Yearly Archives: 2008

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Drug Patent Expirations in June 2008

*Drugs may be covered by multiple patents

Tradename Applicant Generic Name Patent Number Patent Expiration
ADALAT CC Bayer Pharms nifedipine 4,892,741 Jun 8, 2008
CAVERJECT IMPULSE Pharmacia And Upjohn alprostadil 4,968,299 Jun 28, 2008
EFFEXOR Wyeth Pharms Inc venlafaxine hydrochloride 4,535,186 Jun 13, 2008
EFFEXOR XR Wyeth Pharms Inc venlafaxine hydrochloride 4,535,186 Jun 13, 2008
GENOTROPIN Pharmacia And Upjohn somatropin recombinant 4,968,299 Jun 28, 2008
GENOTROPIN PRESERVATIVE FREE Pharmacia And Upjohn somatropin recombinant 4,968,299 Jun 28, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,004,610 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,342,623 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,344,656 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,364,630 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,462,745 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 5,633,008 Jun 14, 2008
NICODERM CQ Sanofi Aventis Us nicotine 6,165,497 Jun 14, 2008
PREVACID Tap Pharm lansoprazole 5,026,560 Jun 25, 2008
RISPERDAL Janssen Pharma risperidone 4,804,663 Jun 29, 2008
RISPERDAL CONSTA Janssen Pharma risperidone 4,804,663 Jun 29, 2008
SONATA King Pharms zaleplon 4,626,538 Jun 6, 2008
SULAR Sciele Pharma Inc nisoldipine 4,892,741 Jun 8, 2008
TESTIM Auxilium Pharms testosterone 5,023,252 Jun 11, 2008

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Guest content from Sandy Graham, managing partner at Sequoyah Associates:

Can you “see the field” of opportunity? Have your clearly defined your plan to achieve your entrepreneurial dreams? Have you mapped out the strategic direction to attain your plan? Have you envisioned your market and know how to position your business to acquire it? Do you still have that “entrepreneurial flame” that caused you to spend nearly every wakening minute working ‘on” your business or have you succumbed to the daily chores of working “in” your business? Too often, new entrepreneurs and small business owners get caught up in the “day-to-day” running of their business, and find themselves unable to focus on their passion and keep the “entrepreneurial flame” going in the attainment of business initiatives, envisioning the market, reaching the optimal strategic direction, and seeing the field of opportunity.

The Golf Analogy

A new venture entrepreneur or small business owner who can “see the field” of opportunity is much like the PGA Professional who “sees the field” when he stands in the tee-box and looks down the fairway to the flag stick. He envisions the best approach to the green, determines the strategic direction to get there, and focuses all his efforts on attaining the goal of getting to the green and setting up a short birdie putt. The result is success, and if continuously repeated, will lead to a very strong finish. The great Bobby Jones was said to be the best at this. The present day version is Tiger Woods. In business, I believe we can achieve the same ‘vision’ as Tiger and Bobby if you can ‘see the field’ of opportunity.

How you ‘see the field’ of opportunity will largely determine your level of success. It is here you have the decision to make to either work ‘on’ your business, or work ‘in’ your business. Positioned to work ‘on’ your business keeps your entrepreneurial flame burning, fueled by the passion that first inspired you to leave corporate or blue-collar America and take that entrepreneurial leap-of-faith. Conversely, if the field of opportunity is clouded, foggy and difficult to see, then you likely will succumb to the notion that it is better to work ‘in’ your business to keep it going. There is certainly nothing wrong with that, except it means status quo and not growth.
компютри втора употребаThe Consequence of Not Seeing the Field

Now I am not a biology wiz, but I do know this; in the natural world, if an organism stops growing, assimilating and adapting to its environment, and basically reaches a point of accepting a natural status quo, decay sets in and the result is not good. The same goes for a new venture or small business enterprise. The ability to “see the field” of opportunity is critical to your ability to be successful; where growth, assimilation and adaptation come about through preparation, planning and execution which are extricably linked to how well you see the field of opportunity, followed by how you achieve it.

The Importance of Preparation and Planning

To “see the field” of opportunity, in my opinion, involves spending the requisite time to properly prepare and plan how you are going to attain your entrepreneurial goals, envision your market, and determine the strategic direction to achieve them. In business, any business be it biotech, telecommunications, software, medical, manufacturing, or even golf, preparation involves and includes sound strategic planning, market analysis, profitability assessment, and finally looking at your financing status, options and position.
At Sequoyah Associates we can work with you to review your business objectives and initiatives, and recommend the best strategy for attaining them, both in the near- and long-term. Of course, if there are current growth needs or issues, we can help with those as well. Our service offerings range from strategic planning that includes business plan development and business expansion strategy, to market and opportunity analysis, profitability analysis and financing assessment. Whatever your situation is as a new or growing small business, Sequoyah Associates provides the services that can help you attain your goals. Please feel free to peruse our site at and do give us a call for confidential, FREE, no obligation discussion of your business.

Gerald S. “Sandy” Graham
MBA, MS Economics
Sequoyah Associates

Sandy Graham is Managing Partner at Sequoyah Associates, with over 20 years of progressive senior level experience with some of our Nation’s leading organizations and Fortune 50 companies, as well as new ventures and small business enterprises. His experience includes business strategy, planning and development; new business solution development and delivery; client services delivery; and engagement management. Sandy’s academic credentials include an MBA and an MS in Economics, and is a recipient of the Ewing Marion Kauffman Foundation Internship in Entrepreneurship. In addition, he is a contributing author on Free Cash Flow. Since 2005, Sandy has been driving winning business strategies that have met client needs using consultative, coaching and advising skills to deliver the right business solutions for the small business firm and new venture enterprise.

The Journal of Commercial Biotechnology is looking for papers on investing strategies in the biotechnology space. The scope can include valuation models, strategies to identify under-valued companies, case studies in developing and managing a portfolio, etc.

The Journal of Commercial Biotechnology is a peer-reviewed journal focused on the business of biotechnology. More information, instructions for authors, and a sample issue are available at

For those attending BIO2008 in San Diego this year, I’ll be doing a signing of my books on Wednesday June 18th from 10-11. There will also be a limited number of free copies of the Journal of Commercial Biotechnology, so be sure and show up early!

I’ll also be speaking on Friday morning:
Title: Scientific Communications – Trends and Liabilities
Track: Public Relations/Investor Relations
Date and Time: Friday, June 20 9:00 AM – 10:30 AM

Hope to see you there!

I’ve nearly completed revisions for the third edition of Building Biotechnology, the leading textbook on the business of biotechnology. This new edition has several new chapters, new case studies, updated case law, and fresh industry stats — more than 100 pages longer than the second edition.

I’m looking for volunteers to review the chapters and potentially contribute case studies of:

- Entrepreneurship
– Career development
– Managing reimbursement
– Communications
– General management

Reviewers and contributors will be given a free copy of the final edition (an $80 value).

The chapter list is pasted below. If you are interested in reviewing/contributing, please drop me a brief note stating your interest and the chapter(s) you would like to review or contribute to. For an example of previous contributions, see these samples.



1 – Introduction

2 – The Development of Biotechnology

Knowledge and Skills
Industry Trends


3 – Introduction to Molecular Biology

Information Flow in Molecular Biology
The Big Picture

4 – Drug Development

Biologic vs. Pharmaceutical Drug Development
The Five Basic Steps of Drug Development
Qualities of a “Good” Drug

5 – Tools and Techniques

Combinatorial Chemistry
Drug Delivery
Functional Genomics

6 – Applications

Green Biotechnology: Agriculture
White Biotechnology: Industrial Processes and Bio-based Products
Red Biotechnology: Medical Applications

Laws, Regulations, and Politics

7 – Intellectual Property

When Patents Expire
Patent Infringement, Exemptions, and Licenses
Trade Secrets
The Role of Intellectual Property in Biotechnology

8 – Regulation

Food and Drug Administration
Department of Agriculture
Environmental Protection Agency
Securities and Exchange Commission

9 – Politics

Balancing Innovation Incentives with Economic Constraints

The Business of Biotechnology

10 – Biotechnology Company Fundamentals

Company Formation
Business Model
Company Characteristics

11 – Finance

Development Stages and Funding
Private Equity
Public Markets
Other Funding Sources

12 – Research and Development

R&D Stages
Project Selection
Outsourcing Innovation

13 – Marketing

Marketing as a Guide for R&D
Market Structure and Marketing Environment
Marketing Planning and Strategy

14 – Licensing, Alliances, and Mergers

Licensing and Outsourcing
Alliance Partnerships
Mergers and Acquisitions
Selecting Partnership Options

15 – Managing Biotechnology

Starting Up
Managing R&D
Intellectual Property Protection
Management Changes with Growth
Dealing with Failure
Public Relations

16 – International Biotechnology

Benchmarking against the United States
Intellectual Property Protection


17 – Building Biotechnology

Business Models
First Steps
Selecting Opportunities and Business Planning

18 – Investing

Caveat Emptor
Investing in Biotechnology

19 – Career Development

Job Descriptions
Ph.D., MBA, or Both?

20 – Final Words


Internet Resources

Annotated Bibliography


The science of biotechnology is tough. R&D can be unpredictable, and most products need regulatory approval before they can be sold. But biotechnology companies also need to worry about other problems, like management issues. The case of Dyadic’s illustrates some of the often-overlooked challenges in commercializing biotechnology.

Mark Emalfarb founded Dyadic in 1979 as a supplier of tools for stone-washing jeans. When cellulase enyzme technologies for stone-washing emerged, they threatened Dyadic’s use of pumice stones. Rather than fight this change, the company sought to out-innovate early cellulase suppliers and developed a promising fungal expression system with the potential to produce large quantities of complex proteins and enzymes, including cellulase. Opportunities also exist in cellulosic biofuel production and drug manufacturing.

As is often the case in dynamic industries, innovators can be blindsided by unexpected challenges. In spring 2007, Dyadic became aware of operational and financial improprieties at its Asian subsidiaries. An investigation conducted under the supervision of the board of directors audit committee found that Emalfarb had willfully concealed facts relating the improprieties, which led to his termination.mebeli [a representative from Dyadic opted not to comment on this case, and instead directed me to their press release archives]. A report detailing their justification for firing Emalfarb does not imply direct malfeasance, but claims that Emalfarb did not take strong-enough action to stop off-the-books and tax-evading transactions.

Emalfarb, who maintains his innocence, is the largest shareholder of Dyadic, and has been fighting to regain control of the firm. In February 2008 Emalfarb and two hedge funds, who collectively own more than 50% of the shares, issued a letter to the company demanding the resignation of the new CEO and two board members. Interestingly, despite the protests of this group representing a controlling share of the company, the battle for control continues.

Sadly, this is a case with no clear winner. Regardless of who will direct the company in the future, the share price has been decimated and growth opportunities have certainly been missed. Rather than focusing on developing applications of Dyadic’s core technologies, the founder and company are engaged in legal battles.

[Update: Emalfarb regained control of the company]

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Drug Patent Expirations in May 2008
*Drugs may be covered by multiple patents

Tradename Applicant Generic Name Patent Number Patent Expiration
HABITROL Novartis nicotine 5,016,652 May 21, 2008
REQUIP Glaxosmithkline ropinirole hydrochloride 4,824,860 May 19, 2008
SARAFEM Lilly fluoxetine hydrochloride 4,971,998 May 20, 2008

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