BIO CEO & Investor Conference: Mergers and Acquisitions

In a year of recession, a non-existent IPO window, more cautious public and private investors, and the need to conserve cash, it’s clear why 2008 was the year of M&A.

While the biotech industry is expected to rebound this year, M&A is still top of mind for small biotechs and big pharma.

Small biotechs and big pharma encourage quick movement in this uneasy economy—a “be honest, let go, and move on” mentality to be exact! Industry experts advise small biotechs to funnel their assets to avoid confusing potential buyers who are only going to fund programs driving value.

For big pharma, just because a company’s for sale, doesn’t mean it’s a good deal. They’re looking for opportunities in promising therapeutic areas with clear, definable and mutually agreeable terms.

With more than 350 publicly traded biotechs, less optimistic experts estimate that as little as 175 will survive the current market.

BIO CEO & Investor Conference: Feeding the need for new obesity treatments

With obesity becoming a worldwide epidemic, there’s no need to question why new treatment options are important. In fact, according to recent reports, obesity-related health and economic costs are estimated at $100 billion per year.

Unfortunately, the options currently available to treat obesity only produce modest weight loss. But what about the conditions often associated with obesity, like diabetes, heart disease, osteoarthritis and sleep apnea? The majority of treatments currently available don’t account for improving these conditions and often don’t account for the dangerous side effects of quickly loosing an excessive amount of weight.

Fortunately, according to leading companies and clinicians, there are several obesity products in development that could significantly improve both the weight and lives of obese patients. These new treatments aim to provide patients with a safe and effective treatment that will help them loose weight, improve their behavior, and ultimately, help reduce mortality rates.

In today’s challenging regulatory environment for FDA approval, the FDA will look closely at the safety, efficacy and method of action for each treatment. Companies say approval may come in early 2011—positive news for the greatest medical problem facing the nation and the world.

BIO CEO & Investor Conference: more than 5 million patients suffering

There are more than 5 million patients suffering from gout. Unfortunately, most gout patients steer clear of medications unless experiencing a flare-up.

With the gout population getting older, fatter and more complex, and with no new treatments approved for the last 50 years, is there hope for gout sufferers?

Actually, there is. There are two new drugs awaiting FDA approval in 2009 that may offer long-term gout management and provide physicians with the ammo needed to improve patient education. While the drugs prove to be efficacious, questions regarding safety remain. And, with today’s challenging environment for FDA approval, the Agency will not trend lightly when it comes to safety. In fact, they’ll seek advice from and advisory committee panel and factor the drug’s efficacy, safety, tolerability, compliance and physiology.

If approved, these new treatments may help change this therapeutic landscape and hopefully offer an improved lifestyle for those suffering from gout.

BIO CEO & Investor Conference: The New Administration & Congress: Short or Loose Change?

Speakers in a policy session at the BIO CEO & Investor Conference on Monday talked about prospective industry changes based on the new administration. Amid the discussion, speakers shared insights on health care reform and agreed that there can no longer be incremental changes, comprehensive health care reform is needed. Based on their inside knowledge of DC, they strongly felt that efforts are well underway to start the debate this year on comprehensive health care reform.

Session Information

The New Administration & Congress: Short or Loose Change?

Monday, February 9th

After one of the most exciting and historic presidential elections in recent history, it’s now time to get back to business and ascertain how the current, yet ever-changing, political environment will affect the biotechnology and pharmaceutical industries. Join a lively discussion among congressional staffers, biotech political experts, and policy lawyers as they predict the impact of the change of power on the industry and discuss how the incoming administration will likely come down on the policy matters most critical to the drug development process.

Moderator

James C. Greenwood; President and CEO, BIO
Panelists
• Michael R. Bloomberg, Mayor of New York City
• Michelle Easton, Partner, Tarplin, & Young; (Former Chief Health and Welfare Counsel, Senate Finance Committee Chairman Max Baucus)
• Scott Gottlieb, Resident Fellow at The American Enterprise Institute (Former Deputy Commissioner for Medical and Scientific Affairs, U.S. Food and Drug Administration)
• Steve Usdin, Washington Editor, BioCentury Publications Inc.
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Who’s Who
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Michael R. Bloomberg; Mayor Bloomberg is an internationally known businessman and politician and also among the world’s richest with a net worth approaching $5 billion. He is president of Bloomberg Financial Markets and was elected mayor of New York City in 2001.

Michael Rubens Bloomberg was born on February 14th, 1942 to middle class parents in Medford, Massachusetts. In 1964 he went to Johns Hopkins University to study a BS in Electrical Engineering and in 1966 he studied a Master of Business Administration degree at Harvard University.

After University Bloomberg advanced through the ranks at Salomon Brothers and became a partner in 1972. Soon after, he was supervising all of Salomon’s stock trading, sales and information systems, but in 1981, after a merger, he was fired. He received a $10 million severance payout which he used to start a financial data and communications company called Bloomberg LP which sold financial information terminals to Wall Street firms.

Bloomberg LP has over 165,000 subscribers worldwide. As the business proved its feasibility, the company branched out and in 1990 launched a news service, and then radio, television, Internet, and publishing operations. Bloomberg Financial Markets is a global, multimedia-based distributor of information services, combining news, data and analysis for global financial markets and businesses.

As the company showed strong growth Bloomberg dedicated more of his time to philanthropy, his desire to improve education, medical research and increase access to the arts, has provided the motivation for much of his philanthropy. In 1997 Bloomberg published his autobiography, Bloomberg by Bloomberg. All of the royalties from sales of the book are donated to the Committee to Protect Journalists.

In 2001, Michael Bloomberg run for mayor of New York, spending record breaking amounts of his own money on the campaign. He was elected mayor, succeeding Rudy Giuliani. Bloomberg served as the Chairman of the Board Trustees for Johns Hopkins University until May 2002 and was honored when its School of Hygiene and Public Health was renamed “The Bloomberg School of Public Health” a tribute to his leadership and use of philanthropy to improve the human condition.
James C. Greenwood; Mr. Greenwood is President and CEO of the Biotechnology Industry Organization (BIO) in Washington, D.C., which represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

Since his appointment in January of 2005, he has markedly enhanced the trade association’s capacity – increasing both its staff and budget by nearly fifty percent. BIO is now a world class advocacy organization playing a leading role in shaping public policy on a variety of fronts critical to the success of the biotechnology industry at the state and national levels as well as internationally.

Mr. Greenwood represented Pennsylvania’s Eighth District in the U.S. House of Representatives from January 1993 through January 2005. A senior member of the Energy and Commerce Committee, he was widely viewed as a leader on health care and the environment.

From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee’s vast jurisdiction. He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation’s infrastructure; and waste and fraud in federal government agencies.

Prior to his election to Congress, Mr. Greenwood served six years in the Pennsylvania General Assembly (1980-86) and six years in the Pennsylvania Senate (1986-1993).

Mr. Greenwood graduated from Dickinson College in 1973 with a BA in Sociology. From 1977 until 1980, he worked as a caseworker with abused and neglected children at the Bucks County Children and Youth Social Service Agency.

Mr. Greenwood resides in Upper Makefield, Pennsylvania with his wife and three children.
Michelle Easton; Ms. Easton served as chief health counsel to Senate Finance Committee Chairman Max Baucus, D-Mont. Ms. Easton has worked on health care reform, Medicare, and Medicaid at the Finance Committee since early 2006. She’s also a former staff director for the Senate Special Committee on Aging, and was a legislative counsel to then-Sen. John Breaux, D-La.
Scott Gottlieb, MD; Dr. Scott Gottlieb is a practicing physician and resident fellow at the American Enterprise Institute, a private, nonpartisan, not-for-profit institution dedicated to research and education on issues of government, economics and social welfare. In addition, he is an internist on the hospital’s inpatient medical wards at Stamford Hospital in Stamford, Connecticut.

From 2005-2007, Dr. Gottlieb served as FDA Deputy Commissioner and before that, from 2003-2004, as a senior advisor to the Food and Drug Administration’s Commissioner Mark McClellan and as the FDA’s Director of Medical Policy Development. He left FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a Senior Adviser to the Administrator of Medicare and Medicaid Services, where he supported the agency’s policy work on quality improvement and coverage and payment decision-making, particularly related to new medical technologies.

Dr. Gottlieb is the author of more than 300 articles that have appeared in leading medical journals, as well as the Wall Street Journal, the New York Times, USA Today and Forbes magazine. Dr. Gottlieb has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on the cable financial news channel CNBC.

Dr. Gottlieb completed his residency in internal medicine at Mount Sinai Hospital in New York and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University, in Connecticut.

Steve Usdin; The original Washington Editor of BioCentury, Mr. Usdin has spent the past 15 years covering political and policy issues affecting the life sciences sector in Washington. He also is the Senior Editor responsible for coverage of social issues involving biotechnology. Steve’s reporting about biotechnology and biomedical policy have been cited in The Economist, The Wall Street Journal, the Washington Post, New Scientist and other publications. He also has traveled and reported extensively on the intersection of science, technology and policy, as well as on intelligence and national security issues, in Japan, Russia and the former Soviet Union, India, China and Western Europe. His book, “Engineering Communism: How Two Americans Spied for Stalin and Founded the Soviet Silicon Valley,” was published in 2005 by Yale University Press.

BIO CEO & Investor Conference: Being upfront about upfront payments

With today’s economy, it’s important to be upfront about upfront payments in biotech licensing. Since licensing deals allow big companies to fill their pipelines without the upfront work and provide small companies with the capital they crave, a win/win partnership is important.

Today, big pharma is driven by scientific data—often from late phase II clinical trials. And, sometimes one molecule can make or break a deal. For big pharma, it’s not the price that drives a deal; it’s the number of opportunities that may come out of the deal. These conglomerates are willing to pay it forward for hard data and new technologies—especially in areas with an unmet need.

According to both big pharma and small biotechs, strategic partnerships work best and partnerships built on a track record for delivery work even better.

For 2009, big pharma and small biotech executives are optimistic about licensing deals. While sellers might demand upfront cash because of the economy, there is plenty of solid data and attractive molecules to help move deals forward to reach fair market value.

Unmet Needs are in the Genes — Treatment Options for Rare Genetic Disorders

Genetic disorders known as Lysosomal Storage Diseases, including Gaucher disease, Fabry disease and Pompe disease, continue to be an area of high unmet medical need. According to physicians, it’s challenging to diagnosis these diseases and many patients often go misdiagnosed.

Physicians push for newborn screening since early detection is key to treating these life-threatening diseases. However, most physicians admit that treatments are often provided on a “learn as you go” basis. Physicians monitor patient and family history, as well as the effects of the treatments currently available.

But, how would new treatments affect the market share? Physicians today agreed that new treatment options (a.k.a. competition) would increase the price of treatments, but newer agents would have to show remarkable improvements to justify switching a patient from his or her existing therapy.

Companies in this unique field are hopeful that new therapies would help better treat these rare diseases and aim to price treatments accurately so they can continue to profit and develop newer and more effective treatment options.