Dew, I think "best story" could be changed to "revolutionary"
June 1 (Bloomberg) -- Six weeks after Sanofi-Aventis SA Chief Executive Officer Chris Viehbacher agreed to pay $500 million for a company with 18 employees, the acquisition looks like a bargain.
The experimental drug added by Paris-based Sanofi when it bought BiPar Sciences Inc. of San Francisco prolonged survival in women with aggressive breast cancer by 3.5 months, to 9.2 months, when added to chemotherapy in a study. The finding, presented at the American Society of Clinical Oncology meeting yesterday, was called “a huge bombshell” by Powel Brown, director at the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston, Texas.
The result could fuel a new class of drugs, called PARP inhibitors, to treat the toughest cancers, said Paul Chew, Sanofi’s chief medical officer. Mark Dainty, an analyst at Citigroup, said the drug could have sales of about $1 billion in 2012. Viehbacher said the BiPar acquisition came from a philosophy he’s pushed since joining Sanofi six months ago.
“The size of teams and the size of their budget does not correlate to research and development success,” Viehbacher said in an interview at the meeting yesterday. Sanofi is changing the way it conducts research, seeking “true innovation” by shifting more than half of its drug discovery work to smaller companies through acquisitions and partnerships, he said.
Sanofi rose 3.6 percent, the most since April 29, to 46.57 euros in Paris trading.
18 People
BiPar researchers in San Francisco will keep their offices there, and will continue to lead development of the experimental drug, called BSI-201. Viehbacher said the new treatment is now one of Sanofi’s most promising drugs.
“These 18 people brought this product to where it is now” and will be able to develop the drug more quickly than if Sanofi took over the process, Viehbacher said. If the BiPar scientists are successful, Viehbacker said he would turn their California office into a “center of innovation.”
BSI-201 is the most advanced of the emerging class of PARP inhibitors, designed to stop diseased cells from healing themselves.
Most cancer treatments work by blasting DNA with chemotherapy or radiation. Cancer can fight back by using PARP enzymes to fix damaged strands of DNA within tumors. The new medicines are designed to block the enzymes, helping standard treatments to kill the cancer.
‘The Biggest Story’
BSI-201 shrank tumors and slowed new growth in a study of 116 patients with so-called triple-negative breast cancer, an aggressive disease that resists many treatments, according to the study presented at the world’s biggest yearly cancer meeting, held this year in Orlando, Florida.
“These PARP inhibitors are the biggest story in breast cancer, by far,” said Baylor’s Brown, who wasn’t involved in the study, in an interview before the study was presented. She predicted U.S. Food and Drug Administration approval for Sanofi’s drug could come within two years.
The research, though impressive, “still needs further study to confirm the results,” said Richard Schilsky, president of the oncology society and associate dean for clinical research at University of Chicago. The studies presented at the meeting, “taken together, show that PARP is a very promising drug target,” he said.
Seeking Approval
Sanofi will begin enrolling 400 patients in the next two months for an expanded trial. That could take as little as a year to complete before the drugmaker asks regulators for marketing approval, Chew said.
The drugmaker believes the new trial “will be sufficient” for approval, he said.
The drug may have breast cancer sales of 700 euros, or $991 million, in 2012, Citigroup’s Dainty, based in London, said in a note to clients today. Approval would reduce breast-cancer sales of Roche Holding AG’s Avastin by as much as 25 percent, he said.
Large pharmaceutical companies have been bogged down by scientific approaches that have worked in the past, Viebacher said. Smaller organizations such as BiPar are more likely to “challenge the current way of thinking” and reach breakthroughs, he said.
BSI-201 is an intravenous infusion, added to standard chemotherapy, in the research.
A similar drug, called olaparib and made by London-based AstraZeneca Plc, shrank tumors even when administered without chemotherapy or radiotherapy, according to a separate study reported at the meeting. That research wasn’t designed to measure the drug’s ability to slow the disease.
Variety of Cancers
The tests of Sanofi’s drug, the second of three stages typically required for regulatory approval, focused on breast cancer. The PARP inhibitor method of blocking DNA repair may also work against other cancers and might reduce the amount of chemotherapy needed, Sanofi’s Chew said.
“It’s a portal to other tumors,” said Chew, who was appointed to his job in March.
Healthy human cells have six mechanisms to repair DNA. As cancer develops, many of those mechanisms break down, leaving the cell reliant on PARP to fix genetic damage from cancer treatments.
Scientists have found that severe forms of cancer in the ovaries, uterus, lungs and pancreas all have unusually high PARP enzyme activity, meaning they could make good targets for the therapies, said Barry Sherman, BiPar’s chief medical officer.
In Sanofi’s study, half of patients were given BSI-201 and a combination of chemotherapies, carboplatin and Eli Lilly & Co.’s Gemzar, and half were given chemotherapy and a placebo.
Increasing Survival
About 60 percent of patients who took BSI-201 saw their tumors shrink and cancer slow, almost three times as many as those who took only chemotherapy. The median lifespan after treatment with BSI-201 was 9.2 months, compared with 5.7 months in the control group.
Triple negative breast cancer is responsible for about 15 percent of breast cancers and sickens younger women more than other forms. If the cancer is detected early enough, treatment with a PARP inhibitor may be able to permanently destroy the tumors, Sherman said in an interview at the conference yesterday.
“There is an opportunity here to actually use the term ‘cure’ when it’s applied to early-stage disease,” Sherman said. “That is perhaps one of the most exciting notions to come out of this. This is the forefront of a field that is about to open up, about DNA repair.”
Abbott Laboratories and Pfizer Inc. are also investigating PARP inhibitors in early-stage human trials.
Other Targets
Abbott’s version, called ABT-888, is being examined in 10 clinical trials to determine which treatments it works best with, said Vincent Giranda, director of PARP research at the Abbott Park, Illinois-based company.
There are “hints” that PARP inhibitors may show benefits in diseases other than cancer and may one day be used to limit damage after a heart attack or stroke, Giranda said. For now, companies are focusing on oncology, where the most dramatic results may come, he said in an interview last week.
The AstraZeneca trial focused on breast cancer patients with a mutation in a gene called BRCA, another severe disease form affecting about 5 percent of breast cancer patients.
The mutation hampers other mechanisms to repair DNA, making the cancer especially reliant on PARP enzymes. The trial of 54 patients showed olaparib was safe and shrank tumors.
Breast Cancer
Breast cancer is the second most common malignancy in women, after skin tumors, according to the Atlanta-based U.S. Centers for Disease Control and Prevention. About 187,000 women were diagnosed with breast cancer and 41,000 died from it in 2005, the most recent year for which CDC data are available.
“Any time you open up a new target, that’s an exciting moment,” Clifford Hudis, chief of breast cancer medicine at Memorial Sloan Kettering Cancer Center in New York, said in a telephone interview last week. “These drugs may potentially be active not just to treat metastatic disease but to prevent recurrence.”
To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net.
Last Updated: June 1, 2009 12:58 EDT
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