Athena Pharmaceutiques Oral Dispersible Tablets

Athena Pharmaceutiques Oral Dispersible Tablets

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Halozyme Completes Antares Pharma Acquisition

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Halozyme and Antares will create a drug delivery and specialty product company. The Antares business consists of a best-in-class, auto injector and ENHANZE platform that offers broad licensing opportunity, with 3 commercial products including Tlando (testosterone undecanoate).

Lead Product(s): Testosterone Undecanoate

Therapeutic Area: Endocrinology Product Name: Tlando

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Halozyme Therapeutics

Deal Size: $960.0 million Upfront Cash: $960.0 million

Deal Type: Acquisition May 24, 2022

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FDA Approves TLANDO® (testosterone undecanoate), an Oral Treatment for Testosterone Replacement Therapy by Antares Pharma, Inc., developed by Lipocine Inc.

Details:

TLANDO® is an oral treatment for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone in adult males.

Lead Product(s): Testosterone Undecanoate

Therapeutic Area: Endocrinology Product Name: Tlando

Highest Development Status: Approved Product Type: Small molecule

Recipient: Lipocine

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 25, 2022

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Halozyme to Acquire Antares Pharma to Create a Specialty Product and Drug Delivery Leader

Details:

The combination of Halozyme and Antares will create a drug delivery and specialty product company. The Antares business consists of a best-in-class, auto injector and ENHANZE platform that offers broad licensing opportunity, with 3 commercial products including Tlando.

Lead Product(s): Testosterone Undecanoate

Therapeutic Area: Endocrinology Product Name: Tlando

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Halozyme Therapeutics

Deal Size: $960.0 million Upfront Cash: $960.0 million

Deal Type: Acquisition April 13, 2022

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Antares Pharma Announces FDA Approval Of TLANDO, an Oral Treatment for Testosterone Replacement Therapy

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TLANDO ® (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”) indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males.

Lead Product(s): Testosterone Undecanoate

Therapeutic Area: Endocrinology Product Name: Tlando

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Lipocine

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 29, 2022

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Antares Pharma Announces Positive Results From Phase I Study For ATRS-1902 For Adrenal Crisis Rescue

Details:

The results of the Phase I study met its primary objective showing ATRS-1902 delivered a comparable pharmacokinetic profile and also demonstrated that ATRS-1902 was safe and well-tolerated for the treatment of acute adrenal insufficiency.

Lead Product(s): Hydrocortisone

Therapeutic Area: Endocrinology Product Name: ATRS-1902

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 11, 2022

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Assertio Holdings, Inc. Announces the Acquisition of Otrexup® (Methotrexate) a Drug Device Combination from Antares Pharma, Inc.

Details:

Under the terms of the definitive agreements, Assertio acquired Otrexup from Antares in a partially seller financed transaction inclusive of working capital investments. Otrexup is a once weekly single dose auto-injector containing a prescription medicine, methotrexate.

Lead Product(s): Methotrexate

Therapeutic Area: Immunology Product Name: Otrexup

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Assertio Holdings

Deal Size: $44.0 million Upfront Cash: $18.0 million

Deal Type: Acquisition December 15, 2021

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Antares Pharma Enters into Exclusive License Agreement With Lipocine for TLANDO® in U.S.

Details:

In granting tentative approval, the FDA concluded that TLANDO® met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S.

Lead Product(s): Testosterone Undecanoate

Therapeutic Area: Endocrinology Product Name: Tlando

Highest Development Status: Approved Product Type: Small molecule

Recipient: Lipocine

Deal Size: $25.0 million Upfront Cash: $11.0 million

Deal Type: Licensing Agreement October 18, 2021

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Antares Pharma FDA Acceptance of IND Application for ATRS-1902

Details:

The active IND enables Antares to initiate a Phase 1 clinical study for ATRS-1902 for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.

Lead Product(s): Hydrocortisone

Therapeutic Area: Endocrinology Product Name: ATRS-1902

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 22, 2021

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Antares Pharma Enters Exclusive License Agreement With Ferring Pharmaceuticals for Nocdurna® in U.S.

Details:

This license agreement for NOCDURNA expands Antares Pharma's urology portfolio, which already includes XYOSTED, the best-selling branded testosterone replacement product in the United States.

Lead Product(s): Desmopressin Acetate

Therapeutic Area: Urology Product Name: Nocdurna

Highest Development Status: Approved Product Type: Large molecule

Recipient: Ferring Pharmaceuticals

Deal Size: $25.0 million Upfront Cash: $5.0 million

Deal Type: Licensing Agreement October 01, 2020

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First Commercial Product Using Antares Pharma’s Multi-Dose Pen Platform Launches in Europe

Details:

Antares development partner Teva, launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s brand product Forsteo® featuring the Antares multi-dose pen platform in Austria, Croatia, Hungary,

Lead Product(s): Teriparatide

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

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