Galapagos to Advance Filgotinib to Phase 3 in Rheumatoid Arthritis; Celgene's VIDAZA Receives Positive CHMP Opinion Print E-mail
By Josh Gee   
Friday, 25 September 2015 18:38
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 25, 2015.
Galapagos NV (Euronext & NASDAQ: GLPG) announced the Company will be moving filgotinib, its highly selective JAK1 inhibitor, into Phase 3 in rheumatoid arthritis by early 2016.  Filgotinib has shown best-in-class efficacy and safety in the DARWIN Phase 2B studies in rheumatoid arthritis and is now fully owned by Galapagos.   
    
Galapagos has demonstrated  that high selectivity for JAK1 results in excellent efficacy and safety in rheumatoid arthritis patients.  Based on our own human whole blood assays comparing ABT-494 to filgotinib, filgotinib is three-fold more JAK1 selective than ABT-494.  Galapagos reported best-in-class efficacy and safety in 24-week Phase 2B studies in 877 patients with filgotinib.  Furthermore, Galapagos has  more than 700 patient-years of treatment experience with filgotinib in RA patients, of which more than 500 years at the highest 200 mg dose, all with  a clean safety profile consistent with JAK1 inhitbition: filgotinib showed a clear dose dependent increase in hemoglobin concentration without any impact on NK cells and lymphocyte counts.
    
"We see a rapid path forward in development for filgotinib, which we will be taking into Phase 3.  Galapagos is currently in advanced discussions with a substantial number of large pharma  companies to partner filgotinib.  We anticipate starting Phase 3 in rheumatoid arthritis with filgotinib early in 2016 and we are expecting data from our Phase 2B FITZROY study with filgotinib  in Crohn's disease by yearend,"said Onno van de Stolpe, CEO of Galapagos.   
     
    
   
   
   
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Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG) announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an expanded indication of VIDAZA® (azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation (HSCT). The expanded indication now covers patients who have >30% myeloblasts according to the WHO classification; previously, the indication covered AML patients with <30% blasts.
     
Myeloblasts are white cells in the bone marrow; in AML, their functioning is disrupted and results in numerous non-functioning white cells, which can potentially interfere with the body's ability to control infections and can lead to anaemia and haemorrhages.
     
For many patients, AML is typically associated with a poor prognosis and deteriorating quality of life, particularly for those patients who cannot tolerate curative therapies like stem cell transplantation. In Europe, more than 14,000 people suffer from AML, and most of these patients will die within less than 1 year. As an acute leukaemia, AML progresses rapidly and is typically fatal within months if stem cell transplant is not an option. Specific to elderly patients, overall survival with AML has not improved in more than 40 years1, and there is a clear need for treatments that can support this patient population.
      
"While progress has been made in treating younger, fitter AML patients who can undergo intensive and potentially curative therapies such as stem cell transplant, there is still a clear need for treatments for elderly and more frail patients," said Hervé Dombret, M.D., Chief, Blood Disease Department (Leukaemia Unit), University Hospital Saint-Louis, AP-HP, Paris, France. "Azacitidine has demonstrated a median overall survival of 10.4 months, and these results suggest that, if approved, azacitidine could provide a valuable treatment option for patients who have limited options today."
     
Adds Tuomo Pätsi, President of Celgene in Europe, Middle East and Africa (EMEA): "Celgene is committed to bringing innovative medicines to patients with haematological diseases including AML. With the positive CHMP opinion for VIDAZA in AML, Celgene has an opportunity to advance the treatment options available to patients with AML. And, we will continue to focus on meeting the unmet needs of patients with myeloid disease, as we have several partnerships and development programmes that will build on what we are learning about treating these diseases."
     
The CHMP decision was based on data from AML-001, a global, multi-centre, randomized, open-label pivotal study of patients at least 65 years old with newly diagnosed or secondary AML with >30% bone marrow blasts. VIDAZA plus best supportive care (n=241) was compared with conventional care regimens (n=247). Median overall survival (OS), the primary endpoint of the study, was 10.4 months (95% CI 8.0-12.7 months) for patients receiving azacitidine compared with 6.5 months (95% CI: 5.0-8.6) for patients receiving conventional treatment regimens (HR=0.85 [95% CI 0.69, 1.03], stratified log-rank p=0.1009). One-year survival rates with azacitidine and conventional treatment regimens were 46.5% and 34.2%, respectively (difference 12.3% [95% CI: 3.5% - 21%]).
     
In the study, grade 3-4 anaemia, neutropenia, febrile neutropenia, and thrombocytopenia rates, respectively, were 16%, 26%, 28%, and 24% with azacitidine; 5%, 5%, 28%, 5% with best supportive care; 23%, 25%, 30%, 28% with low-dose Ara-Cytarabine; and 14%, 33%, 31%, 21% with intensive chemotherapy.
      
In addition to recommending the marketing authorisation for the new indication to the European Commission, the CHMP also noted that this new therapeutic indication brings significant clinical benefit in comparison with existing therapies; if the European Commission adopts the CHMP decision in full, VIDAZA will receive extended market protection in all its indications for an additional year throughout the European Economic Area.
      
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).
      
The anticipated European Commission decision would add to the portfolio of indications VIDAZA is authorised for across high-risk myeloid diseases, including myelodysplastic syndromes (MDS) and AML. VIDAZA has been approved in the EU since 2008 for the treatment of adult patients ineligible for transplantation diagnosed with intermediate 2 and high-risk MDS; chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder; or acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia.
      
In the United States, VIDAZA is not indicated for treatment of patients with AML. VIDAZA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anaemia (RA) or refractory anaemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
      
       
       
       
      
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Agora Holdings, Inc. (OTC PINK: AGHI), parent company of Geegle Media, will add a payment gateway to its health and nutrition project, 1000salads.com.     Geegle Media is a multi-platform entertainment network that curates high-quality and engaging content from around the world. 1000salads, a division of Geegle Media and one of its largest projects, aims to bring together a community of health and fitness conscious individuals. Users will be able to receive expert nutritional advice, view healthy recipes and share their thoughts and experiences with other users in the community. Looking ahead, 1000salads aims to become the foremost web destination in the market for health and fitness.      Set to launch in 2016, developers of 1000salads will be adding a payment gateway allowing users to purchase products and produce online. The eCommerce store will accept all variations of credit card and have a cross-platform design, functioning on mobile and tablets.     "By adding an eCommerce component to 1000salads, we are able to bring to market a best-in-industry shopping destination that offers commercial opportunities for our advertisers and retail partners, and a convenient and useful shopping experience for our consumers," says Daniel Terziev, CEO of Geegle Media.
     
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced that a late-breaking abstract on AR-12 has been accepted for poster presentation at the upcoming 15th European AIDS Conference, hosted by the European AIDS Clinical Society (EACS) and being held October 21-24 in Barcelona, Spain.
   
Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused biotechnology company, announces today its CEO, Jim Caruso, will be presenting at the Ladenburg Thalmann 2015 Healthcare Conference in New York City on September 29, 2015 at 4:00 PM ET.     "The Ladenburg Thalmann conference attracts a wide array of emerging companies and investors alike, providing an excellent opportunity for us to communicate our value proposition," said Mr. Caruso. "We look forward to presenting the company and our PDC delivery platform, which possesses the ability to link diverse oncologic payloads for targeted delivery to a broad range of cancer and cancer stem cell targets."      Cellectar will be presenting on September 29 at 4:00 PM ET at the Sofitel in New York City. Following the presentation, a link to the latest presentation deck will be posted on the company's website.
    
Ebix, Inc. (NASDAQ:EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance, financial and healthcare industries, today announced that senior executives of 16 broking firms representing more than 80 percent of business placed in the London market have made a formal commitment to electronic placement of insurance through the Placing Platform Limited (PPL) electronic placing platform, powered by Ebix's technology.     The communiqué, signed through the auspices of the London & International Insurance Brokers' Association (Liiba) board, was revealed by Steve Hearn, chairman of the London Market Group (LMG), at a market-wide forum held by the trade body yesterday, in London. An open letter signed by the executives said they were committed to all risks being captured and processed electronically.
    
Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet needs, and Intrexon Corporation (NYSE:XON), a leader in synthetic biology, today provided an update on the status of the previously filed Investigational New Drug (IND) application for FCX-007, Fibrocell's orphan gene-therapy drug candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), including feedback from the U.S. Food and Drug Administration (FDA) on the IND.     The FDA's feedback related to the proposed Phase I/II clinical trial protocol and the areas of CMC and toxicology. With respect to toxicology, a hybrid pharmacology/toxicology study based on the injection of FCX-007 in RDEB human skin that was xenografted onto SCID (severe combined immunodeficiency) mice was included in the IND and showed no signs of toxicity. However, the FDA has now requested that Fibrocell execute a toxicology-specific study in which FCX-007 will be injected in non-grafted SCID mice. The new toxicology study is targeted to initiate in the fourth quarter of 2015. Fibrocell expects to amend the IND in response to the FDA's feedback and to include data from the new toxicology study in the first quarter of 2016.  
        
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer, will present at the Leerink Partners Inaugural Immuno-Oncology Roundtable on Thursday, October 1, 2015 at 1:05 PM Eastern Daylight Time. The conference will take place at the Le Parker Meridien Hotel in New York City.     The live webcast will be accessible at http://investor.fiveprime.com/events.cfm or directly at http://leerink.metameetings.com/confbook/immunooncology15/directlink?p=735. Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.
     
HealthEquity, Inc. (NASDAQ:HQY) announced today the closing of the previously announced secondary offering of shares of its common stock. Certain of HealthEquity's stockholders have sold an aggregate of 3,450,000 shares of the company's common stock in an underwritten public offering at a price to the public of $29.50 per share, which included 450,000 shares issued pursuant to the exercise in full of the underwriter's option to purchase additional shares. HealthEquity did not receive any proceeds from the sale of the shares offered by the selling stockholders.     Wells Fargo Securities, LLC acted as the sole underwriter for the offering.     A registration statement relating to these securities was filed with the Securities and Exchange Commission (SEC) and became automatically effective on September 9, 2015. The offering was made only by means of a prospectus supplement and accompanying prospectus. 
     
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced that Carlos Paya, M.D., Ph.D., President and Chief Executive Officer, will present at the Leerink Partners Inaugural Immuno-Oncology Roundtable on Thursday, Oct. 1, 2015 at 11:20 a.m. Eastern time in New York.     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.
     
LED Medical Diagnostics Inc. (TSX VENTURE: LMD) (OTCQX: LEDIF) (FRANKFURT: LME) announced today that it is completing the second tranche to the previously announced debenture financing as disclosed in a news release by LED on July 22, 2015. In this second tranche the Company will issue US$500,000 of 10% senior secured debentures each in the amount of US$10,000 (the "Debentures") and maturing after 12 months. The Debentures are being issued as part of a non-brokered private placement of units (each a "Unit") with each Unit consisting of: (i) a Debenture; and (ii) 7,143 common share purchase warrants of the Company (each a "Warrant"). The lender for all Debentures will be the Bloom Burton Healthcare Lending Trust. The subscription price for each Unit is US$10,000.     The Company is granting the Warrants as a loan bonus in accordance with Exchange Policy 5.1 of the TSX Venture Exchange (the "TSX-V") and each such Warrant will entitle the holder thereof to acquire one common share in the capital of the Company for USD$0.28 for a period of 12 months from the closing of the issuance of the Debentures.     The proceeds will be used by LED for general corporate purposes.
       
LifeVantage Corporation (Nasdaq:LFVN), announced today that Nathalie Chevreau, PhD, Senior Vice President of Research and Development, presented two abstracts describing the innovative aspects of TrueScience skin care regimen at the 2015 International Federation of Societies of Cosmetic Chemists Conference in Zurich, Switzerland.     Dr. Chevreau presented the anti-aging effect of the TrueScience skin care regimen through gene modulation in the skin layers, as well as a treatment of intrinsic and extrinsic aging.  Visible and measurable clinical outcomes can be attributed to the unique Nrf2 ingredients extensive anti-aging efficacy and reversal of cellular stress and DNA damage.     The International Federation of Societies of Cosmetic Chemists (IFSCC) is a worldwide federation dedicated to international cooperation in cosmetic science and technology.  Currently 47 Societies representing 57 countries are members. Individual membership now exceeds 15,000.   
    
Lumenis Ltd. (NASDAQ:LMNS), the world's largest energy-based medical device company for surgical, aesthetic and ophthalmic applications, announced the launch of the UltraPulse DUO at the 119th Annual American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting, taking place September 27 - 30, 2015 in Dallas, Texas.     Continuing to innovate in the laser technology space, Lumenis' UltraPulse CO2 laser platform is considered to be the industry gold standard solution for minimally invasive proceduresfor over three decades.     Featuring superior precision and high-end performance technology, the UltraPulse DUO provides surgeons with the option to easily shift between free beam and fiber energy deliveries all within the same platform. This unique energy delivery combination allows for the superior precision needed to protect delicate tissue and the extended flexibility required for targeting difficult-to-reach anatomy.
    
PotNetwork Holdings Inc., (OTC PINK: POTN) is pleased to announce that its wholly owned subsidiary, PotNetwork Inc., will be providing coverage as media sponsor at the Speed of Sound Festival on Saturday, September 26, 2015 at Dutchess County Airport in Wappingers Falls, NY.     "Mingling alongside others in the cannabis community, Radio Woodstock is sure to be an exciting event for us to cover. Packed with exciting entertainment, this event will be all about building relationships and gaining great exposure for us, as we continue to bring PotNetwork into the limelight as a robust and diverse source of quality content. We expect that this festival will be entertaining and abundantly productive in furthering our objective to bolster the PotNetwork brand and bring national recognition to our swiftly growing network," stated Richard Volpe, Chief Executive Officer, PotNetwork Incorporated.     Conceived by the creators of Mountain Jam in celebration of Radio Woodstock's 35th year of local and independent broadcasting, Speed of Sound Fest aims to showcase the breadth of the creative community based in the Hudson Valley with local farm-to-table food vendors, Hudson Valley craft artisans and art installations.
      
Premier, Inc. (NASDAQ: PINC), a leading healthcare improvement company, has been awarded a contract from the Centers for Medicare & Medicaid Services (CMS) to participate in the second round of Hospital Engagement Networks in the Partnership for Patients initiative.     The Partnership for Patients initiative is focused on reducing preventable readmissions to hospitals by 20 percent and reducing preventable hospital-acquired conditions (HACs) by 40 percent. Premier has received approximately 500 letters of intent from hospitals to participate in its Hospital Engagement Network (HEN) for the second round of the program.



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