Raleigh, NC, United States
Raleigh, NC, United States

Patheon Inc. is a pharmaceutical company, incorporated in Canada with its corporate head offices in Durham, North Carolina, that provides contract development and manufacturing services of prescription and over-the-counter pharmaceutical products for approximately 300 pharmaceutical and biotechnology companies.Patheon's competitors in the contract manufacturing marketplace include Baxter and Cardinal Health, both based in the USA.In 2008, the company won the European Outsourcing Award in the category of Most Effective Scale-Up and Technical Transfer award. Wikipedia.

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The present invention relates to a method for producing chiral -nitro alcohol compounds. The invention relates in particular to an (R)-selective cupin-nitroaldolase, which enantioselectively can catalyze the Henry reaction, wherein an aldehyde or ketone compound is converted to the corresponding -nitro alcohol compound in the presence of a nitroalkane compound and a cupin-nitroaldolase.


News Article | May 9, 2017
Site: www.prnewswire.com

-Currently Implementing a Bold Program Aimed at Allowing All Patients to Access Yosprala for Only $10.00 Per Month- MISSISSAUGA, Ontario, May 9, 2017 /PRNewswire/ -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) (Aralez or the Company) today announced financial results for the first quarter ended March 31, 2017. The Company also highlighted certain recent corporate and commercial achievements. All figures are in U.S. dollars. "We are pleased to report a solid first quarter of 2017, together with important updates to our business addressing a number of the challenges we face," said Adrian Adams, Chief Executive Officer of Aralez. "We are making a bold and significant change to our pricing strategy for Yosprala® aimed at allowing all patients to access the product for only $10.00 per month. In addition, we continue to implement our cost savings plan to further improve our cost structure and balance sheet to maximize and preserve our financial flexibility. Our updated financial guidance for 2017 reflects our commitment to reaching break-even on an Adjusted EBITDA basis this year. We also continue to opportunistically look at business development opportunities with a strong focus on value creating and transformative M&A with the goal of enhancing shareholder value." "Deerfield Partners remains fully supportive of Aralez and its management team as the company navigates its way through recent challenges," said James Flynn, Managing Partner at Deerfield. "We are encouraged by the new pricing strategy for Yosprala and the prospects for Zontivity." Cost Savings Initiatives The Company previously announced in April 2017 that it had begun implementing cost savings initiatives as part of the Company's ongoing objective to maximize value from its assets and preserve financial flexibility. The total expected operating expense reduction in 2017 of approximately $23.0 million includes the previously announced 32% reduction in its U.S. sales force, which is expected to yield 2017 savings of approximately $5.5 million ($7.5 million on an annual basis), a decrease of approximately $9.0 million in 2017 commercial spend, which primarily relates to non-direct marketing spend on Yosprala, and decreased 2017 departmental expenses across the business of approximately $8.5 million. While Aralez has made significant reductions to its expenses, the Company plans to invest an additional $7.0 million to support a successful phased launch of Zontivity that commenced on April 24, 2017, which the Company views as an increasingly attractive opportunity. The Company also continues to assess various business development opportunities with the goal of providing improved cash flow and an enhanced platform for creating value. First Quarter 2017 Financial Results Aralez's financial results for the three months ended March 31, 2016 include the operations of Tribute Pharmaceuticals Canada Inc. (Tribute) from February 5, 2016, the closing date of the Pozen and Tribute merger transaction (the Merger), through March 31, 2016, but do not include the results of Zontivity or Toprol-XL and its currently marketed authorized generic (the Toprol-XL franchise) as these acquisitions were completed on September 6, 2016 and October 31, 2016, respectively. Aralez's financial results for the three months ended March 31, 2017 include the results of Tribute, Zontivity and the Toprol-XL franchise. Total revenues for the three months ended March 31, 2017 were $26.0 million compared to $8.1 million for the three months ended March 31, 2016. Net product revenues of $6.7 million for the three months ended March 31, 2017 primarily related to the product portfolio acquired with the acquisition of Tribute as well as net product revenues from Yosprala and Fibricor®. Other revenues of $19.3 million for the three months ended March 31, 2017 were comprised of net revenues of $15.6 million from the acquisitions of the Toprol-XL franchise and Zontivity, which are recorded net of related cost of product revenues and fees paid during the respective transition service periods, and Vimovo® royalties of $3.7 million. Pursuant to the Company's agreement with Horizon in the U.S., subject to certain conditions described in our public filings, Aralez is guaranteed a quarterly minimum royalty amount (calculated based on a minimum annual royalty of $7.5 million), which was reflected in the Company's first quarter results. Net product revenues of $3.6 million for the three months ended March 31, 2016 related to the Tribute product portfolio acquired in the Merger, which was completed on February 5, 2016. Other revenues of $4.5 million for the three months ended March 31, 2016 were comprised solely of Vimovo royalties. Cost of product revenues were $2.8 million for the three months ended March 31, 2017 compared to $2.5 million for the three months ended March 31, 2016. The increase related primarily to costs of product revenues for the full quarter in 2017 from the Company's product portfolio that was acquired as part of the Merger in February 2016. SG&A expenses were $30.8 million for the three months ended March 31, 2017 compared to $37.5 million for the three months ended March 31, 2016. The decrease in SG&A expenses was primarily driven by costs related to the Merger in the prior year of approximately $19.4 million, partially offset by increased costs related to the build out of our U.S. sales force in 2016 and increased promotional expenses in the U.S. during the first quarter of 2017. R&D expenses for the three months ended March 31, 2017 were $0.1 million compared to $4.4 million for the three months ended March 31, 2016. The decrease related primarily to higher costs incurred in the first quarter of 2016 for Yosprala in advance of its U.S. approval in September 2016. Amortization of intangible assets of $8.5 million for the three months ended March 31, 2017 related to the acquisitions of Tribute, Zontivity and the Toprol-XL franchise. Amortization of intangible assets for the three months ended March 31, 2016 of $1.3 million related solely to the acquisition of Tribute. The change in fair value of contingent consideration of $4.4 million for the three months ended March 31, 2017 related to accretion for the Toprol-XL franchise and Zontivity acquisitions. There was no expense related to fair value changes in contingent consideration for the three months ended March 31, 2016. Interest expense of $6.7 million for the three months ended March 31, 2017 was primarily attributable to the borrowing of $200 million under the Company's credit facility in the fourth quarter of 2016 in connection with the acquisitions of Zontivity and the Toprol-XL franchise and $75 million convertible notes. Interest expense of $0.3 million for the three months ended March 31, 2016 related to the $75 million convertible notes. Other income, net for the three months ended March 31, 2017, was $0.4 million compared to $4.8 million for the three months ended March 31, 2016, a decrease of $4.4 million. The decrease principally related to a $4.6 million decrease in the fair value of the warrants liability acquired from Tribute during the prior year, offset by a $0.3 million gain from the sale of a building in London, Ontario during the three months ended March 31, 2017. The net loss for the three months ended March 31, 2017 was $27.5 million, or $0.42 loss per share on a fully diluted basis, compared to a net loss for the three months ended March 31, 2016 of $33.8 million, or $0.73 loss per share on a fully diluted basis. Adjusted EBITDA was ($3.6) million for the three months ended March 31, 2017 compared to Adjusted EBITDA of ($11.1) million for the three months ended March 31, 2016. Balance Sheet As of March 31, 2017, approximately 65.8 million of the Company's common shares were issued and outstanding and the Company had cash and cash equivalents of approximately $73.7 million. Updated 2017 Guidance Aralez's estimates are based on projected results of the Company for the year ending December 31, 2017 and reflect management's current beliefs and expectations about, among other things, prescription trends, competition, pricing levels, inventory levels, and anticipated future events. The Company's guidance on Adjusted EBITDA includes, among other things, costs to support the commercialization efforts with respect to Yosprala, Zontivity and the Canadian product portfolio as well as costs to support the global corporate structure. It excludes share-based compensation expense and certain discrete costs, including merger and product acquisition-related expenses. See "Use of Non-GAAP Financial Measures" below. For the year ending December 31, 2017, assuming, among other factors more particularly set out in "Cautionary Note Regarding Forward-Looking Statements" below, the Company currently expects: See the table below for a comparison of the Company's original 2017 guidance compared to the updated 2017 guidance: First Quarter Results Webcast Aralez will host a webcast this morning, May 9, 2017 at 9:00 a.m. ET to present results for the first quarter 2017. The webcast can be accessed live and will be available for replay at www.aralez.com. Conference Call Details Date: Tuesday, May 9, 2017 Time: 9:00 a.m. ET Dial-in (U.S.): 877-407-8037  Dial-in (International): 201-689-8037 About Aralez Pharmaceuticals Inc. Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez's Global Headquarters is in Ontario, Canada, the U.S. Headquarters is in Princeton, New Jersey and the Irish Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com. Use of Non-GAAP Financial Measures The Company has presented certain non-GAAP financial measures, including Adjusted EBITDA (as defined below). These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Adjusted EBITDA for the Company is defined as net income (loss) before income taxes, interest expense and financing costs, depreciation and amortization, stock-based compensation and gains or losses related to warrants, changes to the fair value of contingent consideration, restructuring costs, retention costs, impact of an acquisition of a business or product, including transaction related expenses, acquired in-process R&D, and tax equalization payments, interest income, the impact of changes in foreign currency rates, asset impairment charges, losses or gains on sale of assets, losses or gains on extinguishment or modification of debt and the impact of a sale or disposition of a business or product, including discontinued operations. Management believes this non-GAAP information is useful for investors, taken in conjunction with GAAP financial statements, because it provides greater transparency regarding the Company's operating performance by excluding (i) non-cash expenses that are substantially dependent on changes in the market price of our common shares, and (ii) discrete items, such as merger and acquisition-related costs, including transaction fees, and severance and retention expenses, that may not be consistently recurring. Management uses these measures, among other factors, to assess and analyze operational results and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company's operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release. Cautionary Note Regarding Forward-Looking Statements This press release includes certain statements that constitute "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements regarding the Company's expectation to reduce 2017 operating expenses by approximately $23.0 million through its cost savings plan (of which approximately $9.0 million was included in our original 2017 Adjusted EBITDA guidance), including a decrease of approximately $5.5 million expected in 2017 due to the previously announced sales force reduction ($7.5 million on an annual basis), a decrease of approximately $9.0 million in 2017 commercial spend and decreased 2017 departmental expenses across the business of approximately $8.5 million, that the Company plans to invest an additional $7.0 million to support the successful phased launch of Zontivity which the Company views as an increasingly attractive opportunity, the Company's  commitment to reaching break-even this year on an Adjusted EBITDA basis, that the Company has identified other initiatives to drive an increase in profitability, including an increased focus on the Canadian core growth brands, implementing our cost savings plan to further improve our cost structure and balance sheet to maximize and preserve financial flexibility, that the Company is currently implementing a bold and significant change to its pricing strategy for Yosprala aimed at allowing all patients to access the product for only $10.00 per month regardless of coverage or co-pay level set by their insurer, that this program will be available for all patients through retail pharmacies or through select national mail order partners, that we continue to look opportunistically at business development opportunities with a strong focus on value creating and transformative M&A with the goal of enhancing shareholder value, providing improved cash flows and an enhanced platform for creating value, that the full launch of Zontivity is expected in early June 2017 with 75 sales representatives targeting approximately 12,000 physicians, that Deerfield Partners remains fully supportive of Aralez and its management team, the extension of the VA Contract, payments or potential payments under the non-exclusive Japanese patent license entered into by Pozen, the outlook for the Company's future business and financial performance, including the Company's updated 2017 guidance on Adjusted EBITDA and net revenues, our strategies, plans, objectives, goals, prospects, future performance or results of current and anticipated products, and other statements that are not historical facts, and such statements are typically identified by use of terms such as "may," "will," "would," "should," "could," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "likely," "potential," "continue" or the negative or similar words, variations of these words or other comparable words or phrases, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements included herein represent management's current judgment and expectations, and are based on current estimates and assumptions made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that it believes are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct and, as a result, the forward-looking statements based on those estimates and assumptions could prove to be incorrect. Accordingly, actual results, level of activity, performance or achievements or future events or developments could differ materially from those expressed or implied in the forward-looking statements. Material factors, risks or assumptions that were applied or taken into account in providing updated financial guidance for the year ending December 31, 2017, including with respect to the statements that Aralez's net revenues are expected to be in the range of $80 million to $100 million and Adjusted EBITDA is expected to be in the range of $(5) million to $5 million include, but are not limited to, (i) successfully integrating Zontivity and the Toprol-XL franchise, (ii) expected costs to support the commercialization efforts with respect to Yosprala, Fibricor, Zontivity (in process of being re-launched) and the Canadian product portfolio as well as expected costs to support the global corporate structure, (iii) the exclusion of any impact from additional potential strategic business transactions, such as mergers, acquisitions, divestures, or financings that may be consummated, (iv) an increase in prescription trends and revenues for both Yosprala and Zontivity in 2017 relative to 2016, (v) with respect to the Toprol-XL franchise, pricing with respect to the AG business at or near current levels and pricing with respect to VA business as reflected in our modified VA National Contract, (vi) our ability to source and qualify suppliers for our drugs, including for Yosprala, (vii) our ability to mitigate legal and regulatory risks and uncertainties, including ongoing litigation related to Vimovo and Yosprala, that may negatively impact our expectations regarding our products and product candidates, (viii) future performance of our commercialization partners being in line with our expectations and the impact such performance is anticipated to have being consistent with our expectations with respect to our revenue projections, (ix) currency rates remaining at or near current levels for the remainder of fiscal 2017, (x) ongoing operational activities to manage expenses and improve profitability; and (xi) prescription trends, competition, pricing levels, inventory, and the anticipated timing of future product launches and events remaining in line with management's current beliefs. Readers are cautioned that actual future operating results and economic performance of the Company, including with respect to our net revenues and Adjusted EBITDA for the year ending December 31, 2017, are subject to a number of risks and uncertainties, including, among other things, those described below, and could differ materially from what is currently expected as set out in this press release. In addition, our operations and 2017 updated financial guidance involve risks and uncertainties, many of which are outside of our control, and any one or any combination of these risks and uncertainties could also affect whether the forward-looking statements ultimately prove to be correct and could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward- looking statements. These risks and uncertainties include, without limitation, our inability to maintain a sales force of sufficient scale for the commercialization of our products in a timely and cost-effective manner; our failure to successfully commercialize our products and product candidates; competition, including increased generic competition; costs and delays in the development and/or approval of our product candidates (including Yosprala in the EU), including as a result of the need to conduct additional studies or due to issues with third-party API or finished product manufacturers, or the failure to obtain such approval of our product candidates for all expected indications, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; with respect to certain products, dependence on reimbursement from third-party payors and the possibility of a failure to obtain coverage or reduction in the extent of reimbursement; the inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca AB and Horizon Pharma USA, Inc. for the sales and marketing of Vimovo, our dependence on Patheon Pharmaceuticals Inc. for the manufacture of Yosprala, our dependence on Schering-Plough (Ireland) Company for the supply of Zontivity and our dependence on AstraZeneca AB for the manufacture and supply of Toprol-XL and its currently marketed authorized generic (AG); our dependence on maintaining and renewing contracts with customers, distributors and other counterparties (certain of which may be under negotiation from time to time), including our inability to renew existing contracts on favorable terms, and the risks that we may not be able to maintain our existing terms with certain customers, distributors and other counterparties; our ability to protect our intellectual property and defend our patents; regulatory obligations and oversight; failure to successfully identify, execute, integrate, maintain and realize expected benefits from new acquisitions, such as the acquisitions of Tribute, Zontivity and Toprol-XL and its AG; failure to realize the expected benefits of our initiatives to reduce costs and improve profitability; fluctuations in the value of certain foreign currencies, including the Canadian dollar, in relation to the U.S. dollar, and other world currencies; changes in laws and regulations, including tax laws and unanticipated tax liabilities and regulations regarding the pricing of pharmaceutical products; risks related to our financing and liquidity; general adverse economic, market and business conditions; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in the Company's Securities and Exchange Commission (SEC) filings and reports and Canadian securities law filings, including in our Annual Report on Form 10-K for the year ended December 31, 2016 and our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2017, which will be available on EDGAR at www.sec.gov, on SEDAR at www.sedar.com, and on the Company's website at www.aralez.com, and those described from time to time in our future reports filed with the SEC and applicable securities regulatory authorities in Canada. You should not place undue importance on forward-looking statements and should not rely upon this information as of any other date. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/aralez-reports-first-quarter-2017-financial-results-300453792.html


News Article | May 9, 2017
Site: www.prnewswire.com

The lyophilization process requires specialized equipment, expertise and care. Contract manufacturing organizations (CMOs) that provide such services have specialized facilities and dedicated lines for lyophilization operations. A number of biopharmaceutical companies are outsourcing their lyophilization operations to CMOs to leverage their expertise and capabilities. It is well-known that setting up in-house lyophilization capabilities and operations is an expensive and time-consuming process. In order to decrease the overall cost of the product and yield cost savings, we expect that drug developers will continue to outsource such operations to CMOs. Key drivers, both in the short-mid term and long term, not only include the increasing demand for biological therapies but also the expected entry of a number of biosimilars and the technological advancements that are steadily resulting in improved productivity for clients. SCOPE OF THE REPORT The 'Lyophilization Services for Biopharmaceuticals, 2017-2027' report provides an extensive study on the current market landscape of lyophilization services for biopharmaceuticals. The study presents an in-depth analysis of a diverse set of companies that provide such services across different regions worldwide. In fact, we identified close to 90 companies that are actively involved in providing lyophilization services for biopharmaceuticals. In addition to other elements, the report covers the following: - The current state of the market with respect to key players along with information on location of facilities, the type of biopharmaceuticals lyophilized (antibodies, proteins, peptides, vaccines, nucleic acids and ADCs), scale of operation (lab, clinical and commercial) and the containment systems (vials, bulk containers, syringes, ampoules and cartridges) utilized for lyophilization operations. - Elaborate profiles of established / emerging players that primarily have expertise in providing broader lyophilization services and / or are focused on providing lyophilization services for emerging containment systems such as syringes; each profile provides a company overview, financial information, details on lyophilization capabilities and facilities, recent developments and an informed future outlook. - Most active regions in terms of lyophilization services for biologics; the report contains schematic representations of world maps that clearly indicate the location of active lyophilization service hubs. - Benchmark analysis allowing companies to compare their existing capabilities within respective peer groups and identify ways to become more competitive in the industry. - Competitive landscape of companies providing lyophilization cycle development and / or optimization services for biopharmaceuticals. - A case study on alternative approaches to lyophilization such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying. The study features a detailed analysis of the existing size and potential future growth opportunities (2017-2027) in the lyophilization services market for biopharmaceuticals. We have provided insights on the likely regional evolution of the market covering North America, Europe (UK, France, Italy, Spain, Germany and rest of Europe), Asia Pacific (Japan, China, India and South Korea) and rest of the world. In addition, we have provided the likely evolution and a market attractiveness analysis on the basis of the type of containment system (bulk containers, vials, syringes, ampoules and cartridges). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market's evolution. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 80 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities, challenges and likely future trends. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. These included contributions from Steven Nail (Principal Scientist, Baxter BioPharma Solutions), Adam Viverette (Lyophilization Manager, Patheon), Patrick DePalma (Director, CMO Business Development, BioDefense Division, Emergent BioSolutions) and John Shaw (Head of Business Development and Marketing, Vibalogics). RESEARCH METHODOLOGY The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information. The secondary sources of information include: - Annual reports - Investor presentations - SEC filings - Industry databases - News releases from company websites - Government policy documents - Industry analysts' views While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information. CHAPTER OUTLINES Chapter 2 provides an executive summary of the insights captured in our research. This summary offers a high level view on the current state of the lyophilization services market for biopharmaceuticals and its likely evolution in the mid-long term. Chapter 3 provides an introduction to the lyophilization approach. It includes a detailed discussion on the history / evolution of the lyophilization technology, the principle on which the process is based, the basic components of a lyophilizer, and highlights the advantages / disadvantages and applications of the lyophilization process. Chapter 4 highlights the importance of lyophilization for biopharmaceuticals. It elaborates on the steps involved in the process of lyophilization, lyophilization cycle development and optimization, and the containment systems in which lyophilization services for biopharmaceuticals are carried out. Chapter 5 includes a comprehensive market landscape of the companies that provide lyophilization services for biopharmaceuticals. It presents an analysis of the lyophilization service providers on the basis of their geographical location, types of biopharmaceuticals lyophilized (antibodies, ADCs, proteins, peptides, nucleic acids and vaccines), scale of operation (lab, clinical and commercial) and the containment systems (vials, bulk containers, syringes, cartridges and ampoules). Chapter 6 provides detailed profiles of some of the lyophilization service providers for biopharmaceuticals based in North America. Each profile presents a brief overview of the company, its financial information, lyophilization capabilities and facilities, recent developments, and a comprehensive future outlook. The chapter also provides insights on the overall evolution of the North American lyophilization services market, specifically distributed on the basis of type of containment system. Chapter 7 provides detailed profiles of some of the lyophilization service providers for biopharmaceuticals based in Europe. Each profile provides a brief overview of the company, its financial information, lyophilization capabilities and facilities, recent developments, and a comprehensive future outlook. The chapter also provides insights on the overall evolution of the European lyophilization services market, specifically distributed on the basis of type of containment system. Chapter 8 provides brief profiles of some of the lyophilization service providers for biopharmaceuticals based in the Asia Pacific region. The chapter also provides insights on the overall evolution of the Asia Pacific lyophilization services market, specifically distributed on the basis of type of containment system. Chapter 9 presents a comprehensive view on how the lyophilization services market for biopharmaceuticals is likely to evolve over the next ten years. We have segregated the financial opportunity on the basis of different regions (North America, Europe (UK, France, Italy, Spain, Germany and rest of Europe), Asia Pacific (Japan, China, India and South Korea) and rest of the world) and the type of containment system (bulk containers, vials, syringes, ampoules and cartridges). All our predictions are backed by robust analysis of data procured from both secondary and primary sources. The analysis also presents insightful 2 X 2 matrices based on Market Share and Market Attractiveness derived from the current and likely future state of the market. Due to uncertainties surrounding some of the assumptions within our forecast model, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios. Chapter 10 provides a benchmark analysis of the companies that provide lyophilization services for biopharmaceuticals. The key parameters considered for this analysis include the scale of operation, number of biologics lyophilized and type of containment system used for the lyophilization of biologics. The analysis allows the companies to compare their existing capabilities within their peer group and identify opportunities to become more competitive in the industry. Chapter 11 presents elaborate details on lyophilization cycle development and optimization services, highlighting the important parameters and techniques required for these processes and the list of players providing such services for biopharmaceuticals. Chapter 12 features a case study on alternative methods to lyophilization such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying. It specifically elaborates on spray drying, covering information such as step-wise approach, applications of spray drying for biopharmaceuticals, key players providing such services and an informed comparison with lyophilization. Chapter 13 presents insights from the survey conducted for this study. We invited over 80 stakeholders involved in providing lyophilization services for biopharmaceuticals. The participants, who were primarily Directors / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential. Chapter 14 summarizes the overall report. It presents a list of key takeaways and offers our independent opinion on the current market scenario and key trends that are likely to determine how the market is likely to evolve in the short and long term. Chapter 15 is a collection of interview transcripts of our discussions with some of the key players in this industry. We have presented the details of our conversations with Steven Nail (Principal Scientist, Baxter BioPharma Solutions), Adam Viverette (Lyophilization Manager, Patheon), Patrick DePalma (Director, CMO Business Development, BioDefense Division, Emergent BioSolutions) and John Shaw (Head of Business Development and Marketing, Vibalogics). Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures in the report. Chapter 17 is an appendix, which contains the list of companies and organizations that have been mentioned in the report. EXAMPLE HIGHLIGHTS 1. Over 80 companies, with a diverse array of offerings and scale of operations, are providing lyophilization services for biopharmaceuticals. Majority (more than 80%) of these companies are based in North America and Europe. A number of players have also emerged in Asia Pacific; examples include (in alphabetical order) Bovogen Biologicals, Kemwell Biopharma, Mycenax Biotech, Pharmagen, Piramal Pharma Solutions, Samsung Biologics, Siam Bioscience and WuXi AppTec. 2. It is worth highlighting that, while majority of the companies provide a broader suite of services, there are several companies that solely / primarily focus on providing lyophilization services. These include (in alphabetical order) Anteco Pharma, Biopharma Technology, LSNE Contract Manufacturing, Lyofal, LYOCONTRACT, Lyophilization Technology and Quality BioResources. 3. The companies are providing lyophilization services for a wide range of biopharmaceuticals, including antibodies, proteins, peptides, vaccines, nucleic acids and ADCs. As expected, a larger proportion of companies (~ 70%) provides services for antibodies and proteins followed by peptides (~ 50%) and vaccines (~ 45%). 4. Development and optimization of the lyophilization cycle are crucial methods for generating a lyophilized formulation of the product. During our research, we identified over 70 players specializing in providing such services. North America is home to majority of these companies (approximately 47%); this is followed by the EU, where approximately 40% of the companies are based. 5. Methods, such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying, have emerged as potential alternatives to lyophilization for the production of dry formulations of biologics. Specifically, spray drying has gained relatively more popularity in recent years. RAPLIXA®, a blend of spray-dried thrombin and fibrinogen, was the first spray dried novel biologic to receive USFDA approval in April 2015. In fact, we identified 16 players, including (in alphabetical order) Biopharma Technology, IDIFARMA, Lonza, Micro-Sphere, Nova Laboratories and Upperton, which provide spray drying services for biopharmaceuticals. 6. The increasing focus on biological therapies is the key factor that is likely to drive the lyophilization services market in coming years. Additionally, technological advances in the field and the entry of a number of biosimilars in the near future are likely to provide the necessary impetus. We expect the lyophilization services market for biopharmaceuticals to grow at an annualized growth of 9.5% between 2017 and 2027. North America and Europe, the current hubs, are likely to continue to dominate the market in the next decade. Download the full report: https://www.reportbuyer.com/product/4886788/ About Reportbuyer Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers http://www.reportbuyer.com For more information: Sarah Smith Research Advisor at Reportbuyer.com Email: query@reportbuyer.com Tel: +44 208 816 85 48 Website: www.reportbuyer.com To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/lyophilization-services-for-biopharmaceuticals-2017-2027-300453749.html


News Article | May 10, 2017
Site: globenewswire.com

LONDON, May 10, 2017 (GLOBE NEWSWIRE) -- Visiongain launches report on Manufacturing, Logistics and Distribution, Supply Chain Management, Packaging, Cold Chain Logistics. The Global Clinical Trial Supply and Logistics Market is expected to grow at a CAGR of 7.0% from 2016-2021 and CAGR of 5.6% from 2021-2027 says visiongain. The market is expected to grow at a CAGR of 6.2% from 2016 to 2027. The market is estimated at $14.84bn in 2016 and $28.75bn in 2027. How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand, new 197-page report you will receive 120 charts – all unavailable elsewhere. The 197-page report provides clear detailed insight into the Global Clinical Trial Supply and Logistics Market. Discover the key drivers and challenges affecting the pharma market. By ordering and reading our brand-new report today you stay better informed and ready to act. Report Scope • Revenue and growth forecasts to 2027 for the global clinical trial supply and logistics market • Revenue and growth forecasts to 2027 for the leading segments of the global clinical trial supply and logistics market. • Revenue and growth forecasts to 2027 for the leading countries • Profiles the leading companies offering clinical trial supply and logistics services to the pharmaceutical industry • Discusses the regulatory outlook for the clinical trial supply chain in the national markets. • Provides qualitative analysis of the clinical trial supply and logistics market. • Assesses the outlook for cold chain logistics in the clinical trial sector, as well as regulatory aspects of cold chain distribution for clinical trial materials Individual sales predictions at world level to 2027 for the main submarkets: • Manufacturing – also with sub forecasting for packaging and for other production • Logistics and distribution – also with sub forecasts for cold chain logistics and for other services • Supply chain management.   Individual revenue forecasts to 2027 by country: • United States • Japan • Germany • France • United Kingdom • Italy • Spain • Brazil • Russia • China • India • Rest of the World Profiles of the leading companies offering clinical trial supply and logistics services to the pharmaceutical industry: Visiongain’s study is intended for anyone requiring commercial analyses for the global clinical trial supply and logistics market. You find data, trends and predictions. Buy our report today Global Clinical Trial Supply and Logistics Market for Pharma 2017-2027: Manufacturing, Logistics and Distribution, Supply Chain Management, Packaging, Cold Chain Logistics. To see a report overview please email sara.peerun@visiongain.com or for the full report Table of Contents please click on: AbbVie Contract Pharmaceutical Manufacturing Agência Nacional de Vigilância Sanitária (ANVISA) Allergan Almac Group AmerisourceBergen AMGEN AndersonBrecon Aptuit Astellas Pharma AstraZeneca. Bellwyck Packaging Solutions Boehringer Ingelheim Bristol-Myers Squibb British Telecom (BT) Catalent Pharma Solutions Celesio Central Drugs Standard Control Organization (CDSCO) China FDA (CFDA) Chinese Ministry of Health ClinIntel Comissão Nacional de Ética em Pesquisa (CONEP) Consorcio de Apoyo a la Investigación Biomédica – Plataforma Española de Ensayos Clínicos (CAIBER) COREX Cortec Cryoport DHL Drug Controller General of India (DCGI) Eli Lilly. EMD SERONO European Medicines Agency (EMA) EPS European Commission Eurodifarm Food and Drug Administration (FDA) Federal Express (FedEx) Fisher Clinical Services Frazier Healthcare GE Healthcare Greenbox GSK. IMP Logistics Intelsius International Air Transport Association (IATA) International Pharmaceutical Federation Japanese Ministry of Health, Labour and Welfare (MHLW) Johnson & Johnson Komtur Pharmaceuticals LabCorp LCAG USA LifeConEx Lonza Marken Mawdsleys Medgenics Medicines and Healthcare Products Regulatory Agency (MHRA) Merck & Co. Mitsui & Co. Movianto National Institutes of Health (NIH) Novo Nordisk Novotech Nuvilex Octapharma Owens & Minor Parexel. Patheon Packaging Coordinators Inc. (PCI) Perceptive Informatics Pfizer. Pharmaceuticals for Human Use (ICH) Pieffe Group Quintiles. Recipharm. Roche.  Sanofi.  SF Express Thermo Fisher Scientific.  TNT Express TransCelerate BioPharma Transportation Administration Security (TAS) Tufts Center UCB United Parcel Service (UPS) US Pharmacopeia (USP) World Courier World Health Organization (WHO) To see a report overview please email sara.peerun@visiongain.com or for the full TOC please click on:


News Article | May 9, 2017
Site: www.prnewswire.com

How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new 144-page report you will receive 150 charts - all unavailable elsewhere. The 144-page report provides clear detailed insight into the global clinical nutrition market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • This report also shows forecast revenue to 2027 for the leading segments and sub segments of the clinical nutrition market: • Our analyses show individual revenue forecasts to 2027 for these regional and national markets: - North America: the US and Rest of North America - Europe: Germany, France, the UK and Rest of Europe - Asia-Pacific: China, Japan, India and Rest of Asia-Pacific - Rest of the World (RoW): Middle East and Rest of RoW Each regional market is further segmented into the leading segments and sub segments of the clinical nutrition market. Whereas, each national market is further segmented into the leading segments of the clinical nutrition market. • This report discusses the leading companies that hold the majority of market shares in the clinical nutrition market: - Baxter International. NYSE: BAX - Abbott Laboratories. NYSE: ABT - B. Braun Melsungen AG. - Nestle S.A. VTX: NESN - Groupe Danone. EPA: BN - Mead Johnson. NYSE: MJN - Fresenius Kabi. ETR: FRE - Hospira. NYSE: HSP - Perrigo. TLV: PRGO • This report also discusses Porter's Five Forces Analysis. These forces analyze the clinical nutrition market from five different perspectives such as competitive rivalry within the industry; threat of new entrants; bargaining power of suppliers; bargaining power of buyers; and threat of substitute products. Visiongain's study is intended for anyone requiring commercial analyses for the clinical nutrition market. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 Abbott Alere Inc Astellas Baxter Healthcare Beverage Partners Worldwide Biersdorf Braun Melsungen AG Bristol-Myers Squibb Cereal Partners Worldwide Chuv Lausanne Dairy Partners Americas Elli Lilly Fresenius Kabi Gerber Gillette GlaxoSmithKline (GSK) Groupe Danone Heinz Hipp Hormel Health Lab Hospira Immunocal Immunotech Research Institut national de la recherche agronomique (INRA) Kanebo Kao Massey Mead Johnson Merck Nature's One Nestle Novartis Numico Nutritek Nutrition Nutritionals Otsuka Pharmaceuticals Pacific Health Pharmaceuticals Patheon Royal Numico N.V Schwartz Bio-Research SHS Smithkline St. Jude Medical, Inc. U.S. Dentek Warner Lambert Wyeth Ayerst Yale New Haven Hospital Yashili International Holdings Ltd List of Organizations Mentioned in the Report Columbia University European Medicines Agency (EMA) Food and Drug Administration (FDA) Harvard School of Nutrition Institute of Dentistry University of Turku Milk & Health Research Center United Nations Department of Economic and Social Affairs (UN-DESA) World Health Organization (WHO) To see a report overview please email Sara Peerun on sara.peerun@visiongain.com

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