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Details:
Dr. Reddy's Laboratories launched Ciprofloxacin0.3%and Dexamethasone 0.1% Otic Suspension,USP,a therapeutic equivalent generic version ofCiprodex®(ciprofloxacin 0.3% and dexamethasone 0.1%)Otic Suspension,approved by the U.S. Food andDrug Administration (USFDA).
Lead Product(s): Ciprofloxacin,Dexamethasone
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 11, 2020
Details:
Lonza will develop, optimize, and qualify a method utilizing Neuron-Derived Exosomes, set to be integrated into the development program of PrimeC, a novel extended-release oral formulation of a unique fixed-dose combination of ciprofloxacin and celecoxib, by NeuroSense.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lonza Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 09, 2024
Details:
Ciprofloxacin and dexamethasone otic suspension is a combination product which is indicated for the treatment of Acute Otitis Externa in pediatric (age 6 months and older), adult & elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
Lead Product(s): Ciprofloxacin,Dexamethasone
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Ciprodex-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 25, 2024
Details:
PrimeC is a novel extended-release oral formulation composed of a unique FDC of ciprofloxacin and celecoxib. It is under phase 2 clinical development for the treatment of amyotrophic lateral sclerosis (ALS).
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2024
Details:
PrimeC is a novel extended-release oral formulation composed of a unique FDC of ciprofloxacin and celecoxib. It is under phase 2 clinical development for the treatment of amyotrophic lateral sclerosis (ALS).
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
Details:
PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2023
Details:
PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2023
Details:
NeuroSense terminated the offering as the company is fully funded beyond clinical phase 2b ALS results of PrimeC, a unique formulation of a fixed-dose combination drug comprising ciprofloxacin and celecoxib, for amyotrophic lateral sclerosis.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering October 02, 2023
Details:
The net proceeds will advance the clinical development of PrimeC (ciprofloxacin) for amyotrophic lateral sclerosis and for the clinical development potential investigational new drug applications for Alzheimer's disease, for Parkinson's disease and for other indications.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $4.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 22, 2023
Details:
Under the terms of the agreement, Biogen will evaluate the impact of PrimeC (ciprofloxacin) and celecoxib on neurofilament levels in the plasma of participants in PARADIGM, NeuroSense’s Phase 2b clinical trial for the treatment of amyotrophic lateral sclerosis.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 14, 2023
Details:
PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2023
Details:
StabiliC is a combination consisting of ciprofloxacin and celecoxib which is currently being investigated in preclinical studies for the treament of parkinson's disease.
Lead Product(s): Celecoxib,Ciprofloxacin
Therapeutic Area: Neurology Product Name: StabiliC
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
NeuroSense & Massachusetts General Hospital will explore the neurotherapeutic effects of PrimeC, utilizing a novel in vitro model generated from post-mortem ALS brain tissue. PrimeC is a novel unique fixed-dose combination of ciprofloxacin and celecoxib.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Massachusetts General Hospital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 27, 2023
Details:
PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2023
Details:
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2022
Details:
PrimeC is a novel formulation composed of unique doses of two FDA-approved drugs, Ciprofloxacin and Celecoxib, which aim to synergistically inhibit the progression of ALS by aiming to regulate microRNA synthesis, reduce neuroinflammation, and influence iron accumulation.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
PrimeC's (ciprofloxacin) upgraded formulation, which is a unique extended-release tablet, designed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
PrimeC (ciprofloxacin) is a novel extended-release oral formulation composed of a unique fixed-dose combination of the two drugs, which are U.S. Food and Drug Administration (FDA)-approved. NeuroSense is currently evaluating PrimeC in PARADIGM, a Phase IIb clinical trial.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
Phase IIa clinical study of PrimeC's (ciprofloxacin) successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC (ciprofloxacin) biological activity.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
PrimeC is a novel formulation composed of unique doses of two FDA-approved drugs, Ciprofloxacin and Celecoxib, which aim to synergistically inhibit the progression of ALS.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
Phase IIa study for PrimeC (Ciprofloxacin), successfully met safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biomarkers.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
PrimeC (ciprofloxacin), is a novel formulation consisting of unique doses of two FDA-approved drugs designed to work synergistically on several targets including regulating microRNA synthesis, affecting iron accumulation, and reducing neuroinflammation.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
The patent covers NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, two US FDA-approved drugs that are active ingredients in PrimeC, for treating amyotrophic lateral sclerosis.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of two drugs ciprofloxacin and celecoxib, is designed to synergistically target key mechanisms of amyotrophic lateral sclerosis.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
Deal will allow Binnopharm Group to acquire anti-bacterial medicines under the Ciprolet® and Levolet® brands from Dr. Reddy’s in Russia, Uzbekistan and Belarus. The portfolio includes various dosage forms such as tablets, solution for infusions and eye drops.
Lead Product(s): Ciprofloxacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Ciprolet
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dr. Reddy\'s Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 21, 2022
Details:
The positive opinion from the CHMP was based on the EARNEST trial, which assessed the safety and efficacy of Entyvio (vedolizumab) IV if approved it Will Be the First Authorized Treatment in Europe for active chronic pouchitis.
Lead Product(s): Vedolizumab,Ciprofloxacin
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
OTIPRIO is a sterile, preservative-free, otic suspension of 6 percent ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.
Lead Product(s): Ciprofloxacin
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otiprio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ALK
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 03, 2021
Details:
The study, NST002, aimed at establishing various safety endpoints for the company's first drug candidate PrimeC in 15 ALS patients, over a 12-month period. Study results clearly demonstrated that the drug was both safe and tolerable in ALS patient population.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct 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 decision by the EMA to grant orphan designation to PrimeC comes on the heal of another achievement which saw NeuroSense granted a Seal of Excellence by the European Commission, indicating a vote of confidence in NeuroSense's scientific and clinical programs.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: PrimeC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2021
Details:
Under the terms of the agreement, ALK will have exclusive rights to promote OTIPRIO for AOE to office-based healthcare professionals in the U.S. including ENT physicians, pediatricians and select primary care physicians.
Lead Product(s): Ciprofloxacin
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otiprio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otonomy
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 17, 2020
Details:
Under the terms of the agreement, Savara has obtained the worldwide rights to develop and commercialize Apulmiq.
Lead Product(s): Ciprofloxacin
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Savara
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 02, 2020
Details:
Grifols, S.A.will acquire the Company’s assets and intellectual property that pertain to Lipoquin, Free Ciprofloxacin, Apulmiq and any derivatives thereof.
Lead Product(s): Ciprofloxacin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Grifols International
Deal Size: $6.2 million Upfront Cash: $3.2 million
Deal Type: Acquisition February 21, 2020
Details:
The clinical trials initiated in the United States and in Israel will evaluate safety, tolerability and efficacy of PrimeC, NeuroSense's product for ALS patients.
Lead Product(s): Ciprofloxacin,Celecoxib
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2020
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