Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of INFERGEN

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July 06, 2010 08:00 AM Eastern Daylight Time

Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of

INFERGEN®

New Labeling Provides Alternative for Hepatitis C Patients Who Need Retreatment

WARRENDALE, Pa.--(BUSINESS WIRE)--Three Rivers Pharmaceuticals, LLC, today

received expanded labeling from the U.S. Food and Drug Administration (FDA) to

include daily use of INFERGEN (Consensus Interferon) in combination with

ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded

labeling targets hepatitis C patients who need retreatment. In the clinical

trial leading to the expanded labeling, the primary endpoint of increased

sustained virological response (SVR) was achieved demonstrating that INFERGEN

provides a second chance for patients to clear their hepatitis C virus.

“Approximately 50 percent of patients with chronic hepatitis C do not respond to

their initial course of therapy,” stated Dr. Bruce Bacon, the lead investigator

for the registration trial. “The FDA’s recognition of this expanded label allows

patients failing therapy a safe and efficacious retreatment strategy. The

results from this study legitimize how we properly treat these patients helping

them to achieve SVR.”

The data reported and published in Hepatology (2009) from the U.S.-based,

randomized, DIRECT clinical trial (Daily-Dose Consensus Interferon and

Ribavirin: Efficacy of Combined Therapy) led to the approval of the expanded

label. Results from the DIRECT trial had shown that the use of INFERGEN and RBV

is a safe and effective retreatment strategy for patients failing initial

therapy with PEG-IFN/RBV. This was especially apparent with interferon-sensitive

patients with lower baseline fibrosis scores. In fact, up to 38 percent of

non-cirrhotic patients (in the 15mcg arm) who were sensitive to Peg-IFN/RBV and

who did not modify their INFERGEN and RBV dosages achieved an SVR. Additionally,

patients with cirrhosis were less likely to benefit from retreatment with

INFERGEN and RBV unless they displayed previous interferon sensitivity or at

least 1-log10 drop in viral levels on prior therapy.

“The expanded labeling for INFERGEN is a significant step forward for

retreatment of hepatitis C patients who deserve a second chance to overcome

their HCV,” stated Kerrish, R.Ph, M.B.A., President of Three Rivers

Pharmaceuticals, LLC. “Our hope is that INFERGEN will become the standard of

care for the retreatment of chronic hepatitis C patients.”

Three Rivers Pharmaceuticals, LLC is expanding its INFERGEN and hepatitis C

education efforts via physician outreach and online patient support programs. An

instructional video and guide about proper at-home injections of INFERGEN, tips

for patient compliance, access to reimbursement specialists and a hotline

staffed by nurse counselors are available at www.infergen.com.

About Consensus Interferon (INFERGEN®)

Consensus Interferon or INFERGEN is a unique, bio-optimized, selective and

highly potent type 1 interferon alpha. Because it is a bioengineered interferon,

it is also different from other interferons currently used to treat chronic

hepatitis C virus. INFERGEN is indicated for the treatment of chronic hepatitis

C infection in patients 18 years of age or older with compensated liver disease.

Additionally, INFERGEN is now FDA approved for daily use in combination with

ribavirin in HCV patients who need retreatment. More prescribing information

regarding INFERGEN, including the product’s safety profile and the box warning

for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and

infectious disorders, are available by visiting the product website at

www.infergen.com.

About Hepatitis C

Hepatitis means inflammation of the liver. Hepatitis C is a liver disease that

results from infection with the hepatitis C virus. It can range in severity from

a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C

virus can be either " acute " or " chronic. " Acute hepatitis C virus infection is a

short-term illness that occurs within the first 6 months after someone is

exposed to the hepatitis C virus. Seventy five-85% of acute HCV infections

become chronic HCV infections. Chronic hepatitis C virus is a serious disease

than can result in long-term health problems, or even death. There is currently

no vaccine available for prevention of hepatitis C virus.

About Three Rivers Pharmaceuticals

Three Rivers Pharmaceuticals is a privately held company headquartered in

Warrendale, Pennsylvania and focuses on specialized therapies including

hepatitis C therapies. With its unique experience and understanding of the

complex challenges of treating chronic, difficult diseases, Three Rivers is a

valuable partner in the healthcare community. The company's mission is to

develop, manufacture, and market the highest quality branded and generic drug

products for patients with serious diseases. More information on the company is

available at www.3riverspharma.com.

Contacts

Pascale Communications, LLC

Audra B. Friis

631-462-1726 (office)

917-519-9577 (mobile)

audra@...

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