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

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 € 20 million. Symphogen is also eligible to receive up to € 225 million for clinical development and regulatory milestones, € 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™ discovery, SymSelect™ lead selection and Sympress™ 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 €10.3 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