Below is a list of the companies that made news in the healthcare sector on Monday, August 9, 2010.
Endo Pharmaceuticals (Nasdaq:ENDP) today announced actions designed to advance the company's leadership and growth in pain management, including an agreement to acquire all outstanding shares of Penwest Pharmaceuticals (Nasdaq:PPCO) for $5.00 in cash per share, or an estimated enterprise value of approximately $144 million at the time of deal close. Penwest has been working with Endo since 1997 on the development and commercialization of OPANA ER and receives a royalty stream on net sales of the product.
"Our acquisition of Penwest sets the stage for maximizing the value of the OPANA franchise and for leveraging Penwest's drug delivery technologies and pipeline across our branded and specialty generics businesses for the benefit of patients," said Julie McHugh, chief operating officer, Endo Pharmaceuticals. "This transaction highlights the growth potential of Endo's core Pain Management franchise, enhances our earnings, and creates significant value for shareholders of both organizations."
Shares of PenWest rose 52 cents or 12.35% to $4.73 and another 23 cents to $4.96 in the after hours market.
Intellect Neurosciences, Inc (OTCBB:ILNS) announced that it has received a Notice of Allowance from the Canadian Patent and Trademark Office for a new patent related to OX1 (OXIGON(TM)), the Company's clinical-stage drug candidate that has disease-modifying potential for Alzheimer's and other neurodegenerative disorders. OX1 is an orally-administered, brain-penetrating, naturally-occurring, copper-binding small molecule targeting multiple mechanisms that contribute significantly to the underlying pathology of Alzheimer's disease. The Company has successfully tested OX1 in human Phase I safety trials, providing initial positive data on safety and tolerability of the drug.
The Notice of Allowance is a written communication from the patent office stating that the application has been allowed and will be granted as a Canadian patent. Patents for OX1 have been issued in the United States, Europe and other countries and are pending in Japan and Mexico. The patents are jointly owned by New York University and the University of South Alabama and are licensed exclusively to Intellect Neurosciences.
Dr. Daniel Chain, Intellect's Chairman and CEO, commented: "OX1 is the most advanced candidate in our internal pipeline and has the potential to slow down or arrest Alzheimer's disease in the early stages by stabilizing amyloid beta in non-toxic form and preventing oxidative damage leading to inflammation and cell death. Moreover, based on OX1's mechanism of action, we believe it has applications for other disease indications as well. The Notice of Allowance of a new patent in Canada relating to OX1 strengthens our intellectual property portfolio and the competitive advantage of our internal drug development pipeline, which boasts clinical stage and preclinical programs. Our goal is to develop OX1 through strategic relationships with major pharmaceutical companies from whom we could obtain R&D funding and revenues from license fees, milestone payments, and royalties. We intend to build off of our previous successes in granting royalty-bearing licenses to major pharmaceutical companies that are developing drugs in Phase 2 and Phase 3 clinical trials for Alzheimer's disease."
Shares of ILNS were up more than 10% on the news.
Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that it has received preliminary results from a Phase II clinical trial of GDC-0449 from Roche and Genentech, Curis’ collaborator and a member of the Roche Group. GDC-0449, a first-in-class Hedgehog pathway inhibitor, was tested by Roche and Genentech as a single agent maintenance therapy for ovarian cancer patients in their second or third complete remission from the disease. Roche has informed Curis that preliminary findings from the primary analysis of the study warrant additional investigation to clarify and interpret potential clinical activity of the drug candidate observed in this trial. Accordingly, Roche and Genentech have indicated that they plan to further analyze the data, including subset analyses in the coming months. Following these analyses, they expect to make a portfolio decision regarding whether, or to what extent, they will continue development of GDC-0449 in advanced ovarian cancer.
Shares of Curis fell more than 12% in Monday trading, dropping 22 cents to $1.52.
Shares of ARYx Therapeutics, Inc. (NASDAQ:ARYX) shot up more than 30% today. Investors are speculating that the company, which has been up for sale since February, might be worth the investment risk. The company was the subject of an opinion piece, published today on BioMedReports, which analyzes the risk/reward.
ARYx closed the day at $0.59, up nearly 14 cents.
BMP Sunstone Corporation (Nasdaq:BJGP) today announced financial results for the second quarter ended June 30, 2010. Highlights: *Revenue increased to $40.9 million from $32.5 million in the prior year period, an increase of 25.8%.
David Gao, Chief Executive Officer of BMP Sunstone, stated, "We are delighted to see the initial benefits of the organizational changes we made earlier in the year. With Mr. Tong at the helm, our manufacturing business is now operating with increased efficiency, particularly within our sales and marketing department, where the reorganization helped drive increased sales of Sunstone's products. We also are starting to see improved margin performance in our distribution business as we continued our push to focus on higher margin products. The managerial and operational improvements we made in the first half of the year are proving to be worthwhile, and we are optimistic about our ability to continue strong growth of revenue and profit for our shareholders in the back part of the year."
CryoLife, Inc., (NYSE:CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration for a five-year shelf-life on its CryoPatch SG pulmonary human cardiac patch processed with the Company's proprietary SynerGraft technology. CryoLife's SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.
"This shelf-life extension allows us to make this advanced technology available to more patients," said Steven G. Anderson, CryoLife's president and chief executive officer. "Further, the extended five-year shelf life will simplify the purchasing decisions and tissue inventory management for hospitals."
Nutra Pharma Corporation (OTC.BB:NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) and Pain, announced today that it has selected Amarey Nova Medical S.A. to serve as the exclusive distributor in Colombia for its Nyloxin-branded pain relievers.
Pluristem Therapeutics Inc. (Nasdaq: PSTI) (DAX: PJT) today announced the results of two separate pre-clinical studies in animal models which demonstrated that its PLacental eXpanded (PLX) cell therapy may be an effective treatment for both neuropathic and inflammatory nerve pain.
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company has received positive written feedback from the FDA regarding the Company’s drug candidate Androxal. The Agency concurred with Repros’ indication statement for the use of Androxal in the treatment of secondary hypogonadism in men wishing to preserve fertility.
The Company believes the FDA’s comments are appropriate and will address them in the protocol that is being drafted. In previous Repros studies of Androxal in hypogonadal men, baseline mean concentrations of luteinizing hormone (LH) and follicle stimulating hormone (FSH) were on the low side of the normal range. Even though these men exhibited low morning testosterone, when sperm counts were available the men would be considered fertile based on World Health Organization (WHO) standards. The Company will use WHO fertility standards as the cut points for determining fertility outcomes.
On heavy volume shares of Repros rose nearly 8%.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration has accepted for Priority Review the Company’s efficacy supplement to the New Drug Application (NDA) for XIFAXAN (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. Non-constipation irritable bowel syndrome (Non-C IBS) encompasses two of the most common IBS subtypes: patients with diarrhea-predominant symptoms (IBS-D) and patients who suffer from intermittent periods of diarrhea and constipation known as mixed IBS (IBS-M).
AbTech Holdings, Inc. (OTCBB: ABHD) wishes to announce that AbTech Industries Inc.'s innovative Smart Sponge® Plus technology has been approved by the U.S. Environmental Protection Agency (EPA) for the reduction of harmful coliform bacteria in stormwater runoff, responsible for 20,000 beach closures per year.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex:ANX) will present to investors as part of the 2010 Southern California Investor Conference on August 17, 2010 at 9:30 a.m. Pacific time in Cabana Room No. 4 at the Island Hotel in Newport Beach, California.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and collaborators from the Massachusetts Institute of Technology (MIT), The University of British Columbia (UBC), AlCana Technologies, Inc., and Tekmira Pharmaceuticals Corporation, presented results from multiple ongoing research efforts regarding the discovery of novel technologies for the systemic delivery of RNAi therapeutics.
American Oriental Bioengineering, Inc. (NYSE:AOB) a pharmaceutical company dedicated to improving health through the development, manufacture and commercialization of a broad range of prescription and over the counter products, today announced that its Boke brand Pai Du Qing Zhi Tablet, a prescription medicine aimed at achieving the balance of Yin Yang by regulating metabolism, in order to cleanse the blood and detoxify, dispose of hemorrhoids, fight obesity and lower hyperlipemia, will be commercially launched in the third quarter of 2010. In a seperate release today the company announced the commercial launch of Boke brand Yi Shen Jian Gu Gel after successful test marketing in the second quarter of 2010.
AmStem Corporation (OTCBB: AMST), a leading provider of biotherapeutic and cosmetic stem cell products, stem cell collection and storage expertise and access to nanotechnology vital to stem cell research, announced today highly positive final results from its preliminary consumer study of SteMixx, a new facial skin care product derived from secreted stem cell proteins and other natural ingredients.
Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for the fourth quarter and full year of fiscal 2010.
AstraZeneca (NYSE: AZN) announced today that, as of August 9, it had reached agreements in principle on monetary terms with attorneys representing approximately 17,500 SEROQUEL product liability claimants in the United States for approximately $198 million.
Axxess Pharma, Inc. (PINKSHEETS: AXXE), a pharmaceutical company specializing in the marketing and distribution of both prescription and non-prescription medical products, is pleased to announce Health Canada approved 11 of their prescription and non-prescription drugs.
China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD) which operates a retail pharmacy chain in Zhejiang Province, today announced store openings in the cities of Quzhou and Hangzhou, increasing Jo-Jo Drugstores' total store count to 42 locations.
Clinical Data, Inc. (NASDAQ: CLDA) today announced operational and financial results for the first quarter ended June 30, 2010, noting key accomplishments including the acceptance of the Company's new drug application (NDA) for vilazodone by the U.S. Food and Drug Administration (FDA) and the successful completion of a public offering.
CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today reported financial results for the second quarter ended June 30, 2010.
Cypress Bioscience, Inc. (NASDAQ: CYPB) today announced financial results for the second quarter of 2010.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today reported financial results for the three months and six months ended June 30, 2010 and provided a business update.
Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical company focused on advanced wound care, will hold a conference call on August 13, 2010 to discuss the financial results for the second quarter ended June 30, 2010. In addition, management will provide a business update and a discussion on recent and upcoming milestones.
Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI): Last week, the US Food and Drug Administration gave their highly-anticipated approval for the first clinical tria using human embryonic stem cells (hESCs), which are the type of cells that can develop into all tissues of the body. Geron Corporation of Menlo Park, California, received the green light from the US FDA to use cells derived from hESCs to treat people with acute spinal cord injuries.
Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced its schedule of participation at upcoming investor conferences: Tuesday, August 10, 2010 @ 8:30 am Eastern time Canaccord Genuity 30th Annual Growth Conference 2010, Boston, MA , Wednesday, September 15, 2010 - 2:15 pm Eastern time Robert W. Baird & Co. 2010 Health Care Conference, New York City, Thursday, September 16, 2010 @ 3:50 pm Eastern time Stifel Nicolaus Healthcare Conference 2010, Boston, MA.
Fibrocell Science, Inc. (OTC Bulletin Board:FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted a clinical study report for its Phase II/III study of azficel-T for the treatment of moderate to severe acne scars to the U.S. Food & Drug Administration (FDA).
Generex Biotechnology Corporation (Nasdaq:GNBT) announced today that it has named Craig Eagle, M.D. to its scientific advisory board. Dr. Eagle brings a wealth of oncology experience to help the Company's wholly-owned subsidiary, Antigen Express, Inc. dba "Generex Oncology", further its synthetic cancer and influenza vaccine development efforts.
GTx, Inc. (Nasdaq: GTXI) today reported financial results for the second quarter of 2010.
Isis Pharmaceuticals, Inc. (Nasdaq:ISIS) today announced its financial results for the quarter ended June 30, 2010.
King Pharmaceuticals, Inc. (NYSE: KG) announced today that total revenue for the second quarter ended June 30, 2010 equaled $371 million compared to $445 million in the second quarter of 2009.
K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that Mr. Robert Baldini was appointed as a new independent member of the Board of Directors by a unanimous vote of the directors, which also voted to increase the size of the Board to eight directors.
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated the progress of its drug development programs and reported financial results for the three and six months ended June 30, 2010.
NBTY, Inc. (NYSE:NTY) a leading global manufacturer and marketer of nutritional supplements, today announced preliminary unaudited net sales results for the month of July 2010.
NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that Anthony DiTonno, President and Chief Executive Officer, and Stephen Ghiglieri, Executive Vice President, Chief Operating Officer and Chief Financial Officer, are scheduled to attend the Collins Stewart Health Care Event on August 11, 2010, at the Omni Berkshire Hotel in New York, NY.
Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) and Pain, announced today that it has selected Amarey Nova Medical S.A. to serve as the exclusive distributor in Colombia for its Nyloxin-branded pain relievers.
Orthofix International N.V. (NASDAQ: OFIX) announced today that it plans to celebrate the opening of its new North American Operations and Education Center in Lewisville, Texas on Thursday, August 12th with a ribbon-cutting and building dedication ceremony.
Osteotech, Inc. (Nasdaq:OSTE), a leader in the emerging field of biologic products for regenerative healing, disclosed today that its Board of Directors engaged Deutsche Bank Securities Inc. in 2009 as its exclusive financial advisor to assist in the identification and evaluation of a range of strategic alternatives focused on enhancing shareholder value.
OXIS INTERNATIONAL, INC. (OTC Bulletin Board: OXIS, Paris: OXI) is extremely proud to announce the appointment of Dr. John Repine to the OXIS International Scientific Advisory Board.
Phase Forward Incorporated (NASDAQ: PFWD) today announced its financial results for the second quarter of 2010.
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients.
Pluristem Therapeutics Inc. (Nasdaq: PSTI) (DAX: PJT) today announced the results of two separate pre-clinical studies in animal models which demonstrated that it PLacental eXpanded (PLX) cell therapy may be an effective treatment for both neuropathic and inflammatory nerve pain.
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today positive results of its Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of its IV (intravenous) formulation of morphine plus oxycodone versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery.
Repros Therapeutics Inc. (NasdaqCM: RPRX) today announced financial results for the second quarter ended June 30, 2010.
Rite Aid Corporation (NYSE:RAD) announced today the terms of an offering of $650 million aggregate principal amount of 8.00% senior secured notes due 2020.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced financial and operating results for the second quarter ended June 30, 2010.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today reported financial results for the three and six-months ended June 30, 2010.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today reported financial results for the quarter ended June 30, 2010.
Unigene Laboratories, Inc. (OTCBB: UGNE) has reported its financial results for the quarter ended June 30, 2010.
Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board:WKBT) a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced that the Company intends to launch several new therapeutics during the fourth quarter of 2010.
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