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FDA Approves Fulyzaq™ (Crofelemer) 125 mg Delayed-Release Tablets for the Symptomatic Relief of Diarrhea in Patients with

  FDA Approves Fulyzaq™ (Crofelemer) 125 mg Delayed-Release Tablets for the
  Symptomatic Relief of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral
  Therapy (ART)

 Fulyzaq™ Offers a Unique Treatment for ART-Related Diarrhea in HIV Positive
                                   Patients

Business Wire

RALEIGH, N.C. -- January 2, 2013

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and
Drug Administration has approved Fulyzaq™ (crofelemer) 125 mg delayed-release
tablets for the symptomatic relief of non-infectious diarrhea in adult
patients with human immunodeficiency virus (HIV)/ acquired immune deficiency
syndrome (AIDS) on anti-retroviral therapy (ART).

“The FDA approval of Fulyzaq™ is a significant step forward in addressing the
unmet medical need of people with HIV/AIDS on ART who experience
non-infectious diarrhea, which often can lead to reduced treatment
compliance,” said Carolyn Logan, President and CEO of Salix. “Since the
introduction of antiretroviral therapy, people with HIV are living longer and
thus medication compliance and tolerability as well as quality of life issues
are increasingly important components of their overall health outlook.
Diarrhea negatively affects quality of life and is a common reason for
discontinuing or switching ART regimen. Salix’s expertise in gastrointestinal
medicine should position the Company to deliver this much-needed treatment to
HIV patients.”

“Fulyzaq™ is a locally-acting, minimally-absorbed drug which is derived from a
botanical source. Fulyzaq™ is believed to act by blocking chloride secretion
and thus reducing the accompanying high volume water loss as seen in HIV
associated diarrhea. It is this secretion that is believed to lead to diarrhea
with the associated symptoms of dehydration, electrolyte imbalance, abdominal
cramping, urgency and increased frequency. FULYZAQ™ is believed to improve HIV
associated diarrhea via dual mechanisms of action with inhibition of both CFTR
(Cystic Fibrosis Transmembrane Conductance Regulator Protein) and CaCC
(calcium-activated chloride channel) resulting in reduced chloride ion
secretion into the GI lumen,” said Bill Forbes, Pharm. D., Executive Vice
President, Medical, Research and Development, and Chief Development Officer,
Salix. “Data support the use of Fulyzaq™ as an orally administered,
anti-secretory anti-diarrheal agent that may provide relief to patients
through the inhibition of chloride secretion into the gut. In addition, the
Phase 3 study showed that Fulyzaq™ did not influence the efficacy or safety of
the patients HIV medications.”

The FDA approval of Fulyzaq™ is based on a randomized, double-blind,
placebo-controlled (one month) and placebo-free (five month), multi-center
study of 374 HIV-positive patients on ART, with a history of diarrhea for one
month or more. The primary efficacy endpoint was the proportion of patients
experiencing less than or equal to two watery bowel movements per week, during
at least two of the four weeks of the placebo-controlled phase of the study.
Patients who received concomitant anti-diarrheal medications or opiates were
counted as clinical non-responders.

Data demonstrated that a significantly larger proportion of patients taking
Fulyzaq™ 125 mg twice daily experienced clinical response compared with
patients in the placebo group. In addition, statistically significant
reductions from baseline to the end of the double-blind period also were
observed for the number of watery bowel movements per day, and daily stool
consistency score, among patients taking Fulyzaq™ compared with placebo.
Further, the Fulyzaq™ treatment effect for clinical response (125 mg twice
daily vs. placebo) was similar in subgroup analyses based on duration of
diarrhea, baseline number of daily watery bowel movements, use of protease
inhibitors (PI), and CD4 cell count. The most common adverse reactions in the
study were respiratory tract infection, bronchitis, cough, flatulence, and
increased bilirubin.

Patents for Fulyzaq™ should provide intellectual property protection to 2018.
With this approval, Fulyzaq™ is eligible for market exclusivity for five years
as a new molecular entity in the United States. Because Fulyzaq™ is a new
molecular entity Salix believes the product may be entitled to patent term
restoration. Fulyzaq™ is a first-in-class gastrointestinal agent of botanical
origin. Fulyzaq™ is not available synthetically and Salix has the right to the
manufacturing process for producing Fulyzaq™ from the biologic source.

Salix currently plans on making Fulyzaq™ accessible to patients with HIV/AIDS
on anti-retroviral therapies suffering from non-infectious diarrhea in early
2013.

Important Safety Information for Fulyzaq™

Fulyzaq™ (crofelemer) delayed-release tablets should not be used for the
treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea
before starting crofelemer. If infectious etiologies are not considered, there
is a risk that patients with infectious etiologies will not receive the
appropriate therapy and their disease may worsen.

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

About Fulyzaq™

Fulyzaq™ is a first-in-class, gastrointestinal agent 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. Unlike other
anti-diarrheal agents, Fulyzaq™ does not appear to affect gut motility.

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 often
negatively impacts patients’ quality of life and can lead to discontinuation
or premature switching of antiretroviral therapy (ART). Currently it is
estimated that approximately 1.2 million persons aged 13 and older are living
with HIV infection in the United States. Additionally, it is estimated that
approximately 150,000 – 180,000 persons on anti-retroviral therapy (ART)
suffer from non-infectious diarrhea. This condition, in this patient
population, cannot only significantly reduce quality of life but also result
in increased direct and indirect healthcare costs. Additionally, patients
often suffer from weight loss, depression, and reduced social interaction.

About Salix Pharmaceuticals

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

Salix markets XIFAXAN^® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP^® (PEG
3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate
and Ascorbic Acid for Oral Solution), OSMOPREP^® (sodium phosphate monobasic
monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets,
APRISO^® (mesalamine) extended-release capsules 0.375 g, METOZOLV^® ODT
(metoclopramide HCl), RELISTOR^® (methylnaltrexone bromide) Subcutaneous
Injection, SOLESTA^®, DEFLUX^®, FULYZAQ™, PEPCID^® (famotidine) for Oral
Suspension, Oral Suspension DIURIL^® (Chlorothiazide), AZASAN^® (Azathioprine)
Tablets, USP, 75/100 mg, ANUSOL-HC^® 2.5% (Hydrocortisone Cream, USP),
ANUSOL-HC^® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT^® Cream
(Hydrocortisone Cream, USP) 1% and PROCTOCORT^® Suppository (Hydrocortisone
Acetate Rectal Suppositories) 30 mg. Budesonide foam, RELISTOR^® , Lumacan^®
and rifaximin for additional indications are under development.

For full prescribing information and important safety information on Salix
products, including BOXED WARNINGS for OSMOPREP, AZASAN and METOZOLV, please
visit www.salix.com where the Company promptly posts press releases, SEC
filings and other important information or contact the Company at 919
862-1000.

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
(www.facebook.com/SalixPharma). Information on our web site, Twitter feed and
Facebook page is not incorporated in our SEC filings.

Please Note: The materials provided herein contain projections and other
forward–looking statements regarding future events. Such statements are just
predictions and are subject to risks and uncertainties that could cause the
actual events or results to differ materially. These risks and uncertainties
include, among others: market acceptance for approved products; generic and
other competition in an increasingly global industry; post-marketing approval
regulation; and litigation and 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 industry. The reader is referred
to the documents that the Company files from time to time with the Securities
and Exchange Commission.

Contact:

Salix Pharmaceuticals, Ltd.
Adam C. Derbyshire, 919-862-1000
Executive Vice President and Chief Financial Officer
or
G. Michael Freeman, 919-862-1000
Associate Vice President, Investor Relations and Corporate Communications
 
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