Ann: Neuren to capture substantially greater value after Phase 3, page-89

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Little T

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05/06/20

11:45

Post #: 45056745
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Originally posted by hottod: ↑

To make it clear for anyone who might be wondering why I am invested in Neuren as well as Opthea, the list below highlights some advantages NEU has compared with OPT.

NEU is ahead of OPT in its drug development program. It has already commenced the pivotal trial in its lead indication, which is expected to have results in 18 months. OPT has not yet commenced Phase 3 trials and they will likely take at least 3 years.

NEU does not have to fund Phase 3 trials in its two lead indications because of its licensing partnership with Acadia. Opthea will need to raise capital or partner in order to pay for further trials. The lead indication alone (wet AMD) requires two Phase 3 trials, with a total of 1320 patients.

NEU still retains ex-North American rights to trofinetide as well as free access to Acadia’s US regulatory package.

Both of NEU’s lead programs have orphan disease designation in both the US and EU. This confers a minimum 7 year post-approval exclusivity period in the US and 10 years in the EU.

At commencement of Phase 3, the likelihood of approval for a neurology drug is slightly higher than for an ophthalmology drug.

At commencement of Phase 3, the average orphan disease drug has a two in three chance of approval, compared with a one in two chance across all drugs.

Trofinetide does not have to demonstrate superiority to existing approved therapies. There are none. OPT-302 does, as there are already approved therapies.

The FDA has a policy of high patient engagement/consultation and flexibility wrt orphan drugs.

Average annual cost of orphan drugs in United States is $150,000. Annual cost of the leading drugs in wAMD and DME is ~$20,000 - $25,000.

NEU has a second drug asset, which has highly positive pre-clinical data across multiple rare disease and non-rare disease indications. This is already in Phase 1 of clinical development in three rare diseases which have all been granted orphan disease designation. OPT is a single drug asset company.

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Hottod .I agree with all your points but the one I am most excited by is NNZ2591 .I have been told my management and the directors that NNZ2591 is a far superior drug in their opinion than NNZ2566.Acadia is spending a small fortune on NNZ2566 so you would think they are keeping a very close eye on the development of NNZ 2591.
NEU Price at posting: $1.69 Sentiment: Buy Disclosure: Held
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Ann: Neuren to capture substantially greater value after Phase 3, page-89

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Ann: Neuren to capture substantially greater value after Phase 3, page-89

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