|Lexicon Announces Closing of Enrollment Telotristat Etiprate; Amgen Seeks Injunction Against Neupogen Competitor|
|By Josh Gee|
|Monday, 09 March 2015 19:20|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 9, 2015.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced that it has completed enrollment in TELESTAR, its pivotal Phase 3 clinical trial of telotristat etiprate for patients with carcinoid syndrome. The company expects to announce top-line data from the TELESTAR trial in the third quarter of 2015.
"The effects of carcinoid syndrome are severely debilitating for many people's lives, causing them to suffer from life-altering diarrhea, flushing and pain," said Lonnel Coats, Lexicon's president and chief executive officer. "Completing enrollment in this pivotal Phase 3 clinical trial marks an important step in bringing telotristat etiprate to market to help improve the lives of these individuals whose carcinoid syndrome is no longer adequately controlled by somatostatin analog treatment."
TELESTAR is Lexicon's pivotal Phase 3 clinical trial of telotristat etiprate evaluating the safety and tolerability of telotristat etiprate and its effect on symptoms associated with carcinoid syndrome. In total, the trial enrolled 135 patients with inadequately controlled carcinoid syndrome on background somatostatin analog therapy, in a randomized, double-blind, placebo-controlled study of 250mg three times daily and 500mg three times daily doses of telotristat etiprate over a 12-week treatment period, followed by a 36-week, open-label extension where all patients receive 500mg three times daily doses of telotristat etiprate. The primary efficacy endpoint under evaluation in the trial is the number of daily bowel movements, with secondary efficacy endpoints including changes in urinary 5-HIAA levels, flushing episodes, abdominal pain and quality of life measures.
Amgen, Inc. (NASDAQ: AMGN) will face competition for its Neupogen chemotherapy treatment from biotechnology, but exactly when a newly approved rival comes to market, and at what price, remains uncertain, an analyst said Monday.
Novartis AG's (NYSE: NVS) Sandoz unit obtained U.S. regulatory approval Friday for its biosimilar Zarxio treatment in an unsurprising development. But Morgan Stanley's Matthew Harrison noted a key March 13 court hearing on Amgen's request for an injunction against Sandoz for an alleged patent violation concerning Zarxio.
"Our conclusion: The mess continues," said Harrison, who maintained an Equal-Weight rating on Amgen. "It's still a a wait-and-see game." Moreover, Harrison cited material from Amgen's lawsuit suggesting it may cut the price of Neupogen to maintain market share. Sandoz "could actually price above Neupogen" while offering physician rebates, according to Harrison.
Sandoz hasn't commented on pricing plans except to note a 20 percent to 30 percent biosimilar price discount in Europe, Harrison said. Neupogen accounted for $840 million of Amgen's 2014 sales of $20.06 billion.
Sandoz has agreed to refrain from launching Zarxio until either April 10, or until a ruling on the case is made; whichever is earlier. Zarxio is heralded as the first-ever biosimilar drug to win U.S. marketing approval.
In contrast with generic drugs, biosimilars are manufactured from living organisms, and market clearance requires that it be "highly similar to an already-approved biological product," rather than an exact copy. Harrison said a regulatory requirement that biosimilar developers share the content of their applications with the original patent holder has opened the doors to significant litigation.
Similar pending cases include Sandoz versus Pfizer Inc. PFE 0.18% related to its Enbrel arthritis treatment and South Korea's Celltrion Inc. versus Johnson & Johnson JNJ 0.55% concerning JNJ's Remicaide drug for arthritis and other ailments.
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced its financial results for the year ended December 31, 2014, in addition to 2014 accomplishments and anticipated milestones for 2015.
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the Company's fourth quarter and year-end 2014 financial results will be released on Monday, March 16, 2015.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), today announced its financial results for the fourth quarter and year ended December 31, 2014.
BioCorRx, Inc. (BICX), developer of the Start Fresh Program, announces the opening of a new center offering the program in Washington D.C. by its licensee, Sobriety and Addiction Solutions, LLC (SAS). SAS operates as MyLife Recovery CentersTM and has two other locations in California: Walnut Creek and Fresno.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that the Company will be presenting at the 27th Annual ROTH Conference, in California.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that, based on a recent meeting with the U.S. Food and Drug Administration ("FDA"), the Company plans to seek clearance of Ablatherm HIFU by way of a Direct De Novo 510(k) application as opposed to the Pre-Market Approval ("PMA") application amendment EDAP had been pursuing.
Emergent BioSolutions Inc. (NYSE:EBS) and MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) today announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, and clinical activity of MOR209/ES414 in patients with metastatic castration-resistant prostate cancer (mCRPC).
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HS-410 (vesigenurtacel-L) for the treatment of non-muscle invasive bladder cancer (NMIBC).
Hemispherx Biopharma, Inc. (NYSE MKT:HEB), reported today that it has executed an agreement with Emerge Health Pty Ltd. ("Emerge") to seek approval of Ampligen, an experimental immunotherapeutic, for Chronic Fatigue Syndrome in Australia and New Zealand and to commence distribution of Ampligen in both countries on a named-patient basis, where deemed appropriate.
iKang Healthcare Group, Inc. (Nasdaq:KANG), the largest provider in China's fast growing private preventive healthcare services market with a market share of 13.6% in terms of revenue in calendar year 2014, today announced its unaudited financial results for the fiscal third quarter ended December 31, 2014.
Immunomic Therapeutics, Inc., a privately-held biotechnology company developing vaccines based on its proprietary LAMP technology, today announces it will be presenting at the BIO-Europe Spring Conference to be held at the Paris Expo, Porte de Versailles on Tuesday, March 10, 2015 at 4:00 PM, Level 0, Room E.
Islet Sciences, Inc. (OTCQB:ISLT), a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, announced today that Chief Operating Officer, Dr. William Wilkison, was invited to present clinical and preclinical data highlighting the unique properties of selective sodium glucose transporter 2 (SGLT2) inhibitor, remogliflozin etabonate, as a novel treatment for non-alcoholic steatohepatitis (NASH) and its precursor, non-alcoholic fatty liver disease (NAFLD).
The Joint Corp. (Nasdaq:JYNT), a national healthcare franchisor of chiropractic clinics, today announced that it will release its 2014 fourth quarter and full year financial results on Thursday, March 19, 2015, at 4:00 p.m. EDT, with a conference call to follow at 5:00 p.m. EDT.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) announced today that the U.S. Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, which is often referred to as a double chin.
Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced that Patrice E. Merrin has been appointed to the Company's Board of Directors.
Parnell Pharmaceuticals Holdings Ltd (Nasdaq:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, today announced that Robert Joseph, President and Chief Executive Officer, will be presenting at the Jefferies 2015 Animal Health Summit in New York on Thursday, March 26, 2015 at 11:40 AM ET.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that its new website is now live and can be viewed at www.PharmaCyteBiotech.com.
Premier, Inc. (Nasdaq:PINC) has been named a 2015 World's Most Ethical Company® by the Ethisphere Institute for the eighth year in a row.
Progenics Pharmaceuticals, Inc., (Nasdaq:PGNX), an oncology company focused on developing innovative ways to target and treat prostate cancer, announced today that it will host a conference call and webcast to review fourth quarter and year end 2014 financial results on Monday, March 16, at 8:30 a.m. ET.
Praxsyn Corporation's (OTCQB:PXYN) wholly owned subsidiary, Mesa Pharmacy Inc. (Mesa), announced today that, as of February 12, 2015, Dr. Amy Lee (Hawkins) Summers, Pharm, D., has joined the company as its new pharmacist in charge (PIC) and director of pharmacy.
Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers, today announced several updates for the investigational drug RAD1901, and its oncology business.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that management will be presenting at the Barclays Global Healthcare Conference at the Loews Miami Beach Hotel in Miami, Florida.
Repligen Corporation (Nasdaq:RGEN) today announced that it will report fourth quarter and full year 2014 financial results on Friday, March 13, 2015.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, announced today that it will release financial results for the fourth quarter and full year ended December 31, 2014, after the market close on Monday, March 16.
TESARO, Inc. (Nasdaq:TSRO) today announced the closing of its previously announced underwritten public offering of common stock.
Transcat, Inc. (Nasdaq:TRNS), a leading provider of accredited calibration and compliance services and distributor of professional grade handheld test, measurement and control instrumentation, announced that it has acquired, effective March 6, 2015, Apex Metrology Solutions ("Apex"), a provider of accredited and commercial calibrations.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the presentation of data highlighting the significant impairment in skeletal health outcomes and physical function in adult patients affected by X-linked hypophosphatemia (XLH).