Staff Writer

MAP Pharmaceuticals Inc. plans to raise $40.9 million in a stock offering priced at $14.50 per share, money that will help the company complete final studies of its migraine drug candidate Levadex. The $14.50 price represents a decrease of 72 cents from MAP's (NASDAQ:MAPP) closing price of $15.22 on Wednesday.

The Mountain View, Calif.-based company still needs to complete the remaining clinical studies for Levadex, including an ongoing 12-month open-label safety extension study and an analysis of results from a study of QT intervals (heart rhythm).

MAP has said that it expects to file for U.S. regulatory approval of Levadex in the first half of 2011.

If approved, Levadex would likely be used in the second- or third-line setting for a broad range of migraines, including menstrual migraine, migraine with allodynia (pain) and migraine related to sensitivity to light and sound, said Liana Moussatos, an analyst with Wedbush Securities Inc.

Patients who currently are not being helped by the leading migraine drug class, triptans, or those who can't get adequate relief from over-the-counter medication could potentially benefit from Levadex, Moussatos said.

But for acute migraine, Levadex would compete against the triptans class led by GlaxoSmithKline plc's blockbuster Imitrex (sumatriptan), which is likely to see sales affected by generic competition.

MAP holds worldwide commercialization rights for Levadex and hopes to market the product in the U.S. using its own sales force targeting neurologists and headache specialists. However, MAP has signaled that it may establish partnerships with pharmaceutical companies to market and sell to primary care physicians and specialists both inside and outside the U.S.

While Moussatos noted that MAP currently is in partner talks, she said, "We think they are a potential takeout [target] as well."

MAP was in a quiet period and could not provide comment about the financing.

Levadex is an inhaled form of a decades-old intravenous migraine medication, dihydroergotamine, or DHE.

In a Phase III trial, Levadex met all four co-primary endpoints, as well as a number of secondary endpoints including pain relief, phonophobia-free and photophobia-free. MAP also reported data from a post-hoc analyses of the FREEDOM-301 Phase III trial of Levadex showing efficacy in two difficult-to-treat patient subpopulations, menstrual migraine and migraine with allodynia, a type of fibromyalgia pain. (See BioWorld Today, Jan. 12, 2010, and April 15, 2010.)

The company had planned to perform a second, confirmatory Phase III trial. But based on the strong efficacy data in the first Phase III trial and prior experience with the compound in other routes of administration, MAP did not have to conduct a second pivotal study.

In other financing news:

• Advanced Life Sciences Holdings Inc., of Chicago, has received $1.5 million of proceeds from the exercise of unit warrants issued in a public offering of securities first announced on July 1. At the time, the company expected gross proceeds of up to $3 million. (See BioWorld Today, July 2, 2010.) The company also reported that it has entered into an agreement with YA Global Master SPV Ltd. for the sale of up to $10 million of common stock over a two-year period. Under the terms with YA, Advanced Life Sciences may from time to time sell newly issued shares of its common stock to YA at a discount to market of 5 percent. The amount of each advance is generally limited to $300,000 in any weekly period and there are no minimum commitments or minimum-use penalties.

• Apricus Biosciences Inc., of San Diego, entered agreements with selected investors to sell up to 1,728,882 units at a price per unit of $5.40, for aggregate gross proceeds of about $9.3 million. The offering of stock and warrants is expected to close on or about Oct. 4. Apricus intends to use the net proceeds for product development and general corporate purposes. Dawson James Securities acted as the exclusive placement agent for the offering.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., plans to offer $35 million in shares of its common stock in a registered public offering, subject to market and other conditions. The company also intends to grant to the underwriters an option to purchase additional shares of common stock to cover any overallotments. Deutsche Bank Securities Inc. is acting as sole book-running manager for the offering. Needham & Co. LLC is acting as a co-manager.

• Lorus Therapeutics Inc., of Toronto, has filed a final prospectus for a rights offering of an aggregate 5 million shares, for gross proceeds of $5.5 million. The subscription price of $1.11 per unit represents a discount of 10 percent to the volume weighted average closing price of the company's shares for the five trading days immediately prior to the final filing. An additional 5 million common shares could be issued if all warrants are exercised. Lorus expects to use the net proceeds from the offering to fund research and development activities, the repayment of interim financing promissory notes to Herbert Abramson (one of Lorus' directors) and for general working capital purposes.

• NeurAxon Inc., of Toronto, closed a debt financing in which the convertible debentures are convertible under specified circumstances into existing class B preferred shares for a total of about $14 million. Investors participating in the financing include CTI Life Sciences Fund, the Ontario Capital Growth Corp., Delphi Ventures, OrbiMed Advisors LLC, Ventures West Capital Ltd., H.I.G. Ventures, BDC Venture Capital, NeuroVentures Fund and NeurAxon CEO Lawrence Bloch.

• Protox Therapeutics Inc., of Vancouver, British Columbia, said that private equity firm Warburg Pincus has committed to invest up to C$35 million (US$33.8 million) in Protox, comprised of an initial tranche of $10 million, and an additional tranche of $25 million. Warburg Pincus will invest the funds through a unit offering at C40 cents per unit, where each unit is comprised of one common share of Protox and 0.6 common share purchase warrants. The investment of the initial tranche will close upon the satisfaction of certain closing conditions, including the approval by Protox's shareholders and the Toronto Stock Exchange. Warburg Pincus will invest the second tranche of $25 million if the FDA grants a special protocol assessment (SPA) for PRX302 for the treatment of benign prostatic hyperplasia prior to Sept. 30, 2011. If the company does not receive the SPA within that time frame, Warburg Pincus will have the right, but not the obligation, to invest up to the additional $25 million. Upon the closing of the initial tranche, Warburg Pincus will hold 25 million common shares (about 21 percent of the company's outstanding shares) and 15 million share purchase warrants, and will be the company's largest shareholder. (See BioWorld Today, May 3, 2010.)

• Repros Therapeutics Inc., of The Woodlands, Texas, said that its board has approved a 1-for-4 reverse split of its common stock, which is expected to take effect at the close of trading Oct. 14. The reverse split is part of the company's plan to regain compliance with the $1 minimum bid price required for continued listing on the Nasdaq Capital Market. The company anticipates that its common stock will begin trading on a split adjusted basis on the Nasdaq Capital Market when the market opens Oct. 15. The reverse split will consolidate every four shares of common stock into one share of common stock at a par value of $0.001 per share.

• Stellar Biotechnologies Inc., of Port Hueneme, Calif., has agreed to complete a C$1.05 million (US$1.01 million) private placement of stocks and warrants. The 3 million units priced at C35 cents per unit are being offered for purchase to a single investor. The financing is subject to acceptance by the TSX Venture Exchange and the cancellation of 1,661,241 shares of the company's outstanding common stock. In a prearranged deal, Stellar cancelled the 1,661,241 common shares on payment by the company of about 7.5 cents per share. Stellar said it believes the retirement of those shares benefits the company and all shareholders by reducing the number of outstanding shares and lowering dilution.