANTA CLARA, Calif-Jan. 24, 2008--Affymetrix Inc. announced the availability of its Drug Metabolizing Enzymes and Transporters (DMET) Early Access solution, currently the world's most comprehensive method for assaying the genetics of drug metabolism. The DMET offering profiles more than 1,069 drug metabolism biomarkers, including 172 "core" genetic markers. Data is automatically interpreted into a common format that can be integrated into clinical trial workflows. The information enables researchers to make more informed drug-development decisions, which in turn significantly streamlines the drug-development process and, therefore, time to market.   The DMET solution is available as a service through Affymetrix' South San Francisco Services Laboratory and Cogenics, a subsidiary of Clinical Data. Both providers have been accepting samples since the fourth quarter of 2007, following the successful completion of a six-week training and certification program to ensure that data is complete, accurate and reproducible. Cogenics is offering DMET as a Good Laboratory Practice (GLP)-compliant service from its North Carolina facility, while Affymetrix' South San Francisco facility is running the service strictly for non-GLP research studies. Additional worldwide service providers will be certified and announced in the near future. Affymetrix and Clinical Data announced a joint marketing agreement today in a separate press release.   Pharmaceutical customers are using the DMET solution to better understand pharmacokinetics, the study of the bodily absorption, distribution, metabolism and excretion (ADME) of drugs. DMET is the only product available with comprehensive coverage of all ADME drug metabolism biomarkers, including common and rare variations, insertions, deletions, copy number, triallelic SNPs and pseudogenes. For the first time, scientists are able to assess all clinically relevant ADME markers in a single assay, unlike previously used single-plex approaches.   "Being able to measure a variety of 'core' genetic markers is critical to delivering accurate clinical assays, something the Affymetrix technology is allowing us to achieve. Accurate clinical assays have the ability to deliver improved patient outcomes because the medicines we develop become more directly targeted to the patient's specific needs," said Richard Deane Hockett, senior clinical research physician, group leader for genomic medicine, Department of Diagnostic and Experimental Medicine at Eli Lilly & Co. "We are implementing this technology across the research portfolio in all phases of clinical trials at Lilly."   Regulatory authorities have indicated a renewed interest in surveying drug metabolism biomarkers to ensure safer dosing, which in turn reduces the possibility of adverse events and improves patient safety. Just three months ago, the U.S. Food and Drug Administration (FDA) made history by updating the label on the anticoagulant drug, Warfarin, to include information on CYP2C9 and VKCORC1.   According to a commentary in Clinical Pharmacology and Therapeutics co-authored by the FDA(1), "Pharmacogenomic data can facilitate our understanding of the sources of variability in drug response and can potentially lead to improved safety and efficacy of drug therapy for individual patients. Through various initiatives, the FDA is encouraging drug developers to apply the rapidly evolving pharmacogenomic tools and integrate these data into the evaluation of patient variability."   Michael Caldwell, M.D., Ph.D., director of the Wound Healing Program at Marshfield Clinic, has been using the DMET solution to research the genetics behind an individual's drug response to Warfarin, a drug that if prescribed at the wrong dose can have serious adverse events. "The DMET panel has allowed us to better delineate the stable therapeutic dose of Warfarin for our patients at the initiation of therapy, where risk of complications from the drug are at their highest," said Dr. Caldwell. "Thus our hope is that these studies will enable us to reduce the overall complications of Warfarin therapy by a better prediction of stable therapeutic dose."   The DMET solution features easy-to-use patient consent tracking and data translation software to identify functional variants across the panel and to convert genotyping results into standardized star nomenclature, a convention commonly used in the genetic analyses of clinical trials. The automated analysis takes only a few minutes to complete and provides pharmaceutical researchers performing clinical trials with familiar data that can be easily integrated into existing workflows. Previously, this analysis was a manual and time-consuming task as scientists were required to scour literature for relevant answers.   "DMET Early Access is the result of an ongoing Affymetrix commitment to develop assays that are targeted at clinical drug development," said Maneesh Jain, senior director of marketing at Affymetrix. "We've been fortunate to work with leading pharmaceutical partners and key medical centers to design and develop an assay that's comprehensive for ADME biomarkers and directly provides information with clinical utility."   About Affymetrix Affymetrix GeneChip(R) microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases.   Today, Affymetrix technology is used by the world's top pharmaceutical, diagnostic and biotechnology companies, as well as leading academic, government and not-for-profit research institutes. More than 1,600 systems have been shipped around the world and more than 10,500 peer-reviewed papers have been published using the technology.   Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit: www.affymetrix.com. Share your Favorite articles on the following Social Networks: Share on Facebook

Merck’s  Strategic Plan, Pipeline in Progress and Implementation of a New Model     -Merck's Pipeline Continues to Progress with Seven Products in Phase III Development-   -Company Expects to File Applications for Expanded Indications on GARDASIL and ISENTRESS in 2008-   -Merck Intends to Initiate a Sequenced Phase III Program for Anacetrapib in 2008-   -Successful Early Launches of GARDASIL, JANUVIA, JANUMET and ISENTRESS-   -Reflect Better Alignment of Product Development and Commercialization Efforts; Replicable Model to Reduce Time to Market of New Medicines and Vaccines-   -Company Remains on Track to Deliver Long-Term, Double-Digit Compound Annual EPS Growth from 2005 to 2010, Excluding Certain Items-    Dec. 11, 2007 - Merck & Co., Inc. hosted its Annual Business Briefing and reviewed the progress the Company has achieved under a strategic plan designed to re-engineer the way Merck develops and distributes medicines and vaccines worldwide.  Since 2005, Merck's senior management team has been developing and implementing a new operating model under which customer focus drives drug discovery, development and marketing at the Company, Merck Chairman, President and Chief Executive Officer Richard T. Clark told investors and analysts today at the Merck Annual Business Briefing.   "We are realizing the benefits of the successful execution of our strategy.  We have created a model for success that encompasses every aspect of our business, including R&D, manufacturing and commercialization," Mr. Clark said.  "As a result, Merck has a sustainable business model that will allow us to realize the goals we set for 2010 and to position the Company for future success."   During his presentation, Mr. Clark highlighted some of the goals the Company has met or expects to meet by 2010, including:   * Launched seven new drugs and vaccines in the past two years, many of them first- or best-in-class * Compound annual revenue growth of 4 percent to 6 percent from 2005 to 2010, including 50 percent of all joint-venture revenue * Double-digit compound annual earnings per share (EPS) growth from 2005 to 2010, excluding certain items * Plan to return product gross margin to pre-ZOCOR levels in 2008 * Reduced clinical development cycle times relative to the pharmaceutical sector   "The changes we have made and are continuing to make at Merck are designed to be sustained over the long term.  They represent a true model for success," Mr. Clark said.  "We have not focused only on short-term successes, but we are making the necessary investments to ensure the success of this Company beyond the year 2010."   Merck's Late-Stage Pipeline Continues to Grow Building on the seven U.S. Food and Drug Administration (FDA) approvals Merck has received in the past two years, the Company anticipates regulatory action will be taken in 2008 on two New Drug Applications (NDA) for EMEND for Injection and CORDAPTIVE, the proposed brand name for MK-0524A.  Also in 2008, the Company anticipates making two additional NDA filings with the FDA for MK-0524B, simvastatin combined with laropiprant and extended-release niacin, and MK-0364, taranabant, an investigational medication for the treatment of obesity, said Peter S. Kim, Ph.D., president of Merck Research Laboratories.   Additionally, Dr. Kim said, the Company anticipates making two supplemental filings with the FDA in 2008: one for GARDASIL, Merck's vaccine for the prevention of cervical cancer, for an expanded indication for adult women through age 45, and one for ISENTRESS, a first-in-class integrase inhibitor for the treatment of HIV-1 infection, for an expanded indication for use in treatment-naïve patients.   During his presentation, Dr. Kim also detailed the following seven drug candidates currently in Phase III development:   -MK-0524B is a drug candidate that combines the novel approach to raising HDL-cholesterol (HDL-C) and lowering triglycerides from extended-release niacin combined with laropiprant with the proven benefits of simvastatin in one combination product. The candidate already is in Phase III development, and Merck continues to anticipate filing an NDA for MK-0524B in 2008.   -MK-0364, taranabant, is a highly selective cannabinoid-1 receptor inverse agonist that in early clinical studies has demonstrated weight loss versus placebo. The Company previously announced the initiation of a targeted Phase III program in 2006. Merck anticipates filing an NDA in 2008.   -MK-0974, an investigational oral calcitonin gene-related peptide receptor antagonist, utilizes a new mechanism for the treatment of migraines that has demonstrated efficacy at least comparable to triptans in early clinical studies. The drug candidate entered Phase III development during 2007. The Company anticipates filing an NDA in 2009.   -MK-7418, rolofylline, is a Phase III investigational drug being evaluated for the treatment of acute heart failure. Merck acquired the drug candidate as part of the 2007 acquisition of NovaCardia, Inc. and anticipates filing an NDA with the FDA in 2009. -MK-8669, deforolimus, is a novel mTOR (mammalian target of rapamycin) inhibitor being evaluated for the treatment of cancer. The drug candidate is being jointly developed and commercialized with ARIAD Pharmaceuticals, Inc. under an agreement reached in mid-2007. The Company anticipates filing an NDA in 2010.   -HEPLISAV, a novel investigational hepatitis B vaccine, currently is being evaluated in a Phase III clinical trial in adults and in patients undergoing dialysis treatment. Merck is jointly developing HEPLISAV with Dynavax Technologies Corporation under an agreement reached in late 2007. Merck anticipates filing an NDA in 2010 for adults.   -MK-0822, odanacatib, is a highly selective inhibitor of cathepsin K enzyme, which is being evaluated for the treatment of osteoporosis. The Phase III program began in mid-2007. Merck anticipates filing an NDA with the FDA in 2012.   Dr. Kim also provided an update on the development of MK-0859, anacetrapib, an inhibitor of the cholesterol ester transfer protein (CETP) that in early clinical trials has shown promise in lipid management by raising HDL-C and reducing LDL-cholesterol (LDL-C) without raising blood pressure.   "In clinical studies, inhibition of CETP raises plasma HDL-C levels and decreases LDL-C levels, which represents a potential therapeutic intervention to reduce the risk of coronary artery disease," Dr. Kim said.  "The safety and tolerability profile of anacetrapib was comparable to placebo in clinical studies conducted to date.  In 2008, we plan to initiate a sequenced Phase III program to obtain additional clinical experience in patients before initiating an outcomes study."   As of Dec. 11, 2007, Merck's updated pipeline chart includes 25 distinct candidates in Phase I and 15 in Phase II.  In addition, there are seven candidates currently in Phase III, one submission currently under FDA review, and another that has received an approvable letter and is awaiting further regulatory action.  In its pipeline review, Merck does not include backup candidates; additional indications for candidates in the same therapeutic area; or additional claims, line extensions or formulations for existing products.   New Commercial Model More Effective and Efficient Kenneth C. Frazier, executive vice president and president, Global Human Health, provided an update on the early successes of Merck's ongoing endeavor to align the Company's product research, development and marketing efforts.   In his presentation, Mr. Frazier said that the successful launches and strong global uptake of GARDASIL, JANUVIA and JANUMET are the result of a replicable model that continues to evolve.  He said that the Merck model is not only proving more cost efficient but is allowing Merck to reduce the time it takes to get new medicines and vaccines into markets around the world.   As part of this effort, Merck Global Human Health, aligned with Merck Research Laboratories and Merck Manufacturing, is utilizing the latest technologies and broadening its engagement with customers, physicians and scientific leaders to get needed medicines and vaccines through the development pipeline and to patients sooner, Mr. Frazier said.   The strong sales of Merck's new products, coupled with continued strong growth from in-line products, especially SINGULAIR, should allow Merck to offset the impact of the loss of U.S. marketing exclusivity for FOSAMAX and other products, Mr. Frazier said.  He also said that the Company has achieved a nearly fourfold increase in global vaccine sales since 2005 and remains on track to double sales in emerging markets to $2 billion by 2010.   Merck Reaffirms 2007 and 2008 Financial Guidance During his presentation, Executive Vice President and Chief Financial Officer Peter N. Kellogg reaffirmed Merck's previously disclosed financial outlook for 2007 and 2008.   "With our 2007 and 2008 guidance, it is clear that our products are driving a healthy top line despite lapping the ZOCOR expiry and the upcoming FOSAMAX exposure," Mr. Kellogg said.  "We are very pleased with our results in 2007, and we anticipate continued strong financial performance from our key franchises in 2008.   "As I previously noted on Dec. 4, our financial guidance in 2008 represents the next step in our journey to reach our stated 2010 top- and bottom-line goals.  Despite the loss of marketing exclusivity for FOSAMAX in the United States in February 2008, the Company anticipates solid earnings growth in 2008," Mr. Kellogg added.   He continued, "As we disclosed in 2005, Merck's new and in-line pharmaceutical products and vaccines are expected to drive revenue at a compound annual growth rate of 4 percent to 6 percent from 2005 through 2010, including 50 percent of the revenues from the joint ventures from which Merck derives equity income.  We also expect that we can fully support our expanding pipeline with mid-single-digit compound annual growth in research funding over the same period.  The productivity generated by our ongoing cost management initiatives allows Merck to fully capitalize on the promise of our expanding product portfolio while maintaining marketing and administrative expense at 2006 levels."   About Merck Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.  Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.  The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them.  Merck also publishes unbiased health information as a not-for-profit service.  For more information, visit www.merck.com.   Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995.  These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements.  The forward-looking statements may include statements regarding product development, product potential or financial performance.  No forward-looking statement can be guaranteed, and actual results may differ materially from those projected.  Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.  Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements set forth in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.     Source: Merck Inc.

FDA's New Generic Drug Program-GIVE Q&A with Gary J. Buehler, RPh.,  Director of FDA’s Office of Generic Drugs (OGD)   Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com December 1st, 2007        VIEW VIDEO   Gary J. Buehler, RPh., is Director of the Office of Generic Drugs (OGD) in FDA's Center for Drug Evaluation and Research (CDER). A graduate of Temple University's School of Pharmacy, Mr. Buehler joined FDA in 1986.   Q: What are generic drugs? A: A generic drug is identical to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance, and intended use. Although the active ingredient is chemically the same as the branded counterpart, a generic drug is typically sold at a substantial discount from the branded product price.     Q: If they are the same, why do generic drugs cost less than their brand-name counterparts? A: Creating a drug and conducting clinical trials is expensive. Generic drug makers don't develop a drug from scratch or have to conduct studies to prove safety and effectiveness. As the result, their expenses for bringing generic drugs to market are less. But generic drug makers must show that their product performs in the same way as the brand-name drug.     Q: What is FDA's role regarding generic drugs? A: CDER ensures that both brand-name and generic drugs are safe and effective, and that their health benefits outweigh their known risks. And, just as it does with brand-name drugs, the agency closely inspects generic makers' production sites and assures products approved are manufactured according to regulations regarding good manufacturing practices.   Health professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid manufacturing standards as the brand-name drug.     Q: What is the Generic Initiative for Value and Efficiency (GIVE) program? A: GIVE is an initiative aimed at optimizing OGD's generic drug review process to increase efficiency. The goals of GIVE are to approve higher numbers of applications for generic products and expedite review of applications for which there are few generics available.     Q: What will the benefits of this program be for the average consumer? A: Consumers will have timely access to safer, higher-quality generic drugs. A more efficient regulatory and approval process will maintain FDA's high standards for generic drug products for the public, while increasing the number of available products.     Q: Why is the GIVE program necessary? A: Over the last three to four years, the number of abbreviated new drug applications submitted to our office has increased. This has led to a growing list of pending applications. We've made a number of successful process improvements during this time. In fact, the office approved a record number of applications during the past two years. We approved 510 products in 2006, and approved more than 650 in the fiscal year that just ended.   But the advancement of medical science and the related increasing cost of health care and disease prevention have caused the role of OGD and its review staff to grow. The number of firms producing generic products and the number of products each firm proposes are growing at an unforeseen pace. The improvements we have made serve to unify and enhance the review process to address the growing workload, and to increase the efficiency of our office's review efforts.     Q: How will the goals of GIVE be accomplished? A: GIVE will work by combining our office's various efforts into one harmonized activity to implement process improvements throughout the entire program. The initiative is a review-oriented program that is focused on three main areas:   * Mobilizing staff efforts to increase review productivity. * Optimizing the capacity and capability of all assets within OGD, and leveraging wherever possible resources from other FDA components. * Using every avenue possible to recruit, hire and train reviewers for our critical-need areas.     FOR MORE INFORMATION VISIT Generic Initiative for Value and Efficiency (GIVE) at http://www.fda.gov/oc/initiatives/advance/generics.html

GlaxoSmithKline and Tolerx form Worldwide Collaboration for Development and Commercialization of Novel Medication

---Collaboration focuses on type 1 diabetes and other autoimmune indications---   October 2007. GlaxoSmithKline and Tolerx, Inc. today announced the execution of a worldwide alliance to develop and commercialize otelixizumab (TRX4), a novel humanized anti-CD3 monoclonal antibody that has potential across a broad range of autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes. Otelixizumab has been evaluated in type 1 diabetes in two Phase II studies and in psoriasis in two Phase I studies. In clinical trials, otelixizumab has been shown to preserve the function of insulin-producing beta cells in the pancreas in patients with type 1 diabetes, reducing the amount of administered insulin needed to control blood glucose levels.   Under the terms of the agreement, Tolerx will have responsibility for the Phase III clinical programme for type 1 diabetes in the US up to and including regulatory submission of the biologics license application (BLA). Tolerx has the option to co-promote otelixizumab in type 1 diabetes in the US with GSK, while GSK will have exclusive rights to develop and commercialise otelixizumab in all other indications in the rest of the world. GSK also has the exclusive right to develop the paediatric indication for type 1 diabetes in the US.    As part of the collaboration, Tolerx will receive an upfront payment, equity and advance R&D funding totaling $70 million. In addition, Tolerx may receive up to $155 million in future development costs of otelixizumab in type 1 diabetes. Tolerx may earn up to $350 million in milestone payments, assuming successful development and approvals of otelixizumab for type 1 diabetes and multiple additional indications. Tolerx may also receive up to $175 million in sales milestone payments based on tiered net sales thresholds of otelixizumab. Tolerx will be entitled to receive tiered, double-digit royalty payments on worldwide sales of otelixizumab in all indications. At the time of an initial public offering of Tolerx’s common stock and at the request of Tolerx and certain other conditions, GSKwill invest up to an additional $10 million in Tolerx’s common stock.    Dr. Moncef Slaoui, Chairman of Research and Development at GSK, commented, “Otelixizumab is another welcome addition to GSK’s rapidly expanding biopharmaceuticals pipeline. This is a key area of future growth and investment for GSK and, as a novel treatment for many T cell-mediated diseases, the potential of otelixizumab is significant. Together with Tolerx, who are pioneers in this area of science, we hope to realise the potential of this compound and bring a valuable new treatment option to patients suffering from type 1 diabetes and other autoimmune disorders.”   "GSK brings a wealth of experience, expertise, and global resources to this collaboration. The agreement with GSK enables us to operationally leverage Tolerx’s expertise in therapeutic immune regulation, expand the development of otelixizumab in type 1 diabetes and other indications, and capitalize on GSK’s considerable worldwide development, regulatory, and commercialisation infrastructure and experience,” said Dr. Douglas J. Ringler, President and Chief Executive Officer of Tolerx. “Moreover, it provides the infrastructural support required to advance our goal of being first-to-market with otelixizumab in type 1 diabetes. We anticipate the collaboration will allow the potential of this novel therapy to be fully explored globally, not only for the treatment of patients with type 1 diabetes but also for those with autoimmune disorders for which the current standard of care is inadequate.”   About type 1 diabetes Diabetes (medically known as diabetes mellitus) is the name given to disorders in which the body has difficulty regulating its blood glucose, or blood sugar levels. There are two major types of diabetes: type 1 and type 2. Type 1, also called juvenile diabetes or insulin-dependent diabetes, is a disorder of the body's immune system. In type 1 diabetes, the pancreas produces little or no insulin as a result of the immune system attacking and destroying the insulin-producing beta cells in the pancreas. Therefore, type 1 diabetes patients require frequent administration of insulin therapy each day to control their blood sugar levels.   About otelixizumab Otelixizumab is a monoclonal antibody that binds to a receptor component found on all T cells known as CD3, which is involved in normal T cell signaling. Otelixizumab is designed to block the function of autoreactive T-effector cells that attack the body’s tissues and cause autoimmune disease while inducing a subset of T cells called T-regulatory cells that are thought to protect against T-effector cell damage well after the drug has been eliminated from the body. In a Phase II clinical study of subjects with new-onset type 1 diabetes, otelixizumab demonstrated the potential to preserve the function of insulin-producing beta cells in the pancreas and reduce the amount of administered insulin needed to control blood glucose levels for up to 18 months after only a single six day course of therapy. In the study, residual betacell function was assessed by measuring glucose clamp-induced C-peptide release before and after the administration of glucagon. Otelixizumab administration was associated with transient symptoms of flu-like syndrome and transient Epstein-Barr Virus (EBV) reactivation. Tolerx has completed dose optimisation studies in subjects with type 1 diabetes and psoriasis and has identified a dosing regimen that thus far has significantly reduced or eliminated these side effects while maintaining important biological activity.   About GlaxoSmithKline GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline at www.gsk.com.   About Tolerx To