Myriad Genetics Selects Lundbeck as European Partner for Flurizan
Myriad Receives $100 Million Upfront for European Rights to Alzheimers Disease Drug CandidateSALT LAKE CITY, UT, May 22, 2008 (MARKET WIRE via COMTEX News Network) -- Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) today
announced the selection of H. Lundbeck A/S for European
commercialization of Flurizan(R), Myriad's lead therapeutic candidate
for the treatment of Alzheimer's disease.
Myriad and Lundbeck have entered into a European commercialization
agreement under which Lundbeck will have rights to market and sell
Flurizan in the European Union and several associated non-EU countries
and will manage the regulatory process. Lundbeck has agreed to pay
Myriad an initial $100 million and will pay up to $250 million in
connection with regulatory approvals. Furthermore, Lundbeck has
agreed to pay attractive commercialization milestones and will
purchase bulk pharmaceutical material from Myriad. Lundbeck has also
agreed to pay escalating royalties of 20 - 39% on sales, less the
amount paid for the bulk drug.
"Lundbeck has an excellent track record in the field of Alzheimer's
disease and is known globally for its reputation as a CNS specialty
pharmaceutical company and I can't think of a better European partner
for Flurizan," said Peter Meldrum, President and CEO of Myriad
Genetics, Inc. "The selection of Lundbeck as our European partner
completes the first stage of our global commercialization strategy
for Flurizan."
H. Lundbeck A/S is a major Europe-based pharmaceutical company with
the largest sales force in the European Union that specializes in
central nervous system disorders, including Alzheimer's disease. Their
marketed drugs include Cipralex(R) (marketed as Lexapro(R) in the
U.S.) for major depressive disorders, Ebixa(R) (marketed as
Namenda(R) in the U.S.) for moderate to severe Alzheimer's disease,
Azilect(R) for parkinson's disease, Serdolect(R) for schizophrenia
and Circadin(R) for insomnia. Lundbeck's local knowledge of the
Alzheimer's disease market in each of the European countries and its
European sales force of more than 1,300 sales representatives will
provide Flurizan with the opportunity for fast and expert initiation
of commercialization.
"We are very excited to be entering this partnership with Myriad.
Flurizan has the potential to bring an important new Alzheimer's
medicine to patients in Europe," said Executive Vice President Anders
Gersel Pedersen of Lundbeck. "Lundbeck is fully committed to the
field of Alzheimer's disease and this partnership further
demonstrates that commitment."
With this partnership in place, Myriad now plans to concentrate on
pre-commercial market development in the United States. Myriad's
strategy in the U.S. is to seek a revenue-share arrangement with a
major pharmaceutical company to access their primary-care physician
sales force, while Myriad's sales force will address the specialty
physician market. Myriad intends to build a 200-person sales force to
call on Alzheimer's disease specialists, who are primarily
neurologists, geriatricians and certain psychiatrists who focus on
Alzheimer's disease. Myriad's sales force is expected to target sales
of Flurizan to the 10,000 specialty physicians that prescribe about
one third of the Alzheimer's drug prescriptions in the U.S.
The remaining two-thirds of prescriptions for Alzheimer's medications
are written by primary care practitioners, which include general
practice, internal medicine and family practice doctors. There are
approximately 50,000 of these physicians in the United States.
In the United States, Myriad intends to have commercial supplies of
Flurizan produced through the API (active pharmaceutical ingredient)
manufacturer and tablet maker that it is presently using for clinical
drug supply. The Company has also identified additional API
manufacturers and tableters to assure a stable and sufficient supply
of Flurizan for market requirements. Myriad expects to utilize
third-party logistic organizations to manage drug distribution in the
United States.
Japan and Pacific Rim countries represent the third regional
component of the Company's strategy. Myriad expects to partner
through a more traditional licensing arrangement, similar to the
agreement with Lundbeck, for commercialization in this region.
For financial reporting purposes, the Company expects the revenue
from the initial $100 million payment from Lundbeck to be recognized
over the life of the agreement. Under the Company's license agreement
with Encore Pharmaceuticals, Inc., the payment from Lundbeck will
trigger a sublicense royalty payment which will be recognized in this
fiscal year and is expected to materially increase the Company's
research expenses and net loss in the fourth quarter of fiscal 2008,
ending June 30, 2008.
Flurizan Clinical Trial Status
Flurizan is being studied in two Phase 3 clinical trials. The U.S.
Phase 3 trial enrolled 1684 patients with mild Alzheimer's disease at
131 investigator sites in the U.S. This trial has been completed and
preparation of the database for analysis is in process. Announcement
of the results of this trial is planned for June, 2008. In addition,
a second Phase 3 trial enrolled 840 patients with mild Alzheimer's
disease at 90 investigator sites globally. This trial is scheduled
for completion around the end of 2008.
Flurizan(R), is a registered trademark of Myriad Genetics, Inc.
Cipralex(R), Lexapro(R), Ebixa(R), Namenda(R), Azilect(R),
Serdolect(R) and Circadin(R) are trademarks of Lundbeck or others.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the
development of novel healthcare products. The Company develops and
markets predictive medicine products, and is developing and intends to
market therapeutic products. Myriad's news and other information are
available on the Company's Web site at www.myriad.com.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to potential milestone and royalty
payments that may be received under the commercialization agreement
with Lundbeck, the expectation that Lundbeck's knowledge of the
European Alzheimer's market will provide an opportunity for the fast
and expert commercialization of Flurizan in Europe, Myriad's
commercialization strategy in the United States, including its plans
to build and utilize its own sales force and to arrange for
manufacturing and supply, Myriad's commercialization strategy in
Japan and the Pacific Rim, the expected impact on Myriad's financial
results of the up-front payment from Lundbeck and the related
sublicense royalty obligations to Encore Pharmaceuticals, and plans
for the announcement of U.S. Phase 3 results and the completion of
the global Phase 3 trial of Flurizan. These forward-looking
statements are based on management's current expectations and are
subject to certain risks and uncertainties that could cause actual
results to differ materially from those set forth in or implied by
forward-looking statements. These risks and uncertainties include,
but are not limited to, our inability to further identify, develop
and achieve commercial success for new products and technologies; our
ability to discover drugs that are safer and more efficacious than
our competitors; our ability to develop molecular diagnostic products
that help assess which patients are subject to greater risk of
developing diseases and who would therefore benefit from new
preventive therapies; the possibility of delays in the research and
development necessary to select drug development candidates and
delays in clinical trials; the risk that clinical trials may not
result in marketable products; the risk that we may be unable to
successfully finance and secure regulatory approval of and market our
drug candidates, or that clinical trials will not be completed on the
timelines we have estimated; uncertainties about our ability to
obtain new corporate collaborations and acquire new technologies on
satisfactory terms, if at all; the development of competing products
and services; our ability to protect our proprietary technologies;
patent-infringement claims; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; and other factors discussed under the heading "Risk
Factors" contained in Item 1A in our Annual Report on Form 10-K for
the year ended June 30, 2007, which has been filed with the Securities
and Exchange Commission, as well as any updates to those risk factors
filed from time to time in our Quarterly Reports on Form 10-Q or
Current Reports on Form 8-K. All information in this press release is
as of the date of the release, and Myriad undertakes no duty to
update this information unless required by law.
Contacts:
Myriad Genetics (Media and Investor)
William A. Hockett
EVP, Corporate Communications
(801) 584-3600
email: Email Contact
Lundbeck (Investor)
Jacob Tolstrup
Director
+45 36 43 30 79
Palle Holm Olesen
Head of Investor Relations
+45 36 43 24 26
Lundbeck (Media)
Jens Harder HĂžjbjerg
Media Relations Mgr
+45 36 43 28 33
SOURCE: Myriad Genetics
http://www2.marketwire.com/mw/emailprcntct?id=2062A5AADAB71E32
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