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Career U-turn brings ex-counsel back to TKT

When Astrue left the biotech firm last year, he hadn't planned to return as leading man

On Jan. 28, with considerable effort, Michael J. Astrue shaved and put on a tie. It was the first time he had attempted either task in 11 days.

Astrue, the former general counsel at Transkaryotic Therapies Inc. of Cambridge, hadn't been taking his legendary casual-dress philosophy to an extreme. On Jan. 17, he had slipped on the ice while walking from his front door to his car. His left arm was pinned beneath him and he fractured his elbow.

But Astrue had a reason to make himself presentable: There was a reception that afternoon for people who had served on Governor-elect Mitt Romney's transition team.

Moreover, just that morning he had received an invitation to attend a board meeting at TKT's Main Street headquarters. Astrue had resigned from the firm just five weeks earlier. The directors wanted to hear his advice for righting TKT, a 15-year-old biotech firm that had just suffered a series of severe regulatory setbacks that had crushed the near-term prospects for the company's Replagal drug and in four months slashed TKT's share price by 85 percent.

Astrue was planning to spend the new year doing research at the Hudson Institute, a conservative think tank based in Indianapolis, and teaching at the Boston University School of Law, while he sought an appointment somewhere in the Bush administration. But he accepted the invitation to meet the directors for two reasons.

"When provided with an opportunity to offer my opinions in detail, I usually take advantage of it," Astrue said. The 46-year-old also had a hunch TKT's board wanted more than to just pick his brain. In fact, Dr. Richard F. Selden, TKT's founder and chief executive, had asked Astrue whether he would consider the chief executive's job in November, just weeks before he left the company.

"I knew they might be thinking about trying to bring me back," said Astrue, who took a taxi and arrived at the company at 2 p.m. Astrue ate a chicken salad sandwich, and talked for about two hours, after which Rodman W. Moorhead III, the chairman, asked him, "Would you consider coming back as CEO?"

Astrue's return to TKT was announced Feb. 11. For the Milton native, it was another in a series of unexpected career U-turns. In 1985, while serving as a staff attorney at the Department of Health and Human Services, he was asked to interview for a position in the White House counsel's office. "I was stunned," recalled Astrue, who advised presidents Reagan and Bush, "but when the White House calls and asks you for your resume, you say yes."

In just a few years, Astrue has become one of the more influential players in Massachusetts' biotechnology industry. After serving as associate counsel to the president, he was general counsel for the Department of Health and Human Services, overseeing an army of hundreds of lawyers. He later was a partner at Mintz Levin Cohn Ferris Glovsky and Popeo PC of Boston, and served as general counsel for Biogen, the Cambridge biotech giant, starting in 1993. He left Biogen for TKT in 2000, and was chairman of the Massachusetts Biotechnology Council in 2001.

For Astrue, the return to TKT is more than just another serendipitous career move. After nearly 20 years spent in supporting roles - overseeing law departments, advising chief executives, handling patent litigation - Astrue is finally the leading man. If he achieves success running TKT, it is likely to be the defining episode of what has already been a high-profile career in the biotechnology industry.

"Mike is an incredibly moral guy," said Dr. Burt Adelman, executive vice president of research and development for Biogen Inc., where Astrue served as general counsel. "I suspect they got him back because he wasn't going to leave something he was committed to when they were having a problem. He doesn't walk away from a fight."

Astrue's ability to execute may be just as pivotal to TKT. The past two years have been punishing for the company. In January 2001, a federal court judge in Boston ruled TKT's version of a top-selling anemia drug infringed on patents held by the drug's maker, Amgen Inc. of Thousand Oaks, Calif. Even when TKT's version of the drug, Dynepo, was approved for sale in Europe, the ongoing patent litigation prevented the company from selling it.

Last year was even worse. TKT's shares fell 60 percent in a single day when the company warned its clinical data wouldn't support the approval of its Replagal treatment for Fabry disease.

An advisory panel to the US Food and Drug Administration ruled unanimously Jan. 14 that clinical data didn't support TKT's claims for the drug. Meantime, the panel recommended approval of a competing drug made by Genzyme Corp. If that drug is approved first, Genzyme's Fabrazyme may be granted "orphan drug" status, giving the company an effective monopoly on the market for treating the rare genetic disease.

It is abundantly clear that Astrue has his work cut out for him. Next month, the company will announce a major layoff affecting about 100 employees, or more than 20 percent of its work force. Major changes are also forthcoming in TKT's senior management, according to a former TKT executive.

In a gesture to employees, Astrue said he would forgo his salary for three months. He also said he asked the board to pay him less than Selden earned last year, but declined to specify what his compensation will be. In 2001, the most recent reported year, Selden earned a salary of $400,000 and a bonus of $150,000, according to company documents.

Much of TKT's basic research will be discontinued. And, in a major shift, TKT will look for larger companies with which to collaborate on its proprietary gene therapy products, which use a patient's own cells to generate unique proteins. TKT will also seek to forge partnerships with Japanese firms, Astrue said.

Astrue said one of his prime tasks is to try again to win approval for Replagal. The company will resubmit pathology data with new analysis to the FDA, he said. Still, a lot depends on how the agency proceeds, and whether it grants the coveted orphan drug status to Genzyme's competing drug.

While the latest setback involving Replagal has dealt the company a serious blow, it also played a crucial role in Astrue's return. Selden had first asked Astrue whether he would consider becoming chief executive in a meeting in Selden's office in November. But the discussion was still too tentative for Astrue to take it seriously. "He had mentioned it a few times, he was sincere, but my read on it was that he wasn't ready to leave this company, which he founded and spent his entire career at," said Astrue.

Astrue left TKT convinced his future lay in Washington, with an appointment to some sort of government post. That ambition had been thwarted in 2001. President Bush was poised to nominate Astrue to head the FDA, and Astrue had been interviewed by White House officials. But Massachusetts Senator Edward M. Kennedy and other Senate Democrats blocked the nomination, saying it would be a conflict of interest for the drug industry's top watchdog to come from the industry the agency regulates.

But Selden apparently decided to leave TKT after the FDA's advisory panel voted against Replagal Jan. 14. The setback to the company would require stiff personnel cuts and a sharp reduction in basic research to discover early-stage drug candidates - the type of work that most excited Selden. He spent two weeks prior to the Jan. 28 meeting lobbying board members in support of hiring Astrue to replace him, and continued to call Astrue, urging him to return.

"Because the pipeline was going to be dramatically cut, TKT wasn't my ideal any more," Selden said. "In January, I explained to Mike that his skill set was what the company needed. I felt like I was a matchmaker."

One director, who asked not to be named, said the board hadn't met with Astrue after he left in early December. But the directors had polled other senior managers for suggestions on saving TKT. "My takeaway at the Jan. 28 meeting was there was a strong alignment between Mike's view of the path forward and what a number of the senior managers felt needed to be done. I was struck by the consistency."

Another director, also speaking on condition of anonymity, said he felt Astrue had the skills to lead TKT through its short-term crisis and beyond. "Three or four items on our agenda are regulatory or legal," said this director, "but you wouldn't want somebody to run a company around short-term legal issues. Mike, unusually for a lawyer, brings broad exposure to the commercial world."

Ultimately, that could be the key to Astrue's return. "Mike is way too smart to be pigeonholed as a lawyer," said one TKT executive who worked closely with Astrue. "He's a strategic thinker and a leader, as well as a lawyer. He wants to prove that he can do it all."

Selden told the directors he would resign on the afternoon of Feb. 11. The board met, via teleconference, just afterward, and voted to offer the job to Astrue. They called him and he agreed. TKT put out a press release at 5:30 p.m.

Astrue knows there are difficult times ahead, and a significant part of his plan to revive the company's fortunes involves Replagal.

But he is determined to succeed, insisting that even if he loses the competition for orphan drug status to Genzyme it won't necessarily preclude Replagal's ultimate success.

"In my course on biotechnology law and policy at BU, I just assigned students an extra-credit question: Name five of the six ways to get around a competitor's orphan drug exclusivity," he said.

Jeffrey Krasner can be reached at krasner@globe.com.

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