Thursday, June 26, 2008

The Bioentrepreneur and Fampridine

What is a bioentrepreneur?

The term, when used loosely, describes the scientist who boldly decides to take his research from the lab, patent his findings, and commercialize a product. Often a bioentrepreneur starts with identifying a need and then creates a specialized niche market to satisfy that need. To be successful, the entrepreneur must become skilled at bringing together the science, research and funding to make it happen. Of course, it doesn't hurt to have the business know-how and convincing bravado to pull it off successfully.

In 1998 Ron Cohen, founder of Acorda Therapeutics, Inc., wrote with the confident voice of a presumedly successful bioentrepreneur. The following are excerpts from Alternative Careers in Science: Leaving the Ivory Tower edited by Cynthia Robbins-Roth (Academic Press, 1998; 2nd edition, Academic Press, 2005). Dr. Cohen contributed Chapter 9 - "Entrepreneur and Company Founder: Starting Your Own Company and Surviving".
During my internal medicine residency at the University of Virginia, I saw my first patient with SCI. That experience stayed with me even after I went back to New York City and practiced medicine while pursuing the other love of my life – the theater. For a while, I lived a dual life as medical director of a clinic in the Wall Street area and as an ER physician, while also taking acting classes, auditioning and working in commercials, starring in off-off Broadway plays, and appearing as a contestant on Jeopardy. I was having a wonderful time, living with one foot in each of two very different worlds.

But then in May 1986, friends from my medical school class at Columbia called and told me about a scientist friend of theirs, Dr. Gail Naughton, who was starting a company that would focus on her work in tissue proliferation. She needed a scientist with an M.D. who was good at making presentations to help build the company. An “acting” M.D. seemed like the perfect solution. My friends had shown Dr. Naughton tapes of me being interviewed for the local news and as a contestant on Jeopardy, and she decided that she had found what she was looking for.

I had never considered going into the business world – but this made no difference to Gail. At my first meeting with her, her husband, and her two kids, she pulled out a piece of paper with three lines of writing that essentially said, “I, Ron Cohen, will work for Marrow-Tech for $X,” and she said, “Sign here!” While I wanted to think about it, Gail said, “You don’t understand. I want you to sign here!” So I did, and that is how I got into biotech – it was an impulse based on the way Gail and I clicked; it just seemed to be the right thing to do.
Brief Bio of Ron Cohen, M.D., President, CEO, and Founder of Acorda Therapeutics., Inc.:
Dr. Cohen previously was a principal in the startup team of Advanced Tissue Sciences (ATS), a public biotechnology company in La Jolla, California engaged in growing human tissues in the laboratory — including skin, cartilage, liver and bone marrow — for use in transplantation. Dr. Cohen served as Vice President, Officer and Director of the Company from 1986 through 1992. He established and headed the Company's clinical, regulatory, quality assurance, and investor & public relations departments, also sharing responsibilities for business development, patent prosecution, public stock offerings and preclinical research and development. Dr. Cohen received his B.A. degree in Psychology from Princeton University, and his M.D. from the Columbia College of Physicians & Surgeons. He completed a residency in Internal Medicine at the University of Virginia Medical Center, and is Board Certified in Internal Medicine. Dr. Cohen also serves as a member of the Health Sciences Advisory Council at Columbia.
According to the record found at American Board of Internal Medicine (ABIM), Dr. Cohen was certified in Internal Medicine on September 12, 1984 and that certification will be valid indefinitely. "Certificates awarded in Internal Medicine prior to 1990 do not require renewal. However, ABIM encourages all diplomates voluntarily to renew certificates relevant to their practice." That can be rather useful to maintain that doctorly persona.
I founded Acorda from scratch and on my own dime. This meant several years of deciding which area I wanted the company to pursue; plowing through the technical literature and attending scientific and clinical conferences to find out the current status of SCI research and therapeutic development; identifying the top scientists in the field and persuading them to work with me; figuring out what the other biopharmaceutical companies were doing in the area; and getting the various not-for-profit foundations that fund SCI research to cooperate with us rather than compete. Then I had to write a business plan that made scientific, clinical, commercial, and financial sense. Hardest of all, I had to round up sufficient investment dollars to fund the company. This last task never ends, but you won’t have a company without the first infusion of dollars.

[...] At some point, however, experience is crucial. My Acorda experience is very challenging – huge amounts of work and stress, but at least I knew what was coming. I strongly urge budding entrepreneurs to ally themselves with people who do have that experience, to balance out their ignorance. Scientists need to align themselves with people with management and people skills, those who have been through it before. This requires swallowing your ego. It is hard to share control with others, but often it is a fatal mistake for entrepreneurs to try and go at it alone. Strong scientific skills do not translate directly into excellence in other areas. A Nobel laureate does not necessarily make a good CEO.
When examining the history of Fampridine-SR (4-aminopyridine in a patented sustained-release formulation) in use to treat spinal cord injury, it becomes apparent that Dr. Andrew Blight was key in the preclinical research. So it is no surprise that Dr. Cohen convinced him to join the team. In fact, it was Dr. Blight who was left to represent Acorda in front of a disgruntled FDA panel in 2000 after Dr. Cohen had given bold ultimatums to the same panel in 1999. The topic of the discussion centered around the develop of 4-aminopyridine in the treatment of multiple sclerosis and patient access to compounded formulations.

Until April 2004 when Acorda announced disappointing results from two Phase III trials of Fampridine-SR in the treatment of incomplete SCI, Acorda had committed more of its resources to studying spinal cord injury. It was then that Acorda turned to focus primarily on multiple sclerosis which had been on the backburner. It's even apparent in reading the early filing materials for the unsuccessful 2003 S-1 Initial Public Offering launch that MS was almost an afterthought.

More from Alternative Careers in Science, 2nd edition (2005) -
In 2003 to 2004, Acorda weathered two significant setbacks, one a decision by some of its investors not to accept a $45 million initial public offering and the other a disappointing result in two pivotal trials of its lead drug candidate for SCI. We promptly set out to acquire a commercial product for our therapeutic area and succeeded in bringing in Zanaflex, an approved drug for spasticity due to SCI, multiple sclerosis (MS), stroke, and other central nervous system injuries. We are now generating revenue from this drug, and we have built our initial sales and marketing organization. In 2005, Acorda has 59 employees and, in addition to Zanaflex, a drug product that is about to enter Phase 3 of a pivotal trial for restoration of function in MS. We have additional, exciting pipeline products that have been shown to repair nerve pathways in the spinal cord and brain of animal models. The company has raised more than $140 million since inception, mostly from venture capital groups. Biotechnology companies underscore (perhaps more than most) the need to have management teams that are creative and opportunistic at every turn, allowing the companies to come through the inevitable setbacks successfully.
Acorda Therapeutics, Inc., was successful in launching its IPO in 2006 shortly after which Ron Cohen rang the bell on Wall Street, on April 7,2006 to be exact. So if Acorda does become a profitable pharmaceutical company, it will be due to the needs and hopeful spirit of multiple sclerosis patients worldwide. We are often looking for ways to improve our symptoms. Just look at the results of the recent survey commissioned by Acorda and the National MS Society which discussed the effect of Mobility on the Quality of Life of MS Patients. I know that some fellow bloggers were just thrilled to read that press release and even more elated to know that Acorda thinks they have the product to help. Yet to be FDA approved and anticipated to cost $5000-10,000 each year.

Finally, to those of you who may be unconvinced that a former actor-physician could become a multi-millionaire before his fledgling drug company launches its lead product, think again. In 1998, the board of directors may have voted to pay Ron Cohen a salary of $120,000. But in the years since, his salary and bonuses have increased substantially, not to mention the stock he has cashed in during the past two years and the substantial stock awards and options he continues to receive.
  • 2003 Salary $290,000 Bonus $ 60,000 = $350,000
  • 2004 Salary $305,000 Bonus $120,000 = $425,000
  • 2005 Salary $305,000 Bonus $145,000 = $450,000
  • 2006 Salary $370,000 Bonus $225,000 = $595,000
  • 2007 Salary $440,000 Bonus $190,000 = $630,000
  • 2008 Salary $460,000 Bonus TBD
  • Stock Profits realized since Oct 2006 - more than $6,000,000
For tips on financing, read Ron Cohen's article from one year ago, "Six Steps to Successful Financing," published online by Bioentrepreneur.

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