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Lead Product(s): Leuprolide Acetate
Therapeutic Area: Endocrinology Product Name: Fensolvi
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
The study evaluated 45-mg subcutaneous leuprolide acetate administered at a 6-month interval in 64 GnRHa-naïve children with CPP. Fensolvi effectively suppressed reproductive hormones and stopped or caused regression of pubertal progression.
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Lead Product(s): Insulin Lispro
Therapeutic Area: Endocrinology Product Name: Lyumjev
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 07, 2020
Details:
Companies will partner to promote Lyumjev, Lilly's new rapid-acting insulin, with Dexcom G6 Continuous Glucose Monitoring (CGM), highlighting the benefits of using each.
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Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Alkindi
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 September 29, 2020
Details:
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children.
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Lead Product(s): Sildenafil Citrate
Therapeutic Area: Endocrinology Product Name: Viagra
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Farmalider SA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 29, 2020
Details:
Aspargo’s Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5 mg of sildenafil citrate per push of the pump (referred to as ASP-001) or via an individual single liquid unit dispensing 100 mg per unit.
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Lead Product(s): Dulaglutide
Therapeutic Area: Endocrinology Product Name: Trulicity
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 September 03, 2020
Details:
The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11. The phase 3 trial showed the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity 1.5 mg.
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Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: MiniMed 770G
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
The 770G System is a first-of-a-kind device for patients aged 2 to 6 years. It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population.
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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 August 31, 2020
Details:
MYCAPSSA, the first and only oral somatostatin analog, approved by the U.S. FDA on June 26, 2020 for the long-term maintenance treatment of patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide.
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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. Lannett to Commence Marketing on August 3, 2020.
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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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