ARIAD soars to 52 week high. iBio surges on license agreement. Pluristem stem cell drug to move to advanced trial. Alexza falls on FDA setback Print E-mail
By Mary Davila   
Tuesday, 18 January 2011 20:27
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 18, 2011.

Shares of ARIAD Pharmaceuticals, Inc.(NASDAQ:ARIA), hit a fresh 52 week high today, soaring 34% after the company reported that its's potential cancer treatment hit its main goal in a Phase III study. The company reported top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the SUCCEED trial. Th study was conducted in patients with metastatic soft-tissue or bone sarcomas who previously responded favorably to chemotherapy. The drug is being developed by in multiple cancer indications under an exclusive license and collaboration agreement with ARIAD. Complete findings from trail will be presented later this year and the company expects to file for marketing approval in 2011.

Shares of ARIAD hit an intra-day high of $7.32 before closing the day at $7.03, up $1.78.

iBio, Inc. (NYSE AMEX:IBIO) moved higher today after the company announced the grant of a commercial, royalty-bearing license to Fiocruz/Bio-Manguinhos of Brazil to develop, manufacture and sell certain vaccines based upon iBio’s proprietary technology. Fiocruz/Bio-Manguinhos will invest more than $6 million to bring the first product – a new yellow fever vaccine – through Phase I clinical trials. Product development will be performed through a commercial collaboration among iBio, Fiocruz/Bio-Manguinhos, and iBio’s research and development collaborator, the Fraunhofer USA Center for Molecular Biotechnology.

The license covers the nations of Latin America, the Caribbean and Africa. iBio retains the right to sell the products developed under the license and collaboration agreement in any other territory with a royalty back to Fiocruz/Bio-Manguinhos. Fiocruz/Bio-Manguinhos is a leading world manufacturer of yellow fever vaccine which it has exported to 70 countries.

"We believe this collaboration among iBio, Fiocruz/Bio-Manguinhos and FCMB will dramatically improve the way vaccines and other biopharmaceuticals are developed and manufactured in Brazil and supplied to the other nations in and beyond the licensed territory," said Robert B. Kay, iBio’s Chairman and CEO. "This should help put Brazil in the forefront of state-of-the-art biologics production and distribution."

Shares of iBio Surged 94 cents or 19% to $5.85

Shares of Pluristem Therapeutics, Inc (Nasdaq:PSTI) (TASE:PLTR) surged higher today after the Israel stem cell therapy company announced that it has completed a Phase I study and has won both US and European approval to go forward with an advanced trial Phase II/III trial for its treatment of peripheral artery disease or PAD, an obstruction of blood vessels, typically in the leg, causing pain anddifficulty in walking. The condition usually leads to amputation.

Commented Zami Aberman, Chairman and Chief Executive Officer of Pluristem, "The completion of two Phase-I CLI clinical studies, performed in parallel in Germany and the U.S., placed Pluristem in a unique position to discuss with the regulatory agencies an approach that should allow a single clinical study protocol to be accepted by both agencies,"

Shares of Pluristem jumped 53 cents or 19.5% to close the day at $3.25.

Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) fell Tuesday after the company announced today that it completed an End-of-Review meeting with the FDA for the Adusuve Staccato (AZ-004) New Drug Application, was not asked to conduct any extra studies and will resubmit the marketing application in July. Th company anticipates a six month review process which will put a regulatory decision by early 2012. Adusuve Staccato is an inhaled drug intended to treat agitation in patients with schizophrenia or bipolar disorder. The company received a CRL in October citing concerns from the FDA about the effects that the Staccato inhaler has on the lungs of patients.

Shares of Alexza sank 24 cents or 14% to $1.43.


BSD Medical Corporation (NASDAQ:BSDM) leading provider of medical systems that utilize heat therapy to treat cancer, today announced the sale and shipment of the MicroThermX Microwave System to Med-Italia Biomedica (Med-Italia), one of the largest interventional radiology/oncology distributors in Italy. This is the first European sale of BSD's MicroThermX Microwave System. BSD personnel will be attending the premiere European clinical use of the system, which will involve the treatment of a patient with a large hepatic tumor. The treatment will be carried out by a key physician in Torino, Italy. Med-Italia is a major distributor and manufacturer of products designed for the interventional radiology and oncology market in Italy. They are an exclusive distributor in Italy for a number of large medical companies, selling strategically adjacent products to the same clinicians and market that will be targeted for the MicroThermX System.

Radient Pharmaceuticals Corporation (AMEX:RPC), a US-based company specializing in the research, development, and international commercialization of In Vitro Diagnostic cancer tests, announced today progress on its clinical study with Mayo Clinic ("Mayo") for the validation of the Company's US FDA-cleared Onko-Sure® in vitro diagnostic (IVD) cancer test as a useful tool in the detection of colorectal cancer in all stages of CRC, especially early stages where effective diagnosis leads to better patient prognosis. Based on recent advancements, RPC anticipates it will complete the clinical trial with Mayo in the first quarter of 2011.

After the bell Tuesday, NuVasive, Inc. (NASDAQ:NUVA), traded higher after the medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced that both CIGNA and Humana recently changed their lumbar spinal fusion policy to include coverage for the eXtreme Lateral Interbody Fusion, or XLIF procedure, reversals from their previous policies that labeled XLIF as non-covered. At this time, all of the major commercial insurance providers that once had non-coverage policies for XLIF have reversed their position. This list includes Aetna, United Healthcare, Health Care Service Corporation, Humana and most recently CIGNA.Accuray Incorporated (Nasdaq:ARAY), a global leader in the field of radiosurgery, announced today that Eric Pauwels has joined Accuray as Senior Vice President and Chief Marketing Officer, effective January 17, 2011.

Also Tuesday:

Amgen Inc. (Nasdaq:AMGN)
and Boehringer Ingelheim today announced they have signed an agreement under which Boehringer Ingelheim will acquire Amgen's rights in and substantially all assets at Amgen's Fremont California development and manufacturing facility.

AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging company dedicated to the development of novel human in-vitro diagnostics for humans and bio-pharmaceuticals for animals, added Erik S. Miller to a new position of Vice President, Marketing and Business Development.BioLife Solutions, Inc. (OTC Bulletin Board:BLFS) announced today that it has significantly increased its financial support for several key organizations in the regenerative medicine industry.

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) manufacturer and distributor of the MedFlash®, the nation's premier Personal Health and Wellness Management System (PHM) for maintaining personal health records (PHR), announced today that the company has signed a marketing agreement with Health Matters International, (HMI) for the marketing and distribution of MedFlash®.

eHealthInsurance (NASDAQ: EHTH), the leading online source of health insurance for individuals, families and small businesses, released a summary review of enrollment periods for child-only individual health insurance plans in select states and answers to frequently asked questions (FAQs) about child-only coverage.

HearUSA, Inc. (NYSE Amex: EAR) responded this afternoon to statements made by Siemens Hearing Instruments, Inc. in a Schedule 13D filed by Siemens earlier today.

Luminex Corporation (Nasdaq:LMNX) today announced that it expects to report results for the fourth quarter and full year 2010 on Monday, February 7, 2011.

Masimo (Nasdaq:MASI) announced today that a new clinical study demonstrating the clinical accuracy of its noninvasive and continuous hemoglobin (SpHb®) monitoring technology breakthrough was presented last week at the Society for Technology in Anesthesia (STA) Annual Meeting.

Micro Identification Technologies, Inc. (OTCBB:MMTC) (MIT) supplies the patented MIT 1000 Rapid Microbial Identification System which can identify bacteria in less than five minutes after the culturing of a bacteria sample and at a cost of less than 10 cents per test.

Neuro-Biotech Corp. (PINKSHEET: MRES) (OTCQB: MRES) announces that it has concluded a Business Development Agreement with Credo-TM, a Russian company. The Agreement provides for an exclusive right to distribute all Neuro-Biotech proprietary blood analysis kits and NeuroCeuticals™ in territories such as Russia, Belarus, Ukraine and Kazakhstan.

Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that it has sponsored Jeffrey Gottfurcht, founder of theJeffrey Gottfurcht Children's Arthritis Foundation (JGCAF), on his attempt to be the first climber with Rheumatoid Arthritis (RA) to scale Mount Everest.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) announced today that the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, has agreed to sponsor a 2-Arm randomized Phase II study of carboplatin, paclitaxel plus REOLYSIN® versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer.

PROLOR Biotech, Inc., (NYSE Amex:PBTH), today announced that it has entered into a definitive license agreement with Yeda Research and Development Company Ltd. for novel technology utilized in the development of long-acting therapeutic peptides and small molecules, termed Reversible PEGylation.

Regenicin, Inc. (OTC Bulletin Board:RGIN) a biotechnology company specializing in the development and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, reports that the company received positive feedback from attendees following their presentations at the OneMedForum conference in San Francisco last week.

Soligenix, Inc. (OTC Bulletin Board:SNGX), a late-stage biopharmaceutical company, announced today promising preliminary results from a preclinical study of SGX202 (oral beclomathasone dipropionate or BDP) in a canine gastrointestinal acute radiation syndrome (GARS) model.

Stellar Pharmaceuticals Inc. (OTCBB:SLXCF), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, announces the retirement of Mr. Peter Riehl, as CEO, President and director, effective January 17, 2011.

TheraBiogen, Inc. (OTCBB: TRAB) announced it has shipped TheraMax® to Hannaford Supermarket and Sweetbay Supermarket.

TRIMEDYNE, INC. (OTCBB: TMED) reported revenues of $6,401,000 for the fiscal year ended September 30, 2010, a 14% decline from revenues of $7,422,000 for the prior fiscal year.

Unilens Vision, Inc. (OTCBB: UVIC) (TSX-V: UVI), which develops, licenses, manufactures, distributes and markets specialty contact lenses, today announced the launch of its new C-VUE Advanced® HydraVUE™ line of silicone hydrogel custom contact lenses for monthly replacement. The new family of products incorporates highly developed lens design technology, including Unilens' world-class patented Toric Multifocal and Multifocal designs and made-to-order Custom Toric and Single Vision options.

 

 




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