IMMUNE PHARMA
BUDS of Ceplene, new attempt in the US - CEO (Direct)
2016-12-08 17:27
STOCKHOLM (AFX) Immune Pharmaceuticals buds of cancer drug Ceplene and form a new company that will make a new attempt to get the drug on the US market. It says immunes CEO Daniel Teper to the news agency Direkt before the company's webcast R & D update at 17:00 CET on Thursday, Swedish time.
The company's shares rose yesterday by more than 70 percent without any news had been presented. Rate increase is according to CEO on selling pressure in immunes shares declined and investors look to the dormant project Ceplene alive again.
"We have been going around and met with investors in recent months, and people are now looking more to the fundamentals of the company than before. Research and development projects are developing rapidly and now bertilimumab our only focus," says Daniel Teper.
Ceplene is an immune stimulant drugs developed against acute myeloid leukemia and is approved in Europe. 2012 out-licensed the drug to the Swedish Meda, which this year was bought by Mylan. Attempts to launch the drug in the US market were up after the FDA demanded additional Phase 3 study, but now the tests will be taken up again.
During the evening will update Daniel Teper talk more about the spin-off of Ceplene in the new company which Immune Pharmaceutical become the largest shareholder. New money should be brought in for the continued development, how much is yet to be decided.
What makes that Ceplene will have better chances of reaching the United States now?
"We published a new study with Ceplene early in 2016 that showed positive results in progression-free survival. The development includes testing of biomarker and the effect can be seen after six weeks, which is advantageous in a health economic perspective," said Daniel Teper and continues:
"In addition, we will in 2017 launch a phase 3 clinical study in which we have collaborated with the FDA on the study design," he says.
Ceplene reaches the US market, sales may exceed $ 200 million, according to Daniel Teper.
Regarding bertilimumab, which is the only substance that remains in immunes portfolio in the future, two ongoing studies in various indications in which results are expected in 2017. The company took in November, up $ 11 million from existing investors and will in 2017 examine more indications of bertilimumab.
Parallel to the development of the company, talks with "several potential partners," according to Daniel Teper. Probably covering a partnership all the indications bertilimumab developed within instead of signing contracts for the various disease area, he says.
Speculation in the market raises the question whether Pfizer is getting ready to devour the research company, but Daniel Teper would not comment on market rumors. However, he certifies that the company has been in dialogue with several major pharmaceutical companies, including Pfizer, but it will not affect the information in tonight's R & D update.
Onderstaand artikel is via Google vanuit het Zweeds vertaald.
Bron:https://www.avanza.se/placera/telegram/2016/12/08/immune-pharma-knoppar-av-ceplene-nytt-forsok-i-usa-vd.html