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Details:
Through a licensing agreement, Apotex will market and distribute Verkazia (cyclosporine) ophthalmic emulsion, which is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Verkazia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Apotex Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 15, 2024
Details:
Cequa (cyclosporine ophthalmic solution) is a patented, novel, proprietary nanomicellar NCELL formulation of cyclosporine in a clear, preservative-free, aqueous solution. It is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Cequa
Highest Development Status: Phase IVProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2023
Details:
CyclASol (cyclosporine) solubilized in a novel water-free excipient, perfluorobutylpentane, it is specifically developed as a potent and comfortable anti-inflammatory dry eye drug therapy with rapid onset of effect for dry eye patients.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: CyclASol
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2023
Details:
Through acquisition, Harrow gains U.S. and Canadian commercial rights for Vevye (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol® water-free technology.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Vevye
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Harrow
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition July 17, 2023
Details:
Vevye (cyclosporine ophthalmic solution) is solubilized in a novel and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Vevye
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2023
Details:
Cyclotears 0.05% eye drops contains cyclosporin which belongs to the group of medicines called Immunosuppressants. It is used to treat severe dry eye syndrome (keratoconjunctivitis sicca) in children and in adolescents (aged between 4-18 years).
Lead Product(s): Cyclosporine,Benzalkonium Chloride
Therapeutic Area: Ophthalmology Product Name: Cyclotears
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2023
Details:
Cequa (cyclosporine ophthalmic solution) is a calcineurin inhibitor immunosuppressant agent is now approved as a novel therapy for dry eye disease in India.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Cequa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2023
Details:
CyclASol® consists of cyclosporine solubilized in a novel water-free excipient, perfluorobutylpentane , it is specifically developed as a potent and comfortable anti-inflammatory dry eye drug therapy with rapid onset of effect for dry eye patients.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: CyclASol
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2023
Details:
CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: CyclASol
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
To minimize potential toxicity a relatively low oral dose of 5 mg/kg/day for a duration of 5 days was selected to be administered to patients randomized into the CSA (cyclosporine) arm.
Lead Product(s): Cyclosporine,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: CsA
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
The Company’s intellectual property portfolio, which includes additional pending patents, covers a broad formulation platform of a unique suspension comprising aqueous, amorphous nanodispersions of cyclosporine.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Cyclosporine-Generic
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
The primary endpoint of this prospective, multicenter, non-randomized study was the improvement of treatment response with Arscimed® (arsenic trioxide) in combination with prednisone, with or without cyclosporine.
Lead Product(s): Arsenic Trioxide,Prednisone,Cyclosporine
Therapeutic Area: Immunology Product Name: Arscimed
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 20, 2022
Details:
Verkazia (cyclosporine) is a prescription-only, uniquely formulated cationic nanoemulsion that provides improved ocular bioavailability of cyclosporine, which has been shown to be effective in the management of VKC.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Verkazia
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
Wellspring Ophthalmics’ newly acquired proprietary broad formulation platform is an innovative suspension comprising aqueous, amorphous nanodispersions of cyclosporine. These formulations are designed to have higher bioavailability for better efficacy and improved dry eye.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: WellSpring
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 23, 2022
Details:
Cyclica’s platform and capabilities in combination with the biological assay development of Arctoris will enable us to yield meaningful results and advance research development for patients suffering from Alzheimers and other neurodegenerative diseases.
Lead Product(s): Cyclosporine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: DiscoveryProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Arctoris
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 23, 2022
Details:
Mylan got approval of generic version of Restasis (cyclosporine ophthalmic emulsion) 0.05% used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Cyclosporine-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2022
Details:
CEQUA (Cyclosporine), a calcineurin inhibitor immunomodulator nanomicellar technology improves the bioavailability and physicochemical stability of cyclosporine to increase ocular tissue penetration.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Cequa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2022
Details:
The patient group receiving CsA Ophthalmic Gel (0.05%, q.d.) has demonstrated statistically significant (P<0.0001) and clinically meaningful improvements in ICSS compared to the patient group receiving a comparator treatment.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2021
Details:
CyclASol® is a topical, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine A in EyeSol®, developed for the treatment of DED.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: CyclASol
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2021
Details:
Verkazia is a prescription-only, uniquely-formulated oil-in-water cationic emulsion that provides improved ocular bioavailability of cyclosporine, which has been shown to be effective in the management of VKC.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Verkazia
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2021
Details:
Mycophenolate Mofetil Tablets USP, 500 mg, are the generic equivalent of CellCept® Tablets of Roche Palo Alto, indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants and to be used with other immunosuppressants.
Lead Product(s): Mycophenolate Mofetil,Cyclosporine,Corticosteroids
Therapeutic Area: Immunology Product Name: Mofecon
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 29, 2020
Details:
Cyclosporine topical ophthalmic emulsion, 0.1% is an investigational treatment for severe VKC in patients ages 4-18. U.S. Food and Drug Administration (FDA) has accepted its NDA submission which is supported by robust data from VEKTIS trial.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: NOVA22007
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Subjects treated with OTX-CSI demonstrated an improvement in signs of DED and an improvement in symptoms of Dry Eye Disease. OTX-CSI is a cyclosporine intracanalicular insert for the treatment of dry eye disease.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: OTX-CSI
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 08, 2020
Details:
The Phase 2 clinical trial is a U.S.-based, randomized, masked, multi-center trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: OTX-CSI
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 29, 2020
Details:
Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
Lead Product(s): Mycophenolate Mofetil,Cyclosporine,Corticosteroids
Therapeutic Area: Immunology Product Name: Mofecon
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 06, 2020
Details:
First study to evaluate the frequency and severity of COVID‐19 in patients treated with Cyclosporin A. There are no evidences that support a preventative discontinuation of CsA during COVID‐19 outbreak in patients with psoriasis and atopic dermatitis, the study concludes.
Lead Product(s): Cyclosporine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 June 01, 2020
Details:
The study will evaluate safety and tolerability of OTX-CSI and assess biological activity by measuring signs and symptoms of DED over this time period.
Lead Product(s): Cyclosporine
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 May 12, 2020
Details:
FDA has granted Fast Track designation to Liposomal Cyclosporine A for Inhalation (L‑CsA‑i), in late-stage clinical development for the treatment of Bronchiolitis Obliterans Syndrome.
Lead Product(s): Cyclosporine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2020
Details:
Company initiated BOSTON-4 phase 2 multi-center clinical study of Liposomal Cyclosporine A for Inhalation (L‑CsA‑i) for the treatment of bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic stem cell transplant (alloHSCT).
Lead Product(s): Cyclosporine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2020
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