Urges Stockholders to Vote “FOR ALL” XenoPort
Director Nominees on WHITE Card Today
XenoPort, Inc. (Nasdaq:XNPT) today announced that it is mailing
a letter to stockholders in connection with the Company’s upcoming
Annual Meeting, which will be held on June 11, 2014.
Highlights of the letter include:
- XenoPort’s Board of Directors and
management team are executing a strategic plan that is
working;
- XenoPort has the right Board and team
in place to execute its strategy and deliver long-term value;
- Clinton’s thesis for XenoPort
demonstrates a fundamental misunderstanding of the biotech industry
and XenoPort’s assets; and
- If implemented, Clinton’s agenda could
negatively impact stockholder value.
The full text of the letter follows:
VOTE “FOR ALL”
OF THE XENOPORT NOMINEES ON THE WHITE
CARD TODAY
May 9, 2014
Dear Fellow XenoPort Stockholder:
You have an important choice to make at the upcoming Annual
Meeting of Stockholders on June 11, 2014.
We believe that XenoPort has the right Board, the right
leadership, and the right strategy to realize the full potential of
XenoPort’s assets and enhance stockholder value.
Therefore, we believe the right choice is for stockholders to
vote on the WHITE proxy card “FOR ALL” of XenoPort’s
director nominees: Ronald W. Barrett, Ph.D., Jeryl L. Hilleman and
Wendell Wierenga, Ph.D., “FOR” Proposals 2 through 4 and 9
through 14 and “AGAINST” Clinton Proposals 5 through 8.
Your vote is important. We encourage you to make your
voice heard by voting online, by telephone, or by signing and
dating the enclosed WHITE proxy card today.
We urge you not to return any gold proxy card – even as a
sign of protest – that is sent to you by Clinton Relational
Opportunity Master Fund, L.P. and its affiliates (“Clinton”).
YOUR BOARD OF DIRECTORS AND MANAGEMENT TEAM
ARE EXECUTING A STRATEGIC PLAN THAT IS WORKING
Recent results demonstrate that we are continuing to execute
successfully our strategic plan. We remain on track to optimize
XenoPort’s assets and while we are disappointed in the performance
of our stock price, we believe the actions we are taking will lead
to enhanced stockholder value.
We believe we continue to make meaningful progress on our
commercialization efforts for HORIZANT® (gabapentin
enacarbil) Extended-Release Tablets. As depicted in the graph
accompanying this press release, only 10 months after
re-introducing HORIZANT into selected markets, prescription trends
have surpassed the results of our previous partner with
substantially fewer resources.
Building on this momentum:
- Under XenoPort’s commercialization
efforts, the nationwide total of HORIZANT prescribed pills for the
first quarter of 2014 increased by 15%
over the fourth quarter of 2013 and increased by 25% compared to the first quarter of
2013. Total prescribed pills in territories where XenoPort is
promoting HORIZANT increased by 20%
for the first quarter of 2014 compared to the fourth quarter of
2013 and increased by 64% compared to
the first quarter of 2013. Promotional
efforts are driving results. In areas of the country where
XenoPort is not promoting HORIZANT, total prescribed pills for the
first quarter of 2014 increased by only 2% compared to the fourth
quarter of 2013 and decreased by 30% over the first quarter of
2013.
- Recently, we also
presented new data for gabapentin enacarbil, the active
ingredient in HORIZANT, at the Annual Scientific Meeting of the
American Pain Society (APS) and, separately, at the Annual Meeting
of the American Academy of Neurology (AAN). The data included new
post-hoc analyses of results from the gabapentin enacarbil clinical
trial program. The data included efficacy analysis in important
sub-populations of patients, the duration of efficacy throughout
the full day and head-to-head data comparing certain side effects
for HORIZANT with another product of the same drug class.
Given the growth trends for HORIZANT, the new data analyses that
support its benefit/risk profile, the positive feedback we continue
to receive from physicians who prescribe HORIZANT and the digital
direct-to-consumer campaign that has now resulted in 1.5 million
visits to the HORIZANT website, we believe we
are on the right track to realize the value of this asset for
XenoPort stockholders.
At the same time, your Board and management team are closely
monitoring the progress of our HORIZANT commercialization strategy.
We continue to engage in discussions with potential partners, and
we will adjust our plans as appropriate to ensure that we meet our
goal of maximizing HORIZANT’s value and its contribution to
increasing stockholder value.
Recent data on XP23829 reinforces our belief in its
potential. Your Board and management team are focused on
continuing to advance the development of XP23829 as quickly as is
appropriate and possible.
- At the AAN meeting in April, we
presented data including the results from a clinical trial
evaluating the safety, tolerability and pharmacokinetics of
XP23829. These data support the advancement
of this product candidate into Phase 2 development in
moderate-to-severe chronic plaque type psoriasis patients, a
program that we believe will ultimately guide selection of doses
for a potential Phase 3 program in moderate-to-severe chronic
plaque type psoriasis and/or relapsing forms of multiple sclerosis
(MS).
- We also submitted
an Investigational New Drug (IND) application to the U.S.
Food and Drug Administration (FDA) Division of Dermatology and
Dental Products for XP23829 as a potential treatment for
moderate-to-severe chronic plaque type psoriasis. Assuming
clearance of the IND, we plan to initiate a Phase 2 clinical trial
of XP23829 for this indication by mid-2014. Previous XP23829
clinical studies were conducted under an active IND with the FDA
Division of Neurology Products as a potential treatment for
relapsing forms of MS.
In addition, we continue to engage in discussions with potential
partners regarding the development and commercialization of
XP23829.
XENOPORT HAS THE RIGHT BOARD AND TEAM IN
PLACE TO EXECUTE ITS STRATEGY AND DELIVER LONG-TERM VALUE
Your Board is comprised of nine highly-qualified and proven
leaders, including eight independent directors and XenoPort’s Chief
Executive Officer, Ronald W. Barrett, Ph.D. Your directors are
active, engaged and focused on stockholder value.
XenoPort’s directors have experience in:
- Leading other biotechnology and
pharmaceutical companies, with several independent members of your
Board serving as Chief Executive Officer of other successful
biopharmaceutical companies;
- Biopharmaceutical operations, strategic
planning and oversight, research and product development,
manufacturing, regulatory, compliance, sales and marketing, risk
oversight, and quality;
- Investing in, partnering and growing
healthcare companies;
- Finance, auditing, accounting and
investment banking in the life sciences and healthcare industries;
and
- Developing fund raising and capital
allocation strategies, and in evaluating and setting compensation
and corporate governance policies and practices.
As detailed in our previous letter to you, your Board’s
broad-based and relevant expertise is reflected in the Company’s
nominees for election:
- Dr. Barrett has more than 20
years of executive management experience in the pharmaceutical
industry. As a founder and the Chief Executive Officer of the
Company, Dr. Barrett’s leadership and strategic direction have led
to XenoPort’s discovery and development of numerous novel product
candidates, including XP23829, and have enabled XenoPort to evolve
from a pure research-based company to an integrated pharmaceutical
company with development and commercialization capabilities.
- Ms. Hilleman, Chair of
XenoPort’s Audit Committee, has over 30 years of finance, marketing
and investment expertise and an impressive history of executive
leadership with over 20 years of service as Chief Financial Officer
of both private and public companies. As a result of this work, as
well as her support on XenoPort’s ongoing accounting and financial
compliance needs, Ms. Hilleman possesses important knowledge of
XenoPort’s financials that we believe no replacement as Audit Chair
could provide.
- Dr. Wierenga brings over 40
years of successful leadership of pharmaceutical and
biopharmaceutical companies, including executive leadership of
pharmaceutical research, clinical development and regulatory
functions for national and multi-national corporations, as well as
past and current service on the Boards for several successful
publicly-traded biopharmaceutical companies. As a member of
XenoPort’s Board, he has substantial experience with the
development of the Company’s long-term strategies that have led to
the XP23829 development program as well as to the commercialization
of HORIZANT.
CLINTON’S THESIS FOR XENOPORT DEMONSTRATES A
FUNDAMENTAL MISUNDERSTANDING OF THE BIOTECH INDUSTRY AND XENOPORT’S
ASSETS
IF IMPLEMENTED, CLINTON’S AGENDA COULD
NEGATIVELY IMPACT STOCKHOLDER VALUE
Clinton has made misleading and unsubstantiated claims
regarding XP23829, including wrongly touting that a simple increase
in funding will accelerate its development and regulatory
approval. Drug development is a step-wise and regulated process
that requires much more than an ability to write a check. The
aggregate investment in product candidates is a function of the
stage of development of the product candidates.
More than simple investment, moving
successfully through the drug development and regulatory review
process also requires experience and technical expertise, and in
this regard, your Board has a proven record of success. For
example:
- Dr. Barrett was an instrumental
contributor to the FDA approval of HORIZANT and directed the recent
re-acquisition and commercial re-launch of this product.
- Dr. Wierenga has participated in the
submission of over 70 Investigational New Drug applications and in
the filing of 16 New Drug Applications/Biologics License
Applications, which have led to the launch of 16 FDA-approved drug
products including LIPITOR, NEURONTIN and most recently
UCERIS.
It is disingenuous for Clinton to assert that XenoPort has
had no significant commercial success since its initial public
offering in 2005.
- Clinical development is an inherently
challenging and risky endeavor. The Dimasi study1 reports that
there is only a 13% likelihood that a small molecule drug candidate
that enters clinical development will ever be approved.
- XenoPort has received FDA approval for
HORIZANT for two indications, and is achieving positive sales
trends since the commercialization rights were reacquired just 10
months ago.
Clinton’s claim that HORIZANT has no proven differentiation
in the market is wrong and ignores FDA prescribing information,
published studies and treatment guidelines.
- The low dose, dosing frequency,
titration schedule and pharmacokinetics of HORIZANT are clearly
different from other products in the same class. The prescribing
information of HORIZANT clearly states that it is not
interchangeable with other gabapentin products because of differing
pharmacokinetic profiles.
- There are two publications that report
the results of clinical trials in patients who were switched from
gabapentin to HORIZANT, and at the recent AAN meeting, clinical
trial data was presented comparing certain side effects of HORIZANT
with another product in the same class.
- HORIZANT has been included in new
treatment guidelines from well-respected organizations. These
guidelines include analyses of level of evidence and make specific
recommendations for the choice of drug therapy for patients.
We encourage you to review HORIZANT’s FDA approved prescribing
information, HORIZANT clinical trial publications and published
treatment guidelines. Clinton’s assertion that HORIZANT has no
proven differentiation is not supported by the information and
facts in these sources.
Clinton’s agenda could negatively impact your company and
stockholder value. We believe that replacing your directors
with Clinton’s nominees would remove expertise and experience that
is critical to the continued execution of the Company’s strategic
plans.
Based on Clinton’s public statements, we are also concerned that
if Clinton’s nominees are elected, they may pursue Clinton’s agenda
of immediately discontinuing the commercialization of HORIZANT.
Particularly given the progress we are seeing with the
commercialization of HORIZANT, we believe Clinton’s decision to
stop these efforts would be contrary to the interests of all
XenoPort stockholders and may short circuit XenoPort’s ability to
maximize the overall potential of this asset.
PROTECT YOUR INVESTMENT - VOTE THE
WHITE PROXY CARD TODAY.
We are confident your Board has the skills and expertise
necessary to oversee the continued execution of XenoPort’s
strategic plans, realize the full potential of XenoPort’s assets,
and enhance stockholder value.
We urge you to protect your investment by voting the enclosed
WHITE proxy card today “FOR ALL” of XenoPort’s
nominees: Ronald W. Barrett, Ph.D., Jeryl L. Hilleman and Wendell
Wierenga, Ph.D., “FOR” Proposals 2 through 4 and 9 through
14 and “AGAINST” Clinton Proposals 5 through 8.
On behalf of your Board of Directors and management team, we
thank you for your continued support.
Sincerely,
/s/ Ronald W. Barrett
/s/ John G. Freund
Ronald W. Barrett, Ph.D.Chief Executive Officer John G.
Freund, M.D.Lead Independent Director
Forward-Looking
Statements
This communication contains “forward-looking” statements,
including, without limitation, all statements related to the
potential value of XenoPort’s assets and XenoPort’s ability to
achieve its goal of enhancing stockholder value through the
execution of its strategic plan, including all statements related
to the commercial and value opportunity for HORIZANT and the
suitability of XP23829 as a potential treatment for psoriasis or
relapsing forms of MS; XenoPort’s ability to build value in
HORIZANT through, and the potential of, its targeted educational
efforts; XenoPort’s current strategy for advancing the XP23829
clinical development program, including the initiation or conduct
of planned or potential future clinical trials and the timing
thereof, including XenoPort’s expectations with respect to a
potential Phase 3 development program for XP23829; potential
partnering efforts for XP23829 and/or HORIZANT; and other
statements that are not historical facts. Any statements contained
in this press release that are not statements of historical fact
may be deemed to be forward-looking statements. Words such as
“believe,” “could,” “hope,” “may,” “plan,” “potential,” “will,”
“would” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon XenoPort’s current expectations. Forward-looking
statements involve risks and uncertainties. XenoPort’s actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation: risks
related to XenoPort’s lack of commercialization experience and its
ability to successfully market and sell HORIZANT, including
XenoPort’s ability to maintain sales, marketing, distribution,
supply chain and other sufficient capabilities to sell HORIZANT;
XenoPort’s dependence on the success of its strategies for HORIZANT
commercialization, promotion and distribution, as well as its
ability to successfully execute on these activities and to comply
with applicable laws, regulations and regulatory requirements; the
competitive environment for and the degree of market acceptance of
HORIZANT; obtaining appropriate pricing and reimbursement for
HORIZANT in an increasingly challenging environment; the difficulty
and uncertainty of pharmaceutical product development and the
uncertain results and timing of clinical trials and other studies,
including the risk that success in preclinical testing and early
clinical trials does not ensure that later clinical trials will be
successful; XenoPort’s ability to successfully advance XP23829
development and to conduct or initiate clinical trials in the
anticipated timeframes, or at all; the uncertainty of the FDA’s
review process and other regulatory requirements, including the
risk that FDA action, including with respect to the investigational
new drug application for XP23829, would delay or prevent the
initiation of future clinical trials of XP23829; XenoPort’s need
for and the availability of resources to develop XP23829 and to
support XenoPort’s operations; XenoPort’s dependence on future
collaborative partners; the uncertain therapeutic and commercial
value of HORIZANT and XP23829; as well as risks related to future
opportunities and plans, including the uncertainty of future
operating results. These and other risk factors are discussed under
the heading “Risk Factors” in XenoPort’s Annual Report on Form 10-K
for the year ended December 31, 2013, filed with the Securities and
Exchange Commission on February 28, 2014 and its future filings and
reports, including its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2014. XenoPort expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in the Company’s expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statements are based.
If you have any questions, require
assistance with voting your WHITE proxy card or need additional
copies of the proxy materials, please contact:
MACKENZIE PARTNERS, INC.
105 Madison Avenue
New York, NY 10016
proxy@mackenziepartners.com
(212) 929-5500 (Call Collect)
Or
TOLL-FREE (800) 322-2885
Important Additional Information and Where to Find It
XenoPort, Inc., its directors and certain of its executive
officers may be deemed to be participants in the solicitation of
proxies from stockholders in connection with XenoPort’s 2014 Annual
Meeting of Stockholders. XenoPort has filed with the SEC and
provided to its stockholders a definitive proxy statement and a
WHITE proxy card in connection with such solicitation.
XENOPORT STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE PROXY
STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) AND THE
ACCOMPANYING WHITE PROXY CARD, AND ANY OTHER RELEVANT
DOCUMENTS WHEN THEY BECOME AVAILABLE, BECAUSE THEY CONTAIN
IMPORTANT INFORMATION.
Information regarding the names of XenoPort’s directors and
executive officers and their respective interests in XenoPort by
security holdings or otherwise is set forth in XenoPort’s
definitive proxy statement for the 2014 Annual Meeting of
Stockholders, filed with the SEC on April 22, 2014, including
Appendix B thereto.
The definitive proxy statement (and amendments or supplements
thereto) and the accompanying WHITE proxy card, and any
other relevant documents and other material filed by XenoPort with
the SEC, are or will be available for no charge at the SEC’s
website at www.sec.gov and at XenoPort’s investor relations website
at http://investor.xenoport.com/index.cfm. Copies may also be
obtained free of charge by contacting XenoPort Investor Relations
by mail at 3410 Central Expressway, Santa Clara, California 95051
or by telephone at (408) 616-7200.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on
developing and commercializing a portfolio of internally discovered
product candidates for the potential treatment of neurological
disorders. XenoPort is currently commercializing HORIZANT in the
United States and developing its novel fumaric acid ester product
candidate, XP23829, as a potential treatment for psoriasis and
relapsing forms of MS. REGNITE® (gabapentin enacarbil)
Extended-Release Tablets is being marketed in Japan by Astellas
Pharma Inc. XenoPort's pipeline of product candidates also includes
potential treatments for patients with spasticity related to spinal
cord injury and Parkinson's disease. To learn more about XenoPort,
please visit the Web site at www.XenoPort.com.
HORIZANT, REGNITE and XENOPORT are registered trademarks of
XenoPort, Inc.
1 Dimasi et al., Clinical Pharmacology & Therapeutics 87,
272-277 (March 2010)
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20140509005163/en/
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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