Author: OneMedPlace Team
Immune Pharmaceuticals and Epicept Corporation (NASDAQ OMX Stockholm Exchange and OTCQX: EPCT) in November announced a merger agreement, anticipated to close during the first quarter of 2013.
The combined company, to be named Immune Pharmaceuticals, Inc., will be primarily focused on developing antibody therapeutics and other targeted drugs for the treatment of inflammatory diseases and cancer. The merged company will continue to trade on the NASDAQ OMX Stockholm Exchange and the OTCQX.
Immune’s lead product candidate, bertilimumab, is a full human monoclonal antibody that targets eotaxin-1, a chemokine involved in eosinophilic inflammation, angiogenesis and neurogenesis. Immune is currently initiating a placebo-controlled, double-blind Phase II clinical trial with bertilimumab for the treatment of ulcerative colitis.
The company will also continue to develop AmiKet, Epicept Corporation’s prescription topical analgesic cream indicated for effective, peripheral neuropathic pain. AmiKet has completed 7 Phase II studies, and is poised to enter Phase III. The company is seeking a strategic partner to enter clinical trials. AmiKet consists of two active ingredients, amitriptyline and ketamine.
The merger is subject to satisfaction of certain customary closing conditions, including the approval of a majority of EpiCept shareholders.
Last week, OneMedRadio spoke with Immune Pharmaceuticals founder and CEO Dr. Daniel Teper and Epicept Corporation President and CEO Robert Cook, to discuss the merger and the clinical focus of the merged company going forward.
View the transcript below.
Matt Margolis: This is Matt Margolis with OneMedRadio today speaking with Dr. Daniel Teper founder and CEO of Immune Pharmaceuticals as well as Robert Cook President and CEO of Epicept Corporation. Immune Pharmaceuticals is an Israeli based clinical stage private biotech developing monoclonal antibodies for the treatment of inflammatory diseases and cancer. Earlier in November Immune announced a merger with Epicept Corporation, which is dual listed on the NASDAQ OMX in Stockholm and on the OTC in the US. This merger is expected to close in the first quarter of 2013. The combined company will be named Immune Pharmaceuticals and continue the listing on those exchanges.
Thank you for joining us, guys.
Robert Cook: Thank you.
Daniel Teper: My pleasure
MM: So Dr. Teper you and I spoke earlier in the year about your diverse product portfolio. Let’s start there and catch our readers up a little bit. What is your lead product candidate?
DT: Our lead product is bertulimumab, a first in class fully human antibody entering phase II clinical trials with lead indication in ulcerative colitis and pilot studies in multiple indications. Ulterative colitis is the lead indication. We will also be looking at Crohn’s Disease, severe asthma and potentially several orphan indications.
MM: Can you talk about how this works at the molecular level?
DT: Yes. Bertulimumab targets a cytokine called eotaxin-1 and eotaxin-1 is involved in [inflammation]. so by neutralizing eotaxin-1 bertulimumab works to reduce inflammation in gastrointestinal and respiratory diseases.
MM: Let’s turn to the merger now. What were the details of this agreement?
DT: It’s a merger between two operational companies. When the merger closes, Immune shareholders will have 77.5% of the combined company. Epicept shareholders will have 22.5% of the combined company.
MM:L Let’s look into Epicept’s clinical portfolio. What does this pipeline look like?
RC: From Epicept’s standpoint, the pipeline consists of basically 3 products. 2 of them are earlier stage oncology products. Crolibrulen which is in phase I/II studies for treatment of solid tumors, and Azixa which we just recently received back from Myrexis which is being studied in primary glioblastoma. In addition to the oncology candidates, we have a product called AmiKet which is a topical cream for the treatment of neuropathic pain. AmiKet consists of two active ingredients which is Amitriptyline and ketamine – hence the name AmiKet. This is a program we have been pursuing for several years now. We’ve had I think 7 phase two studies, all of them successful. And this product is ready to go into phase III.
MM: I understand AmiKet has received fast track designation from the FDA?
RC: Yes it did. We had a meeting earlier this year with the FDA concerning AmiKet in the indication of chemotherapy induced peripheral neuropathy, which is a significant problem that is experienced by a large number of patients who take chemotherapy. Given the fact that there are really no approved treatments for this problem the FDA was willing to grant fast track status, which we applied for and received I think it was early in the 2nd quarter, 2012 for that indication.
MM: What is your next step in pushing through AmiKet?
RC: Our plan all along has been to partner the compound for a couple of reasons. 1 – because the phase III program is going to require a fair amount of cash commitment. And secondly because to really be a successful commercial product it needs to be sold to a fairly broad audience of physicians. So we have been moving along that track for most of this year and we look at the merger with Immune as being an opportunity for us to continue and hopefully to reenergize those efforts so we can hopefully get to a successful conclusion.
MM: Dr. Teper, can you describe the main clinical focus in the combined company? Can you talk about the company’s product portfolio?
DT: We now have 4 drugs in clinical development. The primary focus will be over the next two years on bertulimimab, in achieving proof of concept in ulcerative colitis and getting results of initial pilot studies in multiple other indications. It’s really a number of clinical milestones over the next 18 to 24 months. At the same time, AmiKet is poised for an important phase III, once we’ve secured a development and commercialization partner. And the earlier stage oncology drugs I think should have clinical milestones in the next 2 years which will help position them.
MM: Why was Epicept considered the perfect partner for Immune to merge with?
DT: We looked at different ways for Immune to become a public company in the US. We are a young company – we’re not even 3 years old. We’ve grown very fast, with a significant portfolio and a solid management team. Yet, we are a bit young for a full IPO process. So we looked at merging with a shell vs. merging with an operating company. And clearly merging with an operating company provided the management and portfolio compatible – it’s a much more desirable path. It’s a more desirable path because it builds an immediate critical mass and from a listing standpoint emerging shell companies have come under increased scrutiny, as opposed to merger between two operational companies, whereby we could apply for uplisting on the US NASDAQ or the NYSE markets as soon as we meet the listing criteria.
MM: From the Epicept perspective, what is the advantage of merging with a private company and specifically with Immune?
RC: I think there’s a little bit of history here that we should discuss which is, beginning in January of this year we announced that we were looking for a partner. Ostensibly to develop AmiKet but in any event to try and move that program forward, because at the time, we were finding it financially very difficult to raise that kind of money needed to finance that phase III program. And we spend the better part of this year looking at opportunities to do that. What we found attractive with Immune is that we have an opportunity to offer our shareholders the upside of the products that Immune represents and brings to the table of this transaction, while we continue to look for partnership development for Phase III of AmiKet. I think that’s one of the main attractions that came here. The other part of the story is it’s a good combination – I think that there is a fit here. Our cancer compounds fit therapeutically with what Immune is trying to do with its technology. There may be some synergies there that we need to explore. And AmiKet is a good out-partnering opportunity that can really benefit both companies. SO I think as we looked at this it is a great stepping stone to getting AmiKet partnered but in the meantime provides our shareholers with more shots on goal in order to realize clinical success and commercial success in a portfolio.
MM: That was Dr. Daniel Teper, Founder and CEO of Immune Pharmaceuticals and Robert Cook, President and CEO of Epicept Corporation discussing the company’s recent merger announcement. With OneMedRadio this is Matt Margolis signing off.