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Details:
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Lead Product(s): Amoxicillin Trihydrate,Rifabutin,Omeprazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
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, 2023
Details:
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
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:
Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics and a proton pump inhibitor (PPI) (omeprazole), used for the treatment of H. pylori infection.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
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 01, 2023
Details:
Under the agreement, RedHill will make Talicia, a novel, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole magnesium), approved for H. pylori infection, available via the PhilRx Patient Access Platform.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Phil
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2023
Details:
RHB-204 (clarithromycin) is a 70s Bacterial ribosome inhibitor combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
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 22, 2023
Details:
The Company intends to use the net proceeds for the development of RHB-204, a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 03, 2023
Details:
The net proceeds will be used in the development of RHB-204, a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 30, 2023
Details:
RHB-204 (clarithromycin) is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 08, 2023
Details:
RHB-204 is a Phase 3-stage proprietary, xed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
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:
BioVersys' lead candidate, BV100 (rifabutin), is being developed for lung and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii (CRAB).
Lead Product(s): Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: BV100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: AMR Action Fund
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing January 05, 2023
Details:
BV100 is a much-needed injectable formulation of rifabutin to treat serious infections caused by Carbapenem Resistant Acinetobacter baumannii in patients with ventilator-associated bacterial pneumonia, hospital-acquired bacterial pneumonia and bloodstream infections.
Lead Product(s): Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: BV100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: BioVersys AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 25, 2022
Details:
RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
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 August 17, 2022
Details:
Talicia (Omeprazole Magnesium) efficacy and safety profile evaluated in patients with H. pylori infection and diabetes mellitus, a large and challenging patient population associated with sub-optimal outcomes with clarithromycin-based H. pylori eradication therapy.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
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 25, 2022
Details:
Gaelan Medical will receive the exclusive rights to commercialize Talicia in the UAE, as well as a right of rst refusal to [1] 1 commercialize Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gaelan Medical
Deal Size: Undisclosed Upfront Cash: $2.0 million
Deal Type: Licensing Agreement January 06, 2022
Details:
Talicia is designed to address the high resistance of H. pylori bacteria to historical standard-of-care therapies. Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) with omeprazole magnesium.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
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 12, 2021
Details:
Talicia is designed to address the high resistance of H. pylori bacteria to historical standard-of-care therapies. Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) with omeprazole magnesium.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
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 06, 2021
Details:
U.S. patents for opaganib combination for the treatment of Ebola virus disease provides patent protection until 2035. Opaganib also undergoing two oncology Phase 2 U.S. studies as well as several development programs for inflammatory and viral indications, including Ebola.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Gastroenterology Product Name: RHB-104
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 August 23, 2021
Details:
RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Financing March 02, 2021
Details:
The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Gastroenterology Product Name: RHB-104
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 01, 2021
Details:
The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Gastroenterology Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering January 11, 2021
Details:
RedHill recently initiated a Phase 3 study evaluating the safety and efficacy of RHB-204 as a first-line treatment for pulmonary NTM disease, to be conducted at up to 40 sites across the U.S.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RHB-204
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 06, 2021
Details:
RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line therapy.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
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 20, 2020
Details:
BioVersys has developed a proprietary human IV formulation of BV100 for the CRAB hospital market and elucidated the unique mode of action that accounts for its tremendous potency and coverage of clinical CRAB isolates.
Lead Product(s): Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: BV100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
Details:
Orphan Drug Designation, along with RHB-204’s FDA QIDP priority designation, will extend U.S. potential market exclusivity to a total of 12 years.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
Details:
Pursuant to the agreement, the companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection. Cosmo is to receive the exclusive European rights to the new drug.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cosmo Pharmaceuticals
Deal Size: $21.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 13, 2020
Details:
The non-dilutive financing will support the acquisition of rights to Movantik® from AstraZeneca, the planned U.S. launch of Talicia® this quarter and the ongoing promotion of Aemcolo®.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: HealthCare Royalty Partners
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing February 25, 2020
Details:
RedHill provided a notice of termination to Entera Health regarding the license agreement for EnteraGam® and the co-promotion agreement with Advanz Pharma Corp. for Donnatal® will not be renewed.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Entera Health
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination Agreement January 21, 2020
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