Heron Reports Positive Top-Line Results from Phase 2 Study of HTX-011; Impax Receives FDA Approval for Generic Version of Testred® C-III Print E-mail
By David Fowler   
Tuesday, 22 September 2015 19:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 22, 2015.
Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, today announced positive, top-line results from its Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. The primary and all key secondary endpoints in the study were met with a high degree of statistical significance.
This randomized, placebo-controlled, double-blind, Phase 2 clinical study in 64 patients undergoing bunionectomy evaluated the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. The primary endpoint was the difference as compared to placebo in pain intensity as measured by the Summed Pain Intensity (SPI) score in the first 24 hours post-surgery (SPI 0-24). Key secondary endpoints included: the difference in SPI in the first 48 hours post-surgery (SPI 0-48); the difference in SPI in the first 72 hours post-surgery (SPI 0-72); time to the first use of opiate rescue medication; and the percent of patients who received no opiate rescue medication in the first 72 hours post-surgery. The study's major efficacy findings for the more effective, 400 mg dose of HTX-011 as compared to placebo include:    Pain intensity in the first 24 hours post-surgery was reduced by 69% (SPI of 38.5 versus 124.2, p<0.0001);  Pain intensity in the first 48 hours post-surgery was reduced by 52% (SPI of 106.9 versus 224.8, p<0.0001);   Pain intensity in the first 72 hours post-surgery was reduced by 40% (SPI of 170.2 versus 285.9, p=0.0064);   Time to the first use of opiate rescue medication was increased by 488% (48.2 hours versus 8.2 hours, p<0.0001);    32% of patients received no opiate rescue medication during the entire 72-hour period post-surgery, compared to 5% for placebo (p<0.0001);   HTX-011 was generally well tolerated in the study. The most frequent adverse events reported were headache, nausea, vomiting, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related.
"Although opioid analgesics are standard of care for post-operative pain management, too often they are associated with unacceptable adverse effects often prolonging hospitalization and recovery," stated Jeffrey A. Gudin, MD, Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center, Englewood, NJ. "Thus, there is a major unmet need for a pain management treatment that can substantially reduce our dependence on post-operative opioids. The ability of HTX-011, administered once during surgery, to significantly reduce pain and the need for pain medications for three days following surgery (as compared to a control group) is truly promising."
"At Heron, we are dedicated to the development of best-in-class medicines that can have a major impact on patients' lives," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "We are very pleased with these results, and we now will turn our attention to executing on a broad-based development program designed to enable us to bring HTX-011 to the many patients undergoing a wide range of surgeries who experience significant post-operative pain."
Conference Call and Webcast   ---   Heron Therapeutics will host a conference call and webcast on Wednesday, September 23 at 8:30 a.m. ET (5:30 a.m. PT). The conference call can be accessed by dialing (877) 311-5906 for domestic callers and (281) 241-6150 for international callers. Please provide the operator with the passcode 46461973 to join the conference call. The conference call will also be available via webcast under the investor relations section of Heron's website at www.herontx.com and will be archived there for 90 days following the call. Please connect to Heron's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
Impax Laboratories, Inc. (NASDAQ: IPXL) announced the U.S. Food and Drug Administration has approved its generic version of Testred Capsules 10 mg.
"This represents the second Abbreviated New Drug Application approval from the Hayward, CA facility following resolution of the warning letter in early September 2015," said Fred Wilkinson, President and Chief Executive Office of Impax. "We expect to be the first generic methyltestosterone capsule to the market and are in the final stages of preparing for commercialization through Impax's generic division."
According to IMS Health (NSP), U.S. brand sales of methyltestosterone 10 mg products were approximately $14.5 million for the 12 months ending in July 2015.
Also Tuesday:
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced that it will present at the Ladenburg Thalmann 2015 Healthcare Conference on September 29, 2015 in New York City at the Sofitel New York.    Adam Grossman, President and Chief Executive Officer will provide a corporate overview, which is scheduled for 3:30 PM ET. A live webcast may be accessed under the "Investor Relations" tab on the Company's website at www.admabiologics.com. A replay of the webcast will be available after the conclusion of the live event.
athenahealth, Inc. (NASDAQ:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced results from the 10th annual Epocrates Future Physicians of America survey. The results reveal the opinions of more than 1,000 medical students on medical school training, the future of technology, and industry challenges.
Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical company focused on the discovery and development of direct-acting antivirals that address infections that have limited therapeutic options, announced today that Biota's CEO & President Joseph Patti, PhD will present a corporate overview at the Ladenburg Thalmann 2015 Healthcare Conference on Tuesday, September 29, 2015 at 2:30 p.m. ET in New York, NY.    A live webcast of the presentation can be accessed under "Events and Presentations" in the Investors section of the Company's website at www.biotapharma.com or at http://wsw.com/webcast/ladenburg/bota.
Caladrius Biosciences, Inc. (NASDAQ:CLBS), a cell therapy company combining an industry-leading external development and manufacturing provider (PCT) with a development pipeline in immunotherapy, announced today that it has entered into a collaboration agreement with Sanford Research ("Sanford") to develop the Company's T regulatory cell therapy product candidate CLBS03 for the treatment of adolescents with recent-onset type 1 diabetes (T1D). The initial focus of the collaboration will be the execution of a prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate the safety and efficacy of CLBS03 in adolescents. The Phase 2 study (The Sanford Project Trutina Study) has an open and active IND and subject enrollment is expected to commence as early as the first quarter of 2016.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that it will present a poster at the 8th World Congress on Itch, which will be held at the Nara Kasugano International Forum IRAKA in Nara, Japan. The poster will discuss positive data from Cara's Phase 2 study of I.V. CR845 in uremic pruritus, a chronic systemic itch condition in patients with renal failure, often receiving hemodialysis. CR845 is the Company's first-in-class peripherally-selective kappa opioid agonist currently in development for the treatment of acute and chronic pain and pruritus.
CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for prenatal and postnatal developmental disorders and pre-implantation genetic screening services, announces that President and Chief Executive Officer Mark McDonough will present a company overview at the upcoming investment conferences:    Ladenburg Thalmann 2015 Healthcare Conference on Tuesday, September 29, 2015, at 4:00 p.m. Eastern time (1:00 p.m. Pacific time). The conference is being held at the Sofitel New York hotel in New York City;    2015 Aegis Capital Growth Conference on Friday, October 9, 2015, at 10:45 a.m. Pacific time (1:45 p.m. Eastern time). The conference is being held at the Encore at Wynn Las Vegas hotel in Las Vegas.
FBR & Co. (Nasdaq:FBRC), a leading investment bank serving the middle market, announced the successful completion of its Second Annual Healthcare Conference. The event was held on Wednesday, September 9, 2015 at the Four Seasons Hotel in Boston, Massachusetts.    Approximately fifty management teams from the biotechnology, healthcare IT, managed care, pharmaceutical services and clinical laboratories sectors participated in the conference, which brought together corporate executives and institutional investors for in-depth discussions on the future of the healthcare industry. Participants heard business strategy and general corporate updates from specific companies as well as emerging themes across the healthcare industry. With a 40% increase year over year in the number of one-on-one meetings between management teams and investors, the conference capitalized on the ongoing growth and strength of FBR's healthcare investment banking and equity research coverage.
FutureLand Corp. (OTC: FUTL), a leading provider of strategic real estate investment and grow facilities and material solutions to the global cannabis industry, today announced that it has signed a Memorandum of Understanding to acquire 35% of Raw Essentials International LTD ("REI"), a Jamaican Cannabis Company. The agreement involves all REI enterprises including bottling, growing, production, research and development, security, management and a heavy emphasis on extractions. HempTech and CB Scientific will also have major roles in this agreement. The MOU is signed to encourage greater economic relations and to facilitate domestic and bilateral trade.
Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that Peter G. Traber, M.D., chief executive officer, president, and chief medical officer of Galectin Therapeutics, will make a corporate presentation at the 2015 Ladenburg Thalmann Healthcare Conference on September 29th at 11 a.m. Eastern Time. The conference is being held at the Sofitel Hotel in New York City.     To listen to the presentation, investors may visit the investor relations section of Galectin Therapeutics' website at www.galectintherapeutics.com. An archived audio of the presentation will also be available on Galectin Therapeutics' website for 90 days.
II-VI Incorporated (NASDAQ:IIVI), a leading provider of solutions for next generation optical networks, today announced that it will showcase the new 1 Watt 980 nm pump laser product as well as the new OTDR+ product platform at the European Conference on Optical Communication (ECOC 2015) in Valencia, Spain, on Sep 28-30, 2015, in Booth # 739.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 6,900,000 shares of its common stock at a public offering price of $43.50 per share. All of the shares in the offering will be sold by Intra-Cellular Therapies. Net proceeds to Intra-Cellular Therapies from the sale of the shares, after deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $284.7 million.
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, announced today that the Company was named as a finalist in three categories for Internationale Textilmaschinen Ausstellung’s (“ITMA”) Future Materials Awards 2015.    “I would like to thank ITMA, the world’s largest international textile machinery exhibition, for recognizing our technology and efforts, and congratulate the other finalists for making the shortlist.  We are excited to once again be recognized by the ITMA for our technology and our contributions to the industry.  I believe that the recognition by the ITMA for the ‘Most innovative small company’, ‘Best innovation, protective textile’, and ‘Best innovation, sustainable textile’ categories is a testament to the continued effort of our team, our technology and our shareholders.  We look forward to the announcement of the winners in November,” said Kraig CEO and founder, Kim K. Thompson.
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that Mahesh Patel, President and CEO, and Morgan Brown, Executive Vice President and CFO, will present a company overview at the Ladenburg Thalmann 2015 Healthcare Conference on Tuesday, September 29, 2015 at 11:30 a.m. ET.    A live audio webcast of the presentation will be available via the "Investor Relations" page of the Lipocine website, www.lipocine.com. Please log on through Lipocine's website approximately 10 minutes prior to the scheduled start time. A replay of the webcast will also be archived on Lipocine's website for 90 days following the presentation.
MRI Interventions, Inc. (OTCQB:MRIC) today announced that it has received a Phase II grant award from the National Institutes of Health (NIH) for the development of clinical grade, MRI-safe Myocardial Biopsy Forceps. The Company previously completed a Phase I grant for the initial development phase of this technology, and will now enter the next phase of development.
Nanosphere, Inc. (NASDAQ:NSPH), a company enhancing medicine through targeted and flexible molecular diagnostics, announced that new clinical data for the Verigene® Gram-Positive (BC-GP) and Gram-Negative (BC-GN) Blood Culture Tests for rapid sepsis diagnostics were presented during Sepsis Awareness Month at the 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held last week in San Diego, CA.    Four of the five studies presented at ICAAC 2015 included an analysis of the impact of Verigene BC-GP and/or BC-GN on patient outcomes. Results from each of these studies showed a reduction in patient length-of-stay in the hospital or ICU, reduction in the time to organism identification, and reduction in time to optimal therapy.
NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer, announced today that the company will participate in PurpleStride Iowa, a Pancreatic Cancer Action Network (PanCAN) event to promote awareness and raise funds for the fight against pancreatic cancer, the nation’s fourth leading cause of cancer death. The PurpleStride Iowa PanCAN walk is on Saturday, Sept. 26 at 9:30 a.m. at Raccoon River Park.
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that it will host its 3rd annual Analyst and Investor Meeting on Tuesday, September 29, 2015 from 9:00 a.m. – 11:00 a.m. ET in New York, NY.    Senior management will conduct a series of presentations to update analysts and investors on the Company’s ongoing clinical development programs. In addition, a key opinion leader will provide a clinical perspective on respiratory syncytial virus (RSV) disease.
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, will host an Analyst & Investor Day on Monday, November 16, 2015. The event will be held at the Sofitel Hotel in New York, NY from 9:00 a.m. to approximately 12:00 p.m. Eastern Time.     The program will include presentations by NOVADAQ President and Chief Executive Officer, Dr. Arun Menawat, Senior Vice President and General Manager, Dr. Rick Mangat, and Chief Financial Officer, Roger Deck. In addition, leading physicians from prestigious medical institutions will discuss their clinical experiences using NOVADAQ's fluorescence imaging solutions.
OpGen, Inc. (NASDAQ:OPGN) today announced that data on its Acuitas® Resistome Test and Acuitas Whole Genome Sequence (WGS) Analysis for multidrug-resistant organisms (MDROs) will be presented at the American Society for Microbiology's First Conference on Rapid Next-Generation Sequencing and Bioinformatic Pipelines for Enhanced Molecular Epidemiologic Investigation of Pathogens, to be held from September 24 to 27 in Washington, D.C.    Terry Walker, OpGen Senior Vice President of Research and Development and a presenter at the OpGen-sponsored symposium at the ASM conference, said, "Our symposium presentation and three posters underscore our technologies' rapid and highly accurate approach to determine the genetic variability underlying multidrug resistant organisms, and how to use that variability to investigate transmission events, help stop spread, and prevent outbreaks."
Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today announced that members of the senior management team will present and participate in investor meetings at the Ladenburg Thalmann 2015 Healthcare Conference on September 29 at 1:00 PM EDT at The Sofitel Hotel in New York, NY.
Radius Health, Inc. (Nasdaq:RDUS) announced today that it plans to host a conference call and webcast on Thursday, September 24, 2015, to provide an update on the safety and tolerability profile of RAD1901, a selective estrogen receptor degrader, from the completed Phase I study of RAD1901 in 52 healthy volunteers.   On November 5-9, 2015, Radius plans to present one poster with an oral presentation from its investigational drug RAD1901 clinical development program at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting in Boston, MA. The title of the poster and oral presentation is:    RAD1901, an orally available selective estrogen receptor down regulator, has potent anti-tumor activity in in vitro and in vivo models of ER+ breast cancer
RadNet, Inc. (NASDAQ:RDNT), a national leader in providing high-quality, cost-effective diagnostic imaging services through a network of owned and operated outpatient imaging centers, announced today the addition of Lawrence N. Tanenbaum, M.D., FACR to both its operational and clinical teams. Dr. Tanenbaum will serve as Vice President and Medical Director East Region - Director of CT, MR and Advanced Imaging.    Dr. Tanenbaum's operational and management responsibilities will focus on (i) leveraging his unique knowledge of CT and MRI equipment, protocols and workflow to help optimize clinical and operational performance and (ii) utilizing his expertise and luminary status within the industry to drive new business to our centers.
REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company in gene therapy, today announced the closing of its initial public offering of 7,245,000 shares of common stock at a public offering price of $22.00 per share, which includes 945,000 shares of common stock issued upon the full exercise by the underwriters of their option to purchase additional shares. The gross proceeds from the initial public offering to REGENXBIO were approximately $159.4 million, before underwriting discounts and estimated offering expenses.    Morgan Stanley and BofA Merrill Lynch acted as active joint book-running managers of the proposed offering. Piper Jaffray acted as a passive book-running manager. Chardan Capital Markets acted as a co-manager.
Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today announced that Jeff Hatfield, President and Chief Executive Officer, will ring the NASDAQ Closing Bell at the NASDAQ MarketSite in Times Square today at 4:00 p.m. ET.    Mr. Hatfield will be joined by Vitae's executive leadership team to recognize the one-year anniversary of the Company's initial public offering (IPO).
Wellness Center USA, Inc. (OTCQB:WCUI), today announced that its wholly-owned subsidiary, StealthCo, Inc. (dba Stealth Mark), has introduced ActiveDuty, its new proprietary anti-counterfeit digital threat assessment platform. ActiveDuty is a powerful cyber intelligence service and market research tool that empowers clients to proactively identify the possible threats regarding counterfeit and diversion activities.    The ActiveDuty platform is a breakthrough solution for Stealth Mark bringing a multitude of benefits to the company and its clients.  In addition to creating a new revenue stream, the market research capability of ActiveDuty will allow Stealth Mark to partner with corporations to define and create tailored, proactive approaches and strategies that go well beyond conventional methods in protecting corporate brands and assets.  
Xtant Medical Holdings, Inc. (OTCQX:BONE), a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, Bacterin International, Inc., has received notification that the United States Patent and Trademark Office has issued US Patent No. 9,114,191 entitled "Process for Demineralization of Bone Matrix with Preservation of Natural Growth Factors." The patent covers demineralized bone matrices derived from cortical bone, which include Bacterin's branded product lines OsteoSTX®, OsteoWrap®, and OrbitalWrap® HD. Bacterin has pending patent applications in the United States to pursue protection on other aspects of its allograft processing and demineralization technologies.

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