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Star Scientific , Inc. Announces Leadership Transition, Acceleration of Plans for Submission of an IND to FDA for Pharmaceutical Version of Anatabine Compound


11/8/2013 9:50:29 AM

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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.



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