Veristat’s collaboration with Aegerion contributes to FDA approval of Juxtapid™

  Veristat’s collaboration with Aegerion contributes to FDA approval of
  Juxtapid™

Veristat’s strategic guidance contributes to successful approval of Aegerion’s
                             novel drug Juxtapid

Business Wire

HOLLISTON, Mass. -- March 20, 2013

Veristat, a leading Clinical Research Organization (CRO), applauds Aegerion
Pharmaceuticals on their recent FDA approval of Juxtapid for the treatment of
patients with homozygous familial hypercholesterolemia (HoFH) (official press
release.) Dr. John Balser, President of Veristat commented, “Congratulations
to the Aegerion team. As a pivotal strategic partner on the biostatistical,
medical writing, and regulatory strategy for this submission, we are honored
to have played a part in the approval of such an important, lifesaving
therapy.”

HoFH is a serious, rare genetic disease that impairs the function of the
receptor responsible for removing LDL-C ("bad" cholesterol) from the body.
Patients with HoFH often develop premature and progressive atherosclerosis, a
narrowing or blocking of the arteries. The FDA based its approval of Juxtapid
on Aegerion's pivotal Phase 3 study, which evaluated the safety and
effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with
HoFH.

Veristat collaborated with Aegerion as an integral part of their submission
team for Juxtapid, providing strategic insight, statistical analysis, and
medical writing support. Specifically, Veristat worked in partnership with
Aegerion to produce the Phase 3 pivotal clinical study report, the integrated
summary of safety, and all clinical summary documents for simultaneous NDA/MAA
filings. “One of the most gratifying aspects of our collaboration was working
hand-in-hand with Aegerion in preparation for and participation in the FDA
Advisory Committee meeting, where the expert panel members voted in favor of
Juxtapid’s approval,” said Dr. Balser.

“The approval of Juxtapid is a landmark event for patients with this rare
disease," said Martha Carter, Chief Regulatory Officer and Senior Vice
President at Aegerion. “We want to extend our gratitude to the team at
Veristat for their energy, insights, and commitment to the Juxtapid program
over the past few years. Veristat played a key role in the successful
submission and approval of this important therapy.”

“This was a tremendously rewarding project for us,” said Dr. Barbara Balser,
Executive Vice President and Chief Scientific Officer of Veristat. “Every
member of the team was focused on delivering 110% to ensure a successful and
timely submission for Juxtapid.” She went on to say, “The Aegerion team was,
and continues to be, a great partner with Veristat. We are honored to have
been invited to contribute our expertise to the critical elements of the
Juxtapid submission and we continue to support Aegerion in their effort to
make this important therapy available to patients worldwide.”

About Veristat

Veristat, Inc. is an innovative, science-focused clinical research
organization (CRO) in its 20th year of providing dynamic expertise in
supporting clinical trials and regulatory submissions for pharmaceutical,
biotechnology, and medical device companies. Veristat offers comprehensive
services, including biostatistics, statistical programming, medical writing,
clinical monitoring and data management for a single study or an entire
clinical program, as well as preparation of integrated summary documents and
submission-ready CDISC data for regulatory filings. Due to Veristat’s
unwavering commitment to scientific integrity, client focus and exceptional
performance, long-lasting client relationships are our hallmark. For more
information about Veristat and the services provided please visit
www.veristat.com.

Contact:

Veristat
Nicole Powell, 214-432-6126
nicole.powell@veristat.com
 
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