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TMCNet:  Fulyzaq® (crofelemer) 125 mg Delayed-Release Tablets Significantly Improves Noninfectious Diarrhea in Adult Patients Living with HIV on ART Therapy

[January 14, 2014]

Fulyzaq® (crofelemer) 125 mg Delayed-Release Tablets Significantly Improves Noninfectious Diarrhea in Adult Patients Living with HIV on ART Therapy

RALEIGH, N.C. --(Business Wire)--

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that HIV Clinical Trials, an international, peer-reviewed journal focused on human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) research, published a study that supports the efficacy and safety of Fulyzaq® (crofelemer) for the treatment of noninfectious diarrhea caused by anti-retroviral therapy (ART) in adult patients with HIV. The Antidiarrhea Therapy in HIV Disease-Emerging Treatment Concepts (ADVENT) trial concluded that Fulyzaq provides significant improvement in the symptomatic relief of noninfectious diarrhea with a safety profile similar to placebo and with no negative impact on clinical immune parameters (HIV viral load and CD4+ cell count). The study appears in the November /December issue of HIV Clinical Trials.

"Diarrhea can be an unfortunate and persistent occurrence for patients living with HIV who are on ART therapies," said Rodger MacArthur, M.D., professor of medicine at Wayne State University, Division of Infectious Diseases and lead investigator. "The ADVENT trial showed that Fulyzaq (crofelemer) significantly improved diarrhea without negatively impacting ART. This is an important advancement in treatment, as Fulyzaq is the only FDA-approved option for relief of noninfectious diarrhea specifically for people living with HIV."

The ADVENT trial was a randomized, double-blind, phase 3 trial that used a two-stage design to determine optimal dose and evaluate Fulyzaq for the treatment of noninfectious diarrhea in HIV positive patients. Under the placebo-controlled method, the study evaluated 374 patients and revealed that patients achieved significant clinical response when treated with Fulyzaq 125 mg delayed-release tablets compared to the placebo (17.6% vs 8.0%, one-sided, P = .01). Additionally, Fulyzaq was minimally absorbed, well tolerated, did not negatively impact ART efficacy, and had a safety profile comparable to placebo.

"We are excited that the leading peer-reviewed journal HIV Clinical Trials highlights the ADVENT trial that demonstrates the efficacy and safety of Fulyzaq," said Bill Forbes, PharmD, Executive Vice President, Medical, Research and Development and Chief Development Officer, Salix. "It is our hope that increasing knowledge about diarrhea treatment options will enable patients living with HIV to start the dialogue with healthcare providers for managing this often under-discussed and, therefore, undertreated condition."

Fulyzaq acts as an anti-secretory, anti-diarrheal agent that works locally in the gastrointestinal (GI) lumen and exhibits minimal systemic absorption. It normalizes the flow of water in the GI tract to relieve diarrhea in people taking ART. Fulyzaq is derived on a sustainable basis from the Croton lechleri plant, native to northwestern South America. The ADVENT trial led to the Food and Drug Administration approval of Fulyzaq in December 2012. Visit www.fulyzaq.com for more information. For more details regarding the article, visit www.hivclinicaltrials.com.


Indication for FULYZAQ®

FULYZAQ® is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy

Important Safety Information about FULYZAQ®

FULYZAQ® (crofelemer) delayed-release tablets should not be used for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting FULYZAQ. If infectious etiologies are not considered, and FULYZAQ is initiated based on a presumptive diagnosis of noninfectious diarrhea, then there is a risk that patients with infectious etiologies will not receive the appropriate treatments, and their disease may worsen.

Based on animal data, FULYZAQ may cause fetal harm. Safety and effectiveness of FULYZAQ have not been established in patients less than 18 years of age.

In clinical studies, the most common adverse reactions (occurring in =3% of patients and at a rate greater than placebo) were upper respiratory tract infection, bronchitis, cough, flatulence, and increased bilirubin.

About FULYZAQ®

FULYZAQ® is derived on a sustainable basis from the Croton lechleri plant, native to northwestern South America. FULYZAQ ™ acts as an anti-secretory, anti-diarrheal agent that works locally in the GI lumen and exhibits minimal systemic absorption. At the recommended dose of one 125 mg delayed-release tablet taken orally, twice daily, FULYZAQ ™ works to inhibit both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (C1-) channel, and the calcium-activated C1- channels (CaCC).

Inhibiting CFTR and CaCC reduces the secretion of chloride ions, along with the water that enables their transport, out of the circulatory system and into the intestinal lumen. The secretion of chloride ions has been shown to cause diarrhea, with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency.

Salix obtained rights to crofelemer under license from Napo Pharmaceuticals, Inc.

About HIV/AIDS-Associated Diarrhea

Diarrhea remains a common problem for patients with HIV/AIDS that may lead to discontinuation or premature switching of antiretroviral therapy (ART). Currently it is estimated that approximately 1.2 million persons are living with HIV infection in the United States. Additionally, it is estimated that approximately 135,000 - 270,000 persons on anti-retroviral therapy (ART) suffer from noninfectious diarrhea.

About Salix

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription products and medical devices for the prevention and treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and market them through the Company's gastroenterology specialty sales and marketing team.

Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP."

For more information, please visit our Website at www.salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (News - Alert) (www.facebook.com/SalixPharma). Information on our Twitter (News - Alert) feed, Facebook page and web site is not incorporated in our SEC filings.

Please Note: The materials provided herein that are not historical facts are or might constitute forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Although we believe the expectations reflected in such forward-looking statements are based on reasonable assumptions, our expectations might not be attained. Forward-looking statements involve known and unknown risks that could cause actual results to differ materially from expected results. Factors that could cause actual results to differ materially from our expectations expressed in the report include, among others: the uncertainty of market acceptance of our products; intense competition, including from generics in an increasingly global market; the uncertainty of obtaining, and our dependence on, third parties to manufacture and sell our products; results of ongoing and any future litigation and investigations; the high cost and uncertainty of the research, clinical trials and other development activities involving pharmaceutical products; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational New Drug Applications; the possible impairment of, or inability to obtain intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global market; general economic conditions and uncertainties, including related to the U.S. government shutdown and its ability to borrow additional funds; and other risk factors detailed from time to time in our other SEC (News - Alert) filings.


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