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Last updated on April 16, 2014 at 10:37 EDT

Symphogen Grants Exclusive Worldwide License of Phase II Oncology Drug Candidate Sym004 to Merck KGaA

September 5, 2012

COPENHAGEN, Denmark, September 6, 2012 /PRNewswire/ –

– Symphogen Will Host a Conference Call Today (Thursday 6 September 2012) to Discuss
the Announcement at 11:30 CET/ 10:30 BST, Details on How Access This Call and the
Accompanying Presentation are Below.

– A novel investigational antibody mixture targeting the epidermal growth factor
receptor (EGFR)

Symphogen A/S, a private biopharmaceutical company developing recombinant antibody
mixtures, a class of antibody therapeutics under investigation for the treatment or
prophylaxis of serious human diseases such as cancer or infectious and autoimmune
diseases, today announced that an exclusive worldwide license agreement was signed with
Merck KGaA, Darmstadt, Germany, for Sym004, an investigational antibody mixture targeting
the epidermal growth factor receptor (EGFR). Sym004 is currently being evaluated in a
Phase I/II trial for the treatment of patients with advanced KRAS wild-type metastatic
colorectal cancer (mCRC) who have previously progressed on treatment with standard
chemotherapy and a marketed anti-EGFR monoclonal antibody. In addition, a single-arm,
open-label Phase II trial in patients with squamous cell carcinoma of the head and neck
(SCCHN) who have failed anti-EGFR-based therapy is currently ongoing.

Under the agreement, Symphogen will receive from Merck an upfront payment of EUR 20
million. Symphogen is also eligible to receive up to EUR 225 million for clinical
development and regulatory milestones, EUR 250 million in potential combined sales
performance milestones and royalties on net worldwide sales. In exchange, Merck will gain
exclusive worldwide rights to develop and commercialize Sym004.

“We believe that Merck is uniquely well positioned to develop Sym004 based on its deep
knowledge of the EGFR area,” said Kirsten Drejer, Chief Executive Officer of Symphogen.
“This transaction further validates the antibody mixture approach as a highly attractive
option.”

“Sym004 further strengthens our early development pipeline by adding a product that is
thought to act via a proposed synergistic mechanism of action not previously studied, but
more specifically, it has the potential to become a key asset complementing our already
highly successful Erbitux franchise,” commented Dr. Susan Jane Herbert, Head of Global
Business Development and Strategy for Merck Serono. “This collaboration once again
reflects our strong commitment to fighting cancer and to providing new treatment options
to patients.”

Sym004 is comprised of two antibodies that are not only designed to block ligand
binding, receptor activation and downstream signaling but are also thought to elicit
removal of the EGFR receptors from the cancer cell surface by inducing EGFR
internalization and degradation.[1]

As of July 2012, 88 patients have been treated with Sym004 in clinical trials. The
adverse events from the preliminary clinical data include diarrhea, skin rash, mucosal
inflammation, nausea, infusion-related reaction and hypomagnesemia. Exposure data from the
patients, after weekly repeated infusions, do not indicate an anti-drug antibody response.

References

1. Pedersen MW, et al. Cancer Res 2010;70:588-97.

Conference Call

Symphogen will host a conference call today (Thursday 6 September 2012) to discuss the
announcement at 11:30 CET/ 10:30 BST.

Kirsten Drejer, Symphogen’s Chief Executive Officer, will host the call to discuss the
licence agreement with Merck KGaA for Sym004, followed by a Q&A session. The call will be
conducted in English. Please use the following dial-in details:

Denmark: 327-276-25

International: +44(0)1452-555-566

Please quote the following Conference ID: 28172177

An accompanying presentation will be released on Symphogen’s website and available for
download just before the start of the call and can be accessed via

http://www.symphogen.com

Seven day replay dial-in details:

Tel: +44(0)1452-550-000

Conference ID: 28172177

About Symphogen

Symphogen is developing antibody therapeutics (monoclonal, monoclonal mixtures and
polyclonal) to help people with serious diseases and significant unmet medical needs. With
its proprietary Symplex(TM) discovery, SymSelect(TM) lead selection and Sympress(TM)
manufacturing platforms, the company captures the diversity and specificity of the natural
immune response in rationally designed recombinant antibody mixtures. Symphogen is
maturing a diversified pipeline of internal and partnered products across multiple
indications including cancer, autoimmune and infectious disease. Symphogen is a private
biopharmaceutical company headquartered in Copenhagen, Denmark, with a US subsidiary in
Princeton, New Jersey. For more information, please visit http://www.symphogen.com.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA. With headquarters in
Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients
with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as
cardiovascular diseases. In the United States and Canada, EMD Serono operates as a
separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of
both chemical and biological origin in specialist indications. We have an enduring
commitment to deliver novel therapies in our core focus areas of neurodegenerative
diseases, oncology and rheumatology.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR10.3
billion in 2011, a history that began in 1668, and a future shaped by more than 40,000
employees in 67 countries. Its success is characterized by innovations from
entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck
KGaA, in which the Merck family holds an approximately 70% interest and shareholders own
the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated
and has been an independent company ever since.

For more information, please visit http://www.merckserono.com or

http://www.merckgroup.com

        Contacts:
        Dr. Kirsten Drejer,
        Chief Executive Officer,
        Symphogen A/S,
        Phone: +45-22-10-99-59 or +45-45-26-50-50
        E-mail: kd@symphogen.com

        Ms. Heidi K. Roennest,
        Executive Office Manager & PA to CEO Kirsten Drejer,
        Symphogen A/S,
        Phone: +45-61-18-74-94
        E-mail: hkr@symphogen.com

SOURCE Symphogen


Source: PR Newswire