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MADISON, Wis., April 12, 2017 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today announces it has appointed John Friend, II, M.D. as vice president and chief medical officer effective April 17, 2017. “Cellectar has accelerated and expanded its research and development program to include multiple clinical trials for our lead product candidate CLR 131, as well as the active preclinical development of additional compounds utilizing our PDC platform,” said Jim Caruso, president and CEO of Cellectar Biosciences. “John’s depth of drug development experience in the biopharmaceutical industry, specifically, advancing drugs from preclinical stage through clinical studies, as well as successful oversight of the regulatory process, precisely meets our current need in helming our PDC programs and we look forward to benefitting from his leadership.” Dr. Friend, age 47, brings 15 years of global drug development expertise and general management experience in oncology, inflammation, endocrine/metabolism, and pain management to Cellectar.  Prior to joining the company, John spent more than seven years at Helsinn Therapeutics leading its research and development division.  Most recently he served as senior vice president of Medical and Scientific Affairs at Helsinn, building the non-clinical, clinical, medical and regulatory affairs teams to lead multiple global franchises from early product development to market commercialization. Prior to his time at Helsinn, Dr. Friend held executive responsibility for clinical research, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Akros Pharma, Actavis, Alpharma, Hospira and Abbott.  After obtaining an undergraduate degree in Chemistry from Southern Methodist University, John earned his medical degree from UMDNJ-Robert Wood Johnson Medical School (now Rutgers, RWJMS).  He completed post-graduate residency program in family medicine and subsequently served as clinical director and faculty attending physician at Cabarrus Family Medicine Residency Program in North Carolina.   About Cellectar Biosciences, Inc. Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer-targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma, as well as a Phase II clinical study to assess efficacy in a range of B-cell malignancies. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical-stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information please visit www.cellectar.com. This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2016. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.


News Article | April 20, 2017
Site: www.prnewswire.com

Zubsolv® growth in the US drives improved profitability in the commercial operations In a dynamic market environment, I am pleased to report that net sales for Zubsolv US in Q1 2017 increased with 15.9 percent from Q1 2016 and our US business continues to contribute positively to the Orexo revenues and earnings. With this growth and positive contribution from our US business, I can confirm our financial guidance of positive EBITDA for the full year. We are encouraged to see an accelerating growth in the market for treatment of opioid dependence reaching 9.7 percent in the first quarter compared to a growth of 7.6 percent in Q4 2016. This is a trend break as Q1 traditionally is weaker than Q4. The growth this year is primarily driven by the physicians certified to expand to 275 patients and most of the growth is in the public segment. The commercial segment has followed the trend from previous years with Q1 slightly below Q4 volumes. We expect the commercial segment to improve in the next quarters and we are pleased to see the growth in commercial pick-up late in the quarter. This is important for Orexo as we have better market access, market share and pay less rebates in the commercial segment. During the quarter, I have spent time in the US meeting healthcare professionals treating opioid dependence. The feedback on Zubsolv and our work in the US is positive, we have a strong brand awareness both as a company and on a product level with Zubsolv. However, market access remains an important driver of physicians' choice of medication and we need to work relentlessly to open up the market for more unrestricted access for Zubsolv. I know our message resonates well, but physicians need to move out of their comfort zone and direct their patients to get a treatment with Zubsolv versus a "drug" most patients have tried before even starting medical treatment, since they were buying it on the street as a part of their illicit opioid misuse. Another key event during the quarter was a new litigation against Actavis for infringement of our patent 8,454,996 with their generic versions of Suboxone® and Subutex®. The validity of the '996 patent was confirmed by the district court and Actavis has not appealed the decision. Actavis has been successful with the generic version of Suboxone and was the market leader the first year after launch in March 2013. The total cumulated gross sales of the generic versions of Suboxone and Subutex exceed USD 500 million and Orexo will seek compensation for damages caused by Actavis's infringement of the '996 patent. I remain confident that we will continue to see a positive development of Zubsolv and Orexo, spurred by improved market and volume growth in the US. Beyond Zubsolv in the US, our pipeline is progressing well. Zubsolv launch in Europe is anticipated early next year, we have concrete discussions with partners for OX51 and OX-MPI and we have some exciting new formulation technologies which could be ready for first clinical trials already this year. With our continued strengthening of our financial position, with six consecutive quarters with positive cash flow from operating activities, we are well positioned to capture the opportunities and continue the development of Orexo. For further information, please contact : Nikolaj Sørensen, President and CEO, or Henrik Juuel, EVP and CFO Tel +46-18-780-88 -0  E-mail ir@orexo.com CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference on April 20, 2017, at 2:00pm CET. Please view instructions below on how to participate. Internet: https://wonderland.videosync.fi/orexo-q1-report-2017. Telephone: (SE) +46 8 566 425 09, (UK) +44 20 300 89 807 or (US) +1 855 831 5945. There will be a Q&A session and questions can also be sent in advance to ir@orexo.com at latest 11am CET. The presentation will be available at Orexo´s website one hour prior to the teleconference. This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00am CET on April 20, 2017. This information was brought to you by Cision http://news.cision.com http://news.cision.com/orexo/r/interim-report-q1-2017,c2242893 The following files are available for download: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/orexo---interim-report-q1-2017-300442507.html


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global Asset Purchase Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2010 to 2017" report to their offering. The Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2010-2017 report provides a detailed understanding and analysis of how and why companies enter business, product, technology and royalty assets. The report provides a detailed understanding and analysis of how and why companies enter business, product, technology and royalty assets. The focus of the report is on partnerships for business, product, technology and royalty assets where partners have entered an agreement to dispose of or acquire said assets. Companies may seek to dispose of an asset simply because it is surplus to requirements. Or it may seek to dispose of assets in order to raise funds to invest in others parts of its business. Or it may be due to a regulatory requirement to dispose of certain business or product assets as a result of a pending business merger in order to meet competition regulations. The report provides access to asset purchase deal payment terms as announced between the parties. This data provides useful insight into the payment and other deal terms. The report includes deals announced by hundreds of life science companies including big pharma such as Abbott, Abbvie, Actavis, Amgen, Astellas, AstraZeneca, Baxter, Bayer, Biogen Idec, BMS, Celgene, Eisai, Eli Lilly, Gilead, GSK, J&J, Kyowa Hakko, Merck, Mitsubishi, Mylan, Novartis, Pfizer, Roche, Sanofi, Shire, Takeda, Teva, and Valeant, amongst many others. The report focuses on four primary types of asset available for purchase: In Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2010-2017, the available deals are listed by: For more information about this report visit http://www.researchandmarkets.com/research/g7x5ql/global_asset


News Article | May 29, 2017
Site: www.prnewswire.com

NEW YORK, May 29, 2017 /PRNewswire/ -- This report analyzes the worldwide markets for Testosterone Replacement Therapy (TRT) in US$ Million. The Global and the US markets are further analyzed by the following Product Segments: Topicals, Patches, and Others. The report provides separate comprehensive analytics for the US, Canada, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Read the full report: http://www.reportlinker.com/p04910451/Global-Testosterone-Replacement-Therapy-TRT-Pharmaceuticals.html Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 29 companies including many key and niche players such as - AbbVie, Inc. - Acerus Pharmaceuticals Corporation - Acrux Limited - Antares Pharma, Inc. Read the full report: http://www.reportlinker.com/p04910451/Global-Testosterone-Replacement-Therapy-TRT-Pharmaceuticals.html I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations Disclaimers Data Interpretation & Reporting Level Quantitative Techniques & Analytics Product Definitions and Scope of Study Topicals Patches Others II. EXECUTIVE SUMMARY 1. INDUSTRY OVERVIEW TRT Market in a State of Flux List of FDA Approved TRTs by Formulation and Year of Approval Timeline for Launch of Various Types of Testosterone Replacement Therapies Table 1: World Hypogonadism Prevalence by Age Group: Percentage of the Disorder in 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, and >80 Age Groups (includes corresponding Graph/Chart) Recently Approved/ Pipeline Testosterone Replacement Therapy Products US Dominates the Global TRT Market Markets, Other than the US, to Witness Tremendous Growth Topicals Dominate the US Market, Conventional Drugs Rule Elsewhere Leading TRT Products Available in the Market Cardiovascular Risks Taint the TRT Market 2. GROWTH DRIVERS AND MARKET TRENDS Aging Global Population Drives Adoption Table 2: Percentage of Total Population above 65 Years of Age in Select Countries for 2000 and 2025 (F) (includes corresponding Graph/Chart) Table 3: Global Male Population Distribution (15-64 Yrs) by Geographic Region: 2015 (includes corresponding Graph/Chart) Table 4: Global Male Population Distribution (65+Yrs) by Geographic Region: 2015 (includes corresponding Graph/Chart) Undiagnosed Patients - A Strong Indicator of Growth Potential Rising Awareness - A Critical Factor for Growth Untapped Developing Markets - The Future Growth Engine for TRT Emerging Data on Positive Impact on Co-morbidities to Support Growth Debunking Conventional Wisdom, New Studies Dissociate Prostate Cancer Risk with TRT Marketing Campaigns and Patient Referrals to Fuel Growth Easy-to-use Formulations - A Major Boost to TRT Market Testosterone as Treatment for Other Conditions - A Growing Area of Focus 3. COMPETITION TRT- A Highly Consolidated Market Table 5: Sales of Select testosterone Replacement Therapies: 2015 & 2016 (in US$ Million) (includes corresponding Graph/Chart) Entry of Large Multinational Players Generic Incursion - A Major Threat Expiration of Patents and Market Exclusivity of Leading TRT Brands in the US An Overview of Select Drugs on The Market AndroGel (AbbVie) AndroGel's Market Performance Raises Concerns for AbbVie Axiron (Eli Lilly) Axiron - A Comparison with Other Products Axiron's Patent Profile Testim (Endo/Auxilium) Testim Scores High on Efficacy over AndroGel Small Packaging Works for Testim Testim' Sales Continue to Plunge Androderm (Actavis) Fortesta (Endo Pharmaceuticals) Tostran (Kyowa Kirin) Natesto™ TRT - A Comparative Review Inherent Attributes to Help Natesto Scale Sizable Growth Threat from New Products Pipeline Analysis Oral Drugs Dominate Drug Development Pipeline Lipocine's Tlando Hits Regulatory Bump Uncertainly Looms Large Over Enclomiphene's Pending Approval Clarus Persists with its Oral TRT VIBEX QS T - A New Hope to Injectables Users Rextoro (formerly CLR-610) New Drug in Development Promises Availability of Native Oral Testosterone Spray-on Testosterone - A New Chapter in Topical Testosterone Therapies 4. TESTOSTERONE DEFICIENCY AND TRT - AN OVERVIEW Testosterone - An Introduction Testosterone Deficiency Primary Hypogonadism Secondary Hypogonadism Symptoms General Symptoms Clinical Symptoms Table 6: Major Symptoms in Hypogonadal Patients: Percentage of Hypogonadal Patients Affected with Moderate to Severe Symptoms of Low Energy Levels, Irritability, Sparse Beard, Diminished Libido, and Sleepiness After Lunch (includes corresponding Graph/Chart) Causes Co-Morbid Conditions Table 7: Hypogonadism Prevalence in Some Common Medical Conditions (includes corresponding Graph/Chart) Diabetes and Hypogonadism Diagnosis Testosterone Replacement Testosterone Replacement Therapy - Evolution Topicals Patches Others Injections Orals Pellets A Comparison of Key Benefits and Drawbacks of Existing Testosterone Preparations Major Potential Benefits of TRT Major Potential Risks of TRT Precautions Treatment Alternatives 5. PRODUCT LAUNCHES/APPROVALS Perrigo Obtains FDA Clearance of ANDA for Generic Axiron Acerus Launches Natesto™ in Canada Endo Pharmaceuticals Launches Natesto™ Perrigo Releases AB Therapeutics Equivalent of Testosterone Gel Endo Introduces Authorized Generic FORTESTA® Gel Auxilium Rolls Out Authorized Generic Version of Testim Endo Gets FDA Nod for Aveed FDA Denies Rextoro Oral Testosterone by Clarus Therapeutics FDA Approves sNDA for STENDRA Endo International Launches Generic Version of its Fortesta MonoSol Rx Launches Clinical Trial of MSRX-110 Perrigo Receives AB Therapeutic Equivalent Rating from FDA for Testosterone Gel FDA Confirms Endpoints for ZA-304 and ZA-305 Studies Auxilium and Prasco Launch Testim® Generic FDA Approves NDA for Vogelxo USFDA Approves Natesto Testosterone Nasal Gel BioThermo Labs Introduces T9 Testosterone Supplement iSatori Launches Fenu Test HRTI Obtains FDA Clearance for Commencing Testagen® TDS Clinical Trials Eli Lily Launches Axiron® in Canada FDA Approves Generic Depo-Testosterone Injection of Sun Pharmaceutical Perrigo Obtains FDA Approval for AndroGel® 1% TestoMeds Launches Androfeme, Andromforte and Profeme Testosterone Replacement Creams 6. RECENT INDUSTRY ACTIVITY Lipocine Finishes Enrollment for New Dosage Studies on LPCN 1021 FDA Accepts NDA for Antares Pharma's QST Teva Sells Actavis' Operations in UK and Ireland to Accord TesoRx and ASKA Team Up to Commercializes Oral TRT in Japan Acerus Grants Korean Commercialization License for NATESTO to Hyundai Pharm Repros Files for European Approval of Enclomiphene Teva Acquires Actavis Generics Acerus Consummates Transition of NATESTO from Endo to Aytu FDA Rejects NDA for Lipocine's Oral Testosterone Product ProStrakan Changes Name to Kyowa Kirin Apricus Biosciences Shelves Fispemifene Developmental Trials Acerus Cancels Commercialization Deal for NATESTO with Endo Ventures Novartis and Phase 4 Partners form Mereo BioPharma Group Repros Gets Complete Response Letter of NDA Rejecting Approval for Enclomiphene ANI Acquires Approved NDA for Teva's Testosterone Gel 1% Endo Takes Over Auxilium Pharmaceuticals Trimel Files for Approval for Natesto with Health Canada Trimel Confers Endo with Natesto Marketing Rights TesoRx Awards Aspen Global with Select International License of TSX-002 Viramal Acquires TestoCream License from Aptys Vivus Provides Auxilium North American Marketing Rights for STENDRA CoreRx and TesoRx Pharma Form Production Joint Venture for TSX-002 Eli Lilly Files Lawsuit against Perrigo for Infringing Axiron Patents Perrigo Files for Generic Axiron Approval with FDA Auxilium Wins Patent Challenges for Testim Auxilium Pharmaceuticals Takes Over Actient Holdings Ferring Submits Patent Application for New Testosterone Formulations in Australia Perrigo Submits ANDA for Testosterone 1.62% with the US FDA Watson Pharmaceuticals Rebrands to Actavis US FDA Accepts to Review Complete Response Submission for NDA of Endo Pharmaceuticals's Aveed Lipocine Announces Positive Phase I Clinical Trial for LPCN 1111 Candidate 7. FOCUS ON SELECT PLAYERS AbbVie, Inc. (US) Acerus Pharmaceuticals Corporation (Canada) Acrux Limited (Australia) Antares Pharma, Inc. (US) Bayer HealthCare Pharmaceuticals (Germany) Eli Lilly and Company (US) Endo Pharmaceuticals Inc. (US) Kyowa Kirin (UK) 8. GLOBAL MARKET PERSPECTIVE Table 8: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy (TRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 9: World Historic Review for Testosterone Replacement Therapy (TRT) by Geographic Region - US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 10: World 14-Year Perspective for Testosterone Replacement Therapy (TRT) by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Europe, Asia-Pacific, Latin America and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 11: World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 12: World Historic Review for Testosterone Replacement Therapy (TRT) by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 13: World 14-Year Perspective for Testosterone Replacement Therapy (TRT) by Product Segment - Percentage Breakdown of Dollar Sales for Topicals, Patches and Others Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) III. MARKET 1. THE UNITED STATES A.Market Analysis Hypogonadism - High Prevalence, Low Treatment, Offers Increasing Potential Topical Gels - The Largest Selling Segment Table 14: Total TRT Prescriptions Trends in the US: Number of Total Prescriptions (March 2015 - December 2016) (includes corresponding Graph/Chart) A Comparison of Commonly Prescribed Topical TRT Products in the US "Low T" Trend Litigations New Products Strive to Address Transference Issues High-Concentration Products Gain Market Share in the Topicals Market Debate Continues Over the Need for TRT Big Pharma Spends Millions to Push TRT Sales Increasing Ad Spending Draws Flak Product Landscape AndroGel Retains Leadership in Total Prescriptions Table 15: Leading Drugs in the US TRT Market (2015): Percentage Breakdown of Value Sales for Androderm, Androgel, Axiron, Fortesta, Testim, Transdermal Testosterone and Others (includes corresponding Graph/Chart) Table 16: TRT Prescriptions in the US (2015): Percentage Breakdown of Total Prescriptions for Androgel, Axiron, Fortesta, Transdermal Testosterone and Injectables (includes corresponding Graph/Chart) AbbVie Fights on for AndroGel's Market Sustenance Axiron Faces Tough Market Conditions Table 17: Axiron Quarterly Sales Worldwide: FY2012 through FY2016 (includes corresponding Graph/Chart) Co-Pay Scheme Helps Axiron Attract Users Testim Revenues Head South Impending Patent Expiries Patent Expiries of Leading TRT Brands in the US Generics Hurt Sales of Branded Drugs FDA Mandates Labeling Changes despite Lack of Consensus Related to Cardiac Events after TRT Product Launches/Approvals Strategic Corporate Developments Key Players B.Market Analytics Table 18: US Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 19: US Historic Review for Testosterone Replacement Therapy by Product Segment - Topicals, Patches and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 20: US 14-Year Perspective for Testosterone Replacement Therapy by Product Segment - Percentage Breakdown of Dollar Sales for Topicals, Patches and Others Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 2. CANADA A.Market Analysis Current & Future Analysis Available TRT Therapies in Canada Product Approvals/Launches Strategic Corporate Developments Acerus Pharmaceuticals Corporation - A Major Canada-based TRT Player B.Market Analytics Table 21: Canadian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 22: Canadian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 3. EUROPE A.Market Analysis Current & Future Analysis Gels to Drive European TRT Market Lower Normal Serum Testosterone Concentration in Select European Nations Strategic Corporate Developments B.Market Analytics Table 23: European Recent Past, Current & Future Analysis for Testosterone Replacement Therapy by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 24: European Historic Review for Testosterone Replacement Therapy by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 25: European 14-Year Perspective for Testosterone Replacement Therapy by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 3a. FRANCE Market Analysis Table 26: French Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 27: French Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 3b. GERMANY A.Market Analysis Current & Future Analysis Strategic Corporate Development Bayer Healthcare Pharmaceuticals - A Key Player in the TRT Market B.Market Analytics Table 28: German Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 29: German Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 3c. ITALY Market Analysis Table 30: Italian Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 31: Italian Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 3d. THE UNITED KINGDOM A.Market Analysis Market Overview Product Launch/Approval Strategic Corporate Development Select Key Player B.Market Analytics Table 32: UK Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 33: UK Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 3e. SPAIN Market Analysis Table 34: Spanish Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 35: Spanish Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 3f. REST OF EUROPE A.Market Analysis Current & Future Analysis Product Launch B.Market Analytics Table 36: Rest of Europe Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 37: Rest of Europe Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 4. ASIA-PACIFIC A.Market Analysis Current & Future Analysis Increasing Use of Testosterone in Australia Strategic Corporate Developments Select Key Player B.Market Analytics Table 38: Asia-Pacific Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 39: Asia-Pacific Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 5. LATIN AMERICA Market Analysis Table 40: Latin American Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 41: Latin American Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) 6. REST OF WORLD A.Market Analysis Current & Future Analysis Product Launch B.Market Analytics Table 42: Rest of World Recent Past, Current & Future Analysis for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 43: Rest of World Historic Review for Testosterone Replacement Therapy Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) IV. COMPETITIVE LANDSCAPE Total Companies Profiled: 29 (including Divisions/Subsidiaries - 31) The United States (17) Canada (2) Japan (2) Europe (7) - Germany (1) - The United Kingdom (4) - Rest of Europe (2) Asia-Pacific (Excluding Japan) (3) Read the full report: http://www.reportlinker.com/p04910451/Global-Testosterone-Replacement-Therapy-TRT-Pharmaceuticals.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-testosterone-replacement-therapy-trt---pharmaceuticals-300465051.html


News Article | May 29, 2017
Site: www.prlog.org

The Canada generic drug market has witnessed a significant growth over the past several years, reaching a volume of around 0.46 Billion Units in 2016. -- Canada currently represents the ninth-largest generic drug market worldwide, accounting for nearly 3% of the total global share. The share of generic drugs in the pharmaceuticals market has increased significantly over the past several years. At present, generic drugs account for around 70% of the total retail prescriptions, and 22% of the total pharmaceutical sales value in the region. This can be attributed to the various public and private sector drug programs aimed at cost-containment and increasing awareness about generic drugs. The latest report by IMARC Group titled, "Canada Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2017-2022", finds that the Canada generic drug market reached a volume of around 0.46 Billion Units in 2016, growing at a CAGR of around 8% during 2010-2016.*Generic drugs account for nearly 70% of the total retail prescriptions in Canada.*Changing demographics and government initiatives are the major growth drivers.*Patent expiry of a number of blockbuster drugs is expected to provide growth opportunities.Population growth, changing demographics, increasing prevalence of chronic diseases and a rise in the use of drug therapy are projected to put more pressure on Government healthcare initiatives such as the 'drug benefit plans' operative in the Canadian territories and provinces. As the sustainability of these programmes is largely dependent on the use of generic drugs, the demand for these drugs is expected to increase over the next several years. Moreover, the patent expiry of a number of blockbuster drugs is also anticipated to expand the generic drug market in Canada. According to the report, the market is further expected to reach a volume of nearly 0.7 Billion Units by 2022.The report analyses the competitive landscape of the market and provides details of the major players in the market. Some of these include Teva Pharmaceutical Ltd., Apotex Inc., Snadoz Canada, Actavis, Mylan, Pharmascience Inc., Taro Pharmaceuticals, Novartis, Ranbaxy Pharmaceuticals Canada and Hospira. The report provides a comprehensive insight into the historical and current trends as well as the future prospects of the generic drug market in Canada. This study serves as an exceptional tool to understand the sales trends, volume trends, growth, key segments, competitive structure, regulations, major manufacturer, major distributors, top drugs, manufacturing requirements, opportunities and future prospects of the Canada generic drug market. This report can serve as an excellent guide for manufacturers, consultants, researchers, marketing strategists and all those who plan to foray into the Canada generic drug market in any form.http://www.imarcgroup.com/categories/healthcare-market-research-reports


News Article | May 11, 2017
Site: www.businesswire.com

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE: TEVA, TASE: TEVA) today reported results for the quarter ended March 31, 2017. “In the three months since I have stepped in as the Interim CEO, we have worked tirelessly to ensure that we extract synergies related to the Actavis Generics transaction, drive additional efficiencies throughout the organization, support cash generation, pay down debt, deliver on the promise of the specialty pipeline and execute key generic launches,” stated Dr. Yitzhak Peterburg, Interim Chief Executive Officer. “We are pleased that the transaction synergies and additional cost reductions are on track, and we now expect to realize cumulative net synergies and cost reduction of approximately $1.5 billion by the end of 2017, an increase of $200 million compared to our previous guidance. Notably, we have reduced our gross debt by $1.2 billion in the quarter. We are also pursuing the sale of certain non-core assets, including our global Women’s Health business and our Oncology and Pain business in Europe, to pay down debt. In Specialty, we have received several important approvals, including the recent approval and launch of AUSTEDO™ for Huntington's disease.” Dr. Peterburg continued, “Looking forward to the rest of 2017, we are reaffirming our full-year outlook. While we have several challenges facing us, including the U.S Generics market dynamics and greater instability in the Venezuela market, we are very confident that the global business we have built will allow Teva to thrive in the future as the leader in the generics industry. I would like to thank the employees of Teva for their hard work and dedication to continuing to deliver on our commitment to patients around the world.” Dr. Peterburg concluded, “I would also like to thank Eyal Desheh, whose planned departure we announced a few weeks ago, for his contributions to Teva’s growth and success throughout his tenure. We are pleased to announce that Michael McClellan will serve as the Interim CFO, effective July 1, 2017. For the last two years, Mike has served as the CFO of our Global Specialty Medicines division. Prior to joining Teva, Mike was the U.S. CFO at Sanofi, where his career spanned over 20 years in roles of increasing responsibility in global finance and healthcare. I am confident Mike will be an excellent addition to our team. Eyal and Mike will work closely together to ensure a smooth transition. As we have stated previously, we expect our new CEO to have a significant role in identifying a permanent successor.” Revenues in the first quarter of 2017 were $5.6 billion, up 17% compared to the first quarter of 2016, primarily due to the inclusion of the Actavis Generics business, following the closing of the acquisition on August 2, 2016. Excluding the impact of foreign exchange fluctuations, revenues increased 22%. Exchange rate differences between the first quarter of 2017 and the first quarter of 2016 reduced revenues by $254 million, GAAP operating income by $78 million and non-GAAP operating income by $81 million. Changes in exchange rates used for the Venezuelan bolivar, as well as inflation-driven price increases in Venezuela, decreased revenues by $217 million, GAAP operating income by $71 million and non-GAAP operating income by $67 million, compared to results in the first quarter of 2016. In light of the economic conditions in Venezuela, the changes in revenues and operating profit in Venezuela have been excluded from any discussion of currency effects. GAAP gross profit was $2.8 billion in the first quarter of 2017, up 1% compared to the first quarter of 2016. GAAP gross profit margin was 50.1% in the first quarter of 2017, compared to 58.0% in the first quarter of 2016. Non-GAAP gross profit was $3.2 billion in the first quarter of 2017, up 6% from the first quarter of 2016. Non-GAAP gross profit margin was 56.8% in the first quarter of 2017, compared to 62.7% in the first quarter of 2016. The decrease in gross profit margin, on both a GAAP and a non-GAAP basis, was the result of the addition of the low-margin Anda distribution business, as well as lower margins in both the generic and specialty medicines businesses. Research and Development (R&D) expenses for the first quarter of 2017 amounted to $457 million, up 17% compared to the first quarter of 2016, mainly due to the inclusion of R&D expenses for the Actavis Generics business. R&D expenses excluding equity compensation expenses and purchase of in-process R&D in the first quarter of 2017 were $446 million, or 7.9% of quarterly revenues, compared to $375 million, or 7.8%, in the first quarter of 2016. R&D expenses related to our generic medicines segment were $191 million, an increase of 48% compared to $129 million in the first quarter of 2016, mainly due to the inclusion of R&D expenses for the Actavis Generics business. R&D expenses related to our specialty medicines segment were $255 million, an increase of 7% compared to $239 million in the first quarter of 2016, mainly due to increased expenses for the development of late-stage migraine (TEV-48125, fremanezumab) and pain (fasinumab) products. Selling and Marketing (S&M) expenses in the first quarter of 2017 amounted to $971 million, an increase of 16% compared to the first quarter of 2016. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $907 million, or 16.1% of revenues, in the first quarter of 2017, compared to $821 million, or 17.1% of revenues, in the first quarter of 2016. S&M expenses related to our generic medicines segment were $400 million, an increase of 16% compared to $345 million in the first quarter of 2016, mainly due to the inclusion of the S&M expenses of the Actavis Generics business and the launch of our business venture in Japan in the second quarter of 2016. S&M expenses related to our specialty medicines segment were $461 million, up 1% compared to $457 million in the first quarter of 2016. General and Administrative (G&A) expenses in the first quarter of 2017 amounted to $236 million, compared to $304 million in the first quarter of 2016. G&A expenses excluding equity compensation expenses were $222 million in the first quarter of 2017, or 3.9% of quarterly revenues, compared to $294 million, or 6.1% in the first quarter of 2016. The lower G&A expenses in the first quarter of 2017 mainly reflect income related to a legal recovery in Canada and income from milestone payments from the AttenukineTM out-license, partially offset by expenses related to the Actavis Generics business. GAAP operating income in the first quarter of 2017 was $0.9 billion, down 23% compared to $1.2 billion in the first quarter of 2016. GAAP operating margin was 15.9% in the first quarter of 2017 compared to 24.2% in the first quarter of 2016. Non-GAAP operating income in the first quarter of 2017 was $1.6 billion, up 6% compared to $1.5 billion in the first quarter of 2016. Non-GAAP operating margin was 28.8% in the first quarter of 2017 compared to 31.7% in the first quarter of 2016. EBITDA (non-GAAP operating income - which excludes amortization and certain other items - as well as excluding depreciation expenses) was $1.8 billion in the first quarter of 2017, up 9% compared to $1.6 billion in the first quarter of 2016. GAAP financial expenses for the first quarter of 2017 were $207 million, compared to $298 million in the first quarter of 2016. Non-GAAP financial expenses were $235 million in the first quarter of 2017, compared to $52 million in the first quarter of 2016, mainly due to higher interest expenses related to the debt raised to finance the acquisition of Actavis Generics. GAAP income taxes for the first quarter of 2017 amounted to $54 million, or 8% on pre-tax income of $688 million. In the first quarter of 2016, GAAP income taxes amounted to $228 million, or 26% on pre-tax income of $867 million. Non-GAAP income taxes for the first quarter of 2017 amounted to $240 million on pre-tax non-GAAP income of $1.4 billion, for a quarterly tax rate of 17%. Non-GAAP income taxes in the first quarter of 2016 amounted to $302 million on pre-tax non-GAAP income of $1.5 billion, for a quarterly tax rate of 21%. GAAP net income attributable to ordinary shareholders and GAAP diluted EPS were $580 million and $0.57, respectively, in the first quarter of 2017, compared to $570 million and $0.62, respectively, in the first quarter of 2016. Non-GAAP net income attributable to ordinary shareholders for calculating diluted EPS and non-GAAP diluted EPS were $1.1 billion and $1.06, respectively, in the first quarter of 2017, compared to $1.2 billion and $1.20, respectively, in the first quarter of 2016. For the first quarter of 2017, the weighted average outstanding shares for the fully diluted earnings per share calculation on both a GAAP and a non-GAAP basis was 1,017 million. The weighted average diluted shares outstanding used for the fully diluted share calculation for the first quarter of 2016 was 920 million shares on a GAAP basis and 979 million on a non-GAAP basis. The increase in the number of shares resulted mainly from the issuance of shares to Allergan in August 2016 in connection with the closing of the Actavis Generics acquisition. For the three months ended March 31, 2017, no account was taken of the potential dilution resulting from the conversion of the mandatory convertible preferred shares amounting to 59 million weighted average shares, since they had an anti-dilutive effect on earnings per share. As of March 31, 2017, the fully diluted share count for calculating Teva's market capitalization was approximately 1,082 million shares. Non-GAAP information: Net non-GAAP adjustments in the first quarter of 2017 were $499 million. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items: Teva believes that excluding such items facilitates investors' understanding of its business. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP figures. Cash flow from operations generated during the first quarter of 2017 was $0.5 billion, compared to $1.4 billion in the first quarter of 2016. The decrease was mainly due to higher payments for legal settlements of $0.6 billion, primarily the FCPA settlement with the SEC and DOJ and payments related to the ciprofloxacin settlement, as well as $0.3 billion related to the final settlement of our forward starting interest rate swaps and treasury lock agreements that matured during the first half of 2016. Free cash flow, excluding net capital expenditures, was $0.3 billion, compared to $1.2 billion in the first quarter of 2016. Segment Results for the First Quarter 2017 Beginning in the fourth quarter of 2016, our OTC business, conducted primarily through PGT, as well as our API manufacturing business, are included in our generic medicines segment, which includes chemical and therapeutic equivalents of originator medicines in a variety of dosage forms. All data presented has been conformed to the new segment structure. Generic medicines revenues in the first quarter of 2017 were $3.1 billion, an increase of 24% compared to the first quarter of 2016, reflecting the inclusion of the Actavis Generics business. Generic medicines revenues comprised 54% of our total revenues in the quarter, compared to 51% in the first quarter of 2016. Gross profit of our generic medicines segment in the first quarter of 2017 was $1.4 billion, an increase of 22% compared to $1.1 billion in the first quarter of 2016. The higher gross profit was mainly a result of the inclusion of Actavis Generics and our business venture with Takeda in Japan, both of which impacted the current quarter but not the first quarter of 2016. Gross profit margin for our generic medicines segment in the first quarter of 2017 decreased to 44.8% from 45.7% in the first quarter of 2016. Our generic medicines segment generated profit of $779 million in the first quarter of 2017, an increase of 20% compared to the first quarter of 2016. Generic medicines profitability as a percentage of generic medicines revenues was 25.5% in the first quarter of 2017, down from 26.4% in the first quarter of 2016. Specialty medicines revenues in the first quarter of 2017 were $2.0 billion, down 6% compared to the first quarter of 2016. U.S. specialty medicines revenues were $1.5 billion, down 11% compared to the first quarter of 2016. European specialty medicines revenues were $438 million, an increase of 11%, or 17% in local currency terms, compared to the first quarter of 2016. ROW specialty revenues were $90 million, up 11%, or 9% in local currency terms, compared to the first quarter of 2016. Specialty medicines revenues comprised 36% of our total revenues in the quarter, compared to 45% in the first quarter of 2016. The decrease in specialty medicines revenues compared to the first quarter of 2016 was primarily due to lower sales of our CNS and respiratory products, partially offset by a payment of $75 million which we received in connection with our agreement to sell our royalties and other rights in Ninlaro® (ixazomib) to a subsidiary of Takeda. The following table presents revenues by therapeutic area and key products for our specialty medicines segment for the three months ended March 31, 2017 and 2016: Global revenues of Copaxone® (20 mg/mL and 40 mg/mL), the leading multiple sclerosis therapy in the U.S. and globally, were $970 million in the first quarter of 2017, a decrease of 4% compared to the first quarter of 2016. Copaxone® revenues in the United States, were $782 million, a decrease of 5% compared to the first quarter of 2016, mainly due to lower volumes of Copaxone® 20 mg/mL, partially offset by a price increase of 7.9% for both Copaxone® products in January 2017. At the end of the first quarter of 2017, according to March 2017 IMS data, our U.S. market shares for the Copaxone® products in terms of new and total prescriptions were 25.4% and 28.4%, respectively. Copaxone® 40 mg/mL accounted for over 85% of total Copaxone® prescriptions in the U.S. Copaxone® revenues outside the United States were $188 million, an increase of 2%, or 5% in local currency terms, compared to the first quarter of 2016 mainly due to higher volumes. Over 70% of the total European Copaxone® prescriptions are now filled with the 40 mg/mL version. Our global Azilect® revenues were $60 million, a decrease of 47% compared to the first quarter of 2016 following the introduction of generic competition to Azilect® in the United States in 2017. Revenues of our respiratory products were $304 million, down 17% compared to results in the first quarter of 2016. ProAir® revenues in the first quarter of 2017 were $121 million, down 30% compared to the first quarter of 2016, due to lower volumes mainly from wholesaler and retailer inventory reductions and net pricing effects. QVAR® global revenues were $98 million in the first quarter of 2017, down 27% compared to the first quarter of 2016, primarily due to net pricing effects and wholesaler and retailer inventory reductions in the United States. Revenues of our oncology products were $270 million in the first quarter of 2017, up 1% compared to the first quarter of 2016. Combined revenues of Treanda® and Bendeka® were $157 million, up 1% compared to the first quarter of 2016. Gross profit of our specialty medicines segment was $1.8 billion, a decrease of $117 million compared to the first quarter of 2016. Gross profit margin for our specialty medicines segment in the first quarter of 2017 was 86.8%, compared to 86.9% in the first quarter of 2016. Our specialty medicines segment profit was $1.0 billion in the first quarter of 2017, down 12% compared to the first quarter of 2016. Specialty medicines profit as a percentage of segment revenues was 51.4% in the first quarter of 2017, down from 54.6% in the first quarter of 2016. The following tables present details of our multiple sclerosis franchise and of our other specialty medicines for the three months ended March 31, 2017 and 2016: Other revenues (primarily sales of third-party products for which we act as distributor, mostly in the United States via Anda, contract manufacturing services related to products divested in connection with the Actavis Generics acquisition and other miscellaneous items) were $552 million in the first quarter of 2017, compared to $200 million, in the first quarter of 2016. The increase was mainly related to the inclusion of Anda's revenues beginning in the fourth quarter of 2016. Revenues from these other activities comprised 10% of our total revenues in the quarter, compared to 4% in the first quarter of 2016. On May 10, 2017, the Board of Directors declared a cash dividend of $0.34 per ordinary share for the first quarter of 2017. For holders of our ordinary shares that are traded on the Tel Aviv Stock Exchange, the dividend will be converted into new Israeli shekels based on the official exchange rate as of May 11, 2017. The record date will be June 5, 2017, and the payment date will be June 22, 2017. Tax will be withheld at a rate of 15%. On May 10, 2017, the Board of Directors also declared a cash dividend of $17.50 per Mandatory Convertible Preferred Share for the first quarter of 2017. The record date will be June 1, 2017 and the payment date will be June 15, 2017. Tax will be withheld at a rate of 15%. Teva will host a conference call and live webcast along with a slide presentation on Thursday, May 11, 2017 at 8:00 a.m. ET. to discuss its first quarter 2017 results and overall business environment. A question & answer session will follow. In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-869-2321; Canada 1-866-766-8269 or International +44(0) 203 0095710; passcode: 97789997. For a list of other international toll-free numbers, click here. A live webcast of the call will also be available on Teva's website at: www.ir.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company's website. The replay can also be accessed until June 11, 2017, 9:00 a.m. ET by calling United States 1-866-247-4222; Canada 1-866-878-9237 or International +44(0) 1452550000; passcode: 97789997. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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