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Details:
Skytrofa (lonapegsomatropin) is designed to deliver unmodified somatropin, which is used for treatment of children and adolescents with growth failure due to insufficient endogenous growth hormone secretion. Its BLA has been accepted in China.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: Skytrofa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2024
Details:
Vector will employ its sales and marketing expertise to distribute both Skytrofa (lonapegsomatropin-tcgd) and Yorvipath in the GCC countries for pediatric growth hormone deficiency in the case of Skytrofa, and adult hypoparathyroidism in the case of Yorvipath.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: Skytrofa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Ascendis Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 08, 2024
Details:
Specialised Therapeutics will commercialise Ascendis' weekly injectable paediatric human growth hormone treatment SKYTROFA (lonapegsomatropin), hypoparathyroidism treatment YORVIPATH (palopegteriparatide) and investigational achondroplasia therapy TransCon CNP (navepegritide).
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: Skytrofa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Ascendis Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 07, 2024
Details:
TransCon hGH (lonapegsomatropin) is a once-weekly growth hormone, is designed to deliver unmodified somatropin. which is being evaluated in phase 3 clinical trials for the treatment of growth hormone deficiency.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Details:
Under the agreement, Teijin will receive exclusive license to further develop and commercialize TransCon hGH (lonapegsomatropin-tcgd), TransCon PTH, and TransCon CNP for endocrinology rare disease, in Japan.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Teijin Pharma
Deal Size: $245.0 million Upfront Cash: $70.0 million
Deal Type: Licensing Agreement November 29, 2023
Details:
ACP-011 (lonapegsomatropin), a long-acting prodrug of unmodified somatropin is being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: ACP-011
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Ascendis Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
Top-line results of TransCon hGH, from the trial indicate that lonapegsomatropin was well-tolerated and with comparable safety to daily growth hormone. The safety profile of lonapegsomatropin in Chinese children with GHD was consistent.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
VISEN’s Phase 3 Trial achieved primary endpoint; pediatric growth hormone deficiency (GHD) patients treated with TransCon hGH (lonapegsomatropin) demonstrated greater annualized height velocity at 52-weeks (p=0.0010) compared to patients treated with daily growth hormone.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Data from Week 130 of enliGHten trial reporting consistent long-term safety and sustained growth in pediatric growth hormone-deficient patients treated for 2.5 years with TransCon hGH (lonapegsomatropin).
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2022
Details:
Ascendis Pharma intends to use the net proceeds to support the commercialization and further development of TransCon hGH, to fund pre-commercialization activities and clinical development of TransCon PTH, clinical development of its other endocrinology rare disease programs
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Financing March 24, 2022
Details:
The EC approval for TransCon hGH (Lonapegsomatropin) is based on clinical results submitted in the Marketing Authorisation Application, including data from the Company’s Phase 3 heiGHt, fliGHt and enliGHten Trial.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2022
Details:
TransCon hGH is a long-acting once-weekly, transiently pegylated somatropin that in the body releases somatropin indicated for growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
Details:
U.S.FDA notified the Company that information the Company submitted in connection with the FDA’s ongoing review of the Biologics License Application (BLA) for lonapegsomatropin for the treatment of pediatric growth hormone deficiency constituted a major amendment to the BLA.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Proceeds of the Series B financing will be used to accelerate the clinical development of the potential best-in-class portfolio drug candidates and to build a strong foundation for commercialization.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Sequoia China
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing January 09, 2021
Details:
Data from the phase 3 fliGHt Trial of TransCon hGH (lonapegsomatropin) in pediatric growth hormone deficiency (GHD) and from two clinical trials of the auto-injector for lonapegsomatropin will be presented at the Pediatric Endocrinology Nursing Society national conference.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
Ascendis has filed a Clinical Trial Notification with the Pharmaceuticals and Medical Devices Agency in Japan to start company’s phase 3 riGHt Trial of TransCon™ hGH (lonapegsomatropin), a long-acting prodrug of somatropin, to treat pediatric growth hormone deficiency.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: ACP-001
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2020
Details:
This MAA submission, which follows the approval of our Paediatric Investigation Plan (PIP) from EMA, is an important next step for extending the global reach of TransCon hGH.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: ACP-001
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
New data from the four-week, fixed dose, double-blind portion of PaTH Forward demonstrated statistically significant and clinically meaningful improvements in SF-36 functional health and well being outcomes.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: ACP-001
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
Paediatric Committee of the European Medicines Agency supports the investigation of TransCon hGH for treatment of growth hormone deficiency in the pediatric population from 6 months to less than 18 years of age.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
TransCon hGH is designed to maintain the same mode of action as daily hGH therapies by releasing the same growth hormone molecule, somatropin.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2020
Details:
The fliGHt Trial data presented at ENDO Online demonstrate that subjects taking daily somatropin can safely switch to TransCon hGH, an investigational long-acting prodrug that releases somatropin, with consistent and predictable efficacy.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
Details:
FDA has granted Orphan Drug Designation to TransCon hGH, as a treatment for growth hormone deficiency. There is no approved long-acting growth hormone treatment on the market in the U.S. or Europe.
Lead Product(s): Lonapegsomatropin
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2020
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