|Onyx Drug's Toxic Side Effects Concern FDA; Favorable Decision in Watson's Sactura XR® Patent Suit|
|By Staff and Wire Reports|
|Monday, 18 June 2012 18:02|
The toxic side effects of an experimental cancer drug from Onyx Pharmaceuticals (NASDAQ:ONXX) may outweigh its benefits for patients with a type of blood cancer, federal health regulators said Monday.
The Food and Drug Administration warned that patients in a company study of the drug had a high rate of heart and lung side effects, some which were fatal. The FDA posted its review of carfilzomib online ahead of a meeting Wednesday, where its panel of cancer experts will recommend whether the drug should be approved.
Despite the negative tone of the review, some analysts said they expect the FDA's panel of outside experts to take a more favorable view. FDA panels are mainly comprised of practicing physicians from leading universities and hospitals.
BMO Capital Markets analyst Jim Birchenough said he expects "panel members to be more constructive toward the carfilzomib data package." Birchenough recommended buying the stock, in a note to investors.
Shares of Onyx Pharmaceuticals Inc., based in San Francisco, fell $1.90 to close at $44.08 Monday after rising as high as $46.99 earlier in the session. They are near their 52-week high of $47.80 in late April.
Onyx has asked the FDA to approve carfilzomib as a treatment for patients with advanced forms of multiple myeloma whose disease has spread despite treatment with other drugs.
Multiple myeloma affects plasma cells in bone marrow. Over 50,000 people have the disease in the U.S., and about 20,000 new cases are diagnosed every year.
Onyx studied the drug in 266 patients who had already been treated with two other cancer drugs. About 22 percent of patients studied responded to the drug, with the typical patient surviving slightly less than eight months after beginning treatment. In its briefing, FDA reviewers commented that the response rate was so low "it may not provide an advantage over available therapy."
FDA reviewers said they were also "very concerned with severe toxicities," including heart problems, which affected 23 percent of patients. The agency's scientists said the root cause of those problems "is not understood."
The FDA has already approved seven drugs for multiple myeloma. Doctors use different therapies depending on the patient's age, health and stage of disease.
The FDA will ask its cancer panel to vote on whether the benefits of carfilzomib outweigh the risks. The agency is not required to follow the group's advice, though it often does. A decision on the drug is expected by July 27.
Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed the U.S. Court of Appeals for the Federal Circuit has affirmed the United States District Court for the District of Delaware's March 31, 2012 decision that the asserted claims of U.S. Patent Nos. 7,410,978; 7,759,359; 7,781,448; 7,781,449 and 7,763,635 relating to Sanctura XR® (trospium chloride extended-release capsules) are invalid.
Watson's Abbreviated New Drug Application for a generic version of Sanctura XR® is pending with the FDA.
Sanctura XR® is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. For the twelve months ending April 30, 2012, Sanctura XR® had total U.S. sales of approximately $66 million, according to IMS Health data.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that Thomas Moore, Chairman & CEO of Advaxis, will present at the 2012 BIO International Convention.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that data from two Phase 2 trials in renal cell carcinoma (RCC) for the Company's oral anticancer drug, perifosine, have been published in the June 2012 issue of Cancer, a publication of the American Cancer Society.
Assisted Living Concepts, Inc. ("ALC") (NYSE: ALC) reported that on Friday, June 15, it signed and closed on an agreement (the "Agreement") with Ventas Realty, Limited Partnership ("Ventas Realty") and MLD Delaware Trust ("MLD") to purchase 12 residences consisting of 696 units for a purchase price of $97 million plus $3 million for a litigation settlement fee plus Ventas's expenses in connection with the litigation.
Axia Group's (PINKSHEETS:AGIJ) (www.axiagroup.com/) Collagenna Skin Care Products is pleased to announce that it will open its first International Clinic Concept in the Middle East (Dubai).
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to announce that since the Food and Drug Administration ("FDA") conveyed last week that Prurisol™, the Company's drug in development for psoriasis, would be eligible for a 505(b)(2) designation, progress is immediately being made by the Company toward the goal of filing an Investigational New Drug ("IND") application to advance Prurisol into late-stage clinical trials.
Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that the University of Washington ("UW") has begun enrolling patients in a randomized phase II study testing the combination of tosedostat with either cytarabine or decitabine for elderly patients with newly-diagnosed acute myeloid leukemia ("AML") or high-risk myelodysplastic syndrome ("MDS").
Deaf-Talk, Inc. (PINKSHEETS: MGQG), dba DT Interpreting (DTI), the industry leader in on-demand video sign language interpreting, today announced the launch of its new website.
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V. (NYSE, Euronext: DSM KON), announced today that it has signed a commercial agreement for contract manufacturing services using its proprietary XD® high cell density process technology with a major pharma company.
KineMed, Inc. (www.kinemed.com) announced today a multi-year R&D collaboration with GlaxoSmithKline plc (GSK) (LSE: GSK, NYSE: GSK) that will apply KineMed’s proprietary biomarker discovery platform in therapeutic areas of interest to GSK.
Illumina (NASDAQ:ILMN) announced today that the company has filed an additional patent infringement suit against Complete Genomics, Inc. Illumina is seeking all available remedies, including injunctive relief.
ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC), a clinical stage biotechnology company that is focused on developing new immune-based products to treat and diagnose cancer, today announced that it is scheduled to join the U.S. broad-market Russell 3000®, Global and Microcap Indexes when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 25, 2012, according to a preliminary list of additions posted on June 8 on the Russell website at www.russell.com/indexes.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced interim data from its Phase 2, double-blind, randomized, placebo-controlled study of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma.
Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it has entered into a co-promotion agreement with Horizon Pharma, Inc. (NASDAQ: HZNP) to promote DUEXIS® (ibuprofen and famotidine). DUEXIS is a proprietary single-tablet combination of the non-steroidal anti-inflammatory drug ibuprofen and the histamine H2-receptor antagonist famotidine and is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers.
Ohr Pharmaceutical Inc. (OTCBB: OHRP) announced today that Dr. Irach B. Taraporewala, President and Chief Executive Officer, will present a corporate overview at the 2012 BIO International Convention taking place in Boston, MA from June 18-21, 2012.
Pacific Biosciences of California, Inc., (NASDAQ:PACB) today launched a new and unique solution to detect DNA base modifications associated with epigenetic regulation and DNA damage using the PacBio® RS High Resolution Genetic Analyzer.
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced the launch of the PAREXEL MyTrials™ platform, a fully-integrated eClinical solution that simplifies the clinical trial process.
SDIX (Nasdaq: SDIX) today announced that it will be showcasing progress with its advanced Genomic Antibody TechnologyTM (GATTM) data package this week’s BIO International Convention, one of the largest global partnering events for the biotechnology industry.
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced new clinical data presented in an oral presentation for ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use at the 17th Congress of the European Hematology Association (EHA).
Stakool, Inc. (OTCQB: STKO) (OTCBB: STKO), a Florida-based corporation, a supplier of natural and organic and health and wellness products, announced Mr. Peter Hellwig, the President and CEO of Stakool, Inc., conducted an online interview to discuss current operations, share structure, and relationship with seven-time Olympic medalist Shannon Miller as company spokesperson.
Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, extended its leading FT-IR spectrometry platform by introducing the first research-grade FT-IR system designed for simple one-touch operation.
XenoPort, Inc. (Nasdaq:XNPT) announced today the appointment of Ernest Mario, Ph.D., to its board of directors. Dr. Mario has extensive experience in the pharmaceutical industry, including previously held positions of chief executive officer of Glaxo Holdings plc and ALZA Corporation.
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), a Danish biotechnology company dedicated to the discovery and development of novel peptide drugs, has signed a collaboration agreement with Protagonist Therapeutics, Inc., a privately-owned US incorporated biotechnology company.