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Societal CDMO
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Country
U.S.A
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Address
1300 Gould Dr. Gainesville, GA 30504
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Telephone
415-675-7401
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Details:

Under the agreement, Societal CDMO will provide a range of its Clinical Trial Services offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, the most active metabolite of the FDA approved SERM, tamoxifen.


Lead Product(s): Endoxifen

Therapeutic Area: Oncology Product Name: Endoxifen

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Atossa Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 23, 2023

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Under the agreement, Societal CDMO will provide to support the ongoing clinical development of iNexin™, a patented new chemical entity based on company's aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) platform.


Lead Product(s): iNexin

Therapeutic Area: Ophthalmology Product Name: iNexin

Highest Development Status: Phase IProduct Type: Peptide

Recipient: Xequel Bio

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 08, 2023

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The agreement spans a range of Societal CDMO’s offerings including technology transfer and analytical method validation activities to support Longboard’s Oral, Centrally Acting 5-HT2C Receptor Superagonist, LP352, being developed for treatment of refractory seizures.


Lead Product(s): LP352

Therapeutic Area: Neurology Product Name: LP352

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Longboard Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 05, 2023

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Under the agreement, Societal CDMO will manufacture all clinical, registration, and commercial batches of Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), an investigational medication for the treatment of Attention Deficit / Hyperactivity Disorder (ADHD).


Lead Product(s): Dexmethylphenidate

Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Cingulate Therapeutics, LLC

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 24, 2022

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The new contracts are focused on a range of analytic method, tech transfer, formulation, manufacturing and packaging services designed to support ongoing clinical development programs, as well as planned commercial activities.


Lead Product(s): Undisclosed

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement September 29, 2022

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Under terms of the first new contract, Societal will execute a range of clinical trial services to support the initiation of a U.S.-based Phase 2 clinical study of a novel melatonergic antidepressant already approved for use in Europe and Australia.


Lead Product(s): Undisclosed

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 04, 2022

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Under terms of the amendment, Societal will now receive improved overall economics, including a 10% increase in the profit share component of revenue from Verapamil PM product sales, as well as immediate and scheduled increases in manufacturing prices.


Lead Product(s): Verapamil Hydrochloride

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Verelan PM

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Lannett Company, Inc.

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 12, 2022

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Details:

AD101 (Raloxifene), a 100 Series lead compound and a novel T-type calcium channel modulator demonstrated statistically significant improvement in both core symptoms of AD in Concept Trials.


Lead Product(s): Raloxifene Hydrochloride

Therapeutic Area: Neurology Product Name: AD101

Highest Development Status: Phase IIProduct Type: Small molecule

Recipient: AmyriAD

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2022

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Under terms of the new contract, Societal will execute a range of clinical trial services to support the initiation of Phase 3 and Phase 4 clinical studies of AD101 (raloxifene).


Lead Product(s): Raloxifene Hydrochloride

Therapeutic Area: Neurology Product Name: AD101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: AmyriAD

Deal Size: $1.0 million Upfront Cash: Undisclosed

Deal Type: Agreement June 01, 2022

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Details:

Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the SODAS (Spheroidal Oral Drug Absorption System) technology.


Lead Product(s): Methylphenidate Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Ritalin LA

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: InfectoPharm Drugs and Consilium

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 05, 2022

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