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23 LIFESCIENCELEADER.COM MARCH 2015 autonomic nervous system that, accord- ing to the McGill Pain Index, ranks as the most painful form of chronic pain. Since pain management is a Grünenthal core competency, the company set out to obtain (which it did successfully) the licensing rights for Neridronate for the Americas. With less than 200,000 U.S.-Americans suffering from CRPS, Grünenthal executives knew this repre- sented an unmet medical need, as well as a possible orphan drug indication for Neridronate. "Worldwide, two things we look for when assessing development, licensing, or commercial opportunities are drugs with niche and/or orphan indications," Langner states. Neridronate fits the bill. Apparently, the FDA agreed. On March 25, 2013, Neridronate was granted orphan drug designation by the FDA for CRPS-I, CRPS-II, and CRPS-NOS (not otherwise specified). "We think we can make a real difference in the treat- ment of patients suffering from CRPS-I, and we are highly committed to starting clinical trials in the U.S." The only thing missing is an R&D; partnership to help bring Neridronate to patients in pain. Grünenthal will start clinical trials without a partner, but is seeking a part- nership for future R&D; and marketing activities. If successful, Neridronate would be the first drug on the U.S. market specifically approved for the treatment of pain due to CRPS-I. Grünenthal's approach to creating a networked and entrepreneurial R&D; program seems simple. Know what you are good at. Find synergistic opportu- nities that play to that strength. Then, find partners that complement your strengths and that also fill in your weak- nesses. This is one of the main reasons for Langner's visit to J.P. Morgan. As Grünenthal's strength is pain, Langner sees complementary opportunities in conditions (e.g., certain inflammatory diseases), niches in neurology, cancer- supportive care, as well as various pain treatment settings (e.g., postop- erative pain). "If we see an opportu- nity to bring something new to patients where there is a high unmet medical need and it fits to our target audience, we would go into the business," says Langner. For example, when California- based AcelRx Pharmaceuticals was seeking a European collaborator for Zalviso, its novel combination pain drug-delivery device, the firm picked Grünenthal. According to AcelRx CEO Richard King, though the search for an EU collaborator involved a number of large players, Grünenthal was selected because of its footprint in Europe's post- operative pain setting with tapentadol.