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Details:
Argentina's regulatory body approved the drug product, Orladeyo® (berotralstat), a plasma kallikrein inhibitor, is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Details:
Orladeyo (berotralstat) is an oral, once-daily, plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Details:
Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
Under the collaboration, Er-Kim Pharmaceuticals will commercialize Orladeyo (berotralstat), the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older, in Turkey.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BioCryst Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 19, 2023
Details:
Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pint Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2023
Details:
Orladeyo® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) by decreasing the activity of plasma kallikrein in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 03, 2023
Details:
Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 January 26, 2023
Details:
Under the terms of the agreement, Swixx will be responsible for commercializing ORLADEYO in 15 markets within CEE. Orladeyo (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of HAE in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Swixx BioPharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 23, 2023
Details:
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 28, 2022
Details:
ORLADEYO® (berotralstat) is first and only oral therapy designed specifically to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 28, 2022
Details:
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Details:
Data from APeX-2 and APeX-S clinical trials evaluating oral, once-daily ORLADEYO (berotralstat) for prophylactic treatment of HAE showing sustained reductions in attack rates and improvement in QoL among patients living with HAE.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2022
Details:
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
Under the terms of the agreement, Pint Pharma will be responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in the pan-LATAM region.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BioCryst Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 09, 2022
Details:
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Details:
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
The 96-week data from APeX-2 showcase durable, long-term efficacy of ORLADEYO and build on strong reductions in attack rates that have previously been reported, with all patients experiencing an average of 94 percent attack-free days at Week 96.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 24, 2022
Details:
The data show that, regardless of which therapy patients switched from, or when they switched, ORLADEYO provided consistently low attack rates when used as a monotherapy. This oral, once-daily therapy is a beneficial treatment option for many HAE patients.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2021
Details:
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2021
Details:
ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. Approval was based on Phase 3 APeX-2 trial.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
The EC approval of ORLADEYO is applicable to all European Union member states plus Iceland, Norway and Liechtenstein. In the pivotal Phase 3 APeX-2 trial, ORLADEYO significantly reduced attacks at 24 weeks, and this reduction was sustained through 48 weeks.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 30, 2021
Details:
Oral, once-daily ORLADEYO was approved in Japan in January 2021 for prophylactic treatment of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Torii Pharmaceutical
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration April 14, 2021
Details:
ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2021
Details:
The European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of ORLADEYO™ (berotralstat) for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 25, 2021
Details:
BioCryst plans to invest the combined proceeds to support the launch of ORLADEYO in the U.S. and Europe and to advance the development of BCX9930 into clinical trials in multiple complement-mediated diseases.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $325.0 million Upfront Cash: $125.0 million
Deal Type: Funding December 07, 2020
Details:
The APeX-J trial met its primary endpoint of a reduction in the rate of HAE attacks for berotralstat 150 mg compared to placebo during the 24-week period. Berotralstat was safe and generally well-tolerated in the trial.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 November 30, 2020
Details:
Patients treated with oral, once-daily berotralstat 150 mg for 48 weeks experienced a sustained reduction in mean investigator confirmed HAE attack rates through month 12.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 November 13, 2020
Details:
Under the EAMS, hereditary angioedema (HAE) patients in the UK aged 12 years and older can gain access to berotralstat for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the European Commission (EC).
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 October 30, 2020
Details:
The data from APeX-2 show that berotralstat may provide an important oral option for patients with HAE that could allow them to prevent HAE attacks and reduce their overall burden of therapy.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Orladeyo
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 October 22, 2020
Details:
A new drug application for berotralstat is currently under review by the FDA with an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA).
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 June 09, 2020
Details:
BioCryst is going to present clinical data on Berotralstat which demonstrates robust and durable reduction in the rate of hereditary angioedema attacks over 48 weeks of the phase 3 apex-2 study.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 May 26, 2020
Details:
The allowed patent application covers crystalline salt forms of berotralstat active pharmaceutical ingredient (API).
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 May 05, 2020
Details:
150 mg of oral, once-daily berotralstat for prophylaxis of hereditary angioedema attacks reduced patients’ monthly use of standard of care on-demand medicine by 53.6 percent compared to placebo.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 March 16, 2020
Details:
In the NDA filing acceptance letter, the FDA stated that they are not currently planning to hold an advisory committee meeting to discuss the NDA.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 February 18, 2020
Details:
Torii Pharmaceutical will pay tiered royalties of up to 40 percent of Japanese net sales of berotralstat to BioCryst upon receipt of a reimbursement price approval NHI Japan.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Torii Pharmaceutical
Deal Size: $42.0 million Upfront Cash: $22.0 million
Deal Type: Agreement February 03, 2020
Details:
NDA submitted to U.S Food and Drug Administration in December 2019. APeX-J trial in Japan met its primary endpoint for prevention of HAE attacks, and berotralstat was well-tolerated.
Lead Product(s): Berotralstat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 January 12, 2020
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