Staff Writer

MAP Pharmaceuticals Inc. has secured a committed equity financing facility allowing it to sell up to $60 million of its registered common stock to Azimuth Opportunity Ltd. as it casts an eye toward regulatory approval of its migraine compound.

"We really see this as insurance, if we need it," MAP CEO Tim Nelson, told BioWorld Today. "These financial markets have been choppy ones at best, open and then not open," he said. The credit line gives the company some funding flexibility, Nelson explained.

Mountain View, Calif.-based MAP is far from desperate, with $79 million in cash and investments and is under no obligation to use the $60 million financing facility. The company raised $30 million in a stock offering in August. (See BioWorld Today, Aug. 7, 2009.)

The long-term equity line of credit was in place in case MAP needs to tap additional funds as it moves its Phase III migraine drug candidate Levadex toward a regulatory filing and potential launch.

Opening the credit line does not change MAP's talks with potential partners, Nelson said, though it could strengthen the company's position in those discussions. And the guaranteed money shows that there is strong interest in the product, he said.

Levadex hit all four of its study objectives in the first of two Phase III trials. Patients from the first study are being evaluated in a safety extension study, and six-month data showed no drug-related serious adverse events.

A second, confirmatory Phase III study of Levadex is set to begin the first quarter of 2010. MAP's goal is to submit a new drug application for Levadex soon after the completion of that second Phase III trial.

The second trial could have a shorter timeline than the first because, as Nelson pointed out, it has no long-term safety arm.

If approved for acute migraine, Levadex would compete against the triptans class led by GlaxoSmithKline plc's Imitrex, which in 2007 had sales of about $1.2 billion in the U.S. and $1.6 billion worldwide, according to data published by IMS Health.

The triptans class as a whole, which includes seven drugs, generates $2.2 billion in U.S. sales, according to MAP's figures. But those numbers are changing, Nelson said, now that Imitrex (sumatriptan) has generic competition.

Of the 29 million prescriptions written for U.S. migraine sufferers each year, about 12 million are for triptans and 17 million are for other drugs such as Topomax and opioids.

Levadex is designed to treat migraine attacks as well as broader symptoms such as vomiting and nausea. Data from the first Phase III study showed that the drug worked well in a subgroup of patients - including those with menstrual migraines and allodynia, a type of fibromyalgia pain - who have not responded well to current therapies such as triptans. (See BioWorld Today, Sept. 11, 2009.)

Levadex is an inhaled form of a decades-old migraine medication called dihydroergotamine, or DHE. According to research by Pacific Growth Equities, several other companies are pursuing migraine drug candidates, including inhaled-drug candidates Alexza Pharmaceutical Inc.'s prochlorperazine and Capnia Inc.'s disposable, inhalable gas treatment.

In June, Zogenix Inc. received FDA approval for Sumavel DosePro (sumatriptan injection) needle-free delivery system to treat acute migraine, with or without aura, and cluster headache.

Shares in MAP (NASDAQ:MAPP) were up 8 cents, closing at $8.90.

In other financing news,

• Novelos Therapeutics Inc., of Newton, Mass., has issued and sold to Purdue Pharma LP, of Stamford, Conn., an existing investor, 8.3 million shares of Novelos' common stock and warrants, expiring Dec. 31, 2015, to purchase 2.9 million shares of common stock at an exercise price of 66 cents per share, for gross proceeds of $5.5 million. It is the last tranche in a $9 million private placement that will support the company's development program into third-quarter 2010, which includes a pivotal 900-patient Phase III lung cancer trial.

• Quest Diagnostics Inc., of Madison, N.J., said that it intends to offer $750 million in aggregate principal amount in two series of senior notes in a public offering, subject to market and other conditions. The company intends to use the net proceeds from the offering to repurchase any notes tendered under its concurrent tender offer, and for general corporate purposes, including acquisitions, capital expenditures, share repurchases and repayment of other indebtedness.

• Synergy Pharmaceuticals Inc., of New York, has completed a private placement in which it raised gross proceeds of an aggregate $8.6 million through the sale of shares of common stock at a price of 70 cents per share. The proceeds from the financing will be used to fund a Phase IIa trial of Synergy's SP-304 for chronic constipation, which the company plans to initiate in the first quarter of 2010.