Salix Announces FDA Acceptance for Filing and Priority Review Designation For XIFAXAN550 sNDA For the Treatment of Non-Constipation Irritable Bowel Syndrome

(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company’s efficacy supplement to the New Drug Application (NDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. Non-constipation irritable bowel syndrome (Non-C IBS) encompasses two of the most common IBS subtypes: patients with diarrhea-predominant symptoms (IBS-D) and patients who suffer from intermittent periods of diarrhea and constipation known as mixed IBS (IBS-M).

“We are pleased with the FDA’s acceptance of the sNDA for XIFAXAN550 and their decision to grant Priority Review for our application”

A Priority Review classification is granted to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this classification, the FDA has issued an action date of December 7, 2010 under the Prescription Drug User Fee Act (PDUFA).

“We are pleased with the FDA’s acceptance of the sNDA for XIFAXAN550 and their decision to grant Priority Review for our application,” said Bill Forbes, Pharm.D., Executive Vice President and Chief Development Officer, Salix Pharmaceuticals. “This review classification signals that the FDA considers that XIFAXAN550 may have the potential to provide a significant advance in the treatment of non-constipation irritable bowel syndrome. We believe the availability of XIFAXAN550 has the potential to change the treatment paradigm for Non-C IBS. Today’s news marks a milestone for Salix, XIFAXAN550 and patients suffering from this widespread condition.”

About Irritable Bowel Syndrome (IBS) and Non-Constipation Irritable Bowel Syndrome (Non-C IBS)

IBS affects approximately 15 percent of or, potentially, over 30 million adults in the United States and is among one of the most common, chronic conditions. IBS includes altered bowel habits with bloating, abdominal pain and discomfort. Non-constipation irritable bowel syndrome (Non-C IBS) encompasses two of the most common IBS subtypes: patients with diarrhea-predominant symptoms (IBS-D) and patients who suffer from intermittent periods of diarrhea and constipation known as mixed IBS (IBS-M). Among other contributors, recent science has shown that alterations in gut flora/bacteria have been identified as a potentially important contributor to the pathophysiology of IBS. The Company now estimates the U.S. commercial opportunity represented by the non-constipation IBS market to be approximately $7 billion in peak year.

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St. John's Wort Not Helpful Treatment for Irritable Bowel Syndrome, Mayo Clinic Researchers Say

A Mayo Clinic research study published in the January issue of The American Journal of Gastroenterology finds that St. John's wort is not an effective treatment for irritable bowel syndrome (IBS). While antidepressants are frequently used to treat IBS, to date, no study has examined the success of using the herbal supplement St. John's wort in treating IBS.

"Our study investigated if herbal antidepressants such as St. John's wort could benefit irritable bowel disease patients," says Yuri Saito, M.D., M.P.H., a gastroenterologist and lead physician scientist on the study. "Several of the chemical neurotransmitters that are in the brain are also in the colon. Therefore, it's been thought that antidepressants may affect sensation in the colon in a similar way to how they affect sensation in the brain. Our goal was to evaluate the usefulness of St John's wort in treating IBS."

In this placebo-controlled trial, 70 participants with IBS were randomized where half the patients received St. John's wort and the other half received a placebo for three months. In all, 86 percent of the participants were women, and the median age was 42 years. After three months of observing symptoms such as stomach pain, diarrhea, constipation and bloating, Mayo researchers found that the placebo group had a better response than the group taking the herbal supplement, St. John's wort.

"Because people tend to struggle with IBS for several years, patients are really looking for inexpensive, over-the-counter treatments such as St. John's wort," says Dr. Saito. "Unfortunately, our study showed that St. John's wort was not successful in helping IBS patients."

St. John's wort is an herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes. Research has shown it to be as effective as conventional, prescription anti-depressants in treating mild to moderate depression.

"The challenge with IBS is that there is no cure, no one treatment tends to be wholly effective and some treatments come with significant side effects," explains Dr. Saito. "However, well-designed studies of herbal supplements are important so that physicians and patients can make informed decisions about which supplements to recommend or try. Studies of alternative treatments are generally lacking and patients are forced to use a "trial and error" approach to over-the-counter treatments for their IBS."

IBS is a common disorder that affects the colon and commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. Approximately 58 million people struggle with IBS, mostly women.

Each year, Mayo Clinic physicians treat thousands of people with IBS. Read more information on treatment for irritable bowel syndrome at Mayo Clinic.

Mayo Clinic's Division of Gastroenterology and Hepatology has been ranked #1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 20 years ago.

Other members of the Mayo Clinic research team included Enrique Rey, M.D.; Ann Almazar-Elder; W. Scott Harmsen; Alan Zinsmeister, Ph.D.; G. Richard Locke , M.D.; and Nicholas Talley, M.D., Ph.D.
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The Kenneth Rainin Foundation Announces $100,000 Innovator Awards Program for Inflammatory Bowel Disease (IBD) Research

/PRNewswire/ -- The Kenneth Rainin Foundation announced today its new Innovator Awards Program for Inflammatory Bowel Disease. The Program is designed to accelerate the pace of discovery in IBD research. Approximately four million people worldwide suffer from some form of IBD and most are diagnosed between the ages of 20 and 40.

"Launching the Kenneth Rainin Foundation's Innovator Awards Program for IBD research is very exciting for all of us," said Jen Rainin, president of the Kenneth Rainin Foundation. "Our Program is unique in that it encourages investigators from all scientific disciplines and from any non-profit research institution to collaborate to explore bold and innovative ideas that can expand our understanding of IBD, which, in turn, will have a major impact in finding a cure for IBD."

Jen Rainin is the daughter of the late founder, Kenneth Rainin, who suffered greatly from IBD. To further his memory and accomplish the Foundation's mission of no one suffering from IBD, the Innovator Awards Program is focused on finding applicants with diverse backgrounds who can help build a creative, conceptual paradigm for IBD with emphasis on the importance of nurturing interdisciplinary collaboration between fields. Alternative approaches that are nutrition-based or holistic in nature may also play an important role in our research.

Initial one-year grants of $100,000 will be awarded once annually. The first round of applications will be accepted February 15 - March 15, 2010. Applications must be submitted online, and selected applicants will be notified in July, 2010. Applications will be initially reviewed by our Scientific Advisory Board. Based on their recommendations, final selections will be made by the Foundation's Board. Successful projects will be eligible for significant multi-year funding based on the initial year's proof of principle work.

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the gastrointestinal tract. The main forms of IBD are Crohn's Disease and ulcerative colitis. Symptoms include pain, bleeding and debilitation. Current therapeutic options for patients are largely limited to the use of anti-inflammatory steroids applied either systemically or locally for the treatment of the symptoms. Removal of the colon is the only cure at this time.

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Alte Biosciences Files Patent for New Inflammatory Bowel Disease Drugs

(BUSINESS WIRE)--Alte Bioscience, Inc., a development stage pharmaceutical company, is pleased to announce the filing of a provisional patent for a new class of drugs that may benefit patients with inflammatory bowel disease. This is the latest in a series of pharmaceutical inventions held by Alte Biosciences, adding to its portfolio of patents of drugs for the treatment of late onset depression and innovative systems for drug delivery, packaging, and manufacturing. The composition of matter in the new filing was discovered in collaboration with PharmaDirections, Inc.

Dr. Richard Soltero and Dr. Bruce Rehlaender of PharmaDirections are the co-inventors on the patent application entitled “A COMPOSITION AND METHOD FOR THE TREATMENT OF A GASTROINTESTINAL DISORDER.” PharmaDirections, under contract to Alte Biosciences, developed these innovative molecules to treat inflammatory bowel disease, (IBD) - a chronic syndrome that afflicts the digestive tract and is usually defined by an uncontrolled inflammatory response at the gut epithelial layer. Each molecule consists of two mutual pro-drugs that release medicines that are well known in the treatment of IBD. PharmaDirections will develop specialized formulations to deliver these molecules in ways that will improve their anti-inflammatory, anti-microbial and cytoprotective properties.

“We are pleased that our research efforts resulted in the identification of new chemical entitles that have the potential to benefit patients with inflammatory bowel disease,” stated Dr. Thomas Colatsky, CSO of Alte Biosciences. “Our ability to harness the talent and skills of PharmaDirections’ scientific staff in our pipeline development efforts has paid significant dividends, as evidenced by this latest discovery.”

Inflammatory bowel disease affects nearly 2 million people worldwide, and has two recognized manifestations: Crohn’s disease and ulcerative colitis. Crohn’s disease, also known as regional enteritis, can occur anywhere in the gastrointestinal tract from mouth to anus. Most commonly, it is found in the terminal ileum/proximal colon and is characterized by distinct ulcerations that run deep into the epithelial tissue. Ulcerative colitis is only found in the colon, with the greatest majority of patients exhibiting effects in the terminal colon. The patent filed by Alte Biosciences claims separate compositions of matter for treating each of these disease states. These treatments offer the possibility of improved efficacy by targeting drug to the sites of inflammation, while reducing the prevalence of gastrointestinal side effects associated with current treatments.

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FDA Approves Entereg to Help Restore Bowel Function Following Surgery

The U.S. Food and Drug Administration approved Entereg (alvimopan) May 20, 2008, to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.

"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."

FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.

In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.

Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.

The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.

The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).

FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.

Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Adolor Corporation, the manufacturer of Entereg, is based in Exton, PA. Adolor and GlaxoSmithKline, London, England, are collaborating on the development and marketing of Entereg.