|Anthera Announces Initiation of the SOLUTION Clinical Study of Oral Sollpura(R) (liprotamase); FDA Accepts Novartis/Sandoz Regulatory Submission for Proposed Biosimilar to Enbrel|
|By Josh Gee|
|Friday, 02 October 2015 18:55|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 2, 2015.
Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) announced the initiation of the SOLUTION (Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in People With Cystic Fibrosis) Phase 3 clinical study evaluating the efficacy and safety of Sollpura® (liprotamase), a microbial derived, biotech pancreatic enzyme replacement therapy (PERT), compared to an approved, porcine-derived, enteric-coated product for the treatment of exocrine pancreatic insufficiency (EPI).
The Phase 3 SOLUTION clinical study is a multicenter, randomized, open-label, assessor-blind, non-inferiority, active-comparator study designed to evaluate the efficacy and safety of Sollpura in people with EPI due to cystic fibrosis. This pivotal study is intended to evaluate the non-inferiority of Sollpura compared with a commercially available PERT in a population enriched for PERT responders. The primary efficacy endpoint of this study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) at the end of therapy. For more information on the SOLUTION clinical study, please visit https://clinicaltrials.gov/ct2/show/NCT02279498.
"The initiation of the SOLUTION clinical study marks a critical milestone for Anthera. With its solubility, stability, and absence of bulky enteric coating, we believe Sollpura has the potential to significantly improve the lives of people with EPI," said Dr. Colin Hislop, Anthera's Chief Medical Officer. "We are extremely excited to advance the Sollpura development program, and today we have taken another step towards making a much needed treatment available for people who are unable to maintain appropriate nutritional health with existing enzyme therapies."
"We extend our sincere appreciation to the Cystic Fibrosis Foundation for their continued support of this program. They have been an invaluable resource throughout the development of the SOLUTION study," said Paul F. Truex, Anthera's President and Chief Executive Officer. "We look forward to their continued support as we further the development of Sollpura."
Results from the SOLUTION clinical study are anticipated to support marketing approval for Sollpura as a treatment for exocrine pancreatic insufficiency.
On Friday October 9th, 2015 from 8:00 to 10:00 PM, during the North American Cystic Fibrosis Conference, Anthera will host a reception to discuss the SOLUTION clinical study with Sollpura. The reception will be held at the Sheraton hotel, 340 N 3rd Street, Phoenix, Arizona. To receive an invitation to the event, please contact Nikhil Agarwal at [email protected], prior to Wednesday, October 7th, 2015.
Sandoz, a Novartis (NYSE: NVS) company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's (NASDAQ: AMGN) US-licensed Enbrel®* (etanercept) - a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affecting approx. 1.3 million and 7.5 million people (respectively) in the US.
Etanercept is an anti-TNF medicine used to treat a range of immunological diseases including rheumatoid arthritis and psoriasis. Sandoz is seeking approval for all indications included in the reference product's label.
Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product.
Holzkirchen, October 2, 2015 - Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel®* (etanercept) - a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affecting approx. 1.3 million and 7.5 million people (respectively) in the US.
Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz said "anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines." McCamish continued "we believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept."
This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway. The BLA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide confirmation of similarity to the reference product established in prior analytical comparability investigations.
Sandoz has an unwavering commitment to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global market leader and currently markets three biosimilars. Sandoz recently launched ZarxioTM (filgrastim-sndz) - the first biosimilar in the United States, signaling a shift toward more competition and affordability in the healthcare system. Sandoz has a leading pipeline with several biosimilars across the various stages of development including five programs in Phase III clinical trials or registration preparation. The company plans to make ten regulatory submissions in the next three years. As part of the Novartis Group, Sandoz is uniquely positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
ACETO Corporation (NASDAQ:ACET), a global leader in the marketing, sale and distribution of Human Health products, Pharmaceutical Ingredients and Performance Chemicals, today announced that Rising Pharmaceuticals, Inc., its finished dosage form generics subsidiary, is launching the 1mg and 2mg strengths of Glycopyrrolate Tablets, an FDA approved generic version of Shionogi's Robinul® and Robinul® Forte, and the 5mg and 10mg strengths of Methimazole Tablets, an FDA approved generic version of Pfizer's Tapazole®. According to IMS Health data, U.S. market sales for Glycopyrrolate Tablets, which is indicated for the treatment of peptic ulcers, were approximately $20 million for the twelve months ended July 31, 2015. U.S. market sales for Methimazole Tablets, which is indicated for the treatment of hyperthyroidism, were approximately $12.3 million for the twelve months ended July 31, 2015. Sal Guccione, Aceto CEO said, "We are very pleased to launch these products which were recently acquired in a transaction that demonstrated Rising's recognition by regulatory authorities as a viable acquirer of products being divested as a result of ongoing M&A activities in our industry."
Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of therapies for rare and orphan diseases, today announced additional regulatory guidance from the U.S. Food and Drug Administration (FDA) on the oral small molecule pharmacological chaperone migalastat for the treatment of Fabry disease. Amicus has received final FDA minutes from the September pre-NDA meeting and has conducted additional follow-up interactions with the Agency this week. In conjunction with the Agency, Amicus is further evaluating several U.S. pathways including potentially generating additional data on migalastat's effect on gastrointestinal symptoms in Fabry disease to support submission requesting full approval as well as a Subpart H strategy. In addition, the Agency has requested further integration of existing clinical data across studies which will require more time to complete. Based on this guidance from the FDA, Amicus does not anticipate being in a position to submit the NDA for migalastat monotherapy in the United States by the end of this year. The timing of an NDA submission will be based on the determination of the optimal regulatory pathway. "Amicus remains committed to making migalastat available to Fabry patients with amenable mutations in the U.S. as rapidly as possible. We are appreciative of the FDA's ongoing collaboration in this program," stated John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics.
Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of therapies for rare and orphan diseases, announced that in follow-up to the press release issued earlier today about the regulatory update from the U.S. Food and Drug Administration (FDA) on the oral small molecule pharmacological chaperone migalastat, Amicus is hosting a conference call and live audio webcast Friday, October 2, 2015 at 11:00 a.m. ET. The call will be hosted by John F. Crowley, Chairman and Chief Executive Officer. He will be joined on the call by additional members of the Amicus management team. Interested participants and investors may access the conference call at 11:00 a.m. ET by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international). A live audio webcast can also be accessed via the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicustherapeutics.com/events.cfm, and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download and install any necessary software. A telephonic replay of the call will be available for seven days beginning at 2:00 pm ET on October 2, 2015. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); participate code 54594506.
Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies based on the Arcelis® technology platform, announced that Shawn Leland, PharmD, RPh, Argos's director of corporate development and strategy, will present at the annual Partnering Forum, part of the 2015 Stem Cell Meeting on the Mesa to be held Oct. 7-9 at the Estancia La Jolla Hotel & Spa in La Jolla, Calif. Dr. Leland will give a company overview presentation on Thursday, October 8 at 4:30pm PDT in La Jolla Ballroom 1. A live video webcast will be available at http://stemcellmeetingonthemesa.com/webcast/. Co-hosted by the Alliance for Regenerative Medicine (ARM), the California Institute for Regenerative Medicine (CIRM) and the Sanford Consortium for Regenerative Medicine, the 2015 Stem Cell Meeting on the Mesa brings together senior executives and top decision makers with the shared goal of advancing and translating cutting-edge research into revolutionary treatments. For more information visit http://stemcellmeetingonthemesa.com/.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that it received approval from the United States bankruptcy court in Delaware to purchase substantially all of the assets of Los Angeles-based Response Genetics, Inc. ("RGI"). In connection with the transaction, CGI also agreed to assume certain of RGI's liabilities. The sale is subject to certain customary closing conditions and is anticipated to close by October 9, 2015. The acquisition, if consummated, is expected to contribute an additional $10 to $12 million to CGI in revenue over the next 12 months and to expand CGI's solid tumor molecular diagnostics offering to include lung cancer, colorectal cancer and melanoma tests that help determine a patient's response to cancer therapy. Once integrated, the combined entity will have expertise in solid and hematological cancers, a national geographic footprint, and the ability to provide services to large-scale clients including biotechnology/pharmaceutical companies and clinicians. The lease for RGI's 27,000 sq. ft. CLIA-certified and CAP-accredited laboratory, located in Los Angeles, California is being assumed by CGI in the transaction. Cancer Genetics plans to develop RGI's Los Angeles facility into a center of excellence in solid tumors, with a particular emphasis on lung cancer once the purchase is finalized.
Cellectar Biosciences, Inc. (NASDAQ:CLRB) today announced the closing of its registered direct offering of 1,017,272 shares of its common stock and Series B pre-funded warrants to purchase 482,728 shares of common stock at a price of $2.20 per share. In addition, the Company completed the private placement of Series A warrants to purchase 1,500,000 shares of common stock at an exercise price of $2.83 per share, which are not exercisable for six months from issuance and are exercisable for five years thereafter. Gross proceeds from this offering were approximately $3,300,000, before deducting the estimated offering expenses payable by the company. Ladenburg Thalmann & Co., Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE MKT:LTS), acted as the exclusive placement agent for the offering.
Integra LifeSciences Holdings Corporation (NASDAQ:IART) today announced that it closed the acquisition of the United States rights to Tornier's Salto Talaris® and Salto Talaris® XT ankle replacement products and Tornier's Futura™ silastic toe replacement products. "The addition of the Salto Talaris® enhances our lower extremities product offering and accelerates our entry into the U.S. total ankle replacement market," said Nick Gallucci, Integra's Vice President, U.S. Sales Leader, Extremity Reconstruction. "We are also pleased to welcome several key employees who will be joining Integra's commercial organization." Integra expects the contribution to adjusted earnings per share to be immaterial during the first 12 months, given the normal sales transition and expected costs associated with the integration. Integra will provide further information on the expected revenues from the transaction on its third quarter earnings call.
The Joint Corp. (NASDAQ:JYNT) announced today that Steven Knauf, D.C. has been appointed Senior Director of Chiropractic Operations. In his new position, Dr. Knauf will oversee management, quality assurance and ongoing training for chiropractors of The Joint in Arizona. Dr. Knauf will focus on ensuring consistent delivery of high quality chiropractic care and developing professional relationships with both local chiropractors and patients. Dr. Knauf has practiced chiropractic since 2011 after completing his chiropractic prerequisites at the University of Minnesota and both his BS in human biology and his Doctorate of Chiropractic at Northwestern Health Sciences University. Dr. Knauf had studied pre-dental before switching to pre-chiropractic after his recovery from an elbow injury that, after several failed attempts using other approaches, was successfully treated through regular, ongoing chiropractic care. "I attribute my good health and well-being to getting weekly adjustments to ensure my body is operating at its maximum potential," said Dr. Knauf. "I am passionate about providing quality, affordable chiropractic care to the people of Arizona so they, too, can feel the benefits of regular chiropractic care."
LHC Group, Inc. (NASDAQ:LHCG), a national provider of comprehensive post-acute healthcare services, announced today that it has completed the previously announced acquisition of Halcyon Hospice LLC for $58.5 million in cash or, net of tax benefit, for $51.5 million. The transaction is expected to be accretive to LHC Group's 2016 earnings by between $0.15 and $0.20 per diluted share, while earnings for the fourth quarter of 2015 are expected to reflect transaction and integration costs totaling $0.06 per diluted share. Based in Cumming, Georgia, Halcyon is one of the largest independent providers of hospice services in the southeastern United States. It operates 16 hospice locations across three states, including two inpatient hospice facilities, and has approximately 400 employees. Halcyon's service area covers 183 counties across Georgia, Mississippi and South Carolina, including 59 counties in which LHC is licensed for home health. Annual revenue for Halcyon is approximately $41 million. This acquisition will increase LHC's hospice service line to 53 locations in 12 states with over $110 million in annual revenue.
Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, announced today that the Company will release its financial results for the third quarter ended September 30, 2015, after the close of the stock market on Thursday, October 22, 2015. Merit will hold its investor conference call on the same day (Thursday, October 22, 2015) at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). The domestic telephone number to call is (888) 344-6698, and the international number is (785) 830-7979. A live webcast will also be available for the conference call at www.merit.com.
Pathway Health, a leading post-acute consulting services, interim management and education services organization, and PointRight, the industry-standard predictive analytics leader, announce they have entered into a strategic partnership agreement to provide analytics solutions to providers across the post-acute continuum. As part of this agreement, Pathway Health will integrate PointRight's analytics solutions into their consultancy practice, assisting providers with an analytics-driven approach to effectively measure quality clinical outcomes, manage costs and reduce risk. The two organizations will roll-out specific offerings that target these operational challenges in the weeks ahead, and will continue to evolve their joint offering within the next year and beyond. "We are pleased to arm our expert consultants with PointRight's analytics solutions," commented Deborah L. Schuna, founder and Chief Executive Officer for Pathway Health. "Enabling providers to make better-informed business decisions is key as they position for value-based purchasing and the overall impact of healthcare reform."
Signal Genetics, Inc. (NASDAQ:SGNL), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced that Samuel D. Riccitelli, President and CEO, will present a corporate overview at the 2015 Aegis Growth Conference on October 8, 2015 at 10:00 a.m. PT. The Company was previously scheduled to present on October 8, 2015 at 10:45 a.m. PT. Event: 2015 Aegis Growth Conference, Date: Thursday, October 8, 2015, Time: 10:00 a.m. PT. An audio webcast of the Company's presentation will be available on the investor relations section of the Signal Genetics website at www.signalgenetics.com. A replay of the presentation will be available for 90 days.
Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, through its Chairman/CEO Dr. William Donovan, MD is pleased to announce the nomination of Jeffery Cronk DC, JD, a nationally recognized expert in accident induced spine injuries, for election to the Board of Directors at the upcoming 2015 Annual Meeting of Stockholders. The 2015 Annual Meeting is scheduled for November 10, 2015. Additionally, after three months of rigorous product safety testing of its patented proprietary Quad Video HALO™ (QVH), the Company has been notified that it passed the specific Immunity and Emission standards required by IEC 60601-1-2:2007. The Company has now filed all paper necessary for safety component approval and is not expecting any further required changes in the final QVH. Formal certification is expected shortly and will be announced upon receipt.
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced it has successfully filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for aceneuramic acid prolonged release (Ace-ER; UX001) tablets intended for patients with GNE Myopathy. Ace-ER is designed to replace the deficient sialic acid substrate in patients with GNE Myopathy, also known as Hereditary Inclusion Body Myopathy (HIBM), a rare, progressive muscle-wasting disease. "We have reached an important milestone for both Ultragenyx and patients living with GNE Myopathy," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer of Ultragenyx. "It is the company's first filing for marketing approval, just five years after its founding, and the first marketing application of a potential treatment for patients affected by this progressive debilitating muscle disease." Ultragenyx is seeking to obtain conditional approval from the EMA for Ace-ER for the treatment of adult patients with GNE Myopathy. The MAA submission is based on positive data from a Phase 2 randomized, double-blind, placebo-controlled clinical study. If a positive opinion is received from the Committee for Medicinal Products for Human Use (CHMP), a decision from the European Commission would be expected in the second half of 2016.
XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced publication of clinical results from a Phase 2 open label, randomized, parallel-group, multicenter study examining SFA restenosis in patients following successful percutaneous revascularization. The results, now available online as an "Article in Press" in the Journal of Vascular Surgery, point towards Xilonix's potential as a safe and effective therapy to preserve vessel patency after endovascular intervention. This program has previously been granted Fast Track Designation by the US FDA. In the article titled, "A Randomized Phase II Study of Xilonix, a Targeted Therapy Against Interleukin 1 alpha, for the Prevention of Superficial Femoral Artery Restenosis After Percutaneous Revascularization," XBiotech reported that researchers observed tendencies toward improved vessel patency and fewer major adverse cardiovascular events following dosing of MABp1 over a 3-month period. Hosam El Sayed, M.D., Ph.D., associate professor of surgery in the Division of Vascular Diseases and Surgery at The Ohio State University Medical Center and lead author, said, "The cardiovascular field has marked many advancements in recent years, and endovascular interventions to treat peripheral arterial disease have saved and improved many lives, however, the natural history of these lesions after intervention appears to be progression to restenosis. Even as initial reports on newer endovascular technologies have reported lower rates of restenosis of arteries in the lower extremities, a systemic pharmacologic approach to prolong the restenosis free duration would be a major step forward for the treatment of these patients."