conditional marketing authorisation29 Apr 2018 14:39
I think that IMM will do a close analysis of the data before applying for conditional marketing authorisation. There may be dosing issues, route issues or patient targetting issues; which P3 data will help resolve.
From the EMA website; Lupuzor ticks the relevant boxes IMV
1/ "aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases;" - Lupus [tick]
2/ "the benefit-risk balance of the product is positive"; - Lupuzor is efficacious and has zero side effects, [tick].
3/ "It is likely that the applicant will be able to provide comprehensive data"; IMM have data for phases 1-3 [tick].
4/ "unmet medical needs will be fulfilled;" Very few medications for Lupus, most have severe side effects with long-term use e.g. steroids [tick].
5/ "the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data." Again, Lupuzor is efficacious and has zero side effects, [tick].
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000925.jsp&mid=WC0b01ac05809f843b
Interestingly, these are the very issues highlighted by the company. IMM are a very small pharma and, as many have pointed out, have done well to get this far with limited resources. The EMA conditional marketing authorisation has been developed partly with this type of situation in mind.
Although a CMA would allow IMM to market and profit from Lupuzor, there are obligations attached to this authorisation.
"The holder will be required to complete specific obligations (ongoing or new studies, and in some cases additional activities) with a view to providing comprehensive data confirming that the benefit-risk balance is positive."
"Once comprehensive data on the product have been obtained, the marketing authorisation may be converted into a standard marketing authorisation (not subject to specific obligations). Initially, this is valid for 5 years, but can be renewed for unlimited validity."
The benefit would be that they will have a funding stream to conduct ongoing studies which are likely to be better targetted.
There pre-authorisation guidance here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000167.jsp&mid=WC0b01ac0580b18196
In conclusion, the results were mixed and would probably have benefited from a lager study (which is outside the scope of IMM ability currently). As such I imagine the p3 study is being used like a comprehensive p2b study which will help the company with further testing.
We all have our time scales. I'm a long-term buy and hold and will simply ride out the short-termer games. As milestones are achived I'll buy more. Hopefully you'll agree with me that my comments above are objective and factual.