1.Date of occurrence of the event:2016/06/06
2.Company name: OBI Pharma, Inc.
3.Relationship to the Company (please enter ”head office” or ”affiliatecompany”): The Company head office
4.Reciprocal shareholding ratios: N/A
5.Name of mass media: www.appledaily.com.tw Limited and cnYES.com
6.Content reported: (1) Taiwan Apple Daily: The legal person believes that, the above data indicate that OBI-822 is useful for some patients, ‘is also harmful for some patients,’ based on the status of this contradiction, FDA cannot accept screening standard made by the company earlier. In addition, this data revealed in ASCO shows ‘ treatment reaction of the OBI-822 is irrelevant with the Globo-H amount contained in the patient’s system’, and this conclusion would make FDA call for more tests, which is not in favor of proving the proof-of-concept. (2) cnYES: the new pharmaceutical OBI Pharma (4174-TW) yesterday announced the detailed data of the breast DRUG OBI-822 and the foreign investment states that OBI Pharma still have two big hurdle to cross, including about 4.4 months difference of the risk-free survival in the experimental group and the control group, ‘ the difference of 10 months with competitors’, in addition, OBI-822 is harmful to the patient does not produce immune response, thus the screening criteria of the treatment of ethnic groups will be changed.
7.Cause of occurrence: The Company solemnly states, many medias ’ reports have serious mistakes regarding to the paper about the company’s therapeutic breast cancer vaccine OBI-822, which will seriously mislead the public and investors, and the company clarifies the important results about the OBI-822 research results and lists them as follows:
(1) The reports about the harm for some patients: test group, namely acceptor of OBI-822 injection, if they produce an immune response (antibody titers produced for Globo H ≧ 1: 160), its progression-free survival (PFS ) and overall survival (OS), whether comparing with people with no immune response (antibody titer <1: 160), or the control group, the significant difference will be presented. The groups called no immune response here (antibody titer <1: 160), in fact, can be subdivided into at least four groups, namely, the antibody titer of 1: 40,1: 80, the group produced only IgM antibodies, and the testers neither produced IgG, nor IgM.
In fact, the first three sub-groups in this trial have been observed for the effect after injection of OBI-822 as well, which confirms the previous theory about with the antibodies, there will be therapeutic effect, and for the acceptors not producing the antibodies of lgG or lgM, there is no therapeutic effect. And for all the subjects regardless of the groups they are, , throughout the entire trial observation period, in addition to the occurrence of the pain and swelling in the injection site , there is no serious side effects observed, and how to say it is harmful to the subject? Some media quoted the analysts of the investment advisers, saying the OBI-822 is harmful for some patients, which is not only a serious error, but also a fabricate rumor.
(2) About the report regarding to the treatment response of OBI-822 unrelated to the performance amount of Globo-H inside of the patient: part of the reports seriously misunderstood this findings, saying the treatment response of OBI-822 is unrelated to the performance amount of Globo-H inside of the patient, which is totally in the opposite side. OBI-822 is a vaccine designed based on the antigen identification of Globo-H. This research has been confirmed that, after treatment with OBI-822, no matter the antibodies produced or not there is no significant correlation with the existing of the Globo-H; that is, without antigen of Globo-H, after the treatment with OBI-822, the antibodies will be produced, and with the antibodies, there will be therapeutic effect; and the higher the antibody concentration, the better the effect is.
(3) About the report of the ten-month difference with the competitors: For these 104 patients who completed nine OBI-822 injection, the progression-free survival (PFS) is 22.5 months with the difference of 4.4 months compared with the control group (64 people)of 18.1 months. The reports compare this result with the one with the difference of ten months between another targeted medicine Ibrance for breast cancer of small molecule and the control group and then believed that there is still a big gap for OBI-822 to catch up, and it will be challenged in the breast cancer treatment market of hormone receptor-positive populations in the future. In fact, Ibrance and OBI-822 enjoys different pharmaceutical properties and the treating subject as well as the mechanism is different. Meanwhile, compared to the serious side effects such as the decreasing of the white blood cells and infections caused by Ibrance, OBI-822 almost has no side effects, therefore the difference between these two is quite enormous. Furthermore, OBI-822 and Ibrance might be used together in the future to complement each other in the treatment, rather than to be mutually exclusive or competitive in the market.
9.Any other matters that need to be specified: The results of a single clinical trial are not enough to fully reflect the success or failure of future development of new drugs listed, and the investors should carefully make the judgement and be prudent in their investment.