|Aeterna Zentaris Announces Selection of Ergomed for Macrilen; Exactech Receives FDA 510k Clearance for Its Optetrak Logic Constrained Condylar Prosthesis|
|By Marilyn Mullen|
|Thursday, 25 June 2015 18:59|
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 25, 2015.
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) announced it has executed a definitive agreement with Ergomed PLC, pursuant to which Ergomed will manage the new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency.
David A. Dodd, Chairman, President and Chief Executive Officer of the Company remarked regarding the selection of Ergomed, "We have great confidence in Ergomed's ability to conduct our confirmatory clinical study of Macrilen™ on schedule and within budget. Ergomed's performance as our clinical research organization supporting our pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer has been excellent. We are committed to Macrilen™ because of our confidence in its efficacy and safety and the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD."
Miroslav Reljanovic, M.D., CEO of Ergomed said, "We are delighted that Aeterna Zentaris has selected us to manage their confirmatory study of Macrilen™. We have a strong and deep working relationship with the Company's scientific staff and hold them in the highest regard."
About the Study -- The confirmatory Phase 3 clinical study of Macrilen™ will be conducted as a two-way crossover study with the insulin tolerance test as the benchmark comparator. The study population will consist of patients with a medical history documenting risk factors for AGHD and will include a spectrum of patients from those with a low risk of having AGHD to those with a high risk of having the condition. Based on meetings with the US FDA as well as the European Medicines Agency (the "EMA") and subsequent written scientific advice, the Company believes that the study meets FDA's and EMA's study-design expectations allowing US and European approval, if successful.
Exactech, Inc. (NYSE: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced it has received clearance from the U.S. Food and Drug Administration to market the Optetrak Logic® Constrained Condylar (CC) Prosthesis for revision knee arthroplasty cases.
Exactech CEO David Petty said, "The FDA clearance of Optetrak Logic CC further expands the Exactech Knee system offerings for surgeons who desire predictable and reproducible outcomes. Our new revision system will give knee surgeons additional options to treat their patients with revision total knee surgery including difficult challenges like significant bone loss."
A surgeon-focused, patient-driven innovation, Optetrak Logic CC offers a modern solution for reproducibility in the most complex and challenging knee arthroplasty cases. The new addition to Exactech's clinically recognized knee system introduces an advanced implant system and precision tools to consistently achieve optimized implant placement and bone coverage.
The Optetrak Logic CC Prosthesis is indicated for use in patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; this device is also indicated for when previous devices have failed.
Surgeons around the world have documented excellent Optetrak® results.1 Offering advanced approaches to knee replacement, the Exactech Knee system combines a clinically-recognized system of proven implant system with personalized surgical workflows for reproducible outcomes, case after case.
The Optetrak Logic CC system will have limited availability in 2015, ramping up to a full market launch in 2016.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced the appointment of Gregory D. Perry as chief financial officer, effective July 6, 2015.
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, announces that it convened its Annual Meeting of Stockholders earlier today.
Alliqua BioMedical, Inc. (Nasdaq:ALQA), a provider of advanced wound care products today announced that a review of an observational study, focusing on the use of the Company's Biovance Amniotic Tissue Allograft to treat chronic wounds was published in WOUNDS, the most widely-read, peer-reviewed journal focusing on wound care and wound research.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) and the Centralized Procedure has begun for the oral small molecule pharmacological chaperone Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. As previously announced, Galafold is the first investigational Fabry drug to be granted Accelerated Assessment in the EU.
Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, and Dinaco Importação Comércio S.A. ("Dinaco"), a Brazilian company specializing in cosmetic product distribution for the Brazilian market, today announced an exclusive re-seller agreement for Amyris's Neossance® cosmetic ingredients in Brazil. Dinaco, which distributes products and ingredients for many of the world's most important cosmetics and other manufacturers, will purchase and exclusively re-sell Amyris's Neossance® Squalane and Neossance® Hemisqualane products throughout Brazil.
Aquinox Pharmaceuticals, Inc. (Nasdaq:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced today results from its Phase 2 LEADERSHIP randomized clinical trial investigating the therapeutic potential of AQX-1125 in treating pain in patients with bladder pain syndrome/interstitial cystitis (BPS/IC).
BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage orphan disease-focused biotechnology company, announced today that it has been granted Orphan Drug Designation by the European Commission for Cabaletta for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD).
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced pre-treatment biomarker and histology data from the first 16 patients enrolled in the company's Phase 2b clinical trial of its lead drug candidate, emricasan, in post-orthotopic liver transplant (POLT) recipients.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced that the latest Ekso Bionics robotic gait therapy software upgrade, first available in Europe, will be revealed at the 28th Annual Meeting of the German Speaking Medical Society for Paraplegia (DMGP) in Kassel, Germany.
HealthEquity, Inc. (Nasdaq:HQY), one of the largest HSA custodians, today announced that the company has been added to the S&P SmallCap 600 Index effective after market close on June 25, 2015.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired two additional provider groups, Arcwell Medical, a post-acute internal medicine practice, and Innovative PsychiatriCare, a post-acute psychiatry group, both headquartered in the New York metro area.
Herborium® Group, Inc. (OTC Pink: HBRM), a Botanical Therapeutics® Company and the provider of unique all botanical medicinal products (Botanical Therapeutics®) that target dermatological problems such as acne, and other health and wellness concerns, reports that its sales for the Second Quarter of 2015 grew by 10% in comparison to the same period of 2014, and by over 30% for the 6 months period of 2015 in comparison to the same period of 2014.
Premier, Inc. (Nasdaq:PINC) has recognized more than 120 hospitals, health systems and suppliers for their outstanding work to improve community health and reduce costs.
SANUWAVE Health, Inc. (OTCQB:SNWV) announced today that the Company will release an update on the Phase III supplemental clinical trial using the dermaPACE® for treating diabetic foot ulcers on June 30, 2015.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced the presentation of six abstracts at the 2015 Multinational Association of Supportive Care in Cancer (MASCC/ISOO) Annual Meeting, June 25 to 27, 2015, in Copenhagen.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the Board of Directors has elected Daniel G. Welch as the Company's non-executive Chairman of the Board effective June 18, 2015. Mr. Welch, Executive Partner at Sofinnova Ventures and former Chairman and Chief Executive Officer at InterMune, Inc., has served as an independent director to Ultragenyx since April 2015.