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LIFESCIENCELEADER.COM MARCH 2015 37 bottom line," says Greenleaf. "We shifted resources from commercial activities to development capabilities, using them to build a strong clinical operation and medical organization and to establish internal processes that prosecute, moni- tor, measure, and manage the pipeline through the entire development process." For the four prostones in the pipeline, mostly designated for indications in the company's core areas of gastroenterol- ogy and ophthalmology, the company also has earlier programs in supportive- care oncology and lumbar spinal ste- nosis. The supportive-care indication is oral mucositis caused by radiation and chemotherapy in patients with neck cancer. The lumbar indication is to alle- viate the pain and disability of stenosis with a "proprietary ion channel activa- tor." Sucampo has also stated its readi- ness to bring nonprostone drugs into the pipeline, which will take the company out of its comfort zone, into new MOAs (mechanism of action) — yet another way to scale up. INTO EMPTY SPACE Besides bulking up its product portfolio, Sucampo also plans to grow through expansion of its main commercial product into the huge unoccupied spaces of the GI market. New geographic markets, new indications, and new formulations will continue to unfurl for Amitiza. Competition in such a large potential market for Amitiza in constipation also accelerates rather than impedes expan- sion of development, adoption, and use of the product, in Greenleaf 's view. "The space in constipation is really wide open and undeveloped, and the majority of solutions are either over-the-counter, acute-use treatments or prescription- based generic acute-use treatments, for which tens of billions of prescriptions are written every year. Right now, inno- vative new products only account for a single-digit percentage of that market." Sucampo and its competitors with innovative constipation therapies, such as Forest/Actavis and Ironwood with Linzess (linaclotide), have used patient and doctor education to create a rising tide that lifts all boats, he says, and adoption of the newer drugs is on the rise. "It would be wrong for us as inno- vative companies at this stage to focus on fighting each other when we are the minority of the market, and I believe all of the companies coming into this space with new solutions recognize that. A product that provides a more consistent solution and one that's been studied as a chronic solution, though it will take time to turn a market, is a better solution for patients." THE FOCUS EXTERNAL Greenleaf says the big picture of the market and the small-frame view of Sucampo and its products overlap. As competition drives market expansion for Amitiza, for instance, it will eventually put pressure on companies in multiple ways. More price competition will force more price-matching, negotiation with payers and managed care organizations, and adjustments in the product's cost structure. "We will be forced to continue to look at better ways to modify cost of goods and operations and how we bring new products to market through our manufacturing processes," he says. Sucampo, its partners, and its competi- tors will also need to influence perceptions in the market about the disease and its treatment. "We need to continue to build awareness of the disease burden around constipation in general and make sure it is no longer qualified as a lifestyle problem, but truly as a problem with associated challenges. Patients miss work, live their lives in pain, and bear other consequences of constipation." Like many start-up and scaling-up life sciences companies, Sucampo is chal- lenging its own market with innovation. Perhaps its greatest advantage in developing further innovative treatments is its disruptive presence in the market- place. Many small companies are now learning the benefits of venturing out early in development to visit their would- be customers. Sucampo already now occupies a space reserved for players, and according to Greenleaf, it will hold onto that space and continue to scale up its business — as an independent and free agent. L