|Protea commences REDIchip shipments; Flexion Expands Supply Capacity for FX006|
|By Josh Gee|
|Tuesday, 04 August 2015 19:01|
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 4, 2015.
Protea Biosciences Group, Inc. (OTCQB: PRGB) announced it has commenced shipments of a new, proprietary, silicon nanochip, known as REDIchip, that reduces the time to identify and quantify small molecules in biofluids. Initial shipments have been made to customers in North America, Europe and Asia.
Known as REDIchip™ (“Resonance-Enhanced Desorption Ionization”), the product employs a patented, “nanopost array” (NAPA) nanotechnology invented in the laboratory of Prof. Akos Vertes, PhD., Department of Chemistry, The George Washington University, and exclusively licensed to Protea.
“We are pleased to have commenced shipments of REDIchips to our customers. REDIchip greatly improves a researcher’s ability to rapidly detect and quantify small molecules in biofluids, in a contaminant-free environment. REDIchip employs a highly organized, high density nanopost array design that produces 27 million nanoposts for each two millimeter spot”, stated Steve Turner, Protea CEO. He added, “REDIchip provides exceptional sensitivity and reproducibility of results.”
REDIchip technology was developed by Protea in conjunction with a $14 million DARPA cooperative research agreement led by The George Washington University and including GE Global Research and SRI International. The DARPA project goal is to develop new tools to elucidate the mechanism of action of a threat agent, drug, biologic or chemical on living cells within 30 days from exposure. Uncovering the mechanism of action of such agents in 30 days compared to the years currently required will enhance and support the development of effective threat countermeasures.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced it has entered into a strategic manufacturing and supply agreement with Patheon, a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharmaceutical industries, for the manufacture of FX006, Flexion's lead program. This agreement will complement Flexion's existing manufacturing relationship with Evonik Corporation and create redundant supply for FX006, which is an intra-articular (IA) sustained-release steroid for the treatment of osteoarthritis (OA). Patheon and Flexion will establish a dedicated manufacturing suite at Patheon's specialty sterile manufacturing facility in Swindon, England, to allow Flexion greater control of unit production and provide added scale to meet long-term product demand.
Flexion expects to report topline data from a pivotal Phase 2b clinical trial of FX006 in September 2015 and has recently completed enrollment of patients in a Phase 3 clinical trial, each of which is exploring FX006 as a treatment for pain associated with OA of the knee.
"With data from our second FX006 pivotal trial expected during the first quarter of 2016, entering into a complementary manufacturing agreement with Patheon, a world-class CMO, is important at this time as we prepare for the potential submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration for FX006 in 2016," stated Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We believe having two leading manufacturers to the global biopharmaceutical industry as our partners will help ensure that we have appropriate supply capacity and redundancy in manufacturing capabilities for the future commercialization of FX006."
Under the agreements with Patheon, Patheon will be responsible for the construction of the dedicated manufacturing suites, installation and validation of the manufacturing equipment and the potential commercial manufacture of FX006. Flexion will oversee the purchase and design of the dedicated manufacturing equipment to be installed in the facility and will have personnel on-site to ensure the optimization of Flexion's proprietary manufacturing process.
"This agreement with Flexion is testament to our company's mission to be a critical partner to our customers who rely on our customized formulation, development and manufacturing expertise to address their growing needs," said Antonio Magnelli, Senior Vice President, European Commercial Operations, Patheon. "We are pleased to have been selected by Flexion to support the manufacturing needs for FX006."
Allscripts Healthcare Solutions, Inc. (NASDAQ:MDRX) announced its financial results for the three and six months ended June 30, 2015.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today financial results for the second quarter ended June 30, 2015.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced the closing of its underwritten public offering of 4,327,956 shares of its common stock at a public offering price of $18.60 per share, which included 564,516 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares.
Cerner Corporation (Nasdaq:CERN) today announced results for the 2015 second quarter that ended July 4, 2015.
The Cooper Companies, Inc. (NYSE:COO) today announced it will release third quarter 2015 financial results on Thursday, September 3, 2015, at 4:00 PM ET.
Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced financial results for the second quarter ending June 30, 2015, and provided a clinical update.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that it entered into a syndicated senior secured term loan facility with MidCap Financial and Silicon Valley Bank that allows Flexion to borrow up to $30 million at an annual interest rate of 6.25 percent with a maturity of February 2020, subject to certain conditions and other applicable fees.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has priced its previously announced underwritten public offering of 3,300,000 shares of its common stock at $61.00 per share. In connection with the offering, Integra has also granted the underwriters a 30-day option to purchase an additional 495,000 shares of common stock.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive technologies and techniques, today reported financial results for the second quarter ended June 30, 2015.
Macrocure Ltd. (NASDAQ:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today provided a corporate update and reported financial results for the second quarter and six months ended June 30, 2015.
NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the second quarter ended June 30, 2015.
National Research Corporation (NASDAQ:NRCIA) and (NASDAQ:NRCIB) today announced results for the second quarter of 2015.
Novadaq Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, announced today that management will present an update on the Company's business at the Canaccord Genuity 35th Annual Growth Conference on Wednesday, August 12, 2015 at 9:00 a.m. Eastern Time.
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the second quarter of 2015.
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing novel therapies for treatment of cancer, today reported financial results for the quarter ended June 30, 2015.
Sabra Health Care REIT, Inc. (NASDAQ:SBRA) today announced results of operations for the second quarter of 2015.
T2 Biosystems (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, today announced the appointment of veteran finance and operations management executive Maurice Castonguay as the Company's chief financial officer (CFO), effective immediately.
T2 Biosystems (NASDAQ:TTOO) today reported operating highlights and financial results for the second quarter ended June 30, 2015. Recent operational highlights included:
TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation Prime® Abdominal Stent Graft System, today reported financial results for the second quarter ended June 30, 2015.
Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that Mr. Jay Shepard, President and Chief Executive Officer, is scheduled to present at the Canaccord Genuity 35th Annual Growth Conference on Wednesday, August 12, 2015 at the InterContinental in Boston, Massachusetts.
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, reported today its operating and financial results for the second quarter ended June 30, 2015.
Xtant Medical Holdings, Inc. (OTCQX:BONE), a leader in the development of revolutionary bone graft material, today announced that it will release its financial results for the period ended June 30, 2015, at the close of the financial markets on August 12, 2015.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that it will host a conference call on Tuesday, August 11, 2015 at 4:30 p.m. ET to discuss its financial results for the second quarter ended June 30, 2015.