Merck Serono: The Power of Two - Pharmaceutical Executive


Merck Serono: The Power of Two
When Merck KGaA and Serono merged last September, some said it was a shotgun wedding, while others called it a good fit. Now that the honeymoon is over, Pharm Exec takes the measure of the match.

Pharmaceutical Executive

As a result, Merck Serono is exploring other targeted approaches to oncology. Among monoclonal antibodies, it is testing adecatumumab (MT201) in Phase I trials against EpCAM-expressing tumors. On the anti-angiogenesis front, cilengitide is showing encouraging results in Phase II against both prostate and brain cancers. The firm is also testing two immunocytokines, one in Phase II for adult melanoma and pediatric neuroblastoma, the other in ovarian cancer. And it can lay claim to the first-ever therapeutic cancer vaccine, Stimuvax, currently in Phase III for metastatic non-small cell lung cancer.

EMD Serono, for its part, is continuing its aggressive strategy with Rebif, which was boldly pitted in 2002 against a similar interferon, Biogen's Avonex, thereby gaining a competitive edge—and blockbuster status—in the relapsing-remitting MS indication. Now Rebif is in a head-to-head trial with Teva's Copaxone. But with a crop of new oral MS drugs on the way, all these injectables risk being left in the dust. The plan is to squeeze the brand for every drop of potential—as a reformulation, for different subtypes of the disease, and, more ambitiously, possibly even as a preventive. (And as a treatment for hepatitis C—a Phase III study found that patients of Asian origin benefit from it.) Meantime, EMD Serono is stepping up to compete in the oral-MS category with cladribine, which won fast-track status in Phase III for relapsing disease. It is also has two selective inhibitors for MS in its early-stage pipeline.

Several co-development deals are bearing fruit. This fall, Merck Serono plans to submit data to the European Medicines Agency (EMEA) for the orphan drug Phenoptin for pediatric phenylketonuria (Biomartin has the rights in the United States). With ZymoGenetics, the company is testing Atacicept—a recombinant protein that Merck Serono can also manufacture—against a range of targets, including autoimmune disorders, such as lupus and rheumatoid arthritis, and cancers, such as chronic lymphocytic leukemia and multiple myeloma. And to build its neurology category beyond MS, Merck Serono joined with Newron Pharmaceuticals to develop safinamide for Parkinson's, Alzheimer's, and other cognitive disorders; last month, they reported solid results from a Phase III trial.

Mergers are notorious for causing leadership attrition, and one leader Schnee is likely to work hard to hold onto is Fereydoun Firouz, president of Serono's US headquarters since 2003. A Swiss native like Schnee, Firouz, 43, has spent his entire career at the biotech, growing its global business by starting subsidiaries in emerging markets, then taking over the reproductive health division in the United States before moving to the top spot.

Firouz has scored some important successes as an innovator of specialty marketing. "Being in specialized pharmaceuticals, we focus on delivering products to specific populations with serious unmet medical needs," he says. "So, for us, it's not about advertising. Our priority is driving the pipeline and bringing new products to patients—not 'consumers'—while our marketed brands are supported by superior educational, support, and access resources."

Commercializing specialty products for serious diseases like MS requires a certain sensitivity—and the education and support programs developed by Serono are among the best in the business. Branded "Lifelines," the call-centers and home visits evolved, says Firouz, from the company's "exploring a more holistic approach. We are drug discoverers and developers, yes, but ultimately we are talking about an individual coping with a very complex, confusing, even horrendous, chronic disease. A member of my family has MS, so I know how difficult it is."

The medical focus expanded to include community building, with webcasts, telecasts, and local events. The company further deepened its commitment to the MS community last June with MS Lifelines Access Made Simple, offering immediate treatment with Rebif for no more than a $50 co-pay (a year's worth of Rebif runs $22,000), as patients struggle to negotiate the red tape of reimbursement assistance.

EMD Serono has gone on to apply the Lifelines model to its fertility and growth-hormone product lines much as a drug is extended for additional applications. "You could very easily say EMD Serono equals biopharmaceutical company, and biopharmaceutical company equals a vial with a biologic in it. But it's not that at all. In fact, EMD Serono is this entire holistic approach."


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