FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Approved Endocrinology Drugs in Clinical Development

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            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cediprof

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 16, 2020

            Details:

            The companies have entered into an interim exclusive supply and distribution agreement for Cediprof's FDA approved Levothyroxine Sodium Tablets USP.

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            Lead Product(s): Octreotide Acetate

            Therapeutic Area: Endocrinology Product Name: Mycapssa

            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 02, 2020

            Details:

            Chiasma has obtained approval from the US Food and Drug Administration for MYCAPSSA® (octreotide) capsules. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA.

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            Lead Product(s): Octreotide Acetate

            Therapeutic Area: Endocrinology Product Name: Mycapssa

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Jefferies

            Deal Size: $70.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering July 01, 2020

            Details:

            Chiasma intends to use the net proceeds from the offering primarily for advancing the ongoing commercialization of MYCAPSSA® in the United States for the treatment of acromegaly and for other pipeline activities.

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            Lead Product(s): Macimorelin

            Therapeutic Area: Endocrinology Product Name: Macrilen

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $12.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering July 01, 2020

            Details:

            The Company intends to use the net proceeds of this offering for general corporate purposes, which includes funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen, the investigation of further therapeutic uses of macimorelin.

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            Lead Product(s): Tolvaptan

            Therapeutic Area: Endocrinology Product Name: Samsca

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            Oral vasopressin V2-receptor antagonists Samsca® Tablets, Samsca® OD Tablets and SAMSCA® Granules 1% have received regulatory approval in Japan for the indication of hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults.

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            Lead Product(s): Semaglutide

            Therapeutic Area: Endocrinology Product Name: Rybelsus

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            The approval of Rybelsus® in Japan is based on results from the PIONEER clinical trial programme, which involved more than 9,500 adults with type 2 diabetes, including approximately 1,300 adults from Japan.

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            Lead Product(s): Osilodrostat

            Therapeutic Area: Endocrinology Product Name: Isturisa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 17, 2020

            Details:

            ISTURISA® (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease.

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            Lead Product(s): Ertugliflozin

            Therapeutic Area: Endocrinology Product Name: Steglatro

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 16, 2020

            Details:

            Phase 3 VERTIS CV cardiovascular outcomes trial evaluated STEGLATRO (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, vs placebo, added to background standard of care treatment, in patients with type 2 diabetes and atherosclerotic CV disease.

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            Lead Product(s): Insulin

            Therapeutic Area: Endocrinology Product Name: Afrezza

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Company announced that new data from clinical studies of Afrezza® demostrating safe and effective dosing, its association with weight loss in patients with type 2 diabetes, and an evaluation of a comprehensive two year safety study showing that significant changes in FEV1.

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            Lead Product(s): Alogliptin

            Therapeutic Area: Endocrinology Product Name: Nesina

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Celltrion

            Deal Size: $278.0 million Upfront Cash: $266.0 million

            Deal Type: Divestment June 11, 2020

            Details:

            The portfolio to be divested to Celltrion includes a variety of OTC products and pharmaceutical products such as Nesina® and Edarbi® and Products in a variety of indications.

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