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Details:
ANI will commercialize a generic version of the reference-listed drug Fleqsuvy (baclofen). It is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain.
Lead Product(s): Baclofen
Therapeutic Area: Neurology Product Name: Fleqsuvy-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 April 09, 2024
Details:
Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist. It is indicated for treatment of patients with multiple sclerosis, cerebral palsy, spinal cord injuries, and other conditions that result in muscle spasms.
Lead Product(s): Baclofen
Therapeutic Area: Neurology 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 March 18, 2024
Details:
Arbaclofen selectively activates GABA-B receptors to decrease presynaptic release of excitatory neurotransmitters while simultaneously decreasing excitability of the postsynaptic neuron.
Lead Product(s): Baclofen
Therapeutic Area: Genetic Disease Product Name: STX209
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 23, 2023
Details:
The financing by Neovacs will support Pharnext operations and cash requirements, in particular the Phase III PREMIER pivotal study assessing its PTX3003 (baclofen) candidate in CMT1A, a rare debilitating peripheral neuropathy with currently no existing approved therapy.
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PTX3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neovacs
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Financing October 03, 2022
Details:
PXT3003 (baclofen) completed an international Phase III trial with positive topline results for the treatment of CharcotMarie-Tooth disease type 1A (‘CMT1A’) and benefits from orphan drug status in Europe and the United States.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
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 13, 2022
Details:
PXT3003 (baclofen) is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day for the treatment of Charcot-Marie-Tooth disease type 1A.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
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 12, 2022
Details:
Clinically meaningful magnitudes of improvement were observed on all three ABCFX subscales for 45% of individuals receiving high dose of arbaclofen vs 4% treated with placebo (P=0.00003), clearly demonstrating efficacy of STX209 (arbaclofen) in individuals with Fragile X.
Lead Product(s): Baclofen
Therapeutic Area: Genetic Disease Product Name: STX209
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 14, 2022
Details:
LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Musculoskeletal Product Name: Lyvispah
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
New data from the ongoing Open-Label Phase III Extension Study of PXT3003 (baclofen), the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total trial time.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
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 16, 2022
Details:
Amneal is adding Saol’s experienced institutional commercial team for Lioresal that can be utilized to support product launches, including biosimilar products, filgrastim (biosimilar for Neupogen), pegfilgrastim (biosimilar for Neulasta) & bevacizumab (biosimilar for Avastin).
Lead Product(s): Baclofen
Therapeutic Area: Musculoskeletal Product Name: Lioresal
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amneal Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 05, 2022
Details:
PXT3003 is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day used in Charcot-Marie-Tooth Disease Type 1A.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
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 18, 2021
Details:
This financing agreement for up to 81 million euros will enable Pharnext to strengthen its cash position and continue to develop its pivotal Phase III clinical trial of PXT3003, the PREMIER trial, in Charcot-Marie-Tooth disease type 1A (CMT1A).
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alpha Blue Ocean
Deal Size: $96.0 million Upfront Cash: Undisclosed
Deal Type: Financing June 10, 2021
Details:
The new results announced today continue to show sustained treatment benefits for CMT1A patients treated with PXT3003 at High Dose (‘HD’) in the PLEO-CMT-FU Period 2 trial with a data readout at 54 months of total trial time (double-blind + open-label).
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
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 April 28, 2021
Details:
Arbaclofen is the active enantiomer of baclofen, a GABA-B receptor agonist. Statistically significant and clinically meaningful efficacy was observed in a prior Phase 3 trial conducted by Seaside Therapeutics in humans with Fragile X Syndrome.
Lead Product(s): Baclofen
Therapeutic Area: Genetic Disease Product Name: STX209
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Allos Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 19, 2020
Details:
The primary objective of this collaboration is to identify and validate potential treatment responsive CMT1A biomarkers that could be further explored in future clinical studies, in particular the upcoming Phase III study of PXT3003, Pharnext’s lead drug candidate.
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pharnext
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 03, 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:
Baclofen Tablets are indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Lead Product(s): Baclofen
Therapeutic Area: Musculoskeletal 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 July 10, 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
Details:
PXT3003 is a novel drug candidate for the treatment of CMT1A and has been granted both Orphan Drug Designation and Fast Track Designation by the US Food and Drug Administration.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Neurology 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 June 10, 2020
Details:
All existing data indicate that PXT3003 is a safe and well tolerated drug combination.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease 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 March 18, 2020
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