|FDA Confirms Approval of Gilead's Zydelig; FDA Approves Eagle Pharmaceuticals' Ryanodex|
|By Staff and Wire Reports|
|Wednesday, 23 July 2014 19:19|
The U.S. FDA said it has approved Gilead Sciences Inc's Zydelig, a drug to treat three types of blood cancer.
The FDA approved the use of Zydelig in combination with Roche AG's Rituxan for patients with relapsed chronic lymphocytic leukemia (CLL).
It also approved Zydelig under a so-called accelerated approval program for relapsed follicular B-cell non-Hodgkin lymphoma (NHL) and relapsed small lymphocytic lymphoma, when patients have received at least two prior therapies.
For drugs given accelerated approval, companies must conduct additional trials to confirm that the drug's apparent benefit is real.
Zydelig, known generically as idealisib, will carry a boxed warning highlighting the risk of serious and potentially fatal toxicities, including liver toxicity, diarrhea, inflammation of the colon and lung, and perforation of the intestine.
It will be marketed using a special risk management program.
"We believe this broad boxed warning will lead docs to be cautious with this drug," Joseph Pantginis, an analyst at Roth Capital Partners, said in a research note.
Shares of Gilead rose 0.4 percent to $89.66 in afternoon trading. Shares of Pharmacyclics Inc, which makes a rival product, Imbruvica, for chronic lymphocytic leukemia and mantle cell lymphoma and does not carry a boxed warning or risk management program, rose 8.8 percent to $105.05.
Geoff Porges, an analyst at Sanford Bernstein, forecasts revenue for Zydelig growing to $1.5 billion in 2017, higher than the consensus estimate for that year of $990 million.
"Gilead has global rights to the product, and are likely to commercialize it for multiple indications and subtypes of NHL as well as CLL," Porges said in a research report.
Porges said his more optimistic view on the drug is based on its activity in indolent NHL and lead in this disease over Imbruvica and other drugs in the class.
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) today announced that the U. S. Food and Drug Administration (FDA) has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.
“We are very pleased with today's approval of Ryanodex, which enables health care providers to better meet the needs of patients experiencing a life-threatening MH crisis,” said Scott Tarriff, CEO of Eagle Pharmaceuticals. “This significant milestone exemplifies our strategy of developing innovative products and we plan to ship the product in the very near future.”
Eagle is the exclusive licensee of four U.S. patents for Ryanodex. Approval of Ryanodex represents two major milestones: in addition to adding to the Company's portfolio of approved compounds, Ryanodex represents the first product to be solely marketed by the Company.
Ryanodex is the first significant enhancement to MH treatment options in more than three decades, reformulated to improve performance in managing MH. The product has the potential to become a new standard of care for the treatment of malignant hyperthermia, because it enables anesthesiologists to deliver a therapeutic dose of the only antidote for MH (dantrolene sodium) in a much more expedient manner than currently possible with existing formulations of IV dantrolene sodium, potentially saving lives and reducing MH-related morbidity. Ryanodex can be prepared and administered in less than one minute by a single healthcare practitioner.
Utilizing innovative nanosuspension technology, Ryanodex now provides a therapeutic loading dose of dantrolene sodium in a single vial. 250 mg of Ryanodex is mixed with only 5 mL of sterile water and administered to the patient in less than one minute. Other dantrolene sodium formulations require multiple 20mg vials reconstituted in large volumes of sterile water, a process that can take 15 to 20 minutes to mix reconstitute and administer.
“When a patient experiences malignant hyperthermia during surgery, it is a life-threatening emergency requiring immediate treatment including the administration of the ‘antidote' drug dantrolene sodium,” said Henry Rosenberg, MD, CPE, a founder and President of the Malignant Hyperthermia Association of the United States (MHAUS). “The ability for healthcare professionals in hospitals and surgery centers to more quickly prepare and administer this new formulation of the antidote dantrolene sodium is expected to bring the crisis under control more rapidly and prevent severe complications from MH.”
Ryanodex was granted priority review status by the FDA in March 2014, a regulatory review process that expedites the review of drugs that treat life threatening and serious conditions and provide a significant improvement in safety or effectiveness over the existing therapies. Ryanodex will be available to order through national and regional drug wholesalers in August with product shipping shortly after. For more information about Ryanodex, please visit RYANODEX.COM.
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases thought to be related to free aldehydes, today announced that it will issue its financial results for the second quarter of 2014 on Monday, August 4, 2014, prior to the market open.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the fourth quarter and fiscal year ended May 31, 2014.
Brewer Sports International (BSI), a multi-faceted global sports advisory firm, and Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to cell cycle dysregulation, endoplasmic reticulum stress, neurodegeneration and apoptosis, today announced a presentation by Dr. Thomas Arendt, Professor at University of Leipzig, at the 3rd Alzheimer's focused #C4CT (Coalition for Concussion Treatment) Concussion Awareness Summit, powered by MDM Worldwide on Thursday, July 31, 2014 at the United Nations in New York City, NY.
athenahealth, Inc.(Nasdaq:ATHN), a leading provider of cloud-based services for electronic health records (EHRs), practice management, and care coordination, and the New Haven Community Medical Group (NHCMG), one of the largest independent physician associations (IPA) in Connecticut, today announced that NHCMG has selected athenahealth as one of its preferred health information technology (HIT) vendors.
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced that a 1:10 reverse split of its common stock will be effective at the close of business on Friday, July 25, 2014 and in effect for trading purposes on Monday, July 28, 2014.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) and Sarah Cannon Research UK today announced a collaboration to enroll patients in an ongoing Phase 3 clinical trial of its PARP inhibitor, BMN 673, for the treatment of hereditary breast cancer with a BRCA mutation.
CEL-SCI Corporation (NYSE MKT:CVM) announced that Turkey's Ministry of Health had cleared the company to begin patient enrollment in CEL-SCI's global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine.
CONMED Corporation (Nasdaq:CNMD) today announced that Joseph Corasanti is stepping down as Chief Executive Officer, President and a member of the Board of Directors, effective immediately.
CONMED Corporation (Nasdaq:CNMD) today announced financial results for the second quarter ended June 30, 2014.
Eternity Healthcare Inc. (OTCBB:ETAH), a medical device and diagnostic company, announced today that it has signed an agreement with Shanghai Yin Jun Investment & Development Inc., to establish a Joint Venture manufacturing operation in China.
FutureWorld Corp. (OTCQB: FWDG), the leading provider of advanced solutions to the Cannabis industry globally, announces today that its Board of Directors has approved a dividend consisting of 54% of its holdings of the common stock of URVape, Inc. to its shareholders.
Hansen Medical, Inc. (Nasdaq:HNSN), a global leader in intravascular robotics, today announced it will release its financial and operating results for the second quarter ended June 30, 2014, after market close on Thursday, July 31, 2014.
ID Global Corp. (OTC:IDGC) is pleased to announce that it has signed a Letter of Intent (LOI) today to begin the due diligence process with an established Medical Marijuana grower in Vancouver BC, Canada.
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician group practice, today announced financial results for the second quarter ended June 30, 2014.
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, announced today that it will report financial results for the second quarter ended June 30, 2014 after the market close on Wednesday, August 6, 2014.
LHC Group, Inc. (Nasdaq:LHCG), a national provider of post-acute care services, announced today details for the release of its results for the second quarter and six months ended June 30, 2014.
Lion Biotechnologies, Inc. (OTCQB:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TILs), today announced that it has entered into a five-year lease agreement for a new research laboratory at University of South Florida Research Park in Tampa, FL.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, announced today the scheduling of its second quarter 2014 earnings call, which will be held at 8:30 AM ET on Wednesday, July 30, 2014.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that it will report its results for the second quarter of 2014 on Wednesday, August 6, 2014.
Natus Medical Incorporated (Nasdaq:BABY) today announced financial results for the three months ended June 30, 2014.
Oxford Immunotec Global PLC (Nasdaq:OXFD) today announced that it plans to release second quarter 2014 financial results prior to market open on Tuesday, August 5, 2014.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will report second quarter 2014 results on Tuesday, August 5, 2014.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including cancer, today reported financial results for the quarter ended June 30, 2014.
The Spectranetics Corporation (Nasdaq:SPNC) today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance of their peripheral atherectomy products, Turbo-Tandem® and Turbo Elite®, for the treatment of in-stent restenosis (ISR).
Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP), a global biopharmaceutical company, today announced that the United Kingdom's National Institute of Health and Care Excellence (NICE) has published the technology appraisal guidance recommending the use of AMITIZA® (lubiprostone) in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives.
TriVascular Technologies, Inc. (Nasdaq:TRIV) today announced that the Company will release 2014 second quarter financial results after market close on Wednesday, August 6, 2014. Company management will host a conference call beginning at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on Wednesday, August 6 to discuss those results and to answer questions.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced it has appointed Sunil Agarwal, M.D. as its Chief Medical Officer and Senior Vice President, effective August 25, 2014.