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Details:
Voydeya (danicopan) is a first-in-class, oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual haemolytic anaemia.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Voydeya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2024
Details:
Ultomiris (ravulizumab) has been approved in the US as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2024
Details:
Voydeya (danicopan) is an investigational oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual haemolytic anaemia.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Voydeya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Details:
Voydeya (danicopan) is a first-in-class oral Factor D inhibitor. It is approved in combination with Ultomiris or Soliris for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Voydeya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2024
Details:
Danicopan is an investigational oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who experience clinically significant extravascular haemolysis.
Lead Product(s): Danicopan,Ravulizumab,Eculizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: ALXN2040
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2023
Details:
OMERS has acquired royalties for Ultomiris (ravulizumab-cwvz), a humanized monoclonal antibody complement inhibitor for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, and Monjuvi (tafasitamab-cxix), used in combination with lenalidomide.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Xencor
Deal Size: $215.0 million Upfront Cash: Undisclosed
Deal Type: Divestment November 07, 2023
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. It is being recommended for the treatment of neuromyelitis optica spectrum disorder.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2023
Details:
ALXN2040 (danicopan) is an investigational oral medicine in development as an add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) for patients with PNH who experience clinically significant EVH.
Lead Product(s): Danicopan,Eculizumab,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: ALXN2040
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alexion Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2023
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. It is being recommended for the treatment of neuromyelitis optica spectrum disorder.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2023
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. It is EU approved for the treatment of neuromyelitis optica spectrum disorder.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. It is being recommended for the treatment of neuromyelitis optica spectrum disorder.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
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 April 03, 2023
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition,is administered intravenously every eight weeks in adult patients, following a loading dose.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
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 October 27, 2022
Details:
ULTOMIRIS (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
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 October 12, 2022
Details:
ULTOMIRIS (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
The data will show there were zero adjudicated on-trial relapses observed in patients with AQP4 Ab+ NMOSD with a median treatment duration of 73 weeks, representing a relapse risk reduction of 98.6% (p<0.0001) compared to the external placebo arm.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
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 October 12, 2022
Details:
In the trial, Ultomiris (ravulizumab-cwvz) was superior to placebo in the primary endpoint of change from baseline in the MG-ADL total score at Week 26, a patient-reported scale that assesses patients’ abilities to perform daily activities.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2022
Details:
The Phase III trial evaluating danicopan (ALXN2040) met its primary endpoint of change in haemoglobin from baseline at 12 weeks and key secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: ALXN2040
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
Details:
Danicopan (ALXN2040) plus ULTOMIRIS or SOLIRIS demonstrated superiority compared to placebo plus ULTOMIRIS or SOLIRIS for specific population and clinically meaningful improvements in hb levels, transfusion avoidance and FACIT Fatigue scores from baseline.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: ALXN2040
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. Ultomiris is approved in the US and Japan for the treatment of certain adults with gMG.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2022
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. Ultomiris is administered intravenously every eight weeks in adult patients, following a loading dose.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alexion Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
Positive high-level results from CHAMPION-NMOSD trial showed that Ultomiris (ravulizumab-cwvz) achieved a statistically significant and clinically meaningful reduction in risk of relapse in adults with anti-aquaporin-4 (AQP4) (Ab+) in NMOSD compared to external placebo arm.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
FDA approval based on positive results from CHAMPION-MG Phase III trial, in which ULTOMIRIS was superior to placebo in primary endpoint change from baseline in MG-ADL at Week 26, a patient-reported scale that assesses patients’ abilities to perform daily activities.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Approval by FDA was based on positive results from CHAMPION-MG Phase III trial, in which Ultomiris was superior to placebo in primary endpoint of change from baseline in the MG-ADL total score at Week 26, abilities to perform daily activities.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Prolonged results from Phase III CHAMPION-MG trial showed that Ultomiris demonstrated long-term efficacy in adults with AChR antibody-positive myasthenia gravis, with improvements in activities of daily living, muscle strength and quality of life, sustained through 60 weeks.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Product Name: Ultomiris
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 April 06, 2022
Details:
Submission based on positive Phase III trial in which Ultomiris (Ravulizumab-cwvz) significantly improved functional activities as measured by Myasthenia Gravis-Activities of Daily Living Profile.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Product Name: Ultomiris
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 December 21, 2021
Details:
Approval of Ultomiris is based on interim results from Phase III trial demonstrating complete terminal complement inhibition with reduced dosing frequency compared to Soliris.
Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2021
Details:
The IDMC recommended that the trial be discontinued due to lack of efficacy. No new safety findings were observed and the data were consistent with the established safety profile of Ultomiris.
Lead Product(s): Ravulizumab
Therapeutic Area: Neurology Product Name: Ultomiris
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alexion Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 20, 2021
Details:
The NICE recommendation of ravulizumab is based on the assessment of a comprehensive clinical and health economic submission by Alexion, as well as evidence provided by patient advocacy organisations and clinical experts.
Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
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 15, 2021
Details:
Alexion will pause further enrollment in the global Phase 3 study of ULTOMIRIS® in adults with severe COVID-19 requiring mechanical ventilation. Independent data monitoring committee recommends pausing study enrollment due to lack of efficacy in pre-specified interim analysis.
Lead Product(s): Ravulizumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Ultomiris
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 January 13, 2021
Details:
New data from 2 Phase 3 extension trials showing similar safety, consistent and durable efficacy of ULTOMIRIS® through 52 weeks when used to treat adults with paroxysmal nocturnal hemoglobinuria who are 65 and above than those who are 65 years old or younger to be presented.
Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
ULTOMIRIS 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL while delivering comparable safety and efficacy.
Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
ULTOMIRIS is the first and only long-acting C5 inhibitor for aHUS and is administered every other month for adults and children (20 kg or more) and monthly for children (<20 kg).
Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
ULTOMIRIS is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases—paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
PNH with Extravascular Hemolysis (EVH): Alexion plans to initiate a Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH by the end of 2020.
Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
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 30, 2020
Details:
Study will evaluate the impact of ULTOMIRIS, a biologic medicine, on survival, duration of mechanical ventilation, and hospital stay compared to best supportive care.
Lead Product(s): Ravulizumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2020
Details:
A 50-week global study to enroll approximately 350 patients across broad ALS population.
Lead Product(s): Ravulizumab
Therapeutic Area: Neurology Product Name: Ultomiris
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2020
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