Business Wire

Mundipharma Strengthens Position as a Leader in Biosimilars with Acquisition of Development Company Cinfa Biotech

Del

The Mundipharma global network of independent associated companies has today added development capabilities to its biosimilars platform with the purchase of biosimilars development company Cinfa Biotech.

The announcement sees the Mundipharma network (including NAPP Pharmaceuticals in the UK) gain immediate access to Pelmeg® (B12019), a biosimilar to Neulasta® (pegfilgrastim), which received CHMP recommendation for approval on 20th September 2018.

Alberto Martinez, President and CEO, Mundipharma International Ltd, “Our biosimilars platform is a key component of our growth strategy and today’s acquisition is the obvious next step in us ensuring we remain agile and innovative in the biosimilars space.

“We have successfully demonstrated our commercial excellence in biosimilars by building a market leading platform. Through our partnership with Celltrion on Remsima ® and Truxima ® we estimate savings for healthcare systems of approximately €330m 2 from launch to the end of 2017. By acquiring Cinfa Biotech we have now taken the first step in our plans to, not only expand our biosimilars footprint, but to develop future biosimilars which will continue to afford healthcare systems further savings and, in some cases, wider access for patients.”

Pelmeg® (originator Neulasta®3) is a pegylated version of granulocyte-colony stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the incidence of infection.

With a non-US market worth of $603mllion1 and originator patents already expired, pegfilgrastim biosimilars offer an exciting market opportunity.

Enrique Ordieres, President of Infarco the parent company of Cinfa Group, commented, “After having successfully developed and manufactured our first biosimilar, we strongly believe Mundipharma is best placed to take Pelmeg ® forward through the Cinfa Biotech acquisition. They have the pedigree and proven track record of launching biosimilars in Europe, have built strong partnerships with payers, hospital specialists and decision makers and have the deep local understanding of complex tender environments.”

-Ends-

Notes to editors:

About the Mundipharma network

The Mundipharma global network of privately-owned independent associated companies was founded in 1956 by doctors, and now operates in over 120 countries worldwide. We are focused on developing business partnerships to identify and accelerate meaningful technology across an increasingly diverse portfolio of therapy areas including respiratory, oncology, pain, and biosimilars. Consistent with our entrepreneurial heritage, we like to think we see what others don’t by challenging conventional wisdom and asking different and challenging questions. By working in partnership with all our stakeholders, the Mundipharma network develops medicines that create value for patients, payers and wider healthcare systems.

For more information please visit: www.mundipharma.com.

About Cinfa Biotech

Cinfa Biotech was created in 2013 as part of the Spanish Cinfa Group. The company conduct biosimilars development and manufacturing exclusively in Europe. Highest European quality standards based on strict guidelines and their specialist know-how are the key to their success in the global biosimilars market.

They currently have two product candidates in development including: Cinfa Biotech’s lead product candidate, pegfilgrastim, a biosimilar version of Neulasta® (INN: pegfilgrastim) to treat chemotherapy-induced neutropenia. Pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF) receptor agonist, is used to stimulate bone marrow to produce more neutrophils in order to decrease the incidence of infection in patients undergoing chemotherapy.

About biosimilars

Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical medicines that are made available by a different company following patent and exclusivity expiry on the original product. Biosimilars are classed as biologic medical products, which mean they contain an active drug substance that is comprised of, or derived from, a living organism.

Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved reference product via a thorough development programme including quality, nonclinical and clinical data.

Remsima® (infliximab) and Truxima® (i.v. rituximab) are both registered trademarks of Celltrion, Inc. and are used under licence.

Neulasta® is a registered trademark of Amgen, Inc.

Pelmeg® is a registered trademark of Cinfa Biotech, S.L.

References:

1 Sales of Neulasta® in 2017: data from Amgen 2017 Fourth-quarter results (Global: $4,534 million. ROW: $603million). ROW sales: Available from: https://www.amgen.com/media/news-releases/2018/02/amgen-reports-fourth-quarter-and-full-year-2017-financial-results/
2 Figure based on Mundipharma data - Biosimilar savings: Truxima and Remsima net price vs originator list price x units or vials sold. Time periods are from launch, with data based on five markets for Remsima and six markets for Truxima through to year end 2017.
3Neulasta® patient information leaflet. Available from: https://www.medicines.org.uk/emc/product/6770/pil

Contact information

Mundipharma
For further information please contact:
Alison Dyson
T: +44 (0)1223 397346
alison.dyson@mundipharma.com
or email:
communications@mundipharma.com

Om 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.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Tory Burch Names Pierre-Yves Roussel Chief Executive Officer11.12.2018 21:26Pressemelding

Tory Burch, LLC, today announced it has named Pierre-Yves Roussel Chief Executive Officer, starting early 2019. A longtime LVMH executive, Mr. Roussel will be based out of Tory Burch’s New York headquarters; he will join and report to the Company’s board of directors. In partnership with Ms. Burch, he will lead and implement the company’s global strategy with a focus on operations. “There are very few leaders in the industry who have both a commercial track record and a deep admiration for the creative process. I respect what he has built at LVMH and value the way he thinks about business, luxury and the fashion industry as a whole. He also shares my belief in the importance of a culture-led company. We have a strong management team in place and Pierre-Yves is a natural fit as we continue to focus on long-term growth and global expansion,” said Tory Burch, who is currently Chief Executive Officer and will assume the role Executive Chairman and Chief Creative Officer. “I’m very excited

United Nations Climate Action Award Goes to Germany for the First Time11.12.2018 19:00Pressemelding

Within the context of the United Nations Framework Convention on Climate Change, two ProVeg projects were awarded the Momentum for Change Climate Action Award 2018 in the category Planetary Health. One of these is the health promotion project Aktion Pflanzen-Power, jointly initiated with BKK ProVita. ProVeg and its partner received the award for their work in schools. It marks the first time that this award has gone to Germany. The award ceremony took place yesterday in the Polish city of Katowice as part of the 24th UN Climate Change Conference. ProVeg and BKK ProVita promote children’s health and climate action Aktion Pflanzen-Power aims to improve the availability and quality of vegan and vegetarian dishes in schools. Together with BKK ProVita, ProVeg has so far reached 24,800 students at 41 schools throughout Germany on the subject of wholesome, plant-based nutrition as part of the health promotion project. Healthy nutrition with Aktion Pflanzen-Power Andreas Schöfbeck, member of t

Thales and Gemalto are granted regulatory clearance by the European Commission11.12.2018 17:01Pressemelding

Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto announce today that they have been granted merger control Regulatory Clearance by the European Commission, following Thales’s commitment to divest its general purpose hardware security modules (GP HSM) business globally1 to a suitable purchaser. This clearance is effective immediately. Together with the merger control clearances obtained in China, Israel, South Africa and Turkey, and clearances relating to f

Starr Insurance Companies Expands Aviation Insurance Operations to Brazil11.12.2018 15:43Pressemelding

Starr Insurance Companies today announced that Starr International Brasil Seguradora S.A. (“Starr Brazil”) has been granted a local license to offer aviation insurance. “We are thrilled to be adding aviation capability in an important, growing economy like Brazil,” stated Steve Blakey, president and chief executive officer for Starr Insurance Holdings, Inc. “As a worldwide leader in aviation insurance solutions, we are constantly seeking new opportunities and markets to meet the growing needs of the aviation and aerospace industry around the globe.” Fernanda Strachino, aviation specialist underwriter, has joined Starr Brazil to head the new aviation division. Fernanda brings more than 16 years’ of experience in the aviation and insurance market. Starr Brazil will offer a variety of aviation coverages, including: Aircraft Hull & Liability; Spare Parts; Third-Party Legal Liability; Corporate Non-Owned Aircraft Liability; General Liability; RETA Insurance (Mandatory Liability), Hangarkeep

Andersen Global Continues Growth in United Kingdom With Claritas Tax Limited11.12.2018 14:30Pressemelding

Today, Andersen Global expanded its reach in the United Kingdom with the addition of Claritas Tax Limited, a tax advisory and compliance services firm based in Birmingham, the second largest city in the country. Claritas is the fourth firm collaborating with Andersen Global in the UK. “Adding a sought-after firm like Claritas is not only a logical extension for Andersen Global, but it broadens our offering in the UK. Their practice focuses on corporation tax, R&D tax reliefs, mergers and acquisitions, private equity and venture capital in addition to serving individuals,” said Mark Vorsatz, Andersen Global Chairman and Andersen Tax LLC CEO. “Iain Wright and his team enhance our already robust core competences in the UK, a critical market for our clients, and we look forward to working with Claritas on a number of upcoming corporate opportunities.” Founded in 2012, Claritas Tax Limited is an advisory led business that provides a full range of tax advisory and compliance services to entr

Seoul Semiconductor Wins Patent Litigation against Everlight in Germany and Is Awarded Statutory Litigation Costs11.12.2018 14:00Pressemelding

Seoul Semiconductor Co., Ltd. (KOSDAQ:046890) (“Seoul”), a leading global innovator of LED products and technology, announced that it won a patent litigation against Everlight Electronics Co., Ltd. (“Everlight”) in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181211005233/en/ Seoul Semiconductor's Headquarters in Korea (Photo: Business Wire) The patent involved in this litigation relates to an LED package structure for thermal dissipation. Everlight purchased this patent from a U.S. company in 2017, and subsequently brought a patent lawsuit against Seoul in the Manheim Court of Germany. In December 2018, however, the Manheim Court ruled in favor of Seoul and ordered that Everlight, as the losing party, should bear the statutory costs of the court proceeding. In the United Kingdom, Seoul had already won a patent litigation against Everlight earlier this year. At that time, the UK Patent Court also ordered that Ever