Amarin to develop oral apomorphine formula within six months

By Elaine Rigoli

Tampa, Fla., May 18 - Following Wednesday's announcement that Amarin Corp. plc has acquired global rights to a new oral formulation of apomorphine in clinical trials to treat semi-paralysis in advanced Parkinson's disease, the company said its next steps will be to optimize the formulation to maximize the bioavailability.

"The objective of this process, which is estimated to take around six months, is to produce a product that is not only superior to the injectable in terms of convenience and compliance, but also could have a superior side-effect profile," chief executive officer Rick Stewart said during a conference call.

"Once an optimized formulation is selected, its clinical trials could be relatively short given the existence of an already approved formulation of apomorphine. We estimate that a phase 2 trial could be completed by mid-2007 and a phase 3 trial, in a limited number of patients, commenced by the end of 2007, with a NDA filing some time in 2008."

The transaction has been structured to minimize payments in the near term and acknowledge progress with milestones, officials said.

The consideration payable by Amarin for the acquisition of the product rights comprises an upfront payment of $75,000, milestones totaling about $1.3 million and a mid single-digit royalty on sales. The milestone payments breakdown as follows:

• Future development success payments;

• Regulatory filing milestones of $100,000 on each filing in the United States and Europe;

• Approval milestones of $500,000 on each approval in the United States and Europe.

"After including expected cash outflows for apomorphine, Amarin still forecasts having sufficient cash to fund operations into the fourth quarter of 2007. That is unchanged from what we have said in the past, prior to announcing this deal, because we had taken account of expenditure on a newly acquired project of this kind," Stewart added.

The company estimates that there are more than 100,000 cases of patients with advanced Parkinson's disease who experience periods of semi paralysis, often called "off" episodes, in the United States, and a similar number in Europe.

The current method of treating those patients relies on frequent injections of apomorphine, which can sometimes be associated with severe side effects, such as swelling and the development of painful nodules at the injection site. In addition, patients are often unable to administer the injection and have to rely on caregivers for support when an episode occurs.

Amarin said preliminary research conducted suggests that the use of apomorphine is limited by the current form of administration and that a more user-friendly oral form would lead to greater usage.

Amarin is a London neuroscience company focused on the research, development and commercialization of novel drugs to treat central nervous-system disorders.

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