WALTHAM, Mass., July 9 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSE: AXO, OTC: ALXFF.PK) announced today that the Committee for
Orphan Medical Products (COMP) of the European Agency for the Evaluation of
Medicinal Products (EMEA) has adopted a positive opinion recommending the
granting of orphan medicinal product designation for OvaRex(R) MAb
(Oregovomab) for the treatment of ovarian cancer. The COMP has forwarded its
opinion of June 27, 2002 to the European Commission for final decision
expected within 45 days. European orphan drug designation enables recipient
companies to receive regulatory guidance in the drug development process as
well as reduced filing fees and allows for up to ten years of European market
exclusivity upon approval of the market application. OvaRex(R) was granted
Orphan Drug status by the Food and Drug Administration (FDA) in the United
States in 1996 and received FDA Fast Track designation in 1998.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
AltaRex has advanced OvaRex(R) MAb through phase II studies in North
America and has recently entered into collaboration for further development
with a wholly owned subsidiary of United Therapeutics Corporation under which
AltaRex licensed OvaRex(R) (and other products) for North America and other
regions worldwide excluding the European Union and certain other countries.
United Therapeutics has disclosed its intention, subject to a program review
with the U.S. Food and Drug Administration, to initiate a phase III randomized
pivotal trial of OvaRex(R) by the first quarter of next year. United
Therapeutics is also addressing manufacturing requirements for both the U.S.
Biologics License Application and product commercialization.
European OvaRex(R) development is being conducted by the Company with
guidance from its Southern European and Middle East collaborative partners and
in particular Dompe Farmaceutici of Italy. AltaRex expects that these and any
new collaborative partners the Company is seeking for Northern Europe will
work closely with AltaRex and United Therapeutics to guide a worldwide
registration strategy. However, because United Therapeutics is responsible
for clinical development in North America and AltaRex remains similarly
responsible for Europe, decisions pertaining to clinical development and
manufacturing for Europe could differ in some respects from those for North
America.
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, such as the alliance in Northern Europe that the Company is
seeking, 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 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.
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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
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