BIOLASE soars on upped forecast. Cleveland BioLabs lead drug shows anticancer effect. Teva increases its stake in Rexahn Print E-mail
By Mary Davila   
Thursday, 20 January 2011 19:33
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 20, 2011.


BIOLASE Technology, Inc. (NASDAQ:BLTI) today announced that it expects to report higher than expected 2011 revenue. Shares shot up more than 65% on the news. The company is expecting revenue between $55-$60 million for the year, significantly higher than average analysts forecast of $40 million. The company cited its change in marketing strategy, from 3rd party distribution to a direct sales force as a major reason for the upped forecast as well as better than expected performance from its online store. The company's newly launched e-commerce site exceeded revenue goals by more than 40% and is forecasted to become a multi-million dollar revenue contributor in 2011. "We foresee a very promising 2011 with revenue and earnings growth on a quarterly basis," CEO Federico Pignatelli said.

BIOLASE is a leading dental laser manufacturer and distributor.

On heavy volume, shares surged $1.10 to $2.77.

Shares of Cleveland BioLabs, Inc. (NASDAQ:CBLI) jumped more than 6% today after the announced that it has accumulated preclinical data demonstrating that CBLB502, a drug under development to treat exposure to radiation, has direct anticancer effect in several transplanted cancer models grown in mice and rats including colon and lung cancer, lymphoma and melanoma. In one of the animal models of transplanted colon cancer, CBLB502 treatment resulted in complete tumor regression with no recurrence of the disease in a large percentage of animals.

Experimental results suggest that CBLB502's anticancer effect stems from the same mechanism which underlies its ability to treat radiation exposure and which involves tissue-specific activation of innate immune response mediated by CBLB502's interaction with its receptor, TLR5. Antitumor effects largely depend on the expression of TLR5 by the tumor. However, in the case of tumors residing in the liver, the organ which has been identified as the natural primary target site for CBLB502 activity, tumors become effectively suppressed as a result of host immune system attack regardless of their TLR5 status. This characteristic makes liver metastasis a favorable target for potential anticancer applications of CBLB502.

Andrei Gudkov, Ph.D., D. Sc., Chief Scientific Officer of Cleveland BioLabs and Senior Vice President of Basic Science at Roswell Park Cancer Institute, commented, "We are very excited by these initial results, which extend CBLB502's potential medical applications in cancer treatment from use as a supportive care agent to reduce toxicities of radio and chemotherapy to use as a direct anticancer agent. We believe that clinical development of CBLB502's potential immunotherapy effects may be pursued in parallel to or in some cases as part of, our prior plan for supportive care applications, and we are currently modifying our development plan to integrate this important new opportunity. We expect to complete these adjustments shortly and move forward into the clinic."

Shares of Cleveland BioLabs jumped 43 cents to $7.41 and continued higher in extended trading.

Rexahn Pharmaceuticals, Inc. (NYSE Amex:RNN), surged today after the company announced that Teva Pharmaceutical Industries Limited (NasdaqGS:TEVA) increased its ownership stake by purchasing 2,334,515 shares of Rexahn’s common stock in a private offering for $3.95 million, or $1.692 per share. After this transaction, Teva will own 6.29% of the outstanding shares of Rexahn. Rexahn intends to use the money to support the research and development program for the pre-clinical stage, anti-cancer compound RX-3117.

"We are excited by Teva’s increased commitment to this collaboration and the development of RX-3117," said Dr. Chang Ahn, Rexahn’s Chairman and Chief Executive Officer. "We are also pleased with RX-3117’s development to date, and we are working to advance the compound into clinical trials in 2011."

Shares of Rexhan gained 12 cents or 9.84%. Volume of 3.3 million shares was more than eight times the daily average.

Cytori (NASDAQ:CYTX) received approval from The Netherlands to initiate a pivotal European trial, named ADVANCE, to investigate adipose-derived stem and regenerative cells (ADRCs), processed by the Celution One System, in the treatment of patients with acute heart attacks. This is the first country and trial-center approval for ADVANCE. Additional country and trial-center approvals are anticipated throughout Europe during the first half of 2011. One of the goals of the trial is to expand the Celution System CE Mark to include acute heart attack claims and to provide economic data to justify its implementation and reimbursement.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Lamivudine and Zidovudine Tablets, 30 mg/60 mg. The NDA is based on the reference listed drug Combivir, by ViiV Healthcare. This innovative pediatric fixed-dose combination (FDC) in tablet form was developed by Matrix for use in treating children with HIV/AIDS. This product will be eligible for purchase outside the U.S. in certain developing countries.

Mylan President Heather Bresch said: "The approval of Lamivudine and Zidovudine is particularly important because it makes available an innovative FDC treatment option for children who are living with HIV/AIDS in developing countries. The addition of this product to our ARV franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS and to continue to expand access to high quality, affordable ARVs."

Also Thursday:

Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced the pricing of a previously announced underwritten public offering of 2,750,000 shares of its common stock, offered at a price to the public of $26.00 per share.


Bacterin International Holdings, Inc. (OTC Bulletin Board:BIHI), today announced that it has closed on the Bridge Bank, N.A. revolving accounts receivable line of credit facility for up to $5 million that was announced on November 22, 2010.

Biostar Pharmaceuticals, Inc. (Nasdaq:BSPM) Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsules, and a variety of pharmaceutical products, today announced that its Chairman and Chief Executive Officer, Mr. Ronghua Wang, is a Chinese Entrepreneur Representative on Chinese President Hu Jintao's delegation during the official visit to the United States in January 2011.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser manufacturer and distributor, today announced the launch of the Waterlase® iPlus™ System dual-wavelength all-tissue laser, the first major breakthrough in all-tissue laser technology since the Waterlase MD™ was introduced in 2005.

First China Pharmaceutical Group, Inc. (OTCBB: FCPG) , a rapidly growing pharmaceutical distribution company headquartered in Yunnan, China, is pleased to announce the signing of an exclusive drug distribution agreement that clearly demonstrates the Company's establishment as an industry leader.

Harriet L. Robinson, Ph.D., Chief Scientific Officer at GeoVax Labs, Inc. (OTCQB/OTC Bulletin Board:GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, is one of three recipients of the 2011 Georgia Bio (GaBio) Community Awards.

Health Enhancement Products, Inc. (OTCBB: HEPI) has contracted the analytical services arm of scientific instrument maker Bruker Corporation, based in Billerica, MA, to conduct liquid chromatography, nuclear magnetic resonance and mass spectroscopy on the final remaining isolates identified by the HEPI research team over the last year.

Healthnostics, Inc. (PINKSHEETS: HNSS) announced record earnings for the year ending December 31, 2010, of $1,991,706 or $.012 per share (which exceeded earlier guidance) on revenues of $2,334,842, including $1,314,451 from extraordinary gains.

Herborium Group, Inc. (PINKSHEETS:HBRM)a Botanical Therapeutics™ company, announced today that it added Mr. Laurence Woo to the company Board of Directors.

Masimo (Nasdaq:MASI) announced today that a new study demonstrating the clinical accuracy and value of its noninvasive and continuous hemoglobin (SpHb®) monitoring technology breakthrough was presented this week at the Society of Critical Care Medicine (SCCM) Annual Critical Care Congress in San Diego.

NeoStem, Inc. (NYSE Amex:NBS) and Progenitor Cell Therapy LLC announced today the closing of their previously announced merger transaction.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC), a US-based company specializing in the research, development, and international commercialization of In Vitro Diagnostic cancer tests, announced today it has received CE-Mark approval from the European Union (EU) for the use of its Onko-Sure® In Vitro diagnostic (IVD) cancer test as a pan tumor marker for cancer.

Repligen Corporation (Nasdaq:RGEN) announced today that it has entered into an exclusive license agreement with the University of California, Irvine (UCI) for a patent application covering the use of histone deacetylase 3 (HDAC3) inhibitors for the treatment of disorders involving preservation or extinction of memory including Alzheimer's disease, memory impairment and post traumatic stress disorder.

Soligenix, Inc. (OTC Bulletin Board:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication.

Spherix Incorporated (Nasdaq:SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that it has entered into definitive agreements to sell $2.77 million of shares of its common stock and warrants to purchase shares of its common stock in a registered direct offering to institutional investors.

UV Flu Technologies, Inc. (OTCBB:UVFT) (the "Company") is pleased to announce one of UV Flu's distributors, INE Global, has placed an order with The Rogerson House, one of Boston's pre-eminent Assisted Living Facilities.

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a life sciences product development company advancing a diverse portfolio of promising hematology and cancer-related products at various stages of development, today announced that results were reported from a randomized Phase II gastric cancer study of nimotuzumab being conducted by its licensees, Daiichi Sankyo Co., Ltd. in Japan and Kuhnil Pharma Co. Ltd., in Korea.




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