As it prepares regulatory filings for anidulafungin and dalbavancin, Vicuron Pharmaceuticals Inc. priced a public offering worth $70.8 million in gross proceeds.

The King of Prussia, Pa.-based company sold 4.8 million shares of common stock at $14.75 per share. It granted its one underwriter, New York-based Morgan Stanley & Co. Inc., an overallotment option for an additional 720,000 shares. If exercised in full, the option would bring Vicuron an additional $10.6 million.

Dov Goldstein, the company's chief financial officer, declined to comment due to SEC-imposed quiet-period rules.

According to the company's prospectus, net proceeds of about $67.8 million, not including the overallotment option, will go toward clinical development of product candidates, as well as commercialization activities and general corporate purposes, which include working capital and research expenses. Vicuron also might use proceeds to hire additional sales representatives and other personnel, or to acquire or invest in businesses, products and technologies.

Following the offering, the company has 59.8 million shares outstanding. As of June 30, Vicuron had $117.4 million in cash, cash equivalents and marketable securities.

With a focus on developing competitive antibiotics and antifungals, the company's lead candidates are anidulafungin and dalbavancin.

In early 2003, Vicuron submitted a new drug application for anidulafungin, which belongs to a new class of agents called echinocandins. In May, the FDA issued an approvable letter for anidulafungin indicating the company could achieve approval upon completion of an ongoing Phase III trial to treat invasive candidiasis/candidemia or of further clinical work in patients with candidal disease refractory to other treatments. (See BioWorld Today, May 25, 2004.)

Clinical trials showed that anidulafungin demonstrated potent fungicidal activity and had a good resistance profile, but the FDA said the company had not presented sufficient efficacy and safety data to establish a satisfactory risk-benefit rationale for the use of anidulafungin in the initial treatment of esophageal candidiasis.

The FDA's approvable letter was followed by several class-action lawsuits alleging that the company misled investors. And in June, Vicuron laid out plans to decrease its expenses by more than $25 million this year and another $25 million in 2005 through operational changes and by reducing its head count. (See BioWorld Today, June 25, 2004.)

To gain final approval for anidulafungin, the company intends to amend its existing NDA for the treatment of esophageal candidiasis in the second quarter of 2005, meaning the earliest it could be approved is the fourth quarter of next year. A marketing authorization application filed in Europe last December is under review.

In addition to amending its NDA for esophageal candidiasis, Vicuron intends to file a new NDA for anidulafungin to treat invasive candidiasis/candidemia in the third quarter of 2005. Phase III data should be available in the first half of the year. (See BioWorld Today, Sept. 22, 2004.)

Vicuron also plans to file a new drug application for dalbavancin later this year. Dalbavancin is a second-generation glycopeptide antibiotic belonging to the same class as vancomycin. It is designed to treat serious systemic infections, particularly those caused by staphylococci. It kills the bacteria and has the potential to be dosed weekly, which might be a competitive advantage.

Phase III data in patients with complicated and uncomplicated skin and skin-structure infections showed dalbavancin was well tolerated and met its primary endpoint of non-inferiority when compared to linezolid, cefazolin or vancomycin.

Vicuron's third product candidate, ramoplanin, is an oral non-absorbable form of antibiotic called a lipopeptide being developed by Waltham, Mass.-based Oscient Pharmaceuticals Corp., the licensee in North America. Oscient recently completed a Phase II trial of ramoplanin to treat Clostridium difficile-associated diarrhea, and expects to begin a Phase III trial in that indication by the end of the year.

In addition to research collaborations with Basel, Switzerland-based Novartis Pharma AG to develop deformylase inhibitors and with New York-based Pfizer Inc. to discover second- and third-generation oxazolidinones, Vicuron is studying VIC-Acne, a topical cream antibiotic that shows selective activity against Propionibacterium acnes. The drug was safe and well tolerated in a Phase I trial.

Vicuron plans to establish its own direct sales force in certain markets for anidulafungin and dalbavancin, and it also has a strategy to collaborate with pharmaceutical companies to discover and develop orally administered antibiotic and antifungal products. It intends to keep hospital product candidates in internal programs, while partnering out community product candidates.

Vicuron's stock (NASDAQ:MICU) dropped 85 cents on Thursday to close at $14.68.

No Comments