GLEN ALLEN, Va., Nov. 7, 2013 /PRNewswire/ -- Star
Scientific, Inc. (NASDAQ: STSI) today announced that the Company
has filed its preliminary proxy statement on Form 14A with the
Securities and Exchange Commission in preparation for its
December 27 annual shareholder
meeting. The proxy statement outlines the Company's plan to
accelerate the submission of an Investigational New Drug (IND)
application to the FDA, with the assistance of a respected global
contract research organization (CRO). The Company intends to
continue the expansion of its dietary supplement business as well,
including the addition of a time-release version of its Anatabloc®
dietary supplement. The proxy statement proposes a
shareholder vote for a transition in leadership in connection with
this dual-track business plan.
(Logo:
http://photos.prnewswire.com/prnh/20130319/PH79245LOGO)
The Company believes it has reached a point of inflection
following a management and board review of the progress of research
on forms of anatabine, for which the Company holds several patents
and has patents pending. The Company's Chairman and the Chief
Executive Officer both recommended to the Board that significant
leadership changes are needed to better leverage opportunities in
pharmaceutical development and FDA approval in the biotechnology
space. The Company intends, following the leadership
transition, to accelerate plans for submission of an IND to the FDA
and, with FDA guidance, to undertake appropriate Phase I/II
clinical trials.
The proposed transition process, outlined in the proxy statement
for a vote by the Company's shareholders, centers on the election
of five new board members and one current director. Two of
the proposed directors would then assume senior leadership
positions with the Company. The remaining existing board
members, who nominated the new board candidates and unanimously
support their election, will not stand for re-election. As
proposed in the proxy, Michael J.
Mullan, MBBS (MD), PhD, who currently is CEO of the Roskamp
Institute and Archer Pharmaceuticals, Inc., would serve as the
Company's new Chief Executive Officer; it is anticipated that he
also would be elected to serve as Chair of the Company's new board.
Dr. Mullan would withdraw from the day-to-day operations of
both Roskamp and Archer if elected by the board. Prior to
relocating to Florida, Dr. Mullan
resided in London, England, where
he was a part of the team to identify the first-known genetic cause
of Alzheimer's disease. Dr. Mullan has almost 30 years
of experience in the development of biotechnology and intellectual
property, and has authored or co-authored more than 200 articles on
an array of medical topics. He also has worked with the
Company's anatabine compound for more than three years as part of
the Company's research collaboration with the Roskamp
Institute.
Christopher C. Chapman, MD,
currently an independent director, would serve as President, and
would be a management member of the new board. The Company believes
that Dr. Chapman's prior experience, including his role as the
Medical Director of Quintiles Transnational (NYSE: Q), from
1996-2001, makes him uniquely qualified to oversee the development
of the Company's novel anatabine compound. Dr. Chapman also
managed clinical trials for autoimmune diseases at Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN). During Dr. Chapman's
tenure as medical director at both Quintiles and Regeneron, he and
his medical teams were involved at various stages of clinical
development with more than 15 products that met the requirements
for regulatory approval. Dr. Chapman is the founder and
Chairman of Chapman Pharmaceuticals Consulting, which currently
manages the clinical development of several products for major
pharmaceutical and biotech companies in the United States.
The Company believes that Dr. Mullan and Dr. Chapman each bring
extensive experience to the Company in the commercial aspects of
pharmaceutical product development, approval and marketing, as well
as in clinical research.
Drs. Mullan and Chapman would assume their responsibilities if
the slate of new board members is elected. At that time,
Jonnie R. Williams and Paul L. Perito, Esq. would resign their current
senior executive positions and board memberships. Mr. Williams, the
Company's founder and current Chief Executive Officer, who has been
instrumental in the development of the Company's anatabine patent
portfolio and products, would serve for one year as a non-executive
employee while working with current patent applications, new
supplement product development, and advising on business
development issues. Mr. Perito, who has served since 2000 as
the Company's President and Chief Operating Officer, as well as
board chair, would assume the role of Vice President & Senior
Counsel, Legal and Regulatory Affairs, for one year. Mr. Perito
would oversee all third-party litigation and generally would be
available to provide advice during the transition period on all
germane matters when requested by Dr. Mullan and/or Dr.
Chapman.
Mr. Perito commented, "The impressive progress in research with
anatabine has formed the basis of our belief that a two-track
business plan – with greater emphasis on development and approval
of a pharmaceutical product in addition to our current dietary
supplement product program – represents both our shareholders' best
interests and the potential for enhanced shareholder
value. We also believe, however, that these next steps
require leadership with in-depth knowledge of pharmaceutical
development and approval. Dr. Mullan and Dr. Chapman bring
the combination of expertise and experience that we have sought,
and which herald an exciting future for the Company." Mr.
Williams added, "We are proud of the successes we have had in
identifying and developing truly innovative processes and products
that can make a difference in people's lives. Our anatabine
compound is now well-positioned to help millions of people.
It is time to further leverage these successes, and I have great
respect for the skills and experience that Mike Mullan and Chris
Chapman will bring to lead the Company to the next level."
In addition to the election of new board members and subsequent
leadership transition, shareholders will be asked to approve
changing the parent Company's name to Rock Creek Pharmaceuticals
Inc., to more clearly align the Company's dual-track business plan
and mission as it moves forward.
The candidates who will stand for election to the Company's
board, in addition to Drs. Mullan and Chapman, are:
- Benjamin M. Dent, CEO of the
Dent Consulting Group LLC and an adjunct professor with the
St. Louis University graduate program
in Entrepreneurial Management. Mr. Dent previously has served
in senior financial management positions with several
public and private companies, and also has served as a management
consultant to Lehman Brothers Investment Management Portfolio
Company;
- Scott P. Sensenbrenner, who has
executive experience in the areas of nutraceutical marketing,
supply chain, operations and financial management in the natural
products industry. Mr. Sensenbrenner is President and CEO of
Enzymedica, Inc., a market leader in the area of enzymes
supplementation, a position he has held since 2009. He
previously has overseen sales and marketing programs in public and
private companies, including in his role as Group Director,
Nutrition Division with Perrigo, Inc. (NYSE: PRGO);
- Naomi Whittel founder and CEO of
Reserveage™ Organics and its parent, Organic Holdings, Inc.
Reserveage™ Organics was named to Inc. Magazine's 2013 list of Top
500 Fastest Growing Companies. Ms. Whittel has overseen the
growth of sales of her company's products since its inception,
which now are sold in more than 10,000 stores – including Vitamin
Shoppe and GNC – and in 40 countries;
- Thomas L. Wilson, who served as
President of Southern Commerce Bank from 1988 to 2010, and chaired
its board from 1988 to 2006. Mr. Wilson has more than thirty
years of experience in the banking industry and currently heads his
own firm, which provides consulting services in business planning,
bank financing and private equity fundraising.
The leadership transition plan mandated the selection of a later
date for the shareholder meeting in December. Dr. Mullan
commented, "If the proposed new leadership team is elected by the
shareholders, we will plan to hold an investor conference during
first quarter 2014 in Sarasota,
Florida to introduce new management to existing shareholders
and/or individuals interested in the worthy mission of the
Company."
Certain statements contained in this release constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to statements identified by words such as
"believes," "expects," "anticipates," "estimates," "intends,"
"plans," "targets," "projects" and similar expressions. The
statements in this release are based upon the current beliefs and
expectations of our company's management and are subject to
significant risks and uncertainties. Actual results may differ from
those set forth in the forward-looking statements. Numerous factors
could cause or contribute to such differences, including, but not
limited to, results of clinical trials and/or other studies, the
challenges inherent in new product development initiatives,
including the continued development and market acceptance of our
nutraceutical dietary supplements products, the effect of any
competitive products, our ability to license and protect our
intellectual property, our ability to raise additional capital in
the future that is necessary to maintain our business, changes in
government policy and/or regulation, potential litigation by or
against us, any governmental review of our products or practices
and the outcome of the ongoing investigations as well as other
risks discussed from time to time in our filings with the
Securities and Exchange Commission, including, without limitation,
our annual report on Form 10-K for the fiscal year ended
December 31, 2012 and our quarterly
reports on Form 10-Q for the quarters ended March 31, 2013 and June
30, 2013. We undertake no duty to update any forward-looking
statement or any information contained in this press release or in
other public disclosures at any time.
About Star Scientific
Star Scientific, Inc. is a technology-oriented company with a
mission to promote maintenance of a healthy metabolism and
lifestyle. Through its wholly owned subsidiary, Rock Creek
Pharmaceuticals, Star Scientific has been engaged in the
manufacturing, sale, and marketing of two nutraceutical dietary
supplements, cosmetic products, and the development of other
nutraceuticals and pharmaceuticals. The company also continues to
pursue the licensing of the technology behind its proprietary
StarCured® curing process and its related products. Rock Creek
Pharmaceuticals has scientific and research offices in Gloucester, MA, and a regulatory office in
Washington, DC. Star Scientific
has a Corporate and Sales Office in Glen
Allen, VA, and an Executive, Scientific & Regulatory
Affairs office in Washington,
DC.
Contact:
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(202)887-5100
ttuck@starscientific.com
SOURCE Star Scientific, Inc.