- Gilead to reduce momelotinib commercial royalty
rates in exchange for equity in Sierra -
- Amendments become effective upon Sierra Oncology closing a
qualified financing -
VANCOUVER, Nov. 7, 2019 /CNW/ - Sierra Oncology, Inc.
(Nasdaq: SRRA), a late-stage drug development company focused on
the development and commercialization of momelotinib, a JAK1, JAK2
& ACVR1 inhibitor with a potentially differentiated therapeutic
profile for the treatment of myelofibrosis, today announced that it
has agreed to amend its Asset Purchase Agreement with Gilead
Sciences, Inc. for momelotinib upon Sierra closing a qualified
financing.
"These are significant amendments that meaningfully enhance the
potential long-term value of momelotinib for Sierra and its
stockholders. The amendments also affirm Gilead's support for the
continued development of momelotinib with the goal of bringing
meaningful benefit to patients with myelofibrosis," said Dr.
Nick Glover, President and CEO of
Sierra Oncology. "Following the closing by Sierra of a qualified
financing, Gilead will become a stockholder in Sierra,
the annual royalty rates payable to Gilead will be
reduced, which will benefit the company and all its stockholders
should momelotinib prove commercially successful, and we will also
eliminate a milestone payment that would be due to Gilead in the
coming months with the anticipated initiation of the MOMENTUM Phase
3 trial for momelotinib, further extending our financial
resources."
"We are pleased to enter into this amended agreement with Sierra
in order to support the company's continued advancement of
momelotinib. Gilead continues to believe in the potential of
momelotinib, and we are pleased that Sierra will continue
development of the compound in hopes that it will benefit patients
in the future," said Andrew
Dickinson, Chief Financial Officer of Gilead.
In consideration for amending the royalty rates and milestones
in the Asset Purchase Agreement, following the automatic conversion
of shares of preferred stock to be issued in connection with
Sierra's recently announced financing, Sierra and Gilead Sciences
would enter into a Securities Purchase Agreement, pursuant to which
Sierra would issue to Gilead Sciences shares of Sierra Common Stock and a warrant to purchase
Sierra Common Stock. The number of
shares of Common Stock to be issued would be equal to 7.5% of
Sierra's outstanding shares of Common Stock, after giving effect to
certain adjustments related to the financing. The Warrant would be
exercisable to purchase up to an additional 7.5% of Sierra's
outstanding shares of Common Stock. The Warrant would include
a blocker provision, that may be waived by Gilead upon specified
notice, that prevents Gilead from exercising the warrant for a
number of shares that would result in Gilead owning more than 9.99%
of Sierra's issued and outstanding shares of Common Stock.
About Sierra Oncology
Sierra Oncology is a late stage
drug development company focused on advancing targeted therapeutics
for the treatment of patients with significant unmet medical needs
in hematology and oncology.
Momelotinib, Sierra's lead drug candidate, is a potent,
selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor
with a differentiated therapeutic profile in myelofibrosis
encompassing robust constitutional symptom improvements, a range of
meaningful anemia benefits, including eliminating or reducing the
need for frequent blood transfusions, and comparable spleen control
to ruxolitinib. More than 1,200 subjects have received momelotinib
since clinical studies began in 2009, including more than 800
patients treated for myelofibrosis. Sierra plans to launch the
MOMENTUM Phase 3 clinical trial in the fourth quarter of 2019 to
support potential registration of momelotinib on a global basis.
Momelotinib is wholly owned by Sierra Oncology and is covered by
patents anticipated to provide potential exclusivity to 2040 in
the United States and Europe (including Patent Term Extension or
Supplementary Protection Certificate).
Sierra is also developing a portfolio of DNA Damage Response
(DDR) assets, consisting of SRA737 and SRA141, and is conducting a
campaign intended to seek non-dilutive strategic options to support
their further advancement. SRA737 is a potent, highly selective,
orally bioavailable small molecule inhibitor of Checkpoint kinase 1
(Chk1), a key regulator of cell cycle progression and the DDR, and
has demonstrated preliminary clinical efficacy. SRA141 is a potent,
selective, orally bioavailable small molecule inhibitor of Cell
division cycle 7 kinase (Cdc7) with a potential novel mechanism of
cytotoxicity, and has successfully completed the IND process with
the FDA enabling the commencement of clinical trials.
Sierra Oncology retains the global commercialization rights to
momelotinib, SRA737 and SRA141. For more information, please visit
www.sierraoncology.com.
Cautionary Note on Forward-Looking Statements
This
press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including, but not limited to,
statements regarding the effectiveness of the amendments to the
Asset Purchase Agreement, any qualified financing by Sierra
Oncology (including the timing and terms thereof), the issuance of
any shares or warrants to Gilead, Sierra Oncology's expectations
regarding the commercial success of momelotinib, the timing of the
initiation of MOMENTUM and potential benefits of Sierra Oncology's
product candidates. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. These statements are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to
differ materially from those described in the forward-looking
statements. Such forward-looking statements are subject to risks
and uncertainties, including, among others, the risk that Sierra
Oncology may be unable to successfully develop and commercialize
product candidates, product candidates may not demonstrate safety
and efficacy or otherwise produce positive results, Sierra Oncology
may experience delays in the preclinical and anticipated clinical
development of its product candidates, Sierra Oncology may be
unable to acquire additional assets to build a pipeline of
additional product candidates, Sierra Oncology's third-party
manufacturers may cause its supply of materials to become limited
or interrupted or fail to be of satisfactory quantity or quality,
Sierra Oncology's cash resources may be insufficient to fund its
current operating plans and it may be unable to raise additional
capital when needed, Sierra Oncology may be unable to obtain and
enforce intellectual property protection for its technologies and
product candidates and the other factors described under the
heading "Risk Factors" set forth in Sierra Oncology's filings with
the Securities and Exchange Commission from time to time. Sierra
Oncology undertakes no obligation to update the forward-looking
statements contained herein or to reflect events or circumstances
occurring after the date hereof, other than as may be required by
applicable law.
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SOURCE Sierra Oncology