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Monthly Archives: April 2011

The May 2011 issue of the Journal of Commercial Biotechnology is now available. The links below will take you to the abstract for each paper:

Volume 17, Issue 2

Editorial

Building biotechnology in OkinawaPDF
Yali Friedman

Commentary

Startup America: What it includes and opportunities for innovatorsPDF
David B Orange
Singapore – Home base for expansion in AsiaPDF
Kian-Teik Beh
Traditional ecological knowledge: Impact on commercial healthPDF
Mohammadali Khalvati, Ikway (Yvonne Fulton) Michine, Wabiska (Zane Bell) Mukwa, Mary Jane Metatawabin

Articles

The growing importance of incorporating US payers into biotechnology drug development decision-makingPDF
Sarah Collins
Anticipating opportunities in industrial biotechnology: Sizing the market and growth scenariosPDF
Peter J Nieuwenhuizen, David Lyon
Founding angels as early stage investment model to foster biotechnology start-upsPDF
Gunter Festel
The economic potential of plant-made pharmaceuticals in the manufacture of biologic pharmaceuticalsPDF
James Kaufman, Nicholas Kalaitzandonakes

From the Classroom

Developing graduate skills for the United Kingdom’s commercial life science sector: Experiences from the ORBIS internship programmePDF
James Gazzard

Legal and Regulatory Updates

EU Legal and Regulatory UpdatePDF
Gerry Kamstra
Impact of recent IP caselaw on biomarkers and personalized medicinePDF
David A Gass
Licensing issues in today’s bankruptcy worldPDF
Michael Schein, Brandon J Fleischman
Limitation of gene patents to functioning DNAPDF
Philip Webber

Book Reviews

Chronicling the development of myozyme: The Cure and Chasing MiraclesPDF
Derek J Francis
Anatomy of a Patent CasePDF
Michael G Sullivan

This is a guest post by Jurgita Ashley

You are a small company ready to take a leap into the public market, whether it is for growth, liquidity or to attract greater investor interest. But, oh man, those dollar figures for IPOs would make anyone’s head spin. But wait, don’t discount it yet as a viable alternative. If done right, going public does not have to cost a fortune. Small companies can take advantage of the SEC’s relaxed reporting regime, may strategically decide to list on the Bulletin Board (the OTCBB) rather than the NYSE or NASDAQ, and can significantly limit their corporate governance-related expenses.

Your first major—and unavoidable—expense will be the preparation of a registration statement. Inevitably, it will require management’s time, preparation of audited financials and legal fees. You do not have to be charged, however, $1,000 per hour or other exorbitant fees, and your IPO team does not have to include 50 professionals. If you are a “smaller reporting company,” which is a company with a public non-affiliate common equity float of less than $75 million (or annual revenue of less than $50 million if the float cannot be calculated), your reporting requirements will be limited. Your registration statement – whether it is on a Form S-1 (involving an immediate capital raise) or a Form 10 (initial registration with the SEC to position the company for a subsequent capital raise) – will include less financial information and disclosures than is required for larger companies. In addition, this first registration statement is the “meat and bones,” so your subsequent filings will build upon this information and will involve much less drafting from scratch. This first registration statement will most likely be reviewed by the SEC, which will issue comments requiring one or more amendments. This review, however, will most likely be limited. With the Dodd-Frank and other legislative initiatives and demands on the SEC’s resources, the days of 100 plus comments are largely over. As long as your accounting is in order and your legal advice is good, you should be able to maneuver through the SEC’s comment process without excessive delays or expense.

Now, let’s say your primary goal is to obtain greater investor interest in the company and to create an avenue to sell stock. To achieve this, it is not necessary to pay the NYSE’s or NASDAQ’s listing fees or to become subject to their reporting and governance requirements. Although the OTCBB is usually not the market of first choice, it can be an effective vehicle to provide some liquidity and disseminate information about the company. To list on the OTCBB, a company only needs a market maker and to file reports with the SEC. By listing on the OTCBB, the company becomes subject to the oversight of FINRA, but there are no listing fees, no additional reporting requirements, and no special governance requirements. In addition, if down the road you are ready to transition to the NYSE or the NASDAQ, your platform will already be in place.

As a company that is listed on the OTCBB only, you are subject to limited corporate governance requirements (imposed by the SEC). Yes, some of your directors should be independent, committees should operate under board-approved charters and the company should have a code of ethics and reasonable internal controls, but all of these policies and procedures need not become all consuming. There is no need for a small company with limited financial resources to adopt all the latest “best practices” in governance or add a whole department to address the company’s new reporting obligations. Pursuant to recent SEC relief, “smaller reporting companies” also do not need to obtain—and pay for—an auditor’s report on internal control over financial reporting. Reasonable disclosure controls and procedures are important and, in some instances, improving the company’s policies and procedures is desirable and appropriate. In many cases, however, most new obligations of a small public company can be satisfied without exorbitant expense.

Nearly 50 percent of all public companies in the United States are “smaller reporting companies.”(1) Of course, not every small private company will find it desirable to go public, and for some, a full-blown—and expensive—IPO is an appropriate option. The perceived costs, however, should not discourage other companies from evaluating the option of a lower cost IPO. Access to the public markets is no longer insurmountable.

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Jurgita Ashley is an attorney in the Cleveland, Ohio office of Thompson Hine LLP and is a member of its Corporate Transactions and Securities practice group. Her practice is focused on public company matters, primarily securities law, corporate governance and takeover matters. She can be reached at  Jurgita.Ashley@ThompsonHine.com or through www.ThompsonHine.com. The views expressed in this article are attributable to the author and do not necessarily reflect the views of Thompson Hine LLP or its clients. The author would like to thank Derek D. Bork, a partner at Thompson Hine LLP, for his review and invaluable input on this article.

(1) Forty-eight percent of all U.S. companies filing annual reports on Form 10-K with the SEC were “smaller reporting companies” for the period from October 1, 2009 through September 30, 2010, which is the SEC’s latest fiscal year for which data is available. Proxy Disclosure Blog by Mark Borges at CompensationStandards.com (December 3, 2010), available at www.compensationstandards.com.

Today, the Biotechnology Industry Organization (BIO) announced a distinguished panel of judges who will evaluate nominations for the third annual Biotech Humanitarian Award and select the 2011 Honoree.  BIO created the Award to recognize an everyday hero who has helped to heal, fuel and feed the planet through their work in or support of biotechnology.  Nominations for the Award will be accepted online through the April 15, 2011 deadline.

“The Biotech Humanitarian Award is an important way that we can recognize a true innovator, who is leading and pushing the field of biotechnology to solve the world’s most pressing challenges and improve our everyday lives,” said BIO President and CEO Jim Greenwood.  “I look forward to working with this distinguished panel of judges on the challenge of selecting just one honoree from an impressive group.”

The following thought leaders in science, advocacy and media have agreed to serve as judges for the Award:

·        Dr. David Agus – Professor of Medicine, Director, USC Center for Applied Molecular Medicine, Director, USC Westside Cancer Center, University of Southern California Keck School of Medicine

·        Dr. Yali Friedman – Managing Editor of the Journal of Commercial Biotechnology, author of Building Biotechnology and blogger at Biotech Blog

·        Jim Greenwood – President and CEO, Biotechnology Industry Organization

·        Dr. Lovell Jones – Director, Center for Research on Minority Health, University of Texas-MD Anderson Cancer Center and Founding Co-chair, Intercultural Cancer Council

·        Rachel King – Chief Executive Officer and Founder, GlycoMimetics Inc.

·        Robert Klein – Chairman, California Institute of Regenerative Medicine and 2010 Biotech Humanitarian Award Honoree

·        Dr. Antonio Moreira – Vice Provost for Academic Affairs, University of Maryland Baltimore County

·        David Rejeski – Director, Project on Emerging Nanotechnologies at the Woodrow Wilson Center

·        Dr. Stephen Sherwin – Co-founder and Chairman, Ceregene, Inc. and Chairman of the Board, Biotechnology Industry Organization

·        Dr. Ellen Sigal – Chair and Founder, Friends of Cancer Research

·        H. Thomas Watkins – President and Chief Executive Officer, Human Genome Sciences

“Since its inception in 2009, the Biotech Humanitarian Award has honored two exemplary individuals, Dr. Jay Keasling and Robert Klein, who are leading ground-breaking initiatives in biotechnology to heal, fuel and feed the planet.  They have set an extremely high standard for the Award and I look forward to working with this well-regarded group of experts to select an Honoree who demonstrates a similarly exemplary dedication to furthering the positive impact of biotech on society,” said Stephen A. Sherwin,M.D., BIO Board Chairman.

Klein, who was honored in 2010, for authoring and serving as the Chairman of California’s Proposition 71, the $6 billion “California Stem Cell Research and Cures” ballot initiative, joins this year’s panel of judges for the Biotech Humanitarian Award.  Klein’s work supports research with a focus on pluripotent (embryonic) and progenitor stem cell research.

The Biotech Humanitarian Award and the $10,000 prize will be bestowed on the Honoree during the 2011 BIO International Convention, in Washington, DC on June 27-30, 2011.

Nominations can be made until 11:59 pm Eastern on April 15, 2011 via http://biotech-now.org/humanitarian-award-nomination.

Drug Patent Expirations in April 2011

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent Number Patent Expiration
AROMASINPharmacia And Upjohnexemestane4,808,616Apr 1, 2011
VIVELLENovartisestradiol5,300,291Apr 5, 2011
DEFINITYLantheus Medclperflutren5,547,656Apr 5, 2011
DEFINITYLantheus Medclperflutren6,773,696Apr 5, 2011
DEFINITYLantheus Medclperflutren6,528,039Apr 5, 2011

This information is also available in an email newsletter: Subscribe to the DrugPatentWatch Patent Expiration Bulletin. Courtesy of DrugPatentWatch.com