A $45 million public offering priced by Guilford Pharmaceuticals Inc. Thursday gave the Baltimore-based company another reason to celebrate with fireworks and flags this weekend.
Now, the company has the funds to cover clinical trials of Aquavan and Aggrastat, and to advance preclinical candidates. Guilford also intends to use proceeds for working capital, capital expenditures and other general corporate purposes.
Guilford offered 10 million shares at $4.50 apiece, and is granting underwriters an overallotment option for another 1.5 million shares. New York-based UBS Investment Bank is acting as sole book-running manager, while CIBC World Markets Corp. and Citigroup, both of New York, are co-managers.
Company officials could not comment Thursday, due to SEC-imposed quiet-period rules. Guilford's stock (NASDAQ:GLFD) rose 6 cents, to close at $4.81.
Guilford markets two products: Gliadel Wafer (polifeprosan 20 with carmustine implant) to treat brain cancer, and Aggrastat Injection (tirofiban hydrochloride) to treat acute coronary syndrome. In its pipeline, the company's anesthetic Aquavan, a prodrug of propofol, entered a Phase III program in May as a candidate for procedural sedation. The company will begin the first Phase III trial in the third quarter, said Stacey Jurchison, Guilford's director of corporate communications.
Guilford also is planning to do another Phase III trial of Aggrastat to expand the product for use during percutaneous coronary intervention (PCI), Jurchison told BioWorld Today. That trial should start later this year.
Aggrastat Injection is a glycoprotein GP IIb/IIIa receptor antagonist that was developed by Merck & Co. Inc., of Whitehouse Station, N.J. It received FDA approval in May 1998. Guilford acquired U.S. rights to the product in October for $84 million plus certain royalty payments to Merck. Between 1999 and 2001, Merck conducted a Phase III trial of Aggrastat in PCI, but the trial failed to show the drug was not inferior to ReoPro (abciximab). Guilford believes the dose used was not sufficient and plans to design its PCI trials accordingly.
Guilford licensed rights to Aquavan Injection from ProQuest Pharmaceuticals Inc., of Lawrence, Kan., in the first quarter of 2000. The program, which will include four trials in 900 patients undergoing colonoscopy, bronchoscopy, cardiac procedures and minor surgical procedures, should be completed in 2005. The company expects to file a new drug application in early 2006. (See BioWorld Today, May 11, 2004.)
At the preclinical stage, Guilford is studying NAALADase (N-acetylated-alpha-linked-acid-dipeptidase) inhibitors in the fields of neuropathic pain, prostate cancer, drug addiction and traumatic brain and spinal cord injury. NAALADase is believed to play a role in modulating the release of glutamate in the nervous system. The company also is researching PARP (poly [ADP-ribose] polymerase) inhibitor compounds, which are potential therapies for cancer chemosensitization and radiosensitization. PARP is an abundant nuclear enzyme found in most eukaryotic tissues.
In June, Guilford licensed U.S. rights of GPI 1485 to Symphony Neuro Development Co., of New York, a new company formed for the sole purpose of advancing the compound in four indications - Parkinson's disease, post-prostatectomy erectile dysfunction, HIV neuropathy and HIV-dementia. The compound is in Phase II for the first two indications and in preclinical studies for the HIV indications. Symphony will invest up to $40 million in capital to advance the product, and Guilford has an option to acquire all of Symphony's equity between April 2005 and March 2007. (See BioWorld Today, June 21, 2004.)
Guilford reported $81 million in cash, cash equivalents and investments as of March 31. The company has an expected burn rate this year of between $50 million and $60 million, Jurchison said.
Following the offering, Guilford has 43.9 million shares outstanding.