Today's Information |
Provided by: EirGenix Inc. | |||||
SEQ_NO | 10 | Date of announcement | 2022/01/20 | Time of announcement | 21:38:50 |
Subject | EMA has officially accepted the review of the MAA submitted by Sandoz AG (exclusive partner of EirGenix) for trastuzumab biosimilar EG12014 (150 mg, for IV use) | ||||
Date of events | 2022/01/20 | To which item it meets | paragraph 53 | ||
Statement |
1.Date of occurrence of the event:2022/01/20
2.Company name:EirGenix,Inc.
3.Relationship to the Company (please enter ��head office�� or
��subsidiaries��): head office
4.Reciprocal shareholding ratios: Not applicable.
5.Cause of occurrence:
Sandoz AG,an exclusive partner of EirGenix,Inc.,has officially received
the letter stating that EMA has accepted the review of the Marketing
Authorization Application (MAA) for trastuzumab biosimilar EG12014
(150 mg, for intravenous use) on 2022/01/20 the European time.
6.Countermeasures: None.
7.Any other matters that need to be specified:
(1) Name or code of new drug: EG12014 (proposed trastuzumab biosimilar)
(2) Usage: The treatment of HER2 overexpressing early breast cancer,
metastatic breast cancer and metastatic gastric cancer.
Trastuzumab biosimilar EG12014 confirmatory phase III
study in early HER2+ breast cancer:
(https://www.clinicaltrials.gov/ct2/show/NCT03433313?term=
EG12014&draw=2&rank=1)
(3) All expected developmental stages:
Marketing Authorization Application (MAA) application in review.
(4) Stages of status:
A. Filing an application / Approval/ Disapproval/
Results of different phase of human clinical trials
(including interim analysis) / Any major events affecting
the development of new drugs:
Marketing Authorization Application (MAA) in review.
B. Risks and responses faced and applied if the results
of human clinical trials (including interim analysis)
have not passed the approval from regulatory authorities,
or the results do not reach statistical significance or
any major events affecting the development of new drugs:
Not applicable.
C. Further steps when receiving approval from regulatory
authorities, or the results of any phase of human clinical
trials (including interim analysis) has statistical significance
or other major events affecting the development of new drugs:
(such as continuing in development, authorizing to others
for sale, etc.):
In April of 2019, EirGenix signed an exclusive license to Sandoz AG
for right of commercialization of EirGenix's breast cancer biosimilar
drug, EG12014 (proposed trastuzumab biosimilar) globally
with the exception of Taiwan, mainland China, Japan,
South Korea and Russia.
EirGenix has received an upfront payment on signing the contract,
milestone payments, and is responsible for the production of product
to sell in the authorized markets and royalties and profit sharing
according to the Licensing Agreement following product launch
on market.
D. Invested expenses:
It was agreed to not to disclose this information in publicly
in order to protect the company and investors�� rights according to
the signed confidentiality agreement with Sandoz AG.
(5) The following steps:
A. Estimated completion time:
After the EMA receives the application, they will assess the
completeness of the submitted document package and notify the
start of the review process.
The review progress is carried out in accordance with the schedule
set by the EMA and approval time of MAA are the decision of EMA
and subject to the official notification of the EMA.
B. Expected Obligations: (for example, fees payable for
obtaining a technology license, etc.): None.
(6) Current market situation:
According to Roche��s annual report, global sales of Herceptin
totaled 3.73 billion CHF in 2020. The US and EU Herceptin
market are 1.36 billion CHF and 0.67 billion CHF respectively.
Herceptin sales declined compared to 2019 driven by strong
competition from biosimilars, which were introduced in 2018 and 2019
in Europe and US, respectively.
The biosimilar drugs have taken a high proportion of the market since
their entry into the market. Taking Amgen��s Trastuzumab biosimilar
drug Kanjinti as example, in 2020, the sales were 567 million U.S.
dollars. With the launches of more biosimilar drugs,
the Trastuzumab's global market has continued to grow allowing
more patients benefit from the biosimilar drugs.
In 2019, Taiwan's health insurance payment for Trastuzumab products
was nearly NT$1.66 billion and ranks the ninth place among
the top ten drugs under the national health insurance program.
(7) Due to the long duration of development for innovative drugs,
the investment of development is high, therefore success of
the innovative drug cannot be guaranteed.
This will lead to investment risk, and investors should show
due diligence in investment.
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EirGenix Inc. published this content on 20 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 January 2022 13:50:03 UTC.