WALTHAM, Mass., Aug. 2 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSE: AXO, OTC: ALXFF.PK) confirmed today that the European
Commission has granted orphan medicinal product designation for OvaRex(R) MAb
(Oregovomab) for the treatment of ovarian cancer. Orphan drug designation
makes the product eligible for orphan drug exclusivity. If a product which
has an orphan drug designation receives the first marketing approval for the
indication for which it has such designation, the product will be entitled to
orphan drug exclusivity. This exclusivity means that applications to market
the same product for the same use may not be approved by the European
Commission, except in very limited circumstances, for a period of up to 10
years and enables the Company to receive regulatory guidance in the drug
development process as well as reduced filing fees. OvaRex(R) was granted
Orphan Drug status in the United States in 1996 and received Fast Track
designation in the U.S. in 1998.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
Ovarian cancer is a devastating disease that is usually diagnosed at late
stages with high mortality rates. Orphan Drug regulations have been developed
to encourage research and development of new therapies for diseases with low
incidence. The European orphan medicinal product designation is granted for
products which treat life-threatening or severely debilitating diseases
affecting fewer than 5 in 10,000 residents of the European Union and for which
no satisfactory alternative is available.
Additional information about AltaRex research and development, clinical
trials, news and events can be found on the Company website http://www.altarex.com.
This news release contains forward-looking statements that involve risks
and uncertainties, which may cause actual results to differ materially from
the statements made. For this purpose, any statements that are contained
herein that are not statements of historical fact may be deemed to be forward-
looking statements. Without limiting the foregoing, the words "believes,"
"anticipates," "plans," "intends," "expects" and similar expressions are
intended to identify forward-looking statements. Such risks and uncertainties
include, but are not limited to our need for capital; the risk that the
Company can not raise funds on a timely basis on satisfactory terms or at all;
the need to obtain and maintain corporate alliances, such as the alliance with
United Therapeutics, and the risk that the Company cannot establish corporate
alliances on a timely basis, on satisfactory terms, or at all; changing market
conditions; uncertainties regarding the timely and successful completion of
clinical trials and patient enrollment rates, uncertainty of pre-clinical,
retrospective, early and interim clinical trial results, which may not be
indicative of results that will be obtained in ongoing or future clinical
trials; whether the Company and/or its collaborators will file for regulatory
approval on a timely basis; uncertainties as to when, if at all, the FDA or
other equivalent regulatory authorities will accept or approve regulatory
filings for the Company's products; the need to establish and scale-up
manufacturing processes, uncertainty as to the timely development and market
acceptance of the Company's products; the risk that the claims allowed under
any issued patent owned or licensed by the Company will not be sufficiently
broad to protect the Company's technology, that any patents issued to the
Company will not be sustained if challenged in court proceedings or otherwise
or that third parties will be able to develop products or processes that do
not infringe valid patents owned or licensed by the Company, and other risks
detailed from time-to-time in the Company's filings with the United States
Securities and Exchange Commission and Canadian securities authorities. The
Company does not assume any obligation to update any forward-looking
statement.
THE TORONTO STOCK EXCHANGE HAS NOT APPROVED OR DISAPPROVED OF THE
INFORMATION CONTAINED HEREIN
SOURCE AltaRex Corp.
 back to top
Related links:
http://www.altarex.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
http://www.prnewswire.com/comp/128163.html
CONTACT:
Trudy Chimko, Human Resources & Corporate
Communications of AltaRex Corp., +1-781-672-0138,
investor@altarex.com
|
