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Details:
Under the termination, Neurimmune regained global rights to aducanumab, a recombinant human antibody developed to deplete brain amyloid, for the treatment and prevention of Alzheimer’s disease.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: $380.0 million Upfront Cash: Undisclosed
Deal Type: Termination January 31, 2024
Details:
The company withdrew its application following interactions with EMA’s Committee for Medicinal Products for Human Use indicating that data provided thus far would not be sufficient to support a positive opinion on marketing authorization of aducanumab by EMA.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Details:
The confirmatory ENVISION trial is a requirement based on FDA’s accelerated approval of ADUHELM® (aducanumab-avwa), a monoclonal antibody directed against amyloid beta, 100 mg/mL injection for intravenous use in early Alzheimer’s disease.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
The accelerated approval of ADUHELM, a monoclonal antibody has been granted based on data from clinical trials showing effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Data from the long-term extension study showed that ADUHELM (aducanumab-avwa) significantly reduced amyloid beta plaque levels out to Week 132. The data also showed that ADUHELM continued to decrease plasma p-tau181 levels at 128 weeks.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
The collaboration between both companies has resulted in the approval of ADUHELM in the U.S. as the first treatment to address a defining pathology of Alzheimer’s disease, which is a significant step into a new chapter of Alzheimer’s therapy.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 14, 2022
Details:
ADUHELM® (aducanumab-avwa) injection 100 mg/mL for intravenous use, is a monoclonal antibody that reduces amyloid-beta plaque and plasma p-tau181 is indicated for the treatment of Alzheimer’s disease.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2022
Details:
The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2022
Details:
ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2022
Details:
ADUHELM is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2021
Details:
Negative opinion has been Updated by EMA for Aduhelm (Aducanumab-avwa) and it is requested to re-examine the opinion by the CHMP, followed by submission of documentation with detailed grounds for the request.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai Co.
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
The accelerated approval of ADUHELM in the United States has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2021
Details:
The accelerated approval of ADUHELM in US has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
Details:
The analysis highlighted that ADUHELM (aducanumab-avwa) significantly reduced tau pathology, a defining feature of Alzheimer’s disease, as measured by plasma p-tau181, when compared to placebo. The effect was greater with higher doses and longer duration of ADUHELM treatment.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2021
Details:
Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 23, 2021
Details:
ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2021
Details:
The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2021
Details:
The efficacy of ADUHELM was evaluated in two Phase 3 clinical trials—EMERGE (Study 1) and ENGAGE (Study 2)—in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
The data of three separate clinical studies unequivocally show that aducanumab’s biological activity removed amyloid from brains of patients with Alzheimer’s disease.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: Aduhelm
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
Aducanumab, an amyloid beta-targeting antibody, has been shown in clinical trials to remove amyloid beta in the brain and significantly slow clinical decline in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
Data from Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab's eventual approval, boosting chances that Biogen's drug could the market for Alzheimer's patients in the future.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
Details:
Clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease demonstrate that treatment with aducanumab resulted in the removal of amyloid beta and better clinical outcomes.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2020
Details:
If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2020
Details:
Biogen’s AD portfolio of investigational assets includes aducanumab, an investigational treatment that, if approved, could meaningfully change the course of the disease.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
Biogen has requested Priority Review. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2020
Details:
Biogen has wrapped up construction on a "state-of-the-art" facility in Solothurn, Switzerland, that will be ready to manufacture aducanumab at scale beginning in mid-202.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 07, 2020
Details:
Biogen had scrapped two clinical studies of the drug, aducanumab, in March 2019 after initial analysis showed the trials would not succeed.
Lead Product(s): Aducanumab
Therapeutic Area: Neurology Product Name: BIIB037
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2020
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