Interest in biotech firms — and possibly Mayo Clinic — is on the rise, as drug companies are looking to find new popular treatments.
Last week, Pharmabusiness giant Bristol-Myers Squibb Co. announced a $2 billion merger deal with a Princeton, N.J., biotech called Medarex Inc., a company with links to Mayo Clinic. Bristol-Myers said it is paying $16 per share in cash, a 90 percent premium.
“This acquisition is another important step in our BioPharma transformation,” stated Bristol-Myers CEO James M. Cornelius.
It is unclear how Mayo Clinic, which has licensed at least two molecules to Medarex that potentially could be used to treat cancer, might benefit from the deal. Mayo and Medarex also have worked together on research, according to the company.
However, when Mayo Clinic and Medarex made health news headlines last month, it had nothing to do with the molecules.
A freak occurrence in a Mayo Clinic-run clinical trial of a Medarex antibody called MDX-010 or ipilimumab spurred great excitement and may have played a role in a more than 20 percent spike in the company’s stock price.
Patients received a hormone therapy that usually reduces tumors somewhat. Next the subjects of the trial were given a single dose of ipilimumab, which builds on the anti-tumor action of the hormone.
The study was funded primarily by the U.S. Department of Defense. Medarex’s only direct connection was providing a free supply of the antibody.
Things got interesting when two Mayo patients in the trial responded so well that surgery once thought impossible became an option. However, choosing surgery meant they had to drop out of the clinical study.
That’s when the Mayo doctors in charge of the study, Dr. Michael Blute and Dr. Eugene Kwon, were stunned by what was not found during surgery.
“The tumors had shrunk dramatically,” Blute said. “I had never seen anything like this before.”
Kwon even went as far as saying, “This is one of the holy grails of prostate cancer research.”
The men, who had come into the study with advanced prostate cancer that extended into their abdomens, left healthy enough to resume their lives.
While a wonderful result for the patients, the situation did not help or hurt the clinical trial, which is still ongoing, said Bob Nellis, a Mayo Clinic spokesman, last week.
The news about the patients hit the national scene in late June when the men were the subject of a story in Mayo Clinic’s research magazine, “Medical Edge.”
“The story’s genesis was that we had asked a wide range of researchers for interesting patient stories in connection to research,’’ says Nellis. “And this was one them that came forward.”
When the article, as well as a press release announcing it, reached the media, the results became the “medical miracle” of the day and Medarex’s stock took off for a short-lived rocket ride of a more than 20 percent increase.
That spurred discussion in the financial and scientific communities about the story which was criticized for not detailing much about the study, focusing solely on the men’s positive results.
“It was unorthodox to say the least,” said drug industry expert Michael Beck last week of the article. He wrote a commentary in late June called, “Much Ado About Medarex.”
He pointed out that neither the Mayo article nor a Medarex posting about the article mentioned the results of a Phase 2 clinical study of Ipilimumab’s effects on agressive prostate cancer that was reported by Memorial Sloan-Kettering Cancer Center in early June.
Those results found that only one of 45 patients came out cancer-free.
“Fair balance was really lacking in the Mayo communication and that is problematic,” says Becker.
Not so says, Nellis.
“This was intended as a human interest story,” he says. “We weren’t drawing any conclusions. Had they (the two patients) still been in the study, we would not have done this story.”
Nellis stresses that Mayo Clinic does not have any financial stake in ipilimumab.
However, Kwon, one the doctors leading the ipilimumab study, was key in the development of the two molecules - B7-H1 and B7-H3 - that Medarex does license from Mayo Clinic.
A disclousure at the end of the magazine article did note, “Mayo Clinic and Dr. Kwon have received royalties from Medarex from the licensing of technologies unrelated to this research.”
While Becker says that connection could have been more transparent, “My real gripe is with consistency of communication. They should have included the less favorable results.”
Writing such an article would have been OK, in his opinion, if it had been framed differently.
“In my opinion, it could have been a human interest story if they said…here’s a promising treament for prostate cancer combining two different modalities. To talk about that this patient had a cure and this patient also had a great response and we expec several more such situations,” Becker said. “Now you’ve crossed the line from a human interest story into a full-fledged primary trial results piece.”
Since that article came out and caught the attention of investors as well as prostate cancer patients, two more patients participating in the study have had similar positive results, says Nellis.
That doesn’t impress Becker too much.
“If you do the analysis on how patients normally respond the way those ‘miracle patients’ did to hormone therapy alone without the addition of the medarex product, 3.5 people would be expected to have that result,” he said. “That’s just a rounding error. “I’m not convinced by the two patients. I’m not convinced by four patients. It is not vetted by scientific data.”
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