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 | April 24, 2017
Site: www.prnewswire.co.uk

Global pharma services company taps always-on agency following review NEW YORK, April 24, 2017 /PRNewswire/ -- Patheon, a leading global provider of pharmaceutical development and manufacturing services, has named Madras Brand Solutions as its global advertising agency of record...


News Article | April 24, 2017
Site: www.prnewswire.com

NEW YORK, April 24, 2017 /PRNewswire/ -- Patheon, a leading global provider of pharmaceutical development and manufacturing services, has named Madras Brand Solutions as its global advertising agency of record following a review. Madras will combine strategy, storytelling and distribution...


News Article | May 8, 2017
Site: www.businesswire.com

DURHAM, N.C.--(BUSINESS WIRE)--Patheon N.V (NYSE: PTHN), a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma sectors, announced that it has completed an expansion project at its Greenville, NC manufacturing site. The company invested approximately $26 million to update one of its sterile Pharmaceutical Development Services (PDS) suites and to build a state-of-the-art, fully integrated sterile PDS suite which are compliant with regulatory authorities. The PDS Suites 1 and 2 provide 7,000-square-feet in GMP steriles manufacturing space. The newly built PDS suite will manufacture sterile liquid and lyophilized drug products. It features freeze dryers and a fully integrated filling line fitted with a Restricted Access Barrier System (RABS) for sterile drug products. The company has made the investment in disposable manufacturing in this suite eliminating the need for cleaning verification for liquid filling, reducing set up time/product losses and enhancing sterility assurance. This suite is highly sophisticated, fully integrated and designed for products in clinical development with the ability to scale up to much larger batch sizes via Patheon’s network of commercial scale capabilities either co-existing within the Greenville facility, or in Europe. “As the industry continues to innovate, customers will require even more advanced solutions, integrating development and commercial service, to meet their business needs,” said Franco Negron, president of Patheon’s drug product and pharmaceutical development services for North America. “The increasing focus on pharma to reduce costs will lead forward-thinking companies to capitalize on their core competencies – focusing on what they do best, while strategically partnering with companies such as Patheon to deliver the expertise, customized solutions and technical capabilities to support the production of their small and large molecule products.” Patheon’s Greenville, NC manufacturing site is a large multi-purpose pharmaceutical manufacturing and packaging campus. The facility provides both solid dose form manufacturing/packaging and sterile dose manufacturing, filling and lyophilization of both biopharmaceuticals and small molecules. Another exciting development in Greenville, NC is the installation of a state of the art continuous manufacturing suite. About Patheon Patheon is a leading global provider of pharmaceutical development and manufacturing services. With approximately 9,100 employees and contractors worldwide, Patheon provides a comprehensive, integrated and highly customizable set of solutions to help clients of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle. A Healthier World. Delivered. www.patheon.com Aseptic processing is the process by which a sterile (aseptic) product (a pharmaceutical) is packaged in a sterile container in a way that maintains sterility. Freeze-drying—technically known as lyophilisation, lyophilization, or cryodesiccation—is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Freeze-drying works by freezing the material and then reducing the surrounding pressure to allow the frozen water in the material to sublimate directly from the solid phase to the gas phase. cGMP Facility: cGMP refers to current Good Manufacturing Practices, a rigorous set of manufacturing guidelines the U.S Food and Drug Administration (FDA) uses to document and ensure the products it regulates are produced safely and consistently. Sublimation is the transition of a substance directly from the solid to the gas phase without passing through the intermediate liquid phase.


News Article | April 25, 2017
Site: marketersmedia.com

— The Global Softgel Capsules Market report analyzes market by Players, types, applications and regions. The Global Softgel Capsules Market was valued at US $162.8 billion in 2012 at a CAGR of 5.6% from 2012 – 2017 and it is expected to reach US $275 billion by 2022. Companies profiled in this report are Catalent, Aenova, NBTY, Procaps, Patheon, IVC, EuroCaps, Captek, Strides Arcolab, Capsugel, Amway Corporation, Weihai Baihe Biology, Capsugel Inc., Qingdao Donghai, GuangDong Yichao, Nature's Bounty, Inc. and more in terms of basic information, product categories, Sales (Volume), Revenue (Million USD), Price (USD/Unit) and Gross Margin (%) (2012-2017). Global Softgel Capsules Market Report covers Gelatin type, and Non-animal type as product types whereas applications covered in this report are Health Supplements, Pharmaceutical, and Others. Table of Contents: 1 Softgel Capsules Market Overview 2 Global Softgel Capsules Competition by Players 3 Global Softgel Capsules Competition by Types 4 Global Softgel Capsules Competition by Application 5 Global Softgel Capsules Production Market Analysis by Region 6 Global Softgel Capsules Sales Market Analysis by Region 7 Imports and Exports Market Analysis 8 Global Softgel Capsules Players Profiles and Sales Data 9 Softgel Capsules Manufacturing Cost Analysis 10 Industrial Chain and Downstream Buyers 11 Marketing Channels Analysis 12 Global Softgel Capsules Market Forecast (2017-2022) 13 Research Findings and Conclusion Inquire for more details / sample / discount at: https://www.themarketreports.com/report/ask-your-query/478615 For more information, please visit https://www.themarketreports.com/report/2017-global-softgel-capsules-industry-research-report


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition" report to their offering. The report examines 91 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) in 2016 along with 1 therapeutic drug approved by the FDA Center for Biologics Evaluation and Research (CBER) under the BLA process. PharmSource's data-rich Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition, has ascertained that 2016 was not a halcyon year for new drug approvals with only 25 NMEs being approved since 2010. Global bio/pharma companies received 22 approvals in 2016 (24% of all NDAs), 10% below their 2011-2015 average. Small commercial companies were responsible for 21 approvals (23% of the total), some 5% above their five-year average. There was a clear difference between outsourcing propensity of NME and Non-NME drugs. Only 13% of NMEs sponsored by global bio/pharma companies were outsourced compared with an average of 28% from 2011-2015. However, the largest companies increased their outsourcing of Non-NME drugs from an average of 32% in 2011-2015 to 57% in 2016. In 2016, the FDA approved 92 NDAs and BLAs including new molecular entities (NMEs), therapeutic drugs approved through CBER and new formulations of older drugs. This figure represents a 25% decrease from 2015 (122) and is also 5% less than the 2011-2015 average of 97. Furthermore, 48% of NMEs were outsourced compared to 64% of Non-NME NDA products. 28 dose CMOs garnered approvals in 2016 although two companies, Vetter and Patheon, won 7 out of the 12 NMEs that were outsourced. No other company secured more than a single NME approval for contract manufacturing, although Catalent and DPT were responsible for 7 Non-NME NDA drugs. The CMO landscape is dominated by the quartet of Patheon, Baxter, Vetter and Catalent, which collectively accounted for over 30% of all NDA approvals between 2007-2016. Parenteral NME outsourcing is dominated by the first three of these, which are responsible for manufacturing 47% of all drugs, with the remainder split between 28 other companies. In depth, this report provides the following: - Provides the detailed analysis of drugs examined by the European Medicines Agency (EMA). The centralized procedure is mandatory for all New Active Substances, as well as Biosimilar drugs and certain generics depending on their therapeutic category. - Analyzes propensity to outsource by dosage form, sponsor type, nature of API and special handling requirements. In addition, it includes information on product approvals, which have utilized formulation technologies such as amorphous solid dispersion (ASD), hot melt extrusion (HME) and jet milling. - Helps for CMO executives and strategic decision-makers who seriously follow the global CMO industry, including dose and API manufacturers. For more information about this report visit http://www.researchandmarkets.com/research/9b6jb9/pharmsource_cmo


News Article | May 4, 2017
Site: globenewswire.com

-- EXPAREL® Net Product Sales Up 6% Year-Over-Year -- -- Conference Call Today at 8:30 a.m. ET -- PARSIPPANY, N.J., May 04, 2017 (GLOBE NEWSWIRE) --  Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today provided updates on EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the first quarter ended March 31, 2017. “We’re pleased with our strong first quarter highlighted by important strategic advances and solid revenue growth,” said Dave Stack, chairman and chief executive officer of Pacira. “Our newly launched partnerships with DePuy Synthes and Trinity Health center on our shared commitment to providing patients and healthcare providers with an opioid-sparing solution. We are also advancing a robust clinical program with important value-drivers on the near-term horizon, including mid-year data readouts for our two Phase 3 nerve block studies and the publication of our successful Phase 4 study in total knee arthroplasty. Finally, we significantly strengthened our balance sheet during the first quarter. We believe the foundation is in place to drive EXPAREL sales growth for the rest of 2017 and beyond.” Pacira reiterated its full year 2017 financial guidance as follows: See “Non-GAAP Financial Information” and “Reconciliations of GAAP to Non-GAAP 2017 Financial Guidance” below. The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, May 4, 2017, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 4977296. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 4977296. The replay of the call will be available for two weeks from the date of the live call. The live, listen-only webcast of the conference call can also be accessed by visiting the “Investors & Media” section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call. This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income (loss), non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) and non-GAAP selling, general and administrative (SG&A) expenses, because such measures exclude stock-based compensation, amortization of debt discount and loss on early extinguishment of debt. These measures supplement our financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D and SG&A outlook for 2017 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2017 financial guidance for gross margins, R&D and SG&A. Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com. EXPAREL (bupivacaine liposome injectable suspension) is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com. EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting. Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf. Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL and our other products; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical trials in support of an existing or potential DepoFoam-based product; our plans to continue to manufacture and provide support services for our commercial partners who have licensed DepoCyt(e); our commercialization and marketing capabilities; our and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; and other factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


News Article | June 8, 2017
Site: www.businesswire.com

DURHAM, N.C.--(BUSINESS WIRE)--Patheon N.V. (NYSE: PTHN), a leading global provider of pharmaceutical development and manufacturing services, today reported financial results for the quarter ended April 30, 2017. Second quarter 2017 revenue was $483 million, compared to $469 million in the prior-year period, and second quarter 2017 adjusted EBITDA was $94 million, compared to $98 million in the prior-year period. Revenue for the first six months of fiscal 2017 was $941 million, compared to $875 million in the comparable fiscal 2016 period, representing 8% year-over-year growth. Adjusted EBITDA for the first six months of fiscal 2017 was $177 million, compared to $157 million in the comparable fiscal 2016 period, representing 13% year-over-year growth. “During the second quarter we continued to build momentum with customers and make strategic investments to support our long-term growth outlook,” said Patheon CEO, Jim Mullen. “Looking forward, we believe the announced sale to Thermo Fisher is a logical next step in the evolution of our company and is in the best interests of all stakeholders. Together, both companies will be better positioned to add scale and new value chain capabilities, delivering even greater value to customers.” Second quarter 2017 net income from continuing operations was $28 million. Second quarter 2017 net income from continuing operations per diluted share was $0.19. Second quarter 2017 adjusted net income from continuing operations was $29 million. Second quarter 2017 adjusted net income from continuing operations per diluted share was $0.20. As of April 30, 2017, cash and cash equivalents were $93 million and total debt was $2.1 billion, resulting in net debt of approximately $2.0 billion. FY17 Financial Outlook and Second Quarter 2017 Conference Call In light of the Company’s previously announced agreement to be acquired by Thermo Fisher Scientific Inc., Patheon does not plan to provide or update its fiscal year 2017 guidance. Also as a result of the pending transaction, Patheon will not hold a conference call to discuss the Company’s second quarter 2017 financial results. Patheon is a leading global provider of pharmaceutical development and manufacturing services. With approximately 9,100 employees and contractors worldwide, Patheon provides a comprehensive, integrated and highly customizable set of solutions to help customers of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle. This press release contains forward-looking statements which reflect the current beliefs and expectations of Patheon’s management regarding the company’s future growth, results of operations, performance (both operational and financial) and business prospects and opportunities. The statements in this press release that are not historical facts may be forward-looking statements. Readers can identify these forward-looking statements by the use of words such as ‘‘outlook,’’ ‘‘believes,’’ ‘‘expects,’’ ‘‘potential,’’ ‘‘continues,’’ ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘seeks,’’ ‘‘approximately,’’ ‘‘predicts,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘estimates,’’ ‘‘anticipates’’ or the negative version of these words or other comparable words. Such forward looking statements are subject to various risks and uncertainties, which could cause actual results to differ from those indicated in these forward looking statements. For more information concerning factors that could cause actual results to differ materially from those conveyed in the forward-looking statements, please refer to the "Risk Factors" section included in the company’s fiscal 2016 Annual Report on Form 10-K filed with the SEC. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by applicable law. Accordingly, readers should not place undue reliance on forward-looking statements as a prediction of actual results. Use of Non-GAAP Financial Measures We define Adjusted EBITDA as income (loss) from continuing operations before repositioning expenses (including certain product returns and inventory write-offs recorded in gross profit), interest expense, foreign exchange losses reclassified from other comprehensive income (loss), refinancing expenses, acquisition and integration costs (including certain product returns and inventory write-offs recorded in gross profit), gains and losses on sale of capital assets, Biologics earnout income and expense, income taxes, impairment charges, remediation costs, depreciation and amortization, stock-based compensation expense, consulting costs related to our operational initiatives, purchase accounting adjustments, acquisition-related litigation expenses and other income and expenses. Adjusted EBITDA margin is Adjusted EBITDA divided by revenues. We define Adjusted net income as Adjusted EBITDA minus depreciation expense (excluding amortization from intangibles acquired in acquisitions), interest expense (excluding amortization of the deferred financing costs), and tax expense. In addition, we exclude discrete tax items and apply an estimated tax effect on adjustments within the calculation. The estimated tax effect is calculated using statutory tax rates on each expense item, except in the case where a jurisdiction is under a full valuation allowance at the time of the expense, in which we apply a tax rate of 0%. We define Adjusted EPS as Adjusted net income divided by the average number of shares outstanding on a diluted basis for the related period. Our management uses Adjusted EBITDA as one of several metrics to measure the Company’s operating performance. Adjusted EBITDA is also a component of the performance objectives used to determine the short and long-term incentive portions of executive compensation. We present Adjusted net income and Adjusted EPS because we believe they are useful supplemental measures in evaluating the performance of our operations and provide greater transparency into our results. We believe that providing these non-GAAP financial measures to investors as a supplement to the comparable U.S. GAAP measures in evaluating the performance of our operations provides greater transparency to the information used by the Company’s management in its financial and operational decision-making. These non-GAAP financial measures do not have standard meanings, so they may not be comparable to similarly-titled measures presented by other companies and should not be considered in isolation or as a substitute for U.S. GAAP financial measures of performance. Reconciliations of these non-GAAP measures to their most comparable U.S. GAAP financial measures are included with the financial statements in this press release. The Company does not provide a reconciliation of forward-looking non-GAAP financial measures to their comparable GAAP financial measures because it could not do so without unreasonable effort due to the unavailability of the information needed to calculate reconciling items and the variability, complexity and limited visibility of the adjusting items that would be excluded from the non-GAAP financial measures in future periods. When planning, forecasting and analyzing future periods, the Company does so primarily on a non-GAAP basis without preparing a GAAP analysis as that would require estimates for various cash and non-cash reconciling items that would be difficult to predict with reasonable accuracy. For example, equity compensation expense would be difficult to estimate because it depends on the Company’s future hiring and retention needs, as well as the future fair market value of the Company’s common stock, all of which are difficult to predict and subject to constant change. It is equally difficult to anticipate the need for or magnitude of a presently unforeseen one-time restructuring expense or the values of end-of-period foreign currency exchange rates. As a result, the Company does not believe that a GAAP reconciliation to forward-looking on-GAAP financial measures would provide meaningful supplemental information about the Company’s outlook.


Patent
Patheon | Date: 2014-03-11

Disclosed herein are novel methods of treating diseases, novel dosage forms, and novel methods of modulating the pharmacokinetics of active ingredients.


Patent
Patheon | Date: 2015-09-15

Disclosed herein are novel methods of treating diseases, novel dosage forms, and novel methods of modulating the pharmacokinetics of active ingredients.

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