News Article | May 9, 2017
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, this week presented clinical data on the effect of linaclotide on abdominal pain in irritable bowel syndrome with constipation (IBS-C) patients and preclinical data on linaclotide’s effect on pain originating in other visceral organs at Digestive Disease Week® (DDW) 2017 in Chicago. Detailed data from a Phase IIb clinical trial evaluating the effects of two investigational delayed release formulations of linaclotide on abdominal pain in adult patients with IBS-C were presented as a late-breaker by Dr. William Chey, University of Michigan. Ironwood previously reported positive topline data for both delayed release formulations in December 2016. In addition, Ironwood and its collaborators delivered oral and poster presentations at DDW regarding a series of preclinical studies suggesting that linaclotide may have effects on pain associated with conditions affecting visceral organs outside of the gastrointestinal tract, such as the bladder or vagina. “ Millions of patients are estimated to suffer from chronic conditions characterized by pain in the abdominal and pelvic regions, and pain is a primary symptom driving patients to seek treatment from a healthcare provider,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “ As we continue to better understand linaclotide’s effect on visceral hypersensitivity, we look forward to further studying its ability to relieve pain in IBS-C, as well as potentially in other conditions such as IBS with diarrhea, IBS-Mixed, ulcerative colitis, diverticulitis, interstitial cystitis/bladder pain syndrome and endometriosis.” Effect of Linaclotide Delayed Release on Abdominal Pain in IBS-C In the Late-Breaking Clinical Science session at DDW, Dr. Chey presented data (poster presentation Tu2031) from a double-blind, placebo-controlled, dose-ranging Phase IIb trial evaluating two investigational delayed release formulations of linaclotide in adult patients with IBS-C. Data from the Phase IIb study of linaclotide delayed release-1 (DR1) demonstrated dose-dependent improvements in abdominal pain as well as in complete spontaneous bowel movements and stool consistency, compared to placebo, across all studied doses. Additionally, improvements in abdominal pain and stool consistency were greater for the DR1 300 mcg dose compared to the 290 mcg immediate release (IR) formulation of linaclotide. Data from the Phase IIb study of linaclotide delayed release-2 (DR2) showed that all studied doses improved abdominal pain and other abdominal symptoms, relative to placebo, with no apparent effect on bowel movement function, as intended. These comparisons reflect numerical differences. Diarrhea was the most common adverse event. Across all DR1 and DR2 dose groups, 0-3% of patients withdrew from the trial due to diarrhea. “ The data from the linaclotide delayed release study represent a significant advance in the GI field and in our understanding of abdominal pain,” said Dr. Chey. “ The DR1 data suggest that delaying delivery of linaclotide to the mid-ileum region of the distal small intestine and colon could improve abdominal pain relief while preserving constipation relief. The DR2 data are also exciting: delaying linaclotide delivery to the ileocecal junction in the colon could improve abdominal pain relief with little to no effect on fluid secretion, which could represent a potential opportunity to treat patients suffering from lower gastrointestinal conditions characterized by abdominal pain.” Ironwood and its U.S. collaboration partner Allergan intend to engage with the U.S. Food and Drug Administration (FDA) to discuss Phase III development plans, with trials in adults with IBS-C expected to begin in the second half of 2017. The companies are evaluating DR2 in adult patients with non-constipation subtypes of IBS, and plan to discuss next steps with the FDA for advancing DR2 into Phase IIb dose-ranging clinical trials. Effect of Linaclotide on Various Models of Visceral Hypersensitivity (Preclinical Data) In preclinical oral and poster presentations, linaclotide’s effects on pain and its potential role in visceral organ cross-sensitization and visceral hypersensitivity were further elucidated. In a poster presentation titled, Linaclotide attenuates visceral organ crosstalk: importance of guanylate cyclase c (GC-C) activation in reversing colonic hypersensitivity induced by urinary bladder hyperpermeability (poster presentation Tu1602), Ehsan Mohammadi, University of Oklahoma Health Science Center, presented preclinical data in a model of colonic hypersensitivity induced by bladder injury, which suggested that oral administration of linaclotide significantly reduced this colonic hypersensitivity, as measured by visceromotor responses (abdominal contractions) to colonic distention and pERK expression (spinal nerve activation). These data suggest that GC-C agonism may be able to affect various abdominal and pelvic area organ pain through visceral organ crosstalk, which is enabled by the fact that multiple organs in this region of the body share sensory peripheral and central innervation pathways. Just as visceral organ cross-sensitization is hypothesized to explain linaclotide’s ability to reduce colonic sensitivity caused by bladder injury, a study by Pei Ge, Ironwood Pharmaceuticals, tested the hypothesis that linaclotide could reduce visceral pain in other pelvic conditions. In a poster presentation titled, Oral administration of the gut-restricted guanylate cyclase-c agonist, linaclotide, reduces endometriosis-induced vaginal hyperalgesia (poster presentation Mo1541), both acute and chronic oral administration of linaclotide significantly reduced vaginal pain in a preclinical model of endometriosis, measured by visceromotor responses to vaginal distension. GC-C expression was detected in the intestine, but not in endometrial cysts and the vagina, suggesting that the effect of linaclotide on visceral pain in this model involves shared nervous pathways between visceral organs. An oral presentation delivered by Stuart Brierley, Ph.D., SAHMRI, Flinders University, Adelaide, SA, Australia, titled Chronic oral administration of linaclotide inhibits nociceptive signaling in response to noxious colorectal distension in a model of chronic visceral hypersensitivity (oral presentation 1098) showed the results of a preclinical study evaluating the effects of chronic oral administration of linaclotide on colonic hypersensitivity caused by colorectal distention. In this study, linaclotide reduced colonic hypersensitivity, as measured by visceromotor responses, and also reversed the sprouting of colonic afferent nerves in the spinal cord, which had sprouted in response to pain stimuli in preclinical models. These data suggest that further study is warranted looking into whether linaclotide has the ability to reduce hypersensitivity in the colon and reverse neuroplasticity within the spinal cord associated with chronic visceral hypersensitivity. Another preclinical study by Dr. Brierley provided additional insight on the mechanism of GC-C agonism in pain reduction by investigating its effects on pain-sensing nerves in the dorsal root ganglia (DRG). In an oral presentation titled, Extracellular cGMP reduces the excitability of sensory dorsal root ganglion neurons via an extracellular mechanism (oral presentation 723), he showed that, in this preclinical study, linaclotide did not directly inhibit DRG neurons, but rather its downstream mediator, cyclic guanosine monophosphate (cGMP), was responsible for decreasing activity of these pain-sensing nerves. The study also showed that extracellular cGMP did not enter DRG neurons, lending further support to the hypothesis that cGMP’s inhibitory effect is mediated via an extracellular, rather than intracellular, mechanism. About Linaclotide Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that binds to the GC-C receptor locally, within the intestinal epithelium, and is thought to work in two ways, based on nonclinical studies. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit, as well as a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is marketed by Ironwood and Allergan plc in the United States as LINZESS® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), with nearly 1.5 million unique patients in the United States having filled nearly 7.5 million linaclotide prescriptions since launch, according to QuintilesIMS. In Europe, Allergan markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C. Ironwood also has partnered with AstraZeneca for development and commercialization of linaclotide in China and with Allergan for development and commercialization of linaclotide in all other territories worldwide. LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). About Ironwood Pharmaceuticals Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology company focused on creating medicines that make a difference for patients, building value for our fellow shareholders, and empowering our passionate team. We are commercializing two innovative primary care products: linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and lesinurad, which is approved to be taken with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with uncontrolled gout. We are also advancing a pipeline of internally and externally generated innovative product candidates in areas of significant unmet need, including uncontrolled gastroesophageal reflux disease and vascular and fibrotic diseases. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations. Forward-Looking Statement This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the development and commercial potential of linaclotide and the drivers, timing, impact and results thereof; market size, prevalence, and opportunity; the potential indications for, and benefits of, linaclotide; anticipated preclinical, clinical and regulatory activities and developments (including discussions with the FDA) and the design, timing and results of clinical and preclinical studies; and the potential for, and timing of, regulatory submissions and approvals for linaclotide. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; efficacy, safety and tolerability of linaclotide; decisions by regulatory authorities; and the risks listed under the heading "Risk Factors" and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, and in our subsequent SEC filings. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements.
News Article | May 10, 2017
Additional analysis of only the IBS-M patients in IBSREST™ demonstrated that there was a statistically significant reduction vs. placebo in the Total IBS Symptom Score (TISS) at 4 weeks. TISS is a composite score of the eight individual IBS symptoms. When evaluating the individual symptoms at 4 weeks, there was a favorable reduction on both major types of bowel dysfunction (diarrhea and constipation) and favorable reduction in viscerosensory symptoms, including abdominal pain and other IBS symptoms. IBS-M is a challenging and difficult to diagnose and treat sub-type of IBS and represents an area of high unmet need. Most individuals with IBS (74 percent of those medically diagnosed and 63 percent not medically diagnosed) reported variable symptoms of constipation and diarrhea.1 There are no FDA-approved interventions for IBS-M. It has been posited that l-Menthol, the principal component found in IBgard®, works via several different mechanisms of action in the gut, including exerting anti-inflammatory, smooth muscle relaxing and anti-nociceptive effects. Immune-activated gut barrier disturbance in the small intestine is believed to be another possible source of IBS-related altered stool form, as well as abdominal pain and other IBS symptoms. IBgard® is specially formulated for the dietary management of IBS and is the first product using a patented, breakthrough technology called Site Specific Targeting (SST®) to deliver individually triple-coated, solid-state, sustained release microspheres of Ultramen®, an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions help manage IBS. According to Ali Rezaie, M.D., assistant director, Gastrointestinal Motility Program at Cedars-Sinai Medical Center in Los Angeles, "Alternating bowel habits can happen on a daily basis… Intervals between the patterns [IBS-D and IBS-C] can vary widely." He added, "I have patients who say they have constipation in the morning, and then, by evening, they have loose watery stools. Even with the same bowel movement, some patients may start with hard stool that has to be pushed, and by the end, it will be watery."2 "Over the last several years, we in the gastroenterology community have tended to bracket IBgard® as an anti-spasmodic for IBS-D, similar to prescription antispasmodics, but with minimal side effects," said Dr. Cash. "The current findings raise the possibility that there may be broader clinical applications for IBgard® in reducing IBS-M symptoms as well. This is an important observation that needs further research in terms of the most important mechanisms of action of l-Menthol." "We are gaining a great understanding of the underlying causation of IBS," said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®, the innovators of IBgard®. "The largest and most dissatisfied group of IBS patients should start seeing the benefit of recent advances in IBS science." Gut Mucosal Barrier Dysfunction Is Key Factor in IBS As a complex and multifactorial disorder, IBS involves several factors that interact in the body to produce, at various times, digestive tract symptoms, including constipation, diarrhea, bloating, abdominal pain and discomfort. As new diagnostic tools help advance science in gastrointestinal disorders, gut mucosal barrier dysfunction associated with reversible and low-grade inflammation is now becoming better accepted as a root cause. Overview of Clinical Sub-Analysis of IBS-M in IBSREST™ RCT As mentioned earlier, the IBSREST™ RCT had already shown favorable results in a combined group of IBS-D and IBS-M patients. In view of the unmet need in IBS-M, researchers performed an additional analysis to test the efficacy of IBgard® in patients with IBS-M in the IBSREST™ study. The analysis showed that in the composite score of all eight symptoms measured, IBgard® demonstrated a significant reduction vs. placebo. It also showed favorable results in individual IBS symptoms, including diarrhea and constipation, where it showed significance (P=0.0085) despite the smaller sample size. More specifically, the analysis of IBS-M patients in the IBSREST™ study showed that after four weeks of daily intake of IBgard®, patients experienced the following: Reduction across the Syndrome of Symptoms (abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus): IBSREST™ Study Design To qualify for entry in the IBSREST™ study, the participants had to meet Rome III criteria for IBS-M. They had to have average daily IBS-related abdominal pain of ≥ 4 on a 0-10 scale, and a TISS of ≥ 2 on a 0-4 scale. In the study, there were 34 IBS-M participants, 16 who received IBgard® and 18 who received placebo. Study participants were randomly allocated to receive IBgard® 180 mg TID or identical placebo for four weeks. Primary analysis was based on the TISS score. Additional assessments included change from baseline in frequency and intensity of individual IBS symptoms. About Irritable Bowel Syndrome One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, under-diagnosed and under-treated condition characterized by recurrent abdominal pain, often associated with alteration in stool frequency and/or form. Bloating is also a common symptom experienced by patients with IBS. Recent understanding regarding the multiple etiologies of IBS point to gut mucosal barrier dysfunction associated with reversible, low-grade inflammation as a potential contributor to abdominal pain and altered stool form symptoms of IBS. About IBgard® IBgard® is a medical food specially formulated for the dietary management of IBS. IBgard® capsules contain solid state microspheres of peppermint oil, including its principal component l-Menthol, plus fiber and amino acids (from gelatin protein), in a unique delivery system. With its patented Site Specific Targeting (SST®) technology, pioneered by IM HealthScience®, IBgard® capsules release Ultramen®, an ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions help manage IBS. The food nutrients in IBgard® (peppermint oil along with fiber and amino acids) may help reduce the low-grade, reversible inflammation found in some IBS and help normalize gut mucosal barrier function. Additionally, peppermint oil has also been shown to help normalize intestinal transit time. IBgard® was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called the rritable owel yndrome eduction valuation and afety rial™ (IBSREST). Patients suffering from IBS-M and IBS-D were included in the study. The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal. The data showed that IBgard® demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours and at four weeks. The TISS represents a composite score of eight individual IBS symptoms. Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during flare-ups. Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard® for their patients. In a recent nationwide survey of gastroenterologists, IBgard® is the number one recommended peppermint oil for IBS among gastroenterologists for the second consecutive year by an overwhelming margin. Like all medical foods, IBgard® does not require a prescription, but it must be used under medical supervision. Only doctors can diagnose IBS. The usual adult dose of IBgard® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day. IBgard® is available to patients in the digestive aisle at most Walmart, CVS/pharmacy, Walgreens and Rite Aid stores nationwide as well as in independent drug stores and grocery stores across the country. About IM HealthScience® IM HealthScience® (IMH) is the innovator of IBgard® for the dietary management of irritable bowel syndrome. It is a privately held company based in Boca Raton, Florida, that is also the innovator of FDgard® for the dietary management of functional dyspepsia. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com or www.FDgard.com. Data Presented at DDW Poster Session on Irritable Bowel Syndrome Tuesday, May 9, 2017 For more information about featured studies, as well as a schedule of availability for featured researchers, please visit www.ddw.org/press. About Digestive Disease Week® (DDW) Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 6-9, 2017, at McCormick Place, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org. Regulation of Medical Foods IBgard® is a medical food product and not a drug or dietary supplement. A medical food is defined by section 5(b)(3) of the Orphan Drug Act (21 U.S.C, 360ee (b)(3) as a "food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinct nutritional requirements, based on scientific principles, are established by medical evaluation." Medical foods do not require prior approval by the FDA and are in a unique category separate from drugs or dietary supplements. Medical foods must contain ingredients that are "Generally Recognized As Safe" (GRAS), or are approved food additives, as defined under sections 201(s) and 409 of the Federal Food, Drug and Cosmetic Act. 1 Hungin, A.P.S., Chang, L., Locke, G.R., Dennis, E.H. & Barghout, V. (2005, June 2). Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Alimentary Pharmacology and Therapeutics, 21 (11): 1365-1375. doi: 10.1111/j.1365-2036.2005.02463.x. 2 Swift, D. & Bilal, M. (2016, December 15). IBS Purgatory: Mixed Irritable Bowel Syndrome – Symptoms can fluctuate rapidly, and psychological burden is onerous. Retrieved from http://www.medpagetoday.com/reading-room/aga/lower-gi/62101. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/additional-data-analysis-from-an-ibs-irritable-bowel-syndrome-clinical-trial-demonstrate-ibgard-delivered-unprecedented-symptom-reduction-in-the-largest-and-most-dissatisfied-group-of-ibs-patients-300454295.html
News Article | May 12, 2017
Make your own purified great tasting water from the air NEW YORK, NY--(Marketwired - May 12, 2017) - In Ovations Holdings Inc. ( : INOH), a minority owner of Aquarius Brands, is pleased to announce a special promotion for Atmospheric Water Solutions' (a member of the Aquarius Brands group) global-award-winning AquaBoy® Pro II -- please use the special promo code "2017DWMAB" at checkout http://www.atmosphericwatersolutions.com/shop/ to receive your discount. Their innovative and patented world-class appliance makes 2 to 5 gallons of purified great tasting water from the air -- higher quality and less expensive than bottled water -- and it uses none of our increasingly scarce groundwater resources. The AquaBoy® Pro II has won the following awards: 1. Winner - (2 Categories) 2017 NAHB International Builders' Show - "Best Product in Show" winner and "Best Kitchen Product" winner; 2. Finalist - (4 Categories) 2016 NAHB International Builders' Show - "Best of IBS Awards"; 3. Winner - 2016 International Home and Housewares Show Global Innovation Awards - best "Kitchen Electrics" product winner; and 4. Winner - 2015 International Hotel, Motel and Restaurant Show (HX: The Hotel Experience) - Editor's Choice Awards - "Best New Product". INOH is pleased to be able to offer this special pricing to our shareholders and hope that you will purchase an AquaBoy® Pro II before the May 31, 2017, deadline for this discount. Financing is available starting as low as ~$15/month. http://www.atmosphericwatersolutions.com/financing-programs/ . Atmospheric Water Solutions ("AWS") is a controlled subsidiary of Aquarius Brands™, a group of companies specializing in water generation, conservation and education for homes, businesses, hotels, restaurants, schools, utility companies and more. Aquarius Brands™ products include AWS AquaBoy® air to water generators™, Boomerang™ high-capacity compact bottling machines™, Retrax solar solutions™ and DroughtBuster™ water saving devices. In Ovations Holdings, Inc. is a minority owner of Aquarius Brands. Also, through its subsidiary, Electro Verde Inc., it has entered into a marketing distribution agreement with Seychelle Water Environmental Technologies, Inc., which manufactures and supplies revolutionary water filtration systems featuring breakthrough technology, most notably, Ionic Adsorption Micro Filtration. Seychelle is a prominent company in the fast-growing water filtration industry, who markets a complete line of top-quality portable water filtration products and brands in North America and worldwide.
News Article | May 9, 2017
SALEM, Mass.--(BUSINESS WIRE)--Commonwealth Diagnostics International, Inc. (CDI), announced today findings from three studies presented at the Digestive Disease Week (DDW) Annual Meeting 2017 in Chicago, IL. Given the prevalence of Irritable Bowel Syndrome (IBS), there is an interest in gaining a better understanding of the disease and available diagnostic testing methods. Through the three studies shared at DDW, CDI provided new insights linking IBSchekTM to issues related to IBS-D (Irritable Bowel Syndrome with Diarrhea) testing methods. IBS, a common gastrointestinal disorder accompanied by symptoms such as bloating, intermittent abdominal discomfort, diarrhea, and constipation, is often difficult for healthcare providers to diagnose. Frequently, IBS is diagnosed by a process of exclusion, meaning patients are diagnosed after numerous tests, and after excluding all other conditions. These testing methods can be invasive, expensive, and time-consuming. IBSchek is considered to be the only reliable blood test for the diagnosis of IBS-D and is predictive of an IBS-D diagnosis based on the presence of 2 antibodies – anti-cytolethal distending toxin B (CdtB) and anti-vinculin. IBSchek allows healthcare providers to quickly and confidently diagnose IBS-D, as these biomarkers can accurately differentiate IBS from other causes of diarrhea without excessive investigation. “DDW is the world’s largest gathering of gastroenterologists, and we are pleased to present new scientific data at this meeting that will contribute to a better understanding of IBS-D,” said Craig S. Strasnick, president and CEO at CDI. “Through the three studies showcased at DDW, we hope to generate dialogue between patients, healthcare providers, and payers about the value of leveraging less invasive testing methods that can quickly and confidently diagnose this common disease.” Studies presented at DDW include these by Dr. Mark Pimentel, of Cedars-Sinai: Cytolethal distending toxin B (CdtB) exposure alone is sufficient to precipitate autoimmunity and changes to the small intestinal microbiome in a rat model of post-infectious IBS: Results from this study support that CdtB is an important factor in the development of functional changes after gastroenteritis. Many cases of IBS begin after a bout of acute gastroenteritis. This study suggests that the presence of two specific antibodies (CdtB and anti-vinculin) can be highly predictive of an IBS-D diagnosis, and these biomarkers can accurately differentiate IBS from other causes of diarrhea. 1 Measurement of hydrogen sulfide (H S) during breath testing correlates to patient symptoms: This study provided evidence that H S appears to be important in predicting clinical symptoms of small intestinal bacterial overgrowth (SIBO), particularly diarrhea and fatigue. Additionally, increased levels of H S may correlate to increased severity of symptoms.2 An additional study, also done in partnership with Cedars-Sinai, will be presented to explore the cost-effectiveness of IBS-D testing: The Cost-Effectiveness of Laboratory Biomarkers for Irritable Bowel Syndrome with Diarrhea: A Framework for Payers: This study helped determine the cost savings—both direct and indirect—to the patient and healthcare system from receiving a faster IBS-D diagnosis. Additionally, the study provides a framework for payers to evaluate the return on investment of implementing IBS-D biomarkers of varying accuracy and cost.3 “As a gastroenterologist, it is helpful to evaluate this diverse data, as it provides insights into a variety of issues related to IBS-D testing,” said Mark Pimentel, MD, principal investigator and Executive Director, MAST Program (Medically Associated Science and Technology), Cedars-Sinai. “In particular, I am intrigued by the studies that explored various biomarkers and how these biomarkers specifically affect symptoms and can point to underlying IBS-D disease. The ability to effectively and quickly diagnose an IBS-D patient is essential, as we know this is a disease that can significantly affect a patient’s quality of life.” Brennan Spiegel, MD, MSHS, Director, Health Services Research in Academic Affairs and Clinical Transformation at Cedars-Sinai, believes the new testing is a great benefit to patients, and noted, “Although IBS is the most common disease managed by gastroenterologists, it can still be surprisingly difficult to diagnose because other conditions can present with the same symptoms. With the increasing development of biomarkers to help clinicians distinguish IBS from other conditions, it’s important to measure the cost-effectiveness of these new blood tests.” IBSchek is marketed internationally by CDI. Cedars-Sinai has entered into an exclusive license agreement with CDI for several patent applications covering the blood tests to detect both anti-CdtB and anti-vinculin antibodies in the diagnosis of irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), developed by Mark Pimentel, MD. IBSchek is a simple ELISA-based blood test that is highly predictive of an IBS-D diagnosis based on the presence of 2 antibodies – anti-CdtB and anti-vinculin. IBSchek is considered to be the only quick and reliable blood test for the diagnosis of IBS-D. With IBSchek, IBS-D may no longer be a diagnosis of exclusion and healthcare providers can now confidently diagnose certain mechanisms of IBS without excessive investigation. Additional information about IBSchek can be found at www.CommDx.com. IBS is a functional gastrointestinal disorder that is associated with bloating, chronic abdominal pain and cramping, and changes in bowel frequency and form. Diarrhea and constipation are common symptoms associated with IBS, and the exact cause is unknown.4 Treatments are available to help manage the symptoms of IBS4, but there is no known cure. It is estimated that IBS affects between 25 and 45 million people in the United States5 and is the most commonly diagnosed functional GI disorder. Commonwealth Diagnostics International, Inc. is an international diagnostic service provider specializing in cutting-edge diagnostic products that assist physicians and patients with the diagnosis of some of the common sources of digestive distress and functional gastrointestinal disorders. CDI’s current diagnostic portfolio (excluding R&D) specializes in customized Gas Chromatography, ELISA, and Isotope-Ratio Mass Spectrometry solutions. CDI partners internationally with some of the most reputable and preeminent diagnostic service providers, medical and health technology companies, life sciences and biotechnology organizations, academic and research institutions, and public health consortiums in the world. The company is headquartered in Salem, MA, and additional company information can be found at www.CommDx.com. Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars-Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow’s health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
News Article | May 10, 2017
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) will present a corporate update at the Bank of America Merrill Lynch Healthcare Conference on Wednesday, May 17, 2017 at 1:00 p.m. Pacific Time / 4:00 p.m. Eastern Time in Las Vegas, Nevada. A live webcast of Ironwood’s presentation will be accessible through the Investors section of the company’s website at www.ironwoodpharma.com. To access the webcast, please log on to the Ironwood website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Ironwood’s website for 14 days following the conference. Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology company focused on creating medicines that make a difference for patients, building value for our fellow shareholders, and empowering our passionate team. We are commercializing two innovative primary care products: linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and lesinurad, which is approved to be taken with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with uncontrolled gout. We are also advancing a pipeline of internally and externally generated innovative product candidates in areas of significant unmet need, including uncontrolled gastroesophageal reflux disease and vascular and fibrotic diseases. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
News Article | May 10, 2017
SAN FRANCISCO--(BUSINESS WIRE)--Jaguar Animal Health, Inc. (NASDAQ: JAGX) (Jaguar), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, and Napo Pharmaceuticals, Inc. (Napo), a human health company developing and commercializing novel gastrointestinal prescription products from plants used traditionally in rainforest areas, today announced the appointment of Dr. Pravin Chaturvedi, a highly experienced drug development veteran who has spent more than 25 years in the pharmaceutical/biotech industry, as Chair of the combined company’s Scientific Advisory Board, following the expected close of the proposed merger of Jaguar and Napo. Dr. Chaturvedi has served as Chair of Napo’s Scientific Advisory Board since March 27, 2017. Dr. Chaturvedi is responsible for providing direction on strategy, tactics and oversight regarding advancing the development and commercialization of the companies’ drug pipelines, including, but not limited to, Mytesi® and SB-300. From 2006 to 2013, Dr. Chaturvedi served as Napo's Chief Scientific Officer and has remained a scientific adviser to the company since 2014. His track record of successful development includes participating in and/or leading development efforts for seven drugs, including Napo’s Mytesi® (crofelemer) product, which is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. For this indication, Dr. Chaturvedi led the key opinion leader efforts that contributed to the successful use of adaptive clinical trial design for the Mytesi® pivotal trial and its approval by the FDA. As announced March 31, 2017, Napo and Jaguar have entered a definitive merger agreement. Napo and Jaguar are in the process of evaluating potential follow-on indications for Mytesi® as part of the anticipated combination of the product pipelines of the two companies. Dr. Chaturvedi is chairing the investigation of Mytesi® for possible follow-on indications, which include chemotherapy-induced diarrhea, irritable bowel syndrome (IBS), for which proof of concept data is already in hand, inflammatory bowel diseases (IBD) and diarrhea resulting from hospital-acquired infections such as Clostridium difficile, a bacterium that is the most common cause of infectious diarrhea in hospital settings. Napo recently convened a Scientific Advisory Board meeting with expert gastroenterologists, who provided advice on study populations and designs in IBS and IBD. As Douglas Drossman, MD, Professor Emeritus at the University of North Carolina, who is a gastroenterologist in private practice at Drossman Gastroenterology, noted, “The safety profile of crofelemer constitutes an advantage that differentiates it from many other gastrointestinal products.” Mytesi® is also being explored for treatment of important orphan gastrointestinal indications such as congenital diarrheal disorders (CDD) and diarrhea associated with short-bowel syndrome (SBS). CDDs are a group of rare, chronic intestinal channel diseases characterized by large, watery stools containing an excess of chloride and sodium, lifelong diarrhea, and a lifelong need for nutritional intake with a feeding tube. CDDs are related to specific genetic defects inherited as autosomal recessive traits, and the incidence of CCDs is much more prevalent in regions where consanguineous marriage is part of the culture. Patients with SBS are born with a substantial shortening of the small intestine, to a mean length of 50 cm, compared with a normal length at birth of 190-280 cm. This could be due to either a genetic disorder or pre-mature birth. In regions such as the United Arab Emirates and Saudi Arabia, both CDD and SBS occur with much higher incidence. Napo has recently visited with medical centers in this region. “With the early and extreme morbidity and mortality suffered by CDD and SBS patients, we welcome the opportunity to participate in the investigation of a novel drug to address the devastating diarrhea and dehydration caused by these lifelong diseases for which there is currently no available treatment except parenteral nutrition, and help limit the suffering of patients and their family members,” stated Dr. Mohamad Miqdady, Chief of Pediatric Gastroenterology, Hepatology & Nutrition at Sheikh Khalifa Medical City in Abu Dhabi. Dr. Chaturvedi is also providing oversight for development of Napo’s proprietary second-generation anti-secretory agent for cholera—a possible indication that may present Napo with an opportunity for an FDA tropical disease priority review voucher. Under FDA regulations, the sponsor of a human drug application for a qualified tropical disease may be eligible for a priority review voucher, which can be used to obtain priority review for any subsequent human drug application submitted to FDA. These vouchers, which are transferable, have recently sold for $125 million - $350 million, and provide an immediate return on investment for the development of a novel product for important indications. “I am thrilled to be supporting Napo’s and Jaguar’s shared mission to change the global standard of care for gastrointestinal diseases,” stated Dr. Chaturvedi. “I look forward to evaluating potential multiple follow-on gastrointestinal indications for Mytesi®, and leveraging the collective expertise of our team in advancing drug development through innovative approaches such as the adaptive clinical trial design that led to the FDA approval of Mytesi® for its current indication of treating noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.” “We are very pleased that Dr. Chaturvedi has returned to support these principal development activities,” Conte commented, “which, if approved, will complement our current sales of Mytesi® for noninfectious diarrhea in adult HIV/AIDS patients on antiretroviral therapy. We consider Mytesi® a ‘pipeline within a product’, and Napo has global unencumbered rights to this novel first-in-class anti-secretory agent with multiple potential follow-on indications.” Dr. Chaturvedi has co-founded and led multiple biotech enterprises including Scion, IndUS and Oceanyx, and has served as the CEO or CSO for Scion, IndUS, Napo, and Oceanyx and is the CEO for Pivot Pharmaceuticals. Over his career, Dr. Chaturvedi led discovery and/or development activities for several new chemical entities (NCEs) and has participated in the discovery and/or development of novel drugs for treatment of HIV, hepatitis C, epilepsy and Alzheimer's disease. Earlier in his career, Dr. Chaturvedi was head of lead evaluation at Vertex Pharmaceuticals and was in the preclinical group at Alkermes. He started his career in the product development group at Parke-Davis/Warner-Lambert Company (now Pfizer). Dr. Chaturvedi holds a Ph.D. in Pharmaceutical Sciences from West Virginia University and a Bachelor's in Pharmacy from the University of Bombay. The proposed merger of Jaguar and Napo remains subject to customary conditions to closing. Upon the consummation of the merger, Jaguar’s name will be changed to Jaguar Health, Inc., and Napo will operate as a wholly-owned subsidiary of Jaguar, focused on human health. Subject to the conditions to closing, the proposed merger is expected to close by the end of July 2017. Mytesi® (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. 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 at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). More information and complete Prescribing Information are available at Mytesi.com. Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity. San Francisco-based Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. For more information, please visit www.napopharma.com. Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Canalevia™ is Jaguar’s lead prescription drug product candidate, intended for the treatment of various forms of diarrhea in dogs. Equilevia™ (formerly referred to as SB-300) is Jaguar’s prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia™ and Equilevia™ contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are the Company’s lead non-prescription products. Neonorm™ is a standardized botanical extract derived from the Croton lechleri tree. Canalevia™ and Neonorm™ are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm™ in six additional target species, formulations of Equilevia™ in horses, and Canalevia™ for cats and dogs. For more information about Jaguar, please visit www.jaguaranimalhealth.com. Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the development, approval and sales of potential follow-on indications of Mytesi®, the proposed merger between Jaguar and Napo, Jaguar’s intention to develop species-specific formulations of Neonorm™ in additional target species, and the Company’s plan to develop formulations of Canalevia™ for cats, horses and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
News Article | May 14, 2017