Businessweek

Zogenix, Inc., a pharmaceutical company, engages in commercializing and developing products for the treatment of central nervous system disorders and pain. Products Sumavel DosePro: The company’s commercial product, Sumavel DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January 2010. Sumavel DosePro offers fast-acting, needle-free subcutaneous administration of sumatriptan for the acute treatment of migraine and cluster headache in a pre-filled, single-use delivery system. Sumavel DosePro is approved by the U.S. Food and Drug Administration (FDA) that allows for the needle-free, subcutaneous delivery of medication. Zohydro: The company’s main product candidate, Zohydro (hydrocodone bitartrate, formerly ZX002) is a 12-hour extended-release formulation of hydrocodone without acetaminophen for the treatment of moderate to severe chronic pain requiring around-the-clock opioid therapy. The company completed Phase 3 development of Zohydro in 2011. Relday: The company also develops Relday, a proprietary, long-acting injectable formulation of risperidone using Durect Corporation’s SABER controlled-release formulation technology in combination with DosePro needle-free, subcutaneous drug delivery system through a 2011 development and license agreement with Durect Corporation. Risperidone is used to treat the symptoms of schizophrenia and bipolar disorder in adults and teenagers 13 years of age and older. Collaborations, Commercial, and License Agreements Durect Corporation (Durect) Development and License Agreement: In 2011, the company entered into a development and license agreement with Durect. Under the terms of the agreement, the company would be responsible for the clinical development and commercialization of Relday. Durect would be responsible for non-clinical, formulation and chemistry, manufacturing and controls, and development responsibilities. Desitin Arzneimittel GmbH (Desitin) License and Distribution Agreement: The company has a licensing and distribution agreement with Desitin. Under the terms of the agreement, the company granted Desitin the right under intellectual property rights related to Sumavel DosePro to develop, use, distribute, sell, offer for sale, and import Sumavel DosePro and any potential modified versions of Sumavel DosePro in the European Union, Norway, Switzerland, and Turkey. Alkermes plc (Alkermes) License Agreement: The company has a license agreement with Alkermes. Under the terms of this license agreement, Alkermes granted to the company a license in the United States and its possessions and territories, with defined sub-license rights to third parties other than certain technological competitors of Alkermes, to certain Alkermes intellectual property rights related to Zohydro product candidate. Suppliers The company’s suppliers include MGlas AG and Dr. Reddy’s Laboratories, Inc. Customers The company’s customers include Cardinal Health, Inc., McKesson Corporation, and AmerisourceBergen Corporation. Business Strategy The company’s strategy is to commercialize and develop differentiated central nervous system and pain therapeutics that can address significant unmet medical needs and overcome limitations of existing products. Research and Development The company invested $33.0 million in research and development for the year 2011. Distribution The company primarily sells Sumavel DosePro to wholesale pharmaceutical distributors, who, in turn, sell the products to pharmacies, hospitals, and other customers. Intellectual Property Needle-free Drug Delivery Technologies: The company’s patent portfolio is directed to various types and components of needle-free and other drug delivery systems. As of February 1, 2012, the company had 17 issued U.S. patents, 12 pending U.S. patent applications, 49 issued foreign patents and 22 pending foreign patent applications. Of the above, the company has 7 issued U.S. patents, 3 pending U.S. patent applications, 39 issued foreign patents, and 5 pending foreign patent applications relating to various aspects of Sumavel DosePro and DosePro technology. Zohydro: Zohydro is an or