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Patent
Merck And Co. | Date: 2015-06-15

The present invention is directed to stable pharmaceutical formulations. More specifically, the present invention is directed to stable pharmaceutical formulations of testosterone undecanoate.


The BLA filing for tildrakizumab with the U.S. FDA is based on two pivotal Phase III trials (reSURFACE 1 and 2) which included over 1,800 patients across more than 200 clinical trial sites, including some patients who have been treated with tildrakizumab for up to three and a half years. Data from these trials were most recently presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 25th European Academy of Dermatology and Venereology Congress. Future presentations and publications of the reSURFACE Phase-3 pivotal trials will include more scientific insights on the data to week 52 and beyond. The clinical trials are designed to evaluate safety and efficacy for up to five years, and to date, some clinical trial participants have been treated with tildrakizumab for up to three and half years. About Psoriasis Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million people in the U.S. and approximately 125 million people worldwide1. It is a non-contagious disorder that speeds the growth cycle of skin cells1 and results in thick scaly areas of skin2. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed2. Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease. About Tildrakizumab Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. With this precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system. Phase-3 tildrakizumab data provide further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis. About Tildrakizumab Phase-3 reSURFACE Trial Design Tildrakizumab Phase-3 studies (reSURFACE 1 and 2) are randomized, placebo-controlled, multicenter, three-part studies designed to demonstrate efficacy of tildrakizumab in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. Part one of the studies randomized patients into three or four treatment arms, including tildrakizumab 200mg, tildrakizumab 100mg, placebo and etanercept (reSURFACE 2 only). After Week 12 patients on placebo and etanercept were then re-randomized into tildrakizumab 200mg and 100mg treatment arms to proceed into part two of the studies. Finally, in part three of the studies, responders (PASI ≥75) and partial responders (PASI ≥50 and PASI <75) were re-randomized after Week 28 continue the same treatment, a different dose of tildrakizumab or placebo. The co-primary efficacy endpoint of the two placebo controlled studies were the proportion of patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician's Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The reSURFACE 2 also included a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoint of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28. PGA measures lesion thickness, erythema and scaling across all of a patient's psoriasis lesions in order to determine the disease activity on a six-point scale from "clear" to "severe." A PASI score is a measure of psoriatic plaque redness, scaling and thickness and extent of the involvement in each region of the body. Treatment efficacy is often measured by reduction of PASI from baseline (i.e. 75 percent reduction is known PASI 75), a 90 percent reduction is known as PASI 90 and PASI 100 is total clearance of skin disease. About Sun Dermatology Sun Pharma is committed to expanding our dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions with high unmet medical needs like psoriasis. Sun Pharma, along with its subsidiaries, is ranked fourth in dermatology prescription volume within the U.S. per IMS and is fifth largest specialty generic pharmaceutical company globally. In addition to the investigational candidate tildrakizumab, an investigational anti-IL- 23p19 monoclonal antibody, Sun Dermatology is comprised of several branded products indicated for the treatment of acne and actinic keratosis with a focus on other dermatologic conditions with unmet needs such as psoriasis and atopic dermatitis. For further information, please visit www.sunpharmaderm.com About Sun Pharma, Merck & Co., Inc., Kenilworth, NJ, USA, Agreement Sun Pharmaceutical Industries Ltd.'s wholly owned subsidiary acquired worldwide rights to tildrakizumab from Merck (through a Merck subsidiary), known as MSD outside the United States and Canada, in 2014. Funded by a Sun Pharma subsidiary, Merck is responsible for the completion of Phase- 3 trials in patients with mild-to-moderate plaque psoriasis and, as appropriate, submission of a Biologics License Application to the United States Food and Drug Administration (FDA). Merck is also responsible for manufacturing finished goods to support Sun Pharma's initial product launch. Post-approval in the U.S., Sun Pharma will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialization of approved products for all non-U.S. markets. Merck is eligible to receive milestone payments and royalties on sales of tildrakizumab. The agreement between Sun Pharma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck. About Sun Pharma, Almirall S.A, Europe, Agreement Sun Pharma and its wholly owned subsidiary and Almirall (Spanish Stock Exchange ticker: ALM) closed on July 2016 a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Under terms of the license agreement, Almirall is able to lead European studies, and participate in larger Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agreements, as well as certain cost sharing agreements. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe. The agreement between Sun Pharma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck. Disclaimer: Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 49 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. The consolidated revenues for 12 months ending March 2016 are approximately US$ 4.3 billion, of which US contributes US$ 2.1 billion. In India, the company enjoys leadership across 12 different classes of doctors with 31 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 4 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of over 8% of annual revenues. For further information please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sun-pharma-announces-us-fda-filing-acceptance-of-biologics-license-application-bla-for-tildrakizumab-300463108.html


The invention is a pharmaceutical tablet formulation comprising between about 12.5 mg and 100 mg losartan potassium, between about 6.25 mg and about 50 mg chlorthalidone, and sodium bicarbonate in an amount between about 1.0% and about 10.0% by weight.


Patent
Sharp Corporation, Merck And Co. and Msd R&D China Co. | Date: 2015-07-10

The present invention is directed to a process for making Tetracyclic Heterocycle Compounds of Formula (I) and pharmaceutically acceptable salts thereof, wherein X^(1), X^(2), R^(1), R^(2 )and R^(3 )are defined above herein. The present invention is also directed to compounds that are useful as synthetic intermediates in the process of the invention.


Patent
Merck And Co. | Date: 2017-04-26

The present invention is directed to stable pharmaceutical formulations. More specifically, the present invention is directed to stable pharmaceutical formulations of testosterone undecanoate.


Grant
Agency: European Commission | Branch: H2020 | Program: IA | Phase: NMP-04-2014 | Award Amount: 7.88M | Year: 2015

Bringing intelligence and communication to everyday objects is a major challenge for future electronics. This Internet of Things concept envisions wide dissemination with new performances: robustness, large area, flexibility, eco-efficient large volume manufacturing at low cost. Beyond current TOLAE demonstration, a major technology jump driving the scalability towards nanoscale resolution via high-definition cost-effective printing is required to deliver the properties and electrical performances expected by applications. ATLASS Innovation Action takes this huge step by bringing high resolution technologies to the printing industries for the demonstration of products at TRL6 in high impact markets. New multifunctional high-performing inks (semiconductor mobility >1cm2/Vs, dielectrics, ferroelectrics) and high-resolution (down to 500nm and ~100nm thickness) R2R/S2S printing including nano-imprinting and gravure printing will be engineered and scaled-up on pre-industrial pilot lines, enabling high performance devices (speed ~ 10 MHz). In-line control and novel automatic optical inspection tools and methodology will be installed to ramp-up the yield of developed processes (>99%) thus enabling cost-efficient fabrication of advanced circuits (>1000 transistors, 50kHz clock rate). The technology capability is benchmarked with conventional TOLAE process and demonstrated with 4 applications in the field of Interactive objects and Sensing surfaces (temperature tag for smart food packaging, electronic label for logistics, impact force sensing foils for automotive safety -, proximity sensing for safer human-robot collaboration ). With a consortium of 11 top companies (7 SMEs) from the cutting-edge, fast growing printed electronics sector and 4 RTOs with high-level technology expertise, ATLASS will strongly impact the global market of sensors, labels and smart objects expected to reach revenue of several EUR billion with printed sensors share of EUR 644 million by 2022.


Grant
Agency: European Commission | Branch: H2020 | Program: MSCA-ITN-ETN | Phase: MSCA-ITN-2016 | Award Amount: 3.83M | Year: 2016

Organic solar cells (OSCs) have the potential to become an environmental friendly, inexpensive, large area and flexible photovoltaics technology. Their main advantages are low process temperatures, the potential for very low cost due to abundant materials and scalable processing, and the possibility of producing flexible devices on plastic substrates. To improve their commercialization capacity, to compete with established power generation and to complement other renewable energy technologies, the performance of state-of-the-art OSCs needs to be further improved. Our goals within SEPOMO Spins in Efficient Photovoltaic devices based on Organic Molecules are to bring the performance of OSCs forward by taking advantage of the so far unexplored degree of freedom of photogenerated species in organic materials, their spin. This challenging idea provides a unified platform for the excellent research to promote the world-wide position of Europe in the field of organic photovoltaics and electronics, and to train strongly motivated early stage researchers (ESRs) for a career in science and technology oriented industry that is rapidly growing. Our scientific objectives are to develop several novel routes to enhance the efficiency of OSC by understanding and exploiting the electronic spin interactions. This will allow us to address crucial bottlenecks in state-of-the-art OSCs: we will increase the quantum efficiency by reducing the dominant recombination losses and by enhancing the light harvesting and exciton generation, e.g. by means of internal upconversion of excited states. Our ESRs will be trained within this interdisciplinary (physics, chemistry, engineering) and intersectoral (academia, R&D center, enterprise) consortium in highly relevant fundamental yet application-oriented research with the potential to commercialise the results. The hard and soft skills learned in our network are central for the ESRs to pursue their individual careers in academics or industry.


Scapin G.,Merck And Co.
Acta Crystallographica Section D: Biological Crystallography | Year: 2013

The 'phase problem' in crystallography results from the inability to directly measure the phases of individual diffracted X-ray waves. While intensities are directly measured during data collection, phases must be obtained by other means. Several phasing methods are available (MIR, SAR, MAD, SAD and MR) and they all rely on the premise that phase information can be obtained if the positions of marker atoms in the unknown crystal structure are known. This paper is dedicated to the most popular phasing method, molecular replacement (MR), and represents a personal overview of the development, use and requirements of the methodology. The first description of noncrystallographic symmetry as a tool for structure determination was explained by Rossmann and Blow [Rossmann & Blow (1962), Acta Cryst. 15, 24-31]. The term 'molecular replacement' was introduced as the name of a book in which the early papers were collected and briefly reviewed [Rossmann (1972), The Molecular Replacement Method. New York: Gordon & Breach]. Several programs have evolved from the original concept to allow faster and more sophisticated searches, including six-dimensional searches and brute-force approaches. While careful selection of the resolution range for the search and the quality of the data will greatly influence the outcome, the correct choice of the search model is probably still the main criterion to guarantee success in solving a structure using MR. Two of the main parameters used to define the 'best' search model are sequence identity (25% or more) and structural similarity. Another parameter that may often be undervalued is the quality of the probe: there is clearly a relationship between the quality and the correctness of the chosen probe and its usefulness as a search model. Efforts should be made by all structural biologists to ensure that their deposited structures, which are potential search probes for future systems, are of the best possible quality.


Marino M.J.,Merck And Co.
Biochemical Pharmacology | Year: 2014

Descriptive, exploratory, and inferential statistics are necessary components of hypothesis-driven biomedical research. Despite the ubiquitous need for these tools, the emphasis on statistical methods in pharmacology has become dominated by inferential methods often chosen more by the availability of user-friendly software than by any understanding of the data set or the critical assumptions of the statistical tests. Such frank misuse of statistical methodology and the quest to reach the mystical α < 0.05 criteria has hampered research via the publication of incorrect analysis driven by rudimentary statistical training. Perhaps more critically, a poor understanding of statistical tools limits the conclusions that may be drawn from a study by divorcing the investigator from their own data. The net result is a decrease in quality and confidence in research findings, fueling recent controversies over the reproducibility of high profile findings and effects that appear to diminish over time. The recent development of "omics" approaches leading to the production of massive higher dimensional data sets has amplified these issues making it clear that new approaches are needed to appropriately and effectively mine this type of data. Unfortunately, statistical education in the field has not kept pace. This commentary provides a foundation for an intuitive understanding of statistics that fosters an exploratory approach and an appreciation for the assumptions of various statistical tests that hopefully will increase the correct use of statistics, the application of exploratory data analysis, and the use of statistical study design, with the goal of increasing reproducibility and confidence in the literature. © 2013 Published by Elsevier Inc.


Gaffen S.L.,Merck And Co.
Nature reviews. Immunology | Year: 2014

Following the discovery of T helper 17 (TH17) cells, the past decade has witnessed a major revision of the TH subset paradigm and substantial progress has been made in deciphering the molecular mechanisms of T cell lineage commitment and function. In this Review, we focus on the recent advances that have been made regarding the transcriptional control of TH17 cell plasticity and stability, as well as the effector functions of TH17 cells, and we highlight the mechanisms of IL-17 signalling in mesenchymal and barrier epithelial tissues. We also discuss the emerging clinical data showing that IL-17-specific and IL-23-specific antibody treatments are remarkably effective for treating many immune-mediated inflammatory diseases.

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