Pharmapark LLC

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Global Biosimilars Partnering Terms and Agreements 2010 to 2022" report has been added to ResearchAndMarkets.com's offering. The Global Biosimilars Partnering Terms and Agreements 2010 to 2022 report provides an understanding and access to 190 biosimilars partnering deals and agreements entered into by the worlds leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter biosimilars partnering deals. The majority of deals are early development stage whereby the licensee obtains a right or an option right to license the licensors biosimilars technology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. 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 - contract documents provide this insight where press releases and databases do not. This report contains links to online copies of actual biosimilars deals and 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. 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 biosimilars dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in biosimilars dealmaking since 2010, including details of average headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading biosimilars deals since 2010. Deals are listed by headline value, signed by big pharma, most active biosimilars dealmaking companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in biosimilars dealmaking with a brief summary followed by a comprehensive listing of biosimilars deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 5 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. The chapter is organized by company A-Z, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010. The chapter is organized by specific biosimilars technology type in focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided organized by biosimilars partnering company A-Z, deal type definitions and biosimilars partnering agreements example. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Analyzing actual company deals and agreements allows assessment of the following: What is actually granted by the agreement to the partner company? What exclusivity is granted? What are the precise rights granted or optioned? What is the payment structure for the deal? How are sales and 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? Global Biosimilars Partnering Terms and Agreements 2010 to 2022 includes: Trends in biosimilars dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to over 190 biosimilars deal records and contract documents where available The leading biosimilar deals by value since 2010 Most active biosimilars dealmakers since 2010 The leading biosimilars partnering resources In Global Biosimilars Partnering Terms and Agreements 2010 to 2022, the available contracts are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy and technology target Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in biosimilars dealmaking 2.1. Introduction 2.2. Biosimilars partnering over the years 2.3. Most active biosimilars dealmakers 2.4. Biosimilars partnering by deal type 2.5. Biosimilars partnering by therapy area 2.6. Deal terms for biosimilars partnering 2.6.1 Biosimilars partnering headline values 2.6.2 Biosimilars deal upfront payments 2.6.3 Biosimilars deal milestone payments 2.6.4 Biosimilars royalty rates Chapter 3 - Leading biosimilars deals 3.1. Introduction 3.2. Top biosimilars deals by value Chapter 4 - Most active biosimilars dealmakers 4.1. Introduction 4.2. Most active biosimilars dealmakers 4.3. Most active biosimilars partnering company profiles Chapter 5 - Biosimilars contracts dealmaking directory 5.1. Introduction 5.2. Biosimilars contracts dealmaking directory Chapter 6 - Biosimilars dealmaking by technology type Appendices Appendix 1 - Biosimilars deals by company A-Z Appendix 2 - Biosimilars deals by stage of development Appendix 3 - Biosimilars deals by deal type Appendix 4 - Biosimilars deals by therapy area Appendix 5 - Appendix 6 - Recent report titles from Companies Mentioned 3SBio 180 Life Sciences Abbvie Abreos Biosciences Abzena Accord Healthcare Aceno Biotherapeutics AdAlta AET Biotech Aetos Biologics AffaMed Therapeutics Agila Specialties AIT Bioscience Algorithme Pharma Holdings Alteogen Altiora Alvogen Alvotech Amedica Amgen Amneal Pharmaceuticals Arecor Avid Bioservices Axantia Back-A-Line Bacterin International Baxalta Baxter International BeiGene Bio-Manguinhos/Fiocruz Bio-Thera Solutions Biocnd Biocon Bioeq IP Bio Farma Biogen Biooutsource BiosanaPharma BioSavita BioSciencesCorp Bioton BioXpress Boehringer Ingelheim Bolt Biotherapeutics Boston Oncology Bruker C-Bridge Capital Catalent CEA-Leti Celares Celerion Cellectis Celltrion Changchun High & New Technology Industries Chemo Sa Lugano Chungnam National University Cipla CJ Corp Clinigen Cobra Biologics Coherus Biosciences Compass Biotechnologies Concord Biosciences Cook Pharmica CR Pharma Daiichi Sankyo Diabeloop DM Corporation Dong-A ST Dr. Reddy's Laboratories Dyadic International EirGenix EMD Millipore Enzene Biosciences Epirus Biopharmaceuticals Epivax European Commission Evercyte Evotec Ewopharma Formosa Pharmaceuticals Formycon Fujifilm Fujifilm Kyowa Kirin Biologics Fuji Pharma GC Pharma Gedeon Richter GE Healthcare Genentech Genhelix Biopharmaceutical Genor Biopharma GenScript ProBio Gerresheimer Hadasit Medical Research Services and Development Hanwha Chemical Helvetic Biopharma Henlius Biotech Hikma Pharmaceuticals Hoffmann La Roche Horizon 2020 Hospira Innovent Biologics Intas Pharmaceuticals inVentiv Health Ipca Laboratories Ipsen Jacobson Pharma JAMP Pharma Group JHL Biotech Kamada Karolinska Institute Kemwell BioPharma Kymos Pharma Services Kyowa Hakko Kirin Laboratorios Liomont LABORATORIOS SAVAL Ligacept Livzon Mabpharm Lupin M+W Group Mab-Venture Biopharma Mabion mAbXience Medicago Medicure Medipolis Meiji Seika Merck and Co Merck BioVentures Merck KGaA Merck Serono MGC Diagnostics Ministry of Health (Brazil) Mithra Pharmaceuticals Mitsubishi Chemical Mochida Pharmaceutical Momenta Pharmaceuticals Mundipharma Mylan Laboratories Mylan Pharmaceuticals Nan Fung Group NanoLock Natco Pharmaceuticals National Cancer Institute National Comprehensive Cancer Network (NCCN) NCPC GeneTech Neoletix Biotechnology NeuClone Nora Pharma Novo Nordisk Ocumension Therapeutics Oncobiologics ORF Genetics Orox Pharmaceuticals Orygen Biotecnologia Pall Corporation Pangen Biotech Parexel PBS Biotech Perfinity Biosciences Pfenex Pfizer Pharmapark PharmaPraxis PlantForm PlantPraxis Biotecnologia Polpharma Portal Instruments PPD PRA Health Sciences Premier Inc Premier Research Prestige BioPharma ProBioGen PT Etana Biotechnologies Qilu Pharmaceutical Quanta BioDesign QuiaPEG Pharmaceuticals For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Prestige BioPharma and Pharmapark LLC announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma´s Trastuzumab biosimilar in the Russian Federation. SINGAPORE, July 08, 2019 / B3C newswire / -- Prestige BioPharma and Pharmapark LLC today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma´s Trastuzumab biosimilar in the Russian Federation. Prestige´s Trastuzumab is a mAb biosimilar to Roche’s Herceptin®, which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The product has recently been accepted for review at the European Medicines Agency (EMA), based on excellent clinical results achieved with regard to the products´ safety and efficacy pro to Herceptin®. The partnership arrangement includes the exclusive rights for Pharmapark to commercialize the Trastuzumab biosimilar in the Russian Federation, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in the Russian Federation with the option to manufacture the product in Russian Federation in line with the Russian import substitution strategy. Lisa S. Park, CEO of Prestige BioPharma, commented : “We are very pleased to partner with Pharmapark to commercialize our lead biosimilar program in Russian Federation. We are excited to bring our high-quality product to another key market with the ultimate goal to make the product available globally.“ Vasily Skrypin, CEO of Pharmapark, commented: “The partnership with Prestige BioPharma demonstrates the successful execution of our strategy and marks a further milestone for our company as we work to expand our existing pipeline of biosimilars for the Russian and CIS markets. We are excited about the opportunity of bringing an additional biosimilar product to our market that would provide a new safe and effective treatment option for our citizens.” About Prestige BioPharma Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 trastuzumab biosimilar, has been filed with EMA and will also be filed with USFDA in 2019. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages. Manufacturing facilities for global commercial supply are located in Osong, South Korea. For more, please visit , or click on Facebook , LinkedIn . About Pharmapark LLC Pharmapark is a privately-owned Russian biopharmaceutical company that is focused on development, manufacture and commercialization of biosimilar products. The company possesses the know-how and has a successful track record performing complete biotechnological drug development through commercial production. Pharmapark successfully market 5 biosimilar products and has in-house pipeline of novel formulations and biosimilars focused on value-adding treatments. Contacts Prestige BioPharma Global Communication Team Ms. Felicia Ang +65 6924-6535 info@pbpsg.com Pharmapark LLC Vyacheslav Lebedyansky Chief Operating Officer +7 903 726 17 81 lebedyansky@pharmapark.ru