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News Article | November 7, 2016
Site: globenewswire.com

MORRISTOWN, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company with a focus on Pain and CNS conditions, today announced the appointment of Graham G. Miao, Ph.D. and Dennis H. Langer, M.D., J.D. to its Board of Directors, effective immediately. The Board also determined that Dr. Langer is an independent director and appointed him as chairperson of the Compensation Committee and as a member of the Audit and Nominating Committees. Accordingly, Pernix regained compliance with NASDAQ Listing Rule 5605(c)(2)(A), which requires Pernix to have at least three independent directors on its Audit Committee for continued listing on The NASDAQ Global Market. “I’m pleased to welcome Dr. Miao and Dr. Langer to the Board,” said John Sedor, Chairman and Chief Executive Officer. “Dr. Miao and Dr. Langer are industry leaders. Their breadth of knowledge and experience will provide invaluable insight to Pernix as we move forward with the vision that I outlined when I first took over as Chief Executive Officer – to grow our current brands, pursue other growth opportunities and, ultimately, maximize shareholder value.” Dr. Miao has served as Pernix’s President and Chief Financial Officer since July 2016. He was Senior Advisor to the Pernix interim CEO and Board of Directors from May 2016 to July 2016. Prior to joining Pernix, Dr. Miao served as Executive Vice President, Chief Financial Officer of PDI, Inc., a NASDAQ listed healthcare commercialization and molecular diagnostic company, from October 2014 until March 2016. In this role, he helped achieve double-digit revenue growth and lead the successful sale of PDI's contract sales business to Publicis Healthcare. From September 2011 to September 2014, Dr. Miao served as Executive Vice President and Chief Financial Officer and held the additional role as Co-President and Co-Chief Executive Officer from September 2013 to September 2014 of Delcath Systems, Inc., a NASDAQ traded specialty pharmaceutical and medical device company focused on cancer treatment. From September 2009 until September 2011, Dr. Miao served as Chief of Staff for the Global CFO Organization at Dun & Bradstreet Corporation. Previously, Dr. Miao held senior management roles including EVP and CFO at Pagoda Pharmaceuticals and Vice President of Strategic Planning & Financial Analysis at Symrise Inc. He also worked at Schering-Plough Corporation, serving as division CFO for the company's $3 billion primary care pharmaceuticals franchise. Dr. Miao held management roles at Pharmacia Corporation, including division CFO for the company's $1.3 billion Global Oncology franchise where he led finance teams across marketing, sales, medical affairs, business development, and mergers & acquisitions. Earlier in his career, Dr. Miao worked as a biotechnology equity analyst at J.P. Morgan and a research scientist at Roche. Dr. Miao earned an M.B.A. in Finance and a Ph.D., M.Phil., M.A. in Biological Sciences from Columbia University, an M.S. in Molecular Biology from Arizona State University, and a B.S. in Biology from Fudan University. Dr. Langer has served as director of several biotechnology, specialty pharmaceutical, and diagnostic companies, and has been CEO and/or co-founder of several health care companies. From January 2013 to July 2014 he served as Chairman and Chief Executive Officer of AdvanDx, Inc., a healthcare solutions company. From 2005 to 2010, Dr. Langer served as a Managing Partner of Phoenix IP Ventures, a private equity/venture capital firm specializing in life sciences. Previously, he was President, North America, of Dr. Reddy’s Laboratories, Limited, a multinational pharmaceutical company. From September 1994 until January 2004, Dr. Langer held several high-level positions at GlaxoSmithKline plc, and its predecessor, SmithKline Beecham, including most recently as a Senior Vice President of Research and Development. Prior to SmithKline Beecham, Dr. Langer was President and CEO of Neose Technologies, Inc. and before that held R&D and marketing positions at pharmaceutical companies Eli Lilly and Company, Abbott Laboratories and G. D. Searle & Company. At the beginning of his career, he was a Chief Resident at Yale University School of Medicine, and held clinical fellowships at Harvard Medical School and the National Institutes of Health. Dr. Langer currently serves as a Director of Myriad Genetics, Inc., Dicerna Pharmaceuticals, Inc., and several private companies. Dr. Langer served as a Director of several pharmaceutical and biotechnology companies, including Auxilium Pharmaceuticals, Inc., Ception Therapeutics, Inc. (acquired by Cephalon, Inc.), Cytogen Corporation, (acquired by EUSA Pharma, Inc.) Delcath Systems, Inc., Myrexis, Inc. Pharmacopeia, Inc. (acquired by Ligand Pharmaceuticals, Inc.), Sirna Therapeutics, Inc. (acquired by Merck & Co., Inc.), and Transkaryotic Therapies, Inc. (acquired by Shire plc). Dr. Langer is a Clinical Professor, Department of Psychiatry, Georgetown University School of Medicine. Dr. Langer received a J.D. from Harvard Law School, a M.D. from Georgetown University School of Medicine, and a B.A. in Biology from Columbia University. About Pernix Therapeutics Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its integrated Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc. To learn more about Pernix Therapeutics, visit www.pernixtx.com.


This report studies Proteomic Cancer Biomarkers in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with Production, price, revenue and market share for each manufacturer, covering  Abbott Diagnostics  Agilent Technologies  Eli Lilly & Co.  EUSA Pharma  CytoCore, Inc.  GE Healthcare  Bruker Daltonics, Inc.  Biomarker Technologies, LLC  BioCurex, Inc.  Asuragen, Inc.  DiagnoCure, Inc.  Beckman Coulter, Inc. For more information or any query mail at [email protected] Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Proteomic Cancer Biomarkers in these regions, from 2011 to 2021 (forecast), like  North America  Europe  China  Japan  Southeast Asia  India Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into  Type I  Type II  Type III Split by application, this report focuses on consumption, market share and growth rate of Proteomic Cancer Biomarkers in each application, can be divided into  Colorectal  Prostate  Lung  Breast  Ovarian Global Proteomic Cancer Biomarkers Market Research Report 2016  1 Proteomic Cancer Biomarkers Market Overview  1.1 Product Overview and Scope of Proteomic Cancer Biomarkers  1.2 Proteomic Cancer Biomarkers Segment by Type  1.2.1 Global Production Market Share of Proteomic Cancer Biomarkers by Type in 2015  1.2.2 Type I  1.2.3 Type II  1.2.4 Type III  1.3 Proteomic Cancer Biomarkers Segment by Application  1.3.1 Proteomic Cancer Biomarkers Consumption Market Share by Application in 2015  1.3.2 Colorectal  1.3.3 Prostate  1.3.4 Lung  1.3.5 Breast  1.3.6 Ovarian  1.4 Proteomic Cancer Biomarkers Market by Region  1.4.1 North America Status and Prospect (2011-2021)  1.4.2 Europe Status and Prospect (2011-2021)  1.4.3 China Status and Prospect (2011-2021)  1.4.4 Japan Status and Prospect (2011-2021)  1.4.5 Southeast Asia Status and Prospect (2011-2021)  1.4.6 India Status and Prospect (2011-2021)  1.5 Global Market Size (Value) of Proteomic Cancer Biomarkers (2011-2021) 7 Global Proteomic Cancer Biomarkers Manufacturers Profiles/Analysis  7.1 Abbott Diagnostics  7.1.1 Company Basic Information, Manufacturing Base and Its Competitors  7.1.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.1.2.1 Type I  7.1.2.2 Type II  7.1.3 Abbott Diagnostics Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.1.4 Main Business/Business Overview  7.2 Agilent Technologies  7.2.1 Company Basic Information, Manufacturing Base and Its Competitors  7.2.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.2.2.1 Type I  7.2.2.2 Type II  7.2.3 Agilent Technologies Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.2.4 Main Business/Business Overview  7.3 Eli Lilly & Co.  7.3.1 Company Basic Information, Manufacturing Base and Its Competitors  7.3.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.3.2.1 Type I  7.3.2.2 Type II  7.3.3 Eli Lilly & Co. Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.3.4 Main Business/Business Overview  7.4 EUSA Pharma  7.4.1 Company Basic Information, Manufacturing Base and Its Competitors  7.4.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.4.2.1 Type I  7.4.2.2 Type II  7.4.3 EUSA Pharma Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.4.4 Main Business/Business Overview  7.5 CytoCore, Inc.  7.5.1 Company Basic Information, Manufacturing Base and Its Competitors  7.5.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.5.2.1 Type I  7.5.2.2 Type II  7.5.3 CytoCore, Inc. Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.5.4 Main Business/Business Overview  7.6 GE Healthcare  7.6.1 Company Basic Information, Manufacturing Base and Its Competitors  7.6.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.6.2.1 Type I  7.6.2.2 Type II  7.6.3 GE Healthcare Proteomic Cancer Biomarkers Production, Revenue, Price and Gross Margin (2015 and 2016)  7.6.4 Main Business/Business Overview  7.7 Bruker Daltonics, Inc.  7.7.1 Company Basic Information, Manufacturing Base and Its Competitors  7.7.2 Proteomic Cancer Biomarkers Product Type, Application and Specification  7.7.2.1 Type I  7.7.2.2 Type II For more information or any query mail at [email protected] Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports features an exhaustive list of market research reports from hundreds of publishers worldwide. We boast a database spanning virtually every market category and an even more comprehensive collection of market research reports under these categories and sub-categories.


ATHLONE, Ireland, Nov. 15, 2016 (GLOBE NEWSWIRE) -- Innocoll Holdings plc (Nasdaq:INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need, today announced that it will report third quarter financial results before the open of U.S. financial markets on November 22, 2016. Innocoll management will host a webcast and conference call at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update. Interested parties may access the live webcast and call through the Investors section of the company website at www.innocoll.com or directly through the registration link. A recording will be archived on the company website for 90 days. The live call may be accessed by dialing 877-407-9039 for domestic callers and 201-689-8470 for international callers. A telephone replay of the call will be available until 11:59 p.m. ET on November 29, 2016 by dialing 877-870-5176 for domestic callers or 858-384-5517 for international callers and entering the conference code: 48285346. Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL® for the treatment of postoperative pain and COLLAGUARD (INL-003), a barrier for the prevention of post-surgical adhesions. Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of our native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at our certified, integrated plant in Saal, Germany. For more information, please visit www.innocoll.com. CollaRx®, Collatamp®, COLLAGUARD®, Collieva®, CollaCare®, Collexa®, COGENZIA® LidoColl®, LiquiColl®, and XARACOLL® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced that its development partner, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has submitted its responses to the European Medicines Agency (EMA) Day 120 List of Questions. The Day 120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA)


News Article | November 21, 2016
Site: www.newsmaker.com.au

Oral mucositis (OM) is the inflammation of oral mucosa and is manifested by pain and erythema or ulcerations. This condition is generally seen as a complication due to side effects of chemotherapy and radiotherapy in cancer patients. The systemic effects of cytotoxic chemotherapy agents and radiation effects on oral mucosa led to oral mucositis. The National Institutes of Health estimates that more than 400,000 patients in the U.S. are diagnosed with oral mucositis annually. Since the prevalence of cancer patients is on rise across the globe, the market for OM therapeutics is also expanding. In addition, the pain emanated from oral mucositis and the resultant need to cure the condition at the earliest is the foremost driver for the growth of this market. The oral mucositis therapeutics market includes several kinds of drug formulations and treatments such as cryotherapy, growth factors, antioxidants, anti-inflammatory agents, low-level laser therapy (LLLT), mouthwashes, barriers and coating agents. On the basis of geography, the global oral mucositis therapeutics market is segmented into four major regions, namely, North America, Europe, Asia-Pacific and Rest of the World. North America is the largest market for OM therapeutics, closely followed by the European region. The currently marketed major preparations for oral mucositis are Gelclair, Caphosol and Kepivance. Recently, the FDA granted "Fast Track" Designation for SGX942 (Soligenix, Inc.) for the treatment of oral mucositis in patients with head and neck cancer. This drug along with MuGard (tasteless viscous mouth rinse) and pipeline candidate drug nepidermin (Daewoong Pharmaceutical Co.) are expected to further drive the oral mucositis therapeutics market. The major restraint for the development of this market is that most of the drugs are not to be ingested and therefore restricts their usage for esophageal ulcers. Request TOC (desk of content material), Figures and Tables of the report: http://www.persistencemarketresearch.com/toc/5585 Some of the key players in the global oral mucositis therapeutics market include Access Pharmaceuticals, Inc., EKR Therapeutics, Inc., EUSA Pharma Inc., Swedish Orphan Biovitrum Ltd., Soligenix, Inc., Daewoong Pharmaceutical Co., Eisai Inc., and BioAlliance Pharma SA.


- First Quarter 2015 Total Revenues of $309 Million, Driven by Strong Sales of Xyrem, Erwinaze and Defitelio DUBLIN, May 7, 2015 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter ended March 31, 2015 and reaffirmed financial guidance for 2015. "We are pleased with our strong top-line performance during the first quarter, driven by sales growth of our key products," said Bruce C. Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. "For 2015, we will remain focused on execution of our key objectives, including advancing our development pipeline, completing the rolling NDA submission for defibrotide, preparing for the potential launch of defibrotide in the U.S. and continuing our efforts to further diversify our business through corporate development activities." Adjusted net income attributable to Jazz Pharmaceuticals plc for the first quarter of 2015 was $125.1 million, or $1.99 per diluted share, compared to $99.5 million, or $1.59 per diluted share, for the first quarter of 2014. GAAP net income attributable to Jazz Pharmaceuticals plc for the first quarter of 2015 was $70.7 million, or $1.12 per diluted share, compared to GAAP net loss attributable to Jazz Pharmaceuticals plc of $92.7 million, or $1.58 per diluted share, for the first quarter of 2014. GAAP net loss attributable to Jazz Pharmaceuticals plc for the first quarter of 2014 included acquired in-process research and development expense of $127.0 million. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included in this press release. Total revenues for the first quarter of 2015 were $309.3 million, an increase of 25% over total revenues of $246.9 million for the first quarter of 2014. The increase in total revenues was driven primarily by higher net product sales of Xyrem® (sodium oxybate) oral solution, Erwinaze®/Erwinase® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide). Total revenues include net product sales, royalties and contract revenues. Net product sales for the first quarter of 2015 were as follows: Tables showing actual net product sales for the three months ended March 31, 2015 and actual and pro forma net product sales for the same period in 2014 are included in this press release. Operating expenses for the first quarter of 2015 were $192.5 million on a GAAP basis compared to $313.6 million for the first quarter of 2014. Operating expenses decreased over the prior period primarily due to acquired in-process research and development expenses of $127.0 million on a GAAP basis for the first quarter of 2014, which was comprised of upfront and milestone payments made in connection with the company's acquisition of rights to JZP-110. Other changes in operating expenses for the first quarter of 2015 and 2014 were as follows: Net interest expense for the first quarter of 2015 was $16.2 million compared to $10.1 million for the first quarter of 2014. The increase was due to the company's higher debt levels following the sale in August 2014 of $575.0 million principal amount of 1.875% exchangeable senior notes due 2021. As of March 31, 2015, cash and cash equivalents were $782.6 million and the outstanding principal balance of the company's long-term debt was $1.5 billion. Cash and cash equivalents increased from December 31, 2014 primarily due to cash generated by the business and proceeds from the sale of certain products acquired as part of the acquisition of EUSA Pharma, offset in part by cash used to fund capital expenditures and the repurchase of ordinary shares under the company's share repurchase program. In the first quarter of 2015, the company repurchased 0.1 million ordinary shares under its share repurchase program for $10.3 million at an average cost of $164.54 per ordinary share. As of March 31, 2015, the amount remaining under the current share repurchase program was $11.0 million. Karen Smith, M.D., Ph.D joined the company as the Global Head of Research and Development and Chief Medical Officer on April 13, 2015. Dr. Smith brings more than 20 years of experience in the industry, and a track record of success in global development, medical affairs and lifecycle management. Dr. Smith has held positions of increasing responsibility with Merck, Pfizer, Bristol-Myers Squibb, AstraZeneca and most recently, Allergan, where she was Senior Vice President, Global Medical Affairs and Therapeutic Area Head (Dermatology), Research and Development. "We are pleased to have Dr. Karen Smith join Jazz Pharmaceuticals at this exciting time of expansion of our R&D activities," said Russell Cox, executive vice president and chief operating officer of Jazz Pharmaceuticals plc. "Karen brings expertise in multiple therapeutic areas, including oncology, and has deep experience across pharmaceuticals, devices and biologics.  Her strong leadership, global R&D and regulatory experience, and results-driven approach will bring significant value to our organization." Jazz Pharmaceuticals is reaffirming its full year 2015 financial guidance, which is as follows: Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2015 first quarter results. The live webcast may be accessed from the Investors & Media section of the company's website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1-877-415-3179 in the U.S., or +1-857-244-7322 outside the U.S., and entering passcode 74301034. A replay of the conference call will be available through May 14, 2015 by dialing +1-888-286-8010 in the U.S., or +1-617-801-6888 outside the U.S., and entering passcode 39160618. An archived version of the webcast will be available for at least one week in the Investors & Media section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution and Erwinaze® (asparaginase Erwinia chrysanthemi) in the U.S., and markets Erwinase® and Defitelio® (defibrotide) in Europe and other countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com. To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP (also referred to as "adjusted" or "non-GAAP adjusted") financial measures in this press release and the accompanying tables. The company believes that each of these non-GAAP financial measures is helpful in understanding its past financial performance and potential future results, particularly in light of the effect of various acquisition and divestiture transactions effected by the company.  They are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP.  Jazz Pharmaceuticals' management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. Compensation of executives is based in part on the performance of the company's business based on certain of these non-GAAP financial measures. In addition, Jazz Pharmaceuticals believes that the presentation of these non-GAAP financial measures is useful to investors because it enhances the ability of investors to compare its results from period-to-period and allows for greater transparency with respect to key financial metrics the company uses in making operating decisions, and also because the company's investors and analysts regularly use them to model and track the company's financial performance. Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the company's results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time-to-time in the future there may be other items that the company may exclude for purposes of its non-GAAP financial measures; likewise, the company has ceased and may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the company's presentation of 2015 non-GAAP financial measures, the company no longer includes an adjustment for depreciation expense in its non-GAAP adjusted financial measures. Likewise, for purposes of comparability, non-GAAP adjusted financial measures for 2014 included in this press release and accompanying tables do not include an adjustment for depreciation expense. In addition, because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the company's competitors and other companies. As used in this press release, (i) the historical adjusted net income measures attributable to Jazz Pharmaceuticals plc (and the related per share measures) exclude from GAAP reported net income (loss) attributable to Jazz Pharmaceuticals plc (and the related per share measures), as applicable, intangible asset amortization, share-based compensation expense, restructuring charges, transaction and integration costs, acquired in-process research and development expenses, acquisition accounting inventory fair value step-up adjustments and non-cash interest expense; adjust the income tax provision to the estimated amount of taxes that are payable in cash; and adjust for the amount attributable to noncontrolling interests; (ii) the historical adjusted SG&A expense measures exclude from GAAP SG&A expenses, as applicable, share-based compensation expense, restructuring charges, and transaction and integration costs; (iii) the historical adjusted R&D expense measures exclude from GAAP R&D expenses, as applicable, share-based compensation expense and transaction and integration costs; (iv) the adjusted net income attributable to Jazz Pharmaceuticals plc (and the related per share measures) guidance exclude from estimated GAAP net income attributable to Jazz Pharmaceuticals plc (and the related per share measures) intangible asset amortization, share-based compensation expense, upfront and milestone payments, transaction, integration and restructuring costs and non-cash interest expense; and adjust the income tax provision to the estimated amount of taxes that are payable in cash; (v) the adjusted gross margin percentage guidance excludes from estimated GAAP gross margin percentage share-based compensation expense; (vi) the adjusted SG&A expenses guidance excludes from estimated GAAP SG&A expenses share-based compensation expense and transaction, integration and restructuring costs; (vii) the adjusted R&D expenses guidance excludes from estimated GAAP R&D expenses share-based compensation expense and a potential milestone payment; and (viii) the adjusted interest expense guidance excludes from estimated GAAP interest expense non-cash interest expense. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' future financial results, including 2015 financial guidance, the advancement of the company's development pipeline, the anticipated completion of the rolling NDA submission for defibrotide and the potential acceptance for filing by the FDA thereof, the potential commercial launch of defibrotide in the U.S., the potential future diversification of the company's business through corporate development activities and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with maintaining and increasing sales of and revenue from Xyrem, such as the potential introduction of generic competition or other sodium oxybate products that compete with Xyrem and changed or increased regulatory restrictions on or requirements with respect to Xyrem, as well as similar risks related to effectively commercializing the company's other lead marketed products; risks related to effectively commercializing the company's product candidates, including defibrotide if it receives marketing approval, including the need to establish pricing and reimbursement support and, in the case of defibrotide, the lack of experience of U.S. physicians in diagnosing and treating VOD; protecting and enhancing the company's intellectual property rights; delays or problems in the supply or manufacture of the company's products which could impact the company's ability to meet commercial demand; obtaining and maintaining appropriate pricing and reimbursement for the company's products in an increasingly challenging environment; the challenges of compliance with the requirements of U.S. and non-U.S. regulatory agencies; the challenges of achieving and maintaining commercial success of the company's products; the risks and costs associated with business combination or product or product candidate acquisition transactions; the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials; the inherent uncertainty associated with the regulatory approval process, including the risk that the company may be unable to obtain regulatory approval for defibrotide in the U.S. in a timely manner or at all; the company's potential inability to identify and acquire, in-license or develop additional products or product candidates to grow and diversify its business; possible restrictions on the company's ability and flexibility to pursue certain future corporate development and other opportunities as a result of its substantial outstanding debt obligations, which increased significantly in 2014; risks related to future opportunities and plans, including the uncertainty of expected future financial performance and results; and those other risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Annual Report on Form 10-K for the year ended December 31, 2014 and future filings and reports by the company, including the Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations. The following unaudited pro forma information represents net product sales for the three months ended March 31, 2014 as if the acquisition of Gentium had been completed on January 1, 2014:


BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, has entered into an exclusive license agreement with privately-held immuno-oncology company, Apogenix (www.apogenix.com), to develop, manufacture and commercialize Apogenix’s lead product, APG101, in glioblastoma multiforme in China, Macao, and Hong Kong, with options for other indications. APG101 is a fully-human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) superfamily. By blocking the CD95 ligand, APG101 restores the immune response against tumors and inhibits invasive tumor cell growth. APG101 showed an improved overall survival benefit in patients with relapsed glioblastoma in a Phase II trial conducted in Europe. Additionally, the trial showed that glioblastoma patients with a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101. Apogenix is developing a companion diagnostic test to identify those patients most likely to benefit from APG101 treatment. APG101 is also in a Phase I trial for myelodysplastic syndromes (MDS) in Europe. Under the terms of the agreement, Apogenix will receive upfront and milestone payments, as well as royalty payments, at tiered, double-digit royalty rates following commercial launch of APG101 in China. “Development of this targeted therapeutic fits the CANbridge mission of bringing promising Western treatments to China and other Asian territories, where patients’ severe medical needs are going unmet,” said James Xue, CANbridge Chairman and CEO. “The mortality rate of malignant glioma is one of the top ten among all cancers in China. With very limited treatment options, the outcomes for Chinese patients are even more grim than in the West. The potential to develop a targeted immuno-oncology product represents a tremendous advance for glioblastoma treatment in China.” “The licensing agreement with CANbridge represents an important milestone in our goal to develop and commercialize our immuno-oncology compound APG101 as a new therapy for difficult-to-treat tumor indications on an international level,” said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. “We are delighted to have found a strong and committed partner with a seasoned management team and extensive drug development expertise in these important Asian markets. We look forward to working with CANbridge to obtain approval for APG101 in China, Macao, and Hong Kong, so we can provide patients suffering from glioblastoma with a novel, much-needed therapeutic option as soon as possible.” “The CANbridge and Apogenix missions and cultures are perfectly aligned, which bodes well for the success of this partnership,” said Henri Termeer, CANbridge’s Advisor and former Chairman and CEO of Genzyme Corporation. “Each company is dedicated to bringing forth treatments in their respective markets for patients with few options. Together, CANbridge and Apogenix can move this exciting program forward more effectively than either could alone in China.” “Glioblastoma multiforme is a very serious disease with limited therapeutic options at present. Based upon the data already generated by Apogenix, I am very excited about the possibility of APG101 to greatly improve clinical outcomes in patients with glioblastoma multiforme,” said Mark Goldberg, MD. Medical Advisor to CANbridge and practicing hematologist and oncologist at Brigham and Women’s Hospital and Dana Farber Cancer Institute. Glioblastoma multiforme is the most lethal form of brain cancer and the hardest to treat. It is the only grade IV glioma by World Health Organization classification. Current standard-of-care consists of surgical resection of the tumor followed by radiation and chemotherapy. The five-year survival rate is less than 3%, with the mortality rate the third highest, after pancreatic cancer and lung cancer. In China, glioblastoma incidence is predicted to grow from 1.75 per 100,000 people in 2014, to 2.05 per 100,000 in 2024, which represents a 17% increase. CANbridge Life Sciences, Ltd. is a bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets for commercialization in China and North Asia. CANbridge has an exclusive licensing agreement with U.S.-based Azaya Therapeutics, Inc., to develop and commercialize ATI-1123 in China, for the treatment of non-small cell lung cancer and other solid tumors. CANbridge also has an agreement with EUSA Pharma, to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize lead candidate, onco-immunotherapy, APG101, for the treatment of glioblastoma multiforme in China, Macao and Hong Kong. Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions. CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.


BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, has entered into an exclusive license agreement with privately-held immuno-oncology company, Apogenix (www.apogenix.com), to develop, manufacture and commercialize Apogenix’s lead product, APG101, in glioblastoma multiforme in China, Macao, and Hong Kong, with options for other indications. APG101 is a fully-human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) superfamily. By blocking the CD95 ligand, APG101 restores the immune response against tumors and inhibits invasive tumor cell growth. APG101 showed an improved overall survival benefit in patients with relapsed glioblastoma in a Phase II trial conducted in Europe. Additionally, the trial showed that glioblastoma patients with a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101. Apogenix is developing a companion diagnostic test to identify those patients most likely to benefit from APG101 treatment. APG101 is also in a Phase I trial for myelodysplastic syndromes (MDS) in Europe. Under the terms of the agreement, Apogenix will receive upfront and milestone payments, as well as royalty payments, at tiered, double-digit royalty rates following commercial launch of APG101 in China. “Development of this targeted therapeutic fits the CANbridge mission of bringing promising Western treatments to China and other Asian territories, where patients’ severe medical needs are going unmet,” said James Xue, CANbridge Chairman and CEO. “The mortality rate of malignant glioma is one of the top ten among all cancers in China. With very limited treatment options, the outcomes for Chinese patients are even more grim than in the West. The potential to develop a targeted immuno-oncology product represents a tremendous advance for glioblastoma treatment in China.” “The licensing agreement with CANbridge represents an important milestone in our goal to develop and commercialize our immuno-oncology compound APG101 as a new therapy for difficult-to-treat tumor indications on an international level,” said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. “We are delighted to have found a strong and committed partner with a seasoned management team and extensive drug development expertise in these important Asian markets. We look forward to working with CANbridge to obtain approval for APG101 in China, Macao, and Hong Kong, so we can provide patients suffering from glioblastoma with a novel, much-needed therapeutic option as soon as possible.” “The CANbridge and Apogenix missions and cultures are perfectly aligned, which bodes well for the success of this partnership,” said Henri Termeer, CANbridge’s Advisor and former Chairman and CEO of Genzyme Corporation. “Each company is dedicated to bringing forth treatments in their respective markets for patients with few options. Together, CANbridge and Apogenix can move this exciting program forward more effectively than either could alone in China.” “Glioblastoma multiforme is a very serious disease with limited therapeutic options at present. Based upon the data already generated by Apogenix, I am very excited about the possibility of APG101 to greatly improve clinical outcomes in patients with glioblastoma multiforme,” said Mark Goldberg, MD. Medical Advisor to CANbridge and practicing hematologist and oncologist at Brigham and Women’s Hospital and Dana Farber Cancer Institute. Glioblastoma multiforme is the most lethal form of brain cancer and the hardest to treat. It is the only grade IV glioma by World Health Organization classification. Current standard-of-care consists of surgical resection of the tumor followed by radiation and chemotherapy. The five-year survival rate is less than 3%, with the mortality rate the third highest, after pancreatic cancer and lung cancer. In China, glioblastoma incidence is predicted to grow from 1.75 per 100,000 people in 2014, to 2.05 per 100,000 in 2024, which represents a 17% increase. CANbridge Life Sciences, Ltd. is a bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets for commercialization in China and North Asia. CANbridge has an exclusive licensing agreement with U.S.-based Azaya Therapeutics, Inc., to develop and commercialize ATI-1123 in China, for the treatment of non-small cell lung cancer and other solid tumors. CANbridge also has an agreement with EUSA Pharma, to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize lead candidate, onco-immunotherapy, APG101, for the treatment of glioblastoma multiforme in China, Macao and Hong Kong. Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions. CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.


News Article | September 14, 2015
Site: www.businesswire.com

MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ:TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced financial results for the first quarter fiscal year 2016 ended July 31, 2015, and provided a corporate update. “Throughout this calendar year, we have continued to execute on our clinical plan for levosimendan as we work to increase the enrollment speed for our Phase 3 LEVO-CTS trial in Low Cardiac Output Syndrome (LCOS),” said John Kelley, Chief Executive Officer of Tenax Therapeutics. “With 179 patients enrolled thus far and 62 sites activated, we have made significant progress increasing our trial’s visibility within different regions and educating our participating sites; and we expect enrollment pace to increase throughout the rest of 2015 to enable a topline data readout in calendar year 2016.” “Meanwhile, the LeoPARDS trial in septic shock conducted by Imperial College London has continued to progress nicely, with 428 patients enrolled now out of an estimated 516 patients,” continued Mr. Kelley. “Upon full enrollment, we look forward to seeing the eventual presentation of data next year by our Imperial College colleagues, which will inform our regulatory pathway with this additional indication. We were also pleased to announce our recent partnership with Sepsis Alliance to help raise awareness of this deadly condition that still has few effective treatment options. “And on the corporate side, we were excited to announce the nomination of James Mitchum to our Board of Directors, where we believe his extensive and diverse pharmaceutical experience will be a valuable resource to help guide our developing critical care pipeline.” The Company reported a net loss of $3.0 million or $0.11 per share for the first quarter fiscal year 2016, compared to a net loss of $2.2 million, or $0.08 per share in the same period in fiscal 2015. The Company reported general and administrative expenses of $1.4 million for the first quarter fiscal year 2016, compared to $1.4 million in the same period in fiscal 2015. The Company reported research and development expenses of $1.8 million for the first quarter fiscal year 2016, compared to $1.0 million in the same period in fiscal 2015. As of July 31, 2015, the Company had $43.9 million in cash, including the fair value of its marketable securities, compared to $48.1 million at April 30, 2015. The Company expects that its cash balance, including the fair value of its marketable securities, will be sufficient for it to accomplish its corporate goals through calendar year 2017, including the full readout of its ongoing Phase 3 LEVO-CTS trial and a potential New Drug Application for levosimendan in the LCOS indication. The Tenax management team will host a call today at 8:30 a.m. ET to discuss financial results for the first quarter fiscal year 2016. To participate in the call, please dial 877‐407‐8029 (domestic) or 201‐689‐8029 (international) and refer to conference ID 13619395. A live webcast of the call can be accessed under “Events and Presentations” in the Investors section of the Company’s website at www.tenaxthera.com. An archived webcast recording will be available on the Tenax Therapeutics website beginning approximately two hours after the call. Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. The Company owns the North American rights to develop and commercialize levosimendan, and the United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). The Company is currently enrolling a Phase 3 trial with levosimendan in that indication, and is also supporting Imperial College London’s ongoing LeoPARDS trial for levosimendan in septic shock. For more information, visit www.tenaxthera.com. This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the company's control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on September 9, 2015, and annual report on Form 10-K filed on July 14, 2015, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.


MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that James Mitchum has been nominated to be elected to the Company’s Board of Directors at the annual meeting of stockholders scheduled for September 15, 2015. Mr. Mitchum is an experienced, highly-regarded pharmaceutical executive and has served as the chief executive officer of Heart to Heart International, a non-profit humanitarian organization, since September 2014. From 2009 to July 2012, Mr. Mitchum served as president of the Americas for EUSA Pharma (USA), Inc., where he oversaw the streamlining of that business as well as the development, FDA approval and successful launch of a pediatric oncology drug in 2011. Previously, he served as president and chief executive officer of Enturia, Inc., a privately owned drug-device company based in Kansas City. From 2003 to 2005, Mr. Mitchum served as the president and chief executive officer of Sanofi-Aventis Group Japan, and he was chief executive for Aventis Pharma UK from 2000 through 2002. He has also worked in a variety of other senior financial roles. Mr. Mitchum currently serves as a director for NephroGenex Inc., a company developing drugs to treat kidney disease, and has also served as a director on numerous private company and organization boards. He holds an M.B.A. from the University of Tennessee and a B.S. in Business and Math from Milligan College. “We believe that the election of James Mitchum to our Board of Directors will be a significant and very positive addition for the Company,” said John Kelley, chief executive officer of Tenax. “His experience leading companies in the life sciences industry, as well as his financial and operational expertise, will be a great resource for us as we continue to execute on our late-stage development programs for levosimendan.” Mr. Mitchum was nominated by the Company’s Nominating Committee to fill the vacancy created by current board director William Chatfield’s decision not to stand for re-election when his term expires at this year’s annual meeting of stockholders. The Company’s Nominating Committee has endorsed Mr. Mitchum’s candidacy in a proxy statement, which can be found on the Company’s website (www.tenaxthera.com) in the Investors section under “SEC Filings.” Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. The Company owns the North American rights to develop and commercialize levosimendan, and the United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). The Company is currently enrolling a Phase 3 trial with levosimendan in that indication, and is also supporting Imperial College London’s ongoing LeoPARDS trial for levosimendan in septic shock. For more information, visit www.tenaxthera.com. This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the company's control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on March 17, 2105 and annual report on Form 10-K filed on July 14, 2015, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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