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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 2, 2017
Site: www.prlog.org

Dustin Muriel, the aspiring hip hop singer has been releasing back to back new beats in soundcloud. Log onto soundcloud and listen to his new single "Actavis".


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


LONDON, May 4, 2017 /PRNewswire/ -- Download the full report: https://www.reportbuyer.com/product/3812932/ Description 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 focuses on four primary types of asset available for purchase: Business assets - the most common asset exchanging hands. Business assets are in the form of a business unit or subsidiary of a parent company. Common assets include territorial businesses or non-core businesses such as an OTC or diagnostics business, separate from the core business operations Product assets - in the form of marketed product, clinical phase development compound, or drug delivery-compound combination. These assets are commonly available as a result of a merger or change in direction of the selling company. The buyer acquires the asset for global or territorial exploitation. It is often the case that the acquiring company is normally a competitor to the seller, but in this situation the trade is of mutual benefit Royalty assets - where a specialist investment company acquires the rights to future royalty payments in return for payment of a lump sum payment to the licensor for the product Technology asset - where a buyer is acquiring a technology platform, research program, patent portfolio or other intellectual property asset. The acquisition is often due to the technology being surplus to a sellers interests, but may also be as a consequence of a sale of assets in advance of the seller entering liquidation Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered and rights transferred – contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of over 1,000 asset purchase deals announced since 2010 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual asset purchase contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. The initial chapters of this report provide an orientation of Asset Purchase dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview and analysis of the trends in Asset Purchase as well as a discussion on the merits of the type of deal. Chapter 3 provides an overview of the structure of Asset Purchase deals. The chapter includes numerous case studies to enable understanding of both pure Asset Purchase deals and multicomponent deals where Asset Purchase forms a part. Chapter 4 provides a review of the leading Asset Purchase deals since 2010. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database. Chapter 5 provides a comprehensive listing of the top 50 most active Asset Purchase dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand. Chapter 6 provides a comprehensive and detailed review of Asset Purchase deals organized by company A-Z, therapy, technology and industry type signed and announced since 2010 where a contract document is available. Contract documents provide an indepth insight into the actual deal terms agreed between the parties with respect to the Asset Purchase deal. The appendices to the report includes a comprehensive listing of all Asset Purchase deals announced since 2010. Each listing is organized as an appendix by company A-Z, stage of development at signing, therapeutic area and industry type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. 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 also includes numerous table and figures that illustrate the trends and activities in Asset Purchase dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about Asset Purchase alliances. Key benefits Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2010-2017 provides the reader with the following key benefits: - In-depth understanding of asset purchase deal trends since 2010 - Analysis of the structure of asset purchase agreements with numerous real life case studies - Comprehensive access to over 1,000 actual asset purchase deals entered into by the world's biopharma companies - Detailed access to actual asset purchase deals entered into by leading biopharma companies - Insight into the terms included in a asset purchase agreement, together with real world clause examples - Understand the key deal terms companies have agreed in previous deals - Undertake due diligence to assess suitability of your proposed deal terms for partner companies Report scope Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2010-2017 is intended to provide the reader with an in-depth understanding of the asset purchase trends and structure of deals entered into by leading biopharma companies worldwide. Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2010-2017 includes: - Trends in asset purchase dealmaking in the biopharma industry since 2010 - Analysis of asset purchase deal structure - Case studies of real-life asset purchase deals - Access to over 1,000 asset purchase deal records - The leading asset purchase deals by value since 2010 - Most active asset purchase dealmakers since 2010 - The leading asset purchase partnering resources In Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2010-2017, the available deals are listed by: - Company A-Z - Headline value - ge of development at signing - Therapeutic area - Technology type Each deal title links via Weblink to an online version of the actual deal record, providing easy access to each contract document where available. The Global Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2010-2017 report provides comprehensive access to available records for over 1,000 asset purchase deals, including contract documents where available. Analyzing actual contract agreements allows assessment of the following: - What are the precise rights granted or optioned? - What is actually granted by the agreement to the partner company? - What exclusivity is granted? - What is the payment structure for the deal? - How aresalesand payments audited? - What is the deal term? - How are the key terms of the agreement defined? - How are IPRs handled and owned? - Who is responsible for commercialization? - Who is responsible for development, supply, and manufacture? - How is confidentiality and publication managed? - How are disputes to be resolved? - Under what conditions can the deal be terminated? - What happens when there is a change of ownership? - What sublicensing and subcontracting provisions have been agreed? - Which boilerplate clauses does the company insist upon? - Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? - Which jurisdiction does the company insist upon for agreement law? Download the full report: https://www.reportbuyer.com/product/3812932/ About Reportbuyer Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers http://www.reportbuyer.com   For more information: Sarah Smith Research Advisor at Reportbuyer.com Email: query@reportbuyer.com   Tel: +44 208 816 85 48 Website: www.reportbuyer.com To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-asset-purchase-partnering-terms-and-agreements-in-pharma-biotech-and-diagnostics-2010-to-2016-300451761.html

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