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C h a i n D r u g s t o r e D a i l y S u n d a y, A p r i l 2 6 , 2 0 1 5 2 2 broad spectrum of pharmaceutical for- mulas. Traditionally we have been in oral solids only, however recently we have started adding liquids to our portfolio. We service private label customers, national brand customers and do research and development work for some clients. CDD: How do you handle sales? JM: As our role in the industry has been that of a high quality low cost manufac- LNK International (Cont'd. from p. 1) turer, we have always maintained a lean organization. We have a small internal sales department for house accounts and marketing team who report to Doug Bausch our Vice President of Sales and Marketing. We also utilize a series of independent representatives who handle the day to day issues, administrative duties and are the local faces of LNK CDD: What would you say makes your company unique? JM: After 35 years of operation our focus is rooted in our foundation of customer service. Providing the highest quality at a very competitive price and being able to react at a moments' notice with a full range of products and packaging options enables us to service our customers in a way that many are not able to or desire to. CDD: Are you introducing any new prod- ucts? JM: In answer to our customers' repeat- ed requests to enter the liquid market because of a void of quality liquid sup- pliers, LNK has entered into liquids and semi-solid dosage forms. Now offering the industry the same quality and reliabil- ity it has come to know from LNK. Additionally we are working on some strategic alliances to bring additional option for ANDA products to market as well as filing more ANDA's directly. CDD: What distinguishes your products from the competition? JM: As a prime manufacturer, LNK con- trols every step of the manufacturing process, from the acquisition of raw mate- rials, the manufacturing and the distribu- tion of finished products. By controlling all aspects of production, LNK is able to control the quality and keep costs low. CDD: To what do you attribute your company's success? JM: At LNK quality and service are taken very seriously as it is the founda- tion for everything we do. We have worked hard to earn our clients business and they see us as a resource; we have a great deal of respect for the trust that these accounts place in us personally and in our expertise. CDD: How do you see the next year in terms of economy, sales, technology and product evolution? JM: I think there is a world of opportunities for this industry and with the right products, the right partners and the right quality, the future holds endless opportunity for us. For more information, visit www .lnkintl.com, call 631.435.3500 or email dbausch@lnkintl.com or look for booth #230. AURIS MEDICAL ANNOUNCES COMPLETION OF INTERIM ANALYSIS IN AM-101 TRAIL Auris Medical Holding AG, a clinical- stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, has announced the completion of the planned interim analysis in the post-acute tinnitus stratum of the TACTT3 trial ("Stratum B") with AM-101 and that enrollment could continue since the pre-specified futility threshold was not reached. Based on rec- ommendations by the Independent Data Review Committee, the inclusion criteria will be adapted in order to focus on the early post-acute stage where higher levels of activity were observed than at the later stage. Accordingly, Stratum B will contin- ue to enroll patients with tinnitus having started between three and six months prior and stop enrollment of patients with onset 6 to 12 months prior. The TACTT2 trial and Stratum A of TACTT3, which enroll patients with tinnitus up to three months from onset and were not part of the inter- im analysis, will continue unchanged. The interim analysis on Stratum B of the randomized, double-blind, placebo- controlled European TACTT3 trial was performed based on 150 study participants (50 percent of the planned total) complet- ing their second follow-up visit on Day 35. Futility was assessed since AM-101 had never before been tested beyond the acute stage of tinnitus (up to three months from onset). The evaluation was based on the primary efficacy variable of the trial, improvement in subjective tinnitus loud- ness, as well as on improvement in the Tinnitus Functional Index. "We are very encouraged about the positive outcome from the interim analysis and look forward to continuing Stratum B to explore AM-101's therapeutic benefits in the post-acute stage", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. He added: "The outcome lends further support to our approach of treating inner ear tinnitus early, while the symptom is still of peripheral rather than central char- acter." Bettina Stubinski, Chief Medical Officer of Auris Medical, stated: "Although accumulating evidence points to the bene- fits of early treatment, therapeutic benefits may still be possible to achieve even at later stages. The full analysis of outcomes from Stratum B will provide us with important further insights into the therapeutic time window for AM-101 and the natural histo- ry of inner ear tinnitus." About AM-101 AM-101 is a small molecule N-methyl-D- aspartate (NMDA) receptor antagonist for- mulated in a biocompatible gel for intratympanic injection. Emerging evi- dence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxici- ty, which is characterized by excessive synaptic release of glutamate, the principal neurotransmitter in the auditory system. GALECTIN THERAPEUTICS ENGAGES PPD TO CONDUCT GR-MD-02 PHASE 2 TRIAL IN NASH Galectin Therapeutics, a developer of ther- apeutics 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 hypertension in patients with non-alcoholic steatohepati- tis (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 finalized 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 pro- gram," said Peter G. Traber, M.D., President, Chief Executive Officer and Chief Medical Officer of Galectin Therapeutics. "PPD's extensive experience in conducting clinical trials in liver-related diseases will serve us well. We are particu- larly attracted to their work with clinical trial sites possessing familiarity with hepat- ic venous pressure gradient (HVPG), as the FDA has indicated that HVPG may serve as a surrogate primary 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, ran- domized, 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 hypertension 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 expected 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 magnetic resonance-elastography and FibroScan score, and by imaging liver fibrosis using multi-parametric magnetic 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 scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular sys- tem. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.