Assistant Managing Editor

Amarin Corp. plc, which rebounded from dismal Huntington's disease data with the December acquisition of Ester Neurosciences Ltd., is moving full steam ahead once again, thanks to a $28 million cash infusion.

Those funds represent the first of two tranches in a potential $56 million private placement of American depositary shares with a syndicate comprised of Sofinnova Venture;, OrbiMed Advisors LLC; Thomas, McNerney & Partners; Panorama Capital; Longitude Capital; and Fountain Healthcare Partners. If the company completes certain business-related milestones, those investors will have the option to provide up to another $28 million in a second tranche.

A spokesman for Amarin said the firm is not disclosing the specific milestones, but said they involve "particular development hurdles," that could be cleared potentially over the next 12 months.

On top of that, the firm, which recently moved its headquarters from London to Dublin, Ireland, could get another $4 million from certain company directors, which also will be distributed in two equal tranches.

Proceeds from the first tranche, expected to fund operations for at least 18 months, and will be used to advance Amarin's central nervous system and cardiovascular drug pipeline. Significant funds, however, are unlikely to be earmarked for Miraxion, which failed to show statistically significant difference compared to placebo in a 600-patient Phase III program in Huntington's disease in April 2007. Though Amarin later reported further analyses indicating that longer treatment with Miraxion might produce a statistical benefit, the company's spokesman said the drug is "no longer the prime focus." (See BioWorld Today, April 25, 2007.)

Amarin has said it intends to seek a U.S. partner to offset the costs of another Phase III trial, which the FDA said would be needed for regulatory approval. The company is in ongoing discussions with the European regulatory authorities regarding Miraxion's approvability in Huntington's disease.

The company, instead, plans to concentrate on the rest of its pipeline, including EN101, an oral, antisense oligonucleotide designed to target acetylcholinesterase. That product, added through Amarin's December acquisition of Israeli biotech firm Ester Neurosciences, is in a Phase IIa trial in patients with myasthenia gravis, a chronic disease characterized by muscle weakness due to an autoimmune attack on acetylcholine receptors at the neuromuscular junction.

EN101, which has orphan drug status in that indication, is the first drug to emerge from Ester's messenger RNA platform technology, which also was included in the $32 million acquisition. Amarin paid $15 million up front - $5 million in cash and $10 million in stock - and agreed to pay up to $17 million in milestones upon the successful development of EN101. (See BioWorld Today, Dec. 6, 2007.)

Earlier in its pipeline, the company has a formulation of Miraxion, an eicosapentaenoic acid, in testing for age-associated memory impairment, as well as a sublingual formulation of the Parkinson's drug apomorphine in Phase I testing.

In addition to advancing the pipeline, funds from the recent private placement also are expected to retire $2.75 million in convertible debentures, leaving the company debt-free, and for general corporate purposes. The company's most recent earnings reported a cash position of $27.6 million, as of June 30, 2007, though it added $8.1 million in December to fund the Ester Neurosciences acquisition.

Cowen and Co. LLC acted as lead placement agent for the transaction.

Shares of Amarin (NASDAQ:AMRN) closed at $2.59 Wednesday, down 4 cents.

In other financings news:

• Cellceutix, of Wilmington, Mass., completed a $400,000 9 percent secured convertible debenture financing. Proceeds will be used to advance the development of Kevetrin, the company's lead drug candidate in head and neck cancers. Under the terms, the debentures and concomitant interest are due Dec. 1, 2009, and are convertible into the company's common stock at $1.50 per share. Cellceutix's stock (OTC BB:CTIX) remained unchanged Wednesday at 80 cents.

• Haemacure Corp., of Montreal, said it obtained shareholder consent to implement a financing strategy aimed at moving back into the clinic for pivotal Phase II/III trials of its next-generation, all-human fibrin sealant in the first quarter of next year. That strategy calls for the firm to amend the terms of its 62.5 million outstanding Series B common share purchase warrants issued in a January 2007 private placement. If all the Series B warrants are exercised during the 10 business-day period and all the warrants are exercised, Haemacure will issue a total of 62.5 million common shares. The company's stock (TSX:HAE) closed at C16 cents, up C1 cent.

• NexMed Inc., of East Windsor, N.J., entered a binding commitment with one of its largest shareholders for a $3 million line of credit. The company said it intends to use it to bridge the anticipated milestone payments from partner Basel, Switzerland-based Novartis AG, which licensed rights to NexMed's NM100060 topical treatment for onychomycosis in 2005. NM100060 is in Phase III testing. Shares of NexMed (NASDAQ:NEXM) closed at $1.08 Wednesday, down 1 cent.

Published  May 15, 2008