The submission of Marketing Authorization Application by Megapharm for CAMCEVI 42 mg to the Ministry of Health of Israel
· Issued by Foresee Pharmaceuticals Co., Ltd.
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Provided by: Foresee Pharmaceuticals Co., Ltd.
SEQ_NO
2
Date of announcement
2022/04/05
Time of announcement
20:05:49
Subject
The submission of Marketing Authorization
Application by Megapharm for CAMCEVI 42 mg to the
Ministry of Health of Israel
Date of events
2022/04/04
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event: 2022/04/04
2.New drug name or code: CAMCEVI 42 mg (FP-001 LMIS 50 mg)
3.Indication: for the treatment of advanced prostate cancer (6-month depot
formulation)
4.Planned development stages: Regulatory review on the Marketing Authorization
Application by the Ministry of Health of Israel.
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials
(include interim analysis):
Megapharm, Foresee's licensing partner in Israel and the Palestinian,
submitted a Marketing Authorization Application for CAMCEVI 42 mg
injectable emulsion to the MOH (Ministry of Health) of Israel.
(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: the regulatory review is expected to
complete in around 1 year. The actual date and final decision are at
authorities' discretion.
(2) Estimated responsibilities: Megapharm, Foresee's licensing partner,
will be responsible for the submission of Marketing Authorization
Application.
7.Market situation:
As the population grows and gradually ages, prostate cancer patients has
grown in number. According to Transparency Market Research, the global
prostate cancer therapeutics market was worth about US$10 billion in 2019.
By estimation, the global prostate cancer drug market value will grow to
US$19.6 billion in 2027, with a CAGR of 8%.
According to IMS data, the market value of GnRH/LHRH therapy in 2018 was
approximately US$4.4 billion (all indications included), with sales of
drugs containing Leuprolide reaching approximately US$2.492 billion
(56.6%) in 2018.
Designed and developed through Foresee's pioneering Stabilized Injectable
Formulation technologies, CAMCEVI 42 mg is a differentiated ready-to-use
6-month depot injection, which overcomes the requirement of manual
reconstitution-an obstacle that the already marketed leuprolide products
face that can lead to handling inconvenience and potential risks of
handing errors.
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.:
