Specialty medicines are the mainstay of today's pharmaceutical pipeline, with companies betting big on prospects for a few pearls to emerge from the sludgy drain of high costs, missed targets, and thwarted expectations. No other company is making a bigger commitment to leadership in the specialty class than Pfizer, which is managing a diverse portfolio of biologics and vaccines through a uniquely autonomous business unit (BU) structure that many regard as the organizational equivalent of targeted therapy.

To explore the Pfizer strategy in detail, Pharm Exec sat down with the Specialty Care Business Unit's President and General Manager, Geno Germano. A pharmacist by background, Germano, 49, is an import from Wyeth, where he ran the US pharmaceuticals business from 2007 until the merger. What follows is a conversation covering the complexities and emerging challenges of building a successful franchise in this still lucrative—but increasingly crowded—sector. Will Pfizer's sheer size trump the competition and win critical provider and payer support in a line of business that prizes niche-driven focus and an intimate connection to the patient?

Geno Germano: Because of the broad diversity within the category, it is difficult to provide one simple definition. Commonalities across Specialty Care typically include medicines that are innovative, sometimes difficult to manufacture and possess clinical profiles of high value to small, but well differentiated customer bases, such as hemophilia or kidney transplant patients. But we also have large customer bases as with our psychiatry and ophthalmology businesses. Leveraging the therapeutic assets of these medicines depends on extensive commitments to clinical exploration, strong, field-based medical support, well trained and knowledgeable sales capabilities and sophisticated deployment of evidence and outcomes data. The entry hurdles are high, often requiring extensive investments in complex biologic manufacturing processes and expertise working with targeted distribution channels. It is also critical that we be deeply engaged with physicians, many of whom dispense our medicines directly to patients, and that we demonstrate a strong commitment to patient education and support.

PE: How well is Pfizer positioned to compete in this segment?

GG: Specialty connotes an image of smallness but the skills and resources required to compete successfully in this segment are actually quite significant. Size and scale count, and Pfizer has these assets in abundance. The combination with Wyeth moves us from number five in revenues in this category to number one. The Specialty Care BU is itself a $15 billion business; standing alone, we'd rank 15th in the league table of the Big Pharma top 20. The combination with Wyeth has already helped us achieve an 84 percent boost in revenues on a year on year basis, reflecting the impact of leading-edge therapies like Enbrel for the treatment of rheumatoid arthritis and psoriasis, and Prevnar for the prevention of pneumococcal disease. And assuming expansion of our pipeline, we are poised for further growth.

PE: What about the reputational pressures associated with the high price of specialty products? Is it fair to state that specialty is a litmus test for how society supports innovation?

GG: The factors I mentioned do add to the cost base, so specialty medicines are frequently priced at a premium compared to other drugs. Nevertheless, specialty medicines have traditionally been seen as an enormous driver of benefit to the healthcare system because of the therapy options they provide for patients with life-threatening conditions, where there are few other treatments. This rich vein of value—still largely untapped—is a distinctive characteristic of the specialty class that Pfizer is putting front and center as we develop the business.