|Positron increases production capacity due to increased demand. After the bell: Conceptus falls on lowered guidance|
|By BioMedReports.com Staff|
|Thursday, 08 July 2010 19:53|
Here is a list of the companies that made news in the healthcare sector on Thursday, July 8, 2010.
Conceptus, Inc. (Nasdaq: CPTS), developer of the Essure® procedure, the first proven non-surgical permanent birth control method available, after the bell today updated second quarter and full year 2010 financial guidance that was previously issued on April 20, 2010.
The Company has lowered net sales guidance for the second quarter and full year 2010 due to domestic macroeconomic factors that are causing a reduction in physician office visits, and, to a lesser extent, a stronger U.S. dollar and Company initiatives related to competitive trialing. Based on third-party research combined with Company projections, domestic physician office visits in general during 2010 are expected to remain depressed over prior-year levels by 5% to 10% due to continued high unemployment rates. In addition, the Company estimates that currency exchange will negatively impact 2010 net sales by approximately $4.0 million and GAAP diluted EPS by approximately $0.09, compared with the Company’s previous expectations.
"2010 has developed into a challenging year for us, with the weak domestic economy and strong U.S. dollar impacting our results more than we had anticipated," said Mark Sieczkarek, president and chief executive officer of Conceptus. "To proactively address competitive trialing, we have been re-educating physicians on the superior clinical results of the Essure procedure, which has temporarily lessened our focus on physician metrics. Even with these factors, we are projecting overall net sales growth of 9% to 10% for the year, which includes international unit volume growth of 30%."
"We remain optimistic about our long-term growth prospects. Permanent birth control is a multi-billion dollar market with more than one million procedures performed annually in the U.S. alone. The Essure procedure is faster, safer, less expensive and more effective than competing procedures," said Sieczkarek. "Our team is dedicated to establishing the Essure procedure as the industry’s standard of care."
Shares fell $3.87 or 24.51% to $11.92 in the after hours market.
Positron Corporation (OTCBB:POSC), announced today that due to a greater demand for the Attrius™ PET scanner, the Company has recently begun increasing production capacities with its joint venture, Neusoft Positron Medical Systems.
Positron’s award-winning, cardiac optimized PET scanner, the Attrius™, is the only advanced, dedicated, cost-effective PET scanner in the marketplace. The introduction of the Attrius™ last year has generated excitement throughout the cardiac molecular imaging industry. Facilitated by the increase in reimbursement for cardiac PET and an industry-wide movement to better and more efficient medical imaging, Positron’s Attrius™ has seen unprecedented interest and sales. As a result of the recent sales, Positron has met its six month projections and has to increase production earlier than previous estimations. Based on Positron’s current sales and a more robust pipeline, the Company believes that they will surpass 2010 and 2011 targets of approximately 70 systems in the next 18 months.
Bioject Medical Technologies Inc. (OTCBB: BJCT), a leading developer of needle-free injection therapy systems, today announced that Bioject’s needle-free injection delivery technology was used to successfully demonstrate that intradermal administration of fractional doses of inactivated poliovirus vaccine given to infants is safe and effective (using seroconversion as an indication of effectiveness), and is preferred by both health care administrators and parents over typical full-dose needle and syringe.
Hana Biosciences, Inc. (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it was issued U.S. patent number 7,745,494, which covers a method of using menadione topical lotion in treating skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy. The issued patent extends patent protection around menadione into 2026.
ImmunoCellular Therapeutics (OTCBB: IMUC) announced today that it has appointed Zvi Ram, M.D. and John Boockvar, M.D. to its Scientific Advisory Board. Dr. Ram is the Chairman of the Department of Neurosurgery at Tel Aviv Medical Center in Israel. Dr. John Boockvar is Co-Director of the Brain and Spinal Tumor Program at Weill Cornell Medical College. Dr. Ram and Dr. Boockvar join an accomplished Scientific Advisory Board that is expected to support the Company’s efforts later this year to commence a Phase II trial of ICT-107, the company’s dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM). In the Phase I clinical study of ICT-107 in GBM, newly diagnosed patients who received the vaccine in addition to the standard of care of surgery, radiation and chemotherapy demonstrated a one year overall survival of 100 percent and a two year survival of 80 percent.
Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative drug discovery and development company, and Intellikine, Inc., a leader in the development of small molecule drugs targeting the PI3K/mTOR pathway, today announced an agreement under which Infinity obtained global development and commercialization rights to Intellikine's portfolio of inhibitors of the delta and gamma isoforms of phosphoinositide-3-kinase (PI3K). Among these inhibitors is INK1197, an orally available dual delta/gamma-specific inhibitor of PI3K for which clinical development in inflammatory diseases is expected to commence in 2011.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced it has received a $500,000 milestone payment from Cempra Pharmaceuticals, Inc. pursuant to the terms of a licensing agreement between the companies. The milestone payment was made as a result of Cempra's continuing development of a next-generation macrolide (CEM-101) for the treatment of respiratory infections. Cempra licensed CEM-101 from Optimer and has successfully completed a Phase 1 study.
"The successful completion of the CEM-101 Phase 1 study further validates our OPopS™ drug discovery platform. We are pleased to see this compound progress into the next phase of development by Cempra," said Pedro Lichtinger, Optimer's President and CEO.
Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate (SFP), a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.
"Meeting with the FDA to review our Phase IIb data and solicit input for our planned Phase III program was an important corporate and clinical milestone," said Robert L. Chioini, Chairman, CEO and President of Rockwell. "The FDA provided clear and valuable feedback for our proposed Phase III program and we now have an acceptable endpoint for our Phase III trial design. We are incorporating the FDA's comments into a final protocol design, which will be submitted shortly, and we expect to remain on track to initiate the Phase III program later this year."
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced positive results from preclinical toxicology and pharmacokinetic studies of an intravenous (IV) formulation of its novel antibiotic, Restanza™ that support its use in a hospital setting.
Aetna (NYSE:AET) is offering fully insured health plan customers, including Medicare members, in Ohio's Wood, Ottawa and Fulton counties an extra two months to make premium payments and file claims, among other assistance.
BioElectronics Corporation (PINKSHEETS: BIEL), manufacturers of innovative pain-relieving medical devices, announced today that it is developing additional markets in Eastern Europe for its clinically-proven ActiPatch, Recovery Rx and Allay Menstrual Relief brands through an expansion of its distribution agreement with Unior Bionic d.o.o.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary technology for diagnostic systems for HIV, hepatitis, tuberculosis and malasia detection, today announced the signing of an agreement with Los Alamos National Security, LLC where Los Alamos National Laboratory's (LANL) scientific and engineering staffs will attempt to identify new potential human tuberculosis biomarkers and will develop a validated assay to detect human tuberculosis using a currently known biomarker to be used in combination with the waveguide-based optical biosensor platform for the detection of disease causing pathogens, developed at LANL and recently licensed to Biomagnetics Diagnostics late 2009.
Bion Environmental Technologies, Inc. (OTC Bulletin Board: BNET) today confirmed its participation at a public issues forum on July 14, hosted by SUNY Oswego's Office of Business and Community Relations at their Campus Center auditorium.
Elan Corporation, plc (NYSE:ELN) announced today that it will host a conference call on Thursday, July 22, at 8:30 a.m. Eastern Time (ET), 1:30 p.m. GMT with the investment community to discuss Elan's second quarter 2010 financial results, which will be released before the European and U.S. financial markets open.
Herbalife Ltd. (NYSE: HLF) welcomed two new doctors to its Nutrition Advisory Board, Yubin He, M.D., a cardiologist from China, and Jonathan Yarom, M.D., who specializes in sports medicine in Israel.
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced the issuance of patents covering compositions and methods of using its synthetic immune modulatory oligonucleotides targeted to Toll-like receptors (TLRs).
Life Technologies Corporation (NASDAQ:LIFE) today announced an unprecedented program that streamlines the detection of three common contaminants of mammalian cell culture-based biopharmaceutical manufacturing.
Merck & Co., Inc. (NYSE: MRK), known outside the U.S. and Canada as MSD, today provided further detail on integration plans for the company's research and development, manufacturing and other business operations as part of a global restructuring program announced following the November 2009 merger of Merck and Schering-Plough.
PhotoMedex, Inc. (Nasdaq:PHMD) announced that the Company has received from AMICO Group, its distributor in the Middle East, a multi-million dollar order to purchase XTRAC laser systems that will be installed in hospitals throughout the Kingdom of Saudi Arabia.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences (NASDAQ:ALIM) has submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien®.
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex: RGN) today announced it has received Notice of Acceptance from the Australian patent office for the use of Thymosin beta 4 (Tβ4), its analogues, isoforms and other derivatives in the treatment of infections and inflammatory disorders including colitis, ileitis, gastrointestinal ulcers and gingivitis, among others.
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development Inc. have filed a lawsuit in the U.S. District Court for the District of Delaware against Cadila Healthcare Limited, doing business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc. (collectively "Zydus") for the infringement of U.S. Patent No. 6,773,720 (the '720 patent).
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.