|BIOLASE soars on upped forecast. Cleveland BioLabs lead drug shows anticancer effect. Teva increases its stake in Rexahn|
|By Mary Davila|
|Thursday, 20 January 2011 19:33|
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."
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.