`
`Experimental Diabetes Drug
`Taspoglutide Late-Stage Trials
`Suspended
`
`By Christian Nordqvist on September 13, 2010
`
`Experimental diabetes drug, taspoglutide, a joint development between
`Roche (Switzerland) and Ipsen (France), had its late-stage trials
`suspended because of side effects. Roche announced that it had stopped
`giving patients taspoglutide because of adverse gastrointestinal
`reactions. The drug already has some “hypersensitivity problems”.
`
`The Swiss pharmaceutical company says it is not abandoning
`taspoglutide. In an announcement the company said it is considering a
`reformulation of the medication. However, any kind of reformulation will
`most likely result in a significant delay in the approval process and date.
`
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`
`Taspoglutide was predicted to become a blockbuster, with annual sales
`exceeding $2 billion per year. This suspension is seen as a major blow for
`both Roche and Ipsen.
`
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`
`
`
`Novo Nordisk Exhibit 2061
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
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`Roche reported on Friday that the rate of discontinuations due to
`gastrointestinal intolerability and serious hypersensitivity reactions
`experienced by some trial participants, led to a decision to suspend the
`trial.
`
`In a written statement, Roche informed:
`
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`
`
`
`Novo Nordisk Exhibit 2061
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`These discontinuation rates compromise interpretation of the
`long-term safety data from the T-emerge studies, therefore
`continuing treatment with the current taspoglutide formulation is
`not considered to be in the best interest of patients.
`
`Earlier on this year disappointing data had been presented at the
`American Diabetes Association revealing hypersensitivity, nausea and
`vomiting among patients taking the experimental drug. Patients were
`receiving a once-weekly injection.
`
`Taspoglutide is a glucagon-like peptide-1 analog drug under investigation
`for treatment of type 2 diabetes.
`
`According to media reports, shares in the French pharmaceutical
`company, Ipsen fell 3% today.
`
`Written by Christian Nordqvist
`
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`
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`
`
`
`Novo Nordisk Exhibit 2061
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
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