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SENTRX Selected as Drug Safety Partner by PRAECIS PHARMACEUTICALS INCORPORATEDSpecialty Firm Will Provide Pharmacovigilance And Risk Management Services Little Falls, NJ –
February 11, 2004 – SENTRX, a leading provider of technology-enabled solutions
and services for global drug safety, announced today that it has signed
agreements with PRAECIS PHARMACEUTICALS INCORPORATED to perform post-marketing
safety and risk management services, as well as safety system hosting. PRAECIS recently
received approval from the United States Food and Drug Administration (FDA) to
market Plenaxis™ (abarelix for injectable suspension), the first of several
drugs in their pipeline to reach the market. SENTRX will provide drug safety operations for this important
new product and will implement the PLUS (Plenaxis™ User Safety) Program. “PRAECIS needed to
leverage a partner with deep experience in pharmacovigilance,” said William K.
Heiden, President and Chief Operating Officer of PRAECIS.
“We selected SENTRX because they are completely focused on drug safety,
they understand how to apply technology to pharmaceutical support programs, and
they were able to meet our aggressive timetable for launch.” Utilizing a dedicated
team of health care professionals in their Safety Response Center, SENTRX will
provide the following services: ·
Intake and data entry of adverse events (AEs), serious adverse events (SAEs),
and events of interest obtained via phone, fax, mail, e-mail, literature
searches and through the PLUS Program; ·
Active query of patients and health care providers to obtain complete
case information; ·
MedDRA coding, narrative writing and medical review; ·
Expedited and periodic report preparation; ·
Handling of medical inquiries, frequently asked questions (FAQs), and
product complaints; ·
Installation, configuration, validation and hosting of a dedicated
instance of the Argus™ Safety System; ·
Configuration, validation and hosting of a Web-based system for medical
inquires, product complaints and FAQs; ·
Configuration, validation and hosting of the Plenaxis™ PLUS Program
registry; and ·
Telephone support to physicians, hospital pharmacists and authorized
distributors for PLUS Program registration, confirmation and adverse event
reporting. SENTRX built the
Plenaxis™ PLUS Program registry utilizing its ultra-secure, Web-based
SafetyTrak® Technology Suite, which allowed the system to be
operational and validated in 60 days. Specialty
distributors will access the registry to confirm a medical professional’s
participation in the PLUS Program before shipping product. “We are excited to
work with PRAECIS, an innovative company that has made patient safety its number
one priority,” said Joseph Albano, Chief Executive Officer of SENTRX.
“The rapid deployment of our technology and service offerings will
allow Plenaxis™ to reach appropriate patients as quickly as possible.” About PRAECIS PRAECIS
PHARMACEUTICALS INCORPORATED is a biopharmaceutical company focused on the
discovery, development and commercialization of innovative therapies to address
significant unmet medical needs. In
the United States, PRAECIS has received approval from the FDA to market Plenaxis™
(abarelix for injectable suspension). PRAECIS employed its proprietary LEAP™ (Ligand
Evolution to Active Pharmaceuticals) technology in the development of Plenaxis™.
PRAECIS also has an innovative product pipeline, including clinical
programs in Alzheimer’s disease, non-Hodgkin’s lymphoma and endometriosis,
as well as discovery programs in oncology, inflammation and anti-viral
therapies. PRAECIS is headquartered
in Waltham, MA. About SENTRX SENTRX is a leading provider of technology-enabled solutions and services for global drug safety. Its mission is to manage the safety risks associated with developing and marketing pharmaceuticals. With multilingual Safety Response Centers in the United States and Europe, SENTRX delivers a unique combination of highly skilled people, exclusive technology, and best practices in pharmacovigilance and risk management. To learn more about SENTRX, please visit their website at www.sentrx.com; send an e-mail to info@sentrx.com; or call 1-888-399-8032, extension 261. Contact: Jill Notte Phone:
973-812-7575 ext. 261 E-Mail:
info@sentrx.com |
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