Significant Milestones Achieved, but SBI’s
Actions Put Business Momentum at Risk
Head of Biology Resigns, Effective May 1,
2015, Resulting in Loss of Core Research Competency
Acucela Inc. (TOKYO:4589), a clinical-stage biotechnology
company that specializes in discovering and developing novel drug
candidates to potentially treat and slow the progression of
sight-threatening ophthalmic diseases, today announced that it has
made significant progress on the three strategic imperatives
previously announced in its 2014 Annual Report to Shareholders to
increase the value of the Company and enhance shareholder return:
maximizing the value of emixustat, advancing research, and pursuing
business development opportunities to grow the Company’s pipeline.
The progress on each of these three imperatives is detailed
below.
- Maximizing the potential value of
emixustat hydrochloride, Acucela’s lead investigational visual
cycle modulation (VCM) product candidate
- The Phase 2b/3 clinical trial for
emixustat is continuing on schedule, and the Company looks forward
to announcing top-line results in mid-2016.
- The Company has made significant
progress in maximizing the commercial potential of emixustat in
markets outside the United States.
- Re-investing in/re-invigorating our
internal research and development efforts
- Acucela is on track to complete its
preclinical animal model studies in 2015 to evaluate emixustat’s
potential in diabetic retinopathy.
- Pursuing business development
opportunities to build the pipeline
- Acucela has at least two active
potential partnerships that could be concluded in 2015, with
several more in the pipeline at various stages of due
diligence.
Brian O’Callaghan, President and CEO, said, “Acucela has strong
cash reserves and continues to strengthen its patent portfolio and
develop its business partnerships. We are proud of what Acucela and
its employees have accomplished and the momentum coming out of the
first quarter of 2015. We hope that all directors will work to keep
this momentum going as we move into the second quarter and
beyond.”
Mr. O’Callaghan continued, “Our objective is to build a highly
integrated, successful, and sustainable biotechnology company based
on the development of an innovative portfolio of ophthalmology
products, designed to serve numerous indications of underserved or
unmet medical need. We wish to achieve this objective by working
closely with our collaborator on our lead program, Otsuka
Pharmaceutical, with whom we have a strong working relationship;
advancing our own internal research and development efforts,
including leveraging our expertise in visual cycle modulation; and
building external partnerships through business development
activities.”
The Company also announced today that its current head of
biology resigned his position, effective May 1, 2015. The Company
has now lost its core research competency and a core member of its
business development team. Further, Acucela’s efforts to hire a
Chief Scientific Officer have been and currently are underway, but
the ongoing situation involving the pending replacement of the
existing board and CEO are negatively impacting these efforts.
As previously disclosed, on January 28, 2015 Acucela received a
letter (the “Letter”) from SBI Holdings, Inc., the parent
corporation of several Acucela shareholders (collectively, “SBI”),
demanding that Acucela hold a special meeting of its shareholders
for the purposes of removing Acucela’s current Board members, other
than Dr. Ryo Kubota, and electing a slate of four directors
identified in the Letter to fill the resulting vacancies. In the
Letter, SBI announced that it had entered into a voting agreement
and had given an irrevocable proxy to Dr. Kubota, expiring on July
28, 2015, to vote SBI’s shares at any shareholders’ meeting,
thereby giving Dr. Kubota unilateral control over more than 50% of
the shares eligible to vote. SBI has also made clear in other
communications with the Company that if SBI is successful in
reconstituting the Board, it plans to reinstate Dr. Kubota as
Acucela’s CEO.
As previously disclosed, Acucela will hold a special
shareholders’ meeting on May 1, 2015, at the Company’s headquarters
in Seattle, Washington. The purpose of the special shareholders’
meeting will be to vote on the shareholder proposals described in
SBI’s January 28, 2015 demand Letter. Acucela will recommend voting
against the proposal to remove the existing directors because the
Company believes that continuing with existing leadership would be
in the best interest of Acucela and its shareholders.
Acucela’s three independent board members, Peter Kresel, Glen
Sato, and Michael Schutzler, added the following statement in
support of the Company’s current strategy and management team:
As Board members, it is our fiduciary
responsibility to act in the interest of all shareholders. The
Company is currently on the right track, as evidenced by the
significant progress achieved by Mr. O’Callaghan, the members of
the management team, and the employees of Acucela.
Please be aware that the strategy currently
in place and the momentum that has been generated, as well as the
current initiatives currently underway across all aspects of the
business, could be jeopardized by a change in the management team.
A change at this critical time risks damaging shareholder value and
the Company’s ability to reach its full potential. We are already
witnessing the departure of several people in the face of the
potential change in the board and CEO.
As the current board of Acucela, we remain
dedicated to building the long-term value of the Company and
maintaining the momentum coming out of the first quarter of
2015.
Mr. O’Callaghan continued, “I am proud to be Acucela’s CEO. As I
communicated late last year upon my appointment, I remain dedicated
to executing on value-building initiatives to enhance shareholder
return, attract top talent at all levels of the organization, and
grow our pipeline and commercial opportunities.”
About Acucela Inc.
Acucela Inc. (www.acucela.com or www.acucela.jp) is a
clinical-stage biotechnology company that specializes in
discovering and developing novel drug candidates to potentially
treat and slow the progression of sight-threatening ophthalmic
diseases impacting millions of individuals worldwide. Acucela
currently has the following candidates in development in
collaboration with Otsuka Pharmaceutical Co., Ltd.: emixustat
hydrochloride for GA associated with dry AMD based on Acucela’s
proprietary visual cycle modulation technology; and OPA-6566 for
ocular hypertension and glaucoma.
Additional Information and Where to Find It
This release may be deemed to be solicitation material in
respect of a proxy contest for the election of directors to the
Board of Directors of Acucela. Acucela has filed an information
statement with the Securities and Exchange Commission (“SEC”).
INVESTORS AND SECURITYHOLDERS ARE URGED TO READ THE INFORMATION
STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE
FILED WITH THE SEC AND TSE WHEN THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders
will be able to receive the information statement and other
relevant documents free of charge at the SEC’s web site at
www.sec.gov; TSE disclosure at
https://www.release.tdnet.info/index.html; or from Acucela Investor
Relations at 1301 Second Avenue, Suite 4200, Seattle, Washington
98101-3805, and http://ir.acucela.com/ or
http://ir.acucela.jp/.
Participants in Solicitation
Acucela and its directors and executive officers and other
members of management and employees may be deemed to be
participants in the solicitation of proxies in respect of a proxy
contest for the election of directors to the Board of Directors of
Acucela.
Acucela Inc.Francesca T. NolanDirector Corporate
CommunicationsPhone: 1-206-805-8300Email:
fnolan@acucela.comorTomomi SukagawaDirector Investor Relations and
CommunicationPhone: +81(0)3.5789.5872Email:
investor@acucela.comorThe Abernathy MacGregor Group, Inc.Michael
Pascale or Kendell MoorePhone: 1-212-371-5999