|SciClone tumbles on SEC probe. After the bell: Jazz moves higher|
|By BioMedReports.com Staff|
|Tuesday, 10 August 2010 18:24|
Below is a list of the companies that made news in the healthcare sector on Tuesday, August 10, 2010.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) after the bell today announced financial results for the second quarter ended June 30, 2010 and updated financial guidance for 2010. The company's updated financial guidance reflects higher expected sales of XYREM® (sodium oxybate) and the effects of recent financing activities.
Total revenues for the quarter ended June 30, 2010 were $40.5 million, compared to $37.3 million for the quarter ended June 30, 2009. Total revenues included net product sales, royalties and contract revenues.
For the second quarter of 2010, net product sales increased 49 percent to $39.5 million, compared to $26.5 million in the second quarter of 2009. Xyrem net sales for the second quarter of 2010 were $33.7 million, compared to $22.4 million for the second quarter of 2009, representing a 51 percent increase. The increase in Xyrem net sales in the second quarter of 2010 was primarily due to the impact of price increases, as well as an increase in prescription volume. Net sales of once-daily LUVOX CR® (fluvoxamine maleate) extended-release capsules were $5.8 million for the quarter, compared to $4.1 million for the second quarter of 2009, representing a 41 percent increase.
"Our strong quarterly results demonstrate the continued growing demand for Xyrem and reflect the significant steps we've taken to strengthen our balance sheet," said Bruce Cozadd, chief executive officer of Jazz Pharmaceuticals. "We look forward to the upcoming FDA advisory committee meeting for our JZP-6 product candidate in fibromyalgia, a debilitating and difficult to treat disease for which patients and physicians continue to seek alternative treatment options."
Shares of Jazz were up 45 cents in extended trading.
Cypress Bioscience, Inc. (NASDAQ:CYPB), after the market closed today announced that it has received written notice of consent and effectiveness from the Office of Chief Scientist of the Ministry of Industry, Trade and Labor of the State of Israel (the "OCS") regarding its previously announced in-license agreement for BioLineRx's novel antipsychotic (BL-1020, now CYP-1020), a potential breakthrough treatment for schizophrenia. The agreement, which was amended to reflect input from the OCS, will enable Cypress to build its strategic focus on R&D. There were no material modifications to the agreement and the financial terms of the transaction remain unchanged.
As a result of the OCS's approval, Cypress has released the upfront payment of $30 million from escrow to BioLineRx.
In news from earlier in the day:
SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) fell nearly 30% today. Monday after the market close the company reported that U.S. SEC and the Justice Department have launched an investigation into the company over possible violations of the Foreign Corrupt Practices Act.
There is speculation that SciClone may be involved in what is being called a wide spread investigation of bribes being paid by pharmaceutical companies in foreign countries.
Shares of SciClone fell $1.03 to close the day at $2.48.
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 it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study of its novel once-daily oral antibiotic Restanza to treat community acquired bacterial pneumonia (CABP). The trial is the first prospectively designed superiority study to be conducted in CABP.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has engaged the investment banking firm Canaccord Genuity Inc. to advise the Company and its Board of Directors as it seeks to expand its product candidate pipeline. To assist in evaluating potential acquisition and merger opportunities, the ADVENTRX Board of Directors has formed a Special Committee, which includes Eric K. Rowinsky and Michael M. Goldberg and is chaired by Odysseas D. Kostas.
"The financial results we recently reported, including over $30 million in cash at June 30, provide us substantial leverage in what remains a difficult financing environment. We believe many programs with substantial potential are available at attractive valuations and that now is the right time to explore expanding our pipeline of assets," said Brian M. Culley, Chief Executive Officer of ADVENTRX.
Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that its MARINE trial, a Phase 3 clinical trial of AMR101, has completed patient enrollment and randomization into the treatment phase of this trial. The Company indicated that top line results from this trial are expected early in 2011, towards the early part of the range of guidance provided previously.
Intellect Neurosciences, Inc (OTCBB:ILNS) announced that it has received a Notice of Allowance from the United States Patent and Trademark Office related to RV01 and RV02, the Company's two lead vaccine candidates. The Notice of Allowance is a written communication stating that the patent application has been allowed and will be granted as a new patent. RV01 and RV02, generated using the Company's RECALL-VAX technology, have the potential to delay the onset of or prevent Alzheimer's disease in individuals susceptible by age, genetic or other risk factor. Patents previously have been issued in Europe, Australia, New Zealand and South Africa, and patents are pending in Canada and Israel.
INVO Bioscience, Inc. (OTC Bulletin Board:IVOB), a medical device company focused on treatment options for patients diagnosed with infertility, today announced that it has commenced the registration process for its INVOCell fertility device with the State Food and Drug Administration (SFDA) of the Peoples Republic of China (PRC). The Company's exclusive distribution partner in the PRC, the Progressive Group, has determined after meetings with the SFDA that the regulatory agency may confer a Class II medical device classification on INVOCell, thereby exempting INVO Bioscience from conducting clinical trials to complete the approval process.
Positron Corporation (OTCBB:POSC) announced today the opening of a cGMP ready (current good manufacturing practices) facility in Indiana for the manufacturing of both radioactive and non-radioactive pharmaceutical products and devices.
"The opening of this facility marks a significant milestone in Positron’s expansion into the consumables market that began with the acquisition of Dose Shield in 2008," stated John Zehner, COO of Positron. "Radioactive and non-radioactive pharmaceutical products are a key component of our Company’s growth strategy; the opening of such a facility affords us significant advantages in every aspect of our business, which enables us to remain competitive in the future. The opening of this manufacturing facility was critical to our plan, as we are now equipped with the staff, equipment and space necessary to manufacture a variety of radioactive and non-radioactive pharmaceutical products. While the Company’s plan is to focus on small batch, radioactive PET products, the facility will also be utilized to support current and future Positron equipment, as well as, expand into new markets. We are presently in discussions with several entities that can utilize our contract manufacturing services," concluded Mr. Zehner.
Vyteris, Inc. (OTC.BB:VYTR), developer of the first FDA-approved active transdermal patch and a leader in alternative drug delivery technology, today announced positive results from a Phase II clinical trial evaluating the safety and efficacy of a pulsatile delivery system for the treatment of female infertility, based on the Company's smart patch technology.
The Phase II trial enrolled 350 women between 18 and 38 years of age with ovulatory dysfunction. The trial assessed the safety and efficacy of three dosage strengths of pulsatile gonadotropin releasing hormone (GnRH) delivered from an iontophoretic patch compared to oral treatment with another leading infertility drug, and placebo. Based on the Company's evaluation of the data, the trial met its primary endpoint by demonstrating a statistically significant difference in ovulation rates for the pulsatile GnRH versus placebo over the single, 21-day treatment cycle. Furthermore, among treatment-compliant patients who had at least one progesterone assessment on or after one week of dosing, the pulsatile GnRH achieved ovulation rates similar to the other leading infertility drug, which is considered a first line treatment option for a majority of these patients. The most common adverse event in the trial was skin irritation at the site of administration.
"The positive outcome of our Phase II trial in female infertility represents a significant milestone for Vyteris and a promising development for the women worldwide who suffer from infertility," said Michael Reidy, Ph.D., Chief Technology Officer at Vyteris. "These data underscore the potential of Vyteris' smart patch technology to meet the growing demand for controlled drug delivery in major therapeutic areas."
YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medical need, in which a patient's bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.
Also Tuesday:A5 Laboratories Inc. (A5 Labs) (OTCBB:AFLB) today announced the appointment of Dr. Gisele Matni M.Sc., Ph.D. to the board of directors and to the position of V.P. Operations.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, will be presenting at the Southern California Investor Conference on August 17, 2010 at 3:30 pm PDT in room 2 of the Island Hotel, Newport Beach, CA.
Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reports a financial update as of June 30, 2010.
American Bio Medica Corporation (Pink Sheets:ABMC), a global provider of point of collection test kits, will release second quarter 2010 results at close of mar et on Wednesday, August 11, 2010 and will hold its conference call to discuss the second quarter results on Thursday, August 12, 2010 at 11 AM Eastern Time (10 AM Central Time).
Arrowhead Research Corporation (NASDAQ: ARWR) today announced that it has signed an option agreement with The University of Texas MD Anderson Cancer Center to negotiate a license in a defined field to a class of compounds that is believed to kill fat tissue by specifically targeting the blood vessels that supply it.
Axia Group Inc. (PINK SHEETS:AGIJ) announced today a change in management at AGIJ. Mr. Anthony Tellez has resigned as president of Axia Group Inc. Michael Arnkvarn, the current CEO of Collagenna Skin Care Products, will succeed Mr. Tellez.
BioClinica, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced it has created strategic partnerships with two privat ly held clinical research organizations (CROs), Axio Research Corporation and Beardsworth Consulting Group, Inc.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that Dr. Mark A. Sirgo, President and Chief Executive Officer, will present at the Bank of merica Merrill Lynch 2010 Specialty Pharmaceuticals Conference at the Southampton Inn in Southampton, New York.
Bionovo, Inc. (Nasdaq:BNVI), a drug discovery and development company focused on the unmet needs in women's health and oncology, announced that LifeTech Capital has initiated independent research coverage on the Company.
China Pharma Holdings, Inc. (NYSE AMEX:CPHI) a leading fully-integrated specialty pharmaceuticals company in China, today announced financial results for the second quarter ended June 30, 2010.
Clarient, Inc. (Nasdaq:CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that the United States Patent and Trademark Office and the European Patent Office have allowed patents covering the technology behind Clarient Insight® Dx Mammostrat®, a test designed to aid in the classification of the risk of recurrence of breast cancer following surgery and initial treatment.
Columbia Laboratories, Inc. (Nasdaq: CBRX) has repurchased 3,333,330 shares of its Common Stock, par value $0.01 per share, from investment funds for which Perry Corp. or an affiliate acts as investment advisor and/or general partner at $0.90 per share for an aggregate total purchase price of approximately $3 million.
CorMedix Inc. (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention an treatment of Cardiorenal disease, today announced the appointment of Robert D. Hopkins as head of clinical operations and project management and Dilip Wadgaonkar as head of product development and manufacturing.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it is "for the second year in a row" teaming up with the New England Patriots Radio Network, 98.5 The Sports Hub, and its 36-station radio network throughout New England, during the 2010 New England Patriots season to recognize innovative science teachers in middle schools and high schools throughout New England.
ERT (Nasdaq:ERES), a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces that Joel Morganroth, MD, Chairman and Chief Scientist, has been acknowledged by PharmaVOICE magazine as one of the 100 most inspiring people in the life sciences industry.
GenSpera, Inc. (OTCBB: GNSZ) announced that its patent application, entitled "Tissue Specific Prodrugs," has been issued by the United States Patent and Trademar Office (USPTO) as US Patent 7,767,648.
Global Health Ventures Inc. (OTCBB:GLHV) a specialty pharmaceutical company hereby provides update on the development of its lead life style drug "X-Excite" designed for male sexual enhancement.
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) today announced that it is scheduled to make an investor presentation at the Bank of America 2010 Specialty Pharmaceuticals Conference Friday, August 13, 2010, at 10:00 a.m. Eastern Daylight Time.
Inhibitex, Inc. (Nasdaq: INHX), today announced that Russell H. Plumb, president and chief executive officer, will present an overview of the company and its pipeline of differentiated antiviral compounds at the Canaccord Genuity 30th Annual Growth Conference on Thursday, August 12, 2010 at 8:00 a.m. EDT.
Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of canc r, announced today that the Company will participate in the Canaccord Genuity 30th Annual Growth Conference, to be held on August 11, 2010 in Boston.
NeoGenomics, Inc. (OTC Bulletin Board: NGNM), announced today that Grant Carlson has been appointed Vice President of Business Development and that Mark W. Smits will join the company as Vice President of Sales & Marketing on August 30, 2010.
NeuroMetrix, Inc. (Nasdaq: NURO), a health care company transforming patient care through neurotechnology, today announced its financial results for the quarter ended June 30, 2010.
Nutrastar International, Inc. (OTC Bulletin Board:NUIN) a leading nutraceutical company which produces and distributes Chinese Golden Grass, today announced that it has recently filed a patent application for the production process related to mass producing Golden Grass wine and Golden Grass oral liquids.
Omnicell, Inc., (Nasdaq:OMCL), a leading provider of system solutions to acute healthcare facilities, today announced a partnership agreement to co-market Sentry Data Systems' Sentinel RCM application, which has a sophisticated 340B solution component.
OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI), announced today that the Company has appointed Mr. David V. Smith to its board of directors.
Sigma-Aldrich® (Nasdaq:SIAL), at the Board of Directors meeting held today, the Directors declared a quarterly cash dividend of $.16 per share.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has completed the acquisition of ratiopharm, Germany's second largest generics producer.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will webcast its presentation at the Canaccord Genuity 30th Annual Growth Conference on Thursday, August 12, 2010 at 11:30 a.m. EDT.
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 the extension of its foreign invested enterprise business license by the Harbin City Administration for Industry and Commerce.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from the Phase 3 ILLUMINATE study, which was designed to evaluate whether there was any benefit to extending therapy from 24 to 48 weeks in people whose hepatitis C virus (HCV) was undetectable at weeks 4 and 12 of treatment (extended rapid viral response or eRVR).