Foresee announces the submission of a phase 3 IND
to US FDA for FP-001 42 mg in patients with central
precocious puberty
Date of events
2022/07/20
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event: 2022/07/20
2.New drug name or code: FP-001 42 mg (CAMCEVI 42 mg, 6-month depot
formulation)
3.Indication: for the treatment of central precocious puberty
4.Planned development stages: to conduct a phase 3 clinical trial and submit
New Drug Application
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials
(include interim analysis):
Foresee has submitted a phase 3 IND (Investigational New Drug)
application to US FDA for FP-001 42 mg for the treatment of patients
with central precocious puberty
(2) Once disapproved by competent authority or each of clinical trials
(include interim analysis) results less than statistically significant
sense, the risks & the associated measures the Company may occur: N/A
(3) After obtaining official approval or the results of statistically
significant sense, the future strategy: N/A
(4) Accumulated investment expenditure incurred: Undisclosed
6.Upcoming development plan:
(1) Estimated date of completion: at authorities' discretion. Material
information will be announced as receiving the notice for the clinical
trial may proceed.
(2) Estimated responsibilities: R&D expenses for conducting this clinical
trial
7.Market situation:
Central precocious puberty (CPP) is a condition that causes early sexual
development in girls and boys, as their "hypothalamus - pituitary gland -
gonadal axis" was activated prematurely, causing children enter puberty
prematurely.
While puberty normally starts between ages 8 and 13 in girls and between
ages 9 and 14 in boys, patients with central precocious puberty begin
exhibiting signs before puberty. The development of secondary sexual
characteristics, such as girls develop breasts and begin their menstrual
periods; boys have growth of genitalia and deepening of the voice. It is
estimated that CPP occurs in 1 out of every 5,000 to 10,000 children. CPP
is more common in girls than in boys, with a female to male ratio of
around 20 : 1.
According to Data Bridge Market Research, the central precocious puberty
(CPP) treatment market was valued at US$ 1,483 million in 2021 and is
expected to reach US$ 2,663 million by 2029, with a CAGR of 7.6%.
GnRH/LHRH agonists, in particularly the leuprolide depot injection, have
been widely used for the treatment of CPP. According to Bloomberg data,
in 2021, the market of leuprolide-containing depot products for the
treatment of CPP in the US is estimated at approximately US$300 million,
led by LUPRON DEPOT-PED, followed by FENSOLVI.
8.Any other matters that need to be specified: None
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:
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Foresee Pharmaceuticals Co. Ltd. published this content on 20 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 July 2022 06:33:00 UTC.
Foresee Pharmaceuticals Co., Ltd. is a Taiwan-based company mainly engaged in the research and development of new pharmaceuticals. The Company's main products include prostate cancer treatment product FP-001 and asthmatic/chronic obstructive pulmonary disease treatment product FP-025. It also engages in new pharmaceuticals clinic trial business.
FORESEE PHARMACEUTICALS CO., LTD. 
