News Article | February 21, 2017
According to a new research report by Transparency Market Research (TMR), the degree of competition in the Global Pharmaceutical Hot Melt Extrusion Market is very high. The presence of a large number of participants characterizes the market, which demonstrates a fragmented landscape. Led by Leistritz AG, Milacron Holdings Corp., Xtrutech Ltd., Coperion GmbH, and Gabler GmbH & Co. KG, the market is expected to continue with intense rivalry between them in the near future. The leading players are likely to invest heavily in R&D initiatives over the years to come, in order to meet the demand of consumers by offering innovative products, states the report. TMR estimates the opportunity in the global market for pharmaceutical hot melt extrusion, which was worth US$26.6 mn in 2015, to expand at a CAGR of 3.90% between 2016 and 2024 and reach a value of US$36.4 mn by the end of the period of the forecast. During the same period of time, the market volume is anticipated to swell at a CAGR of more than 4.7%, boosting the market significantly. Twin screw extruders have emerged as the most valued products in this market and is predicted to continue to enjoy a high demand over the forthcoming years. On Backdrop of Large Pool of Leading Players, North America to Retain its Lead The worldwide market for pharmaceutical hot melt extrusion boasts of a widespread presence across North America, Asia Pacific, Latin America, Europe, and the Middle East and Africa. In this research report, a regional analysis of this market has also been provided to the readers. According to the study, North America led the global market with a share of nearly 38% in 2015. Researchers predicts this regional market to maintain its dominance throughout the forecast period, thanks to the presence of a large pool of established players, especially in the U.S. The Europe market for pharmaceutical hot melt extrusion has also been witnessing steady growth and is predicted to continue doing so in the near future on account of the increasing demand for improved medical equipment and the growing adoption of extruders. Asia Pacific, However, will present the most lucrative growth opportunities for players in this market over the forthcoming years, thanks to rising number of research and development initiatives and the improving situation of the healthcare facilities in emerging economies, such as China, India, and Japan. The heightening standard of medical and healthcare infrastructure and the increase in government initiatives is also expected to impact this regional market in the forthcoming years. Rising Awareness among Consumers to Reflect Positively on Demand for Pharmaceutical Hot Melt Extrusion According to an analyst at TMR, "the rising awareness regarding the benefits hot melt extrusion offers over traditional processing techniques, is the key factor behind the significant growth of the global pharmaceutical hot melt extrusion market." The operating parameters in hot melt extrusion can be easily changed, the segmented screw elements allow agitator designs to be easily optimized to suit a particular application, and the die plates can also be easily exchanged to alter the extrudate diameter. All these characteristics are having a positive influence on the demand for pharmaceutical hot melt extrusion, leading to a significant rise in this market. However, the rising concerns over the quality and the non-compliance of regulatory requirements may limit the growth of this market to some extent over the next few years, notes the research study. The study presented here is based on a report by Transparency Market Research (TMR), titled "Pharmaceutical Hot Melt Extrusion Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 - 2024." The market has been segmented as below: Healthcare CMO Market (Service - Pharmaceutical Contract Manufacturing Services (Active Pharmaceutical Ingredients (API) Manufacturing, Final Dosage Form (FDF) Manufacturing, and Packaging) and Medical Device Contract Manufacturing Services (Outsourcing Design, Device Manufacturing (Material Process Services, Electronic Manufacturing Services, and Finished Products), and Final Goods Assembly) - Global Industry Analysis, Size, Share, Trends, Growth and Forecast 2013 - 2019 Single-use Bioprocessing Systems Market - (Product - Bioreactors & Fermenters, Mixers, Bags, Bioprocess Containers, Filtration Devices, Tubing, Sampling Systems, Connectors & Clamps, Probes & Sensors; End User - Pharmaceutical, Biotechnology, CRO & CMO, and Academic & Research Institutes; Application - Monoclonal Antibody Production, Vaccine Production, Plant Cell Cultivation, and Patient Specific Cell Therapies) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 - 2024 Medical Education Market (Type of Training - Cardiothoracic, Neurology, Orthopedic, Oral and Maxillofacial, Pediatric, Radiology, Laboratory; Mode of Education - On-campus, Distance, Online) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 - 2024 Transparency Market Research (TMR) is a U.S. based provider of syndicated research, customized research, and consulting services. TMR's global and regional market intelligence coverage includes industries such as pharmaceutical, chemicals and materials, technology and media, food and beverages, and consumer goods, among others. Each TMR research report provides clients with a 360-degree view of the market with statistical forecasts, competitive landscape, detailed segmentation, key trends, and strategic recommendations.
News Article | February 28, 2017
RALEIGH, N.C., Feb. 28, 2017 (GLOBE NEWSWIRE) -- INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to Phase IV contract research organization, today reported financial results for the fourth quarter and year ended December 31, 2016. “INC Research delivered a solid performance during the quarter in several key areas, growing net service revenues by 9% and adjusted EPS by approximately 24%. We also were pleased to achieve two key milestones for the full year, surpassing $1.0 billion in net service revenue for the first time in INC’s history and wrapping up the year with a backlog of approximately $2.0 billion,” said Chief Executive Officer Alistair Macdonald. “While we are proud of these accomplishments, new business in the quarter was lower than anticipated due to delayed client decisions with regard to some of our pending proposals, which negatively impacted awards." Mr. Macdonald continued, "As we turn our focus to 2017, we remain confident in our ability to reaccelerate INC’s growth over the mid-to long-term, given our current sales pipeline and the continued investments we are making to strengthen our offerings." Net service revenue for the three months ended December 31, 2016 increased by 9.0% to $263.0 million, compared to net service revenue of $241.4 million for the three months ended December 31, 2015. Net service revenue for the year ended December 31, 2016 increased by 12.6% to $1,030.3 million, compared to net service revenue of $914.7 million for the year ended December 31, 2015. Net service revenue grew across all therapeutic areas during both the fourth quarter and fiscal year 2016 and has been particularly strong in the central nervous system, oncology and other complex therapeutic areas. During the three months and year ended December 31, 2016, fluctuations in foreign currency exchange rates resulted in an unfavorable impact of $3.1 million and $11.7 million, respectively, on net service revenue compared to the same periods in the prior year. Income from operations for the three months ended December 31, 2016 increased by 10.3% to $43.8 million, compared to $39.7 million for the three months ended December 31, 2015. Income from operations for the year ended December 31, 2016 increased by 2.0% to $155.4 million, compared to $152.4 million for the year ended December 31, 2015. Operating margins for the three months and year ended December 31, 2016 were 16.7% and 15.1%, respectively, compared to 16.4% and 16.7% for the same respective periods in the prior year. The Company's income from operations includes certain expenses and transactions that it believes are not representative of its core operations. Excluding these items, adjusted income from operations was $59.3 million for the three months ended December 31, 2016, compared to $52.0 million for the three months ended December 31, 2015, representing growth of 14.0%. Adjusted income from operations was $223.2 million for the year ended December 31, 2016, compared to $203.2 million for the year ended December 31, 2015, representing growth of 9.8%. Adjusted operating margin for the three months and year ended December 31, 2016, was 22.5% and 21.7%, respectively, compared to 21.5% and 22.2% for the same respective periods in 2015. The Company reported net income for the three months ended December 31, 2016 of $37.5 million, resulting in diluted earnings per share of $0.68, compared to $30.7 million, or $0.53 per diluted share, for the three months ended December 31, 2015. Net income for the year ended December 31, 2016 was $112.6 million, resulting in diluted earnings per share of $2.03, compared to $117.0 million, or $1.95 per diluted share, for the year ended December 31, 2015. Adjusted net income for the three months ended December 31, 2016 was $36.9 million, or $0.67 per diluted share, compared to $31.4 million, or $0.54 per diluted share, for the same period in the prior year. Adjusted net income for the year ended December 31, 2016 was $139.0 million, or $2.50 per diluted share, compared to $120.2 million, or $2.00 per diluted share, for the same period in the prior year. Adjusted EBITDA for the three months ended December 31, 2016 increased 15.5% to $65.4 million, up from $56.6 million for the three months ended December 31, 2015. Adjusted EBITDA for the year ended December 31, 2016 increased 10.5% to $244.5 million, up from $221.4 million for the year ended December 31, 2015. For the three months and year ended December 31, 2016, adjusted EBITDA margins were 24.9% and 23.7%, respectively, compared to 23.4% and 24.2%, for the respective periods in 2015. Important disclosures about and reconciliations of non-GAAP measures, including adjusted income from operations, adjusted operating margin, adjusted net income and adjusted diluted earnings per share, EBITDA and adjusted EBITDA, to the corresponding GAAP measures are provided below. Backlog grew by 9.6% to $1.99 billion as of December 31, 2016, compared to $1.81 billion as of December 31, 2015. For the three months and year ended December 31, 2016, fluctuations in foreign currency exchange rates resulted in an unfavorable impact on our December 31, 2016 backlog in the amount of $21.6 million and $19.2 million, respectively, primarily due to the weakening of the Euro and British pound against the U.S. dollar. Net new business awards were $289.6 million for the three months ended December 31, 2016, representing a book-to-bill ratio of 1.1x, compared to $297.4 million for the three months ended December 31, 2015. While net book-to-bill was only slightly below our expectations, cancellations of and delays within our existing backlog had a larger than usual impact on the backlog expected to be recognized as revenue during 2017. Net new business awards were $1.22 billion for the year ended December 31, 2016, representing a book-to-bill ratio of 1.2x, compared to $1.18 billion for the year ended December 31, 2015. The Company's full-year guidance for 2017 is outlined in the following table. The guidance takes into account a number of factors, including current sales pipeline, existing backlog of $872 million expected to be realized in 2017 and our expectations for net awards during 2017. Further, our guidance is based on current foreign currency exchange rates, current interest rates and our expected tax rates, and does not take into account the effects of any future stock repurchases. Important disclosures about and reconciliations of non-GAAP measures, including adjusted net income and adjusted diluted earnings per share, to the corresponding GAAP measures are provided below. INC Research will host a conference call at 8:00 a.m. EST on February 28, 2017, to discuss its fourth quarter and full year 2016 financial results. The live webcast will be available in listen-only mode in the Events section of the Company's Investor Relations website at investor.incresearch.com. To participate via phone, please dial +1 (877) 930-8058 within the United States or +1 (253) 336-7551 outside the United States, approximately 15 minutes before the scheduled start of the call. The conference ID for the call is 63144979. An archived replay of the conference call will be available online at investor.incresearch.com after 1:00 p.m. EST on February 28, 2017. In addition, an audio replay will be available for one week following the call and will be accessible by dialing +1 (855) 859-2056 within the United States or +1 (404) 537-3406 outside the United States. The audio replay ID is 63144979. INC Research (NASDAQ:INCR) is a leading global contract research organization ("CRO") providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 110 countries. For more information, please visit us on LinkedIn or on Twitter. Except for historical information, all of the statements, expectations, and assumptions contained in this press release, including our 2017 guidance, are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include, but are not limited to: our ability to adequately price our contracts and not overrun cost estimates; general and international economic, political and other risks, including currency and stock market fluctuations and the uncertain economic environment as a result of the recent vote by the United Kingdom to exit from the European Union and the U.S. presidential election results and resulting foreign policy activities; fluctuations in our financial results; our ability to maintain or generate new business awards; our backlog not being indicative of future revenues and our ability to realize the anticipated future revenue reflected in our backlog; reliance on key personnel; our customer or therapeutic area concentration; our ability to increase our market share, grow our business and execute our growth strategies; and the other risk factors set forth in our Form 10-K for the year ended December 31, 2016 and other SEC filings, copies of which are available free of charge on our website at investor.incresearch.com. INC Research assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Use of Non-GAAP Financial Measures In addition to the financial measures prepared in accordance with GAAP, this press release contains certain non-GAAP financial measures, including Adjusted Income from Operations, Adjusted Operating Margin, Adjusted Net Income (including Adjusted Diluted Earnings per Share), EBITDA and Adjusted EBITDA. A “non-GAAP financial measure” is generally defined as a numerical measure of a company’s financial performance that excludes or includes amounts so as to be different than the most directly comparable measure calculated and presented in accordance with GAAP in the statements of operations, balance sheets or statements of cash flows of the Company. The Company defines Adjusted Income from Operations as income from operations excluding expenses and transactions that the Company believes are not representative of its core operations, namely, acquisition-related amortization, restructuring, CEO transition and other costs, transaction expenses, asset impairment charges, share-based compensation expense, contingent consideration related to acquisitions and other expense, and R&D tax credit adjustments. The Company defines Adjusted Operating Margin as adjusted income from operations as a percentage of net service revenue. The Company defines Adjusted Net Income (including Adjusted Diluted Earnings per Share) as net income (including diluted earnings per share) excluding the items excluded from adjusted income from operations mentioned previously, other (income) expense and loss on extinguishment of debt. After giving effect to these items and other unusual tax impacts during the period, the Company has also included an adjustment to its income tax rate to reflect the expected long-term income tax rate. EBITDA represents earnings before interest, taxes, depreciation and amortization. The Company defines Adjusted EBITDA as EBITDA, further adjusted to exclude certain expenses and transactions that the Company believes are not representative of its core operations, namely, restructuring, CEO transition and other costs, transaction expenses, asset impairment charges, share-based compensation expense, contingent consideration related to acquisitions and other expense, R&D tax credit adjustments, other (income) expense and loss on extinguishment of debt. The Company presents EBITDA and Adjusted EBITDA because it believes they are useful metrics for investors as they are commonly used by investors, analysts and debt holders to measure the Company's ability to fund capital expenditures and meet working capital requirements. Each of the non-GAAP measures noted above are used by management and the Board to evaluate the Company's core operating results as they exclude certain items whose fluctuations from period-to-period do not necessarily correspond to changes in the core operations of the business. Adjusted Income from Operations, Adjusted Operating Margin and Adjusted Net Income (including Adjusted Diluted Earnings per Share) are used by management and the Board to assess the Company's business. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Also, other companies might calculate these measures differently. Investors are encouraged to review the reconciliations of the non-GAAP financial measures to their most directly comparable GAAP measures included in this press release and the accompanying tables. (a) Represents the amortization of intangible assets primarily for customer relationships and backlog. (b) Restructuring, CEO transition and other costs consist of: (i) severance costs associated with a reduction of workforce in line with the Company's expectations of future business operations, (ii) transition costs associated with the transition to the Company's new Chief Executive Officer, (iii) legal and consulting costs incurred for the continued consolidation of legal entities and restructuring of the Company's contract financial process to meet the requirements of upcoming accounting regulation changes, and (iv) lease obligation and termination costs in connection with abandonment and closure of redundant facilities. (c) Represents fees associated with stock repurchases, debt placement and refinancings and other corporate transactions. (d) Represents impairment of goodwill and long-lived assets associated with the Company's Phase I Services reporting unit. (f) Represents contingent consideration expense incurred as a result of acquisitions and other expenses accounted for as compensation expense under GAAP. (g) Represents additional research and development tax credits in certain international locations for expenses incurred during 2016 and recorded as a reduction of direct costs. The Company has not received similar level of research and development credits in prior years as the associated costs did not qualify. Accordingly, the Company has excluded these expenses for 2016. (h) Represents other (income) expense comprised primarily of foreign exchange gains and losses. (i) Represents loss on extinguishment of debt associated with the debt refinancing activities in May 2015 and August 2016. (j) Adjustment for the income tax effect of the non-GAAP adjustments made to arrive at adjusted net income using the full year estimated effective tax rate of approximately 34% in 2016 and 36% in 2015, in order to reflect the removal of the tax impact of valuation allowances recorded against deferred tax assets and changes in the assertion to indefinitely reinvest the undistributed earnings of foreign subsidiaries. Historically, the Company recorded a valuation allowance against some of its deferred tax assets, but it believes that these valuation allowances cause significant fluctuations in its financial results that are not indicative of the Company's underlying financial performance. Specifically, the majority of the Company's revenue was generated in jurisdictions in which it recognized no tax expense or benefit due to changes in this valuation allowance. (a) Amounts are estimates with an estimated range of +/- 5% and are presented gross without the benefit of income tax reduction. (b) Income tax effect of share-based compensation is calculated using the statutory rates applicable to the tax jurisdictions of the applicable deduction, plus the amount of discrete tax adjustments related to excess tax benefits on share-based payments as a result of share-based payments activity. (c) Income tax expense is calculated and the adjustments are tax-affected at an approximate rate of 32%, which is the midpoint of our range for the expected income tax rate of 31% to 33%, less the Income tax effect of share-based compensation. This adjustment also reverses the impact of unusual tax items during the period.
News Article | February 28, 2017
SAN DIEGO, CA--(Marketwired - Feb 28, 2017) - A Invivoscribe(R) Technologies Inc., uma empresa global com mais de 20 anos de experiência com fornecimento de soluções de testes de clonalidade e com biomarcador para as áreas de oncologia, diagnóstico molecular personalizado (personalized molecular diagnostics(R)) e medicina molecular personalizada (personalized molecular medicine(R)), lançou hoje três kits de ensaios de sequência com marcador CE adicional da próxima geração (marked next-generation sequencing - NGS) para uso com diagnóstico in vitro (in vitro diagnostic - IVD) para auxílio com o diagnóstico de magnilidades da célula B. A Invivoscribe já comercializou mais de 40 ensaios e pacotes de bioinformática para plataformas de eletroférese capilar e NGS, e anunciou recentemente a assinatura de um contrato de longo prazo com a Thermo Fisher Scientific para regular os ensaios de IVD no FDA no Sistema Ion PGM(TM) Dx. A sensibilidade clínica para a detecção da clonalidade na maioria das malignidades da célula B pode chegar até 100 % quando os ensaios IGH e IGK são usados ao mesmo tempo. Além disso, pelo fato de o locus TRG ser reorganizado antes do locus TRB e com a persistência deste arranjo clonal, até mesmo as células T alfa-beta, testes de laboratório para IGH, IGK e TRG em conjunto, podem detectar pelo menos um biomarcador clonal alvo na grande maioria das magnilidades hematológicas. Estes biomarcadores de clonotipia específica do paciente podem ser usados para acompanhar a doença residual, com um mínimo de testes de doenças residuais (minimal residual disease - MRD). Os mixes mestres de PCR incluem o Kit de Ensaio LymphoTrack Dx IGH FR1/2/3 que foca em todas as três regiões da estrutura de trabalho, e o Ensaio LymphoTrack Dx IGK detecta as reorganizações V-J, V-Kde e INTR-Kde. A série de ensaios de clonalidade para Ion PGM(TM) estão disponíveis com 12 mixes mestres indexados para que o produto gerado de múltiplos pacientes possam ser amplificados em um PCR de etapa única, em conjunto com os controles e sequenciados em uma única rodada para reduzir os custos do teste por amostra. O software de bioinformática LymphoTrack Dx marcado para CE identifica, separa e analisa confiavelmente os dados gerados de qualquer combinação de amostras e ensaios, para que os pesquisadores e clínicos possam sequenciar e analisar os arquivos de dados, e gerar resumos de testes nos próprios laboratórios sem a necessidade de carregar dados na Internet. Este pacote de software abrangente melhora o fluxo de trabalho e a produção do laboratório, e reduz o custo do sequenciamento e o tempo de produção do instrumento. A Invivoscribe também lançou as versões LymphoTrack Research Use Only (RUO) dos ensaios de clonalidade IGH, IGK e TRG com a bioinformática que acompanha o LymphoTrack e o software MRD para uso em pesquisa clínica. Os laboratórios agora podem identificar as reorganizações clonais associadas com as magnilidades hematológicas e acompanhar os clones do MRD na própria instalação. Os testes MRD simplesmente exigem equivalentes adicionais de DNA da célula para amostragem e uma profundidade maior de leitura de sequenciamento. Com o uso destes testes os pesquisadores podem acompanhar fácil e consistentemente a doença residual em níveis de até 10^-6. "O nosso acordo com a Thermo Fisher Scientific nos dá uma oportunidade de oferecer algo mais além de ensaios RUO e ensaios marcados com CE. Com ele podemos desenvolver e comercializar reagentes, kits e software de informática padronizados internacionalmente, aprovados pelo FDA e clarificados, para laboratórios clínicos e empresas farmacêuticas para o desenvolvimento de novas drogas e terapias. Isso deve acelerar o desenvolvimento e o lançamento de novas drogas e terapias. Além disso, os resultados destes ensaios padronizados viabilização resultados clínicos mais acionáveis e confiáveis, e tratamento melhores e mais precisos. Isto será um divisor de águas e trará um grande benefício para os pacientes e para as áreas de diagnóstico molecular personalizado e de medicina de precisão", disse o Dr. Jeffrey Miller, Fundador, CSO e CEO da Invivoscribe. "Vários destes ensaios e software de bioinformática foram validados para uso com laboratórios clínicos da Invivoscribe e 'LabPMM', e estão sendo usados por parceiros líderes em centros de tratamento de câncer e de biofarmácia, ambos para otimizar o tratamento dos pacientes e para estratificar, inscrever e acompanhar doenças residuais de pacientes em estudos clínicos internacionais na Fase II e Fase III. Queremos melhora o atendimento do paciente tornando estes produtos acessíveis a todos os nossos parceiros e clientes". A colaboração da Invivoscribe com a Thermo Fisher é parte central da sua iniciativa global para o desenvolvimento e oferta de ensaios de diagnóstico molecular padronizados em suporte à medicina de precisão na oncologia. Os testes e reagentes da Invivoscribe são usados em mais de 650 laboratórios clínicos e de pesquisa em 65 países. A Invivoscribe adotou o valor dos sistemas de qualidade há muitos anos e desenvolve todos os produtos, inclusive software de bioinformática, de acordo com o controle de design ISO 13485, que permite que seus produtos passem pelos processos de regulamentação em todo o mundo. A empresa fechou parcerias de diagnóstico companheiro com a Novartis e a Astellas Pharma, Inc., e espera anunciar parcerias adicionais em 2017. Invivoscribe A Invivoscribe(R) Technologies, Inc. é uma empresa de biotecnologia privada voltada à melhoria da qualidade do cuidado de saúde em todo o mundo por meio de ferramentas de reagentes, testes e bioinformática de alta qualidade, confiáveis e de ponta para o avanço dos campos de personalized molecular diagnostics(R) e personalized molecular medicine(R). A Invivoscribe oferece reagentes PCR e NGS com certificado ISO 13485, fabricados um uma instalação registrada no FDA; kits de teste RUO, IVDs com a marca CE, inclusive ensaios IdentiClone(R) e LymphoTrack(R) Dx e Software MyInformatics(R) para teste de hipermutação de clonalidade, MRD e somática. A Invivoscribe também oferece abrangentes painéis genéticos MyAML(R), MyHeme(R), MyMRD(R), e personalizados. Usado em conjunto com o software MyInformatics(R) proprietário da Invivoscribe, estes ensaios identificam e podem acompanhar mutações de condutores primários, bem como a arquitetura subclonal e a emergência de novos condutores de mutação nos pacientes com doenças hematológicas. Os laboratórios de propriedade da Invivoscribe nos Estados Unidos, Europa e Japão proporcionam acesso internacional aos testes de conformidade clínica CLIA, CAP e ISO 15189 harmonizados e serviços de contrato com organização de pesquisa (contract research organization - CRO). Para mais informação, visite www.invivoscribe.com
News Article | February 15, 2017
TAINAN, Taiwan, Feb. 15, 2017 /PRNewswire/ -- ScinoPharm Taiwan, Ltd (TWSE: 1789), an active pharmaceutical ingredient (API) and formulation specialty company, announced unaudited financial results for its fiscal year 2016. The consolidated revenue was NT$4.031 billion (US$125 million), after-tax net profits were NT$659 million (US$20.4 million). The after-tax earnings per share was NT$0.87 (US$0.027). In 2016, overall revenue increased by 2% compared to 2015 primarily as a result of the sales boost of generic APIs, including an increased market share of Gemcitabine combined with more flexible strategies, increased shipments of Paclitaxel, as well as greater customer needs of Entecavir (HBV) and Riluzole (ALS) in anticipation for commercial launch. In terms of contract research services (CRO), several customers have achieved favorable clinical results in their Phase III trials, suggesting an increased shipment volumes and revenues. Meanwhile, revenue from contract manufacturing services (CMO) suffered a sharp reduction due to lower order volume of anti-depressants and anti-obesity drugs, but the overall performance of 2016 has been promising. Increased profit is evident in an overall gross profit margin of 45%; this is a result of a favorable blend of products and clients, especially with increased sales volume of higher profit oncology products and CRO projects. The strategic entry of oncology API Gemcitabine also contributed strongly in the company's gross margin increase. ScinoPharm also demonstrated profitability improvement by tighter cost control, process optimization, and enhanced management efficiency. ScinoPharm continues to pursue strategic alliances in order to enhance its position as a developer and manufacturer of innovative products with high added value. Currently, two ANDA submissions have been filed: an oncology injectable drug jointly developed with U.S.-based SAGENT Pharmaceuticals, and ScinoPharm-developed Fondaparinux. Product partnerships based on co-development and profit-sharing models have been established for eleven products. Furthermore, ScinoPharm is currently negotiating with major international companies for exclusive distribution rights in Europe and the U.S for the drug products indicated for cancer, multiple sclerosis, osteoporosis, diabetes mellitus, etc. To this end, investments were made to enable a GMP-compliant manufacturing plant for injectable products. The injectable plant is being positioned to prepare its first registration batch this year, file ANDA submission by the end of 2018, and expect a USFDA on-site inspection in 2019. The Changshu site in Jiangsu, China, initiated full-scale operations, contributing to ScinoPharm's overall revenues. In efforts to expand the existing CRAM business operations, the company is focusing on mid- to late-phase projects. The current portfolio includes agents in the indications of oncology, anti-hypertension, diabetes, and other therapeutics. The Changshu site is also seeking large-volume generic APIs and intermediates to increase production utilization and is exploring partnerships with generic formulation firms to maximize market share in China via joint development and registration. Oncology products continue to be the mainstay of the company's portfolio. The three primary products in the last year include Paclitaxel for ovarian, lung, and breast cancer, Irinotecan for colorectal cancer, and Gemcitabine for small cell lung and breast cancer. These three products retained ScinoPharm's market share dominance worldwide, which reaffirms the company position as a global leader in oncology product supply. ScinoPharm's regulatory presence in oncology is demonstrated and strengthened by the number of completed drug master files (DMF): The Company has applied for 733 DMFs worldwide, including 55 in the US. Of the 55 US DMFs, 32 are for oncology products. This is an unparalleled number of total DMFs among the independent global providers of APIs and proof of the company's persistent efforts in oncology products. To date, ScinoPharm has developed 72 generic APIs, including 25 marketed products. Numerous others are awaiting the subsequent expiration of active patents. In 2017, ScinoPharm anticipates launching 2 APIs for generic, 1 API for CMO project, and 1 co-developed generic injectable drug, primarily in the US and European markets. These drugs are for the indications of polyuria, benign prostatic hyperplasia, infections, and oncology. ScinoPharm Taiwan, Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With research and manufacturing facilities in both Taiwan and mainland China, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities for brand companies as well as APIs for the generic industry. The Company also is aggressively pursuing a vertically integrated, one-stop-shopping service for drug product customers by expanding into the field of sterile oncology injectable formulations. For more information, please visit the Company's website at http://www.scinopharm.com To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/scinopharm-reports-financial-performance-for-2016-300406864.html
News Article | February 27, 2017
SEOUL, South Korea, Feb. 27, 2017 /PRNewswire/ -- KAI Inc., a startup based in South Korea, announced KaiCast, an easy way to configure multi-projection setup and Rich360, a smart way to create and enjoy 360 VR content. This year, they have brought these two innovative products to showcase at Mobile World Congress(MWC) 2017 in Barcelona. KAI Inc. is planning to release a closed beta test for these two products. KaiCast enables anyone without professional experience on multi-projection to create their own immersive world by using a couple of low-spec stick PCs with projectors. The system also has the option of automatically calibrating the area using a handheld panoramic camera. "We're passionate about empowering ordinary people to create stunning visual environments for any application," said Daehyeon Wi, CTO of KAI Inc. KaiCast comes with the following features: KaiCast is the only tool in the industry that can create an immersive environment for novices. To apply for the closed beta test for KaiCast visit http://www.kaicast.io/ Rich360 provides content creators with an innovative and powerful way to enhance their 360 video content with higher image quality. Incorporating the company's proven technology, which was presented as a technical paper on ACM SIGGRAPH 2016, Rich360's suite of tools automatically optimizes the content and streams them at the richest quality over the internet. "We never stopped thinking and we never stopped researching to provide a better solution for content creators who must have been disappointed with low-quality rendering results despite all their hard work," said Jungjin Lee, CRO of KAI Inc. Rich360 is a breakthrough technology for 360 video and it meets the expectations of 360 video creators with the following features. Rich360 provides the right set of tools for a richer-quality 360 video for everyone. To apply for the closed beta test for KaiCast visit http://www.rich360.io/ KAI Inc, is a spinoff company from the Visual Media Lab at KAIST, and it presents next generation immersive media. This allows the creation of VR experiences in the simplest and the most powerful way. Their expertise in the area of computer graphics and vision technology brings fascinating applications to life. During its early years, KAI Inc. has proved its expertise in computer graphics and vision technology by jointly developing CJ CGV ScreenX; the world's first multi-projection system for theaters. The system has been installed in more than 100 theaters around the world. For more information on KAI Inc., and its sophisticated technology and premium suite of products, visit http://www.kaistudio.co.kr and follow KAI Inc. on Facebook. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/kai-inc-unveils-kaicast-an-advanced-multi-projection-solution-for-immersive-environments-and-rich360-a-360-degree-video-remastering-service-300413777.html
News Article | February 22, 2017
HOUSTON--(BUSINESS WIRE)--Pharm-Olam International LLC, a multinational, full-service Clinical Research Organization (CRO) serving the biopharmaceutical and medical device industries, today announced the appointment of Julia Graz as Senior Director, Biostatistics. Ms. Graz adds over 25 years of progressive pharmaceutical industry experience to the Pharm-Olam team. Her interests and specialties are varied and well-tested. She has worked in biostatistics, programming, data management, pharmacokinetics and quality control. Her multidisciplinary experience spans dozens of pre-clinical and Phase I-IV clinical trials. “Biostatistics is a key component of our full-service offering,” said Sanjiv Suri, Chief Executive Officer, Pharm-Olam International. “That’s why Julia is such a great addition. Her record is enviable and formidable. I’m confident she’ll be successful in helping us further develop our strategy, create efficiencies, and expand our Biostatistics business unit.” Pharm-Olam operates in more than 60 countries worldwide, offering end-to-end clinical trial support for Phase I-IV clinical trials. More information about Pharm-Olam and its full-service capabilities and offerings are available at www.Pharm-Olam.com, or by request via email (email@example.com). Pharm-Olam International is a multinational Contract Research Organization (CRO) offering comprehensive clinical research services to the pharmaceutical, biotechnology and medical device industries. From Phase I to Phase IV, Pharm-Olam focuses on delivering the highest quality data, achieving targeted enrollment and meeting projected timelines, making clinical research as Easy As I, II, III, IV™. For more information about Pharm-Olam, visit www.Pharm-Olam.com.
News Article | February 27, 2017
HORSHAM, England--(BUSINESS WIRE)--Cmed, an innovative technology-led CRO, will present “Risk-Based Monitoring, Remote Monitoring and eSource: The Unattainable Trilogy of Monitoring?” at the ACDM Annual Conference being held in Brussels on Tuesday, March 14, 2017. In this presentation, Stephanie Langouet, Cmed’s Vice President of Data and Analytics, will explore the practical implementation of more effective monitoring strategies, from traditional 100% Source Data Verification (SDV) to Risk-Based Monitoring (RBM) and increased remote review, and will assess the impact on site monitoring and clinical data management activities. She will touch upon several themes, including the role of data management at the heart of central reviews and the development of analytics tools, as well the benefits of direct capture of source data (eSource). She will also examine how a flexible combination of RBM, Remote Monitoring and eSource, supported by effective and operational processes, can reduce costs and enable smarter trials. This presentation will take place at 11.05am. In addition, Langouet will participate in the panel discussion with other industry leaders. Attendees will also have the opportunity to meet with her and find out how Cmed’s encapsia™ clinical data suite, as well as Cmed’s portfolio of CRO service offerings, which includes both full service and clinical data management and biostatistics functional service provision, can help support the effective delivery of clinical trials. encapsia™ is the first App based new generation clinical data suite, providing a much needed solution to the ever-rising complexity and cost of clinical research. With new and better options to collect, query, clean, visualize and analyze clinical data in real time, all within one clinical data suite, encapsia™ allows Cmed to significantly enhance the delivery of clinical trials. To schedule a meeting with Langouet during the ACDM annual conference, email her at firstname.lastname@example.org. Cmed is an innovative, full service technology-led CRO. Cmed brings together experienced people and technology, providing customers with a friendly, proactive service, and delivers this service using advanced clinical data capture, management and reporting software and processes. Cmed’s new generation clinical data suite, encapsia™, streamlines the capture, management and reporting of clinical data, saving customers time and money. Clinical data can be captured flexibly by eSource, multi-media and web eDC, while being displayed in live visual insights, providing live analytics, and allowing within suite audit trailed actions. It is fully compliant with regulatory guidelines, and allows integration with existing systems. For more information visit www.cmedresearch.com.
News Article | February 15, 2017
HIGH POINT, N.C.--(BUSINESS WIRE)--High Point Clinical Trials Center announced that it has partnered with Verified Clinical Trials (VCT), the global clinical trials database registry, to insure the appropriate selection and qualification of subjects participating in their clinical trials at their North Carolina research facility. “We are extremely pleased to partner with Verified’s Global Clinical Trials Database Registry to ensure the safety of study participants and continue to provide the highest quality data for our clients,” says Dr. Lorraine M. Rusch, President of High Point Clinical Trials. “As a leading clinical research facility, it is our medical and quality mandate to use innovative technology such as VCT’s database to prevent the duplicate enrollment of clinical trial participants across multiple trials in different clinical research facilities across the country.” Duplicate enrollment of subjects (simultaneous enrollment in multiple clinical trials) has become a challenge for the biopharmaceutical sector, impacting clinical research programs across the industry. Verified Clinical Trials uses biometric fingerprint technology to register subjects and create a record of the highest clinical confidence. The result is an improvement in data quality and safety for study volunteers as it prevents duplicate enrollment in trials at facilities in the registry. “We are proud to welcome High Point Clinical Trials to our client base,” says Mitchell D. Efros, MD, FACS, CEO of Verified Clinical Trials. “This collaboration demonstrates their commitment to the highest possible quality of participant safety. Including their data in our registry will also significantly enhance the value of the registry to all our participants. Now research sponsors can have an even higher level of confidence in the data High Point Clinical Trials Center provides.” Originally, High Point Clinical Trials Center was founded by Dr. Adnan Mjalli in 2008. Our founder and staff bring extensive experience to this process as both as a sponsor and CRO. High Point Clinical Trials Center (HPCTC) has transformed into a dedicated clinical trial facility which specializes in the execution of Phase I-III clinical trials. In addition to early development studies, we conduct studies across a range of therapeutic indications including metabolic, respiratory and CNS in a pleasant and comfortable environment managed by caring and experienced staff. At the cutting edge of medical research, we also pride ourselves on our commitment to community care, with physicians volunteering around the community and around the world to provide medical access to patients in need. Verified Clinical Trials is a forward-thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials. Verified Clinical Trials halts duplicate enrollment in clinical trials and defines itself as the world’s leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry selected by the NIH to prevent duplicate enrollment in clinical trials. Verified Clinical Trials is designed specifically to enhance the quality of both early and late phase trials, and has the scalability to reach all sites nationally as well as on a global level.
News Article | February 15, 2017
Digital marketing agency Vizion Interactive announced today that following a competitive agency review, they have been chosen as Search Agency of Record for Perennials and Sutherland, LLC. This announcement came as an exciting addition to Vizion’s proud family of clients. Vizion will develop a strategic search engine optimization plan for Perennials with goals of increasing their overall web presence, driving more qualified leads and sales, and increasing ROI. Vizion Interactive CEO and President Mark Jackson said this about the new partnership, “Perennials and Sutherland has been a leader in its field, for some time, yet had not yet taken the steps necessary to drive its presence via organic search. By working with the team at Perennials, understanding their sales process and historic conversions rates, we were able to crunch the numbers to establish a clear path forward. Our team of experts has clearly defined a project scope for this effort and were able to, with a reasonable level of certainty, visualize a significant positive ROI for the investment that Perennials will be putting forth into this effort. We appreciate the opportunity to partner with them, and look forward to reporting positive results in the near future.” The Perennials and Sutherland group of companies are acknowledged leaders in the international design industry. The company excels at collaborating with leading designers to produce the finest luxury furniture, fabrics and accessories. David Sutherland Showrooms are exclusive to the trade and represent the finest in home furnishings, fabrics and accessories, along with the company's signature Perennials and Sutherland brands. “Vizion brings a sound methodology to increasing organic traffic and a measureable way to quantify results,” said Allen Evans, Director of Marketing, Perennials and Sutherland, LLC. “I’m excited to partner with Vizion once again and begin driving more qualified traffic that will increase the size of our digital footprint, increase the quantity and quality of our KPIs and conversion events, and ultimately lead to more sales activity.” Vizion Interactive is a Google Premier Partner and leading digital marketing services agency, bringing the process and tools that you might expect from the largest agencies, the specialized skills and knowledge of a boutique, and the care and attention of an independent contractor. Vizion Interactive provides a wide array of digital marketing services to B2B, B2C, franchise, and ecommerce clients including SEO, PPC, SMM, UX, CRO and Enterprise Analytics and Reporting. The Perennials and Sutherland, LLC companies are icons and acknowledged leaders in the international design industry. CEO David Sutherland and President Ann Sutherland share an ingenious talent for curating the finest interior and exterior collections of luxury furniture, fabrics, rugs and accessories. Based in Dallas, Texas, the company is comprised of Sutherland Furniture®, Perennials Luxury Performance Fabrics® and David Sutherland Showrooms. Perennials Fabrics® is recognized by interior designers and high-end retail customers as the leader in luxury performance fabrics. Perennials Fabrics® and Perennials Luxury Performance Rugs combine the look and feel of high-quality, natural materials with the superior performance properties of their genuine 100% solution-dyed acrylic fiber technology. View the full collections at perennialsfabrics.com. Sutherland Furniture® is a world leader in luxury outdoor furniture for modern lifestyles. The company has created the preeminent furniture brand through partnerships with the world's leading designers, along with utilizing the highest quality materials. View the full collections at sutherlandfurniture.com. David Sutherland Showrooms are full-service, multi-line showrooms which serve the professional design market in showrooms and studios across the United States. For more information and locations, visit davidsutherlandshowroom.com.
News Article | February 15, 2017
The industry analysis report “Protein A Resins Market Size By Application (Immunoprecipitation, Antibody Purification), By Product (Natural protein A, Recombinant Protein A), By Matrix (Agarose, Glass/Silica Gel, Organic Polymer), By End Use (Biopharmaceutical, Clinical Research, Academic Research, CRO), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, Spain, Italy, Russia, Poland, Japan, China, India, Australia, Argentina, Brazil, Mexico, South Africa, UAE, Saudi Arabia, Qatar, Kuwait, Egypt), Growth Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2024” by Global Market Insights, Inc. says Protein A Resin Market size is slated to surpass USD 900 million by 2024. Protein A resins are crucial and are broadly used as purification and separation materials owing to high resolution, across the biopharmaceutical industry. They exploit the chemical and physical variances among biomolecules for separation of antibodies by immunoprecipitation and antibody purification. Growing diagnostic and therapeutic applications of monoclonal antibodies will be the major driver for protein A resins market size. Request for a sample of this research report @ https://www.gminsights.com/request-sample/detail/1146 High selectivity and improved antibody yield coupled with ease of operation in large and small scale antibody purification and immunoprecipitation will further drive the protein A resins market growth. Chromatography with these has several advantages as a separation method, over conventional techniques like solvent extraction, crystallization, and distillation. For instance, it can separate all the components of a multicomponent biochemical mixture without demanding a detailed foreknowledge of the number, identity, or relative quantities of the materials present in the mixture. U.S. market growth will continue to dominate other regions due to presence of well-established infrastructure for clinical trials. Recombinant protein A resins market will grow at significant CAGR of around 8% during the forecast period owing to the wealth of techniques and products used for their expression and purification. Contract research organizations (CROs) provide modified solutions for monoclonal antibody and recombinant protein production from mammalian cell culture. The segment accounted for second highest revenue share of around 15%. CROs also offer large-scale protein production and virus production, making it suitable for pharmaceutical and biotechnology companies as well as academic institutions to outsource processes. Browse key industry insights spread across 127 pages with 123 market data tables & around 8 figures & charts from this 2017 report Protein A Resins Market in detail along with the table of contents at: In 2015, Spain protein A resins market size was over USD 25 million, increasing investments by public and private companies in the development of biosimilars and increasing demand for biosimilar products are the significant factors driving the market for monoclonal antibodies and eventually Spain market growth. Asia Pacific protein A resins market will grow at highest CAGR of over 8.5%, favorable government policies, dynamic infrastructure development will attract international companies to set-up manufacturing plants in the region and availability of skilled professionals at affordable costs. The region has emerged as a preferred destination for contract research organizations and various biopharmaceutical companies to establish business. Japan protein A resins market accounted for over 40% share, as its healthcare infrastructure is experiencing noteworthy transformation. The government is strategically planning a regulatory system in which public and private companies will contribute to develop novel biosimilar products. India antibody purification market has witnessed notable growth in recent years, which could continue in the vicinity of 10%, with factors such as increasing research into the development monoclonal antibodies, driving protein A resins market growth. Make an inquiry for purchasing this report @ https://www.gminsights.com/inquiry-before-buying/1146 Protein A resins market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD million from 2012 to 2024 , for the following segments: The above information is provided on a regional and country basis for the following : Global Market Insights, Inc., headquartered in Delaware, U.S., is a global market research and consulting service provider; offering syndicated and custom research reports along with growth consulting services. Our business intelligence and industry research reports offer clients with penetrative insights and actionable market data specially designed and presented to aid strategic decision making. These exhaustive reports are designed via a proprietary research methodology and are available for key industries such as chemicals, advanced materials, technology, renewable energy and biotechnology.