HERZLIYA, Israel, March 29, 2012 /PRNewswire/ --
XTL Biopharmaceuticals Ltd. (TASE: XTL) (OTC: XTLBY), a biopharmaceutical development company, today reported its results for the fourth quarter and year ended December 31, 2011.
David Grossman, CEO of XTL, stated, "2011 was a very significant year for XTL and we are very proud of our achievements in expanding our drug development pipeline with SAM-101 for the treatment of schizophrenia. SAM-101 is combination therapy of anti-psychotic existing drugs with minocycline. We now have a worldwide exclusive license for the development and commercialization of SAM-101 for the treatment of psychotic disorders. We in-licensed SAM-101 after it successfully completed a phase 2a prospective, randomized, double-blind, placebo-controlled clinical trial conducted on about 70 schizophrenics in Israel. The trial met its endpoints showing that SAM-101 improves the positive symptoms of the disease as well as the patients' cognitive state, minimizes the negative symptoms (social parameters and patient cognition) and reduces weight-gain side effects among patients".
"In the past year we were granted an orphan drug designation from the FDA for our rHuEPO for the treatment of multiple myeloma. The designation can provide us with significant regulatory and financial advantages to rapidly move our candidate forward in clinical trials. Upon the FDA's marketing approval for rHuEPO for the treatment of multiple myeloma we will be entitled to marketing exclusivity for seven years in the US. In addition, the benefits include among others tax incentives, exemption of FDA filing fees and clinical research financial subsidization". Mr. Grossman added, "Since the 4th quarter of 2011, we are conducting a research which includes collection of data relating to the level of specific proteins in the blood of a group of patients with multiple myeloma with rHuEPO as part of the preparations for our phase 2 rHuEPO clinical trial."
"As of December 31, 2011 we had cash and cash equivalents of $1.5 million and in March 2012, we successfully completed a financing in Israel of approximately $3.8 million by way of private placement which also included an exercise of warrants, led by institutional investors. Such funds will enable us to finance our activities through at least into 2014 and support the acceleration of our drug development programs. Our strategy to continually identify and acquire new technologies remains and we are very keen in this front," stated Mr. Grossman.
"In March 2012, we also enhanced our capabilities of collecting clinical data by signing a strategic collaboration agreement with the research institute of Clalit Health Services, Israel's largest HMO. This agreement enables us to define clinical outcomes that we seek from Clalit's clinical database for the benefit of focusing our clinical trials design."
About XTL Biopharmaceuticals, Ltd
XTL Biopharmaceuticals, Ltd., a biopharmaceutical company, focuses on the acquisition, development, and commercialization of pharmaceutical products for the treatment of clinical unmet needs. The Company is focused on late stage clinical development of drugs for the treatment of multiple myeloma, schizophrenia, and hepatitis C.
The Company's lead drug candidate, rHuEPO for the treatment of multiple myeloma blood cancer was granted an orphan drug designation from the FDA. rHuEPO, has been approved for marketing by the FDA and has for many years been sold for billions of dollars across the world for the treatment of severe anemia.
XTL is a public company traded on the Tel Aviv Stock Exchange (TASE: XTL) and its ADRs are quoted in the US on the Pink Sheets (OTC: XTLBY).
Various statements in this release concerning XTL's future expectations, plans and prospects, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may", "expects", "anticipates", "believes", and "intends", and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of XTL to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of XTL's Form 20-F filed with the Securities and Exchange Commission on March 29, 2012. In addition, any forward-looking statements represent XTL's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. XTL does not assume any obligation to update any forward-looking statements unless required by law.
For more information on XTL, please visit http://www.xtlbio.com or contact:
XTL Investor Relations, Tel: +972-9-955-7080 or email: [email protected]
SOURCE XTL Biopharmaceuticals Ltd