Myriad Genetics Inc.
) inked an expanded, nonexclusive worldwide collaboration
) to offer companion diagnostics for the latter's pivotal Phase 3
clinical development program for the oncology candidate olaparib.
However, specific terms of the expanded agreement remain
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This new deal is an extension of an existing collaboration
between Myriad and AstraZeneca through which Myriad provided
Bracanalysis tests to assist AstraZeneca in its Phase 2
development program for olaparib in breast and ovarian cancer.
Following the expanded agreement, Myriad will execute a
laboratory development plan in its Salt Lake City facility. The
new laboratory will comply with U.S. Food and Drug Administration
(FDA) regulations for companion diagnostic services.
Earlier in June, Myriad filed an Investigational Device Exemption
(IDE) with the FDA for the use of Bracanalysis test as a
companion diagnostic to distinguish potential responders from
non-responders to olaparib therapy in the U.S. The company gained
the FDA approval in August.
According to management at AstraZeneca, the collaboration to
support the Phase 3 development of olaparib should result in
novel treatment options for ovarian and breast cancer patients
with BRCA mutations. It should also lead to improved patient
outcomes as the diagnostic test will help clinicians identify
AstraZeneca has already filed a Letter of Intent to submit
marketing application with the European Medicines Agency for
olaparib for BRCA mutated ovarian cancer. According to Myriad,
the European launch is expected in 2015. Accordingly, the annual
market size in the European Union for BRCA testing is estimated
as $120 million for the company.
The expanded collaboration with AstraZeneca reinforces the fact
that Myriad's BRACAnalysis is considered 'the gold standard
diagnostic test' to ascertain the presence of a BRCA gene
mutation in patients. The companion diagnostic partnership with
AstraZeneca is another positive footstep for Myriad to establish
leadership in this space.
Myriad has collaborations with several pharmaceutical majors to
assert itself as a strong player in the companion diagnostic
market. As per management, these alliances with major
pharmaceutical players collectively reflect a market potential of
over $1 billion for Myriad in the field of diagnostics and
companion diagnostics. We are upbeat about the company's growth
prospects in the companion diagnostics space and believe that
these developments should augur well for the long-term
development of Myriad.
Currently, Myriad carries a Zacks Rank #2 (Buy). Other attractive
Biogen Idec Inc.
), carrying a Zacks Rank #1 (Strong Buy).