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C h a i n D r u g s t o r e D a i l y M o n d a y, A p r i l 2 7 , 2 0 1 5 2 2 GALECTIN THERAPEUTICS ENGAGES PPD TO CONDUCT GR-MD-02 PHASE 2 TRIAL IN NASH Galectin Therapeutics, a developer of therapeutics that target galectin proteins to treat fibrosis and cancer, has engaged the contract research organization Pharmaceutical Product Development, LLC (PPD) to conduct the Phase 2 trial with GR-MD-02 for the treatment of liver fibrosis and resultant portal hyper- tension in patients with non-alcoholic steatohepatitis (NASH) cirrhosis (the NASH-CX trial). Galectin has submitted the protocol for a Special Protocol Assessment (SPA) to the U.S. Food and Drug Administration (FDA) with the goal of accepting the NASH-CX results, if positive, as one of the trials to support approval of the drug candidate. "We are very pleased to have final- ized our engagement of PPD, one of the leading contract research organizations in the world, and are excited to take this step toward the beginning of our Phase 2 program," said Peter G. Traber, M.D., President, Chief Executive Officer and Chief Medical Officer of Galectin Therapeutics. "PPD's extensive experi- ence in conducting clinical trials in liver- related diseases will serve us well. We are particularly attracted to their work with clinical trial sites possessing famil- iarity with hepatic venous pressure gradi- ent (HVPG), as the FDA has indicated that HVPG may serve as a surrogate pri- mary endpoint for NASH cirrhosis. We look forward to the prospect of bringing this new drug to the millions of people in the U.S. with NASH." As previously announced, Galectin's Phase 2 program for GR- MD-02 currently consists of two clinical trials. The NASH-CX trial is designed as a multicenter, randomized, placebo- controlled, double-blind, parallel-group study with 156 patients at up to 60 sites to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hyperten- sion in NASH patients with cirrhosis. Enrollment is expected to commence in the second quarter of 2015, and data readout is expected in the fourth quarter of 2017. In addition, the company will conduct a smaller trial of shorter dura- tion in 30 NASH patients with advanced fibrosis (the NASH-FX trial). This ran- domized, placebo-controlled, blinded study will be conducted at Brooke Army Medical Center with enrollment expect- ed to begin in mid-2015 and top-line data readout in mid-2016. In this study, the safety and efficacy of GR-MD-02 on liver stiffness will be evaluated by mag- netic resonance-elastography and FibroScan score, and by imaging liver fibrosis using multi-parametric magnet- ic resonance imaging (LiverMultiScan ® , Perspectum Diagnostics). About GR-MD-02 GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical pro- tein in the pathogenesis of fatty liver dis- ease and fibrosis. Galectin-3 plays a major role in diseases that involve scar- ring of organs including fibrotic disor- ders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their func- tion. Preclinical data in animals have shown that GR-MD-02 has robust treat- ment effects in reversing liver fibrosis and cirrhosis. SCRIPTPRO BRINGS DEEP UNDERSTANDING TO MAKE PHARMACIES SUCCESSFUL An interview with Mike Coughlin, President and CEO, ScriptPro. CDD: How is the robot business doing in this changing healthcare environment? MC: Quite well. Automation is more important than ever to pharmacies. We have over 7,000 robots working in phar- macies around the world and the technol- ogy ScriptPro pioneered 20 years ago has kept up with the needs of the industry. Almost all of the robots we have ever built are still in service and we see no end of life for these machines. We are now bringing some of the older units back to the factory for refurbishing and we send them back to the customers for at least another 10 years of service. There aren't many technologies that have stood the test of time like that. CDD: We understand that ScriptPro is now more than a robot company. Tell us a little about that. MC: ScriptPro is a one-stop shop for sys- tems to operate pharmacies of all types and sizes. Our customers include chains, independents, health systems and mail service/central fill operations. We also offer a hosted third party management system that is actually a full revenue accounting platform. It can be used with any pharmacy management system and provides everything needed for financial manage- ment of pharmacy revenues. CDD: How about the latest hot topics – like 340B and specialty pharmacy? MC: We have unique offerings in these areas. Our pharmacy management system has built-in real time 340B processing. The system identifies the 340B prescriptions and directs pharmacy staff to select the optimum priced products from inventory. It automatically enters the correct codes for claims submission. There is a virtual class of trade inventory tracking and automated ordering. Other systems rely on after the fact processing to track and replenish 340B inventory and correct the claims. These approaches are complicated and error prone and they cannot deal with the fact that the patient has already left the pharmacy with the wrong drug. We also have a unique approach to specialty pharmacy with integration of workflow checks, advanced DUR processes and case management tools with the pharmacy management system. Other approaches rely on add-on pack- ages and duplication of data entry to han- dle specialty pharmacy and complicated medication therapy support. CDD: What does all this mean to the business of running pharmacies? MC: Like all businesses, pharmacies need to grapple with fundamental issues: how to increase margins, reduce costs and expand access to patients. In the changing healthcare landscape, powerful systems are required to do this. For more information, visit booth #449 or contact them at www.scriptpro.com or call 800.606.7628. proud to announce the recently launched colchicine 0.6 mg capsule. This is the first FDA approved generic colchicine 0.6 mg cap- sule, which is the authorized generic of MITIGARE™. This authorized generic launch will increase patient access to this important product for the prophylaxis of gout flares in adults. Said Darwazah, Chairman and CEO of Hikma PLC, "I am very pleased to be launching our colchicine products, demonstrating our success in developing a more differentiated product portfolio for the US market." Caring about patient access, West- Ward Pharmaceutical Corp. was first to launch significantly discounted generic colchicine 0.6 mg capsules to help deliver savings to patients and pharmacists. This encapsulated form of 0.6 mg colchicine is not only cost-effective, but also provides a great option for prophylaxis of gout flares in adult patients who prefer capsules. West-Ward Pharmaceutical Corp. is a subsidiary of Hikma Pharmaceuticals LLC, a fast growing pharmaceutical group focused on developing, manufac- turing and marketing a broad range of both branded and non-branded generic and in-licensed products. Hikma's oper- ations are conducted through three busi- nesses: "Branded," "Injectables" and "Generics" based primarily in the Middle East and North Africa ("MENA") region, where it is a market leader, the United States and Europe. For more information, visit booth #634 or go to www.west-ward.com. West-Ward (Cont'd. from p. 1) BIC INTRODUCES CASED PENCILS INTO THE U.S. MARKET BIC Consumer Products USA is announcing the introduction of BIC ® Xtra-Fun™, the only #2 pencil with two- toned color barrels in the U.S. market. "BIC is committed to offering con- sumers a reliable and fun writing experi- ence that promotes confidence through self-expression," said Susan Lanzarotto, Director – Stationery Marketing, BIC Consumer Products USA. "The new Xtra-Fun pencil offers high quality and durability, and its bright colors are designed to help inspire students to write." The BIC Xtra-Fun pencil is avail- able in January 2015, and comes in an eight-pack for $2.99 and an 18-pack for $5.99.