Business Wire

Polpharma Biologics Group Announces That Its Joint Venture Company, Bioeq, Has Entered Into a Commercialization Agreement for Biosimilar Ranibizumab

Share

Polpharma Biologics Group announces that its joint venture company with Santo Holding (Strüngmann Group), Bioeq, has concluded a commercial partnership with Teva Pharmaceutical Industries Ltd. for their biosimilar candidate of the ophthalmological drug Ranibizumab (Lucentis®) in Europe, Canada, Israel and New Zealand.

The reference product is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the "wet" type of age-related macular degeneration, a common form of age-related vision loss. Worldwide, at least 25 to 30 million people are affected by age-related macular degeneration. The launch of a biosimilar Ranibizumab can increase market competition, reduce cost and expand patient access with proven analytical and clinical similarity to the original product.

This agreement with Teva complements an existing agreement concluded with Coherus BioSciences, Inc. for commercialisation in the United States.

Dr Joerg Windisch, CEO of the Polpharma Biologics Group, commented on the achievements of the joint venture:

“This is a huge milestone for the progression of a life changing therapeutic. We are proud the development program has been successfully completed, and that, through this agreement, more patients will gain access to highly effective treatments for vision loss including for age-related macular degeneration. This is another demonstration of our passion for providing safe and effective medicines to patients.”

About the Ranibizumab biosimilar

The Ranibizumab biosimilar, FYB201, was originally licensed in from Formycon AG (FRA: FYB/ WKN A1EWVY), a leading German biosimilars company, and subsequently developed by Bioeq AG, a joint venture between Polpharma Biologics and Santo Holding AG (Strüngmann Group). Phase III clinical trials for FYB201 have clinically demonstrated that the efficacy of FYB201 in patients with nAMD is comparable to that of Lucentis®.

Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Biosimilars exhibit proven analytical and clinical similarity to their respective branded reference products.

-------------------------------------------------------------------------------------------------------------------------------------------

About the Polpharma Biologics Group

Polpharma Biologics Group is a biopharmaceutical group focused on the development and manufacture of biosimilars. It provides fully integrated solutions along the biopharmaceutical value chain including cell line development, product and process development and clinical and commercial scale manufacturing to support the development of its proprietary portfolio of products and those of industry partners around the globe.

Polpharma Biologics has two sites in Poland, an advanced research and development center in Gdansk and a commercial scale manufacturing facility in Warsaw. It also has a research center in the Netherlands.

It is the largest Polish biotechnological firm developing and manufacturing biosimilars. It has been active for over 10 years on a scale previously unknown in the Polish biotechnological sector, investing not only in labs and production lines, but also in know-how, creating highly specialised work places and developing co-operation between business and science.

The Group currently employs over 800 people in Poland, including top-class specialists from the country and from around the world.

Learn more at www.polpharmabiologics.com

About Bioeq

Bioeq AG is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Strüngmann Group. Bioeq develops, licenses and commercializes biosimilars.

Learn more at www.bioeq.ch

About Teva

Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. Teva is a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with an established presence in generics, they have significant innovative research and operations supporting a growing portfolio of specialty and biopharmaceutical products.

Learn more at www.tevapharm.com.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Joseph Reeds
Head of Marketing
Polpharma Biologics
M +44 7807832776
E joseph.reeds@polpharmabiologics.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

TA Associates Announces Strategic Growth Investment in Elos Medtech27.7.2021 07:30:00 CEST | Press release

TA Associates, a leading global growth private equity firm, today announced it has completed a majority growth investment in Elos Medtech AB (NASDAQ STOCKHOLM: ELOS B), a leading innovative full-service contract development and manufacturing organization (CDMO) in the global medical device market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005835/en/ Founded in 1923, Elos Medtech is headquartered in Gothenburg, Sweden with operations being conducted at facilities in Sweden, Denmark, China and the U.S. As a global solutions partner offering complete performance and vertical integration to leading medical device companies worldwide, Elos Medtech serves the dental, orthopaedic and life science markets. In long-term partnership with their customers, Elos Medtech provides sustainable and innovative products and supply solutions for the global medical device and life science market. “We have followed Elos Medtech for sev

Ricardo Supports Mexico in Drive to Reduce Freight Emissions27.7.2021 07:01:00 CEST | Press release

Experts from global energy and environment consultancy Ricardo are leading an international consortium to support the Mexican Government’s plan to reduce greenhouse gas (GHG) emissions in the freight sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005697/en/ Ricardo supports Mexico in drive to reduce freight emissions (Photo: Business Wire) Over the next 12 months, specialists in sustainable transport will work with organisations, including Mexico-based Centro Mario Molina and Urbanistica, to provide advice to the German Agency for International Cooperation (GIZ) as part of the Sustainable Transport Programme. The country’s commitment to reducing GHGs by 22% by 2030 depends on the successful decarbonisation of its transport sector, which contributes to 25% of total CO2 emissions nationally. Road activity is responsible for 97% of all transport emissions and freight transport plays a key role by moving nearly 75%

Cat Rock Capital Issues Presentation on Just Eat Takeaway.com27.7.2021 07:00:00 CEST | Press release

Cat Rock Capital Management LP (together with its affiliates, “Cat Rock Capital”), a long-term oriented investment firm and beneficial owner of approximately 10.0 million shares of the common stock of Just Eat Takeaway.com NV (“Just Eat Takeaway.com”, “JET”, or “the Company”) (LSE: JET, AMS: TKWY, NASDAQ: GRUB), representing circa 4.7% of Just Eat Takeaway.com’s outstanding shares, today issues a public presentation on recent developments at the Company. This presentation is available at JustEatMustDeliver.com and upon request via info@catrockcap.com. Cat Rock Capital also comments: “Cat Rock Capital has been a shareholder of Just Eat Takeaway.com and its predecessor companies for over four years, and we have intensively researched the global online food delivery sector over the past six years. “We believe JET is a fantastic online food delivery business with #1 positions in markets representing 90% of its revenue,(1) a huge runway for continued organic growth, and highly experienced o

Logitech Delivers Strong Start to Fiscal Year 202227.7.2021 03:00:00 CEST | Press release

SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the first quarter of Fiscal Year 2022. Q1 sales were $1.31 billion, up 66 percent in US dollars and 58 percent in constant currency, compared to Q1 of the prior year. Q1 GAAP operating income grew 143 percent to $203 million, compared to $83 million in the same quarter a year ago. Q1 GAAP earnings per share (EPS) grew 160 percent to $1.09, compared to $0.42 in the same quarter a year ago. Q1 non-GAAP operating income grew 100 percent to $235 million, compared to $117 million in the same quarter a year ago. Q1 non-GAAP EPS grew 91 percent to $1.22, compared to $0.64 in the same quarter a year ago. “We’ve started strong in Fiscal Year 2022, with Q1 sales up 58% in constant currency and profits doubling versus last year,” said Bracken Darrell, Logitech president and chief executive officer. “Our key categories grew high double digits. This

Adagio Therapeutics Partners with Biocon Biologics to Bring Potent and Broadly Neutralizing COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets26.7.2021 22:05:00 CEST | Press release

Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced a partnership agreement with Biocon Biologics Ltd., to combat the ongoing COVID-19 crisis in southern Asia. Biocon Biologics Ltd. is a fully integrated biosimilars company and a subsidiary of Biocon Ltd., a global biopharmaceuticals company, (BSE code: 532523, NSE: BIOCON). Under the terms of the agreement, Adagio will provide Biocon with materials and know-how to manufacture and commercialize an antibody treatment based on ADG20 in India and additional select emerging markets. ADG20, Adagio’s lead product candidate, is designed to be a potent, long-acting and broadly neutralizing antibody for both the treatment and prevention of COVID-19 as either a single or combination agent. Unlike other antibody-based therapies specifically targeting SARS-CoV-2, ADG20 has demons

SpeeDx Launch Solution for SARS-CoV-2 Variant Analysis26.7.2021 18:40:00 CEST | Press release

SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, have launched a new product line of research reagents to support reflex variant analysis for circulating SARS-CoV-2 variants of concern (VOC). The rapid development of PlexPrime® SARS-CoV-2 Genotyping* tests will support investigations and monitoring of the range of emerging and circulating SARS-CoV-2 VOC that have been linked to increased transmissibility, reduced vaccine efficacy, or other characteristics that may require specific public health actions.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005313/en/ SpeeDx unique technology excels in mutation detection applications and can readily be applied to variants reported in the SARS-CoV-2 sequence databases. Compatible with standard qPCR instrumentation, the PlexPrime® SARS-CoV-2 Genotyping research reagents can reduce the manual process of preparing positive samples for sequence analysis

V-Square Appoints Erik Norland as Head of Distribution26.7.2021 17:00:00 CEST | Press release

V-Square Quantitative Management (V-Square) has announced the hiring of Erik Norland as its Head of Distribution. A 20-year industry veteran with asset management, custody, and global markets expertise, Erik’s addition to the team bolsters our strong client-centric approach to deliver customized ESG solutions as we continue to build our reputation as a specialized global asset manager. He will lead the firm's sales, consultant relationship and client service functions across institutional, insurance and wholesale. Mr. Norland, based in Stockholm, will report to Mamadou-Abou Sarr, co-founder and President and will join the global leadership team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005571/en/ Erik Norland, Head of Distribution (Photo: Business Wire) "Erik is a results-focused leader who brings excellent experience in distribution strategy and execution, sales management and client relationship roles. I had th