CeNeS starts New Year

sicilian_kan (Post 4458):

1) If the European PIII results for M6G are out in January 2007, it could be on the market in Europe no later than Q1 2007 imo.

2) Regarding the launch of M6G in the US, CEN have had a pre-IND meeting with the US regulators that indicates it should be able to go directly into US PIII, without the need for seperate US PI & PII trials; so saving time and expense. Furthermore, these trials should not be subject to the delays that plagued the European trials, the commencement to which were said to have been hindered by the restricted classification of morphine in certain jurisdictions.

3) If the European PIII results for M6G are satisfactory, CEN should be able to conclude a partnering deal in 2007 that will provide further cash, including an upfront payment and sales royalties from when the product launches in early 2008.

4) CNS 5161 is being co-funded for some of the PII's under a development agreement between CEN and Ergomed, enabling it to be progressed with less cost to CEN. CNS 5161 could prove an attractive product for a partner either during PII or at the end of PII, and at present there is no indication that CEN/Ergomed will undertake PIII themselves. Furthermore, there is a good chance that CEN could be taken-over if the expected EU PIII M6G results are satisfactory.

5) M6G should achieve minimum peak sales of around £200m pa based on a basic label (i.e. less nausia but similar efficacy to morphine) and as you say, this is not "blockbuster" territory. However, it could have a huge impact on the current small market capitalisation of CEN.

In addition, CEN have indicated there is scope to extend the label, indications and routes of administration; and thus the market, for M6G.