Bristol-Myers, AstraZeneca Report Cancers With Diabetes Drug - Businessweek

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Bristol-Myers, AstraZeneca Report Cancers With Diabetes Drug

June 25, 2011, 6:28 PM EDT

More From Businessweek

Bristol-Myers Diabetes Drug Safe After 2 Years, Study Finds

Generic Tuberculosis Drug Shows Promise for Reversing Diabetes

Abbott Inflammation Drug Halts Kidney Decline, Researchers Say

Pfizer, Bristol-Myers Blood Thinner Tops Warfarin in Stroke

Bristol-Myers Diabetes Drug Draws Scrutiny After Avandia

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By Lopatto

(Adds analyst comment in fourth paragraph.)

June 25 (Bloomberg) -- Bristol-Myers Squibb Co. and AstraZeneca Plc. said

patients taking their experimental diabetes pill, shown effective in a two-year

study, had more breast and bladder cancers than those on a standard drug.

In all the clinical programs, nine breast cancers and nine bladder cancers were

seen among 5,478 patients taking the drug, dapagliflozin, compared with one

breast and one bladder cancer among the 3,156 in control groups, Bristol-Myers

and AstraZeneca said in a statement today. There was no imbalance in overall

cancer risk, the companies said.

The dapagliflozin cancer findings will be a topic at a U.S. Food and Drug

Administration advisory panel on July 19, said Mark Schoenebaum, an analyst for

ISI Group. The treatment is facing increased scrutiny from regulators and

doctors after two rivals were tied to malignancy and heart risks. Data presented

today at the American Diabetes Association meeting in San Diego has been shared

with the FDA, the companies said.

“No doubt they’ll bring this up at the advisory committee,†Schoenebaum

said in an interview today. “But I’d be very surprised if this blocked

approval.â€

Patients probably already had the cancer when they enrolled in the trial,

Schoenebaum said. The timing of the cases made it seem unlikely that

dapagliflozin caused the cancers, although it may have accelerated them, he

said.

What is likelier is that the agency will require a post- marketing study on

cancer risks, he said. At the very worst, there may be a black box warning on

the drug, Schoenebaum said.

‘Numerical Imbalance’

“We look at this very seriously,†said beth Svanberg, the vice

president of development for New York-based Bristol-Myers, in an interview

today. In preclinical studies in rats and mice, where the animals were given up

to 100 times the human dose, dapagliflozin didn’t increase cancer risks,

Svanberg said.

“It’s probably a numerical imbalance,†she said. “Those occur in

clinical trials.â€

Results from a two-year study released yesterday reported that dapagliflozin in

combination with metformin, a standard treatment, was safe and effective. The

study, funded by Bristol- Myers and London-based AstraZeneca, showed that

patients getting dapagliflozin lowered their blood sugar more than patients on

metformin and another generic diabetes drug, glipizide.

An estimated 25.8 million Americans have diabetes, most of the Type 2 variety

linked to weight gain and a lack of exercise, according to the U.S. National

Institutes of Health.

Avandia, Actos Risks

In May, U.S. regulators restricted use of London-based GlaxoKline Plc’s

Avandia, ordering the drug to be pulled from pharmacy shelves and made available

only through a special program. Sales of Avandia fell to $680 million last year

from $1.8 billion in 2007 after a study that year showed a 43 percent increased

risk of heart attacks among patients taking the medicine.

On June 15, a five-year analysis from a decade-long company-sponsored study of

Osaka-based Takeda Pharmaceutical Co.’s Actos showed an increased risk of

bladder cancer. Actos is the world’s biggest-selling diabetes drug. The FDA

had required the study under new guidelines for diabetes drug approvals.

Dapagliflozin works differently than Actos and Avandia. While those drugs adjust

the hormone that regulates blood sugar, the new pill helps patients excrete

sugar through their urine.

The new mechanism would make dapagliflozin the first entry in a class called

SGLT-2 inhibitors that work by allowing patients to excrete their excess blood

sugar in their urine. & , Eli Lilly & Co., Boehringer Ingelheim

GmbH, and Astellas Pharma Inc. are among the companies pursuing similar drugs.

The breast and bladder don’t express SGLT-2, Bristol-Myers and AstraZeneca

said in the statement.

Patients on dapagliflozin were more likely to have urinary tract and genital

infections than those taking metformin alone, according to the two-year results

released yesterday.

--Editors: Zimm, Sylvia Wier

To contact the reporter on this story: Lopatto in New York at

elopatto@....

To contact the editor responsible for this story: Reg Gale at

rgale5@....

Sent via BlackBerry by AT & T

[Guest guest]

http://www.businessweek.com/news/2011-06-25/bristol-myers-astrazeneca-report-can\

cers-with-diabetes-drug.html?

Saturday June 25, 2011



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Bloomberg

Bristol-Myers, AstraZeneca Report Cancers With Diabetes Drug

June 25, 2011, 6:28 PM EDT

More From Businessweek

Bristol-Myers Diabetes Drug Safe After 2 Years, Study Finds

Generic Tuberculosis Drug Shows Promise for Reversing Diabetes

Abbott Inflammation Drug Halts Kidney Decline, Researchers Say

Pfizer, Bristol-Myers Blood Thinner Tops Warfarin in Stroke

Bristol-Myers Diabetes Drug Draws Scrutiny After Avandia

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in

Share

..

add to Business Exchange

E-mail

Print

By Lopatto

(Adds analyst comment in fourth paragraph.)

June 25 (Bloomberg) -- Bristol-Myers Squibb Co. and AstraZeneca Plc. said

patients taking their experimental diabetes pill, shown effective in a two-year

study, had more breast and bladder cancers than those on a standard drug.

In all the clinical programs, nine breast cancers and nine bladder cancers were

seen among 5,478 patients taking the drug, dapagliflozin, compared with one

breast and one bladder cancer among the 3,156 in control groups, Bristol-Myers

and AstraZeneca said in a statement today. There was no imbalance in overall

cancer risk, the companies said.

The dapagliflozin cancer findings will be a topic at a U.S. Food and Drug

Administration advisory panel on July 19, said Mark Schoenebaum, an analyst for

ISI Group. The treatment is facing increased scrutiny from regulators and

doctors after two rivals were tied to malignancy and heart risks. Data presented

today at the American Diabetes Association meeting in San Diego has been shared

with the FDA, the companies said.

“No doubt they’ll bring this up at the advisory committee,†Schoenebaum

said in an interview today. “But I’d be very surprised if this blocked

approval.â€

Patients probably already had the cancer when they enrolled in the trial,

Schoenebaum said. The timing of the cases made it seem unlikely that

dapagliflozin caused the cancers, although it may have accelerated them, he

said.

What is likelier is that the agency will require a post- marketing study on

cancer risks, he said. At the very worst, there may be a black box warning on

the drug, Schoenebaum said.

‘Numerical Imbalance’

“We look at this very seriously,†said beth Svanberg, the vice

president of development for New York-based Bristol-Myers, in an interview

today. In preclinical studies in rats and mice, where the animals were given up

to 100 times the human dose, dapagliflozin didn’t increase cancer risks,

Svanberg said.

“It’s probably a numerical imbalance,†she said. “Those occur in

clinical trials.â€

Results from a two-year study released yesterday reported that dapagliflozin in

combination with metformin, a standard treatment, was safe and effective. The

study, funded by Bristol- Myers and London-based AstraZeneca, showed that

patients getting dapagliflozin lowered their blood sugar more than patients on

metformin and another generic diabetes drug, glipizide.

An estimated 25.8 million Americans have diabetes, most of the Type 2 variety

linked to weight gain and a lack of exercise, according to the U.S. National

Institutes of Health.

Avandia, Actos Risks

In May, U.S. regulators restricted use of London-based GlaxoKline Plc’s

Avandia, ordering the drug to be pulled from pharmacy shelves and made available

only through a special program. Sales of Avandia fell to $680 million last year

from $1.8 billion in 2007 after a study that year showed a 43 percent increased

risk of heart attacks among patients taking the medicine.

On June 15, a five-year analysis from a decade-long company-sponsored study of

Osaka-based Takeda Pharmaceutical Co.’s Actos showed an increased risk of

bladder cancer. Actos is the world’s biggest-selling diabetes drug. The FDA

had required the study under new guidelines for diabetes drug approvals.

Dapagliflozin works differently than Actos and Avandia. While those drugs adjust

the hormone that regulates blood sugar, the new pill helps patients excrete

sugar through their urine.

The new mechanism would make dapagliflozin the first entry in a class called

SGLT-2 inhibitors that work by allowing patients to excrete their excess blood

sugar in their urine. & , Eli Lilly & Co., Boehringer Ingelheim

GmbH, and Astellas Pharma Inc. are among the companies pursuing similar drugs.

The breast and bladder don’t express SGLT-2, Bristol-Myers and AstraZeneca

said in the statement.

Patients on dapagliflozin were more likely to have urinary tract and genital

infections than those taking metformin alone, according to the two-year results

released yesterday.

--Editors: Zimm, Sylvia Wier

To contact the reporter on this story: Lopatto in New York at

elopatto@....

To contact the editor responsible for this story: Reg Gale at

rgale5@....

Sent via BlackBerry by AT & T

[Guest guest]

http://www.businessweek.com/news/2011-06-25/bristol-myers-astrazeneca-report-can\

cers-with-diabetes-drug.html?

Saturday June 25, 2011



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Bloomberg

Bristol-Myers, AstraZeneca Report Cancers With Diabetes Drug

June 25, 2011, 6:28 PM EDT

More From Businessweek

Bristol-Myers Diabetes Drug Safe After 2 Years, Study Finds

Generic Tuberculosis Drug Shows Promise for Reversing Diabetes

Abbott Inflammation Drug Halts Kidney Decline, Researchers Say

Pfizer, Bristol-Myers Blood Thinner Tops Warfarin in Stroke

Bristol-Myers Diabetes Drug Draws Scrutiny After Avandia

Story Tools





in

Share

..

add to Business Exchange

E-mail

Print

By Lopatto

(Adds analyst comment in fourth paragraph.)

June 25 (Bloomberg) -- Bristol-Myers Squibb Co. and AstraZeneca Plc. said

patients taking their experimental diabetes pill, shown effective in a two-year

study, had more breast and bladder cancers than those on a standard drug.

In all the clinical programs, nine breast cancers and nine bladder cancers were

seen among 5,478 patients taking the drug, dapagliflozin, compared with one

breast and one bladder cancer among the 3,156 in control groups, Bristol-Myers

and AstraZeneca said in a statement today. There was no imbalance in overall

cancer risk, the companies said.

The dapagliflozin cancer findings will be a topic at a U.S. Food and Drug

Administration advisory panel on July 19, said Mark Schoenebaum, an analyst for

ISI Group. The treatment is facing increased scrutiny from regulators and

doctors after two rivals were tied to malignancy and heart risks. Data presented

today at the American Diabetes Association meeting in San Diego has been shared

with the FDA, the companies said.

“No doubt they’ll bring this up at the advisory committee,†Schoenebaum

said in an interview today. “But I’d be very surprised if this blocked

approval.â€

Patients probably already had the cancer when they enrolled in the trial,

Schoenebaum said. The timing of the cases made it seem unlikely that

dapagliflozin caused the cancers, although it may have accelerated them, he

said.

What is likelier is that the agency will require a post- marketing study on

cancer risks, he said. At the very worst, there may be a black box warning on

the drug, Schoenebaum said.

‘Numerical Imbalance’

“We look at this very seriously,†said beth Svanberg, the vice

president of development for New York-based Bristol-Myers, in an interview

today. In preclinical studies in rats and mice, where the animals were given up

to 100 times the human dose, dapagliflozin didn’t increase cancer risks,

Svanberg said.

“It’s probably a numerical imbalance,†she said. “Those occur in

clinical trials.â€

Results from a two-year study released yesterday reported that dapagliflozin in

combination with metformin, a standard treatment, was safe and effective. The

study, funded by Bristol- Myers and London-based AstraZeneca, showed that

patients getting dapagliflozin lowered their blood sugar more than patients on

metformin and another generic diabetes drug, glipizide.

An estimated 25.8 million Americans have diabetes, most of the Type 2 variety

linked to weight gain and a lack of exercise, according to the U.S. National

Institutes of Health.

Avandia, Actos Risks

In May, U.S. regulators restricted use of London-based GlaxoKline Plc’s

Avandia, ordering the drug to be pulled from pharmacy shelves and made available

only through a special program. Sales of Avandia fell to $680 million last year

from $1.8 billion in 2007 after a study that year showed a 43 percent increased

risk of heart attacks among patients taking the medicine.

On June 15, a five-year analysis from a decade-long company-sponsored study of

Osaka-based Takeda Pharmaceutical Co.’s Actos showed an increased risk of

bladder cancer. Actos is the world’s biggest-selling diabetes drug. The FDA

had required the study under new guidelines for diabetes drug approvals.

Dapagliflozin works differently than Actos and Avandia. While those drugs adjust

the hormone that regulates blood sugar, the new pill helps patients excrete

sugar through their urine.

The new mechanism would make dapagliflozin the first entry in a class called

SGLT-2 inhibitors that work by allowing patients to excrete their excess blood

sugar in their urine. & , Eli Lilly & Co., Boehringer Ingelheim

GmbH, and Astellas Pharma Inc. are among the companies pursuing similar drugs.

The breast and bladder don’t express SGLT-2, Bristol-Myers and AstraZeneca

said in the statement.

Patients on dapagliflozin were more likely to have urinary tract and genital

infections than those taking metformin alone, according to the two-year results

released yesterday.

--Editors: Zimm, Sylvia Wier

To contact the reporter on this story: Lopatto in New York at

elopatto@....

To contact the editor responsible for this story: Reg Gale at

rgale5@....

Sent via BlackBerry by AT & T

[Guest guest]

http://www.businessweek.com/news/2011-06-25/bristol-myers-astrazeneca-report-can\

cers-with-diabetes-drug.html?

Saturday June 25, 2011



Get our new FREE iPad app now

Home

Finance

Technology

Innovation

Management

Small Business

Global

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Bloomberg

Bristol-Myers, AstraZeneca Report Cancers With Diabetes Drug

June 25, 2011, 6:28 PM EDT

More From Businessweek

Bristol-Myers Diabetes Drug Safe After 2 Years, Study Finds

Generic Tuberculosis Drug Shows Promise for Reversing Diabetes

Abbott Inflammation Drug Halts Kidney Decline, Researchers Say

Pfizer, Bristol-Myers Blood Thinner Tops Warfarin in Stroke

Bristol-Myers Diabetes Drug Draws Scrutiny After Avandia

Story Tools





in

Share

..

add to Business Exchange

E-mail

Print

By Lopatto

(Adds analyst comment in fourth paragraph.)

June 25 (Bloomberg) -- Bristol-Myers Squibb Co. and AstraZeneca Plc. said

patients taking their experimental diabetes pill, shown effective in a two-year

study, had more breast and bladder cancers than those on a standard drug.

In all the clinical programs, nine breast cancers and nine bladder cancers were

seen among 5,478 patients taking the drug, dapagliflozin, compared with one

breast and one bladder cancer among the 3,156 in control groups, Bristol-Myers

and AstraZeneca said in a statement today. There was no imbalance in overall

cancer risk, the companies said.

The dapagliflozin cancer findings will be a topic at a U.S. Food and Drug

Administration advisory panel on July 19, said Mark Schoenebaum, an analyst for

ISI Group. The treatment is facing increased scrutiny from regulators and

doctors after two rivals were tied to malignancy and heart risks. Data presented

today at the American Diabetes Association meeting in San Diego has been shared

with the FDA, the companies said.

“No doubt they’ll bring this up at the advisory committee,†Schoenebaum

said in an interview today. “But I’d be very surprised if this blocked

approval.â€

Patients probably already had the cancer when they enrolled in the trial,

Schoenebaum said. The timing of the cases made it seem unlikely that

dapagliflozin caused the cancers, although it may have accelerated them, he

said.

What is likelier is that the agency will require a post- marketing study on

cancer risks, he said. At the very worst, there may be a black box warning on

the drug, Schoenebaum said.

‘Numerical Imbalance’

“We look at this very seriously,†said beth Svanberg, the vice

president of development for New York-based Bristol-Myers, in an interview

today. In preclinical studies in rats and mice, where the animals were given up

to 100 times the human dose, dapagliflozin didn’t increase cancer risks,

Svanberg said.

“It’s probably a numerical imbalance,†she said. “Those occur in

clinical trials.â€

Results from a two-year study released yesterday reported that dapagliflozin in

combination with metformin, a standard treatment, was safe and effective. The

study, funded by Bristol- Myers and London-based AstraZeneca, showed that

patients getting dapagliflozin lowered their blood sugar more than patients on

metformin and another generic diabetes drug, glipizide.

An estimated 25.8 million Americans have diabetes, most of the Type 2 variety

linked to weight gain and a lack of exercise, according to the U.S. National

Institutes of Health.

Avandia, Actos Risks

In May, U.S. regulators restricted use of London-based GlaxoKline Plc’s

Avandia, ordering the drug to be pulled from pharmacy shelves and made available

only through a special program. Sales of Avandia fell to $680 million last year

from $1.8 billion in 2007 after a study that year showed a 43 percent increased

risk of heart attacks among patients taking the medicine.

On June 15, a five-year analysis from a decade-long company-sponsored study of

Osaka-based Takeda Pharmaceutical Co.’s Actos showed an increased risk of

bladder cancer. Actos is the world’s biggest-selling diabetes drug. The FDA

had required the study under new guidelines for diabetes drug approvals.

Dapagliflozin works differently than Actos and Avandia. While those drugs adjust

the hormone that regulates blood sugar, the new pill helps patients excrete

sugar through their urine.

The new mechanism would make dapagliflozin the first entry in a class called

SGLT-2 inhibitors that work by allowing patients to excrete their excess blood

sugar in their urine. & , Eli Lilly & Co., Boehringer Ingelheim

GmbH, and Astellas Pharma Inc. are among the companies pursuing similar drugs.

The breast and bladder don’t express SGLT-2, Bristol-Myers and AstraZeneca

said in the statement.

Patients on dapagliflozin were more likely to have urinary tract and genital

infections than those taking metformin alone, according to the two-year results

released yesterday.

--Editors: Zimm, Sylvia Wier

To contact the reporter on this story: Lopatto in New York at

elopatto@....

To contact the editor responsible for this story: Reg Gale at

rgale5@....

Sent via BlackBerry by AT & T