DrugDiscovery Technologies

Transcription

1 I I Industry xperts I RedefinesBusinessAcumen Biotechnology DrugDiscovery Technologies AGlobalMarketOverview Thereportreviews,analyzesandprojects theglobalmarketfordrugdiscoverytechnologies fortheperiod Published:Aug2014 ReportCode:BT011 Pages:248 Charts:28 Price:Sample 2014 alrightsreserved

2 Drug Discovery Technologies Drug discovery technologies, for the purpose of this study, are broadly categorized as Bioanalytical Assays, Bioinformatics, Cell Based Assays, Genomic Technologies, High Throughput Screening, Proteomic Technologies and Other Technologies. These key technologies are briefly explained below. Bioanalytical Assays Bio-analytical assays are employed in the pharmaceutical industry for pharmacokinetics, pharmacodynamics, toxicokinetics, and bioequivalence. They are used for qualitative and quantitative assessment of biotics (DNA, proteins, macromolecules, metabolites, and large molecule drugs) and xenobiotics (biological molecules in unnatural concentrations, and locations and drugs along with their metabolites) in biological systems. These assays also applied to drugs used for illicit purposes, anti-doping testing in sports, forensic investigations, and environmental concerns. Bio-Analytical Techniques The high potent feature of modern drugs requires sensitive bio-analytical assays to reliably and accurately establish the drugs at lower concentrations. This has led to improvements in analytical and technology methods. The below table illustrates the widely used techniques in Bioanalytical research. Table 1: Prominent Technologies used for Bioanalytical Research Ligand binding assays o Enzyme-linked immunosorbent assay (ELISA) o Radioimmunoassay (RIA) o Magnetic immunoassay (MIA) o Dual polarization interferometry (DPI) Chromatographic methods o Ultra performance liquid chromatography (UPLC) o High performance liquid chromatography (HPLC) o Supercritical fluid chromatography (SFC) o Gas chromatography (GC) Hyphenated techniques o Liquid chromatography diode array detection (LC DAD) o Liquid chromatography mass spectrometry (LC MS) o Capillary electrophoresis mass spectrometry (CE MS) o Gas chromatography mass spectrometry (GC MS) Nuclear magnetic resonance Mass spectrometry Electrophoresis The exact technique used depends on the size of the molecule. Liquid chromatography coupled with tandem mass spectrometry is the most frequently used technique for small molecules, while for macro molecules it is Enzyme-linked immunosorbent assay. -6-

3 KEY MARKET TRENDS Drug Discovery Gets Faster, Smarter and Cheaper A research team comprising scientists from Collaborative Drug Discovery in Burlingame, California, and rate. the University of Medicine and Dentistry of New Jersey, New Jersey Medical School, has developed a technique for identifying potential drugs that can combat tuberculosis (TB) and other diseases without setting foot in the laboratory. This was achieved by training computers for filtering drug libraries in singling out compounds that could possibly benefit TB patients with minimal side effects to humans. The last four decades has witnessed the approval of only one drug for treating TB, a disease responsible for about two million fatalities on an annual basis. The simultaneous testing of thousands of compounds in a process called high-throughput screening (HTS) that uses robots is being utilized in recent years for the identification and testing of potential new drugs. However, the cost involved in HTS runs into millions of dollars, with the process generating very few prospective anti-tb drug leads, among which also several turning out to be toxic for human cells. This brought experts from the fields of cheminformatics and chemistry into play, who put the onus for initial groundwork on computers. Publicly available HTS data for TB was utilized for teaching the computers in grasping which chemical features of a drug are associated with effectiveness against TB and which are associated with toxicity to mammalian cells. The successful training of the computer resulted in its recognizing agents that could destroy TB bacteria in culture, in the process rediscovering a compound reported to have had anti-tb activity four decades ago but overlooked ever since. This work done by the researchers has established that commercially available computer software and published HTS data can be used for the prospective prediction of effective molecules. Picking and choosing a small number of compounds to test in place of sifting through libraries of thousands of molecules are much cheaper options, enabling in the identification of compounds of highest interest at a much faster -25-

4 August 2014 RECENT PATENTS IN DRUG DISCOVERY LANDSCAPE USPTO Issues '979 Patent for Biohaven's Glutamate Modulating Agents to Treat GAD The United States patent and trademark office (USPTO) has issued the US Patent No. 8,778,979 B2 or '979 for Biohaven's glutamate modulating agents. Biohaven Pharmaceutical Holding Company Limited is an affiliate of Portage Biotech Inc. This '979 patent would address the application of definite glutamate modulating agents in treating Generalized Anxiety Disorder (GAD) and would also encompass reliant mechanical claims relating glutamate modulation in GAD. This patent would offer robust intellectual property protection for their lead drug candidate in GAD and mainly, around three years of patent term adjustments would broaden their patent coverage till April This intellectual property protection would enable the company in maximizing the value of a productive drug development program and would also be captivating possible prospective collaborators. Besides this, Biohaven has selective rights to all continuations, divisionals, and continuations-inpart that have been originated from Yale's parent U.S. Patent Application No. 11/399,188 associated with the application of glutamate modulating agents in a variety of neuropsychiatric disorders. Patents Issued for Suven's New Chemical Entities to treat Neurodegenerative Disorders New Chemical Entities (NCEs) from Hyderabad-based Suven Life Sciences Ltd. have received one patent each from Australia and Eurasia to treat neurodegenerative disease disorders. The claims of these patents would cover the class of exclusive 5-HT compounds discovered by the company, which would further be developed as therapeutic agents. These compounds would be used in treating cognitive impairment related to neurodegenerative disorders, including Alzheimer s disease, attention deficient hyperactivity disorder (ADHD), Huntington s disease, Parkinson s and schizophrenia. July 2014 Japan Patent Office Approves Patent for C4XD's Technology Japan Patent Office has approved C4X Discovery's (C4XD) patent associating to a novel method to determine the three-dimensional (3D) structures of dynamic molecules in solution. The patent has also been registered in other leading regions, including the United States and Europe. C4XZD has owned the exclusive global technology, which could yield precise, experimentally-derived dynamic solution 3D structures of drug molecules. This technology could be applied together with the current technologies to design structure-based drug, and could create high impact in particular while protein crystallography would not be accessible in routine, as would be the case for GPCRs and ion channels. According to the company sources, approval of this patent has been a superior acknowledgement to their creative perspective and their exclusive potential for precise determination of the dynamic 3D structures of molecules. Since the company would employ this patented technology for recognizing multiple new agents targeting high-value therapeutic diseases, the company has anticipated for broader development on this core patent position in the future. Acquiring approval for its patent has demonstrated a key succeeding step of the company in establishing and validating the exclusivity of the C4XD approach, and in defending the intellectual property assets of the Company. -39-

5 KEY GLOBAL PLAYERS The United States ABBOTT LABORATORIES 100 Abbott Park Road, Abbott Park, IL , United States Phone: , Fax: Website: Business Overview Abbott Laboratories develops, manufactures, and sells of a wide range of healthcare products. Established in 1888, the Illinois-based company is a leader in molecular diagnostics and developed several unique products that have transformed diagnostics. Abbott pioneered closure technologies and manufactures both clip-based and suture-based closure products for securing the vascular access after peripheral and coronary catheterizations. The company s pediatric nutrition is ranked #1 in the United States. Abbott s clientele includes hospitals, laboratories, healthcare facilities, physicians offices, wholesalers, retailers, and government agencies. Product Portfolio Product Pharmaceutical Diagnostic Nutritional Vascular Vision Technologies Diabetes Care Animal Health Details Generic pharmaceuticals for treating irritable bowel syndrome (biliary spasm), pancreatic exocrine insufficiency, fever, pain, inflammation, gynecological disorders, hypothyroidism, physiological rhythm of the colon, intrahepatic cholestasis or depressive symptoms, hypertension, and dyslipidemia. Influenza and anti-infective vaccines. Diagnostic systems and tests, therapeutic drug monitoring, assays for screening drugs of abuse, cancer, infectious, physiological, and fertility diseases. Hematology reagents and systems. Genomic-based tests. Instrumentation for automatic preparation, extraction, and purification of DNA and RNA from samples. Diagnostic tests and systems for blood analysis. Pediatric and adult nutritional products comprising various formulas. Endovascular, coronary, structural heart, and vessel closure devices for treating vascular diseases. LASIK surgery, cataract surgery, dry eye products, and contact lens care. Blood glucose test strips, monitoring meters, and data management software. Topical tissue adhesives. Balanced anesthesia and osteoarthritis medication. Blood glucose monitoring system calibrated for cats and dogs. Scientifically formulated nutritional products. I.V. fluid therapy to reduce side effects from postoperative medications. -50-

6 GLOBAL MARKET OVERVIEW Global market for drug discovery technologies is, estimated at US$xx.x billion in 2014 and is expected to reach US$xx billion in 2015, projected to touch US$xxx billion by The market is anticipated to grow by a compounded annual growth rate of xx% during the period Chart 1: Global Drug Discovery Technologies Market Analysis ( ) in USD Million Year Market Value 2010 xxxxxxxxxx 2011 xxxxxxxxxx 2012 xxxxxxxxxx 2013 xxxxxxxxxx 2014 xxxxxxxxxx 2015 xxxxxxxxxx 2016 xxxxxxxxxx 2017 xxxxxxxxxx 2018 xxxxxxxxxx 2019 xxxxxxxxxx 2020 xxxxxxxxxx %CAGR xxxxxxxxxx Market Value

7 EUROPE European Market Overview by Technology Though the market for HTS as a drug discovery platform is the largest in Europe, cornering an estimated 2014 share of xx.x% equating to US$x.x billion and forecast to be US$x.x billion in 2015, demand for the same is expected to be the slowest, and would maintain a CAGR of xx.x% between 2010 and 2020 to reach a projected US$x.x billion by At the other end, genomics is anticipated to emerge as the fastest growing drug discovery technology in Europe, the market for which is projected to reach US$x.x billion in 2020, as against an estimated US$x.x billion in 2014 by compounding annually at xx.x% during Other key technology used for drug discovery, Bioanalytical assays, is the second largest technology market in the region estimated at US$x.x billion in Chart 23: European Drug Discovery Technologies Market Analysis ( ) by Discovery Technology Bioanalytical Assays, Bioinformatics, Cell Based Assays, Genomic Technologies, High Throughput Screening, Proteomic Technologies and Other Technologies in USD Million Year Bioanalytical Assays Bioinformatics Cell Based Assays Genomic Technologies HTS Proteomic Technologies 2010 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2011 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2012 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2013 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2014 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2015 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2016 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2017 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2018 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2019 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx 2020 xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx %CAGR xxxxxxxx xxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx Other Bioanalytical Assays Bioinformatics Cell Based Assays Genomic Technologies HTS Proteomic Technologies Other Total -206-