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Numbrino™ (Cocaine Hydrochloride Nasal Solution) company's branded topical anesthetic product for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
Lead Product(s): Cocaine Hydrochloride
Therapeutic Area: Neurology Product Name: Numbrino
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 21, 2022
Details:
Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Glaricon
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: HEC Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2022
Details:
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
Recipient: Societal CDMO
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 12, 2022
Details:
The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: HEC-Glargine
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
Lannett Company has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva® Handihaler® (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd.
Lead Product(s): Tiotropium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Respirent Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 29, 2021
Details:
Respirent Pharmaceuticals has summited an Abbreviated New Drug Application for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. FDA. The product is the generic equivalent of ADVAIR DISKUS of GlaxoSmithKline.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2021
Details:
Lannett announced that it has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Flovent® Diskus® (Fluticasone Propionate Powder Inhaler) of Respirent Pharmaceuticals.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Flovent Diskus
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Respirent Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 17, 2020
Details:
Under the agreement, Lannett will primarily provide sales, marketing and distribution support for the product, for which it will receive a percentage of net profits. Other financial terms were not disclosed.
Lead Product(s): Mexiletine
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: RIVOPHARM SA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 23, 2020
Details:
The companies have entered into an interim exclusive supply and distribution agreement for Cediprof's FDA approved Levothyroxine Sodium Tablets USP. Lannett to Commence Marketing on August 3, 2020.
Lead Product(s): Levothyroxine Sodium
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cediprof
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 16, 2020
Details:
At the Biosimilar Biological Product Development Type II meeting the FDA provided positive feedback on the clinical and Chemistry, Manufacturing and Controls advancement of company's biosimilar insulin glargine that was consistent with our expectations.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
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