Neoprobe higher on license deal. Salix sinks on drug delay. After the bell: BioCryst gets $55 million from HHS Print E-mail
By BioMedReports.com Staff   
Thursday, 24 February 2011 19:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 24, 2011.


After the bell, shares of BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) got a boost after the company announced that it has been awarded a $55.0 million contract modification by the U.S. Department of Health & Human Services (HHS) intended to fund to completion the Phase 3 development of its neuraminidase inhibitor, intravenous peramivir, for the treatment of patients hospitalized with influenza.

"The shared goal of HHS/BARDA and BioCryst is to achieve approval for peramivir for seriously-ill influenza patients. We value our long-standing relationship with HHS and their continued support," said Jon P. Stonehouse President and Chief Executive Officer of BioCryst; "This contract modification allows us to significantly increase the number of enrolling sites for our ongoing efficacy study and to drive it to completion. Additionally, the FDA and HHS have agreed to changes in the study that we believe greatly improve the likelihood of demonstrating an improvement over standard of care. Our first priority is to complete the Phase 3 program and we believe these changes should help us reach that goal."

This contract modification brings the total award from HHS to $234.8 million, providing funding through completion of Phase 3 development and the filing of a NDA for i.v. peramivir in the U.S. It also extends the contract term by 24 months through December 31, 2013.

In extended trading, shares of BioCryst jumped more than 12% or 49 cents to $4.48.

Shares of Neoprobe Corporation (NYSE Amex: NEOP) moved higher today after the company announced that it has entered into an exclusive licensing agreement with Naviscan, Inc, as a partner to further develop its patented imaging technology. While most of the patents in Naviscan's extensive intellectual property portfolio were designed to enable innovation in organ-specific molecular imaging, several more recently-allowed patents were devised to further broaden the company's product base. One such patent, now licensed to Neoprobe, enables a novel gamma ray detector, or a gamma probe, to translate gamma emission data into a 3-dimensional representation of a gamma-emitting source, such as a malignant lesion or tumor.

Said Mark Pykett, Executive Vice President and Chief Development Officer of Neoprobe; "The Naviscan platform allows Neoprobe to explore gamma detection products that could lead to new indications for Lymphoseek® and RIGScanTM CR. Additionally, Naviscan 's 3-dimensional gamma camera technology could be optimized for surgical applications that may lead to improved diagnosis and care of patients with cancer and potentially patients with other diseases."

On heavy volume, shares of Neoprobe jumped 44 cents or 11.2% to $4.37.

Shares of Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) were hammered today after the company announced that it anticipates having to provide additional information to the FDA in order to gain expanded use approval for Xifaxan as a treatment for non-constipation irritable bowel syndrome and IBS-related bloating. Based on a phone conversation with the agency, the company expects to receive a CRL by its March 7th PDUFA date. The drug is currently marketed by Salix as a treatment for diarrhea and overt hepatic encephalopathy, or neurological problems associated with liver failure.

Salix shares plunged 24% or $9.84 to $31.61.

BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that enrollment of subjects in the first of two pivotal Phase III LibiGel safety and efficacy trials has been completed. The efficacy trials are being conducted under an FDA-approved special protocol assessment agreement. LibiGel is in development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder in menopausal women, for which there is no FDA-approved product.

"This is an important milestone for BioSante. This achievement represents a key positive step toward completing the LibiGel Phase III clinical development program. To date, we have a combined enrollment in our three LibiGel Phase III clinical studies of approximately 4,000 women and we anticipate announcing completion of enrollment in the second efficacy trial very soon," said Joanne Zborowski, BioSante’s vice president of clinical development.

Shares of BioSante gained 16 cents, or 8% to $2.12

Quest Diagnostics Incorporated (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, announced today that it will acquire Athena Diagnostics, an esoteric laboratory specializing in genetic testing for neurological disorders, from Thermo Fisher Scientific (NYSE:TMO) for $740 million in cash.

Athena Diagnostics is the leading provider of advanced diagnostic tests used to rule out, or confirm, physicians' diagnoses of neurological conditions, such as Alzheimer's disease, neuromuscular disorders, such as Spinal Muscular Atrophy, and developmental disorders.

Also Thursday:

AspenBio Pharma, Inc. (NASDAQ:APPY) , an emerging company dedicated to the development of novel in-vitro diagnostics for humans and bio-pharmaceuticals for animals, today announced that NASDAQ, by letter dated February 24, 2011, granted the Company's request for an additional 180 days to remain listed on the NASDAQ Capital Market and to regain compliance with NASDAQ's $1.00 minimum bid price rule, Listing Rule 5550(a)(2).

BioLargo, Inc. (OTCBB: BLGO) announces today that water expert and former Pepsi-Cola International VP of Technical Services, Harry DeLonge has joined the BioLargo management team as a senior advisor.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced that it has formed a new division, BIOLASE Imaging, to design and distribute state-of-the-art extra-oral and intra-oral dental imaging devices.

Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, announced financial results today for the fourth quarter and fiscal year ended December 31, 2010.

Chembio Diagnostics, Inc. (OTCBB: CEMI) has been awarded a three-year $2.9 million Small Business Innovative Research (SBIR) Phase II grant from the United States National Institutes of Health (NIH) to continue development of a simple, rapid, accurate, and cost-effective serological test for active tuberculosis that can be utilized in resource-limited settings.

Codexis, Inc. (Nasdaq:CDXS) today announced that David Anton, Ph.D. has been promoted to Chief Technology Officer and Senior Vice President, Process Development and Manufacturing, a new position.

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX)
, a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced that it has appointed pharmaceutical industry veteran Tan Cheow Choon as Director of International Business. Based in Singapore, Choon will be primarily responsible for executing Cumberland's initiative to expand markets for its products across Asia, including establishing, building and managing the Company's presence there.

Deaf-Talk, Inc. dba DT Interpreting (PINKSHEETS: MGQG), (DTI) the industry leader in on-demand video sign language interpreting, announced today that it recently signed contracts with the Ryan/Chelsea-Clinton Community Health Center in Midtown West NYC, as well as with Advocate BroMenn Medical Center and Advocate Eureka Hospital in central Illinois.

Dendreon Corporation (Nasdaq:DNDN) today announced that management will present at the following conferences: Citi Global Health Care Conference, New York, NY on March 2, 2011 at 2:30 p.m. ETRBC Capital Markets' Healthcare Conference, New York, NY on March 3, 2011 at 11:30 a.m. ET.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, has received CE Mark for the 29 millimeter version of its Edwards SAPIEN XT transcatheter aortic heart valve.

First China Pharmaceutical Group, Inc. (OTCBB:FCPG) announced its results for the third quarter, ending December 31, 2010.

Fresh Start Private (OTCBB: CEYY)
, a leader in the alcohol treatment and rehabilitation industry, announced today that the number of interested potential clients that have been contacting the Orange County clinic is up by 400% in February compared to one month earlier.

Given Imaging (NASDAQ: GIVN) today announced that Homi Shamir, President and CEO, will present at the RBC Capital Markets' Healthcare Conference taking place March 2 - 3, 2011 in New York City.

IDenta Corp. (PINKSHEETS: IDTA) CEO Yaacov Shohamtoday announced the conclusions and recommendations of testing done by the US Department of Defense (DOD) on the Alert Explosive detectors.

Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2010.

Mylan Inc. (Nasdaq:MYL) today announced its financial results for the three and twelve months ended December 31, 2010, and provided its financial guidance for 2011.

Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced today that Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax will be presenting at the Citi 2011 Global Health Care Conference on March 3rd, 2011 at 8:30 am local time at the Hilton New York Hotel, New York, NY.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that the Company will present at several investor conferences in March 2011.

Omni Bio Pharmaceutical, Inc. (OTC Bulletin Board: OMBP) today announced that effective March 1, 2011, Dr. James Crapo will become its Chief Executive Officer.

Palatin Technologies, Inc. (NYSE Amex:PTN) today announced the pricing of its underwritten public offering of 23,000,000 units, consisting of 23,000,000 shares of its common stock, Series A Warrants to purchase 2,000,000 shares of its common stock and Series B Warrants to purchase 21,000,000 shares of its common stock, at a price to the public of $1.00 per unit.

PROLOR Biotech, Inc. (NYSE Amex:PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the 2011 CITI Global Healthcare Conference, to be held at the Hilton New York Hotel in New York City.

Quest Diagnostics Incorporated (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, announced today that it has signed a definitive agreement to acquire Athena Diagnostics, an esoteric laboratory specializing in genetic testing for neurological disorders, from Thermo Fisher Scientific (NYSE:TMO) for $740 million in cash.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces that its subsidiaries Shire LLC and Shire Development Inc. have received a new Paragraph IV Notice Letter from Watson Laboratories, Inc. in Fort Lauderdale, Florida advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of all approved strengths of Shire's ADDERALL XR(R) (mixed salts of a single-entity amphetamine product) dextroamphetamine sulphate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulphate capsules, CII.

SK3 Group, Inc. (PINK SHEETS:SKTO) is proud to announce that it has closed the acquisition of PRN Registry, the nurse and therapist staffing firm based in Los Angeles and serving southern California.

SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories announced that SOHM's India-based operations are expanding its generic pharmaceutical line to include lifestyle disease drugs for anti-hypertension, cardiac disease, and cholesterol reduction.

TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for the treatment of cancer and other diseases, today announced that, on Friday, February 25, the company will be presented with the "Corporate Distinguished Visionary Award" by the American Cancer Society.

ViroPharma Incorporated (Nasdaq:VPHM) reported today its financial results for the fourth quarter and year ended December 31, 2010.

 




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