XOMA Receives Orphan Drug Designation for XOMA 358; FDA Approves Impax Specialty Pharma's ZOMIG® Print E-mail
By Marilyn Mullen   
Tuesday, 16 June 2015 18:44
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 16, 2015.
XOMA Corporation (NASDAQ: XOMA), a leader in the discovery and development of therapeutic antibodies, announced today XOMA 358, a fully human allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and downstream insulin signaling, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of congenital hyperinsulinism (HI).
"The orphan drug designation for XOMA 358 recognizes its potential to address a significant unmet medical need for patients with congenital hyperinsulinism. Patients with hyperinsulinism, a rare and devastating disease, secrete inappropriate and excessive insulin, which cause dangerously low blood sugar levels that can lead to brain damage or, in rare cases, death. Currently options to manage many of these patients are limited to continuous ingestion of glucose or pancreatectomy," said Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA. "We are developing XOMA 358 as a first-in-class therapeutic for conditions of hyperinsulinemic hypoglycemia. We recently completed a positive Phase 1 study, results of which suggest XOMA 358 is active against the insulin receptor and shows potential in treating patients who experience an endogenous over-production of insulin. Congenital hyperinsulinism is one of the indications we are considering for a Phase 2 study, which we expect to initiate later this year."
Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the United States. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance, and waiver of Prescription Drug User Fee Act (PDUFA) filing fees. The OOPD also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.
Impax Specialty Pharma, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced the U.S. Food and Drug Administration has approved ZOMIG Nasal Spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.
ZOMIG Nasal Spray is the first nasal-delivered prescription medicine approved for the treatment of acute migraine attacks in pediatric patients. Nasal sprays may offer an alternative method of administration when patients experience migraine-associated nausea, have difficulty taking oral formulations, or do not have liquids available.
ZOMIG Nasal Spray's approval came after the FDA's review of safety and efficacy data from pivotal clinical trials demonstrating that ZOMIG Nasal Spray 5 mg is significantly more effective than placebo in providing no headache pain, relief of headache, and other associated symptoms of migraine when treating migraine in pediatric patients. In clinical trials, the medication also had a safety profile similar to that demonstrated in adults. For full safety and efficacy information, please see the prescribing information.
The American Migraine Prevalence and Prevention (AMPP) Study estimated the 1-year prevalence of migraine among US children ages 12 to 19 at 6.3%, with prevalence among boys at 5.0% and among girls 7.7%.2 "Until now, there have been few medications to treat pediatric patients with painful, debilitating attacks of migraine," said Dr. Alan M. Rapoport, Past President of the International Headache Society and Clinical Professor of Neurology at the David Geffen School of Medicine. "We are pleased that ZOMIG Nasal Spray has been approved by the FDA for use in patients ages 12 to 17."
"Treatment options have been limited for pediatric patients and we are pleased with FDA's decision and look forward to bringing migraine relief to pediatric patients by making ZOMIG Nasal Spray available to this 'school age' patient population," said Fred Wilkinson, President and Chief Executive Officer of Impax Laboratories. "This expanded indication exemplifies our strategy to broaden the reach of our current product portfolio to address unmet needs in underserved therapeutic areas, thereby adding value for patients and shareholders alike."
The recommended starting dose for ZOMIG Nasal Sprays in pediatric patients 12 years of age and older is 2.5 mg. As the individual response to ZOMIG Nasal Spray may vary, the dose should be adjusted on an individual basis. The maximum recommended single dose of ZOMIG is 5 mg. The maximum daily dose should not exceed 10 mg in any 24 hour period.
Also Tuesday:
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced key new hires in the medical affairs and drug safety functions.
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, is pleased to provide an update on the progress of the Company's Wellness division following the introduction in May of two new breath tests at the World Congress on Anti‐Aging Medicine.
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced that it has met the enrollment target of its CHABLIS-SC1 Phase 3 clinical trial evaluating blisibimod for the treatment of lupus. Final data from the trial is expected in the second half of 2016.
Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced that Jeff Abbey, president and CEO, will present at the 2015 JMP Securities Life Sciences Conference on Tuesday, June 23rd, at 10:00 a.m. Eastern Time. 
Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), announced today that the Annual Meeting of Shareholders scheduled for June 16, 2015 has been adjourned to July 1, 2015 at 10:00 am EDT, and will take place at the Company's offices at 25 Sawyer Passway, Fitchburg, MA 01420.
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced its participation at the JMP Securities Life Sciences Conference 2015. 
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced that it has been selected to be included in the broad-market Russell 3000® Index. 
FlexPower, Inc. (OTC:FLXP), a California consumer products corporation that makes and markets innovative pain management products, is excited to present an interview with the President and Co-Founder of FlexPower, Rasheen Smith, published on equities.com earlier this week.
Foamix Pharmaceuticals (Nasdaq:FOMX) and Merz North America, Inc., today announced that the first milestone payment related to their unique foam technology development program has been made to Foamix.
HealthEquity, Inc. (Nasdaq:HQY), one of the largest HSA custodians, today announced that the company has been added to the NASDAQ's Financial 100 Index (Nasdaq:IXF) effective prior to the market open on June 22, 2015.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired Extended Care Physicians (ECP), one of the largest private practice post-acute groups in the Carolinas.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, is pleased to announce the April 2015 appointment of Michael A. Turpin to the Company's Board of Directors and Audit Committee.
Keryx Biopharmaceuticals, Inc., (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for patients with renal disease, today announced that it will present at the JMP Securities Life Sciences Conference in New York City on Wednesday, June 24, 2015 at 2:30 p.m. EDT.
Kite Pharma, Inc., (Nasdaq:KITE), today announced that the Company will host a live webcast in conjunction with its Investor Day on Tuesday, June 23, 2015 at 12:00p.m. ET in New York, NY.
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced that members of the senior management team will present and participate in investor meetings at the JMP Securities Life Science Conference 2015 on June 23 at 10 a.m. EDT at The St. Regis in New York, NY.
Second Sight Medical Products, Inc. (Nasdaq:EYES), a developer, manufacturer and marketer of implantable visual prosthetics to provide functional vision to blind patients, today announced that Dr. Robert Greenberg, President and Chief Executive Officer, will present at the JMP Securities Life Sciences Conference as follows:  Wednesday, June 24, 2015, 1:00 p.m. EDT, St. Regis, New York City, NY.
SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs, today announced that Jonathan M. N. Rigby, President and Chief Executive Officer, will provide an overview and update on the company's business at the JMP Securities Life Sciences Conference on Tuesday, June 23, 2015 at 12:30 p.m. EDT in New York.
Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the company will present at the following upcoming conferences:  Craig Thompson, Chief Operating Officer, will present at the 2015 BIO International Convention on Thursday, June 18th at 11:15 a.m. Eastern Time at the Pennsylvania Convention Center in Philadelphia, PA; Guy Macdonald, Tetraphase President and Chief Executive Officer, will present at the 2015 JMP Securities Life Sciences Conference on Tuesday, June 23rd at 3:00 p.m. Eastern Time at The St. Regis in New York City.
Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE), a clinical-stage biotechnology company developing a robust and growing portfolio generated by its proprietary structure-based drug discovery platform, today announced that Richard Morris, Chief Financial Officer, will present a company overview at the JMP Securities Life Sciences Conference on Tuesday, June 23, 2015 at 2:00 p.m. EDT at The St. Regis New York.
Vocera (NYSE:VCRA), today introduced the Vocera Clinical Workflow Engine to streamline integrations between the Vocera Communication System and clinical systems such as nurse call and electronic health records (EHRs).

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