Excuse me for being long. Here are som thought of what on the margin might be seen as "news" in the analysis that was published the other day. Some of the points there is just a figure or a question of stressing something. The first point is just for info.
"+ EpiCept is currently in discussions with several large pharmaceutical companies for a marketing partnership and hopes to launch commercial operations by the middle of the year.
+Commercialization of Ceplene may also open discussions for an acquisition of EpiCept by more deep-pocketed pharmaceutical companies looking for new products and new technologies.
+This is a huge market dominated by a few drugs. One of the leading players is Pfizer, whose drug Lyrica achieved $2.573 billion in worldwide revenues, according to the company’s 2008 annual report. The drug treats pain from diabetes (DPN), pain following shingles (PHN), fibromyalgia and epilepsy.
+The total global pain market was $34 billion in 2007, according to LeadDiscovery, a U.K.-based consulting firm that helps pharmaceutical companies identify commercial trends and viable research options for drug discovery (www.leaddiscovery.co.uk).
+ Myelodysplastic Syndrome, a blood disorder often requiring frequent transfusions, strikes about 12,000 Americans and 16,000 Europeans a year. CML affects about 5000 people a year in the U.S. and Multiple Myeloma hits 15,000 people a year. The prevalence of Multiple Myeloma, a cancer of the plasma cells in the bone marrow, is about 45,000 people. Current treatments are chemotherapy, radiation or stem-cell therapy.
+Company estimates are for $150 million in sales of Ceplene in Europe when full market penetration is reached in about 3 years.
+ At a pre-NDA meeting a week earlier, the FDA indicated that it would accept the clinical data submitted to the EMEA for marketing approval in Europe as well as other analyses already completed. However, it did ask for some further statistical data relating to the outcome of studies using IL-2 alone and data supporting the choice of Leukemia-Free Survival instead of Overall Survival as the Ceplene trial endpoint.
+However, one advantage EpiCept will have over Maxim’s filing is the availability of data on IL-2 as a monotherapy for AML that didn’t exist in 2004. Most recently, the headline from the extract of a Journal of Clinical Oncology report on June 30, 2008 stated: “Low-Dose Interleukin-2 Immunotherapy Does Not Improve Outcome of Patients Age 60 Years and Older with Acute Myeloid Leukemia in First Complete Remission: Cancer and Leukemia Group B Study 9720,” published by Maria R. Baer, et al.
+ EP1013 is a novel small molecule that blocks apoptosis in the liver and allows liver cells to regenerate in animal models. GNI hopes to develop EP1013 to treat the epidemic of liver disease in Asia. EpiCept will not be obligated for any costs associated with the drug’s development. The upfront licensing fee was minimal at $125,000 but EpiCept is eligible to earn milestone payments and royalty fees on sales as well as access to all of the data generated by GNI.
If Ceplene sales are launched this summer, it should generate only about $2 million in revenues this year, as it will take many months to establish pricing and reimbursement schedules in all 30 countries where approval was granted. The company hopes to kick off sales in the U.K. and Germany by June or July. Pricing should be in the range of 50 Euros per vial of Ceplene with 42 vials needed per three-week cycle. Treatment is a total of 10 cycles or 420 vials. In 2010, Ceplene revenues could rise to $10 million and by the end of 2011, the company hopes to be generating peak revenues from Ceplene of $25-$35 million."
Thank You Lars! Do you have access to the whole report? Read on Avanza something about Myriad needing to renegotiate with Epicept if they want the new company to keep the rights to it. Could you post something about that?
Yes I have the whole report. It's 12 pages long. That is 12 postings here because of the limited room on this thread.
My list is a little bit "in house" for the ones that already is aware of the earlier news from the CO.
Karen Lazarovic have just about the same figures at the end, but we have different ways of reaching that goal.
She is more careful than I am about about the start, OR put in another way: She comments the fall -09, my prediction is about hole first effective year of sales. I think we will have 1 000 million SEK because of the big group of patients waiting for the drug. CO will concentrate to get agreements in the big five European countries first, then the others. There is a manifest group of 45 000 patients in Europe added by 16 000 each year. The demand is obvious, seen from the patients point of view. The dedication and presence of the partner is important here.
Today Talley stated in a Swedish paper (www.va.se)that royalty was more important than the upfront. Please have a look at the webcast from Antisoma where they describe their ongoing negotiations. www.antisoma.com Listen to Q&A at the end.
I have personally nothing more to add about the Myriad split, and the way that will take. But when performed, it certainly gives part of Epicept a value, Azixa direct and Crinobulin indirect.
"Of some concern is the decision, announced last October, of Myriad’s intention to split itself into two entities, one dedicated to the company’s thriving molecular diagnostics business which would retain the Myriad Genetics name, and the other company devoted to research and drug development. The future of Azixa and other Myriad drug candidates will rest on Myriad’s decisions regarding the strategic importance of this new entity. The main clue will be the amount of capital Myriad allocates to the new company to fund the research and that information is not yet available.
The good news is that Myriad will have to get EpiCept’s approval to transfer the licensing agreement over to the new company which will be called Myriad Pharmaceuticals. That will allow for due diligence of the new structure and pointed discussion about Myriad’s plans for Azixa. Right now, Azixa is highlighted as a key new drug development candidate on Myriad’s website, (www.myriad.com)."