Adding mixtures to the mix

Merck, Symphogen ink $600 million-plus licensing deal for recombinant antibody for oncology

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DARMSTADT, Germany—Pharmaceutical powerhouse Merck KGaA hasacquired exclusive worldwide licensing rights to the oncology drug candidateSym004 by its originator, Denmark-based biopharmaceutical company Symphogen.
Under the terms of the agreement, Merck will make an upfrontpayment of $26 million to Symphogen for Sym004. Symphogen is also eligible toreceive up to $289 million for clinical development and regulatory milestones,another $322 million in potential combined sales performance milestones, aswell as additional royalties on net worldwide sales. In exchange, Merck willassume exclusive rights to the product and all future developmentresponsibilities.
Sym004 is a recombinant antibody mixture comprised of twoantibodies that are intended to simultaneously block ligand binding, receptoractivation and subsequent downstream signaling while also removing epidermalgrowth factor receptor (EGFR) receptors from cancer cells' surfaces by inducingEGFR internalization and degradation. The mixture also stimulates the body'simmune system to target cancer cells by triggering a reaction known asantibody-dependent cellular cytotoxicity. 
Recombinant antibody mixtures are a class of antibodytherapeutics under investigation for the treatment or prophylaxis of illnessesincluding cancer, infectious diseases and autoimmune diseases.
"This approach offers a wide variety of opportunities, themost obvious of which are for patient groups with no treatment optionsavailable to them today," says Symphogen CEO Dr. Kirsten Drejer.
Drejer sees great potential in the antibody mixture approachto cancer treatment in particular, as opposed to the antibody therapeuticapproaches of the past that have focused on closing a single receptor.
"If you hit several targets at the same time, we're findingit's a more effective way to treat cancer," she says. "You get a more uniquemechanism of action, and the cancers actually integrate the receptors ratherthan blocking them."
Symphogen is a relatively small biotech company, but thecompany saw tremendous promise in its Sym004 antibody mixture as it proceededinto a Phase I/II clinical trial for patients with advanced KRAS wild-typemetastatic colorectal cancer, and into a single-arm, open-label Phase II trialin patients with squamous cell carcinoma of the head and neck.
"We see an extremely nice consistency between ourpreclinical results and what we're observing in clinical trials," says Drejer.
Eighty-eight patients have been treated with Sym004 inclinical trials as of July 2012.
Unable to pursue development of the product on a large scaleby itself, the company reached out to larger pharmaceutical groups, speaking toseveral potential partners before ultimately accepting Merck's bid.
"This partnering agreement with Symphogen offered theopportunity to complement Merck's existing Erbitux franchise," says Dr. GangolfSchrimpf, Merck's manager of group external communications. Erbitux(cetuximab)—a chimeric monoclonal antibody—is an EGFR Merck is developing foruse in the treatment of metastatic colorectal cancer as well as cancer of thehead and neck.
"You couldn't ask for a better validation of theattractiveness of the antibody mixture approach than having a company such asMerck take over the development," says Drejer.
"Sym004 further strengthens our early development pipelineby adding a product that is thought to act via a proposed synergistic mechanismof action not previously studied," Dr. Susan Jane Herbert, head of globalbusiness development and strategy for Merck Serono, said in a press releaseannouncing the agreement. "More specifically, it has the potential to become akey asset complementing our already highly successful Erbitux franchise."
"Merck is very well placed to develop Sym004 based on ourdeep knowledge of the EGFR area from Erbitux," says Schrimpf.
Merck is a global pharmaceutical and chemical company withtotal revenues of $1 billion in 2011. Merck Serono is the biopharmaceuticaldivision of Merck KGaA, headquartered in Darmstadt, Germany. Merck Serono'sportfolio includes products designed to treat cancer, multiple sclerosis,infertility, endocrine and metabolic disorders and cardiovascular diseases.
Symphogen is a private biopharmaceutical companyheadquartered in Copenhagen, Denmark, that is developing a diverse pipeline ofproducts to treat cancer and autoimmune and infectious diseases. Its leadproduct is Rozrolimupab (dubbed Sym001), a polyclonal antibody used to treatautoimmune thrombocytopenic purpura, as well as having applications inpreventing isoimmunization in Rh-negative pregnant women.

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