INDUSTRY NEWS


The drug Zarxio is a similar version of the reference biologic Neupogen (filgrastam) and was approved recently for all of the same indications as Neupogen. This will allow Zarxio to compete with Neupogen on all therapeutic fronts, providing the broadest market opportunity possible. Neupogen generated roughly $839 million in US sales for Amgen during 2014.


Zarxio's approval marks the beginning of a relatively new competitive dynamic in the US biologics market, with the most notable exception being the domestic human insulin market. Fitch expects other firms to pursue biosimilar versions of Neupogen and other biological therapeutics. However, given the costs of marketing and manufacturing biosimilars, the likely reservation of some physicians to prescribe them, and the expected moderately discounted pricing, Fitch believes market share shifts will be less rapid than in the traditional small molecule generic markets at the outset.


Sandoz has widely marketed Zarxio outside of the U.S. market as “Zarzio,” so it has significant clinical and marketing experience with this product. In addition, of the many biologics currently marketed, filgrastam has a relatively straightforward chemical structure when compared to others biotherapeutics.


Pharmacists in the US will not be able to automatically substitute Zarxio for Neupogen, so physicians will have to specifically prescribe Zarxio for a patient to receive it. Fitch expects that Zarxio will be priced competitively, relative to Neupogen, but not at the steep discounts that mark the traditional small molecule generic market. As such, Sandoz will have to make its case to physicians as well as third-party payors to prescribe and pay for Zarxio rather than Neupogen.


Fitch expects a relatively moderate but steady ramp of the U.S. biosimilar market during the next few years as acceptance in the medical community grows and competition expands. Both generic and branded pharmaceutical manufacturers are pursuing opportunities in this area, suggesting that there are above-average profitability opportunities in the near to intermediate term.


Derma Sciences Names Pharmaceutical Development Leader John Caminis, MD as Chief Medical Officer


Derma Sciences, Inc., a tissue regeneration company focused on advanced wound and burn care, has announced the appointment of John Caminis, MD, to the newly created position of chief medical officer. Dr. Caminis is a seasoned pharmaceutical physician with particular expertise in clinical drug development, and will report to Edward J. Quilty, the company’s chairman and CEO.


“We are fortunate to be welcoming John Caminis to the Derma Sciences executive management team,” said Edward J. Quilty. “He brings exceptional experience and credentials not only in clinical development, but also in fostering relationships with key opinion leaders, submitting regulatory filings and managing contract research organizations. He is charged with overseeing our clinical development, including the execution of our Phase 3 program with DSC127 in diabetic foot ulcer


healing as well as the pre-clinical programs for DSC127 including scar prevention and the mitigation of effects from radiation exposure. We are confident that Dr. Caminis will add immediate value to the conduct of the DSC127 program. He will additionally have responsibility for clinical studies on our AMNIO line of amniotic allograft products, as well as oversight of clinical studies that support the marketing of our lead advanced wound care products such as MEDIHONEY and TCC-EZ.”


Dr. Caminis has a wide range of experience in managing the clinical trial process for a multitude of therapeutic indications. Since 2011 he served as senior medical director in the immunology, and later in the bone patient value unit at UCB, a global biopharmaceutical company.


Prior to UCB he was vice president, clinical development at Warner Chilcott (now Actavis), where he supported the integration of clinical development functions subsequent to that company’s acquisition of Proctor & Gamble’s pharmaceuticals business. At Warner Chilcott he planned, designed, developed, and oversaw clinical development programs in therapeutic areas such as bone metabolism, urology, dermatology, and infectious disease. Earlier in his career Dr. Caminis had roles of increasing responsibility in clinical development and medical affairs programs at small as well as large companies like NPS Pharmaceutical, Novartis Pharmaceuticals, and Roche Laboratories. While at NPS, he had a pivotal role in the execution and development of key assets for patients with rare diseases.


“This is an exciting time to be joining Derma Sciences as we pursue a tight, patient-focused business strategy and are well-positioned for a greater presence in the growing market of advanced wound care,” said Dr. Caminis. “I look forward to joining an impressive team of dedicated associates and executives to add new perspectives to our clinical efforts and to further build our clinical affairs and development capabilities.”


Dr. Caminis has co-authored numerous conference abstracts and more than 20 publications in peer-reviewed journals. He holds an MD degree from the University of Athens School of Medicine in Greece. He served as a clinical research fellow of The McGill Bone Center and has Masters Certification in Project Management from George Washington University School of Business/ESI International.


Alkermes plc Announces Sale of Gainesville, GA Manufacturing Facility to Recro Pharma, Inc.


Alkermes plc has entered into a definitive agreement to sell its manufacturing facility in Gainesville, GA, the manufacturing and royalty revenue associated with products manufactured at the facility and global rights to Meloxicam IV/IM to Recro Pharma, Inc. (Recro), a specialty pharmaceutical company. Under the terms of the agreement, Alkermes will receive from Recro an initial cash payment of $50 million, development and commercialization milestone payments of up to $120 million related to Meloxicam IV/IM, and low double-digit royalties on net sales of Meloxicam IV/IM. This transaction is subject to antitrust law clearance as well as other customary terms and conditions. This transaction is anticipated to close in the second quarter of 2015.


Assets being sold as part of the transaction include the Good Manufacturing Practices (GMP) facility in Gainesville, which was


pharmoutsourcing.com | 69 | March/April 2015


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