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.
El Hassan E.,Emergency Residency Program |
Mohamed A.,United Arab Emirates University |
Ibrahim M.,Sheikh Khalifa Medical City |
Margarita M.,Sheikh Khalifa Medical City |
And 2 more authors.
Obesity Surgery | Year: 2013
Background: Leaks occur in 1.4-20 % (Bohdjalian et al., Obes. Surg. 20:535-540, 2010; Nocca et al., Obes Surg. 18:560-565, 2008; Stroh et al., 19:632-640, 2009; Aurora et al., Surg. Endosc. 26:1509-1515, 2012) of patients following laparoscopic sleeve gastrectomy (LSG). Leaks may lead to major morbidity and prolonged hospitalization. Endoscopic stent placement is a potential management strategy that needs expertise and also has recognized complications (stent migration, significant dysphagia, and failure) (Rosenthal et al., Surg. Obes Relat. Dis. 8:8-19, 2012). A standard method of managing leaks following LSG has not been established. This study aims to evaluate the outcomes of consecutive patients with leaks following LSG managed at BMI Abu Dhabi Tertiary Multidisciplinary Bariatric Surgery, Abu Dhabi, UAE. Methods: We examined all patients presenting to BMI Abu Dhabi between February 2010 and May 2012 with leaks following LSG. Data were obtained from the hospital medical record, and IRB approval was obtained. All patients were managed by utilizing a standardized operative management strategy without the use of endoscopic stenting. Results: A total of five patients were referred to us for higher level of care; during the same time period, we performed 71 LSGs without a leak. Patients were optimized and resuscitated adequately before surgery. Intraoperatively, all patients had endoscopy, and a T tube was placed inside the leak if clearly identifiable. Otherwise, the leak site was drained adequately without attempting to place sutures, and a jejunostomy tube was inserted. All leaks healed following an initial period of hospital stay, followed by an outpatient period on jejunostomy tube feeding and nil per os. Conclusion: Single-stage operative management of leaks after LSG utilizing a standardized operative strategy without the use of endoscopic stenting is both safe and effective. © 2013 Springer Science+Business Media New York.
Lee P.,Singapore General Hospital |
Kupeli E.,Mesa Hospital |
Mehta A.C.,Sheikh Khalifa Medical City |
Mehta A.C.,Cleveland Clinic
Clinics in Chest Medicine | Year: 2010
Stents are used for palliation of symptoms of central airway obstruction caused by either malignant or benign conditions. Stents may be applied for maintaining airway patency after dilatation of postinflammatory and infectious strictures, for airway dehiscence after lung transplantation, and for the management of tracheobronchomalacia. Fistulas between trachea or bronchi and the esophagus and dehiscence of pneumonectomy stump can be protected with covered stents. Choice of stent depends on careful patient selection, characteristics of airway stenosis, physician's expertise, and availability of equipment. Placement of tube stents requires rigid bronchoscopy and dilatation of strictures beforehand, whereas metal stents can be applied using a flexible bronchoscope. Advantages and disadvantages of commonly used airway stents are discussed. © 2010 Elsevier Inc. All rights reserved.
Waness A.,Sheikh Khalifa Medical City
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia | Year: 2012
Even though rare, tuberculous peritonitis (TBP) in patients on continuous ambulatory peritoneal dialysis (CAPD) is a perilous condition. Physicians worry about continuing treatment of their patients, whether to continue this modality of dialysis or switch to hemodialysis. A retrospective cohort study of 89 patients undergoing CAPD over a 12-year period was carried out for any episode of peritonitis with the objectives to find out the incidence of TBP in these patients, evaluation of patients' 3-year survival, possibility of retention of Tenckhoff catheter, and modality of dialysis post-infection. One hundred and three episodes of peritonitis occurred in our patients. Most of them were bacterial and occasionally fungal. We identified four cases of TBP, with one patient having concurrent bacterial infection in the peritoneal fluid. The clinical presentation was insidious with cloudy fluid in all cases. The diagnosis was established by the polymerase chain reaction (PCR) technique in one case, by positive peritoneal fluid culture for Mycobacterium tuberculosis in two cases, and clinically in the fourth one that responded well to anti-tuberculous therapy. All four patients survived their mycobacterial infection. Removal of catheter was necessary in all four patients and all were converted to hemodialysis. Three patients remained on hemodialysis thereafter, and one patient had to be re-implanted with a new catheter and was restarted on CAPD. TBP in patients undergoing CAPD in Jeddah remains a real concern, especially with the evidence of high prevalence of tuberculosis and with the emergence of drug-resistant tuberculosis. We recommend early initiation of anti-tuberculous therapy and removal of the Tenckhoff catheter for better survival. Most of these patients probably will require conversion to hemodialysis, but in a selected few CAPD can be restarted.
Albrecht E.,University of Cape Town |
Richards J.C.,Royal Perth Hospital |
Pollock T.,Sheikh Khalifa Medical City |
Myers L.,University of Cape Town
British Journal of Ophthalmology | Year: 2011
Aim: To evaluate the use of intravitreal dexamethasone as adjunctive therapy in the treatment of presumed bacterial endophthalmitis. Design: Prospective, double masked, randomised placebo-controlled clinical trial. Methods: Patients with 'post cataract surgery', 'bleb-related' and 'other' endophthalmitis were grouped and randomised to receive intravitreal ceftazidime (2.225 mg/0.1 ml), vancomycin (1 mg/0.1 ml), and either dexamethasone (0.4 mg/0.1) or placebo. All underwent vitreous and aqueous sampling for microbiological analysis. Injections were repeated after 48 h if necessary. The primary outcome measure was Snellen visual acuity on presentation, within the first 14 days post injection, and at 2-4 months. Results: 62 patients completed the protocol from 2001 to 2005. Thirty patients received intravitreal dexamethasone and 32 received intravitreal placebo. There was no statistically significant difference in the visual outcomes of either group with a mean 2.79 Snellen lines improvement of the intravitreal dexamethasone group versus 1.8 lines in the placebo group. Subgroup analysis suggested a clinical trend to better visual acuity in the post cataract steroid subgroup with mean 4.1 lines improvement versus 2.7 in the placebo group (p=0.33). No adverse events attributable to the dexamethasone were reported. Conclusions: Intravitreal dexamethasone appears safe and may be of benefit in post cataract surgery bacterial endophthalmitis.
Khalil A.B.,Sheikh Khalifa Medical City
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists | Year: 2010
To describe a case of papillary carcinoma of the thyroid with fibromatosislike stroma, emphasize the need for a diligent search for papillary thyroid cancer in the presence of a fibroproliferative lesion, highlight the peculiar hormonal response of the stromal component, and review the pertinent literature. We present the clinical, laboratory, radiologic, and pathologic findings in a patient with papillary carcinoma of the thyroid with fibromatosislike stroma and review the related published material. A 29-year-old woman presented to our surgical department because of a large mediastinal mass. She underwent surgical removal of the mass by means of a median sternotomy and neck extension. Pathology examination revealed macroscopically tan scarlike tissue, which by histologic study consisted of a dominant fibroproliferative lesion overshadowing a minor component of papillary carcinoma of the thyroid. Further neck exploration with total thyroidectomy revealed multifocal papillary carcinoma of the thyroid. Postoperatively, the patient received radioiodine treatment. A local and aggressive recurrent tumor was observed during a subsequent pregnancy; the lesion was not amenable to complete resection but fascinatingly responded to antiestrogen therapy (orally administered tamoxifen). The presence of a fibroproliferative lesion could be misleading. A diligent search should be made for a papillary thyroid carcinoma component within fibromatosislike stroma. The mode of manifestation of the tumor and its response to hormonal manipulation are distinctive features of this case.
Rajah J.,Sheikh Khalifa Medical City |
Thandrayen K.,University of Witwatersrand |
Pettifor J.M.,University of Witwatersrand
European Journal of Pediatrics | Year: 2011
Abstract Rickets remains a common problem among infants and children in many countries worldwide. Although the classical presentation associated with bone abnormalities is well known, paediatricians need to be aware of atypical presentations, especially in the first 6 months of life. Furthermore, although vitamin D deficiency rickets remains the commonest form of rickets in most countries, health care providers need to be aware of other possible causes and their typical clinical and biochemical presentations. This article discusses these and highlights the characteristic features of various forms of rickets and possible pitfalls clinicians should be aware of when confronted with a patient with suspected rickets. In conclusion, the recent advances made in understanding the underlying pathogeneses of the various forms of rickets has helped to delineate the diagnostic tests that assist in the diagnosis and management of the disease in children. © Springer-Verlag 2011.
News Article | October 28, 2016
· Continued good growth and results despite holiday period · Our client is pleased with of our initial work at Sheikh Khalifa Medical City Ajman (SKMCA) · Our new management team is now in place and leading the development of SKMCA Third quarter 2016 · Sales revenues increased to SEK 189.1 million (160.4) and organic growth amounted to 15 percent (7) · EBITDA amounted to SEK 7.4 million (1.1) · EBITDA margin amounted to 3.9 percent (0.7) · Result after tax (EAT) amounted to SEK
News Article | October 28, 2016
· Fortsatt bra tillväxt och resultat trots semesterperioden · Goda omdömen från vår uppdragsgivare på vårt initiala arbete i Sheikh Khalifa Medical City Ajman (SKMCA) · Vår nya ledningsgrupp är nu på plats och leder utvecklingen i SKMCA Tredje kvartalet 2016 · Försäljningsintäkterna ökade till 189,1 MSEK (160,4) och den organiska tillväxten uppgick till 15 procent (7) · EBITDA uppgick till 7,4 MSEK (1,1) · EBITDA-marginalen uppgick till 3,9 procent (0,7) · Resultat efter skatt (
News Article | October 28, 2016
GÖTEBORG, Sweden--(BUSINESS WIRE)--Regulatory News: GHP Specialty Care AB (STO:GHP) · Continued good growth and results despite holiday period · Our client is pleased with of our initial work at Sheikh Khalifa Medical City Ajman (SKMCA) · Our new management team is now in place and leading the development of SKMCA Third quarter 2016 · Sales revenues increased to SEK 189.1 million (160.4) and organic growth amounted to 15 percent (7) · EBITDA amounted to SEK 7.4 million (1.1) · EBITDA margin amo