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Details:
Nefegan (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. it is approved for the treatment of primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefegan
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 19, 2024
Details:
Under the agreement, Mankind Pharma will distribute AstraZeneca's anti-asthma inhaled corticosteroid drug Symbicort, (budesonide/formoterol) approved to treat asthma and COPD, in India.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Symbicort
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mankind Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 13, 2024
Details:
Nefecon (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. it is approved for the treatment of primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Everest Medicines
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2024
Details:
TARPEYO (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism, used for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Tarpeyo
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 06, 2024
Details:
Eohilia (budesonide) is an oral suspension, glucocorticoid receptor agonist, which is approved by USFDA for the treatment of Eosinophilic Esophagitis (EoE).
Lead Product(s): Budesonide
Therapeutic Area: Gastroenterology Product Name: Eohilia
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 12, 2024
Details:
Airsupra (albuterol/budesonide) formerly known as PT027, is a first-in-class SABA/ICS. It is now available as the first and only FDA-approved anti-inflammatory rescue option for asthma.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Airsupra
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 22, 2024
Details:
Nefecon (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. it is approved for the treatment of primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 26, 2023
Details:
Tarpeyo (Budesonide), a delayed-release capsule and a Glucocorticoid receptor agonist, has been approved by the U.S. FDA for the indication of kidney function loss in adults with primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Tarpeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. It is being evaluated for the treatment of primary IgA nephropathy in adult patients.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 29, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2023
Details:
Nefecon (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. it is approved for the treatment of primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 27, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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, 2023
Details:
TAK-721 (budesonide oral suspension) is a novel mucoadherent topically active oral viscous formulation of budesonide, formulated specifically as an investigational treatment for eosinophilic esophagitis (EoE).
Lead Product(s): Budesonide
Therapeutic Area: Gastroenterology Product Name: TAK-721
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 20, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 24, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 20, 2023
Details:
Tarpeyo (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism, used for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Tarpeyo
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, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 31, 2023
Details:
Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is the first generic version of AstraZeneca's Symbicort drug-device combination product and is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breyna
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 31, 2023
Details:
TARPEYO (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism, used for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Tarpeyo
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 21, 2023
Details:
Budesonide is a prescription corticosteroid medicine used to help get active, mild to moderate ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission).
Lead Product(s): Budesonide
Therapeutic Area: Gastroenterology Product Name: Uceris-Generic
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 28, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 24, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 06, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary iga nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 12, 2023
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It is being investigated for primary iga nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2023
Details:
Airsupra (albuterol/budesonide), is a first-in-class SABA/ICS rescue treatment for asthma in the US. It is an inhaled, fixed-dose combination of albuterol, a SABA, and budesonide, and has been developed in a pMDI using AstraZeneca’s Aerosphere delivery technology.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Airsupra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Avillion LLP
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2023
Details:
Nefecon (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2022
Details:
Nefecon (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Viatris
Deal Size: $100.0 million Upfront Cash: $20.0 million
Deal Type: Licensing Agreement December 13, 2022
Details:
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
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 27, 2022
Details:
TARPEYO® (budesonide) is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism.
Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: TARPEYO
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2022
Details:
The acceptance brings Nefecon (budesonide), approved and marketed in the U.S. under the name TARPEYO® and in the E.U. as Kinpeygo®,first-ever approved therapeutic option indicated for primary IgAN treatment.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2022
Details:
PT027 (albuterol/budesonide) is a potential first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication in the US containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS).
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PT027
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Avillion LLP
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2022
Details:
TARPEYO® (budesonide) delayed release capsules is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Tarpeyo
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 19, 2022
Details:
Nefecon (budesonide) is a patented novel, investigational oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the ileum where the Peyer’s patches are concentrated.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
Kinpeygo ®(developed under name NEFECON) is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Kinpeygo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
Details:
PT027 (Albuterol Sulfate) is a potential first-in-class inhaled, fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS), in the US, being developed by Avillion and AstraZeneca under an agreement.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PT027
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
Kinpeygo (budesonide) will be the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Kinpeygo
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 19, 2022
Details:
Full results from positive MANDALA Phase III trial showed that PT027 (albuterol/budesonide) at two different strengths of budesonide, demonstrated a statistically significant reduction in risk of a severe exacerbation versus albuterol rescue in patients with asthma.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PT027
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 15, 2022
Details:
NEFECON, a delayed-release formulation of budesonide, with potent glucocorticoid activity and weak mineralocorticoid activity, showed reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after 9 months of treatment in Phase 3 clinical trial NefIgArd.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
In review of marketing authorisation application (MAA) for NEFECON, the CHMP has informed that they will issue an additional list of questions related to manufacturing-related information which will result in the opinion from EMA slipping into the second quarter.
Lead Product(s): Budesonide
Therapeutic Area: Neurology Product Name: Nefecon
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 22, 2022
Details:
Breyna (Budesonide and Formoterol Fumarate Dihydrate), first approved generic version of AstraZeneca's Symbicort, a drug-device combination product, is indicated for certain patients with asthma or COPD and will be available in 160 /4.5 and 80/4.5 mcg dosage strengths.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breyna
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kindeva Drug Delivery
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
U.S.FDA approved generic budesonide and formoterol fumarate dihydrate aerosol for treatment of two pulmonary health conditions: asthma in patients six years of age and older; and maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Budesonide/Formoterol Fumarate Dihydrate-Generic
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 15, 2022
Details:
License agreement with Calliditas Therapeutics, will develop and commercialize NEFECON for the treatment of primary IgA nephropathy (IgAN) in South Korea, expanding its license in addition to rights held in Greater China and Singapore.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Everest Medicines
Deal Size: Undisclosed Upfront Cash: $3.0 million
Deal Type: Licensing Agreement March 14, 2022
Details:
A recently completed Phase I clinical trial of the propellant HFO-1234ze in a pMDI containing budesonide, glycopyrronium, formoterol fumarate in healthy adults was positive, demonstrating similar safety and tolerability profile.
Lead Product(s): Budesonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 22, 2022
Details:
TARPEYO™ (budesonide) is approved under accelerated approval based on achieving its primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study. It is expected that TARPEYO will be available in the U.S. early in the first quarter of 2022.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Tarpeyo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2021
Details:
Under the terms of the agreement, Shandong Luoxin will gain the exclusive rights for the development, manufacture, and commercialization of Budesolv® (Budesonide Nasal spray) in China (including Chinese mainland, Hong Kong and Macao SAR, Taiwan region).
Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Budesolv
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Luoxin Pharmaceutical
Deal Size: $22.0 million Upfront Cash: $2.0 million
Deal Type: Licensing Agreement October 19, 2021
Details:
Nefecon, is a proprietary, novel oral formulation of budesonide got MAA for IgA Nephropathy. With revised standard assessment timeline Calliditas estimates potential impact of 3 months on previously communicated timelines with expected decision by EMA in Q1 2022.
Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Nefecon
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, 2021
Details:
Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN).
Lead Product(s): Budesonide
Therapeutic Area: Immunology Product Name: Nefecon
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 14, 2021
Details:
PT027 significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma in MANDALA trial when used as a rescue medicine in response to symptoms.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PT027
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Avillion LLP
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2021
Details:
The partnership relates to a novel oral formulation, developed under the project name ‘Nefecon’, of a potent and well-known active substance – budesonide – designed to target down regulation of IgA1 with a view to be disease modifying.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Product Name: Nefecon
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: STADA Arzneimittel
Deal Size: $115.0 million Upfront Cash: $24.0 million
Deal Type: Partnership July 21, 2021
Details:
Iconovo is working on a generic Symbicort in ICOres with Amneal. The extended agreement covers 90 percent of the global Symbicort market, doubling the expected annual royalty revenue from Amneal.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ICOres
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Iconovo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 17, 2021
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