IGI Labs Announces FDA Approval And Commercial Launch Of Diclofenac Sodium; Dynavax to Continue Phase 3 Study of HEPLISAV-B(TM) Print E-mail
By Josh Gee   
Thursday, 09 July 2015 19:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 9, 2015.
IGI Laboratories, Inc. (NYSE MKT: IG), announced it has launched its seventh product, diclofenac sodium 1.5% topical solution, after receipt of the final approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The Company now markets seven products in twelve presentations in an IGI label.
Diclofenac sodium topical solution 1.5% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain from osteoarthritis of the knee. Based on IMS Health data for May 2015, the total addressable market for this product is approximately $13.3 million. IGI originally submitted this ANDA to the FDA in December 2010.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Today's action by the FDA represents our second drug approval for a product organically developed from beginning to end by our IGI team. In anticipation of this approval, we have already secured orders from our customers, and we are ready to fulfill these orders immediately.''
''We now have twenty-seven submissions, exclusive of our four partnered submissions, pending approval by the FDA, with a combined addressable market of over $939 million based on May 2015 data from IMS Health, and another fifteen more submissions planned before the end of this year. Our team continues to execute our R&D plan as part of our mission to become a leading player in the specialty generic prescription drug market."
Dynavax Technologies Corporation (NASDAQ: DVAX) announced the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from HBV-23, the ongoing Phase 3 clinical study of HEPLISAV-B, Dynavax's investigational adult hepatitis B vaccine, has completed its third prespecified review and has recommended that the study continue unchanged.
The third DSMB review included safety data for all enrolled subjects collected through the data cut-off in June. As of the cut-off, all continuing subjects who had received the second immunization (which was the last active dose for HEPLISAV-B subjects) had reached at least 8 months of the requisite one year follow-up after the second immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the DSMB recommended continuing HBV-23 with no change to the study.
Over 2,200 subjects have completed their final study visit and all study visits for HBV-23 are expected to be completed by October 2015. Top line results are expected to be released by early 2016.
Separately, Dynavax announced that its cash, cash equivalents and marketable securities at June 30, 2015 were approximately $93.4 million, which does not include approximately $28.8 million in additional cash resulting from stock sales following the end of the quarter under the Company's at-the-market sales agreement ("ATM agreement"). The ATM agreement has concluded because the Company has reached $50 million of gross proceeds as specified in the ATM agreement. At July 8, 2015, the Company had approximately 31,400,000 shares of common stock outstanding and approximately 17,000 shares of preferred stock outstanding which are convertible into approximately 1,700,000 shares of common stock.
Also Thursday:
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the completion of recruitment of its Phase 3 EASE LID study. EASE LID is a confirmatory trial designed to evaluate the efficacy and safety of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID), a motor complication associated with the treatment of Parkinson's disease.
Allscripts Healthcare Solutions, Inc. (Nasdaq:MDRX) will report its financial results for the three months ended June 30, 2015, after the close of regular stock market hours on Tuesday, August 4, 2015. 
The Pima County Board of Supervisors July 7 voted unanimously to approve a lease for an expansion of Accelerate Diagnostics (Nasdaq:AXDX) at the county's Abrams Public Health Center, 3950 S. Country Club Road.
Bacterin International Holdings, Inc. (OTCQX:BONE), a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced preliminary, unaudited revenue for the second quarter of 2015.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today the appointment of Rita Shaknovich, M.D., Ph.D. as Group Medical Director and Vice President of Hematopathology Services. 
Endologix, Inc. (NASDAQ:ELGX), developer and marketer of minimally invasive treatments for aortic disorders, announced today details relating to the release of its second quarter 2015 financial results, which will take place on Monday, August 3, 2015 after the close of the market.
Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on designing, developing and commercializing products for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced that John Bakewell, Chief Financial Officer of Lantheus Holdings, Inc. (NASDAQ:LNTH), has been appointed to its Board of Directors and will be serving on the audit committee, effective July 7, 2015.
Genmab A/S (OMX: GEN) announced its licensing partner Janssen Biotech, Inc. has completed the rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab. 
Herborium® Group, Inc. (OTC Pink: HBRM), has launched the next generation, US and global markets focused websites for its unique lead product for all natural treatment of acne and rosacea, AcnEase. 
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that it has appointed Alan Milinazzo to its board of directors as a Class I director, effective immediately. 
Merge Healthcare Incorporated (NASDAQ:MRGE), a leading provider of innovative enterprise imaging, interoperability, and clinical systems that seek to advance healthcare, today announced Summa Health, one of the largest integrated healthcare delivery systems in Ohio, will integrate Merge's cardiology solutions to support population health initiatives. 
Neptune Technologies & Bioressources Inc. (NASDAQ:NEPT) (TSX:NTB), announces that the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO) has denied Aker and Enzymotec's (collectively the "Petitioner") request for a rehearing of certain claims in Neptune's '351 patent (U.S. Patent: 8,278,351).
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that, effective July 10, 2015, American Stock Transfer & Trust Company (“AST”) will replace Signature Stock Transfer as its stock transfer and dividend disbursing agent.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that the Company will release 2015 second quarter financial results after market close on Thursday, July 23, 2015. Company management will host an investment-community conference call beginning at 2:30 p.m. Mountain Time (4:30 p.m. Eastern Time) on Thursday, July 23 to discuss those results and to answer questions.
StemCells, Inc. (Nasdaq:STEM), in cooperation with the International Society for Stem Cell Research (ISSCR), has posted a video of the presentation made by the Company's vice president of clinical research and chief medical officer Dr. Stephen Huhn, at the ISSCR 2015 Annual Meeting.
TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ), a global bacteria decontamination and infection prevention company, received an endorsement of its SteraMist™ solutions from its customer the Caja del Seguro Social (CCS), Panama's Social Security program that provides healthcare to almost 90% of the country's population.
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive interim data from the first 12 patients in the ongoing pediatric Phase 2 study for its recombinant human monoclonal antibody KRN23 against fibroblast growth factor 23 (FGF23) for the treatment of X-linked hypophosphatemia (XLH).
Urologix, Inc. (OTCQB:ULGX), the leading provider of in-office procedures for the safe, durable and effective treatment of BPH,  today announced its decision to terminate and suspend the registration of its stock with the Securities and Exchange Commission (the “SEC”). 
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, announced the presentation of a poster at the International Liver Transplantation Society's 21st Annual International Congress in Chicago, Illinois earlier today.

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