Insys Therapeutics Submits NDA for Dronabinol Oral Solution; Puma Sinks On Drug Data; Analyst Upbeat Print
By David Fowler   
Tuesday, 02 June 2015 20:11
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 2, 2015.  
 
Insys Therapeutics, Inc. (NASDAQ: INSY) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol (THC).
 
"We are very pleased to have re-submitted the NDA Dronabinol Oral Solution, which was facilitated by our obtaining FDA agreement with the requisite pediatric study plan. We believe Dronabinol Oral Solution can become an important new option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS," said Michael L. Babich, President and Chief Executive Officer.
 
Insys expects that its new, DEA-inspected facility in Round Rock, Texas, will enable it to manufacture ample quantities of its pharmaceutical-grade cannabinoid products, including Dronabinol Oral Solution and pharmaceutical cannabidiol (CBD), for its research needs and to meet anticipated demand for its pipeline products, if approved.
 
The Company received a Refusal to File (RTF) letter in October 2014 for its previously-submitted NDA for Dronabinol Oral Solution because that submission included an inadequate or incomplete pediatric study plan to conduct studies to assess the safety and effectiveness of Dronabinol Oral Solution in pediatric patients. The Company expects the current NDA contains all information required to permit a substantive review by the FDA, and intends to continue to work closely with the FDA throughout the review process.
 
 
  
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Puma Biotechnology Inc. (NYSE: PBYI) plunged more than 13 percent on Tuesday after disappointing drug trial results, even as an analyst called the data "clearly positive."  The development-stage biopharmaceutical company traded recently at $146.83, off $23.14, on more than three times the average volume.
 
On Monday Puma said the two-year, disease free survival rate for breast cancer victims taking its neratinib drug was 93.9 percent, versus 91.6 percent for patients treated with a placebo.  About 40 percent of the neratinib patients experienced diarrhea.
 
The trial included 2,840 patients treated with either neratinib or placebo for one year. Patients were then followed for recurrent disease for an additional year. Although Puma shares are off nearly 25 percent since Friday, "the argument that the trial had a low absolute benefit is weak," RBC's Simos Simeonidis said.
 
Simeonidis, who reiterated an Outperform rating on Puma, said several currently approved breast cancer drugs "had similar levels of absolute benefit" when approval applications were filed.
 
As examples, Simeonidis cited Novartis AG's (NYSE: NVS) letrozole, AstraZeneca plc's (NYSE: AZN), Arimidex and
Pfizer Inc.'s (NYSE: PFE) Aromasin.  Certain subpopulations of patients within the Puma study saw about double the average anti-cancer benefit, while Simeonidis said diarrhea was reduced to about 12 percent of patients who received preventative treatments.
  
"It was clearly a positive trial," according to Simeonidis, who expects Puma will submit the drug for marketing approval in the first quarter of 2016.  "We continue to view neratinib as an approvable drug," Simeonidis said.
  
   
  
Also Tuesday:
  
  
  
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that Robert Bowen, the Company's Vice President and Chief Financial Officer since 2008, who will celebrate his 66th birthday this summer will retire from Abiomed next month and

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that Michael Tomsicek will be appointed as Vice President and Chief Financial Officer, effective July 15, 2015.
  
Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that Liana Wu has joined the company as vice president, commercial. 
  
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced two appointments to its senior management team. Julie Krop, M.D., has joined the company as chief medical officer and
senior vice president, clinical development and regulatory affairs, and Audrey Wu as vice president of commercial strategy and marketing for the company's maternal health business.
  
Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announced the planned resignation of Dr. Nam-Hai Chua and the designation of Bram Klaeijsen to serve as a member of Amyris's board of directors. Klaeijsen is a seasoned business leader from Cargill, Inc. and has served in various roles with affiliates of Temasek Holdings.
  
BioRestorative Therapies, Inc. (OTCQB:BRTX), a life sciences company focused on adult stem cell-based therapies for various personal medical applications, today announced the conversion of $5.15 million of debt into common shares and warrants.
  
Capstone Therapeutics (OCTQB:CAPS) today announced settlement and dismissal of the ongoing qui tam lawsuit initially filed in 2005 against OrthoLogic Corp., the Company's previous corporate name. 
  
ChromaDex Corp. (OTCQX:CDXC), creators of innovative proprietary-based solutions that impact dietary supplement, food and beverage, cosmetic, and pharmaceutical products is pleased to announce that Healthy Directions, a direct-to-consumer nutritional supplement retailer and wholly-owned subsidiary of Helen of Troy Limited (Nasdaq:HELE) is launching a new dietary supplement product— NRG AdvantageTM. 
  
Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced that clinical data from its DRM01 Phase 2a trial in acne will be presented at the 23rd World Congress of Dermatology, being held June 8-13, 2015, in Vancouver, Canada.
 
FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, today announced that management will present a company overview at the Goldman Sachs 36th Annual Global Healthcare Conference on June 10, 2015 at 2:00 p.m. PT.
 
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 medical needs, today announced the appointment of Michael F. Marino as Senior Vice President, General Counsel and Corporate Secretary, effective immediately.
 
Juno Therapeutics, Inc. (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, announced today that it has acquired X-BODY, Inc., a privately held biotechnology company with nine employees based in Waltham, Massachusetts.
 
Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to LPCN 1107, the company's oral hydroxyprogesterone caproate ("HPC") product candidate, a potential treatment for the prevention of preterm birth ("PTB"). 
 
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced that Christophe Lavigne, President and Chief Executive Officer, and Robert McNamara, Executive Vice President and Chief Financial Officer, will be presenting at the William Blair Growth Stock Conference to be held June 9, 2015 to June 11, 2015 at the Four Seasons Hotel in Chicago. 
 
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today signed a three-year group purchasing agreement with Novation to offer its Aorfix™ Endovascular Stent Graft to the more than 100,000 members and affiliates that Novation serves.
 
NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that Oded S. Lieberman, PhD, CEO of NeuroDerm, will ring The Nasdaq Stock Market Opening Bell in New York on Wednesday, June 3, 2015.
  
OpGen, Inc. (Nasdaq:OPGN), an early commercial-stage molecular testing and bioinformatics company, today launched its expanded, comprehensive molecular testing and bioinformatics program for detecting and managing Gram negative multi-drug resistant organisms, or MDROs. 
  
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 the addition of Scott Toner as Senior Vice President of Marketing. 
  
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced new clinical data from the multiple ascending dose portion of its ongoing Phase 1/2 trial of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction.
  
T2 Biosystems, Inc. (Nasdaq:TTOO) a company developing innovative diagnostic products to improve patient health, today announced the presentation of results from an investigational study evaluating the T2Candida® Panel utilizing only 2mL of blood from pediatric patients at the 115th General Meeting of the American Society for Microbiology (asm2015) in New Orleans.
  
TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, will present at the Jefferies Healthcare Conference, being held at the Grand Hyatt New York in New York City. 
  
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive 16-week data from the ongoing pediatric Phase 2 study and provided a regulatory update for its recombinant human monoclonal antibody KRN23 against fibroblast growth factor 23 (FGF23) for the treatment of X-linked hypophosphatemia (XLH).
  
VeriTeQ Corporation (OTC Markets:VTEQ), a provider of implantable medical device identification and radiation dose measurement technologies, announced today that more than 10,000 women have now received Motiva Implant Matrix® breast implants, manufactured by Establishment Labs S.A., with VeriTeQ's Q Inside Safety Technology™.
  
Zealand Pharma A/S (Nasdaq OMX Copenhagen A/S: ZEAL) announces that the company's share capital has been increased by nominal DKK 51,487 divided into 51,487 new shares with a nominal value of DKK 1 each. 
  
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) informs that new data will be presented on lixisenatide, the company's first own-invented marketed medicine for the treatment of Type 2 diabetes, at the upcoming 75th Scientific Sessions of the American Diabetes Association (ADA) to be held in Boston on 5 - 9 June 2015. 



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