DOCSLIB.ORG

2016 Annual Results Presentation

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2016 Annual Results Presentation Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 2016 Annual Results Presentation Stock Code : 0460 0 Disclaimer The sole purpose of this Presentation (the “Presentation”) is to assist the recipient in deciding whether it wishes to proceed with a further investigation of Sihuan Pharmaceutical Holdings Group Ltd. (the “Company”) and it is not intended to form the basis of any decision to purchase securities, interests or assets in or of the Company. This Presentation does not constitute or contain an offer or invitation or recommendation or solicitation for the sale or purchase of securities, interests or assets in or of the Company and neither this document nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. Any decision to purchase or subscribe for securities in any offering must be made solely on the basis of the information contained in the prospectus or offering circular issued by the company in connection with such offerings. All the information in this Presentation has been provided by the Company and has not been independently verified. No representation or warranty, express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company or any of its subsidiaries as to the appropriateness, accuracy, completeness or reliability of, this Presentation or any other written or oral information made available to any interested party or its advisers and any liability therefore is hereby expressly disclaimed. And no reliance should be placed on the accuracy, fairness, completeness or correctness of the information contained in this Presentation. This Presentation is only being made available to parties who have signed and returned a confidentiality agreement and recipients are therefore bound by the confidentiality agreement in respect of all information contained herein. This Presentation is strictly private and confidential and must not be copied, reproduced, distributed or passed (directly or indirectly, in whole or in part) to any other person at any time, whether for gain or otherwise, without the prior written consent of the Company. By accepting this Presentation, the recipient has agreed to be bound by the limitations contained herein. This Presentation has been delivered to interested parties for information purposes only and upon the express understanding that such parties will use it only for the purposes set forth above. By accepting this Presentation the recipient has agreed, upon request and at the recipient’s own costs, to return promptly all material received from the Company (including this Presentation) without retaining any copies. In furnishing this Presentation, the Company and its subsidiaries undertake no obligation to provide the recipient with access to any additional information or to update this Presentation or to correct any inaccuracies therein which may become apparent, and reserve the right, without advance notice, to change the procedure for the sale of securities, interests or assets in or assets of the Company or terminate negotiations at any time prior to the signing of any binding agreement for the sale of securities, interests or assets in or of the Company. This Presentation is directed only at persons which are not “U.S. persons”( “U.S. Persons") as defined under Regulation S of the United States Securities Act of 1933, as amended and, in addition, which are lawfully able to receive this document under the laws of the jurisdictions in which they are located or other applicable laws( “relevant persons”). This document must not be acted on or relied on by persons which are not relevant persons. Any investment or investment activity to which this Presentation relates are available only to relevant persons and will be engaged in only with relevant persons. By accepting this Presentation the recipient represents and warrants that (a) it is lawfully able to receive this document under the laws of the jurisdiction in which it is located or other applicable laws; (b) it is not a U.S. Person, (c) this Presentation is furnished to it outside the United States, and (d) it will not reproduce, publish, disclose, redistribute or transmit this Presentation directly or indirectly, into the United States or to any U.S. Person either within or outside of the recipient’s organisation. The distribution of this Presentation may be restricted by law in certain jurisdictions and persons in whose possession this document comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the laws of any such jurisdictions. Any prospective purchaser interested in purchasing securities, interests or assets in or of the Company or evaluating the Company is recommended to seek its own financial and other professional advice. 1 Agenda I Results Overview II Business Review Financial Review III Financial Review IV Future Strategies V Appendix 2 Section 1 Results Overview 3 Performance Overview in 2016 1 ♦ Revenue increased by 0.6% y-o-y to approximately 3,186 million ♦ Profit attributable to owners decreased by 17.2% y-o-y to 1,708 million; excluding the one-off investment income for the same period of last year, it increased by 11.8% y-o-y Maintained market leadership* 2 ♦ 1st in CCV prescription drug market with a market share of 11.86% in terms of hospital purchase; 4th largest pharmaceutical company in China’s hospital market ♦ The Group’s terminal sales growth rate was 8.87%, which was above the industry growth rate of 8.12% in 2016 *Resource: QuintilesIMS data ♦ Phase I clinical trials of innovative patent drug Pirotinib in the US and China progressed 3 smoothly; Phase II clinical trials of innovative patent drug Imigliptin Dihydrochloride have been commenced ♦ Innovative patent drugs Sirotinib and Fadanafil obtained Phase I/II/III clinical trial approvals granted by the CFDA ♦ 47 generic drugs obtained clinical trial approvals issued by the CFDA ♦ Obtained 13 awards for new drug R&D at national, provincial, and municipal levels ♦ Achieved initial success in low-end market penetration while consolidating its business 4 foundation in high-end markets ♦ Established a marketing management center, introduced talents, intensified construction, and further improved marketing & sales capabilities ♦ Directed marketing & sales by academic promotion, identified potential markets in a scientific manner, and achieved efficient market development ♦ 5 After new GMP certification, the production management and quality control system was further optimized ♦ Quality control and production cost control of the manufacturing facilities were further enhanced under the systematic management by the production management & quality control center ♦ Established an audit & compliance center to conduct stricter management over its 6 subsidiaries and to further strengthen compliant operation ♦ Completed a “comprehensive risk management” program, established a risk management system, and achieved standardization of risk management 4 Section 2 Business Review 5 Hospital Market Growth Slows Down but Revived in 2016 Sales in China‘s hospital market / 5 years trend, 2012-2016 100 million/RMB nationwide sales (100 million/RMB) overall growth rate growth rate y-o-y growth rate of Chinese companies growth rate of multinational companies 8000 16.0% 6975 7000 6452 13.4% 6148 6000 5505 11.7% 12.0% 4855 5000 4000 8.1% 8.0% 3000 4.9% 2000 4.0% 1000 0 0.0% 2012 2013 2014 2015 2016 30.0% 27.2% China’s hospital pharmaceutical markets: 2013-2016 moving annual trend (MAT ) ) 25.0% 25.5% 21.6% overall markets Chinese companies multinational companies 20.0% 20.3% 16.7% % (RMB 20.6% 14.0% 14.1% 15.0% 15.7% 13.3% 12.5% 16.5% 13.7% 11.5% rate 13.4% 13.1% 12.8% 10.4% 13.6% 11.7% 8.7% 8.0% 10.0% 12.7% 12.7% 12.8% 12.2% 10.3% 7.0% 11.5% 8.5% 5.1% 5.4% 6.0% 6.1% 8.1% 10.0% 6.6% 6.2% 6.4% 5.0% 7.7% 4.9% 5.5% 7.6% 8.5% Growth 6.9% 5.5% 4.5% 5.6% 0.0% MAT 13Q2 13Q3 13Q4 MAT 14Q2 14Q3 14Q4 MAT 15Q2 15Q3 15Q4 MAT 16Q2 16Q3 16Q4 13Q1 14Q1 15Q1 16Q1 Resource: QuintilesIMS China’s hospital pharmaceutical market report (>=100 beds), 2016Q4 6 Leading Market Position Top 5 Players in China’s CCV Prescription Drug Market in 2016 (Market share) 11.86% 5.43% 4.92% 4.65% 3.51% Sihuan Pfizer SANOFI QILU Shanghai Fosun Top 10 Corporations in China’s Hospital market in 2016 Shares in hospital market Rank Top 10 Corporations In 2016 (%) 1 PFIZER GROUP 2.47% 2 YANGZIJIANG FTY 2.36% 3 ASTRAZENECA GROUP 2.17% 4 Sihuan Pharmaceutical 2.00% 5 QILU PHARM GROUP 1.86% 6 SHANGHAI FUSUN PH 1.63% 7 JS.L.Y.G. HENGRUIK 1.61% 8 SANOFI GROUP 1.58% 9 E LUN 1.57% 10 C.T-TIANQING GP 1.49% Resource: QuintilesIMS 7 Leading Market Position of Main Non-exclusive Products Sihuan’s Generic Name Sihuan’s Market Share and its Top 5 Pharmaceutical Companies and Their Market Brand Name （Total revenue） Ranking in 2016 Share in 2016 Ranked No.2 Sihuan 1. Qilu (山东齐鲁), 59.57% Ganglioside M1 10.46% 2. Sihuan (四环医药), 10.46% GM1 (RMB 6,868 mil) 3. Harbin Medical University (黑龙江哈尔滨医大), 10.37% 4. BJ Saisheng Pharm (北京赛升), 8.58% 5. SC.Taiji Xinan PH (西南药业), 7.27% Ranked No.3 Sihuan 1. BJ Taide (北京泰德), 26.39% 18.30% 2. Hayao Biological (哈药生物), 22.19% Alprostadil Yimaining 3. Sihuan (四环制药), 18.30% (RMB 5,758 mil) 4. Xian Libang Pharm (西安力邦), 14.76% 5. Chongqing Yaoyou (重庆药友), 11.68% Sihuan Ranked No.2 Salviae Miltiorrhizae 23.30% 1.
Load more

Recommended publications
  • Nexium Control, Esomeprazole
    27 June 2013 EMA/498929/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Nexium Control International non-proprietary name: esomeprazole Procedure No. EMEA/H/C/002618 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8613 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Product information Marketing authorisation application Name of the medicinal product: Nexium Control Applicant: AstraZeneca AB Building 411A, Floor 4 S - 151 85 Södertälje SWEDEN Active substance: esomeprazole (as magnesium trihydrate) International Nonproprietary Name/Common Name: esomeprazole Pharmaco-therapeutic group Proton pump inhibitors (ATC Code): (A02BC05) Therapeutic indication: Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Pharmaceutical form: Gastro-resistant tablet Strength: 20 mg Route of administration: Oral use Packaging: blister (PVC/PVDC) Package sizes: 7 tablets and 14 tablets Assessment report EMA/498929/2013 Page 2/70 Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier .....................................................................................
    [Show full text]
  • Esomeprazole: a New Proton Pump Inhibitor for NSAID-Associated Peptic Ulcers and Dyspepsia
    DRUG PROFILE Esomeprazole: a new proton pump inhibitor for NSAID-associated peptic ulcers and dyspepsia Grace Lai-Hung Wong Ulcer and ulcer symptoms related to the use of non-steroidal anti-inflammatory drugs & Joseph JY Sung† (NSAIDs) and aspirin constitute a major global health issue. Despite various attempts to †Author for correspondence prevent and heal injuries inflicted by NSAIDs and aspirin, acid suppression remains one of The Prince of Wales Hospital, Department of Medicine and the cornerstones in the management of NSAID-associated ulcers. Esomeprazole, the Therapeutics, 9/F, S-optical isomer (enantiomer) of omeprazole, suppresses gastric acid secretion by 30–32 Ngan Shing Road, inhibiting the parietal cell membrane enzyme H+/K+-ATPase. With improved bioavailability, Shatin, NT, Hong Kong SAR due to reduced first-pass metabolism in the liver, esomeprazole promises to be more Tel.: +852 2632 3132 potent in acid suppression in the stomach. Similar to omeprazole, the safety profile of Fax: +852 2645 1699 esomeprazole has been well established. Clinical studies comparing esomeprazole with [email protected] other proton pump inhibitors (PPIs) in the healing of NSAID-related ulcer are few. Recent multicenter randomized studies demonstrated that esomeprazole significantly improves dyspeptic symptoms in patients taking nonselective NSAIDs and specific cyclooxygenase-2 inhibitors. Esomeprazole also protects the stomach from aspirin-induced ulcer bleeding. Safety profiles of esomeprazole appear promising. Non-steroidal anti-inflammatory drugs both basal and stimulated acid secretion. PPIs are (NSAIDs) are the most commonly used medica- most effective against meal-induced gastric acid tions for chronic pain and arthritis due to their secretion [3].
    [Show full text]
  • Dr. Reddy's – Recall of Ranitidine
    Dr. Reddy’s – Recall of ranitidine • On October 23, 2019, Dr. Reddy’s announced the voluntary, consumer-level recall of prescription ranitidine due to potential contamination with N-nitrosodimethylamine (NDMA). • Dr. Reddy’s initially announced retail level recalls for prescription and OTC ranitidine in early October; however, the recall of prescription ranitidine products has been escalated to the consumer level. The recall of OTC ranitidine remains at the retail level. Prescription Ranitidine Capsules Recalled by Dr. Reddy’s Product Description NDC# Ranitidine 150 mg capsules, 60 count bottle 55111-129-60 Ranitidine 150 mg capsules, 500 count bottle 55111-129-05 Ranitidine 300 mg capsules, 30 count bottle 55111-130-30 Ranitidine 300 mg capsules, 100 count bottle 55111-130-01 • Refer to the Dr. Reddy’s announcement for a complete list of the OTC recalled ranitidine products. • Other manufacturers, including Apotex, Perrigo and Sanofi have recently announced retail level recalls of their OTC ranitidine products. • In September, Sandoz issued a consumer level recall of prescription ranitidine products. • These recalls follow a recent FDA statement about NDMA impurities detected in ranitidine medicines. • NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. • Ranitidine is an OTC and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. • Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
    [Show full text]
  • Label Phase of the Study
    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ------------------------WARNINGS AND PRECAUTIONS----------------­ NEXIUM safely and effectively. See full prescribing information for • Symptomatic response does not preclude the presence of gastric NEXIUM. malignancy (5.1) • Atrophic gastritis has been noted with long-term omeprazole therapy NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, for Oral (5.2) Use • PPI therapy may be associated with increased risk of Clostridium NEXIUM (esomeprazole magnesium) For Delayed-Release Oral difficile associated diarrhea. (5.3) Suspension • Bone Fracture: Long-term and multiple daily dose PPI therapy may be Initial U.S. Approval: 1989 (omeprazole) associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.4) -----------------------RECENT MAJOR CHANGES-----------------------­ • Hypomagnesemia has been reported rarely with prolonged treatment Warnings and Precautions, Clostridium difficile associated 09/2012 with PPIs (5.5) diarrhea (5.3) • Avoid concomitant use of NEXIUM with St John’s Wort or rifampin Warnings and Precautions, Concomitant use of NEXIUM with due to the potential reduction in esomeprazole levels (5.6) (7.3) Methotrexate (5.10) 01/2012 • Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and -----------------------INDICATIONS AND USAGE-----------------------­ enterochromaffin-like cell hyperplasia and
    [Show full text]
  • Proton Pump Inhibitors Aciphex
    PHARMACY PRE-AUTHORIZATION CRITERIA DRUG (S) Proton Pump Inhibitors Aciphex (Brand name) Dexilant Nexium/esomeprazole (RX Version) Omeprazole-bicarbonate Prevacid (Brand name) Prilosec (Brand name) Protonix (Brand name) Zegerid (RX Version and Brand name) POLICY # 14157 INDICATIONS These agents are approved for the treatment of duodenal ulcers, gastroesophageal reflux disease (GERD), Zollinger Ellison syndrome and H. pylori eradication. CRITERIA DRUG FREEDOM DRUG LIST Step COMMERCIAL DRUG LIST Step Requirements Requirements Aciphex (brand All of these: All of these: name) • Nexium OTC • Nexium OTC • Prilosec OTC , omeprazole, • Prilosec OTC , omeprazole, or Zegerid OTC or Zegerid OTC • Prevacid 24HR OTC/ • Prevacid 24HR OTC/ lansoprazole lansoprazole • Protonix/pantoprazole • Protonix/pantoprazole Dexilant All of these: ALL of these: • Nexium OTC • Nexium OTC • Prilosec OTC , omeprazole, • Prilosec OTC , omeprazole, or Zegerid OTC or Zegerid OTC • Prevacid 24HR OTC/ • Prevacid 24HR OTC/ lansoprazole lansoprazole • Protonix/pantoprazole • Protonix/pantoprazole esomeprazole All of these: All of these: • Nexium OTC • Nexium OTC • Prilosec OTC , omeprazole, • Prilosec OTC , omeprazole, or Zegerid OTC or Zegerid OTC • Prevacid 24HR OTC/ • Prevacid 24HR OTC/ PHARMACY PRE-AUTHORIZATION CRITERIA lansoprazole lansoprazole • Protonix/pantoprazole • Protonix/pantoprazole lansoprazole PA Not Required PA Not Required Nexium (RX All of these: All of these: Version) • Nexium OTC • Nexium OTC • Prilosec OTC , omeprazole, • Prilosec OTC , omeprazole, or
    [Show full text]
  • PHRP March 2015
    March 2015; Vol. 25(2):e2521518 doi: http://dx.doi.org/10.17061/phrp2521518 www.phrp.com.au Research Manual versus automated coding of free-text self-reported medication data in the 45 and Up Study: a validation study Danijela Gnjidica,b,i, Sallie-Anne Pearsona,c, Sarah N Hilmerb,d, Jim Basilakise, Andrea L Schaffera, Fiona M Blythb,f,g and Emily Banksg,h, on behalf of the High Risk Prescribing Investigators a Faculty of Pharmacy, University of Sydney, NSW, Australia b Sydney Medical School, University of Sydney, NSW, Australia c Sydney School of Public Health, University of Sydney, NSW, Australia d Royal North Shore Hospital and Kolling Institute of Medical Research, Sydney, NSW, Australia e School of Computing, Engineering and Mathematics, University of Western Sydney, NSW, Australia f Centre for Education and Research on Ageing (CERA), Concord Hospital, Sydney, NSW, Australia g The Sax Institute, Sydney, NSW, Australia h National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT i Corresponding author: [email protected] Article history Abstract Publication date: March 2015 Background: Increasingly, automated methods are being used to code free- Citation: Gnjidic D, Pearson S, Hilmer S, text medication data, but evidence on the validity of these methods is limited. Basilakis J, Schaffer AL, Blyth FM, Banks E. To examine the accuracy of automated coding of previously keyed Manual versus automated coding of free-text Aim: in free-text medication data compared with manual coding of original self-reported medication data in the 45 and Up Study: a validation study. Public Health handwritten free-text responses (the ‘gold standard’).
    [Show full text]
  • Acid-Reducing Medications: Interactions with Harvoni and Epclusa
    November 2016 | www.hepatitis.va.gov Acid-Reducing Medications: Interactions with Harvoni® and Epclusa® Sofosbuvir/Velpatasvir = Epclusa® Ledipasvir/Sofosbuvir = Harvoni® • Acid-reducing medications can decrease the effectiveness of Harvoni® and Epclusa® and could prevent successful cure. • Let your provider know if you are taking any acid-reducing medications—either prescribed to you or purchased over the counter. Types of Acid-Reducing What to Do if What to Do if Medications Taking Epclusa® Taking Harvoni® Antacids Separate taking the antacid and Separate taking the antacid and Epclusa® by 4 hours Harvoni® by 4 hours Combinations of aluminum, magnesium, and calcium. Brand names include: Alka-Seltzer® Maalox® Mylanta® Rolaids® TUMS® H2 Blockers Do not take more than the Do not take more than the recommended doses recommended doses Cimetidine (Tagamet®) Famotidine (Pepcid®) May take together with Epclusa® May take together with Harvoni® Nizatidine (Axid®) or 12 hours apart or 12 hours apart Ranitidine (Zantac®) Proton Pump Inhibitors (PPI) It is best to avoid PPIs during treat- It is best to avoid PPIs during ment with Epclusa®. If there are no treatment with Harvoni®. If there Esomeprazole (Nexium®) alternatives, follow these instructions: are no alternatives, follow these Lansoprazole (Prevacid®) instructions: Omeprazole (Prilosec®) Take Epclusa® with food Pantoprazole (Protonix®) Take the proton pump inhibitor 4 Take Harvoni® and the proton Rabeprazole (Aciphex®) hours after taking Epclusa® pump inhibitor at the same time in the morning after fasting overnight Do not take the proton pump (on an empty stomach) inhibitor at the same time as Epclusa® Do not take proton pump Do not take proton pump inhibitors inhibitors at more than the at more than the recommended dose recommended dose U.S.
    [Show full text]
  • Medication Guide Esomeprazole Magnesium
    MEDICATION GUIDE ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, USP (es″ oh mep′ ra zole mag nee′ zee um) 20 mg and 40 mg Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules before you start taking esomeprazole magnesium delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about esomeprazole magnesium delayed-release capsules? Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Esomeprazole magnesium delayed-release capsules can cause serious side effects, including: • Diarrhea. Esomeprazole magnesium delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection ( Clostridium difficile) in your intestines. • Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take esomeprazole magnesium delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take esomeprazole magnesium delayed-release capsules. • Esomeprazole magnesium delayed-release capsules can have other serious side effects. See “What are the possible side effects of esomeprazole magnesium delayed-release capsules?” What are esomeprazole magnesium delayed-release capsules? Esomeprazole magnesium delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI).
    [Show full text]
  • Astrazeneca Plc
    6/15/2020 AstraZeneca - Wikipedia AstraZeneca AstraZeneca plc[3] is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global AstraZeneca plc headquarters in Cambridge, England.[4] Its R&D is concentrated in Cambridge, Gaithersburg, Maryland, and Mölndal in Sweden.[5] AstraZeneca has a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, Type Public limited neuroscience, respiratory and inflammation.[6] company Traded as LSE: AZN (https:// The company was founded in 1999 through the merger of the www.londonstocke [7][8] Swedish Astra AB and the British Zeneca Group (itself formed xchange.com/exch by the demerger of the pharmaceutical operations of Imperial ange/searchengin Chemical Industries in 1993). Since the merger it has been among e/search.html?lang the world's largest pharmaceutical companies and has made =en&x=0&y=0&q= numerous corporate acquisitions, including Cambridge Antibody AZN) Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) NYSE: AZN (http and Definiens (by MedImmune in 2014). s://www.nyse.com/ quote/XNYS:AZN) AstraZeneca has a primary listing on the London Stock Exchange Nasdaq and is a constituent of the FTSE 100 Index. It has secondary listings Stockholm: AZN (ht on the New York Stock Exchange and the OMX exchange. tp://www.nasdaqom xnordic.com/aktier/ microsite?language Contents Id=1&Instrument=S SE3524) History FTSE 100 2000–06 Component 2007–12: The patent cliff and subsequent acquisitions ISIN GB0009895292 2013
    [Show full text]
  • Proton Pump Inhibitors
    Cigna National Formulary Coverage Policy Step Therapy Proton Pump Inhibitors Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 14530 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 3 Revision History ................................................... 4 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.
    [Show full text]
  • New and Future Drug Development for Gastroesophageal Reflux Disease
    J Neurogastroenterol Motil, Vol. 20 No. 1 January, 2014 pISSN: 2093-0879 eISSN: 2093-0887 http://dx.doi.org/10.5056/jnm.2014.20.1.6 JNM Journal of Neurogastroenterology and Motility Review New and Future Drug Development for Gastroesophageal Reflux Disease Carla Maradey-Romero and Ronnie Fass* The Esophageal and Swallowing Center, Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio, USA Medical therapy remains the most popular treatment for gastroesophageal reflux disease (GERD). Whilst interest in drug devel- opment for GERD has declined over the last few years primarily due to the conversion of most proton pump inhibitor (PPI)’s to generic and over the counter compounds, there are still numerous areas of unmet needs in GERD. Drug development has been focused on potent histamine type 2 receptor antagonist’s, extended release PPI’s, PPI combination, potassium-competitive acid blockers, transient lower esophageal sphincter relaxation reducers, prokinetics, mucosal protectants and esophageal pain modulators. It is likely that the aforementioned compounds will be niched for specific areas of unmet need in GERD, rather than compete with the presently available anti-reflux therapies. (J Neurogastroenterol Motil 2014;20:6-16) Key Words Erosive esophagitis; Gastroesophageal reflux; Heartburn; Proton pump inhibitors Most patients with GERD fall into 1 of 3 categories: non- erosive reflux disease (NERD), erosive esophagitis (EE), and Introduction Barrett’s esophagus (BE). The 2 main phenotypes of GERD, Gastroesophageal reflux disease (GERD) is a common con- NERD and EE, appear to have different pathophysiological and dition that develops when reflux of stomach contents cause trou- clinical characteristics.
    [Show full text]
  • Nda 20-839/S-044 Supplement Approval
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 20-839/S-044 SUPPLEMENT APPROVAL Sanofi-Aventis U.S. Inc. Attention: Colleen M. Davenport, Ph.D. Director, Drug Regulatory Affairs 11 Great Valley Parkway P.O. Box 3026 Malvern, PA 19355 Dear Dr. Davenport: Please refer to your supplemental new drug application dated November 2, 2009, received November 2, 2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Plavix (clopidogrel bisulfate) 75 mg Tablets. This Changes Being Effected supplemental new drug application provides information regarding a potential drug interaction between clopidogrel and CYP2C19 inhibitors. The new label revisions are as follows: 1. The following text was added to the beginning of the WARNINGS section: Reduced effectiveness due to impaired CYP2C19 function: The inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. Clopidogrel is metabolized to this active metabolite in part by CYP2C19. This metabolism can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19. Avoid use of Plavix in patients with impaired CYP2C19 function due to known genetic variation or due to drugs that inhibit CYP2C19 activity. Genetic variations: Patients with genetically reduced CYP2C19 function have diminished antiplatelet responses and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function (see CLINICAL PHARMACOLOGY: Pharmacogenetics). Drug interactions: Co-administration of Plavix with omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of Plavix if given concomitantly or if given 12 hours apart.
    [Show full text]