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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM MARCH 2015 34 igning a deal can seal your fate. An exit for your investors may mean the end of your dream. What if you decided to forego the exit route, leapfrog to an IPO, and use commercial partnerships to fuel your scale-up into a fully integrated biopharma company? For an example in progress, look at Sucampo — a still-small company with two FDA- approved products, many more in the pipeline, a healthy balance sheet, and a commitment to maintain its long-term independence. Heading Sucampo is CEO Peter Greenleaf, a biopharma veteran previously featured in these pages when he was president of MedImmune. (See "Antibacterial Drug Discovery And Beyond," July 2011.) Greenleaf left MedImmune in mid-2013 following a management restructuring by AstraZeneca and a tenure as head of Latin America. He says he wanted to reclaim the entrepreneurial spirit of leading a small company still in charge of its own fate. After a short stint helping the tiny start-up Histogenics, he went to a company where he saw the potential for growth with a go-it-alone strategy of full integra- tion, joining Sucampo in March 2014. At that time, Sucampo was already mar- keting the product Amitiza (lubiprostone) globally through partners. Amitiza is a chronic-care drug for chronic idiopathic constipation, irritable bowel syndrome with constipation (IBS-C), and noncancer opioid-induced constipation (OIC) in adult indications. The company was also developing other medicines in a poten- tially huge area of gastrointestinal (GI) therapeutics that could power its next stage of growth. At the time, Sucampo also marketed Rescula (unoprostone isopropyl) for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. But under Greenleaf, the company has decided to terminate its pro- motion of Rescula in glaucoma, turning its attention to diversifying its pipeline into other high-value areas, starting with gastroenterology and ophthalmology, and to new modes of action that will move the company beyond its current pros- tone platform. Prostones are compounds derived from functional fatty acids that act as selective ion channel activators, according to the company. Sucampo's story of independence is also one of repeated scale-ups. It covers all stag- es and issues in company development, from basic start-up challenges such as funding and finances, to best practices in managing partnerships, running virtual operations, removing drains on resources, and applying business-wise leadership in a small-company, science-driven envi- ronment. BACK TO BASIC FUN, ONWARD TO ACCOUNTABILITY When MedImmune began to operate less independently, melding into the AZ corporation, it was the third such expe- rience for Greenleaf. Prior to his nine years at MedImmune, he was leading a commercial team at Centocor when J&J; acquired it and working at Boehringer Mannheim during its acquisition by Roche. He sees the mergers at least partly in a positive light; the new parents helped the acquired-company organizations scale up to commercial capacity. But for Greenleaf and others who helped build the formerly independent enterprises, life in a large corporation lacked the dynamism, sense of discovery, and sheer business joy of working in an entrepre- neurial environment. His move back to "little biopharma" was no simple replay of his previous career, however. In his past run with small-to- midsize companies, the pattern had been successful in moving pipeline products forward, making the company an attrac- tive target for takeover, and terminating in an acquisition by some large company. The AZ/MedImmune merger awoke his determination to break out of the too- familiar cycle. "I learned a lot in the transition process of MedImmune growing within AstraZeneca," he says. "But on the day they decided to integrate MedImmune into the larger entity, I wanted to move on and go build another pharmaceutical company as the leader of that organization." Greenleaf had been observing Sucampo since his time at Centocor, with a spe- cial interest because of Sucampo's base in Maryland where he has worked and lived for years. "Sucampo had a great foundation and a heritage built on strong scientific innovation," he says. "I knew about the development of Amitiza, and I'd been following the science. I knew a lot about the founders, Dr. Ueno and Dr. Kuno, and their philanthropic work here locally. I also knew the company had received heavy investment during the eight years since going public, but had not done much of the work needed to take it into the broader sphere. So I joined the company to raise it from the classic stage of scientific founders doing a start-up to the next stages of scaling, growing, and building a basic company architecture strong enough to support further growth." Sucampo had already made some big strides from the start-up line. Greenleaf walked into a company with marketed products and a development pipeline. The company also had, and still has, excep- tionally healthy financials for a develop- ment-stage company, he says. "We are bringing in around $100 million a year in revenue, and we carry very little debt. We have a very lean infrastructure. We still operate very much like a small start- up environment here, with less than 100 employees globally. And we have a pas- sionate and innovative culture, much like a start-up. Our people are entrepreneur- ial, wear many hats, and are close to the pulse of the organization." As the new leader, Greenleaf took hold of a company he saw as a basically sound ship and steered it in a new direction. He says some of the company's advantages were also the source of its main challenges. For example, because it had marketed products, its pure R&D; culture had given way to a more commercial perspective. Full integration into commercial activi- ties, as well as prolonged IP litigation, had also spread the company's resources thin. "Over time, the company had taken on many battles across multiple fronts," he explains. "So establishing a central focus was absolutely crucial for the organiza- tion. In examining our strategy, it became clear that we needed to rebuild many areas of the company with new capabili- ties and world-class scientific leaders and S SUCAMPO'S DECLARATION OF INDEPENDENCE By W. Koberstein