With a potential FDA approval on the horizon for Cinryze in hereditary angioedema (HAE), Lev Pharmaceuticals Inc. secured a $20 million senior secured term loan facility from MAST Capital Management LLC.
The loan provides $10 million initially and the option to borrow another $10 million within the next 12 months. That money will be used to buy the human plasma from which Cinryze, a C1 inhibitor, is derived.
New York-based Lev had $8.4 million in cash and equivalents as of June 30 and raised $35 million in August through a registered direct stock and warrant offering. But Jason Tuthill, the company's director of investor relations, said the loan provides a less expensive way to buy plasma than using equity.
Tuthill added that Lev is "fully funded" through the Cinryze launch, which is expected in the first quarter of next year following potential FDA approval in January. The Cinryze biologics license application contains data from positive Phase III trials of the drug in both treatment and prevention of HAE. (See BioWorld Today, Aug. 1, 2007.)
Although there are no FDA-approved treatments for HAE, several candidates are in late-stage development. Tuthill called the HAE field a "five-horse race with us in front."
Behind Lev are: ZLB Behring's C1 inhibitor, which completed Phase III enrollment last month; Pharming Group NV's recombinant C1 inhibitor, which recently completed a Phase III trial and should have data by the end of the year; Dyax Corp.'s DX-88 (ecallantide), a recombinant plasma kallikrien inhibitor in its second Phase III trial; and Jerini AG's Icatibant, a synthetic peptidomimetic agent submitted for FDA review late last month.
Tuthill said Cinryze is differentiated from its potential competitors by its potential for both therapeutic and prophylactic use. The drug also goes through a nanofiltration purification process not used by competing C1 inhibitors.
Lev's loan matures in 36 months and is secured by a first priority lien on the company's assets. A three-year warrant was issued to MAST Capital in connection with the loan.
Shares of Lev (OTCBB:LEVP) fell 1 cent to close at $1.80 on Friday.
In other financing news:
• Genesis Pharmaceuticals Enterprises Inc., of Laiyang, China, closed a $5 million private placement of convertible notes and common stock purchase warrants. Proceeds will be used to buy the patent for Ligustrazine Ferulic Acid Acetate (LFAA), an anti-clotting drug that the company believes could be launched in 2009.
• MediciNova Inc., of San Diego, withdrew its proposed public offering of 6 million shares of common stock, citing general market conditions and unusual trading activity in its stock. The company's shares (NASDAQ:MNOV) dropped from $7.15 to $6.10 when the offering was announced late last month, and have since continued to fall to a closing price of $4.91 on Thursday. On Friday, the stock rose 17 cents, to close at $5.08.
• Stem Cell Therapeutics Corp., of Calgary, Alberta, closed its previously announced bought deal financing for gross proceeds of C$12.08 million (US$13.2 million). The proceeds included the full exercise of the overallotment option by underwriters Dundee Securities Corp.; J.F. Mackie & Co. Ltd.; Fraser Mackenzie Ltd.; Loewen, Ondaatje, McCutcheon Ltd.; and Research Capital Corp. Stem Cell Therapeutics said the money will support a Phase IIb stroke trial with NTx-265, a combination of human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO).