FDA Approves Genentech’s Cotellic™ in Combination With Zelboraf®; FORUM Announces Removal of Partial Clinical Hold on Phase 3 Encenicline Program Print
By Josh Gee   
Wednesday, 11 November 2015 20:07
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 11, 2015.   
 

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the U.S. Food and Drug Administration approved Cotellic™ (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf ® (vemurafenib). Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. Cotellic is Genentech’s seventh new medicine approved by the FDA in the past five years.

   
“When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”
   
Today’s FDA approval is based on results from the Phase III coBRIM study, which showed Cotellic plus Zelboraf reduced the risk of disease worsening or death (progression-free survival; PFS) by about half in people who received the combination (HR=0.56, 95 percent CI 0.45-0.70; p<0.001), with a median PFS of 12.3 months for Cotellic plus Zelboraf compared to 7.2 months with Zelboraf alone. An interim analysis also showed the combination of Cotellic and Zelboraf helped people live significantly longer (overall survival) than Zelboraf alone (HR=0.63, 95 percent CI 0.47-0.85; p=0.0019). The objective response rate (tumor shrinkage) was higher with Cotellic plus Zelboraf compared to Zelboraf alone (70 vs. 50 percent; p<0.001), as was the complete response rate (complete tumor shrinkage, 16 vs. 10 percent).
   
Possible serious side effects with Cotellic include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of Cotellic include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. Cotellic can also cause changes in blood test results.
   
The final overall survival analysis from the coBRIM study will be presented at the Society for Melanoma Research (SMR) 2015 International Congress held in San Francisco, California from November 18-21.
   
In September, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a positive opinion for Roche’s marketing authorization application for Cotellic in the European Union. A decision from the European Commission is expected before the end of 2015. Cotellic was approved in Switzerland by Swissmedic in August 2015.
   
Cotellic will be available to people in the United States within two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Cotellic in combination with Zelboraf through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at http://www.Genentech-Access.com.
   
   
   
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FORUM Pharmaceuticals Inc., a biopharmaceutical company singularly focused on the development and
delivery of transformative medicines to treat serious brain diseases, today announced that the U.S. Food and Drug Administration (FDA) has removed a partial clinical hold on the Phase 3 encenicline program for cognitive impairment in schizophrenia (CIS). This partial hold applied to a 26 week Phase 3 extension study. The two global Phase 3 efficacy and

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safety trials evaluating the use of encenicline to treat CIS are nearing completion, with top-line results anticipated in the first half of 2016.
    
“We are enthusiastic about the FDA’s decision to lift the partial clinical hold on the encenicline CIS program because it enables us to continue to move the schizophrenia program forward,” said Deborah Dunsire, M.D., President and
Chief Executive Officer of FORUM. “If supported by Phase 3 trial results, we would plan to submit a New Drug Application (NDA) for approval by the FDA. There are no therapies currently available to treat CIS and we believe that encenicline has the potential to benefit patients and families affected by this condition.”
    
Phase 3 trials of encenicline to treat Alzheimer’s disease remain on clinical hold while FORUM gathers and analyzes trial data, which will be discussed with the FDA during 2016, to potentially lift the hold and define a possible path forward for encenicline in Alzheimer’s disease.
   
   
   
   
   
Also Wednesday:
   
   
   
   
Akers Biosciences, Inc. (NASDAQ:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, will hold a conference call on Friday, November 13, 2015 at 09:00 a.m. Eastern Time to discuss its earnings, which will be published earlier that day, for the third quarter (and nine month) period ended September 30, 2015.
Akers Bio's Co-Founder and Executive Chairman, Raymond F. Akers, Jr. PhD, and Vice President of Finance, Gary Rauch, will host the call and be available during a question-and-answer session.
To participate in the call from within the U.S., please dial 1-888-503-8175 approximately 10 minutes prior to the scheduled start time. International callers should dial 1-719-325-2244. The Conference ID is 464156. Interested parties can also listen via a live Internet webcast, which can be found at http://public.viavid.com/index.php?id=117263
   
   
Applied Genetic Technologies Corporation (Nasdaq:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that Sue Washer, President and CEO, will present at the Stifel 2015 Healthcare Conference on November 18, 2015 at 8:00 a.m. ET in New York. Ms. Washer will provide a corporate update and review the Company's recent and upcoming milestones.
To access a live webcast of the presentation, please visit http://ir.agtc.com/events.cfm. A replay will be available for 30 days following the presentation.
    
    
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 Dr. Derek Chalmers, President and CEO, will present a company overview at the Stifel 2015 Healthcare Conference on Wednesday, November 18, 2015, at 8:45 a.m. ET in New York City.
A live webcast of the presentation can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com. An archived webcast recording will be available on the Cara website for approximately 30 days.
    
    
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it will present research data in a late-breaking poster session at The Liver Meeting® 2015, organized by the American Association for the Study of Liver Diseases' (AASLD), November 13-17, 2015 to be held at the Moscone West Convention Center in San Francisco.
The presentation will take place during the Acute Liver Failure and Artificial Liver Support session, Poster Session IV, on November 17, 2015 from 8:00 a.m. to 12:00 p.m. PT.
"Mechanism of Action of the Anti-NASH effects of Solithromycin in a Predictive NASH HCC Mouse Model" – abstract number 2246. Pierre M. Gholam, M.D. and David Oldach, M.D., will be in attendance from 10:30 a.m. until noon.
    
    
Chiasma, Inc. (NASDAQ:CHMA), a late-stage biopharmaceutical company developing Mycapssa™ (octreotide capsules), an investigational oral drug for the maintenance therapy of adult patients with the orphan disease acromegaly, today announced that management will provide an overview of the company during two upcoming investor conference presentations:
  • Stifel 2015 Healthcare Conference in New York City on Wednesday, November 18, 2015 at 4:30 p.m. ET.
  •  Oppenheimer & Co. 26th Annual Healthcare Conference in New York City on Tuesday, December 8, 2015 at 8:00 a.m. ET.
A live and archived audio webcast of each presentation will be available under the News & Investors section of Chiasma's website at www.ChiasmaPharma.com.
    
    
Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced its scheduled presentation to provide an overview of the company's programs and outlook at the Stifel 2015 Healthcare Conference in New York at 11:45 a.m. ET on Wednesday, November 18, 2015. An audio webcast and copy of the presentation will be available in the Investors section of the company's website at www.conatuspharma.com.
    
    
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that, further to U.S. District Court for the Southern District of New York dismissal of the securities class action lawsuit filed against the Company, the appeals period has concluded with no notice of appeal filed by the plaintiffs in the suit.
Marc Oczachowski, Chief Executive Officer of EDAP said, "We are pleased with the Court's decision last month and believe the ruling supported our position that the suit was without merit, a belief that was reinforced by the lack of an appeal on behalf of the plaintiffs. We look forward to putting this matter behind us and focusing on the growth of the Company following the recent receipt of FDA clearance of our Ablatherm® Robotic HIFU."
    
    
Enzymotec Ltd. (NASDAQ:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today reported financial results for the third quarter ended September 30, 2015.
    
    
Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced today that Dr. Dov Tamarkin, CEO, will provide a corporate overview and business update at the Jefferies Autumn 2015 Global Healthcare Conference in London.
Presentation Details:
Title: Jefferies Autumn 2015 Global Healthcare Conference 
Date: Wednesday, November 18
Time: 5:20 pm GMT
Location: The May Fair Hotel, London 
    
     
Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces that preclinical research from a study led by Stefanie Linch, Ph.D. in the laboratory of tumor immunology expert William L. Redmond, Ph.D. of the Providence Cancer Center's Earle A. Chiles Research Institute was presented at the Society for Immunotherapy of Cancer's (SITC) 30th Anniversary Annual Meeting. The meeting was held November 4-8 in National Harbor, Maryland. The studies presented were conducted by the Institute in collaboration with Galectin Therapeutics.
The poster presentation is titled "Galectin-3 inhibition using novel inhibitor GR-MD-02 improves survival and immune function while reducing tumor vasculature" and an abstract was published in the Journal for ImmunoTherapy of Cancer.
The study found that GR-MD-02 boosts the frequency and persistence of antigen-specific T cells in non-tumor bearing mice. Additionally, GR-MD-02 in combination with anti-OX40, a monoclonal antibody in clinical development that activates the immune system, improved survival in mammary carcinoma models, and in a prostate cancer model. The combination also reduced lung metastases in the mammary carcinoma model. Within the tumor, an increase in the number of CD8 and CD4 tumor-infiltrating lymphocytes was observed. The combination treatment also reduced functional tumor vasculature in the model. The poster is available for review here.
"We are pleased to have this poster presented at the recent Society for Immunotherapy of Cancer Annual Meeting," said Peter G. Traber, M.D., Galectin's chief executive officer, president and chief medical officer. "These data show that GR-MD-02 has multiple important effects on experimental cancer in mice which act in concert with other immunotherapy agents to reduce cancer size and metastasis, and improve survival. These are all effects that might be predicted from inhibiting galectin-3 in the pathophysiology of cancers (see CEO Perspective)."
    
    
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced the start of a randomized Phase 2 trial of CMB305, the company's "prime boost" cancer immunotherapy product candidate, combined with Genentech's investigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1) in patients with soft tissue sarcoma.
The open label trial is designed to evaluate the safety and efficacy of CMB305 in combination with atezolizumab versus atezolizumab alone in up to 80 patients with locally advanced, relapsed, or metastatic synovial sarcoma or myxoid/round-cell liposarcoma expressing the NY-ESO-1 cancer testis antigen. The trial is being conducted pursuant to a clinical collaboration with Genentech, a member of the Roche Group, which will provide atezolizumab for the trial.
CMB305 is a "prime-boost" cancer immunotherapy product designed to synergistically induce and expand in vivo cytotoxic T lymphocytes (CTLs) targeting NY-ESO-1 which is found in a broad set of tumors. Specifically, synovial sarcoma and myxoid/round-cell liposarcoma tend to express NY-ESO-1 broadly, which should make them good indications for clinical studies of this antigen-specific immune therapy. Atezolizumab is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, atezolizumab may enable the activation of T cells.
    
    
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on cancer, today announced that Carlos Paya, M.D., Ph.D., President and Chief Executive Officer, will present at the Jefferies Autumn 2015 Global Healthcare Conference on Wednesday, November 18, 2015 at 12:40 p.m. GMT, 7:40 a.m. Eastern time, in London.
A live webcast of the presentation will be available online from the investor relations page of the company's corporate website at http://ir.immunedesign.com/events.cfm. After the live webcast, an archive of each presentation will be available on the company website.
    
     
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced it will participate in the Jefferies Autumn 2015 Global Healthcare Conference in London on Thursday, Nov. 19, 2015. Sharon Mates, Ph.D., Chief Executive Officer and Chairman, will present at 10:40 a.m. GMT.
The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.
     
    
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today announced that its shares will enter the following Tel Aviv Stock Exchange, or TASE, indexes as planned on November 15, 2015: TA-100, TA-75, TA-Composite, TA-Biomed, TA-Blue-Tech and TA-Tech-Elite.
The Company is reconfirming its expectation of completing a previously-announced registered direct offering of its common stock to selected investment funds in Israel that are required to hold securities included within certain stock indexes of the TASE. The final number of shares to be sold in the offering will be determined based upon the number of shares the purchasers are required to hold within the indexes, and subject to the purchasers' desired allocation amounts.
   
    
MELA Sciences, Inc. (NASDAQ:MELA), a medical technology company dedicated to developing and commercializing innovative products for the treatment and diagnosis of serious dermatological disorders, today announced that Christina L. Allgeier has been promoted to the post of Chief Financial Officer of MELA Sciences, Inc., effective November 9, 2015. Ms. Allgeier is a graduate of Penn State University and is a Certified Public Accountant with significant SEC experience. Ms. Allgeier joined MELA as a result of the recent acquisition of the XTRAC and VTRAC business.
Ms. Allgeier has over 15 years of experience in the medical laser field. She replaces Robert Cook who has tendered his resignation to pursue other matters, but has agreed to remain with the Company through mid-January 2016 in the role of Senior Financial Advisor.
MELA Sciences' President and CEO, Michael R. Stewart, commented, "I have worked with Christina in the past and am thrilled to have her join the MELA team in the position of CFO. I have firsthand knowledge of her background and expertise and I have every confidence that she will prove to be an invaluable asset." Mr. Stewart continued, "Christina's most recent position as Chief Accounting Officer of PhotoMedex, Inc., from whom we acquired the XTRAC and VTRAC business, makes her the perfect candidate for the MELA CFO position."
"I would like to thank Bob Cook for the dedication he has put into the Company and wish him well in his future endeavors," said Mr. Stewart.
   
    
Nabriva Therapeutics AG (NASDAQ:NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, provided a development update and reported today its financial results for the nine months ended September 30, 2015.
"We have been successfully executing on our lefamulin development program," said Dr. Colin Broom, Chief Executive Officer of Nabriva, "and I am delighted to add that we have initiated the first of our two pivotal, Phase 3 clinical trials of lefamulin for the treatment of patients with moderate to severe Community Acquired Bacterial Pneumonia (CABP). This should allow us to take advantage of the winter season in the northern hemisphere, and we plan to add additional sites, including southern hemisphere sites, over the next few months. We expect that the net proceeds from our recently completed initial public offering (IPO), together with our other cash resources, will be sufficient to enable us to fund our operations at least through the receipt of top-line clinical data from these Phase 3 CABP trials, which we anticipate in late 2017."
   
    
NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced financial results for the third quarter ended September 30, 2015.
"We made solid progress in the third quarter developing our next-generation treatments for Parkinson's disease through subcutaneous administration of the first ever liquid formulation of levodopa/carbidopa to provide a better quality of life for patients suffering from this debilitating disease," said Oded Lieberman, PhD, CEO of NeuroDerm. "We look forward to executing on our streamlined clinical development program and initiating our planned clinical trials in the coming months."
    
    
NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that it has modified its U.S. development plan for ND0612H and ND0612L, the company's continuous, subcutaneously delivered levodopa/carbidopa product candidates for the treatment of Parkinson's disease. The updated and abbreviated plan incorporates written feedback that the company recently received from the U.S. Food and Drug Administration (FDA) within the framework of an ongoing Type C meeting communication that was initiated by the company. NeuroDerm asked the agency to provide strategic and operational guidance related to the U.S. clinical and regulatory development of ND0612H and ND0612L.
NeuroDerm's new development plan for ND0612H and ND0612L consists of the following:
ND0612H:    Clinical development of ND0612H for the U.S. will proceed as planned with one Phase II trial and one Phase III trial of essentially the same design, treatment duration and patient numbers as originally planned.  The Phase II trial will include centers in Israel and the EU in addition to U.S. centers, however essentially preserving the original design, number of centers, number of patients and treatment duration.
ND0612L:    Clinical development of ND0612L for the U.S. and the EU will be based on only one and not two pivotal efficacy trials of essentially the same design, treatment duration and patient numbers (200-240) as originally planned.  The second pivotal efficacy trial of 360 patients that was originally planned for this product candidate is not required by the FDA.
ND0612 Safety Follow-up:    A safety follow up study for both ND0612H and ND0612L will include at least 100 patients treated for one year of whom at least half will receive the maximum dose.  The safety follow-up studies that were originally planned included 50-150 patients treated for 6-12 months for each of the product candidates.
Timelines:    The supplier of the delivery devices used in the clinical trials of both ND0612L and ND0612H has been requested by the FDA to provide additional documentation pertaining to good manufacturing practices of the Quality System regulation.  Until documentation is provided to the satisfaction of the FDA, this supplier may not import devices into the U.S.  This does not preclude the sale or use of devices currently in the U.S. nor the importation of devices for investigational purposes if approved as part of an investigational study.  Nevertheless, NeuroDerm has decided to request additional documentation from the device manufacturer before proceeding with enrollment at U.S. investigator sites.  Patient enrollment in its upcoming clinical trials will thus begin at non-U.S. investigator sites. NeuroDerm expects that the requested documents will be provided by the supplier in the first quarter of 2016 enabling the company to start enrolling U.S. patients in the second quarter of 2016.
In the EU, the pharmacokinetic pilot dose finding study of ND0612H is ongoing and topline results are now expected in the second quarter of 2016. NeuroDerm does not foresee any changes to previously disclosed timelines related to anticipated EU submission.
   
   
Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the third quarter ended September 30, 2015.
“Onconova continues to advance the development of rigosertib for the unmet needs of patients with myelodysplastic syndromes (MDS),” said Ramesh Kumar, Ph.D., President and CEO of Onconova.  “Our pivotal Phase 3 INSPIRE trial is now open at multiple sites and we anticipate enrollment of the first patient shortly.  This will mark an important step towards the approval of IV rigosertib as a treatment for higher-risk MDS (HR-MDS). We also look forward to presenting results from a Phase 2 trial of oral rigosertib in combination with azacitidine in MDS and acute myeloid leukemia (AML) patients at the 2015 ASH Annual Meeting this December.”   
     
     
Portola Pharmaceuticals (Nasdaq:PTLA) announced that the results of its  Phase 3 ANNEXA™ (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) studies were published online today by The New England Journal of Medicine. ANNEXA-R and ANNEXA-A evaluated the safety and efficacy of andexanet alfa, an investigational reversal agent, which was designated a breakthrough therapy by the U.S. Food and Drug Administration (FDA), for reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban, respectively, in healthy volunteers. Results showed that both ANNEXA Part 1 (bolus only) and Part 2 (bolus plus continuous infusion) met all primary and secondary efficacy endpoints, including the measurement of reversal Anti-Xa activity (p<0.0001) for both rivaroxaban and apixaban.
In Part 1, andexanet alfa given as an IV bolus reversed the anticoagulant effect of the Factor Xa inhibitors to no-effect levels, as measured by anti-Factor Xa activity, within two to five minutes of administration (p<0.0001). In Part 2, andexanet alfa administered as an IV bolus followed by a continuous two-hour infusion sustained that reversal for the duration of the infusion, reducing anticoagulant activity (p<0.0001). Andexanet alfa was well tolerated, with no serious or severe adverse events, no thrombotic events, and no antibodies to Factor X or Xa observed.
Full results of Part 2 of ANNEXA-R also were presented today during a Late Breaking Clinical Trial session at the American Heart Association’s (AHA) Scientific Sessions 2015 in Orlando, Florida, in an abstract entitled: ANNEXA™-R Part 2: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial Demonstrating Sustained Reversal of Rivaroxaban-Induced Anticoagulation in Older Subjects by Andexanet Alfa (PRT064445), a Universal Antidote for Factor Xa (FXa) Inhibitors.
    
    
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, announced today that Peter D. Suzdak, Ph.D., the Company’s Chief Executive Officer, will present at the Stifel 2015 Healthcare Conference.  Rexahn’s presentation will take place at 3:00 p.m. EST on November 18, 2015 in the Winslow Room at the Palace Hotel in New York City.
A live and archived version of the Company’s presentation may be accessed via webcast under the ‘Investor Relations’ section of the Rexahn website, or by accessing the following link:    http://www.veracast.com/webcasts/stifel/healthcare2015/68210837676.cfm
    
    
Symmetry Surgical Inc. (Nasdaq:SSRG) announced today that Thomas J. Sullivan, President and Chief Executive Officer, and Scott D. Kunkel, Senior Vice President and Chief Financial Officer, are scheduled to present at the Stifel 2015 Healthcare Conference in New York City. This conference includes a formal presentation and will allow institutional investors to meet with Mr. Sullivan and Mr. Kunkel.
Event: Stifel 2015 Healthcare Conference
Date: Wednesday, November 18, 2015
Time: 9:30 am ET
A live webcast of the presentation will be available on Symmetry Surgical's website at www.symmetrysurgical.com. A replay of the webcast will be available for 30 days after the date of the presentation.
     
     
Vical Incorporated (Nasdaq:VICL) today announced that the company will provide an overview of its technologies, development programs, and outlook on Wednesday, November 18, at 8:00 a.m. Eastern Time at the Stifel Healthcare Conference 2015 (New York, November 17 – 18). A webcast of the company's presentation will be available live and archived through the Events & Presentations page in the Investors section of the Vical website at www.vical.com.
    
     
Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of class-leading regenerative medicine products and medical devices, today reported consolidated actual and consolidated pro forma financial results for the third quarter of 2015 and for the nine-months ended September 30, 2015.
As previously announced, the Company completed its acquisition of X-spine Systems, Inc. on July 31, 2015. The consolidated pro forma results are presented as if the Company's current subsidiaries were combined for all periods presented below.
    
    
XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today that it has already identified positive donors for its first anti-Clostridium difficile (C. difficile) product candidate. Just two weeks after initial screening of blood donations from healthy volunteers, XBiotech has identified donors that have antibody reactivity against its targeted moieties on the C. difficile bacteria. Identifying natural antibodies against C. difficile in the healthy population is the first step in the discovery process for True Human therapeutic antibodies. Since it is unknown at the onset whether or not natural antibodies will be present in the healthy population, the Company believes that identifying these antibodies, especially so quickly, is a good indication that they are important in protection against disease.
John Simard, President and CEO of XBiotech, stated, "Once again, we have demonstrated the remarkable efficiency of our True Human platform to identify leads for the development of natural human antibodies against disease. We look forward to now cloning the anti-C. difficile antibody genes, and potentially advancing a lead antibody toward clinical studies. With our C. difficile program we are attempting to do something quite extraordinary—unlike any other marketed antibody therapy, our goal is to develop the first oral-delivered monoclonal antibody therapy. Gut infection with C. difficile is a dreadful disease that attacks the most vulnerable, including the aged and infirm. An oral antibody therapy in this population could be a very important advance. We look forward to achieving further milestones in this program."
    
    
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the company will present at the Jefferies Autumn 2015 Global Healthcare Conference. The conference will be held November 18 to 19, at The May Fair Hotel in London. Zynerba Chairman and CEO Armando Anido will present on Wednesday, November 18, at 3:20 pm Greenwich Mean time.
To listen to a webcast of this presentation during the event, please visit the Investor Relations page of www.zynerba.com. A replay of this webcast will be available for 90 days following the conference.



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