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Dublin, April 17, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Gastrointestinal Therapeutics and Diagnostics: Technologies and Global Markets" report to their offering. The global market for gastrointestinal disorder therapeutics and diagnostics reached $49.6 billion in 2015. This market is expected to grow from nearly $51.8 billion in 2016 to $63.8 billion in 2021 at a compound annual growth rate of 4.3% from 2016-2021. This report is designed to provide an in-depth look at the therapeutic and diagnostic options of various gastrointestinal disorders. The geographic scope of the report is global, with particular emphasis on the key markets such as the U.S. and the European Union Five (EU5). The estimated market data is also global in nature, with geographic segments such as the U.S., EU and Rest of the World (ROW). The report provides a brief overview of the gastrointestinal system, which provides an introduction to the disorders of the gastrointestinal system; cites risk factors, where applicable; presents current pharmaceutical treatments, market size and key market participants (both prescription and OTC); and presents potential treatments in R&D, potential market size and future market entrants. This report provides: - An overview of the global markets for gastrointestinal therapeutics and diagnostics. - Analyses of global market trends, with data from 2015, estimates for 2016, and projections of CAGRs through 2021. - Analyses of therapeutics currently on the market as well as potential products and classes of products that are likely to have a significant impact. - Descriptions of the industry in detail, its relationship to the healthcare industry, its participants, and its trends for the future. - Evaluation of the market's dynamics, specifically growth drivers, restraints, and opportunities. - Profiles of major players in the industry. The market for gastrointestinal pharmaceuticals is divided into two general segments: prescription gastrointestinal pharmaceuticals and OTC gastrointestinal pharmaceuticals. Similarly, the market for gastrointestinal diagnostics, testing and vaccines is divided into three general segments: - Diagnostics and testing market. - Medical devices (endoscopy) - Vaccines. The market is further broken down into the drugs to treat specific disorders within the gastrointestinal system, including the following: - Gastrointestinal tract disorders. - Gastrointestinal tract walls disorders. - Gastrointestinal motility disorders. - Gastrointestinal cancers. Each sub-segment is covered in detail, describing the disorders and diseases, identifying currently available and potential products, and competitors. Key Topics Covered: 1: Introduction Complimentary - Study Goals And Objectives - Reasons For Doing The Study - Intended Audience - Scope Of Report - Methodology And Information Sources 2: Executive Summary - Gastrointestinal Therapeutics And Diagnostics 3: Overview - Gastric Cancer - Inflammatory Bowel Disease (IBD) - Constipation - Opioid-Induced Constipation - Gastroesophageal Reflux Disease 4: Etiology - Anatomy And Physiology Of The Gastrointestinal System - The Enteric Nervous System: An Overview - Factors Affecting The Functioning Of The GI System - Physiology Of The Gi System And The Role Of Each Part In The Gi Process 5: Prescription Therapy Market - Antidiarrheals - Antiemetics - Gastrointestinal Cancer Treatments - Gastroesophageal Reflux Disease Treatments - Proton Pump Inhibitors - Laxatives - Bowel Anti-Inflammatory - Other GI Drugs 6: OTC Therapy Market - Antacids - Locally Acting Antidiarrheals - H2 Inhibitors - Proton Pump Inhibitors - Laxatives - Total OTC Gastrointestinal Drug Market Size And Growth 7: Diagnostics And Devices Market - Enteric Disease Testing Methods - Global Market For Enteric Diagnostic Tests - Campylobacter - Norovirus - Rotavirus - Giardia Parasite - E. Coli - Cryptosporidium - Shigella - Typhoid - Amebiasis - Cholera - Other (H. Pylori, Yersinia) Diagnostic Tests - Medical Devices (Endoscopy) 8: Gastrointestinal Product Pipeline - Therapies For Treating Gastric Cancer - Gerd And Peptic Ulcers - Therapies For Treating IBS - Therapies For Treating Ulcerative Colitis And Crohn'S Disease 9: Patents 10: Company Profiles - Allergan Plc - Ardelyx Inc. - Astellas Pharma Inc. - Astrazeneca - Celgene Corp. - Clovis Oncology - Daewoong Pharmaceutical Co., Ltd. - ELI Lilly And Company - Glaxosmithkline - Horizon Pharma Plc - Immunogenx - Immunomedics - Merck & Co. - Merrimack Pharmaceuticals Inc. - New Link Genetics - Otsuka Holdings Co. Ltd. - Pfizer Inc. - Roche - Sanofi - Shire - Sucampo Pharmaceuticals Inc. - Synergy Pharmaceuticals Inc. - Synthetic Biologics - Taiho Pharmaceutical Co., Ltd. - Takeda Pharmaceuticals - Valeant Pharmaceuticals For more information about this report visit http://www.researchandmarkets.com/research/wqkmrj/gastrointestinal


News Article | February 22, 2017
Site: www.businesswire.com

BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter and year ended December 31, 2016, and provided an update on the Company’s clinical development programs and regulatory outlook for 2017. “ We are extremely pleased with the Rubraca launch to date; our commercial team hit the ground running and we are committed to the successful launch of this new therapeutic option for the treatment of advanced ovarian cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “ We are preparing for a potential approval in the EU in late 2017 or early 2018, and are aggressively building our European organization. We continue to anticipate the ARIEL3 read out in mid-2017, and we look forward to expanding the TRITON program into earlier line castrate-resistant prostate cancer. We will provide additional details on this study and other clinical development plans to develop rucaparib in other indications as well as in combination with an immuno-oncology agent over the course of this year.” Clovis had $266.2 million in cash, cash equivalents and available-for-sale securities as of December 31, 2016. Cash used in operating activities was $54.7 million for the fourth quarter of 2016 and $266.7 million for the year ended December 31, 2016. Clovis had approximately 38.7 million shares of common stock outstanding as of December 31, 2016. In January 2017, the Company raised net proceeds of $221.2 million through an offering of 5.75 million shares of common stock. Clovis reported a net loss for the fourth quarter of 2016 of $70.7 million, or ($1.83) per share, and $349.1 million or ($9.07) per share for the year ended December 31, 2016. The net loss for the fourth quarter of 2015 was $119.5 million or ($3.12) per share and $352.9 million or ($9.79) per share for the year ended December 31, 2015. Net loss for the fourth quarter of 2016 included share-based compensation expense of $10.1 million and $39.8 million for the full year 2016, respectively, compared to $10.9 million and $40.4 million for the comparable periods of 2015. Net product revenue for the quarter and the year was $78 thousand, following the approval and launch of Rubraca on December 19, 2016. The net loss for the year ended December 31, 2016 includes a net expense non-cash impact of $50.6 million relating to the lucitanib product rights recorded in 2013 in connection with the Company’s acquisition of Ethical Oncology Science S.p.A. (EOS), comprised of a $104.5 million non-cash expense for the impairment of the intangible asset, a $25.5 million non-cash expense credit for the reduction in the fair value of the contingent purchase consideration liability and a $28.4 million related non-cash income tax benefit. The non-GAAP adjusted net loss excluding these items was $298.6 million or ($7.76) per share for the full year 2016. Research and development expenses totaled $54.5 million for the fourth quarter of 2016, and $251.1 million for the full year 2016, compared to $76.0 million and $269.3 million, respectively, for the comparable periods in 2015. The decrease year over year is primarily due to decreased development activities for the rociletinib program and to a lesser extent, expenses related to the commercialization of Rubraca, which had been classified as research and development prior to FDA approval, partially offset by higher expenses related to the rucaparib program. Selling, general and administrative expenses totaled $12.2 million for the fourth quarter of 2016, and $40.7 million for the full year 2016, compared to $8.2 million and $30.5 million for the comparable periods in 2015. The increase year over year is primarily due to higher legal costs; selling, general and administrative expenses related to the commercialization of Rubraca, which had been classified as research and development prior to FDA approval; and to a lesser extent, higher personnel costs. On December 19, 2016, the U.S. Food and Drug Administration (FDA) approved Rubraca (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The indication for Rubraca is approved under the FDA’s accelerated approval program, and is based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2 Parts 1 and 2. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The ARIEL3 maintenance confirmatory study has completed enrollment and the ARIEL4 treatment confirmatory study is open for enrollment. The ARIEL3 pivotal study is a randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance therapy to platinum-sensitive patients can extend the period of time for which the disease is controlled after a positive outcome with platinum-based chemotherapy. Patients who have high-grade serous ovarian cancer and have had at least two prior lines of platinum-based chemotherapies are randomized to receive either placebo or rucaparib and the primary endpoint of the study is progression free survival, or PFS. The primary efficacy analysis will evaluate, in a step-down process, BRCA-mutant patients, all patients with a homologous recombination deficiency, or HRD, signature (including BRCA and non-BRCA), followed by all patients. In addition, a pre-specified subgroup analysis is planned to evaluate patients with low volume or no residual disease at baseline, to determine the impact of disease burden on PFS. Importantly, this analysis will also identify the size of the population with meaningful disease still present after a partial response to second-line platinum therapy. Target enrollment in ARIEL3 was completed during the second quarter of 2016. Data from ARIEL3 are expected mid-2017. Clovis has not yet been notified by the independent statistician that the required 70 percent of events in the mutant BRCA population has been reached, which will trigger the final analysis of the data. Pending positive data from ARIEL3, Clovis intends to follow up with a supplemental NDA for second-line maintenance therapy in women with ovarian cancer who have responded to platinum-based therapy. The ARIEL4 confirmatory study, which is open for enrollment, is a Phase 3 multicenter, randomized study of rucaparib versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations (inclusive of germline and/or somatic) who have failed two prior lines of therapy. The primary endpoint of the study is PFS. Also during the quarter, the Company submitted an MAA for rucaparib to the European Medicines Agency for the same ovarian cancer treatment indication that was submitted to the U.S. FDA. Clovis anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) in late 2017, and, pending a favorable opinion from CHMP, an approval would follow shortly thereafter. In October, in support of the anticipated U.S. commercial launch of rucaparib, Clovis entered into a long-term manufacturing and supply agreement with Lonza, the manufacturer of the active pharmaceutical ingredient (API) for rucaparib. This new agreement for a dedicated manufacturing line is expected to provide security of supply and reduce cost of goods over time. In February, Clovis entered into an agreement with Strata Oncology to accelerate patient identification and enrollment in the TRITON prostate cancer development program. The Strata trial is an observational study that provides no-cost tumor sequencing to patients at participating clinical sites, and under this agreement, match BRCA and ATM mutated advanced prostate cancer patients to Clovis’ TRITON studies. Strata has agreed not to provide similar matching services on behalf of any other Strata collaborator for any other metastatic castrate-resistant prostate cancer (mCRPC) clinical trial with respect to patients having those same genetic mutations. In addition to ARIEL3 and ARIEL4 mentioned above, Clovis has a robust clinical development program underway in multiple tumor types, including both Clovis-sponsored and investigator-initiated trials. Several clinical studies are open for enrollment or are anticipated to open during 2017: Clovis will hold a conference call to discuss fourth quarter 2016 results this afternoon, February 22, at 4:30pm ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 68475508. Rubraca is a PARP inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The indication for Rubraca is approved under the FDA’s accelerated approval program based on objective response rate and duration of response, and is based on results from two multicenter, single-arm, open-label clinical trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Please visit rubraca.com for more information. Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. The MAA submission in Europe for an ovarian cancer treatment indication was submitted and accepted during the fourth quarter of 2016. Additionally, rucaparib is being developed as maintenance therapy for ovarian cancer in the ARIEL3 trial for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, as well as biomarker negative patients. Data from ARIEL3 are expected in mid-2017, which, pending positive data, is expected to be followed by the submission of a sNDA for a second line or later maintenance indication. Rucaparib is also being developed in patients with mutant BRCA tumors and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies, or HRD. Studies open for enrollment or under consideration include prostate, breast, pancreatic, gastroesophageal, bladder and lung cancers. Clovis holds worldwide rights for rucaparib. Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK. Please visit clovisoncology.com for more information. To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the market potential of our approved drug, including the performance of our sales and marketing efforts and the success of competing drugs, the performance of our third-party manufacturers, our clinical development programs for our drug candidates, the corresponding development pathways of our companion diagnostics, actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions regarding drug labeling, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K. The Company prepares its consolidated financial statements in accordance with U.S. GAAP. This press release also contains non-GAAP measurements of net loss, net loss per common share and adjusted cash that the Company believes provide useful supplemental information relating to operating performance and trends and facilitates comparisons with other periods. These non-GAAP financial measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. Explanation of adjustments: (1) During the three months ended June 30, 2016, the Company recorded a $104.5 million non-cash impairment charge to the intangible asset related to the lucitanib product rights initially recorded in 2013 in connection with the acquisition of Ethical Oncology Science, S.p.A. (EOS). The Company also recorded a $28.4 million tax benefit associated with this charge. During the three months ended December 31, 2015, the Company recorded an $89.6 million non-cash impairment charge to the intangible asset associated with the Company's acquisition of EOS. The Company also recorded a $28.6 million tax benefit associated with this charge. These adjustments remove the net of tax effect of these charges from our net loss. (2) During the three months ended June 30, 2016, the Company recorded a $25.5 million non-cash credit to operating expenses to reflect the reduction in the fair value of the contingent purchase consideration liability, also associated with the Company's acquisition of EOS. During the three months ended December 31, 2015, the Company recorded a $26.9 million non-cash credit to operating expenses to reflect the reduction in the fair value of the contingent purchase consideration liability associated with the Company's acquisition of EOS. These adjustments, which exclude the normal accretion of the liability, remove the effect of these expense credits from our net loss.


Research and Markets has announced the addition of the "Breakthrough Therapies: Market Dynamics and Investment Opportunities" report to their offering. The Global Market for Breakthrough Therapy Designation Drugs Should Reach $99.2 Billion by 2022 from $48.8 Billion in 2017 at a CAGR of 15.2% This report highlights the challenges and opportunities of developing breakthrough therapies, it compares and contrasts difference fast track drug development approaches (logistics, criteria, and implications) and the potential risk and rewards of gaining BTD. It analyzes BTD in different therapy areas (cardiovascular, central nervous systems and neurology, rare diseases, oncology and other diseases), leading companies, approved and pipeline products, pricing market access and product revenues. It reviews BTD successes and failures and discusses the different business strategies that companies have adopted in order to maximize the competitive advantage of BTD. It summarizes the current regulatory framework and the potential application of BTD in other regions of the world, and the potential to combine BTD with early access to medicine schemes to improve patient access to medicine to treat rare diseases and address areas of high unmet clinical need. - An overview of the global markets for breakthrough therapies, their dynamics, and investment opportunities - Analyses of global market trends, with data from 2015, 2016, and projections of compound annual growth rates (CAGRs) through 2022 - A look at the materials used in the industry ranging from inorganic clays and concrete to iron and steel, and to commodity and specialty polymers - The challenges and opportunities of developing breakthrough therapies - A compare and contrast of different fast track drug development approaches (logistics, criteria and implications) and the potential risk and rewards of gaining break through designation - Profiles of major players in the industry Key Topics Covered: 1: Introduction - Study Goals And Objectives - Reasons For Doing The Report - Scope Of Report - Intended Audience - Methodology And Information Sources 2: Summary 3: Overview - Defining Breakthrough Therapy Designation 4: Commercial Application Of Breakthrough Therapy Designation - Introduction - Cardiovascular - Central Nervous System And Neurological Disorders - Infectious Diseases - Oncology - Rare Diseases - Other Diseases 5: Implications Of Breakthrough Therapy Designation On Business Strategy - Introduction 6: Regulatory Implications And Breakthrough Therapy Designation - Expedited Programs - Significance Of Btd For The Pharmaceutical And Biotechnology Industries 7: Company Profiles - Abbvie Inc. - Acadia Pharmaceuticals Inc. - Adaptimmune Therapeutics Plc - Aduro Biotech Inc. - Aimmune Therapeutics Inc. - Alexion Pharmaceuticals Inc. - Allergan Plc - Amgen Inc. - Anatara Lifesciences Limited - Ariad Pharmaceuticals Inc. - Astrazeneca Plc - Avexis Inc. - Boehringer Ingelheim Gmbh - Celldex Therapeutics Inc. - Clovis Oncology Inc. - Daiichi Sankyo Company, Limited - DBV Technologies - Eisai Co. Ltd. - Eli Lilly And Company - Exelixis Inc. - F. Hoffmann-La Roche Ltd. - Gilead Sciences Inc. - Glaxosmithkline Plc - Immunomedics Inc. - Individor Plc - Jazz Pharmaceuticals - Johnson & Johnson - Juno Therapeutics Inc. - Kite Pharma Inc. - Merck & Co. Inc. - Merck Kgaa - Novartis AG - Pfizer Inc. - Pharmacyclics Inc. - Progenics Pharmaceuticals Inc. - Regeneron Pharmaceuticals Inc. - Rhythm Pharmaceuticals Inc. - Syndax Pharmaceuticals Inc. - Syneurx International Corporation - Teva Pharmaceuticals Inc. - Trevena Inc. - Vertex Pharmaceuticals Inc. - Vtesse Inc. - Wellstat Therapeutics Corporation 8: References 9: Acronyms 10: Endnotes For more information about this report visit http://www.researchandmarkets.com/research/6369n3/breakthrough


SAN DIEGO, Feb. 14, 2017 (GLOBE NEWSWIRE) -- The Shareholders Foundation, Inc. announces that a lawsuit is pending in Colorado on behalf of certain purchasers of shares of Clovis Oncology Inc (NASDAQ:CLVS) over alleged Securities Laws Violations by Clovis Oncology. Investors who purchased shares of Clovis Oncology Inc (NASDAQ:CLVS) before May 2014 and continue to hold any NASDAQ:CLVS shares have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554. On November 19, 2015, a lawsuit was filed against Clovis Oncology Inc over alleged securities laws violations. The plaintiff claimed that the defendants allegedly made false and misleading statements and/or failed to disclose that the NDA that Clovis submitted to the FDA for rociletinib contained immature data sets based on both unconfirmed response rates and confirmed response rates, that Clovis Oncology’s Breakthrough Therapy designation submission contained immature data sets based primarily on unconfirmed responses, that Clovis Oncology presented interim data publicly and at medical meetings that included a data set based primarily on unconfirmed responses, that as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected, and that as a result of the foregoing, Clovis Oncology’s NDA was likely to be delayed and/or rejected by the FDA. On July 27, 2016, the defendants filed their motions to dismiss the case. On February 9, 2017, the judge presiding over the case refused to dismiss the lawsuit. Those who purchased Clovis Oncology Inc (NASDAQ:CLVS) shares should contact the Shareholders Foundation, Inc. by e-mail at mail@shareholdersfoundation.com or call +1 (858) 779-1554. The Shareholders Foundation, Inc. is a professional portfolio legal monitoring and a settlement claim filing service, which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. The Shareholders Foundation, Inc. is not a law firm. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.


Patent
Clovis Oncology | Date: 2015-08-17

A tablet including high dosage of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one camsylate salt has been disclosed.


Patent
Clovis Oncology | Date: 2014-05-05

The present invention provides a salt form and compositions thereof, which are useful as an inhibitor of EGFR kinases and which exhibits desirable characteristics for the same. Examples include hydrobromide and bis-besylate salts of N-(3-(2-(4-(4-acerylpiperazin-1-yl)-2-methoxyphenylamino)-5-(trifluoromethyl)pyrimidin-4-ylamino)phenyl)acrylamide). The salts and their polymorphs are evaluated for their properties such as stability, solubility, and pharmacokinetics.


A process for the preparation in high yields and purity of the compound 6-(7-((1-aminocyclopropyl)methoxy)-6-methoxyquinolin-4-yloxy)-N-methyl-1-naphthamide of formula (I) and of the pharmaceutically acceptable salts thereof is described. The process has various advantages over those previously described, in particular it avoids the use of acyl azide intermediates and their Curtius rearrangement. Novel intermediates useful for the preparation of compound (I) are also described.


Patent
Ventana Medical Systems and Clovis Oncology | Date: 2012-08-02

The subject invention relates to determining the presence and level of hENT1 expression in tumor tissue that is appropriate for gemcitabine therapy, and more importantly, the level of hENT1 expression that signifies that treatment with a gemcitabine derivative is a more appropriate strategy.


Patent
Ventana Medical Systems and Clovis Oncology | Date: 2012-08-02

The subject invention relates to determining the presence and level of hENT1 expression in tumor tissue that is appropriate for gemcitabine therapy, and more importantly, the level of hENT1 expression that signifies that treatment with a gemcitabine derivative is a more appropriate strategy.


A process for the preparation in high yields and purity of the compound 6-(7-((1-aminocyclopropyl)methoxy)-6-methoxyquinolin-4-yloxy)-N-methyl-1-naphthamide of formula (I) and of the pharmaceutically acceptable salts thereof is described. The process has various advantages over those previously described, in particular it avoids the use of acyl azide intermediates and their Curtius rearrangement. Novel intermediates useful for the preparation of compound (I) are also described.

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