Form 20-F/A for ViRexx Medical Corp.
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
20-F/A
(Amendment
No. 1)
(Mark
One)
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REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE
ACT
OF 1934
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OR
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ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
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For
the fiscal year ended December 31, 2006
OR
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
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Commission
file number: 1-32608
ViRexx
Medical Corp.
(Exact
name of Registrant as specified in its charter)
Alberta,
Canada
(Jurisdiction
of incorporation or organization)
8223
Roper Road NW, Edmonton, Alberta, Canada T6E 6S4
(Address
of principal executive offices)
Securities
registered or to be registered pursuant to Section 12(b) of the
Act.
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Title
of each class
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Name
of each exchange on which registered
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Common
Shares, No Par Value
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The
American Stock Exchange (“AMEX”)
Toronto
Stock Exchange (“TSX” )
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Securities
registered or to be registered pursuant to Section 12(g) of the
Act.
Securities
for which there is a reporting obligation pursuant to Section 15(d) of the
Act.
As
of
December 31, 2006, there were 72,760,717 outstanding common shares of
ViRexx.
Indicate
by check mark if the registrant is a well-known seasoned issuer as defined
in
Rule 405 of the Securities Act.
If
this
report is an annual or transition report, indicate by check mark if the
registrant is not required to file reports pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934.
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer or a non-accelerated filer.
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o Large
Accelerated filer
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o Accelerated
filer
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x Non-accelerated
filer
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Indicate
by check mark which financial statement item the registrant has elected to
follow.
If
this is an annual report, indicate by check mark whether the registrant is
a
shell company (as defined in Rule 12b-2 of the Exchange Act).
(APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE
YEARS)
Indicate
by check mark whether the registrant has filed all documents and reports
required to be filed by Sections 12, 13 or 15(d) of the Securities
Exchange Act of 1934 subsequent to the distribution of the securities under
a
plan confirmed by a court.
Explanatory
Note
This
amended Annual Report on Form 20-F/A is being filed by ViRexx Medical
Corp. (the
“Company”) solely to (i) correct the disclosure mistake on page 28 of the Annual
Report on Form 20-F for the fiscal year ended December 31, 2006 initially
filed
by the Company with the Securities and Exchange Commission on April 2,
2007 (the
“Annual Report”), and (ii) file the exhibits indicated as being
filed in the Exhibit Index of the Annual Report that were erroneously
omitted as part of the Company’s initial filing of the Annual
Report.
The
Orphan Drug Designation for OvaRex® MAb is intended for the treatment of ovarian
cancer during the “watchful waiting period”. This affords 7 years marketing
exclusivity in the United States and 10 years marketing exclusivity in Europe.
Although the incidence of ovarian cancer is relatively low in North America
with
16,210 projected deaths in 2005 based on the American Cancer Society (“ACS”)
latest report and 40,000 new cases in Europe, based on GLOBOCAN 2002 statistics,
there is no approved therapy for the treatment of ovarian cancer in the
“watchful waiting” period. The Corporation has issued patents and patents
pending protecting the AIT™ technology. Benchmark monoclonal antibody-based
therapy reimbursements to treat other solid tumors suggest that the Corporation
could receive a premium for its OvaRex® MAb in the treatment of ovarian cancer
patients. However, there is no guarantee that the Corporation or its licensees
including Unither will receive sufficient reimbursement to justify continued
development of OvaRex® MAb.
Market
Overview
Ovarian
cancer is a malignant growth located in the ovaries in the female reproductive
system. In the U.S., Canada, and Europe, ovarian cancer causes more deaths
than
any other cancer of the female reproductive tract, representing 4% of all
cancers among women, and is the fifth most common cause of cancer fatality
for
women, according to statistics compiled by the American Cancer Society (ACS).
Specifically, the ACS estimates that there were 22,491 new cases and 16,210
deaths resulting from ovarian cancer in 2006. Approximately 3,000 new cases
of
ovarian cancer are reported in Canada each year.
Although
detection of ovarian cancer at an early stage is now associated with an improved
chance for successful treatment, survival figures have not changed significantly
over the past 15 years. This is partially due to a lack of efficient diagnostic
methods or markers for routine tests that could increase the number of patients
diagnosed at the early stage of their disease. Consequently, in approximately
three quarters of diagnosed patients, the tumor has already progressed to an
advanced stage (Stage III/IV) (ASC 2003), making treatment
difficult.
In
estimating the global market for treating ovarian cancer we have conducted
the
following analysis. We have started with a conservatively estimate that there
are 70,000 new ovarian cancer patients per year in only those countries with
top
tier medical systems. Of these patients, approximately 27,500 will be eligible
for treatment with OvaRex®MAb, during the “watchful waiting period’ for which
there currently is currently no approved therapy.
In
2006,
Monoclonal Antibody therapies commercially available in the U.S. range in price
(ex-factory) from U.S.$25,000/patient/year to U.S.$43,000/patient/year. OvaRex®
MAb is expected to be priced at the upper end of this range, at about
U.S.$39,000/patient/year. At this price, the U.S. market for the ‘watchful
waiting’ indication is estimated at U.S.$47 million per year, and the global
market at U.S.$1.1 billion per year. A second indication is being explored
for
OvaRex® MAb for frontline use in conjunction with front line chemotherapy. This
indication could open up the ovarian cancer market to the full 70,000
patients/year and therefore translates to a market size of U.S.$1.9 billion
annually.
OvaRex®
MAb has been granted Orphan Drug status in the U.S. and Europe and Fast Track
designation in the U.S. The timeline for regulatory submission of OvaRex® MAb
will be determined by United Therapeutics for their licensed territories (as
per
the April 17, 2002 licensing agreement). The Orphan Drug Designation for OvaRex®
MAb is for the treatment of ovarian cancer during the “watchful waiting period”
(i.e. after treatment by chemotherapy and surgical removal of the tumor). This
affords 7years marketing exclusivity in the United States and 10 years marketing
exclusivity in Europe. Further, ViRexx has issued patents and patents pending
that will afford further protection from competitors in this segment of the
cancer treatment market. Benchmark monoclonal antibody-based therapy
reimbursements to treat other solid tumors suggest that ViRexx could receive
a
premium for its OvaRex® MAb in the treatment of ovarian cancer patients.
However, there is no guarantee that ViRexx or its licensees, including Unither,
will receive sufficient reimbursement to justify continued development of
OvaRex® MAb. Further, there is no guarantee that a competitor will not develop a
therapeutic agent that will directly compete with OvaRex® MAb for the specified
target market.
Treatment
Ovarian
cancer typically exhibits vague symptoms, and is therefore called “The Disease
That Whispers”. It is particularly difficult to detect given the location of the
ovaries and is often not diagnosed until at a late stage in the disease, at
which point, it has already spread to other parts of the body. Consequently,
only approximately 25% of ovarian cancers are diagnosed in the early stages
(Am
Cancer Soc 2003).
Treatments
and patient prognosis are highly dependent upon the type of ovarian cancer
and
the extent to which the disease has spread prior to diagnosis. More than 80%
of
Stage III/IV patients express the tumor associated antigen CA125 an antigen
that
is self produced and is highly associated
with ovarian cancer. The therapeutic approach prescribed for these patients
whose tumors have progressed to an advanced stage consists of surgery to remove
all visible cancerous growth followed by adjuvant chemotherapy. The procedure
may also involve the removal of one or both ovaries and fallopian tubes
(salpingo-oopharectomy), as well as the uterus
(hysterectomy).
SIGNATURES
The
Registrant hereby certifies that it meets all of the requirements for filing
on
Form 20-F and that it has duly caused and authorized the undersigned to sign
this annual report on its behalf.
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VIREXX
MEDICAL CORP.
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By:
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D.
Lorne Tyrrell
Name:
Dr. D. Lorne Tyrrell
Title:
Chief Executive Officer
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Date:
April 5, 2007
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By:
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Scott
Langille
Name:
Scott Langille
Title:
Chief Financial Officer
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Date:
April 5, 2007
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