Threshold Pharma Announces Preclinical Data on Combination of Evofosfamide With Immune Checkpoint Inhibitors; Mylan Receives U.S. FTC Clearance for Proposed Acquisition of Perrigo Print
By Mary Davila   
Tuesday, 03 November 2015 20:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 3, 2015.
   
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) announced preclinical data on the combination of evofosfamide with immune checkpoint inhibitors will be presented in a scientific poster at the Society for Immunotherapy of Cancer (SITC) annual meeting in Maryland, November 4-8, 2015. Evofosfamide is Threshold's investigational hypoxia-activated prodrug, which is currently the subject of two fully-enrolled Phase 3 clinical trials for which Threshold expects to announce top-line data around the end of 2015.
     
"This is an exciting time for the field of cancer immunotherapy, and continued progress will depend on a better understanding of the tumor microenvironment and finding novel combination therapies that are more effective than immunotherapy alone," said Michael A. Curran, Ph.D., Assistant Professor at the University of Texas M.D. Anderson Cancer Center and senior author on the scientific poster.
     
"Our research shows that hypoxia in the tumor microenvironment forms a barrier to T cell infiltration and fosters immunotherapy resistance in prostate cancer and other solid tumors," Curran said. "We found that evofosfamide-driven disruption of hypoxic zones sensitizes highly resistant prostate cancer models to treatment with immune checkpoint inhibitors anti-CTLA-4 and anti-PD-1."
     
Research conducted in Curran's laboratory shows that hypoxic zones in prostate tumors resist infiltration by T cells, which are capable of attacking and killing tumor cells. In contrast, normoxic areas of the same tumor experience robust infiltration by T cells.
     
In mouse models of prostate cancer, Curran and colleagues show that combination therapy with evofosfamide and
anti-CTLA-4/anti-PD-1 treatment opens up the hypoxic zones to T cell infiltration.
     
Furthermore, evofosfamide helps sensitize otherwise immunotherapy-resistant prostate tumors to anti-CTLA-4/anti-PD-1 therapy in models of prostate cancer as evidenced by the smallest tumor burdens on average being observed with combination therapy.
     
"This combination of hypoxia disruption and

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T cell checkpoint blockade has potential to render some of the most therapeutically resistant cancers sensitive to immunotherapy," Curran said.
     
"Combining with immunotherapy is an exciting possibility that fits well with our development strategy to maximize the potential therapeutic applications of evofosfamide," said Tillman Pearce, M.D., Chief Medical Officer at Threshold. "The data from Dr. Curran's research suggests that combining evofosfamide with immune checkpoint inhibitors warrants further investigation."
   
   
   
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Mylan (NASDAQ: MYL) announced the U.S. Federal Trade Commission ("FTC") has cleared the company's proposed transaction to acquire Perrigo Company plc (NYSE: PRGO; TASE) subject to Mylan's divestiture of certain products following the consummation of the offer. The FTC clearance represents the final regulatory clearance needed by Mylan to close its acquisition of Perrigo and
represents the last remaining condition that needs to be satisfied for the successful completion of the offer other than the acceptance condition.
    
Mylan's Executive Chairman Robert J. Coury commented, "We are delighted to have received FTC clearance, making our offer for Perrigo now unconditional other than the one final step, which now rests solely in the hands of Perrigo shareholders. We are very confident that Perrigo shareholders will support this transaction by tendering their shares by 8:00 am ET on Nov. 13, 2015."
     
"In this regard, following the successful completion of our acquisition of Perrigo, and consistent with my comments during our Q3 Earnings Call last Friday and our previously announced steps to cancel the Mylan preferred shares issued to the stichting, Mylan will submit changes to corporate governance for a vote by shareholders of the combined Mylan-Perrigo entity at our next annual general meeting, including proposals regarding whether or not to retain the stichting structure as well as the process for nomination and election of directors."
     
Under the terms of Mylan's offer, Perrigo shareholders will receive $75 in cash and 2.3 Mylan ordinary shares for each Perrigo ordinary share. On September 14, 2015 Mylan officially commenced its formal offer to acquire all outstanding ordinary shares of Perrigo.
    
   
   
   
Also Tuesday:
   
   
   
   
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor (HIF), today announced that Jason A. Amello, Senior Vice President, Chief Financial Officer and Treasurer, will present at the Credit Suisse 24th Annual Healthcare Conference on Tuesday, November 10, 2015 at 3:30 p.m. Mountain Time. The conference will take place at The Phoenician resort, in Scottsdale, Arizona.
Interested institutional investors that wish to schedule a meeting with management should contact Credit Suisse directly.
   
    
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 third quarter ended September 30, 2015.
Third quarter consolidated net revenues of $43 million.
Third quarter adjusted EBITDA of $5.3 million, 12.2% of revenue.
Stabilized U.S. business - revenue of $27.4 million, up sequentially from the second quarter of 2015.
   
    
Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of therapies for rare and orphan diseases, today announced financial results for the third quarter ended September 30, 2015. The Company also provided program updates and reiterated financial guidance for 2015 year ending cash balance of $200-$225 million.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "During the third quarter we made significant progress in executing our patient-centric vision to build one of the world's leading biotechnology companies focused on devastating rare and orphan diseases. We are sharply focused on four key business priorities ahead that we believe have the potential to create substantial shareholder value and to deliver upon our mission for rare disease patients – approval and commercialization of our personalized medicine migalastat for Fabry patients in Europe, development of an optimal U.S. approval pathway for migalastat, initiation of clinical studies in Pompe patients with our novel Pompe ERT ATB200, and completion of our Phase 3 study and rolling NDA submission for SD-101 for Epidermolysis Bullosa."
   
     
Cancer Genetics, Inc. (NasdaqCM:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that it will report financial results for the third quarter ended September 30, 2015 before the market opens on Tuesday, November 10, 2015.  The company will hold a live investor conference call and webcast at 8:30am Eastern on the same day.
Conference Call & Webcast
Tuesday, November 10, 2015 at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time
Domestic: 877-407-4018
International: 201-689-8471
Conference ID: 13622111
Webcast: http://public.viavid.com/player/index.php?id=116550
Replays – Available through November 24, 2015
Domestic: 877-870-5176
International: 858-384-5517
Conference ID: 13622111
Note: To confirm compatibility with your operating system, please dial in ten minutes prior to the start of the call.
    
     
Cerner Corporation (Nasdaq:CERN) today announced results for the 2015 third quarter that ended October 3, 2015.   Bookings in the third quarter of 2015 were $1.59 billion, an all-time high and an increase of 44% compared to $1.1 billion in third quarter 2014.
    
Third quarter revenue was $1.128 billion, an increase of 34% compared to $840.1 million in the year-ago period.
    
On a U.S. Generally Accepted Accounting Principles (GAAP) basis, third quarter 2015 net earnings were $147.3 million and diluted earnings per share were $0.42. Third quarter 2014 GAAP net earnings were $129.0 million and diluted earnings per share were $0.37.
    
Adjusted (non-GAAP) Net Earnings --  Adjusted net earnings for third quarter 2015 were $188.7 million, compared to $145.3 million of adjusted net earnings in the third quarter of 2014. Adjusted diluted earnings per share were $0.54 in the third quarter of 2015, an increase of 29% compared to $0.42 of adjusted diluted earnings per share in the year-ago quarter. Analysts' consensus estimate for third quarter 2015 adjusted diluted earnings per share was $0.54.
     
Adjusted net earnings and adjusted diluted earnings per share are not recognized terms under GAAP. These non-GAAP financial measures should not be substituted for GAAP net earnings or GAAP diluted earnings per share, respectively, as measures of Cerner's performance, but instead should be utilized as supplemental measures of financial performance in evaluating our business. Following is a description of adjustments made to net earnings and the resulting adjustment to diluted earnings per share. For more detail, please see the accompanying schedule, titled "Reconciliation of GAAP Results to Non-GAAP Results."
     
    
Dimension Therapeutics, Inc. (NASDAQ:DMTX), a leading gene therapy company advancing novel, liver-directed treatments for diverse rare diseases, today announced its plans to expand the company's internal research and process development capabilities. Dimension has signed a lease agreement with Alexandria Real Estate Equities, Inc. (NYSE:ARE) for 17,475 square feet of state-of-the-art laboratory and office space at 19 Presidential Way in Woburn, Massachusetts, with occupancy expected in April 2016. The expansion builds upon Dimension's existing mammalian cell platform in Cambridge, and will support continued innovation in vector optimization and development of manufacturing processes required for IND-enabling studies and the reliable production of high quality AAV vectors at commercial scale.
"Dimension's current pipeline has grown substantially over the past 12 months, and the new facility will allow us to meet our needs, as well as accommodate additional, anticipated growth in the portfolio. This includes our entry into clinical testing with our lead candidate, DTX101 for hemophilia B, by the end of this year and further advancement of our therapeutic pipeline in hemophilia A and other rare, monogenic diseases associated with the liver," said Annalisa Jenkins, MBBS, MRCP, Chief Executive Officer of Dimension. "Since its founding, Dimension has made the Greater Boston and Cambridge area its home. We consider ourselves fortunate to be in one of the world's leading centers for the life sciences, attracting top-tier talent with close proximity to leading researchers, academic institutions, medical facilities, and a vibrant business community."
Dimension's expansion to 19 Presidential Way, which is owned and operated by Alexandria Real Estate Equities, Inc., provides many advantages, including Class A shared laboratory systems and high-end shared conference facilities. Dimension will continue to work with its existing contract manufacturing partners (or "CMOs") to augment its manufacturing process development capabilities. The facility will also ensure high quality technology transfer and scale-up capabilities with Dimension's CMOs, enhance flexibility, provide redundancy, and increase capacity in a cost effective manner.     Colliers International represented Dimension in its real estate search and lease negotiation.
    
    
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 third quarter ending Sept. 30, 2015, and provided a clinical update.
"Our Phase 1 dose escalation trials of the folate receptor (FR)- and prostate-specific membrane antigen (PSMA)-targeted tubulysin SMDCs, EC1456 and EC1169, continue to progress well. Both SMDCs are being dose escalated on two different schedules," said Ron Ellis, Endocyte's president and chief executive officer. "Once we have determined the maximum tolerated dose and optimal schedule for each SMDC, we look forward to moving into expansion cohorts where we will evaluate these SMDCs specifically in receptor-positive patients among different tumor types, both as single agents and in combination with standard of care drugs."
Earlier in the third quarter, Endocyte announced the final results from the Phase 2b TARGET trial evaluating its SMDC vintafolide in combination with docetaxel in patients with FR positive recurrent non-small cell lung cancer (NSCLC) at the World Conference on Lung Cancer in Denver, Colorado. Vintafolide plus docetaxel improved overall survival (OS) by 2.7 months in NSCLC regardless of histology (Median OS 11.5 vs. 8.8 months, OS HR=0.86, 95% CI [0.58, 1.26]). In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of FR, vintafolide plus docetaxel improved OS by 5.9 months (12.5 vs. 6.6 months, HR=0.72, 95% CI [0.44, 1.16]). This data is in line with earlier findings from the study of improved progression free survival and higher overall response rates. Final safety results were also consistent with those previously reported.
   
    
Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the third quarter ended September 30, 2015. 
  • Worldwide sales increased 16.3% to $137.0 million, or 17.6% on a constant currency basis
  • Third quarter net income increased 14.8% to $26.5 million, or 18.0% on a constant currency basis
  • Fully diluted earnings per share (EPS) were $0.28 
  • Non-GAAP Adjusted EBITDA was 36.9% of sales
  • Company increases 2015 guidance for sales to $539 million and EPS to $1.07
David Paul, Chairman and CEO said, “We are pleased to report third quarter sales of $137 million, a year-over-year increase of 16.3% as reported and 17.6% on a constant currency basis.  Once again the Globus team achieved strong sales growth and market share gains while maintaining industry leading profitability, with quarterly net income of $26.5 million, or 14.8% higher than the same quarter last year.  During the third quarter, we also launched 3 new products and made further progress on integrating our two most recent acquisitions. We remain confident in our long term growth prospects and our ability to sustain our industry leading profitability by the continued execution of our strategy of introducing innovative products, expanding our U.S. and international sales footprint, and controlling our expenses.”
Third quarter sales in the U.S. grew by 17.9% over the third quarter of 2014.  International sales increased by 1.2% over the third quarter of 2014 on an as reported basis and 14.6% on a constant currency basis. 
    
    
INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to Phase IV contract research organization, today announced that Chief Financial Officer Greg Rush is scheduled to present during the upcoming 24th Annual Healthcare Conference hosted by Credit Suisse in Scottsdale, Arizona on Tuesday, November 10th at 2:00 p.m. Mountain Time.
Links to INC Research’s live presentation and archived audio replay, as well as the presentation materials, will be available via the Company’s Investor Relations website at investor.incresearch.com.
     
     
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 third quarter ended September 30, 2015.
Third Quarter Financial Summary:   
  • Total reported revenue of $55.0 million, up 15.5% year-over-year. Total revenue increased 16.7% year-over-year on a constant currency basis.
  • Domestic revenue of $39.5 million, up 14.8% year-over-year
  • U.S. Complex Spine growth of 15.5% year-over-year
  • U.S. Minimally Invasive Surgery (MIS) growth of 40.8% year-over-year
  • U.S. Degenerative growth of 4.6% year-over-year
  • International revenue of $15.6 million, up 17.5% year-over-year. International revenue increased 22.0% year-over-year on a constant currency basis.
   
   
MRI Interventions, Inc. (OTCQB:MRIC) today announced financial results for the third quarter ended September 30, 2015.   Quarter Ended September 30, 2015  --  Revenues were $1.2 million for the three months ended September 30, 2015, and $633,000 for the same period in 2014, an increase of $613,000, or 97%, attributable to increases in the Company's ClearPoint® System reusable and disposable products.
   
ClearPoint disposable product sales for the three months ended September 30, 2015 were $970,000, compared with $577,000 for the same period in 2014, representing an increase of $393,000, or 68%. This increase was due primarily to a greater number of procedures performed using the ClearPoint system within a larger installed base for ClearPoint, relative to the 2014 period.
    
ClearPoint reusable product sales for the three months ended September 30, 2015 were $239,000, and $11,000 for the same period in 2014. Reusable products consist primarily of computer hardware and software bearing sales prices that are appreciably higher than those for disposable products and historically have fluctuated from quarter to quarter.
   
   
MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, announced the pricing of its public offering of 204,000 shares of 11% Series A Cumulative Redeemable Perpetual Preferred Stock ("Series A Preferred Stock") at a price of $25.00 per share. In addition, MTBC has granted the underwriters a 30-day option to purchase from it an additional 30,600 shares of Series A Preferred Stock.
The total gross proceeds of the offering are expected to be approximately $5.1 million, before underwriting discounts and commissions and other offering expenses. MTBC intends to use the net proceeds of the offering to support growth, including acquisitions and the expansion of its sales and marketing efforts. The remaining proceeds will be used for working capital and other general corporate purposes.
Dividends on the shares of the Series A Preferred Stock will be payable in cash monthly on a cumulative basis when, as and if declared by the Company's board of directors, at the rate of 11% per annum of the $25.00 per share liquidation preference (equivalent to $2.75 per annum per share). The first monthly dividend is anticipated to be paid on December 15, 2015, to holders of record on November 30, 2015. The Series A Preferred Stock has no maturity date and will not be subject to any sinking fund or mandatory redemption. Shares are subject to optional redemption by us after November 4, 2020, and upon the occurrence of a change of control. The terms of the Series A Preferred Stock are described in more detail in the Prospectus.
MTBC's Series A Preferred Stock has been approved for listing on the NASDAQ Capital Market under the ticker symbol "MTBCP" and trading will begin on November 4, 2015.
   
   
MyoKardia, Inc. (Nasdaq:MYOK) today announced the closing of its initial public offering of 6,253,125 shares of common stock at a public offering price of $10.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 815,625 shares of common stock. All of the shares sold in the offering were offered by MyoKardia. The shares began trading on The NASDAQ Global Select Market under the ticker symbol "MYOK" on October 29, 2015. The Company estimates net proceeds from the offering to be approximately $55.7 million, after deducting underwriting discounts and commissions and estimated offering expenses.
Credit Suisse Securities (USA) LLC and Cowen and Company, LLC acted as lead book-running managers. Wells Fargo Securities acted as book-running manager. Wedbush PacGrow acted as co-manager.
A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission on October 28, 2015. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained by contacting: Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, by telephone at (800) 221-1037, or by email at newyork.prospectus@credit-suisse.com; or Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806 or by fax at (631) 254-7140.
   
    
Myriad Genetics, Inc. (NASDAQ:MYGN) today announced financial results for its fiscal first-quarter 2016, provided an update on recent business highlights, maintained its fiscal year 2016 financial guidance and provided fiscal second-quarter 2016 financial guidance.
"We were very pleased with our results in the first quarter and reiterate our fiscal 2016 guidance," said Mark C. Capone, president and chief executive officer of Myriad. "More importantly, we continued the excellent progress on our five-year plan to transform Myriad into a diversified global pioneer in personalized medicine. We are now beginning to see the benefits of the substantial investments the Company has made in our industry-leading pipeline and international expansion, which we believe will drive significant shareholder value over the next five years."
    
    
National Research Corporation (NASDAQ:NRCIA) (NASDAQ:NRCIB) today announced results for the third quarter of 2015.
Net New Sales $5.9 million
Total Contract Value $109.3 million
Revenue up 7% to $25.2 million
Net Income of $4.1 million
Remarking on Company performance, Michael D. Hays, chief executive officer of National Research Corporation said, “The market continues to validate the uniqueness of our product offerings accelerating our goal of distancing ourselves from traditional competitors. In addition to product investments, we are aggressively investing in talent, a great example of which being the recent promotion of Steve Jackson to President of NRC.”
     
     
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 Credit Suisse 24th Annual Healthcare Conference on Tuesday, November 10 in Scottsdale, Arizona.
Event: Credit Suisse 24th Annual Healthcare Conference
Date: November 10, 2015
Time: 8:00 a.m. MT
Location: The Phoenician Hotel - Scottsdale, AZ
An audio webcast of the Company's presentation will be available on the investor relations section of the Versartis website at www.versartis.com. A replay of the presentation will be available for 90 days.



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