|RxNews Recap for Thursday 03-11-10. BioSante reports positive study for Leukemia vaccine. Pfizer drops three Phase 3 trials.|
|By BioMedReports.com Staff|
|Thursday, 11 March 2010 19:51|
Below is a list of the companies that made news in the healthcare sector on Thursday, March 11, 2010.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) shot up today after the company announced positive results of a human clinical study that show that its GVAX Leukemia vaccine may be able to reduce or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients taking the drug Gleevec (imatinib mesylate). All patients enrolled in the trial used Gleevec for at least one year and still had cancer cells present. The study was conducted by researchers at the Johns Hopkins Kimmel Cancer Center in Baltimore, Maryland, led by Hyam Levitsky, M.D., professor of oncology, medicine and urology at the Cancer Center. The research was funded by the National Institutes of Health.
In a study published in Clinical Cancer Research, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center investigators used a vaccine made from CML cells irradiated to halt their cancerous potential and genetically altered to produce an immune system stimulator called GM-CSF. The treated cells also carry molecules, called antigens, specific to CML cells, which prime the immune system to recognize and kill circulating CML cells.
"We want to get rid of every last cancer cell in the body, and using cancer vaccines may be a good way to mop up residual disease," said Dr. Levitsky. "More research to confirm and expand the results is needed," Levitsky said.
Shares traded up 9 cents or 5.26% and continued higher in the after hours session.
Pfizer Inc. (NYSE:PFE) after the bell announced the discontinuation of three (3) Phase 3 trials. The first, A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). An independent Data Safety Monitoring Committee (DSMC) recommended A4021018 be stopped after concluding that the addition of figitumumab to erlotinib is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to erlotinib alone in the study population. The company plans on continuing to study the drug candidate in clinical trials focusing on prostate, breast, and other cancers, including types of lung cancer.
In a seperate announcement after the market closed the company also reported that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone. In addition, the SUN 1099 Phase 3 study of sunitinib plus capecitabine, in previously-treated advanced breast cancer patients, did not show a statistically significant improvement in progression-free survival compared with capecitabine alone. "Sunitinib (Sutent) has been thoroughly evaluated in advanced HER-2 negative breast cancer, and while we are disappointed in the results, these trials have helped us define the limits and opportunities for the compound and better understand the complex biology of this disease," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs at Pfizer's oncology business unit. Shares of Pfizer were trading lower by 9 cents in the after hours market.
In other news after the bell:
Baxter International Inc. (NYSE:BAX), in conjunction with DynPort Vaccine Company LLC (DVC), a CSC Company (NYSE:CSC), today presented Phase III study data measuring the clinical efficacy for PREFLUCEL, a trivalent seasonal influenza candidate vaccine. PREFLUCEL is made using Baxter’s Vero cell culture platform and does not contain an adjuvant or preservatives. The data were presented at the International Congress on Infectious Disease (ICID) in Miami, Florida.
The Phase III clinical study found a 78 percent overall protection rate against culture-confirmed influenza from influenza strains that matched those in the vaccine and a 71 percent rate of prevention of influenza from all circulating strains. The study was conducted during the 2008/2009 influenza season in the United States in more than 7,000 healthy clinical trial participants ages 18 to 49.
Cardiac Science Corporation (Nasdaq:CSCX), a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices, after the market closed announced its financial results for the fourth quarter and the full year ended December 31, 2009. Revenue for the fourth quarter of 2009 was $42.2 million, down 17% from the fourth quarter of 2008, but up 8% sequentially from the third quarter of 2009. Revenue for 2009 was $156.8 million, down 24% from 2008. "We were pleased that fourth quarter revenue was stronger than our guidance and we surpassed our expectations in sales of both AEDs and monitoring products. This bodes well for our ability to drive revenue growth once we get through our current quality and regulatory challenges," said Dave Marver, president and chief executive officer. Shares jumped 11.63% in the after hours market.
Neoprobe Corporation (OTCBB: NEOP.ob), after the market closed today reported that it recently met with the United States Food and Drug Administration to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®. The Phase 3 clinical study (NEO3-05) was conducted in subjects diagnosed with either breast cancer or melanoma. The FDA review included the efficacy and safety results of the NEO3-05 study and Neoprobe’s plans for the submission of a New Drug Application (NDA) for Lymphoseek. The NDA submission will be based on the clinical results of NEO3-05 and other already completed clinical evaluations of Lymphoseek. FDA encouraged Neoprobe to request a series of pre-NDA meetings in the coming months to review the components of the NDA prior to its formal submission. Neoprobe indicated to FDA that the Company plans to submit the NDA following satisfactory completion of these meetings. Neoprobe’s President and CEO, David Bupp, Vice President, Pharmaceutical Research and Clinical Development, Frederick Cope, Ph.D. and Vice President, Regulatory Affairs and Quality Assurance, Rodger Brown, will discuss the NEO3-05 results and FDA meeting results during a conference call scheduled for 8:30 AM EST, Friday, March 12, 2010.
NxStage Medical, Inc. (Nasdaq:NXTM) a leading manufacturer of innovative dialysis products, today announced that it has secured a two-year $15 million revolving line of credit from Silicon Valley Bank (SVB).
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) after the bell announced 2009 fourth quarter and full year financial results and accomplishments.
The company reported a net loss for the three months ended December 31, 2009 of $9.6 million, or $0.28 per common share, as compared to a net loss of $10.4 million, or $0.35 per common share, for the same period in 2008. Optimer reported a net loss for the year ended December 31, 2009 of $42.2 million, or $1.30 per common share, as compared to a net loss of $35.6 million, or $1.24 per common share, for 2008. The increase of $6.6 million was due primarily to an increase in development expenses, manufacturing scale-up expenses, and expenses to prepare regulatory filings related to fidaxomicin and Pruvel™ (prulifloxacin).
As of December 31, 2009, Optimer held cash, cash equivalents and short-term investments of $38.2 million. In March 2010, Optimer raised an additional $51.2 million of net proceeds in a public offering of common stock.
"Recently, we announced robust results from our second Phase 3 trial of fidaxomicin confirming the positive results of our first Phase 3 trial showing that fidaxomicin has the potential to be a first-in-class drug for the treatment of Clostridium difficile infection," said Michael N. Chang, President and CEO of Optimer. "2010 will be a significant year for Optimer, as we focus on completing fidaxomicin and Pruvel regulatory filings, publish existing data and continue to prepare for the commercialization of these product candidates."
Watson Pharmaceuticals, Inc. (NYSE:WPI), announced after the bell the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer. With an anticipated May launch, TRELSTAR® 22.5 mg is the first and only six-month intramuscular (IM) GnRH agonist available for the palliative treatment of advanced prostate cancer. TRELSTAR® 22.5 mg is also the only six-month GnRH agonist that is stored at room temperature; no refrigeration is required. Shares of Watson were up 52 cents in the after hours market.
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced its financial results for the full year and fourth quarter of 2009 and provided a general business update.
"In 2009, we made significant progress in the XOMA 052 clinical development program through completion of a successful Phase 1 program in Type 2 diabetes and initiation of Phase 2 development. XOMA 052 is a novel anti-inflammatory approach to the treatment of Type 2 diabetes and cardio-metabolic diseases," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "We expanded the XOMA 052 program beyond our initial focus on diabetes to cardiovascular disease. This expansion is supported by results from our Phase 1 trials demonstrating benefit in biomarkers of cardiovascular disease, in vivo studies evaluating XOMA 052 in cardio-metabolic disease models, and studies with other IL-1 targeting agents. Some of these results will be presented at the American College of Cardiology meeting this weekend.
"Also during 2009, we significantly increased revenue from antibody discovery, development and licensing collaborations, including expanded or new agreements with Takeda Pharmaceutical Company Limited, Arana Therapeutics, a subsidiary of Cephalon, Inc., and Kaketsuken, a Japanese research foundation. Our growing biodefense program was expanded to include the development of antibodies to the SARS and H1N1/H5N1 viruses." Shares of XOMA traded higher by 8% in the after hours market.
In news from earlier in the day:
ARCA biopharma, Inc. (NASDAQ: ABIO), a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular disease, today announced, as required by NASDAQ Marketplace Rule 5250(b)(2), that the report of the Company’s independent registered public accounting firm, included in its previously filed consolidated financial statements for the fiscal year ended December 31, 2009, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 4, 2010, contained an explanatory paragraph expressing substantial doubt regarding the Company's ability to continue as a going concern. This announcement does not represent any change or amendment to the Company's fiscal year 2009 financial statements or to its Annual Report on Form 10-K.
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS.ob), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical program required to assess the approvability of Restanza™ (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia.
Angeion Corporation (NASDAQ: ANGN) moved higher today after announcing that it has entered into an agreement to serve as the official supplier of metabolic and endurance training systems for Team Garmin-Transitions, the American professional cycling team dedicated to ethical sporting and developing the next generation of cycling champions.
Through the partnership, Angeion will provide Team Garmin-Transitions with New Leaf metabolic assessment and training equipment. The New Leaf Active Metabolic Training System™ is available in premier fitness clubs, corporate wellness programs, and sports training centers to measure human performance and how efficiently a person’s body burns calories.
Boston Scientific Corporation (NYSE:BSX) moved higher today after the company announced that the U.S. Food and Drug Administration (FDA) has approved its Express® LD Iliac Premounted Stent System for use in iliac arteries. The Express LD Iliac Stent is the first and only low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease. The Company said it plans to launch the product immediately in the United States. The Express LD Iliac Stent is designed to be highly deliverable, and its Tandem Architecture™ Stent Design is engineered to balance strength, flexibility and conformability. Shares closed up 2.48% on heavey volume..
Caraco Pharmaceutical Laboratories, Ltd. (NYSE:CPD) jumped more than 9% today after announcing that it has launched oxaliplatin injections. These 50mg and 100mg oxaliplatin injections, which are therapeutically equivalent to Eloxatin® from Sanofi-Aventis, received approval from the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA). Oxaliplatin is an anticancer used in the treatment of colon and rectal cancer. Oxaliplatin injections have annual sales of approximately $1.3 billion in the US.
Eloxatin® is a registered trademark of Sanofi Aventis U.S. LLC
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers. Shares closed up 43 cents to $5.18 on double the average volume.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor (Maria) in Poland as a site to irradiate highly-enriched uranium targets for Molybdenum 99 (Mo 99) production. Covidien will use the Mo 99 obtained from Maria in the manufacture of its Technetium 99m (Tc 99m) generators. Patients should begin to benefit from Maria-produced Mo 99 in the United States and Canada later this month.
Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that Health Management Resources, Inc. (HMR) has recently conducted two focus groups in Indianapolis for Generex Oral-lyn(TM). HMR provides educational programs, materials, and services to the healthcare industry. Specializing in diabetes management, HMR has collaborated with medical associations and industry to develop clinical practice guidelines and to facilitate delivery of diabetes-related information and education to healthcare providers and people with diabetes..
Owensboro Medical Health System, a HealthGrades Distinguished Hospital for Clinical Excellence Award™ recipient, and Masimo (Nasdaq:MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, today jointly announced the completion of Owensboro Medical Health System's system-wide conversion to Masimo pulse oximetry technology. The conversion ensures that Owensboro patients will be monitored using the most technologically and clinically-advanced pulse oximetry and Pulse CO-Oximetry technologies available—providing real-time results for vital measurements that help clinicians to more rapidly assess, diagnose, and treat patients.
OXiGENE, Inc. (Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, today announced that it has entered into a definitive agreement with certain institutional investors to sell 6,578,945 shares of its Common Stock and separate series of warrants to purchase Common Stock in a private placement. Gross proceeds of the financing will be approximately $7.5 million, before deducting placement agent fees and estimated offering expenses, and assuming no exercise of the warrants. The financing is expected to close on or about March 12, 2010, subject to satisfaction of customary closing conditions.
The net proceeds from the offering will be used to fund development of OXiGENE's high priority oncology programs, including its ongoing trials of ZYBRESTAT in non-small cell lung cancer (NSCLC) and of OXi4503 trials in solid tumors, as well as to continue its programs in anaplastic thyroid cancer (ATC) and in ophthalmology.
Roche Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) has purchased assets from BioMicro Systems for all products associated with the Roche NimbleGen microarray workflow. These assets consist of key instrumentation in the comprehensive Roche NimbleGen microarray workflow including the NimbleGen Hybridization Systems (both 4- and 12-bay models). Also included in this purchase are array accessories covering all mixers designed for the Roche NimbleGen high-density microarray portfolio. Roche Diagnostics will continue to provide global sales, service, and support for all products in the NimbleGen microarray workflows.
OccuLogix, Inc., dba TearLab Corporation ("TearLab") (Nasdaq:TEAR) (TSX:TLB), soared today after announcing that TLCVision Corporation, North America's premier eye care services company, will be incorporating the TearLab(TM) Osmolarity System ("TearLab System") in eight of its U.S. refractive surgery centers to study Dry Eye Disease ("DED") symptoms as they relate to LASIK surgery.
The TearLab System is intended to measure the osmolarity of human tears to aid in the diagnosis of DED in conjunction with other methods of clinical evaluation. Using a novel lab-on-a-chip approach, the TearLab System requires less than 50 nL (nanoliters) of tear fluid and displays quantitative osmolarity results in less than 30 seconds. By requiring such a small amount of tears, the TearLab System eliminates the challenges that previously prevented point-of-care osmolarity testing. In addition, it is simple enough to be operated by a technician, greatly improving patient throughput either an office or center setting.
Shares of TEAR shot up 23.30% today, closing at $3.44, up 65 cents.
Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Patent and Trademark Office has issued a patent related to its antibody-drug conjugate (ADC) technology. U.S. Patent No. 7,659,241 covers cleavable linkers and potent auristatin drug payloads used in certain of Seattle Genetics’ ADC programs, most notably brentuximab vedotin (SGN-35), as well as many ADC programs in development by its collaborators. Brentuximab vedotin, an ADC that utilizes the vcMMAE drug-linker unit, is in a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for relapsed and refractory systemic anaplastic large cell lymphoma. The company anticipates submitting a New Drug Application for brentuximab vedotin in the first half of 2011.
"This patent is an important addition to the intellectual property portfolio surrounding our ADC technology, and significantly enhances the patent position for multiple internal and collaborator programs that use the vcMMAE drug-linker unit," said Eric Dobmeier, Chief Business Officer of Seattle Genetics. "Issuance of this patent, which extends protection in the United States to at least 2025, also reflects the culmination of significant and novel research conducted at Seattle Genetics to continue advancing our industry-leading ADC technology."
ACCESS PHARACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced that it has received reports of significant bioavailability of orally delivered insulin in two independently-conducted animal studies.
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