Product is the first FDA approved pre-filled subcutaneous, needle-free delivery system for use in the U.S.
TORONTO, Dec. 15 /CNW/ - Patheon (TSX: PTI) a global provider of drug development and manufacturing services to the international pharmaceutical industry announced today that it has successfully released the first commercial shipments of SUMAVEL DosePro (sumatriptan injection) to Zogenix in anticipation of the planned U.S. commercial product launch scheduled in January 2010. The successful production of this new, needle-free drug product/delivery system is the culmination of joint manufacturing process and equipment development between Patheon and Zogenix. Aseptic drug filling, final product assembly, and packaging of SUMAVEL DosePro needle-free delivery system are performed exclusively by Patheon in its Swindon, U.K. facility with components and assemblies from around the world designed specifically for use in the DosePro technology.
"We are excited to have shipped this initial commercial launch product to Zogenix on time as they prepare for their U.S. launch," said Wes Wheeler, Chief Executive Officer and President of Patheon Inc. "The DosePro manufacturing technology and dedicated manufacturing facility are state-of-the-art. Zogenix and Patheon technical teams worked closely together over the years and we have developed an excellent partnership. We are proud to be part of a first of a kind technology and a product that will meet an unmet medical need."
In commenting on the release, Roger Hawley, Chief Executive Officer and Director of Zogenix said, "We are very pleased with the partnership we have developed with Patheon as we worked to make SUMAVEL DosePro, the industry's first pharmaceutical product employing a pre-filled, needle-free subcutaneous delivery system a success." He added, "This event also clears the path for many other pharmaceutical firms who are interested in developing their drugs for use with the innovative DosePro needle-free technology."
Patheon Inc. (TSX: PTI; www.patheon.com) is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon prides itself in providing the highest quality products and services to more than 300 of the world's leading pharmaceutical and biotechnology companies. Patheon's services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, solid, semi-solid and liquid forms. Patheon uses many innovative technologies including single-use disposables, liquid-filled hard capsules and a variety of modified release technologies. Patheon's comprehensive range of fully integrated Pharmaceutical Development Services includes pre-formulation, formulation, analytical development, clinical manufacturing, scale-up and commercialization. Patheon can take customers direct to clinic with global clinical packaging and distribution services and Patheon's Quick to Clinic(TM) programs can accelerate early phase development project to clinical trials while minimizing the consumption of valuable API. Patheon's integrated development and manufacturing network of ten facilities, and six development centers across North America and Europe, strives to ensure that customer products can be launched with confidence anywhere in the world. Patheon's integrated development and manufacturing network of 11 facilities and eight development centers, across North America and Europe, strives to ensure that customer products can be launched timely and confidently anywhere in the world.
Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a privately held pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company's initial focus is the commercialization of SUMAVEL DosePro. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for SUMAVEL DosePro in December 2007, and received FDA approval in July 2009. The company's pipeline also includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, expected to enter Phase 3 clinical trials in 2010. Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies. For additional information, visit www.zogenix.com.
SOURCE Patheon Inc
For further information: For further information: Patheon Contacts: Wes Wheeler, President & Chief Executive Officer, Tel: (919) 226-3200, Email: email@example.com; Eric Evans, Chief Financial Officer, Tel: (919) 226-3204, Email: firstname.lastname@example.org; Wendy Wilson, Investor Relations, Tel: (919) 226-3313, Email: email@example.com; Zogenix Media Contact: Catherine O'Connor, Sr. Director, Commercial Communications, Tel: (858) 436-3374, Email: firstname.lastname@example.org; Zogenix Investor Contact: David Nassif, Chief Financial Officer, Tel: (858) 436-8583, Email: email@example.com