|FDA Grants Genentech's Obinutuzumab Priority Review; PROLOR to Issues Preclinical Trial Results from Studies of VIIa-CTP|
|By Staff and Wire Reports|
|Wednesday, 03 July 2013 19:19|
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the U.S. FDA has accepted the company's Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for GA101 in the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer, based on final Stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. This acceptance follows the GA101 FDA Breakthrough Therapy Designation that was received in May 2013.
“We're excited that the FDA has granted GA101 in CLL both Breakthrough Therapy Designation and Priority Review,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame.”
The FDA is evaluating data from the pivotal Phase III CLL11 trial, which found that GA101 demonstrated a statistically significant 86 percent reduction in the risk of disease worsening or death (HR=0.14, 95 percent CI 0.09-0.21, p<0.0001) when combined with chlorambucil chemotherapy compared to chlorambucil alone in previously untreated people with CLL and co-existing medical conditions. In CLL11, no new safety signals were detected for GA101. The most common Grade 3-4 adverse events (AEs) for GA101 were infusion-related reactions (IRRs) and low cell count of certain white blood cells (neutropenia) which did not result in an increased risk of infection. The incidence and severity of IRRs decreased after the first infusion and no Grade 3-4 IRRs have been reported beyond the first infusion.
Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Association (EMA), in April 2013. In the United States, Genentech has opened an Expanded Access Program (EAP) to provide GA101 to people with CLL under certain circumstances while the company seeks regulatory approval.
PROLOR Biotech, Inc. (NYSE: PBTH) announced that the company will present new results from preclinical studies of its long-acting clotting factor VIIa (Factor VIIa-CTP), a next-generation investigational therapy in advanced preclinical development for the potential treatment of hemophilia. The data provide further evidence that Factor VIIa-CTP has the potential to be administered by subcutaneous (SC) injection as well as intravenously (IV), which would facilitate its prophylactic use by patients on an ongoing basis. The study results will be discussed in an oral presentation at the XXIV Congress of the International Society of Hemostasis and Thrombosis (ISTH).
Currently available commercial factor VIIa must be administered through IV infusion, which can be onerous for patients. This limits its use for prophylactic treatment and can require frequent administrations if patients are treated only "on demand" when a bleeding episode occurs.
The new preclinical results being presented at the ISTH Congress further confirm the efficacy of PROLOR's long-acting Factor VIIa-CTP and show that it has the potential to be administered using a simple SC injection. The combination of a long-acting product coupled with the ability to be administered by SC injection could change the way that factor VIIa is used, potentially allowing individuals with hemophilia to self-administer the drug at home on a prophylactic basis, improving their quality of life and potentially reducing the need for on-demand treatment of bleeding episodes.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that Nick Colangelo, president and CEO of Aastrom, will present at the 8th Annual JMP Securities Healthcare Conference on Tuesday, July 9 at 2:00 p.m. ET at the St. Regis New York.
Ambit Biosciences Corporation (Nasdaq: AMBI) announced today that Michael Martino, president and CEO, is scheduled to present a company overview at the 8th Annual JMP Securities Healthcare Conference.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the 8th Annual JMP Securities Healthcare Conference to be held July 9-10, 2013 at the St. Regis hotel in New York City.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, July 25, at 5:00 p.m. ET to discuss second quarter 2013 financial results.
Epizyme, Inc., (NASDAQ: EPZM) a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, announced today that Jason P. Rhodes, Executive Vice President and Chief Financial Officer, has been named President of Epizyme.
Generex Biotechnology Corporation (OTCBB: GNBT) today announced that it will be filing an amendment to the Form S-1 Registration Statement it filed with the United States Securities and Exchange Commission yesterday, July 2, 2013 (file number 333-189766).
IEC Electronics Corp. (NYSE MKT: IEC) announced that it is filing today with the Securities and Exchange Commission an amended annual report on Form 10-K/A including its restated financial statements for the fiscal year ended September 30, 2012 and an amended quarterly report on Form 10-Q/A with restated financial statements for the quarter ended December 28, 2012.
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with TOVIAZ® (fesoterodine fumarate extended-release tablets, 4 mg and 8 mg).
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced encouraging results from the Phase Ib study with clivatuzumab labeled with the radioisotope, yttrium-90 (90Y), in patients with metastatic pancreatic cancer who had received at least 2 prior treatments.
Integra LifeSciences Holdings Corporation (Nasdaq: IART) will release its second quarter 2013 financial results on Thursday, August 1, 2013.
Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive-lipid-targeted therapeutics, today announced that it will participate in the JMP Securities Healthcare Conference in New York, taking place July 9-10, 2013. President and Chief Executive Officer Scott R. Pancoast will give his presentation on Tuesday, July 9, 2013 at 2:30 p.m. EDT (11:30 a.m. PDT).
Mast Therapeutics, Inc. (NYSE MKT: MSTX) today announced that the Company's Chief Executive Officer, Brian M. Culley, will present at the JMP Securities Healthcare Conference on Tuesday, July 9, 2013 at 12:00 p.m. Eastern time in the Versailles Salon at The St. Regis Hotel in New York City.
MediSwipe Inc. (OTCQB: MWIP), a data management solutions company for the medicinal marijuana and health care industry, today announced that management will host an investor conference call for Monday July 8th, 2013 at 4:00 pm Eastern time.
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has filed a shelf registration statement on Form S-3 with the United States Securities and Exchange Commission ("SEC").
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will present a company overview at the JMP Securities Healthcare Conference in New York. The presentation is scheduled for Wednesday, July 10th at 9 a.m. Eastern Time.
OvaScienceSM, (NASDAQ: OVAS), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, announced today that OvaScience management will present at the 2013 JMP Securities Healthcare on Wednesday, July 10 at 1:30 p.m. at The St. Regis New York in New York City.
PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that Eric I. Richman, President and Chief Executive Officer will present at the JMP Securities 2013 Healthcare Conference on Wednesday, July 10, 2013 at 3:30 p.m. E. T. in the Library Room, St. Regis Hotel, New York.
PROLOR Biotech, Inc. (NYSE MKT: PBTH), today announced that the company will present new results from preclinical studies of its long-acting clotting factor VIIa (Factor VIIa-CTP), a next-generation investigational therapy in advanced preclinical development for the potential treatment of hemophilia.
Rite Aid Corporation (NYSE: RAD) today announced sales results for June.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it will release its financial results for the second quarter 2013 before the market opens on Wednesday, July 24, 2013, and will hold a conference call on the same day at 8:30 a.m. EDT.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has transferred U.S. development and commercialization rights to the perindopril franchise to Symplmed Pharmaceuticals, LLC ("Symplmed").