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RELEXXII® (methylphenidate hydrochloride extended-release tablets) is an oral medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults up to the age of 65 and pediatric patients 6 years of age and older.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Relexxii
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Brand Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2022
Details:
The financing provides the Company with additional cash to support the commercialization of Upneeq. As a first-in-class treatment for acquired ptosis, Upneeq offers patients and clinicians a convenient non-surgical therapeutic option.
Lead Product(s): Oxymetazoline Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Upneeq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Athyrium Capital Management
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 07, 2021
Details:
Osmotica will retain the RVL Pharmaceuticals business focused on ophthalmology and aesthetics, led by its flagship product, UPNEEQ (Oxymetazoline Hydrochloride).
Lead Product(s): Oxymetazoline Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Upneeq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alora Pharmaceuticals
Deal Size: $170.0 million Upfront Cash: $110.0 million
Deal Type: Divestment June 25, 2021
Details:
Through this acquisition, OSMOLEX ER joins the Adamas portfolio which includes GOCOVRI® extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications.
Lead Product(s): Amantadine Hydrochloride
Therapeutic Area: Neurology Product Name: Osmolex ER
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Adamas Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 05, 2021
Details:
Under the terms of the agreement, both parties will drop their respective claims relating to the patent litigation, and Adamas will acquire the global rights to OSMOLEX ER for $7.5 million.
Lead Product(s): Amantadine Hydrochloride
Therapeutic Area: Neurology Product Name: Osmolex ER
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Adamas Pharmaceuticals
Deal Size: $7.5 million Upfront Cash: Undisclosed
Deal Type: Agreement December 02, 2020
Details:
Phase 3 trials showed UPNEEQ was associated with positive outcomes after instillation on days 1 and 14 and was well-tolerated, demonstrating its potential promise for the treatment of acquired ptosis.
Lead Product(s): Oxymetazoline Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Upneeq
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 01, 2020
Details:
Osmotica Pharmaceuticals plc is developing arbaclofen ER tablets for the treatment of spasticity in patients with MS. This program aims to demonstrate the clinical efficacy and safety of arbaclofen ER tablets in patients with spasticity due to MS.
Lead Product(s): Baclofen
Therapeutic Area: Neurology Product Name: AERT
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 July 20, 2020
Details:
U.S FDA has approved Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision.
Lead Product(s): Oxymetazoline Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Upneeq
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 09, 2020
Details:
Submission based on world’s largest database of patients treated for spasticity associated with Multiple Sclerosis.
Lead Product(s): Baclofen
Therapeutic Area: Neurology Product Name: AERT
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 June 30, 2020
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