Symphogen Enters Clinical cGMP Manufacturing Agreement with Gallus - Gilde Healthcare

Symphogen Enters Clinical cGMP Manufacturing Agreement with Gallus

25. Februar 2014

Symphogen, A/S, a private biopharmaceutical company developing recombinant monoclonal antibody (mAb) mixtures for the treatment of cancer has signed a manufacturing agreement with Gallus BioPharmaceuticals, LLC (Gallus), a premier pure-play biologics contract manufacturing organization (CMO).

This agreement includes process transfer and clinical stage cGMP manufacturing of Symphogen’s antibody mixture product candidates. Gallus will employ the GE Healthcare Life Sciences Flex Factory™, a flexible single-use biomanufacturing platform, at their headquarters in St. Louis to manufacture product candidates for Symphogen.

“We are pleased to work with Gallus, a very experienced CMO with an extensive background in the cGMP manufacture of antibodies, ranging from early stage clinical programs to the commercial supply of approved therapeutics. We look forward to working together to advance our innovative cancer therapeutic programs”

said Kirsten Drejer, CEO of Symphogen A/S.

“Gallus is delighted to partner with Symphogen in the process development and clinical supply of their antibody mixture candidates. Symphogen has developed unique technologies for the controlled, reproducible production of highly characterized mAb mixtures manufactured in a single batch. Gallus’ expertise in process development and scale-up will ensure high quality molecules are delivered to the clinic,”

said Mark R. Bamforth, Gallus’ President & CEO.

About Symphogen A/S

Symphogen is developing next-generation antibody therapeutics for the treatment of cancer and is dedicated to bringing truly innovative oncology products to the market.

The Company has advanced the frontier of antibody discovery by creating well-characterized antibody mixtures that address multiple oncology targets in a single drug product. The Company has matured its oncology pipeline and has currently brought two product candidates into the clinic. The Company’s productive technology suite – capable of identifying, selecting and manufacturing optimal antibody mixtures – fuels Symphogen’s oncology pipeline.

The lead oncology product, Sym004, was out-licensed to Merck KGaA in 2012 following phase 2 clinical data in late stage cancer patients.

In total, the Company has raised €249 million in equity capital from premier international investors including Novo, Essex Woodlands Health Ventures and PKA, and employs 100 people, most of whom are based at Symphogen’s facilities in Copenhagen.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs, and collagens, plus over 15 years of experience in commercial manufacture of ProstaScint®. Both sites maintain exemplary quality and regulatory records.

For additional information visit www.gallusbiopharma.com or email: info@gallusbiopharma.com.

Contact Information:

Gallus BioPharmaceuticals, LLC
Claire Ruzicka, Sr. Marketing Manager
4766 LaGuardia Drive, St. Louis, MO 63134-3117
Phone no.: +1 314 562 5755
Email: claire.ruzicka@gallusbiopharma.com

Symphogen A/S
Gayle Mills, Chief Business Officer
Elektrovej, building 375, DK-2088 Lyngby, Denmark
Phone no.: +1 650 464 3656
Email: gmm@symphogen.com

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