|Impax Pharma Resubmits RYTARY Extended-Release Capsules to FDA; Dendreon Phase II STAND Study Will Be Presented at EAU Congress|
|By Staff and Wire Reports|
|Friday, 11 April 2014 19:29|
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease (PD).
After discussions with the FDA, the Company has resubmitted the NDA for RYTARY providing updated safety and stability information. The FDA will require an inspection of manufacturing facilities involved in the production of RYTARY in connection with the resubmission. The FDA has designated the NDA filing for RYTARY as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.
"We are excited to resubmit the updated NDA for RYTARY and remain enthusiastic about the potential commercial opportunity for the product," said Michael Nestor, president of Impax Pharmaceuticals.
About RYTARY (IPX066) RYTARY is an investigational extended-release capsule formulation of carbidopa and levodopa for the treatment of idiopathic Parkinson's disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
About Parkinson's Disease Parkinson's disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.
Dendreon Corporation (NASDAQ: DNDN) announced the presentation of preliminary data from a long-term analysis of the Phase II STAND study demonstrating that tumor-specific T-cell responses appear to be enhanced and sustained when PROVENGE^® (sipuleucel-T) is given after androgen deprivation therapy (ADT) in patients with biochemically-recurrent prostate cancer (BRPC) at high risk for metastases. These data will be presented at the 29^th Annual European Association of Urology (EAU) Congress taking place from April 11-15, 2014 in Stockholm, Sweden.
“We are pleased with the preliminary STAND data, which show the continued potential for sequencing PROVENGE with other treatments and the impact that immunotherapy has on immune responses in advanced prostate cancer patients,” said Andrew S. Sandler, M.D., executive vice president and chief medical officer at Dendreon. “The presentation of these data at EAU highlights Dendreon's commitment to expanding awareness and understanding of immunotherapy and PROVENGE in Europe as we prepare to make PROVENGE available to advanced prostate cancer patients beyond the United States.”
ADT is a standard treatment option for men with BRPC after failure of local therapy. The STAND study is a randomized, Phase II trial that consisted of two patient study groups, one completing PROVENGE two weeks before ADT and the second receiving PROVENGE three months after the start of ADT. Preliminary results suggest enhanced cellular immune responses when PROVENGE was given after ADT, and these responses were persistent for at least 12 months and robust in both patient groups.
“The STAND study results are encouraging as they provide additional evidence on how sipuleucel-T can be sequenced with other treatments which will assist clinician decision-making upon whether immune responses correlate with certain clinical parameters, such as prostate specific antigen (PSA) recurrence,” said Neal Shore, M.D., medical director at the Carolina Urologic Research Center.
PROVENGE is approved in all 28 countries of the European Union (EU) as well as Norway, Iceland and Liechtenstein for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. Dendreon plans to make PROVENGE commercially available in Europe, beginning with Germany and the United Kingdom, through Centers of Excellence.
BioCorRx, Inc. (OTCQB: BICX), CEO Kent Emry was featured yesterday on Bloomberg Television's Taking Stock with Pimm Fox alongside Start Fresh Program alum Jeremy Miller.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in development, assembly, marketing and sale of medical devices and sleep respiratory products in China, today announced that it has appointed Huili (Alisa) Li as its new Chief Financial Officer and as a Director, in both cases to replace Mr. Jingli (Charles) Li, who resigned on April 8, 2014.
The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign™ Group of skilled nursing, rehabilitative care services, home health and hospice care, assisted living, and urgent care companies, announced today that it has acquired Life's Doors Hospice, Life's Doors Home Health, and Life's Doors Home Care Solutions located in Boise, Idaho.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) will release its first quarter 2014 financial results on Thursday, May 1, 2014.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) today announced results from a preclinical study demonstrating the potential protective effects of the Company's lead product candidate obeticholic acid (OCA) in an experimental model of liver disease.
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 preliminary estimated financial results for the three months ended March 31, 2014.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today that it plans to conduct a conference call and webcast.