|Protalix Wins FDA Approval for Its First Drug; ISTA Reports Positive, Results From BEPOSONE™|
|By Staff and Wire Reports|
|Tuesday, 01 May 2012 18:49|
Protalix BioTherapeutics Inc. (NYSE:PLX) jumped as much as 27 percent in extended trading after the drugmaker won approval for its debut medicine, a treatment it developed with Pfizer Inc. (NYSE:PFE) for a rare genetic disorder.
The FDA cleared the product called Elelyso to treat a condition caused by lack of an enzyme that can lead to spleen and liver enlargement known as Gaucher disease. The drug, chemically known as taliglucerase, is approved for Type 1 Gaucher disease affecting about 6,000 people in the U.S., the agency said in a statement today.
While Gaucher disease is a rare condition, the market is lucrative because of “the severity of the symptoms and chronic nature of the disease,” according to Carmiel, Israel-based Protalix’s website. Elelyso will compete with Sanofi’s Cerezyme, approved in 1994, and Shire Plc (SHP)’s Vpriv, approved in 2010.
Protalix and New York-based Pfizer are prepared to supply all 2,000 patients on Gaucher treatment in the U.S., Vera Wu, Pfizer’s global asset lead for Elelyso, said in a telephone interview. Pfizer, the world’s largest drugmaker, will share in 60 percent of revenue.
Protalix rose as high as $7.88 after closing at $6.19 in New York trading. Pfizer was unchanged after closing at $22.78.
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) announced positive results from its Phase 2 randomized, placebo-controlled, parallel-group environmental clinical study of BEPOSONE™ (bepotastine besilate/steroid) nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. According to the trial findings, BEPOSONE™ nasal spray showed highly statistically significant improvements compared to placebo in patients' nasal symptoms following exposure to one of the most potent seasonal allergy triggers, Mountain Cedar pollen.
These improvements were seen as early as Day 1 of therapy and were sustained through the two-week treatment period. Statistically significant improvement was also seen for BEPOSONE™ within 15 minutes after dosing in a small subgroup of subjects who frequently evaluated their nasal symptoms for 4 hours after their first nasal spray dose. Further, safety data demonstrated BEPOSONE™ was well-tolerated as a nasal spray, with an adverse event profile similar to placebo and generally consistent with those observed with bepotastine besilate dosed as a nasal spray in prior clinical trials and with other antihistamine nasal sprays.
Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and Chief Executive Officer, will present at the Deutsche Bank 37th Annual Healthcare Conference on Tuesday, May 8, 2012 at 11:20 a.m. ET.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will report its unaudited financial results for the first quarter ended March 31, 2012 on Tuesday, May 8, 2012, after the U.S. financial markets close. ACADIA's management will host a conference call and webcast on Tuesday, May 8, 2012, at 5:00 p.m. Eastern Time to discuss ACADIA’s financial results and development programs.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that an abstract has been selected for poster & block symposium presentations at the American Association of Immunologists (AAI) Annual Meeting 2012 in Boston, MA, from May 4-8.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company focused on the development and commercialization of Feraheme® (ferumoxytol) Injection for intravenous (IV) use to treat iron deficiency anemia (IDA), today reported unaudited consolidated financial results for the first quarter ended March 31, 2012.
AmerisourceBergen Corporation (NYSE: ABC) today announced that it has completed the previously announced acquisition of World Courier Group, Inc., a privately held leading global specialty transportation and logistics provider for the biopharmaceutical industry.
Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that David Perry, the company’s Chief Executive Officer, will provide a company overview at the Deutsche Bank Annual Health Care Conference on Monday May 7, 2012 at 4:10 p.m. ET in Boston, Massachusetts.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced it will release its first quarter 2012 financial results before the market opens on Tuesday, May 8, 2012, and host a conference call shortly thereafter at 8:30 a.m. ET (Eastern Time) to discuss the results.
Arrowhead Research Corporation (NASDAQ:ARWR) today announced that it will report its financial results for the fiscal 2012 second quarter ended March 31, 2012, on Tuesday, May 8, 2012 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).
AstraZeneca (NYSE: AZN) today announced results of the LUNAR (Limiting UNdertreatment of Lipids in Acute Coronary Syndrome with Rosuvastatin) study, which showed that CRESTOR 40mg significantly decreased LDL-C or “bad” cholesterol and increased HDL-C or “good” cholesterol compared with atorvastatin 80mg in patients with acute coronary syndrome (ACS).
Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its first quarter 2012 results.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012.
Cerus Corporation (NASDAQ: CERS) today announced financial results for the first quarter ended March 31, 2012.
Compugen Ltd. (NASDAQ: CGEN) today reported financial results for the first quarter ending March 31, 2012.
Covidien plc (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced that it has completed the previously announced acquisition of Newport Medical Instruments, Inc. for an aggregate consideration of approximately $108 million, net of cash and short-term investments acquired.
Dyax Corp. (NASDAQ: DYAX) announced today that executive management will participate in the Deutsche Bank 37th Annual Healthcare Conference, being held May 7-9, 2012 at the InterContinental Hotel in Boston.
Exactech, Inc. (Nasdaq:EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today revenue of $58.6 million for the first quarter of 2012, a 10% increase over $53.4 million in the first quarter of 2011.
Exact Sciences Corp. (Nasdaq: EXAS) today announced its financial results for the quarter ended March 31, 2012.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the first patient has been dosed in a Phase 3 clinical trial evaluating the efficacy and safety of GS-1101 (formerly CAL-101).
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that its corporate presentation will be webcast from the Deutsche Bank 37th Annual Health Care Conference in Boston.
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced that it will be presenting data from preclinical studies of its Toll-like receptor (TLR) inhibitor, IMO-8400, in models of systemic lupus erythematosus (SLE) and psoriasis, which suggest that IMO-8400 may be useful for the treatment of both indications.
Impax Laboratories, Inc. (NASDAQ: IPXL) today reported first quarter ended March 31, 2012 financial results.
Incyte Corporation (Nasdaq: INCY) announced today it will present at the Bank of America Merrill Lynch 2012 Health Care Conference on Tuesday, May 15, 2012 at 11:20 a.m. (PT) / 2:20 p.m. (ET) in Las Vegas.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will host a conference call on Tuesday, May 8, 2012, at 4:30 p.m. ET.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its first quarter 2012 and recent business activities.
InSite Vision Incorporated (OTCBB:INSV) today reported financial results for the quarter ended March 31, 2012. Total revenues for the first quarter of 2012 were $2.3 million, a decrease of $0.8 million from the same quarter of 2011.
NanoViricides, Inc. (OTC: NNVC) (the "Company") announced today that its President, Dr. Anil R. Diwan, will present an overview of the company at the 21st Annual Meeting of the New York Biotechnology Association (NYBA) in NYC.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes reported today that in separate interviews Chief Executive Officer, Shai N. Gozani, M.D., Ph.D., and Thomas T. Higgins, Chief Financial Officer, discussed milestones, product plans, and finances for 2012.
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today announced that it has executed a consulting agreement with Dawson James Financial Services, Inc.
Pall Corporation (NYSE:PLL) will introduce five new single-use products designed to improve bioprocessing efficiency at INTERPHEX 2012, which starts today at the Jacob Javits Center in New York City (booth #3021).
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at three investment conferences during May 2012.
Senesco Technologies, Inc. (NYSE AMEX: SNT) announced today that a high level of tumor eradication in a mouse model of human multiple myeloma was achieved with a combination of SNS01-T and lenalidomide.
Sparton Corporation (NYSE:SPA) announces that Sparton Medical’s collaborative design and engineering work with HS Design in Gladstone, NJ has helped BioMarker Strategies become a finalist for a 2012 Medical Design Excellence Award (MDEA).
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 an overview of the Company’s business strategy will be given at the 37th Annual Deutsche Bank Health Care Conference being held at The InterContinental Boston in Boston, Massachusetts.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has acquired Doe & Ingalls Management, LLC, a premium provider of specialty production chemicals and customized supply-chain services to the life sciences and microelectronics industries, for approximately $175 million in cash.
Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market, today reported financial results for its first quarter ended March 31, 2012.