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C h a i n D r u g s t o r e D a i l y S a t u r d a y, A p r i l 2 5 , 2 0 1 5 1 4 MALLINCKRODT FOCUSES GENERICS PIPELINE AND INCREASES BUSINESS GROWTH An interview with Hugh O'Neill, President and Senior Vice President, Specialty Pharmaceuticals. CDD: What is behind Mallinckrodt's transformation since becoming an inde- pendent, public company? HO: We have pursued strategies that have advanced Mallinckrodt's transfor- mation into a leading global specialty biopharmaceutical company. We remain highly focused on expanding our portfo- lio to provide durable, sustained growth. We have seen strong performance in fis- cal 2015 across all of our businesses, achieving meaningful top and bottom line growth particularly in the Specialty Brands and Specialty Generics segments. CDD: What is your focus for the Specialty Generics segment? HO: One of the many ways we demon- strate our commitment to being a leader in generic pharmaceuticals is our ability to promise customers a reliable source of supply, assure quality and stay competi- tive in the marketplace. Mallinckrodt has decades of expertise in this area and one of the broadest, most diverse generic portfolios in the industry with about 40 different product categories, the largest share in controlled substances. We have a strong ability to master and manage com- plexity. We also are continually investing in the business to maintain the infrastruc- ture, portfolio strength and breadth that allow us to respond effectively to market dynamics. CDD: What is driving Mallinckrodt's business development growth? HO: Our company made bold acquisi- tion moves in 2014, and continues to do so in 2015 with the recently announced Ikaria, Inc. acquisition. We have expanded our platform with strong growth products that are immediately accretive, but sig- nificantly diverse as durable, long-term value producers. We simultaneously created new channel and therapeutic area platforms for growth. The addi- tion of these products and our estab- lished presence in new therapeutic areas creates an important blueprint for future research and development (R&D) and BD&L efforts. CDD: Tell us more about the Ikaria acquisition. HO: Ikaria Inc. is a global critical care company focused on development and commercialization of innovative thera- pies and delivery systems to address the needs of critically ill infants in hos- pital neonatal intensive care unit (NICU) settings. With this transaction, Mallinckrodt is expected to significant- ly strengthen its footprint in hospitals, extending its presence from its current base of diagnostic radiology and multi- modal pain management in surgical specialties to include critical care res- piratory therapies in neonatal intensive care units. The Ikaria transaction also builds potential diversity in Mallinckrodt's nephrology rare disease pipeline. CDD: Detail the company's prod- uct pipeline and R&D focuses. HO: Mallinckrodt applies its unique strengths, experience and expertise to develop products that provide value for physicians and the patients the compa- ny jointly serves. We have had a highly productive R&D team, historically, with U.S. Food and Drug Administration (FDA) approval of 12 new products since 2010. The compa- ny's development pipeline is focused in areas where we think we can bring dif- ferentiated value to the marketplace. We see clear R&D opportunities in the autoimmune and rare diseases as well as the acute care spaces. We are invest- ing millions of dollars in research efforts focusing on exploring the abuse- deterrent potential of our proprietary formulation technologies. For more information, visit booth #318 or go online to www.mallinckrodt.com or call 314.654.2000. THE DRUG QUALITY AND SECURITY ACT: WHAT YOU NEED TO KNOW By Ned Milenkovich, Principal with Much Shelist The Drug Quality and Security Act (DQSA) was passed into federal law on November 27, 2013, but much of it has yet to be implemented by the federal gov- ernment. Following is an overview of the two distinct laws within the DQSA and what pharmacies need to know. The Compounding Quality Act cre- ates a voluntary compliance regime where compounding pharmacies that vol- untarily register as "outsourcing facili- ties" are subject to oversight by the FDA similar to current monitoring of tradition- al pharmaceutical manufacturers. Before the new law, the FDA had limited oversight of pharmacies engaging in the practice of compounding, which were traditionally regulated at the state level. Also, a distinct difference had developed among compounding pharma- cies: those that compounded for identifi- able patients and in limited quantities and those that mass produced compounded medications without an identifiable patient. The Act attempts to distinguish between these two entities. Compounders who wish to practice outside the scope of traditional pharmacy practice must voluntarily register as out- sourcing facilities under a new section 503B of the federal Food, Drug & Cosmetic Act. Those wishing to continue as traditional compounders will still be regulated by state law subject to the provi- sions of 503A. Notably, an outsourcing facility can qualify for exemptions from the FDA approval requirements, but not the exemption from the good manufactur- ing practices requirements. Drugs pro- duced by compounders that are not registered as outsourcing facilities must meet the conditions of 503A in order to be exempt from compliance with current good manufacturing practices, labeling with adequate directions for use and FDA approvals prior to marketing. The Drug Supply Chain Security Act requires the FDA to create and imple- ment a national track-and-trace system requiring manufacturers to affix to each package product identifiers that are either human-readable or machine-readable, or homogenous in the case of a pharmaceu- tical product intended to be introduced into the supply chain. The nationwide drug track-and-trace system allows for efficient tracing in order to respond to recalls and notices of theft and counterfeiting. The public policy goal is to establish within 10 years an interop- erable, electronic tracing system of phar- maceutical products down to the package level, allowing prompt response in the event of a recall or for the purpos- es of investigating a suspect prod- uct or an illegitimate drug product. The law would replace the current patchwork state system of product tracing with a uniform, electronic and interoperable unit- level product tracing system. Manufacturers, wholesale distributors, dispensers and repackagers must develop verification methods to determine whether a drug product is a valid, suspect or illegitimate product. If a supply chain stakeholder determines that they are in possession of a suspect or illegitimate drug product, various operational, report- ing and disclosure obligations are trig- gered under the new law. While these new laws are not yet fully implemented, compliance will be critical to future operations. Retailers would be wise to get ahead of the curve now. For more information, contact Ned at 312.521.2482 or at nmilenkovich@ muchshelist.com. GREATER RESOURCES FOR A GREATER FOCUS ON ADHERENCE Disease-awareness efforts, consumer advertising, physician marketing – phar- maceutical manufacturers put significant work into connecting their products with the patients who can benefit from those medicines. As a result, patients and doctors have more access to treatment information than ever before. But while it's easier than ever to find out about the treatments avail- able to today's patient, there's still a signif- icant shortfall with medication adherence. As many as 30 percent of patients with chronic conditions don't even fill their first prescription; of those who do, as many as 30 percent fall off within 30 days, while up to 60 percent fall off within 180 days, according to Adheris Health data information. Today our healthcare system has an unprecedented focus on outcomes. How likely are patients to have a good outcome if they don't take the treatment? With access to data from 2.2 billion pre- scriptions annually, Adheris Health has the resources and insight to answer that ques- tion, generating important benefits for retailers, prescription manufacturers and, most importantly, patients. Healthcare brands routinely engage an AOR dedicated to HCP marketing, and another for DTC promotion. Adheris Health has created the first and only con- sultancy equipped to take a big-picture, strategic view of adherence. Recognizing that the pharmacy is the backbone of adherence by providing critical interven- tions at the point of care and addressing gaps in care, Adheris Health partners with the best organizations in the busi- ness to advance patient health. That's because Adheris Health has resources no other agency can match. It starts with the Behavioral Insights group: together, health psychologists, behavioral scientists, clinical specialists, consumer marketers, design experts and user expe- rience specialists develop and implement interventions and support programs that are grounded in science. To do that work, they need data, which has been the Adheris Health difference from the start. Its experts work with information from the largest pharmacy network in the country, providing access to more than 175 million Americans. That seasoned team of consultants has deep experience building highly efficient and personalized patient adherence pro- grams that are guided by behavioral insights gleaned from our data resources. As a result, those programs are proven to educate healthcare consumers on the bene- fits of living a healthier life so they see the value in starting and staying on therapy. Adheris Health also targets physi- cians and pharmacists with communica- tion tools that enhance patient interven- tions, creating productive conversations focused on long-term health. Its cus- tomizable programs ensure that patients receive relevant messages that engage them in better health habits and physi- cian/pharmacist dialogue. Adheris Health's strategic approach to patient adherence drives better out- comes and brand performance. In fact, its personalized multichannel programs have been shown to yield up to a 30 per- cent improvement versus single-channel adherence programs. For more information, visit booth #454 or visit www.adherishealth.com.