NEW YORK, April 3, 2017 /PRNewswire/ -- Use this report to: - Explore present and future strategies within the bioseparation systems market. - Learn about the upcoming developments, the holdups and the needs of the market. - Gain an insight into acquisition strategies and collaborations by companies.

Read the full report: http://www.reportlinker.com/p0619255/Separation-Systems-for-Commercial-Biotechnology.html

- Receive an overview of the relevant patents related to the industry.

Highlights - The global market for bioseparation reached $18.4 billion in 2015. This market is expected to increase from $19.0 billion in 2016 to nearly $24.0 billion in 2021 at a compound annual growth rate (CAGR) of 4.7% for 2016-2021. - United States market for bioseparation is expected to grow from $7.0 billion in 2016 to nearly $9.3 billion at a CAGR of 5.9% from 2016 through 2021. - Emerging market for bioseparation is expected to grow from $7.0 billion in 2016 to $8.7 billion in 2021 at a CAGR of 4.4% from 2016 through 2021.

Introduction & Scope

Introduction

Study goals and objectives In recent years, the bioseparation systems (separation systems in biotechnology) segment has been one of growth in the biopharmaceuticals market. Primary use of these systems is for separation and purification of biological products. BCC Research's goal in conducting this study is to provide an overview of the current and future characteristics of the global market for various bioseparation systems. This report explores present and future strategies within the bioseparation systems market. The market is categorized into liquid chromatography, centrifugation, electrophoresis, membrane filtration, flow cytometry, microarray, labonachip, biochip, and magnetic separation. The upcoming developments of the market, the holdups and the needs of the market are discussed in this report. The classifications, comparisons and usage of these products are also portrayed in this report. A detailed analysis of the structure of the bioseparation systems industry has been conducted. The revenues have been broken down by region and sales figures are estimated for the fiveyear period from 2016 through 2021. The report also covers significant patents and their allotments in each category.

Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strengths and weaknesses of each type in light of new technologies, growing competition, and changing customer needs.

Reasons for doing this study Bioseparation systems have a major place in the biopharmaceutical and biotechnology industry. Bioseparation is conducted on biological products like proteins, nucleic acids, and cell cultures, among others. The increasing demand for biopharmaceutical products is driving the global market for bioseparation systems. Increased research in life sciences, newer technological developments are taking bioseparation techniques to prodigious heights. Modern industries have now begun to explore the advantages of bioseparation systems in their production processes, which have led to a steady market. Research and development (R&D) spending, along with increasing competition and patent expiries are giving a new direction to the market. This study looks at almost all the systems affected by these factors.

Contributions of the study and for whom This study contributes to the areas of market growth for the manufacturers and users of bioseparation systems. Genomic research centers, academic institutions, government and private laboratories, as well as pharmaceutical, diagnostic and biotechnology companies will find this study to be of interest.

Scope of report The market for bioseparation systems is growing rapidly across all regions. Bioseparation purifies biological products on a largescale. The report focuses on the global market of bioseparation systems and provides an updated review, including basic design and its applications, in various arenas of biomedical and life science research. The scope of the study is global. BCC Research analyzes each market, new products and advancements, technologies involved, market projections and market shares. The geographical regions covered in the report are North America, Europe and emerging markets. The emerging market covers all countries like India, China, Japan, Korea, Taiwan, Africa, Australia, New Zealand, and Canada, among others. The bioseparation techniques that are covered in this report are chromatography, centrifugation, electrophoresis, membrane filtration, flow cytometry, microarray, labonachip, biochip, and magnetic separation. Among chromatography techniques, liquid chromatography is the most active market.

Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the bioseparation systems market. Key players include Thermo Fisher Scientific, Agilent Technologies Inc., BioRad Laboratories, Danaher Corp., Qiagen N.V., Merck KGaA GmbH, and Waters Corp. among others.

Information sources Many companies were surveyed to obtain data for this study. Included were manufacturers and end users of bioseparation systems. Data was gathered from various industry sources. BCC Research spoke with officials within the industry, consulted newsletters, company literature, product literature, and a host of technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial, trade, and government sources.

Methodology Read the full report: http://www.reportlinker.com/p0619255/Separation-Systems-for-Commercial-Biotechnology.html

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Separation Systems for Commercial Biotechnology - Yahoo Finance

SUNNYVALE, Calif., April 3, 2017 /PRNewswire-iReach/ -- Three business and scientific leaders with early-stage investors today announced the formation of Apostle Inc, a biotechnology company developing a novel bioinformatics-enabled nanotechnology aimed for early cancer detection. This new approach will enable the early assessment of the cancerous signals in human peripheral blood plasma, which is believed to have a significant impact on the global healthcare landscape in both developed countries and emerging markets.

Dr. David Dongliang Ge, an experienced business and scientific leader who was President of BioSciKin Co. and Director of Bioinformatics at Gilead Sciences, will lead the new company. He is joined by two colleagues as co-founders of Apostle and his investment partners. "Biotechnologies, especially those focusing on novel diagnostic or therapeutic advancements aiming for cancer, are among the key focuses in the global economy for the next 5-20 years. By 2020, the market size ofcancerdiagnosis is estimated to reach $168.6 billion. Apostle represents one of these focuses." Dr. Ge said. "With a groundbreaking bioinformatics-enabled nanotechnology approachwe want to inform the general population that we are able to help them identify cancer signals, earlier and more accurate than conventional techniques, and potentially advise their doctors to take highly effective surgical actions. "

"It's been a great pleasure to have the opportunity to work with David and his team on this amazing venture. We're thrilled to work with this scientifically imaginative and visionary company." One of the investors said. Apostleis funded by Amino Capital, ShangBay Capital, Westlake Ventures in the Silicon Valley and a group of individual investors from both the Silicon Valley and China. Apostle is advised by Dr. Charles Cantor, an American molecular geneticist, former director of the Department of Energy Human Genome Project, a member of the National Academy of Sciences, as well as Dr. Hongyu Zhao, the Ira V. Hiscock Professor of Biostatistics and Professor of Statistics and Genetics, Chair of the Biostatistics Department and the Co-Director of Graduate Studies of the Inter-Departmental Program in Computational Biology and Bioinformatics at Yale University.

About Apostle Inc.

Apostle Inc is a biotechnology company in Sunnyvale, CA. It's in the business of the research, development, licensing, and sales of novel bioinformatics-enabled nanotechnologies and the related intellectual properties, products, and services for diagnosis and treatment of human diseases

About the founder team of Apostle Inc.

Dr. David Dongliang Geis CEO and President of Apostle. Previously, he was President of BioSciKin Co. and Simcere Diagnostics Co., two global biotechnology companies headquartered in Nanjing, China. Between 2011 and 2016, he was Director of Bioinformatics at Gilead Sciences, where he founded and provided leadership to the bioinformatics group. Dr. Ge and his group led the phylogenomic analytical support for the critical regulatory approval of Sovaldi, a world-leading anti-HCV drug. In 2014 and 2015, Dr. Ge was invited to be a member of the U.S. NHGRI Special Emphasis Panel. He was appointed as Assistant Professor of Biostatistics and Bioinformatics at Duke University School of Medicine. He received his Ph.D.ofBiostatistics and Genetic Epidemiology from Peking Union Medical College and Chinese Academy of Medical Sciences in 2004. Dr. Ge's work in discovering the IL28B genetic variants associated with the clinical treatment responses, published in Nature in 2009, has received over 3000 times of citations with the U.S. FDA's citation in its several guidance for industry. The invention was licensed to LabCorp and QuestDiagnostics,and has become clinical diagnostic services since then (LabCorp 480630 and Quest AccuType IL28).Dr. Ge has authored over 70 original articles, including 5 in Nature and 1 in Science, in total receiving over 15,000 citations. Dr. Ge was named by the U.S. Genome Technology magazine as one of the "Rising Stars" in 2009, and by the U.K. Phacilitate as one of the "Top 50 Most Influential People in Big Data" in 2015.

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Bo Zhang, Ph.D.is VP of Chemistry of Apostle. Dr. Zhang received his Ph.D.ofChemistry from Stanford University in 2015 and received his B.S.ofChemistry from Peking University in 2010. Dr. Zhang has won the Gold Medal of National Chemistry Olympiad of China in 2006. Dr. Zhang has 10 years of experience in nanotechnology research, with outstanding achievements in developing novel nanomaterials with unique fluorescence characteristics. Dr. Zhang published over 30 original paperson Nature Medicine, Nature Materials, Nature Photonics, Nature Communications, etc. Dr. Zhang's two articles in Nature Medicine about novel nano-platform for type 1 diabetes and Zika virus infection diagnosis have attracted worldwide attention. Dr. Zhang has been PI for research projects funded by the NIH. He holds many patents. Dr. Zhang was the recipient of Materials Research Society Awards, Mona M. Burgess Fellow, William S. Johnson Fellowship, etc.

Xin Guo, Ph.D.is VP of Bioinformatics of Apostle. Previously, Dr. Guo was group leader at Gilead Sciences, in charge of the clinical phylogenomic program for developing Sovaldi. Dr. Guo received his Ph.D. in Computer Sciences from Duke University and M.S. in Informatics from Max Planck Institute of Germany. He received his B.S. in Informatics from Chiba Institute of Technology of Japan. Dr. Guo has over 10 years of experience in the R&D ofhigh performancecomputing, machinelearningand artificial intelligence. Dr. Guo has extensive experience in product development of complex algorithms and databases, with applications in genomic big data.

Wenqi Zeng, MD,PhD, FACMGis Chief Medical Advisor of Apostle. He is Chief Medical Officer of Simcere Diagnostics Co. Previously, Dr. Zeng was Senior Director of Molecular Genetics at Quest Diagnostics and was Director of Clinical Genomics at Ambry Genetics. Dr. Zeng was fellow of Clinical Molecular Genetics and Medical Genetics at Harvard. He received his M.D. from Xiang-Ya Medical School in China and Ph.D. in MolecularPatholgy/Molecular Genetics fromUniversityof Otago. He holds Diploma of American Board of Medical Genetics and Genomics(ABMGG),and is a qualified CAP inspection team leader, and a qualified CAP CLIA lab director in CA,FLand MD. He also has NY state COQ in molecular genetics and molecular oncology.

Media Contact: Public Relations, Apostle, Inc, Apostle, Inc, 650-483-5437, pr@apostlebio.com

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Apostle Inc, a Biotechnology Company for Early Cancer Detection, is Founded in the Silicon Valley - Yahoo Finance

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that interim results from a Phase II clinical trial of Pumas investigational drug PB272 (neratinib) were presented at the 2017 American Association for Cancer Research Annual Meeting (AACR) that is currently taking place in Washington, D.C. The presentation, entitled Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients with HER2-positive early stage breast cancer: the CONTROL trial, was presented as a poster presentation.

The main adverse event that has been seen to date in clinical trials of neratinib is diarrhea and more specifically grade 3 diarrhea. In the Phase III ExteNET trial of neratinib as extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with adjuvant Herceptin, 95.4% of the patients experienced all grade diarrhea and 39.8% of the patients experienced grade 3 or higher diarrhea (there was one event of grade 4 diarrhea). The CONTROL trial is an international, open-label, Phase II study investigating the use of loperamide prophylaxis with or without other agents in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 diarrhea.

In the CONTROL trial, patients with HER2-positive early stage breast cancer who had completed trastuzumab-based adjuvant therapy received neratinib daily for a period of one year. High dose loperamide prophylaxis was given for the first 2 cycles (56 days) of treatment. Initially, the loperamide dosing used was 16 mg on day 1, then 12 mg on days 2 and 3 and then 6-8 mg on days 4-56 (original dosing). The protocol was later amended to simplify the regimen such that patients took 12 mg on days 1-14 and 8 mg on days 15-56 (modified dosing). The CONTROL trial was also expanded to include two additional cohorts. One cohort received the combination of loperamide and budesonide and the other cohort received the combination of loperamide plus colestipol. Budesonide is a locally acting corticosteroid that the Company believes targets the inflammation identified in a preclinical model of neratinib-induced diarrhea and colestipol is a bile acid sequestrant that the Company believes targets the bile acid malabsorption also seen in preclinical models of neratinib-induced diarrhea.

The interim analysis of the trial presented in the poster included a total of 137 patients who received neratinib plus loperamide prophylaxis (28 patients taking the original dosing and 109 patients taking the modified dosing), 64 patients who received neratinib plus loperamide prophylaxis for 2 cycles and budesonide for 1 cycle, and 26 patients who received neratinib plus loperamide prophylaxis for 1 cycle and colestipol for 1 cycle.

The results of the trial showed that the incidence of grade 3 diarrhea for the 137 patients who received the loperamide prophylaxis was 30.7%. For the 137 patients who received the loperamide prophylaxis, the median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 3 days. For the 137 patients who received loperamide prophylaxis, 20.4% discontinued neratinib due to diarrhea.

For the 64 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 23.4%. The median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 2 days. For the 64 patients who received loperamide plus budesonide prophylaxis, 9.4% discontinued neratinib due to diarrhea.

For the 26 patients who received the combination of loperamide plus colestipol, the results of the trial showed that the incidence of grade 3 diarrhea was 11.5%. The median number of grade 3 diarrhea episodes per patient was 2 and the median cumulative duration of grade 3 diarrhea was 2 days. For the 26 patients who received loperamide plus colestipol prophylaxis, no patient (0%) discontinued neratinib due to diarrhea. Further information is provided in Table 1 below:

Table 1: Characteristics of Treatment-Emergent Diarrhea

Loperamide

(original +

modified)

loperamide

loperamide

Loperamide

prn

a

In the ExteNET trial, higher grade (grade 2 and grade 3) diarrhea occurred early and persisted throughout the duration of the 12-month treatment period. In the CONTROL trial, in the loperamide prophylaxis, loperamide plus budesonide prophylaxis and loperamide plus colestipol prophylaxis arms, the results showed that higher grade diarrhea (grades 2 and 3) occurred early but did not typically recur. This is shown in more detail in Figure 1: Treatment Emergent Diarrhea, which is attached to this news release. In addition, a full copy of the poster that was presented at AACR is available on the Puma Biotechnology website.

During the course of the CONTROL trial there has been an increase in the proportion of patients previously treated with pertuzumab (mainly in the neoadjuvant setting). For the 55 patients in the loperamide prophylaxis cohort who received prior pertuzumab, the grade 3 diarrhea rate was 38.2% (Table 2). For the 82 patients who did not receive prior pertuzumab, the grade 3 diarrhea rate was 25.6%. For the 39 patients in the budesonide cohort who received prior pertuzumab, the grade 3 diarrhea rate was 10.3%. For the 25 patients in the budesonide cohort who did not receive prior pertuzumab, the grade 3 diarrhea rate was 36.0%. This analysis suggests that prior pertuzumab exposure may have led to a higher rate of grade 3 diarrhea in the CONTROL trial that was not effectively managed by loperamide prophylaxis alone but was more effectively managed by loperamide plus budesonide.

Table 2: Incidence of Grade 3 Diarrhea in CONTROL by Prior Pertuzumab Treatment

Loperamide Cohort

Budesonide Cohort

(n = 55)

(n = 82)

(n = 39)

(n = 25)

Dr. Carlos H. Barcenas, Assistant Professor, Department of Breast Medical Oncology and Associate Medical Director, Breast Cancer Survivorship Clinic for the University of Texas MD Anderson Cancer Center, said, We are pleased to see the reduction in incidence, severity and duration of neratinib-associated diarrhea when using the three antidiarrheal prophylaxis regimens tested so far in this study. When using either the loperamide prophylaxis, the loperamide plus budesonide prophylaxis or the loperamide plus colestipol prophylaxis, there appears to be a reduction in the incidence and severity of grade 3 diarrhea with neratinib. Importantly, the severe grade 2 and grade 3 diarrhea, when using the prophylaxis, appears to be acute, self-limiting and manageable. Although the study is still ongoing, we are encouraged that the addition of budesonide or colestipol appears to greatly improve the tolerability of neratinib as well. We look forward to completing the loperamide plus colestipol cohort.

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, We are pleased to see the reductions in the incidence of severe neratinib-related diarrhea in the CONTROL trial when using the loperamide, loperamide plus budesonide or loperamide plus colestipol regimens. The severe diarrhea appears to become more acute, whereby it does not typically recur after the first month. We are also very encouraged by the improvements in tolerability that have been seen to date in the budesonide and the colestipol cohorts. This is a marked improvement in tolerability over what was seen in the ExteNET trial and we look forward to continuing to monitor this in the loperamide plus colestipol cohort.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements:

This press release contains forward-looking statements, including statements regarding the development of the Companys drug candidates. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing; the Company's dependence on PB272, which is still under development and may never receive regulatory approval; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Company's drug candidate claims; even if approved, the risk that physicians and patients may not accept or use the Company's products; the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates; the Company's dependence on licensed intellectual property; and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

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Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of ... - Business Wire (press release)

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VSY Biotechnology considers it important to note that this is a ruling by the German Court of First Instance. VSY Biotechnology has the right to and will appeal this judgement with the Higher District Court and if necessary with the Federal Supreme Court in Germany. It is expected that a final ruling on the infringement may take several years and German Court's ruling is only effective in Germany but not in all over the world.

VSY Biotechnology B.V. reserves its right to seek material and moral indemnity for all direct and indirect damages of VSY Biotechnology on basis of unfair competition and defamation due to incomplete press release of Carl Zeiss dated March 27, 2017. Further VSY Biotechnology will ask for all damages they may suffer from the decision of the First German Court in case of District Court or Federal Court rule in favor of VSY Biotechnology.

Additionally, VSY Biotechnology applied for invalidation of Zeiss Patent EP 2 377 493 B1 before EPO with the claim of Zeiss Patent has lack of novelty, lack of inventive step, therefore unpatentable.

VSY filed opposition against Zeiss patent

VSY Biotechnology B. V. (VSY) has, amongst others, filed an opposition against Carl Zeiss Meditec A.G.'s (Zeiss) European patent EP 2 377 493 B1 "Method for manufacturing aphakic intraocular lens" (EP'493) with the European Patent Office (EPO) on May 6, 2016. Zeiss acquired EP'493 from the German IP advisers IP Strategists GmbH who acquired the patent from the Japanese company Menicon Co..VSY is of the opinion that EP'493 does not fulfil the requirements of patentability as it lacks novelty and inventive step, is insufficiently disclosed and includes extension of subject matter.

The patent regards Trifocal intraocular lenses. Trifocal lenses of Zeiss are AT LISA tri and the AT LISA tri toric.

The opposition is still pending.

All details of the opposition can be found on: https://register.epo.org/application?number=EP09837427&lng=de&tab=doclist

About VSY Biotechnology BV

VSY Biotechnology is one of the leading companies in Industry of ophthalmology focusing on cataract surgery, producing premium intra ocular lenses and viscoelastics. For more information, please visit company website. http://www.vsybiotechnology.com.

SOURCE VSY Biotechnology

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Patent Case of Carl Zeiss Meditec AG and VSY Biotechnology B.V. - PR Newswire (press release)