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Chain Drugstore Daily Saturday, April 27, 2019 1 4 Delivering Success: Amneal Closes 2018 with Impressive Stats Amneal set new company records in 2018, closing out the year as the leader in U.S. generic approvals and launches with 62 final and 10 tentative ANDA approvals and 42 product launches. The newly public company celebrates the accomplishment as a bright spot in a challenging generics market rife with increased competition and intense pric- ing pressures. "We achieved industry-leading pipeline execution in 2018 with a consis- tent pace of new approvals and launch- es," noted Amneal Chief Executive Officer Rob Stewart in a recent presenta- tion. Notable launches included methylphenidate hydrochloride extended release tablets, phytonadione tablets, levothyroxine tablets, potassium chloride oral solution, erythromycin instant release tablets and colesevelam hydrochloride tablets. Focusing Generic R&D Efforts on Complex, High-Value Products To help better insulate the company from market competition and pricing chal- lenges, Amneal continues to focus aggressively on building a diversified pipeline of complex, high-value prod- ucts. Its generics R&D team successfully filed 31 ANDAs in 2018, 65 percent of which were non-oral solid products, cre- ating a pipeline of 118 filings across var- ious dosage forms. Additionally, Amneal currently has 97 generic products in development – nearly a quarter of which are injectables – a segment the company plans to increasingly target in 2019 and beyond. Specialty Pharma Business Highlights Amneal is also focused on strengthen- ing specialty pharma, which diversifies its business beyond gener- ics. The company recent- ly provided updates regarding ongoing devel- opment work on investi- gational drug IPX203, its extended release formu- lation of carbidopa-levodopa for patients with advanced Parkinson's disease. Top line results are expected in the first half of 2020, with a New Drug Application (NDA) filing expected in 2021. Integration Highlights Amneal exceeded its 2018 integration synergy target, capturing $60 million in cost savings. Other key highlights includ- ed the harmonization of its order-to-cash system/processes, consolidating all dis- tribution within its Glasgow, Kentucky operations, and the rebranding of its Impax Specialty and Gemini businesses to Amneal Specialty. With integration now complete, Amneal will shift its focus to optimizing and strengthening the compa- ny's infrastructure and systems, generating addi- tional cost-savings that will help Amneal be even more competitive. "2018 was marked by several key strategic milestones, most notably the reshaping of our company through the merger of Impax and Amneal," said Stewart. "By the end of the year, we completed the integration of the two companies and accelerated the capture of synergies, resulting in approx- imately $60 million of cost savings for the year. We also strategically deployed capital with the acquisition of Gemini Laboratories and through several partner- ships including agreements with Jerome Stevens Pharmaceuticals, Inc. and Lannett for Levothyroxine." For more information, visit Outdoor Meeting Space #202 or go to www.amneal.com. Aurobindo to Acquire Dermatology & Oral Solids Businesses from Sandoz Inc., USA Aurobindo Pharma Limited, a world- leading marketer and manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, announces the signing of a definitive agreement to acquire certain assets from Sandoz Inc., USA ("Sandoz"), a Novartis Division, comprising a market leading dermatol- ogy business and a portfolio of oral solid products along with commercial and manufacturing infrastructure in the United States. The acquisition will be on a debt-free and cash-free basis and will be made through its wholly owned subsidiary, Aurobindo Pharma USA Inc. Aurobindo and Sandoz will enter into a transitional services agreement to sup- port the ongoing growth plans of the businesses being acquired by Aurobindo. The transaction will be an all cash transaction which Aurobindo will finance through a fully committed debt facility. This U.S. acquisition is in line with Aurobindo's strategy to strengthen and grow its global business and to expand and enhance its product portfolio offer- ings in key therapeutic areas. The acquisition will give Aurobindo a mar- ket leading dermatology franchise com- prising a wide portfolio of generic and a range of branded products which are well recognized by patients, pharma- cists and retail/wholesale customers. Aurobindo will also acquire a well- established commercial infrastructure with a fully-dedicated dermatology sales force along with a state-of-the-art manufacturing facility with specialized capabilities in creams, ointments, lotions, topical solu- tions and topical sus- pensions that are highly complementary to Aurobindo's current manufacturing foot- print. The acquired generic dermatology portfolio covers a wide range of thera- peutic areas, including topical antibi- otics, gynecological and dermatological antifungal agents, anti-acne agents, local anesthetic analgesics, anti-itch and a dermatological chemotherapeutic agent. The oral nondermatological port- folio that is being acquired spans a wide range of therapeutic areas, including auto-immune disease, anti-neoplastic agents and a variety of hormonal agents, amongst others. Aurobindo has grown its business focusing on vertical integration and its commitment to the needs of its diverse patient population. To support those needs, Aurobindo will leverage its strong scientific princi- ples and extensive product portfolio, which is currently comprised of 180 prod- uct families and are excited for the addition of new therapeutic categories to its existing portfolio. It has experienced substantial growth over the past five years, moving from the eighth largest in the market in 2015 to now second (IQVA National Prescription Audits: Retail and Non-Retail MAT January 2019). This growth has been largely organic, and now with the addition of Sandoz, this exponential growth has stamped Aurobindo's position as a lead- ing generic pharmaceutical manufactur- er. Visit Aurobindo at booth #444. For more information, contact your account manager, visit www.aurobindousa.com or call 866.850.2876.