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Details:
Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna Triple Pack
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Phathom Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 24, 2022
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:
VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. It has been approved by FDA for the treatment of H. pylori infection in adults.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna Triple Pak
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 30, 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:
Amoxicillin oral suspension is one of the most commonly prescribed antibiotics for children for the treatment of particular bacterial infections. Amoxicillin represents the first product that Juno will successfully import to address drug shortages through this division.
Lead Product(s): Amoxicillin Trihydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Amoxicillin-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 January 04, 2023
Details:
Voquezna (vonoprazan) new treatment options contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Phathom Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 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:
VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) is an orally administered potassium-competitive acid blocker from a new class of acid suppressant agents and under development for treatment of erosive esophagitis and non-erosive gastroesophageal reflux disease.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna Triple Pack
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 24, 2022
Details:
The signing of this agreement both validates the belief in the blockbuster opportunity of Voquenza (vonoprazan) and provides near-term, non-dilutive funding for continued development activities and upcoming commercial launch.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Product Name: Voquenza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Morgan Stanley & Co.
Deal Size: $260.0 million Upfront Cash: $100.0 million
Deal Type: Agreement May 04, 2022
Details:
Vaquezna (vonoprazan)TRIPLE and DUAL PAKs each contain vonoprazan, a novel, first-in-class potassium-competitive acid blocker, and have demonstrated superior eradication rates vs. lansoprazole-based triple therapy in overall patient population of pivotal Phase 3 trial.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Product Name: Vaquezna Triple Pak
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 03, 2022
Details:
VOQUEZNA TRIPLE and DUAL PAKs each contain vonoprazan, a novel, first-in-class potassium-competitive acid blocker (PCAB), and have demonstrated superior eradication rates vs. lansoprazole-based triple therapy in the overall patient population of the pivotal Phase 3 trial.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna Dual Pak
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 03, 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:
Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate
Therapeutic Area: Infections and Infectious Diseases 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 October 21, 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 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:
Under the terms of the agreement, should the drug receive FDA approval for its lead product vonoprazan. Catalent will undertake the commercial manufacturing and packaging of the product at its large-scale oral solid dose manufacturing site in Winchester, Kentucky.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Phathom Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 16, 2021
Details:
Phathom Pharmaceuticals has submitted two NDAs to the U.S. FDA for the use of vonoprazan in combination with amoxicillin and clarithromycin and vonoprazan in combination with amoxicillin as a treatment for Helicobacter pylori (H. pylori) infection in adults.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate
Therapeutic Area: Infections and Infectious Diseases Product Name: Vonoprazan
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 08, 2021
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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