Business Briefs

JDRF, Animas Ink Deal

The Juvenile Diabetes Research Foundation is collaborating with Animas, a division of Johnson & Johnson, to develop an automated system for insulin delivery—“the first step on the path to … the development of an artificial pancreas,” according to a statement from the JDRF. The first-generation system would be partially automated and would involve an insulin pump connected wirelessly with a continuous glucose monitor. The CGM would transmit its reading to the insulin pump, which would house a sophisticated computer program designed to prevent hypoglycemia and extreme hyperglycemia. The pump would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high. DexCom is supplying the CGM technology for the system. If successful, the development of this system “would begin the process of automating how people with diabetes manage their blood sugar,” said Alan Lewis, Ph.D., president and CEO of the JDRF. “Even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating, and treating themselves throughout the day.” The JDRF is providing $8 million in funding over 3 years for the project, and aims to have the system ready for regulatory review in about 4 years.

Takeda, Pfizer Market Actos in China

Takeda has signed a copromotion deal with Pfizer to market its Actos type 2 diabetes drug in China. U.S. market exclusivity for Actos (pioglitazone), which generated global sales of over $4 billion in 2008, ends in 2011. China is expected to become the third-largest pharmaceutical market by 2011 and many big drug makers have committed to developing business there, among other promising emerging countries. Pfizer is now the largest drug maker in the country, with 2008 sales of $428 million, a figure analysts project will grow to $1 billion in 2009. For the last 5 years, Takeda has in China been marketing Actos with Tianjin Takeda Pharmaceuticals, a joint venture of Takeda Pharmaceutical Company Limited and Tianjin Lisheng Pharmaceutical Co., a Chinese company. According to the new agreement, which is exclusive, Pfizer will market Actos with the Tianjin joint venture in exchange for an undisclosed cut of sales.

Phenomix Taking Dutogliptin to Europe

A little over a year after partnering with Forest Laboratories to develop the DPP-4 inhibitor dutogliptin for type 2 diabetes in North America, Phenomix has sealed a deal with Chiesi Farmaceutici to commercialize the drug in Europe. The deal is worth up to $28 million in near-term cash and the total value, which includes milestone payments, could reach $163 million. Dutogliptin is now part of a phase III clinical development program that includes five studies of 3,000 patients. The first results are due for release in the second quarter of 2010, according to Forest, which has been Phenomix's partner in North America since October 2008. Milestones in the Chiesi agreement are tied to development and commercialization of dutogliptin in Europe and other territories including Brazil, Russia, and all other members of the Commonwealth of Independent States, Turkey, and North Africa. Chiesi, of Parma, Italy, will be responsible for product development, regulatory approval, and commercialization in the territories covered by the deal. Phenomix, based in San Diego, will also receive an undisclosed cut of sales.

EndoBarrier Gets CE Mark

The EndoBarrier, an investigational gastrointestinal liner designed to mimic the effects of Roux-en-Y gastric bypass, has received CE mark approval for marketing in Europe, the product's maker, GI Dynamics, said in a statement. The EndoBarrier gastrointestinal liner is placed in the GI tract endoscopically to create a barrier between food and the wall of the intestine. The company noted that clinical trials involving more than 270 patients have shown the significant weight loss and diabetes improvement achieved with the EndoBarrier system. “This European approval for 6 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said Stuart A. Randle, the company's CEO.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

JDRF, Animas Ink Deal

The Juvenile Diabetes Research Foundation is collaborating with Animas, a division of Johnson & Johnson, to develop an automated system for insulin delivery—“the first step on the path to … the development of an artificial pancreas,” according to a statement from the JDRF. The first-generation system would be partially automated and would involve an insulin pump connected wirelessly with a continuous glucose monitor. The CGM would transmit its reading to the insulin pump, which would house a sophisticated computer program designed to prevent hypoglycemia and extreme hyperglycemia. The pump would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high. DexCom is supplying the CGM technology for the system. If successful, the development of this system “would begin the process of automating how people with diabetes manage their blood sugar,” said Alan Lewis, Ph.D., president and CEO of the JDRF. “Even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating, and treating themselves throughout the day.” The JDRF is providing $8 million in funding over 3 years for the project, and aims to have the system ready for regulatory review in about 4 years.

Takeda, Pfizer Market Actos in China

Takeda has signed a copromotion deal with Pfizer to market its Actos type 2 diabetes drug in China. U.S. market exclusivity for Actos (pioglitazone), which generated global sales of over $4 billion in 2008, ends in 2011. China is expected to become the third-largest pharmaceutical market by 2011 and many big drug makers have committed to developing business there, among other promising emerging countries. Pfizer is now the largest drug maker in the country, with 2008 sales of $428 million, a figure analysts project will grow to $1 billion in 2009. For the last 5 years, Takeda has in China been marketing Actos with Tianjin Takeda Pharmaceuticals, a joint venture of Takeda Pharmaceutical Company Limited and Tianjin Lisheng Pharmaceutical Co., a Chinese company. According to the new agreement, which is exclusive, Pfizer will market Actos with the Tianjin joint venture in exchange for an undisclosed cut of sales.

Phenomix Taking Dutogliptin to Europe

A little over a year after partnering with Forest Laboratories to develop the DPP-4 inhibitor dutogliptin for type 2 diabetes in North America, Phenomix has sealed a deal with Chiesi Farmaceutici to commercialize the drug in Europe. The deal is worth up to $28 million in near-term cash and the total value, which includes milestone payments, could reach $163 million. Dutogliptin is now part of a phase III clinical development program that includes five studies of 3,000 patients. The first results are due for release in the second quarter of 2010, according to Forest, which has been Phenomix's partner in North America since October 2008. Milestones in the Chiesi agreement are tied to development and commercialization of dutogliptin in Europe and other territories including Brazil, Russia, and all other members of the Commonwealth of Independent States, Turkey, and North Africa. Chiesi, of Parma, Italy, will be responsible for product development, regulatory approval, and commercialization in the territories covered by the deal. Phenomix, based in San Diego, will also receive an undisclosed cut of sales.

EndoBarrier Gets CE Mark

The EndoBarrier, an investigational gastrointestinal liner designed to mimic the effects of Roux-en-Y gastric bypass, has received CE mark approval for marketing in Europe, the product's maker, GI Dynamics, said in a statement. The EndoBarrier gastrointestinal liner is placed in the GI tract endoscopically to create a barrier between food and the wall of the intestine. The company noted that clinical trials involving more than 270 patients have shown the significant weight loss and diabetes improvement achieved with the EndoBarrier system. “This European approval for 6 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said Stuart A. Randle, the company's CEO.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.

JDRF, Animas Ink Deal

The Juvenile Diabetes Research Foundation is collaborating with Animas, a division of Johnson & Johnson, to develop an automated system for insulin delivery—“the first step on the path to … the development of an artificial pancreas,” according to a statement from the JDRF. The first-generation system would be partially automated and would involve an insulin pump connected wirelessly with a continuous glucose monitor. The CGM would transmit its reading to the insulin pump, which would house a sophisticated computer program designed to prevent hypoglycemia and extreme hyperglycemia. The pump would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high. DexCom is supplying the CGM technology for the system. If successful, the development of this system “would begin the process of automating how people with diabetes manage their blood sugar,” said Alan Lewis, Ph.D., president and CEO of the JDRF. “Even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating, and treating themselves throughout the day.” The JDRF is providing $8 million in funding over 3 years for the project, and aims to have the system ready for regulatory review in about 4 years.

Takeda, Pfizer Market Actos in China

Takeda has signed a copromotion deal with Pfizer to market its Actos type 2 diabetes drug in China. U.S. market exclusivity for Actos (pioglitazone), which generated global sales of over $4 billion in 2008, ends in 2011. China is expected to become the third-largest pharmaceutical market by 2011 and many big drug makers have committed to developing business there, among other promising emerging countries. Pfizer is now the largest drug maker in the country, with 2008 sales of $428 million, a figure analysts project will grow to $1 billion in 2009. For the last 5 years, Takeda has in China been marketing Actos with Tianjin Takeda Pharmaceuticals, a joint venture of Takeda Pharmaceutical Company Limited and Tianjin Lisheng Pharmaceutical Co., a Chinese company. According to the new agreement, which is exclusive, Pfizer will market Actos with the Tianjin joint venture in exchange for an undisclosed cut of sales.

Phenomix Taking Dutogliptin to Europe

A little over a year after partnering with Forest Laboratories to develop the DPP-4 inhibitor dutogliptin for type 2 diabetes in North America, Phenomix has sealed a deal with Chiesi Farmaceutici to commercialize the drug in Europe. The deal is worth up to $28 million in near-term cash and the total value, which includes milestone payments, could reach $163 million. Dutogliptin is now part of a phase III clinical development program that includes five studies of 3,000 patients. The first results are due for release in the second quarter of 2010, according to Forest, which has been Phenomix's partner in North America since October 2008. Milestones in the Chiesi agreement are tied to development and commercialization of dutogliptin in Europe and other territories including Brazil, Russia, and all other members of the Commonwealth of Independent States, Turkey, and North Africa. Chiesi, of Parma, Italy, will be responsible for product development, regulatory approval, and commercialization in the territories covered by the deal. Phenomix, based in San Diego, will also receive an undisclosed cut of sales.

EndoBarrier Gets CE Mark

The EndoBarrier, an investigational gastrointestinal liner designed to mimic the effects of Roux-en-Y gastric bypass, has received CE mark approval for marketing in Europe, the product's maker, GI Dynamics, said in a statement. The EndoBarrier gastrointestinal liner is placed in the GI tract endoscopically to create a barrier between food and the wall of the intestine. The company noted that clinical trials involving more than 270 patients have shown the significant weight loss and diabetes improvement achieved with the EndoBarrier system. “This European approval for 6 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe,” said Stuart A. Randle, the company's CEO.

Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.