In an ever-changing industry, sometimes a biotech company must sacrifice a valuable asset - its people - for the good of the company.
Take a bow, Dr. William Haseltine.
As chairman, CEO and founder of Human Genome Sciences Inc., Haseltine plans to retire this year. He will leave the company as 200 other employees also step aside. The Rockville, Md.-based company is laying off 20 percent of its work force in order to reduce expenses and to streamline its focus to five main products. The decision to restructure was strategic, not for a lack of cash, of which the company has $1.3 billion. If the company wants a product to reach the market, then it must focus on its best bets, doing so as efficiently as possible with a management experienced in late-stage development and marketing.
And therefore, it was time to hand over the reigns, Haseltine said.
"I think this marks an important transition, not for me personally, not for my company, but for the genomics pharmaceutical industry," he told BioWorld Today. "It's a sign that we're growing up. We're maturing."
The industry is moving from the early stages of mapping the human genome to developing effective drugs and marketing them.
The investment community considered the company's plans to restructure a positive move. The company's shares (NASDAQ:HGSI) rose 63 cents on Thursday to close at $12.02, and in a research note by New York-based Leerink Swann & Co., analyst William Tanner said the turn of events was not a surprise, as the company recently talked of its intention to control its cash burn and prioritize development of its key products.
"We believe the company will successfully capture value from the human genome," Tanner said, "but HGSI shares are likely to underperform the sector until there is greater visibility of attractive revenue opportunities."
And that's OK, Haseltine said.
"You keep refining and refining," he said. "With a biotech company, all you need is one drug to work and then one drug in the pipeline."
Haseltine will stay at his post until a new CEO is named or until later this year.
"We, as a company, are moving toward a marketplace where the discoveries can benefit patients," said Haseltine, who turns 60 this year. "As a natural part of that, as you move toward that phase, the initial skills that got you there aren't the skills to take you into the marketplace and to the patient's bedside."
He is working with the board to find a replacement, and will lead the company as it restructures.
"We need a CEO and a top team that understands and has been there, has done that," he said. "That's been my initiative. I want to see this company succeed. I'm very driven to make sure genomic medicine reaches patients."
To do that, HGS plans to reduce the number of drugs in early development to five that address the greatest unmet medical needs and offer the most potential for the company's growth. The five in-house products that will remain on board are: LymphoStat-B, to treat systemic lupus erythematosus and rheumatoid arthritis, which is in Phase II trials; anti-TRAIL Receptor 1 and TRAIL Receptor 2 monoclonal antibodies to treat cancer, which are in Phase I trials; Albuferon to treat chronic hepatitis C, which is in Phase I/II trials; and an anti-CCR5 monoclonal antibody to treat HIV/AIDS, which will be the subject of an investigational new drug application later this year.
The company also has partnered products with GlaxoSmithKline plc, of London. An inhibitor of the enzyme Lp-PLA2 for cardiovascular disease is expected to enter Phase III trials this year. HGS and GSK also are studying an inhibitor of a cathepsin enzyme to treat osteoporosis. HGS holds royalty and co-promotion rights in the agreement.
As for HGS's other early stage pipeline products, the company will consider partnering or out-licensing them.
While the narrowed focus will save on expenses, the company expects to reduce them further with the staff layoffs and by consolidating its facilities. Released employees may receive severance pay, a continuation of health benefits and out-placement services. The company will take a one-time charge in the first quarter for its refocusing activities.
Once Haseltine leaves his post, he doesn't expect to be further involved with the company in any capacity.
"I think it's my own personal philosophy, just as when I left Harvard University to start HGS, that you make clean breaks from your own life and start fresh," he said.
Haseltine declined to "hazard a guess" as to when the company might get its first approval, although GSK has estimated that the Lp-PLA2 inhibitor could be on the market in 2008.
Haseltine pioneered the field of genetic research, along with former Celera Genomics Group head J. Craig Venter, which resulted in the human genome mapping. He considers it one of his greatest successes.
And to think, when he began, the idea of taking genes of unknown function and assigning them medical utility was ridiculed. "Now, young scientists coming into the field don't even know that there's another way to do things," Haseltine said. "I count that as a great success. It's what I hoped to do when I left Harvard."
In response to criticism that effective therapeutics are slow in coming, Haseltine said the drug development process always takes time.
"Genomics has done what I thought it would do - provide an abundance of new targets to work on. We can look at diseases like lupus that were really unapproachable before," he said. "The problems in drug discovery and drug development come later, and there's a series of problems."
Those problems include increasing regulatory demands, the nature of clinical trials required, dealing with chronic diseases as opposed to acute diseases and determining how many drugs one person can take safely, among others. Those are challenges a new management should be able to address.
Haseltine, who holds a doctorate from Harvard University in biophysics, founded Human Genome Sciences in 1992. He served as a professor at Harvard Medical School for 20 years and spent much of his career conducting cancer and AIDS research. He has founded seven biotechnology companies and helped create 20 more as an adviser to HealthCare Ventures.
He expects to continue with his other endeavors. Aside from being the founder and president of the Society for Regenerative Medicine, he is the editor-in-chief of the online journal E-Biomed: The Journal of Regenerative Medicine. He also serves on the board of the Biotechnology Industry Organization, the Brookings Institution, the Trilateral Commission, the Council on Foreign Relations, the French-American Business Council, the American Academy in Berlin and the National Health Museum of Washington, D.C.
Haseltine is president of the William A. Haseltine Foundation for Medical Sciences and the Arts. While he doesn't know for sure what the next road brings, he expects to somehow be involved in his life's work at an academic, nonprofit or commercial level.
"Whatever I do, it will be at the interface between science and human health," he said. "That's been the guiding theme."