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Genzyme, FDA Warn of Contamination
Genzyme and the Food and Drug Administration have issued warnings to patients and health care providers that certain lots of five biological drugs, including Thyrogen, have been found to be contaminated with a variety of foreign particles. Physicians have been directed to visually inspect the vials of the products in question before use and also to filter the products to ensure the removal of possible foreign particles. This latest contamination warning is yet another blow to the credibility of Genzyme's management team, which in June was forced to temporarily shut down the company's Allston, Mass., plant because of bioreactor contamination. The facility resumed production in August, and Genzyme asserts that the current problem is not related to recent efforts to decontaminate the plant. Nonetheless, all five of the products in question—Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen—are manufactured and/or finished and filled at the Allston plant. The Cambridge, Mass.–based company asks that vials observed to contain foreign particles be reported via a toll-free telephone number and returned to Genzyme; no adverse events related to the contamination have been reported.
Integrated Diagnostics Gets Financing
Integrated Diagnostics, a start-up diagnostics developer debuts with the support of a $30 million “Series A” financing round, led by InterWest Partners. The Seattle firm is developing genomic and proteomic technologies to identify organ-specific proteins and enable the diagnosis and prognosis of a variety of diseases. Areas of focus include personalized and preventive diagnostics for cancer, diabetes, and Alzheimer's disease.
“Integrated Diagnostics' research enabling technologies will allow us to cut in half the standard development times for diagnostics,” said company founder Leroy Hood. Launched Oct. 14, Integrated Diagnostics is an outgrowth of a public-private partnership between the nation of Luxembourg and several American research institutions, including the Seattle-based Institute for Systems Biology.
Tethys to Expand Rollout
Privately-held Tethys Bioscience is set to expand the rollout of its PreDx Diabetes Risk Score test, after securing $25 million in new financing. Previously, since its 2005 founding, the company had raised more than $54 million in financing. The test, which Tethys says helps identify those most at risk of developing type 2 diabetes, measures several biomarkers in a patient's blood sample, puts the results through an algorithm, and scores risk of developing diabetes within 5 years. Doctors can work with those at highest risk to prevent the onset of disease, according to the company. Launched in January 2009, the product is now available only from the company's California laboratory.
Tethys is in negotiations with a range of larger diagnostic players, including LabCorp, regarding a potential licensing deal that would make the test more widely available.
Takeda, Amylin Sign Deal
Takeda and Amylin have teamed up to develop and commercialize several obesity candidates, including pramlintide/metreleptin and davalintide, the companies have announced. The deal includes additional compounds from both companies' research pipelines. Under the arrangement with Takeda, Amylin will receive $75 million up front. Development and sales milestones across the multiple programs could total more than $1 billion. The deal calls for development milestones up to $200 million for two specific products and up to $50 million for any additional products. Commercial milestones are $140 million per product related to first sale of the products and up to $800 million per product for other sales-based milestones. Amylin is also eligible for double-digit royalties on sales. Amylin will be responsible for development of potential candidates through phase II for regulatory approval in the United States, while Takeda will lead development beyond phase II in the United States and elsewhere. Amylin will be responsible for paying 20% of development costs within the United States, while Takeda will be responsible for 80% of costs nationally and 100% of costs outside the country.
Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.
Genzyme, FDA Warn of Contamination
Genzyme and the Food and Drug Administration have issued warnings to patients and health care providers that certain lots of five biological drugs, including Thyrogen, have been found to be contaminated with a variety of foreign particles. Physicians have been directed to visually inspect the vials of the products in question before use and also to filter the products to ensure the removal of possible foreign particles. This latest contamination warning is yet another blow to the credibility of Genzyme's management team, which in June was forced to temporarily shut down the company's Allston, Mass., plant because of bioreactor contamination. The facility resumed production in August, and Genzyme asserts that the current problem is not related to recent efforts to decontaminate the plant. Nonetheless, all five of the products in question—Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen—are manufactured and/or finished and filled at the Allston plant. The Cambridge, Mass.–based company asks that vials observed to contain foreign particles be reported via a toll-free telephone number and returned to Genzyme; no adverse events related to the contamination have been reported.
Integrated Diagnostics Gets Financing
Integrated Diagnostics, a start-up diagnostics developer debuts with the support of a $30 million “Series A” financing round, led by InterWest Partners. The Seattle firm is developing genomic and proteomic technologies to identify organ-specific proteins and enable the diagnosis and prognosis of a variety of diseases. Areas of focus include personalized and preventive diagnostics for cancer, diabetes, and Alzheimer's disease.
“Integrated Diagnostics' research enabling technologies will allow us to cut in half the standard development times for diagnostics,” said company founder Leroy Hood. Launched Oct. 14, Integrated Diagnostics is an outgrowth of a public-private partnership between the nation of Luxembourg and several American research institutions, including the Seattle-based Institute for Systems Biology.
Tethys to Expand Rollout
Privately-held Tethys Bioscience is set to expand the rollout of its PreDx Diabetes Risk Score test, after securing $25 million in new financing. Previously, since its 2005 founding, the company had raised more than $54 million in financing. The test, which Tethys says helps identify those most at risk of developing type 2 diabetes, measures several biomarkers in a patient's blood sample, puts the results through an algorithm, and scores risk of developing diabetes within 5 years. Doctors can work with those at highest risk to prevent the onset of disease, according to the company. Launched in January 2009, the product is now available only from the company's California laboratory.
Tethys is in negotiations with a range of larger diagnostic players, including LabCorp, regarding a potential licensing deal that would make the test more widely available.
Takeda, Amylin Sign Deal
Takeda and Amylin have teamed up to develop and commercialize several obesity candidates, including pramlintide/metreleptin and davalintide, the companies have announced. The deal includes additional compounds from both companies' research pipelines. Under the arrangement with Takeda, Amylin will receive $75 million up front. Development and sales milestones across the multiple programs could total more than $1 billion. The deal calls for development milestones up to $200 million for two specific products and up to $50 million for any additional products. Commercial milestones are $140 million per product related to first sale of the products and up to $800 million per product for other sales-based milestones. Amylin is also eligible for double-digit royalties on sales. Amylin will be responsible for development of potential candidates through phase II for regulatory approval in the United States, while Takeda will lead development beyond phase II in the United States and elsewhere. Amylin will be responsible for paying 20% of development costs within the United States, while Takeda will be responsible for 80% of costs nationally and 100% of costs outside the country.
Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.
Genzyme, FDA Warn of Contamination
Genzyme and the Food and Drug Administration have issued warnings to patients and health care providers that certain lots of five biological drugs, including Thyrogen, have been found to be contaminated with a variety of foreign particles. Physicians have been directed to visually inspect the vials of the products in question before use and also to filter the products to ensure the removal of possible foreign particles. This latest contamination warning is yet another blow to the credibility of Genzyme's management team, which in June was forced to temporarily shut down the company's Allston, Mass., plant because of bioreactor contamination. The facility resumed production in August, and Genzyme asserts that the current problem is not related to recent efforts to decontaminate the plant. Nonetheless, all five of the products in question—Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen—are manufactured and/or finished and filled at the Allston plant. The Cambridge, Mass.–based company asks that vials observed to contain foreign particles be reported via a toll-free telephone number and returned to Genzyme; no adverse events related to the contamination have been reported.
Integrated Diagnostics Gets Financing
Integrated Diagnostics, a start-up diagnostics developer debuts with the support of a $30 million “Series A” financing round, led by InterWest Partners. The Seattle firm is developing genomic and proteomic technologies to identify organ-specific proteins and enable the diagnosis and prognosis of a variety of diseases. Areas of focus include personalized and preventive diagnostics for cancer, diabetes, and Alzheimer's disease.
“Integrated Diagnostics' research enabling technologies will allow us to cut in half the standard development times for diagnostics,” said company founder Leroy Hood. Launched Oct. 14, Integrated Diagnostics is an outgrowth of a public-private partnership between the nation of Luxembourg and several American research institutions, including the Seattle-based Institute for Systems Biology.
Tethys to Expand Rollout
Privately-held Tethys Bioscience is set to expand the rollout of its PreDx Diabetes Risk Score test, after securing $25 million in new financing. Previously, since its 2005 founding, the company had raised more than $54 million in financing. The test, which Tethys says helps identify those most at risk of developing type 2 diabetes, measures several biomarkers in a patient's blood sample, puts the results through an algorithm, and scores risk of developing diabetes within 5 years. Doctors can work with those at highest risk to prevent the onset of disease, according to the company. Launched in January 2009, the product is now available only from the company's California laboratory.
Tethys is in negotiations with a range of larger diagnostic players, including LabCorp, regarding a potential licensing deal that would make the test more widely available.
Takeda, Amylin Sign Deal
Takeda and Amylin have teamed up to develop and commercialize several obesity candidates, including pramlintide/metreleptin and davalintide, the companies have announced. The deal includes additional compounds from both companies' research pipelines. Under the arrangement with Takeda, Amylin will receive $75 million up front. Development and sales milestones across the multiple programs could total more than $1 billion. The deal calls for development milestones up to $200 million for two specific products and up to $50 million for any additional products. Commercial milestones are $140 million per product related to first sale of the products and up to $800 million per product for other sales-based milestones. Amylin is also eligible for double-digit royalties on sales. Amylin will be responsible for development of potential candidates through phase II for regulatory approval in the United States, while Takeda will lead development beyond phase II in the United States and elsewhere. Amylin will be responsible for paying 20% of development costs within the United States, while Takeda will be responsible for 80% of costs nationally and 100% of costs outside the country.
Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.