Merck Receives Therapy Designation from FDA for KEYTRUDA(R); Cellectar Provides Phospholipid Drug Conjugate Platform Development Update Print E-mail
By Marilyn Mullen   
Monday, 02 November 2015 20:41
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 2, 2015. 
   
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA(R) (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. This is the third Breakthrough Therapy Designation granted for KEYTRUDA.   "We are committed to understanding the full potential of KEYTRUDA to help  patients with a broad range of difficult-to-treat cancers," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "The data investigating the use of KEYTRUDA in patients with advanced colorectal cancer whose tumors have substantial evidence of mismatch DNA repair defects have been encouraging, and we appreciate the opportunity that this FDA Breakthrough Therapy Designation provides us to accelerate our effort to bring KEYTRUDA to these patients."
  
The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. KEYTRUDA was previously granted breakthrough status for advanced melanoma and advanced non-small cell lung cancer (NSCLC). 
  
The Breakthrough Therapy Designation in advanced colorectal cancer is based on data from a Phase 2 study  evaluating the activity of KEYTRUDA in cancers with microsatellite instability, a well-established feature seen in cells with certain types of DNA repair defects. Findings from the study, led by researchers from Johns Hopkins Kimmel Cancer Center, were presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting and were published simultaneously in the New England Journal of Medicine.  Testing tumors for microsatellite instability can identify patients with defective DNA mismatch repair (MMR) systems. DNA MMR is a process that permits cells to recognize and
repair genetic mismatches generated during DNA replication. A defective MMR system allows mismatch mutations to persist. The average tumor has dozens of mutations; however tumors with DNA MMR deficiency may harbor thousands, especially in regions of repetitive DNA known as microsatellites. Tumors that are found to have mutations in select microsatellite sequences, called microsatellite instability (MSI), are considered DNA MMR-deficient. These tumors are referred to as being "MSI high." Overall, DNA MMR-deficiency is present in approximately 15-20 percent in Stage II disease, 10 percent in Stage III disease and

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approximately 5 percent or less in Stage IV disease. In colorectal cancers, MMR-deficiency is seen in approximately 15-20 percent of non-hereditary colorectal cancers and
in most hereditary colorectal cancers associated with Lynch Syndrome.
   
Merck is conducting a Phase 2 registration study (KEYNOTE-164) to evaluate the efficacy and safety of KEYTRUDA based on microsatellite instability status in patients with previously treated advanced colorectal cancers, and is also planning a Phase 3 study (KEYNOTE-177) in a treatment naïve patient population.
   
The KEYTRUDA clinical development program includes patients with more than 30 tumor types in more than 160 clinical trials, including more than 80 trials that combine KEYTRUDA with other cancer treatments.  Registration-enabling trials of KEYTRUDA are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, Hodgkin lymphoma, multiple myeloma and other tumors, with further trials in planning for other cancers.
   
   
   
   
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Cellectar Biosciences, Inc. (NASDAQ: CLRB), an oncology-focused biotechnology company, today provides an update on its recently initiated Phospholipid Drug Conjugate (PDC) chemotherapeutic program, CLR CTX.
    
PDCs are a new class of small-molecules that employ Cellectar's extensively validated phospholipid ether-based cancer targeting and delivery vehicle. The PDC platform possesses the ability to link diverse oncologic payloads for targeted delivery to a broad range of cancers.
    
The objective of the CLR CTX program is to develop PDC chemotherapeutics through conjugation of our delivery vehicle and multiple non-targeted anti-cancer agents to improve therapeutic indices and expand potential indications through the targeted delivery of chemotherapeutic payloads.
    
"The potential advantages of drug candidates developed using the PDC delivery platform over classic cytotoxic approaches are broad-band tumor targeting, including brain metastases, and prolonged tumor cell retention, both of which have been validated by human imaging. Further, PDC delivery technology has demonstrated the ability to target human glioma stem cells ex vivo, suggesting the potential to provide targeted delivery of therapeutic agents to cancer stem cells," said John S. Kuo, MD, PhD, FAANS, FACS, Associate Professor of Neurological Surgery and Human Oncology (Tenure) Director, Comprehensive Brain Tumor Program Chair, CNS Tumors Working Group, Carbone Cancer Center, Center for Stem Cell and Regenerative Medicine at the University of Wisconsin-Madison.
   
   
   
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Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that its Pantheris™ system has achieved all safety and efficacy endpoints in six-month follow-up data for its VISION IDE clinical trial. VISION was designed to evaluate the safety and effectiveness of Pantheris to perform directional atherectomy while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
VISION results from the 130 patients treated per protocol in the study were presented today at the Vascular Interventional Advances (VIVA) 2015 annual meeting by Arne Schwindt, M.D. of St. Franziskus Hospital in Muenster, Germany, one of the lead principal investigators.
   
   
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 host a conference call and live audio webcast on Monday, November 9, 2015, at 4:30 p.m. ET to report third quarter 2015 financial results and provide a corporate update.
To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 67276671. A live webcast of the call 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 beginning approximately two hours after the call.
   
   
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant recipients, announced the expansion to their CLIA lab specifically designed for clinical-grade next-generation sequencing (NGS) testing in Brisbane, CA.
This new laboratory space has been established to support a pipeline of products that target donor-derived cell-free DNA (dd-cfDNA) for the surveillance of transplant recipients. The expanded facility also includes a state-of-the-art laboratory information management system containing best-in-class NGS bioinformatics and CareDx customized software modules.
   
    
ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient's unique anatomy, announced today financial results for the third quarter ended September 30, 2015.
   
   
Cutera, Inc. (NASDAQ:CUTR), a leading provider of laser and energy-based aesthetic systems for practitioners worldwide, today reported financial results for the third quarter ended September 30, 2015.
Key highlights for the third quarter of 2015 were as follows:
  • Revenue increased 23% to $23.1 million, compared to the same period last year, driven primarily by recently launched new products—enlightenTM and excel HRTM—as well as continued strong contributions from legacy products.
  • Product revenue grew 80% in North America and 35% globally.
  • Gross margin improved to 58%, from the 57% in the second quarter of 2015.
  • Net loss narrowed to $957,000, or $0.07 per diluted share, and included $1.3 million of non-cash expenses related to stock-based compensation, depreciation and amortization of intangibles.
  • Cash and investments balance as of September 30, 2015 was $47.7 million, or $3.60 per outstanding share.
  • Share repurchases during the third quarter and year-to-date of 2015 were $19.4 million and $37.1 million, respectively.
   
   
After several years of hearings, a federal jury trial is set to begin tomorrow in the $1.5 billion false advertising case brought by sugar growers against the Corn Refiners Association (CRA) and their members, Archer Daniels Midland Company (NYSE:ADM), Cargill Inc, Tate & Lyle (LON:TATE), Ingredion Inc (NYSE:INGR) and others. 
“This lawsuit is about false advertising, pure and simple. This case may change the way food is made in America. The lawsuit aims to stop the corn processors' false advertising so that families know the truth about the food they buy,” said Mark Lanier, lead attorney for the sugar growers. “The lawsuit alleges that the CRA engaged in a blatantly false campaign to promote high-fructose corn syrup (HFCS) as “corn sugar,” while describing it as “natural” and “nutritionally the same as sugar.”
“At the center of the lawsuit is the $130-million “Sweet Surprise” print, online and television advertising campaign by the CRA, which falsely touted HFCS as natural and equivalent to sugar.  During the trial, the jury will be able to assess critical evidence about HFCS and the conduct of its marketers. While reviewing more than 700,000 pages of confidential documents during discovery, it was revealed that some of the defendants tried to conceal information from the public about HFCS and debated the wisdom of making the “natural” case to consumers,” said Lanier. We will show the jury that they were sneaky and dishonest and secretly colluded with the CRA and urged them to seek a name change for HFCS to corn sugar, which the Food and Drug Administration (FDA) ultimately rejected.” 
   
   
Diversicare Healthcare Services, Inc. (NASDAQ:DVCR), a premier provider of long-term care services, today announced that effective November 1, 2015, the Company has acquired a 60-bed skilled nursing center in Fulton, Kentucky, for a purchase price of $3.9 million. This acquisition increases the number of centers operated by the Company to 55 and is expected to contribute in excess of $3.5 million in annual revenues.
Commenting on the acquisition, Kelly Gill, the Company's Chief Executive Officer, stated, "We are pleased to announce the purchase of Diversicare of Fulton. This center fits well into our current geographical footprint presenting the opportunity for a seamless integration process for our operations team and should be a great addition to our portfolio of owned properties. As we continue to methodically evaluate potential acquisitions in an ever-changing marketplace, we remain committed to pursuing those opportunities that present opportunities to create value for our shareholders."
As of November 1, 2015, Diversicare provides long-term care services to patients in 55 skilled nursing and senior housing centers containing 6,560 licensed beds. For additional information about the Company, visit Diversicare's web site: www.DVCR.com.
   
   
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, such as primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH), today announced that it will report third quarter 2015 financial results prior to the NASDAQ Market open on Monday, November 9, 2015. Intercept management will conduct a conference call and audio webcast on Monday, November 9, 2015 at 8:00 a.m. ET to discuss these results.
Dial-in and webcast information for this event will be available on the Investors page of Intercept's website at http://ir.interceptpharma.com. An archived webcasts will be available on Intercept's website for approximately two weeks.
   
   
MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company specializing in innovative therapies to address unmet needs in severe burn and wound management, announced today that it has provided its flagship product, NexoBrid, a drug for the removal of dead or damaged tissue (eschar) in patients with severe burns, as humanitarian aid to treat patients who were severely burned during a massive fire that occurred at a nightclub in Bucharest, Romania on Friday, October 30, 2015. This mass casualty is one of the most serious disasters in Romania in recent years.
Immediately after learning about the disaster on Friday night, MediWound volunteered to send additional quantities of NexoBrid to Romanian hospitals as quickly as possible, as stock of NexoBrid in the region had been consumed by Romanian hospitals within hours of the event. In addition, MediWound sent two burn specialists from Israel and Europe, who are experts at administering NexoBrid, to help treat the many wounded patients hospitalized in burn centers in Romania.
MediWound's product, NexoBrid, was granted marketing authorization from the European Medicines Agency (EMA) and the Israeli and Argentinean Ministries of Health for the removal of eschar in adults with deep partial and full-thickness thermal burns. NexoBrid represents a new paradigm in burn care management having demonstrated in clinical studies, with statistical significance, its ability to non-surgically and rapidly remove in a single, four-hour application the eschar, earlier than other modalities, without harming viable tissue. In clinical studies NexoBrid has demonstrated a significant reduction in surgical burden with long-term outcomes that are comparable to the current surgical treatment.
   
   
Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced it will report its third quarter 2015 financial and operating results before the open of U.S. financial markets on Monday, November 9, 2015.
In addition, management will host a conference call to discuss the quarterly results and provide an update on corporate activities.
Conference call details are as follows: 
Date:   November, 9th 2015 
Time:   8:00 am US Eastern Time (ET) 
Dial-in number:   (877) 212-6076 (Domestic) or (707) 287–9331 (International) 
Via web:   www.novavax.com, “Investors”/ “Events” 
 
Conference call replay: 
Dates:   Starting at 11:00 am ET, November 9, 2015 until midnight November 16, 2015
Dial-in number:   (855) 859-2056 (Domestic) or (404) 537-3406 (International) 
Passcode:    70778771 
Via web:   www.novavax.com, “Investors”/ “Events” 
   
   
PRA Health Sciences, Inc. (NASDAQ:PRAH) today reported financial results for the quarter ended September 30, 2015.
For the three months ended September 30, 2015, service revenue was $345.1 million, which represents growth of approximately 8%, or $25.0 million, compared to the third quarter of 2014 at actual foreign exchange rates. On a constant currency basis, service revenue grew $36.7 million, an increase of 12% compared to the third quarter of 2014.
Net new business for the quarter ended September 30, 2015 was $431.4 million, representing a book-to-bill ratio of 1.25 for the period. This net new business contributed to an ending backlog of $2.3 billion at September 30, 2015.
“We are delighted to have delivered another quarter with strong results on many fronts,” said Colin Shannon, PRA’s Chief Executive Officer. “Our key financial metrics have continued to improve, as evidenced by our new business wins, our revenue growth and our expanding margins.  Our strong financial performance is a reflection of the exceptional service we provide to our customers, and the continued efforts of our employees.  The strength in our results enables us to continue to focus on our key strategic objectives going into 2016, and we look forward to continuing to deliver strong results.”
   
   
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced that it has completed enrollment in PATENCY-1, the first of two Phase 3 clinical studies of investigational vonapanitase (formerly PRT-201), the company's lead development candidate. The Company expects that top-line data from this study will be available in December of 2016.
PATENCY-1 is a multicenter, randomized, double-blind, placebo-controlled clinical study evaluating the safety and efficacy of a single administration of vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis. Vonapanitase, a recombinant human elastase, is an investigational drug that is intended to improve AVF patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis.
   
   
Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported financial results for its fiscal second quarter and six months ended September 30, 2015.
"We made substantial progress on the commercial scale up of MosaiQ™ over the past quarter," said Paul Cowan, Chairman and Chief Executive Officer of Quotient. "This culminated in Quotient presenting a working prototype of the MosaiQ™ instrument to ninety attendees from forty-seven organizations at the 2015 AABB Meeting held on October 24 to 27 in Anaheim, California. Attendees at these showings ranged from chief executives of donor collection agencies to hospital laboratory managers, with overwhelmingly positive feedback received. Subject to obtaining required marketing clearances, we remain on schedule to deliver a licensed MosaiQ™ platform to these prospective customers over the next 12 to 24 months."
   
    
Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, will host a conference call on Thursday, November 5, 2015 at 4:30 p.m. EST to discuss third quarter 2015 financial results and recent operational highlights. A question-and-answer session will follow Vitae's remarks.
To participate on the live call, please dial 844-423-9893 (domestic) or +1-716-247-5808 (international) and provide the conference ID 70141193 five to 10 minutes before the start of the call.
A live audio webcast of the call will also be available via the "Investor Relations" page of the Vitae website, www.vitaepharma.com. Please log on through Vitae's website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Vitae's website for 90 days following the call.
   
   
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced financial results for the third quarter ended September 30, 2015, and provided an update on the company's recent activities.
"The third quarter saw an important expansion of our pipeline with the signing of a new Exclusive Channel Collaboration with our longtime partner Intrexon to include immunotherapies for the treatment of graft-versus-host-disease, or GvHD," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "This adds to our research programs with Intrexon in virotherapies, T-cell therapies and natural killer cell therapies for the treatment of cancer, all of which are advancing in the lab and clinic. We look forward to presenting a variety of data at scientific meetings before the end of this year."



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