Salix Pharmaceuticals (SLXP)

Website: www.Salix.com

"Advancing Treatment in Gastroenterology"

• Reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

• SLXP focuses on late-stage products serving to reduce the risk, time and expense invested compared to the investment typically associated with the research and early development phases of pharmaceutical products.

• Salix focuses its investment of time and energy on maximizing the commercial potential of their products. Operations such as manufacturing are outsourced. Resources are not tied up in “bricks and mortar” but rather invested in activities directed toward increasing product sales.

• Salix has a direct sales force to promote its products to the fastest-adopting, highest-prescribing physicians in the U.S. responsible for treating gastrointestinal disease. 

• SLXP plans to grow its business by adding new products to its portfolio by: expanding the indications for current products, in-licensing or acquiring new products and Co-promoting selected third-party products.

• The U.S. represents the largest pharmaceutical market in the world. Salix markets its products to gastroenterologists in the U.S. through its own specialty sales force. Saliz will form its own strategic alliances to market  products outside the U.S. in order to avoid the significant costs, risks and infrastructure inherent in assembling an international sales force.

Recent News and Press Releases

XIFAXAN® 550 mg Tablets Demonstrate Significant Reduction of Risk for Episodes of Overt Hepatic Encephalopathy According to Findings Published in The New England Journal of Medicine

FDA Advisory Committee Recommends Approval Of XIFAXAN® (rifaximin) Tablets, 550 Mg for Maintenance of Remission of Hepatic Encephalopathy

Salix Pharmaceuticals to Present at Three Investment Conferences in March

For the latest Quote and News on SLXP Click Here.

Products

Metozolv ODT

Metozolv ODT (metoclopramide HCl) is the first available orally disintegrating tablet that provides convenient relief of diabetic gastroparesis and refractory GERD.Metozolv ODT combines the reliability of traditional metoclopramide with the convenience of a tablet that rapidly melts on the tongue.

Metozolv ODT features Zydis technology, an innovative formulation that makes it possible for Metozolv ODT to be delivered as an orally disintegrating tablet that rapidly melts on the tongue. That means you can conveniently take Metozolv ODT when liquid is not available or if you have difficulty swallowing.

Numerous clinical studies have proven that metoclopramide, the active ingredient in Metozolv ODT, is effective for treating diabetic gastroparesis and refractory GERD. The digestive systems in people with diabetic gastroparesis and refractory GERD may have trouble moving food out of the stomach or have difficulty keeping acidic stomach contents from entering the esophagus. This can cause a variety of uncomfortable symptoms including nausea, vomiting, bloating, heartburn, regurgitation, and chest pain. To relieve these symptoms, metoclopramide works in the digestive system by promoting muscular contractions in the esophagus, stomach, and small intestine.

Apriso

Salix Pharmaceuticals introduces APRISO (mesalamine) 0.375 g for the treatment of ulcerative colitis (UC). APRISO is the first and only once–daily –ASA featuring Intellicor delayed and extended delivery – for the successful long–term management of UC.

APRISO begins releasing mesalamine at a pH ≥ 6 and gradually distributes mesalamine throughout the entire colon. APRISO has been shown to be effective in helping UC patients stay in remission for up to six months.

COLAZAL

COLAZAL (balsalazide disodium) is a treatment for a condition called ulcerative colitis–or UC for short. COLAZAL is approved by the FDA to deliver relief of symptoms caused by mildly to moderately active ulcerative colitis.

UC is 1 of 2 types of inflammatory bowel disease (IBD), the other being Crohn's disease. Ulcerative colitis is characterized by inflammation and ulceration of the lining of the colon. The cause is unknown, and it usually occurs in people aged 15 to 35 years, with a second peak among people aged 55 to 60 years. UC symptoms may include bloody diarrhea, rectal bleeding, bowel urgency, abdominal pain and tenderness, nausea and vomiting, loss of appetite, weight loss, and fever.

COLAZAL is a UC treatment that has been clinically proven to provide complete relief of symptoms in an average of 10 days. COLAZAL is unlike other kinds of ulcerative colitis medications because it delivers 99% of its active ingredient (balsalazide disodium) to the colon to start working to relieve UC symptoms.

Xifaxan

A minimally absorbed (<0.4%) enteric antibiotic that targets noninvasive strains of Escherichia coli

• Minimal net impact on gut flora

• Tolerability and safety comparable to placebo

• No clinically relevant resistance when used as directed

• 20+ years of global use

Proven to treat travelers’ diarrhea

• XIFAXAN is indicated for the treatment of traveler's diarrhea caused by noninvasive strains of Escherichia coli in patients at least 12 years of age

• Works in a unique way to target E. coli—halts overgrowth without overkill

• E. coli is the most common cause of travelers’ diarrhea in Latin America, the Caribbean, and Africa

• Stopped TD symptoms in 79.2% of patients

• Approved in 33 countries, more than 500 clinical citations

Pepcid

Salix is now the exclusive source for PEPCID (famotidine) Oral Suspension. PEPCID is used for several gastrointestinal indications including the treatment of duodenal ulcer, benign gastric ulcer and gastroesophageal reflux disease (GERD). Famotidine is a type of antihistamine that blocks the release of stomach acid.

Pepcid (famotidine) for Oral Suspension is indicated for the short-term treatment of gastroesophageal reflux disease (GERD), active duodenal ulcer, active benign gastric ulcer, erosive esophagitis due to GERD, and peptic ulcer disease. 

OsmoPrep

The latest advancement in colonoscopy preparation is OsmoPrep (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) – The Tablet Prep. Approved by the FDA in March 2006 for cleansing the colon in preparation for colonoscopy in adults, OsmoPrep is unique among bowel preps. OsmoPrep consists of a series of pills instead of a liquid prep and is taken with the clear liquid of your choice. It tastes like the liquid you choose to take it with – not like an unpleasant liquid bowel prep.

Most colon cancer is preventable or treatable if caught in its earliest stages. However, less than half of Americans who should be getting screened for colon cancer actually undergo a colonoscopy or screening by another method.1 The greatest barrier for most individuals is the bowel prep itself. OsmoPrep is a tolerable tablet alternative to traditional liquid bowel preps. In clinical trials, 95% of OsmoPrep users indicated that they would choose to take it again.3

MoviPrep - Bowel Prep

MoviPrep is a prescription medicine a person drinks before a colonoscopy. The liquid, polyethylene glycol (also called PEG), flushes waste from the colon, allowing the physician to get a clear view of the colon wall during the colonoscopy procedure. Drinking this liquid before the colonoscopy is called the bowel preparation (bowel prep) or colonoscopy preparation (colon prep).

There are several liquid PEG bowel preps available, but many require people to drink 4 liters of the prep solution. MoviPrep is different, because it only requires them to drink 2 liters of the prep solution. While it requires the patient to drink less solution, MoviPrep is similar in its effectiveness to 4 liter liquid preps.

Many PEG colon–prep regimens are plagued by bad–tasting liquids, but 86% of people who took MoviPrep rated the taste "acceptable" or "satisfactory."MoviPrep also does not require the use of bisacodyl tablets, thus avoiding bisacodyl–associated abdominal cramping.

Visicol

VISICOL (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are available to adults 18 years of age and older for bowel preparation prior to colonoscopy. These tasteless tablets may be taken with any clear liquid. A study by the Mayo Clinic indicated that the unpalatable taste of liquid bowel preparations is a leading deterrent to patients consenting to colonoscopy.

Anusol

Anusol-HC is available as either a 2.5% hydrocortisone cream or a 25 mg hydrocortisone acetate suppository to provide soothing relief from anal itching, burning, and inflammation. Applied as a thin film to the affected area using a convenient, easily inserted dispensing cap, the concentrated cream forms a protective coating over tissues with no greasy build-up. Providing symptom relief as the product is absorbed, the suppository offers easy, consistent administration for inflammatory processes in the anorectum that require a mild suppository.

Proctocort

PROCTOCORT is available either as a 1% hydrocortisone cream or a 30 mg hydrocortisone acetate suppository to provide soothing relief from anal itching, burning, and inflammation. The cream is a nonstaining, water miscible preparation with a mild unique acid mantle base. The suppository provides convenient, accurate, and consistent dose administration for problems requiring a higher potency agent.

Azasan

Salix is now the exclusive source for AZASAN (azathioprine tablets) 75 mg and 100 mg. AZASAN is a potent immunosuppressive antimetabolite indicated as an adjunct therapy for the prevention of rejection in renal homotransplantations and for the management of severe active rheumatoid arthritis. Immunosuppressants such as azathioprine are effective in helping to control the inflammatory process and thus reducing the need for chronic steroid treatment and its related adverse events.

AZASAN (azathioprine tablets) 75/100 mg is indicated as an adjunct for the prevention of rejection in renal homotransplantations, and also for the management of active rheumatoid arthritis to reduce signs and symptoms.

Diuril

Salix is now the exclusive source for DIURIL (chlorothiazide) Oral Suspension. DIURIL is indicated for the treatment of hypertension and also as adjunctive therapy in edema associated with congestive heart failure, cirrhosis of the liver, corticosteroid and estrogen therapy, and kidney disease. When used for hypertension, it can be used alone or with other hypertension medications. Chlorothaizide is a diuretic that prompts the body to eliminate excess fluid.

Pipeline

Balsalazide Tablets

In July 2007, Salix Pharmaceuticals, Inc. submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) seeking approval to market a tablet formulation of balsalazide disodium, with a 3.3g twice daily dosing regimen, for the treatment of mildly to moderately active ulcerative colitis. Balsalazide 1.1g tablets are an advanced formulation of the azo–bonded 5–ASA prodrug, balsalazide disodium, specifically designed for 99% delivery directly to the colon.

Budesonide

Salix has recently obtained a license from Dr. Falk Pharmaceuticals (Germany) to develop its family of budesonide products in the United States, which includes a patent–protected gastro–resistant capsule and a rectal foam. Salix is currently evaluating the budesonide foam preparation for the treatment of mild to moderately active forms of distal ulcerative colitis, specifically ulcerative colitis affecting the rectum and sigmoid colon.

Crofelemer

Salix recently has acquired rights to crofelemer from Napo Pharmaceuticals, Inc. Crofelemer currently is being investigated as an anti–secretory anti–diarrheal agent for the treatment of chronic diarrhea in people living with HIV, or HIV–associated diarrhea. Crofelemer is a locally–acting, minimally–absorbed product which is believed to possess dual mechanisms of action that may be effective in treating both acute infectious diarrhea and chronic diarrhea.

Mesalamine Granules

Granulated mesalamine is an advanced formulation of 5–ASA with both a delayed and extended release system that delivers mesalamine directly to the colon with minimal systemic exposure and once–daily dosing. In October 2008, Salix was granted approval for the maintenance of remission of ulcerative colitis (trade name: APRISO).

Metoclopramide

In September, 2007, Salix expanded its product portfolio through the acquisition of a fast–dissolving formulation of metoclopramide. Wilmington Pharmaceuticals, the licensor, submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) seeking approval to market an Oral disintegrating tablet (ODT) formulation of metoclopramide, for the treatment of short–term therapy (4–12 weeks) for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Upon approval from the FDA, Salix will have the exclusive worldwide rights to this new ODT metoclopramide formulation.

Rifaximin

Rifaximin, a nonsystemic (<0.4% of the drug absorbed into the bloodstream), gastrointestinal–selective, oral antibiotic, represents Salix's next effort to provide products that meet the needs of gastroenterologists and their patients. The U.S. Food and Drug Administration (FDA) granted marketing approval on May 25, 2004 for XIFAXAN tablets 200 mg for the treatment of travelers' diarrhea caused by noninvasive strains of E. coli in patients 12 years of age and older. Salix is evaluating the utility of rifaximin for the prevention of travelers' diarrhea.

Salix obtained the North American licensing rights to rifaximin from Alfa Wassermann SpA (Italy). The product has been marketed in Italy (Normix and Rifacol) since 1988 and is now approved in 24 countries. Over 432 clinical papers, abstracts and textbook chapters discussing the use of rifaximin for treatment of a broad range of GI disorders have been published to date. These GI disorders include travelers' diarrhea, infectious diarrhea, hepatic encephalopathy, Crohn's disease, ulcerative colitis, irritable bowel syndrome, pouchitis, small–bowel bacterial overgrowth, H pylori/peptic ulcer disease, prophylaxis for GI surgery, and diverticular disease.

Salix is conducting clinical development studies to assess the utility of rifaximin for the treatment of Hepatic Encephalopathy and Irritable Bowel Syndrome.

Three Month Chart

Management

Randy W. Hamilton - Founder

Mr. Hamilton is a founder of Salix Pharmaceuticals, Inc., and served as Chairman of the Board, President, and Chief Executive Officer from the company's inception through November 1999. He remained Executive Chairman of the Board until June 2002. Prior to founding Salix, Mr. Hamilton was Manager of Business Development for California Biotechnology, Inc. (now Scios, Inc.), and responsible for the commercial aspects of several of the company's development projects, including human lung surfactant, drug delivery systems, genetic marker diagnosis, and growth factors. He was also responsible for establishing strategic relationships with the Japanese pharmaceutical industry. Before joining California Biotechnology, Mr. Hamilton was Director of Strategic Planning and Business Development for SmithKline Diagnostics, then a division of SmithKline Beckman, where he also held positions in market research and marketing information services. Mr. Hamilton received a B.A. in sociology from the California State University, Long Beach. In 1998, Mr. Hamilton was named "Man of the Year" by the Crohn's and Colitis Foundation of America, Bay Area chapter.

Lorin K. Johnson, Ph.D. - Founder and Chief Scientific Liaison

Dr. Johnson is a founder of Salix and serves as Chief Scientific Liaison. Previously, he served as Senior Vice President and Chief Scientific Officer from November 1999 through September 2002. Prior to that, he served as Vice President of Research from inception and was a member of the Company's Board of Directors from inception to June 2000. Prior to founding Salix, Dr. Johnson served as Director of Scientific Operations and Chief Scientist at California Biotechnology, Inc., (now Scios, Inc.), where he headed research on anti-inflammatory therapeutics. Prior to joining California Biotechnology, Dr. Johnson was an Assistant Professor of Pathology at Stanford University Medical Center. Dr. Johnson is the co-author of 75 journal articles and book chapters and is the co-inventor on 18 issued patents. Dr. Johnson received his Ph.D. from the University of Southern California and was a post-doctoral fellow at the University of California, San Francisco. 

Contacts

Salix Pharmaceuticals

1700 Perimeter Park Drive
Morrisville, NC 27560-8404
Phone: 919-862-1000
Fax: 919-862-1095

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