|FDA Grants Spectrum Accelerated Approval of Beleodaq™; La Jolla Strengthens Board of Directors with Appointment of Robert H. Rosen|
|By Staff and Wire Reports|
|Monday, 07 July 2014 19:15|
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Beleodaq was approved by the FDA on July 3rd, nearly 5 weeks before the PDUFA date (August 9th). This indication was approved based on data from the multi-center, single-arm BELIEF trial in 120 evaluable patients, refractory to or who had failed at least one prior systemic therapy. In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity.
PTCL comprises a group of rare and aggressive non-Hodgkin’s Lymphomas (NHL) that develop from mature T-cells and accounts for approximately 10 to 15% of all NHL cases in the United States. These patients generally have a poor prognosis with a low response rate (25-27%) to available treatment options, and commonly experience repeated treatment failures until drug resistance or death. Therefore, there has been an important unmet medical need for these patients with PTCL for additional new treatment options that are specifically effective for this disease.
“This FDA approval enables us to help address this unmet medical need, and provide a new treatment option for patients with this difficult-to-treat and ultimately fatal disease,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “First with Folotyn® (pralatrexate injection) and now with Beleodaq, we are very proud to be able to offer patients and clinicians two approved treatment options for R/R PTCL, and be a leader in the treatment of T-cell lymphomas. We will be able to effectively leverage our existing Hematology clinical and sales infrastructure to expedite the launch of Beleodaq. Now with a total of five approved Hematology/Oncology drugs and a strong and maturing development pipeline, Spectrum is well positioned for continued future growth.”
“Peripheral T-cell lymphoma (PTCL) is a poor prognosis subtype of non-Hodgkin's lymphoma with no accepted standard of care,” said Owen A. O'Connor, MD, PhD, Director of Lymphoid Malignancies, Professor of Medicine and Experimental Therapeutics at Columbia Medical Center, New York Presbyterian Medical Center, one of the lead investigators in the BELIEF study. “Relapse is common after initial treatment, and there are limited options for patients in 2nd line and beyond. Histone deacetylase inhibitors have emerged as one promising class of drugs for patients faced with this disease. One interesting observation in the study was the tolerability of Beleodaq in these heavily treated patients. Beleodaq was associated with myelosuppression with an overall rate of anemia of 32%, thrombocytopenia of 16.3% and neutropenia of 9.3% and Grade 3/4 adverse reactions were reported in 10.9%, 7.0% and 6.2% of patients, respectively. The associated severity of hematologic toxicities may prove to be useful in previously treated patients who have poor bone marrow reserve.”
“Interestingly, Beleodaq was shown to have an Overall Response Rate of 25.8% with a high response rate (45.5%) in patients with Angioimmunoblastic T-cell Lymphoma, one of the common PTCL subtypes. In addition, 17% of the patients enrolled in this trial had low Baseline platelet counts (<100,000/mm3) and tolerated therapy with some (15%) attaining partial and complete responses. I believe Beleodaq will be a valuable new option for physicians who treat patients with relapsed or refractory PTCL. This safety profile makes it a potential candidate for the development of new combination treatment paradigms for patients with PTCL,” added Dr. O'Connor.
A review of data from a planned confirmatory Phase III trial of Beleodaq in combination with CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone), to characterize the efficacy and safety of the Beleodaq combination versus CHOP alone, is required by FDA to convert this Accelerated Approval to a Full Approval.
La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced the appointment of Robert H. Rosen to the Company’s Board of Directors.
“We are honored to have Rob, who has a wealth of successful drug development and commercialization experience, join the board of directors of La Jolla Pharmaceutical Company,” said George Tidmarsh, Chief Executive Officer of La Jolla Pharmaceutical Company. “This will be especially important as we prepare to accelerate our drug development efforts.”
Robert H. Rosen is currently President and a Director of Heron Therapeutics, a Nasdaq-listed specialty pharmaceutical company developing products using its Biochonomer polymer-based drug delivery platform. He joined the company in October 2012 as Sr. Vice President and Chief Commercial Officer. Prior to Heron, Mr. Rosen was Managing Partner of Scotia Nordic LLC. From April 2011 to March 2012, Mr. Rosen served as Senior Vice President of Global Commercial Operations at Dendreon Corporation, a biotechnology company. Prior to Dendreon, he served as global head of oncology at Bayer HealthCare, where he was responsible for the development of the global oncology business unit for regions that included the Americas, Europe, Japan, and Asia Pacific from 2005 to 2011. During his tenure at Bayer Healthcare, he led the launch of Nexavar for the treatment of renal cell carcinoma and hepatocellular carcinoma. Nexavar’s worldwide sales in 2011 were $1.0 billion. He also led premarket activities for Stivarga for gastrointestinal stromal tumors and colon cancer and alpharadin for prostate cancer. From 2002 to 2005, Mr. Rosen was vice president of the oncology business unit at Sanofi-Synthèlabo, where he was responsible for the development of Sanofi’s U.S. oncology business and the launch of Eloxatin for colon cancer. Eloxatin U.S. sales in 2005, its third full year on the market, were $1.1 billion, ranking it among the industry’s most successful oncology drug launches. Mr. Rosen received a Bachelor of Science degree in Pharmacy from Northeastern University.
Amarantus BioScience Holdings, Inc. (OTCBB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that Gerald Commissiong, President and CEO will host and participate in a Twitter chat on Thursday, July 10, 2014 from 4-4:30pm EDT via his Twitter handle @G_Commish.
Amarantus BioScience Holdings, (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that analytical performance, clinical performance and 6-year longitudinal data related to the Company's LymPro Test® will be presented at the Alzheimer's Association International Conference (AAIC), held at the Bella Center in Copenhagen, Denmark, July 12-17, 2014.
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced it has launched two new clinical development initiatives for MYDICAR®, its lead product candidate, in patients with end-stage renal disease (ESRD) undergoing surgery for arteriovenous fistula (AVF) creation in preparation for hemodialysis, and in advanced heart failure patients with systolic dysfunction that were previously excluded from MYDICAR trials due to pre-existing levels of neutralizing antibodies.
Cerner (Nasdaq:CERN) today announced it will release its second quarter 2014 earnings results after the market closes on July 24.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that it will relocate the company's corporate headquarters to a new leased facility in northern San Diego at 16745 W Bernardo Drive, Suite 200, San Diego, CA 92127.
Cryo-Cell International, Inc. (OTCQB:CCEL), the world's first private cord blood bank to separate and store stem cells in 1992, announced results for the second fiscal quarter ended May 31, 2014.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today on publication of its clinical study results evaluating the effect of INFAT® usage on crying in healthy infants (link to the journal: http://www.biomedcentral.com/1471-2431/14/152).
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer and virtual administrator of affordable, cloud-based individual health insurance plans and ancillary products, today announced that total approved applications received in the second quarter of 2014 increased 107.3%, compared to the second quarter of 2013.
Shannon O. Stoeger, Senior Vice President, Idaho Independent Bank (OTCBB:IIBK), announced that IIB is partnering with American Health Value to offer Idaho Medical Savings Accounts.
MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it will present at the 56th Annual Meeting of the Japanese Society of Gastroenterology and the 18th General Meeting of the Japan Society of Hepatology during the Japan Digestive Disease Week (JDDW) 2014 in Kobe, Japan.
Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, commercial-stage diagnostics company committed to improving patient care by providing advanced, innovative tests in the field of immunology, today announced that Louis O'Dea, MB, BCh, BAO, has joined the company as Chief Medical Officer.
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that it has entered into a second clinical collaboration agreement with Daiichi Sankyo to study andexanet alfa, Portola's investigational Factor Xa inhibitor antidote, in Phase 3 registration studies with Daiichi Sankyo's Factor Xa inhibitor edoxaban.
Prosensa Holding N.V. (NASDAQ: RNA) the Dutch biopharmaceutical company focusing on rare diseases with a high unmet medical need, today confirmed that on July 3 (one year following the closing of its IPO), it filed a shelf registration statement with the US Securities and Exchange Commission.
Raptor Pharmaceuticals (Nasdaq:RPTP) today announced that Julie Anne Smith, Executive Vice President, Strategy and Chief Operating Officer at Raptor, has been named President and CEO-designate effective immediately.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that the Company will release 2014 second quarter financial results after market close on Thursday, July 24, 2014.
StemCells, Inc. (Nasdaq:STEM) announced today the appointment of Alan Trounson, Ph.D. to its Board of Directors. Dr. Trounson most recently served as President of The California Institute of Regenerative Medicine (CIRM), the largest scientific funding body for stem cell research in the world.
Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP), a global biopharmaceutical company, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has approved AMITIZA® (lubiprostone) 24 mcg for the treatment of opioid-induced constipation (OIC) in adults with chronic, non-cancer pain.