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Drugs in the Pipeline--An R&D AnalysisPublished by: Frost & Sullivan Published: Mar. 25, 2004 Table of Contents1 EXECUTIVE SUMMARY Introduction The Drug Discovery Process Pre-Clinical Studies Overview of Clinical Trials Scope and Methodology Scope and Segmentation Methodology 2 MARKET- AND TECHNOLOGY-BASED ANALYSIS Challenges; Drivers; Restraints Drug Discovery Technology Restraints Drug Discovery Market Restraints Technology and Market Drivers Profiles of Drug Development Industry Partnerships and Collaborations - I Profiles of Drug Development Industry Partnerships and Collaborations - II Profiles of Drug Development Industry Partnerships and Collaborations - III New Technologies and Research Related Impacting Drug Discovery Microdosing Accelerates Early-Phase Drug Development Using Nanotechnology to Enhance the Pharmacological Profile and Extend Exclusivity of Drugs Human Drug Absorption Studies Enhance Candidate Selection Drug Distribution Studies Use Gamma Scintigraphy Advances in Drug Delivery--Injection Technologies; Inhalation Delivery Advances in Drug Delivery--Targeted Delivery; Liposomes; Microencapsulation Advances in Drug Delivery--Polymers; Nanotechnology-MEMS-Microchips Dynamic Combinatorial Chemistry Rationalization of Target Selection 3 DRUGS IN THE PIPELINE FOR THE CARDIOVASCULAR SYSTEM Cardiovascular Therapeutics Research in the Universities Gene Linked to Coronary Artery Disease and Myocardial Infarction Discovered Blood Protein's Link to Heart Disease Corporate Research in Cardiovascular Therapeutics deCODE genetics Finds Heart Attack Risk Gene Hedgehog Gene for Easing Heart Attack Nicotine Boosts Stem Cell Production Celera Finds Heart Attack Marker Drugs in The Pipeline for Cardiovascular Disorders Overview of Cardiovascular Disorders Drugs in the Pipeline for Heart Failure Drugs in the Pipeline for Hypertension Drugs in the Pipeline for Coronary Thrombosis Drugs in the Pipeline for Arrhythmia Drugs in the Pipeline for Deep Vein Thrombosis Drugs in the Pipeline for Ischemic Stroke Drugs in the Pipeline for Coronary Artery Disease Drugs in the Pipeline for Dyslipidemia Drugs in the Pipeline for Angina Drugs in the Pipeline for Myocardial Infarction Adjunctive Therapies 4 DRUGS IN THE PIPELINE FOR THE CENTRAL NERVOUS SYSTEM Corporate Research in CNS Therapeutics AGY Therapeutics Finds Cathepsin B in Alzheimer's BAFF Structure Aids Xencor Anti-TNF Agent Search Nexia Nerve Protection Agent Meets Army Objective Repligen Autism Clinical Does Not Meet Endpoints deCode Begins Study of Autism Genetics Depression/Anxiety Drug Milestone for Neurogen MorphoSys Antibodies Hit Alzheimer’s Brain Target Targacept Finds Alzheimer’s Cell Death Gene University Research in CNS Therapeutics Activated Protein C Protects Brain Cells Pittsburgh Compound Offers a Peep into Alzheimer's Disease Drugs in the Pipeline for CNS Disorders CNS Disorder Overview Drugs in the Pipeline for Alzheimer’s Disease Drugs in the Pipeline for Parkinson’s Disease Drugs in the Pipeline for Schizophrenia Bipolar Disorder Overview Drugs in the Pipeline for Attention Deficit Hyperactivity Disorder (ADHD) Drugs in the Pipeline for Autism Drugs in the Pipeline for Sleep Disorders 5 DRUGS IN THE PIPELINE FOR CANCER Corporate Research in Cancer Cancer Vaccines from Adult Tissue Stem Cells Avi Antisense Drug Boosts Cancer Chemotherapy Genvec Tnf Gene Therapy for Pancreatic Cancer PDL Gets License Fees for Humanized Antibodies Abgenix/Amgen Colorectal Cancer Pivotal Clinical Dendreon Vaccine Extends Prostate Cancer Survival Aphton Asks Australia for First Cancer Agent Ok Genmab Asks for Ok To Start Lymphoma Clinicals How Introgen’s INGN 241 Hits Cancers Lymphoma Therapies Do Well in Clinical Trials Entremed Compound Stabilizes Multiple Myeloma Lymphoma Patients Respond to Genmab Monoclonal Kimmel Center Vaccine is Promising in Mice Enzon Negotiates to Develop a Targeted Cancer Agent Allos Sensitizer Aids Brain Metastasis Radiation AGY Therapeutics Finds Brain Cancer Target Ariad Candidate Reduces Brain Tumor Cell Growth Universities' Research in Cancer Protein Might Contribute to Breast Cancer by Inhibiting Cell Growth Peptide-based Scaffolds as Drug Delivery Vehicles Cancer Drugs in the Pipeline Gastrointestinal Cancer Drugs in the Pipeline Breast Cancer Drugs in the Pipeline Lung Cancer Drugs in the Pipeline Prostate Cancer Drugs in the Pipeline Lymphoma Drugs in the Pipeline Skin Cancer Drugs in the Pipeline 6 PATENTS; COMPANY LISTING; CONTACT DETAILS Some Important Patents Patents Relating to Cardiovascular Therapeutics Patents Relating to CNS Therapeutics Patents Related to Cancer Therapeutics Contacts Companies Universities and Research Institutes 7 FROST & SULLIVAN 2004 SCIENCE AND TECHNOLOGY AWARDS Technology Innovation Award Introduction Award Recipient Excellence in Technology Award Introduction Award Recipient 8 DECISION SUPPORT DATABASE Decision Support Database Pharmaceutical R&D Expenditure (Million USD) Number of Biotechnology Companies by Region Government Investment in Biotechnology Government R&D Investment in Biotechnology as a Percentage of Total Government Healthcare Expenditure Private Investment in Biotechnology (Million USD) Private Investment in Biotechnology as a Percentage of Total Private Healthcare Expenditure Number of European Biotechnology Patents Filed/Granted Number of Neurologists Number of Cardiologists Number of Psychiatric Care Hospital Beds AbstractFunctional Genomics Provides Easy Target Identification and Improved Drug DiscoveryFunctional genomics and proteomics have been quite successful in identifying the function of potential therapeutic targets, such as encoded proteins. In fact, the possible identification of 10,000 novel target antigens in the human genome signals accelerated discovery of new drugs and therapeutic molecules. As opposed to conventional sequence homology, functional genomics adds structure-based predictions to locate gene sequences with assigned and confirmed functions. It simultaneously sifts through well established targets to detect critical therapeutic targets. Such structural information results in enriched annotations that improve the identification process and also provides a clearer understanding of interactions between specific molecules and target proteins. Moreover, functional genomics is likely to bring in a higher level of efficiency to clinical research with the possibilities of genetically demarcating patients and predicting individual responses to drugs. This permits customized medications and dosages for each patient, ultimately improving treatment safety and efficacy in areas such as neuropsychiatry, cardiovascular medicine, endocrinology, and oncology. This Frost & Sullivan research analyzes the drugs in the research and development pipelines for prominent ailments in the cardiovasular, central nervous system, and cancer therapeutic areas. Analysis of the technological trends, drivers, challenges, and recent developments assists in creating effective R&D, marketing and production strategies. The research service also discusses enabling technologies such as nanotechnology, microdosing and drug absorption studies that may be useful in accelerating early phase drug discovery efforts. Participants can identify potential collaborators, stay ahead of the competition, and stay shoulder-to-shoulder with critical developments in their respective therapeutic segments. Increasing Requirement for Target Specificity Challenges Drug Discovery Lead identification proves to be an important component of drug discovery wherein a lead compound or molecule with the potential to treat a disease is located and tested to confirm its effect on the drug target. However, the primary quest in drug discovery is ‘target specificity,’ which goes beyond mere determination of lead compounds. "The more precisely a lead compound interacts with its intended target, the greater its ability to produce the desired therapeutic effect," explains the analyst. "Tissue selectivity and intracellular localization are fast becoming essential criteria in selecting lead compounds for promising therapeutic agents." Demand for Drugs with Reduced Side Effects Challenges Drug Development
"With a wide range of therapeutic options available, the benefit-risk ratio may be the key determinant of a drug's prescription in clinical practice," says the analyst. "The goal is to identify and eliminate potential side effects produced by compounds and develop therapies with the least side effects for a desired action." The urgency to alleviate side effects may be particularly valid in the case of lifetime illnesses such as schizophrenia that require long-term antipsychotic treatment. This has catalyzed research for drugs that lower motor side effects such as tardive dyskinesia. Exciting new developments may be witnessed in breast cancer therapies where long-term chemotherapy necessitates drugs that alleviate harmful side effects from over exposure to radiation. For instance, hematopoietic stem cells that generate new blood cells to replace those killed by chemotherapy are being tested with metastatic breast cancer patients.
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