Raising $60 million in gross proceeds through a public offering, Bioenvision Inc. plans to prepare for the commercial launch of the leukemia drug clofarabine in the European Union.
The New York-based company priced 7.5 million shares of common stock at $8 apiece.
Other companies raising money include Favrille Inc. and Icagen Inc., which conducted initial public offerings, and DOR BioPharma Inc., which conducted a private placement.
Underwriters for the Bioenvision offering included New York-based firms JPMorgan Securities Inc., UBS Investment Bank, CIBC World Markets Corp., and Arlington, Va.-based Friedman, Billings, Ramsay & Co. Inc. They have an option for up to about 1.1 million shares.
According to the company's prospectus, net proceeds of $55.7 million will cover development costs, sales and marketing expenses, in addition to working capital and other general corporate purposes.
Bioenvision filed a marketing authorization application last July for clofarabine to treat pediatric acute lymphocytic leukemia (ALL) and acute myelogenous leukemia (AML). An opinion from the European Medicines Evaluation Agency is expected in the middle of 2005.
A purine nucleoside analogue, clofarabine was approved in December for pediatric ALL patients in the U.S., where Bioenvision's co-development partner, Genzyme Corp., of Cambridge, Mass., will market it under the brand name Clolar. Genzyme holds all rights to clofarabine for all cancer indications in the U.S. and Canada, where Bioenvision is entitled to royalties. Bioenvision will pay a royalty to Genzyme and Southern Research Institute, the inventor of clofarabine, on European sales of the product.
Clofarabine has orphan drug designation in both the U.S. and Europe. The product also is being studied in adult AML, chronic lymphocytic leukemia, indolent lymphoma and solid tumors.
Aside from clofarabine, Bioenvision's Modrenal is marketed in the UK for post-menopausal advanced breast cancer following relapse to initial hormone therapy. The company is seeking approval in the European Union.
If European approvals are granted for clofarabine and Modrenal, Bioenvision plans to add between six and 10 sales representatives in each of five key regions covering 10 countries.
At the earlier stage of development, Bioenvision is focused on two products: Velostan, a cystostatic drug entering a Phase I/II trial this quarter in patients with urological cancers, and Virostat, which is in Phase II trials for hepatitis C.
As of Sept. 30, Bioenvision reported $17.7 million in cash and cash equivalents. The company has 44.4 million shares outstanding. Its stock (NASDAQ:BIVN) dropped 15 cents Thursday to close at $7.95.
Favrille Prices IPO At Low End, Raises $42M
Favrille, of San Diego, priced its initial public offering of 6 million shares at $7 each for total gross proceeds of $42 million.
The company filed for the IPO in April. In January, Favrille said it intended to price its shares between $12 and $14, but it reduced that range earlier this week to between $7 and $8.
The underwriters have an overallotment option for 900,000 shares. They include Bear, Stearns & Co. Inc., CIBC World Markets Corp. and Needham & Co. Inc., all of New York, and St. Louis-based AG Edwards & Sons Inc.
The stock (NASDAQ:FVRL) fell its first day 20 cents to close at $6.80. It dropped another 25 cents Thursday to close at $6.55.
Favrille expects to use $26 million from the IPO and $26 million in existing cash, as well as $19 million to be raised at a later date, to complete development and file for regulatory approval of FavId. Other proceeds will go toward paying down $3.1 million in debt, to develop other product candidates, to cover general and administrative expenses, and to provide working capital.
FavId is an active immunotherapy for the treatment of indolent B-cell non-Hodgkin's lymphoma. Favrille received a special protocol assessment from the FDA for a Phase III trial begun last July. The company expects to retain commercialization rights to all of its oncology products.
A second product, FAV-201, should enter a Phase I/II trial this year in T-cell lymphoma patients. Favrille also plans to start preclinical studies to identify autoimmune disease candidates during the first half of 2005.
The company reported $32.8 million in cash and cash equivalents as of Sept. 30. That amount, added to the IPO proceeds, gives Favrille enough money for at least 24 months.
Favrille has about 20 million shares of common stock outstanding.
Icagen's IPO Raises $40M To Advance ICA-17043
Icagen, focused on oral small molecules that modulate ion channel targets, raised $40 million in its IPO, pricing 5 million shares at $8 apiece.
The Research Triangle Park, N.C.-based company also priced below range. It filed last April, and it set a $10 to $12 price range in January.
Underwriters have an overallotment option for 750,000 shares. They include JPMorgan Securities Inc., UBS Securities LLC and CIBC World Capital Markets Corp., all of New York.
Icagen's stock (NASDAQ:ICGN) dropped 70 cents Thursday to close at $7.30.
The company said in its prospectus that $25 million in net proceeds will fund the further development of ICA-17043 to treat sickle cell disease, which is co-developed with McNeil Consumer & Specialty Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson. About $9.6 million in proceeds will fund further development of ICA-69673 to treat epilepsy and neuropathic pain.
As of Sept. 30, Icagen had cash of about $31.8 million. Between the cash, IPO proceeds and anticipated external sources of funds, Icagen said it has enough to bring ICA-17043 to a new drug application filing in the U.S. and to complete Phase I and Phase II trials of ICA-69673 to treat epilepsy. The funds also should enable the company to advance its preclinical pain, inflammation and glaucoma programs.
Icagen is set to enroll patients in a pivotal Phase III trial of ICA-17043 for sickle cell disease this quarter
At the earlier stage, Icagen has a Phase I compound for atrial fibrillation and a preclinical compound for dementia being developed in collaboration with New York-based Bristol-Myers Squibb Co. and Tokyo-based Yamanouchi Pharmaceutical Co. Ltd., respectively.
The company has about 21.4 million shares outstanding following the IPO.
DOR Brings In $3.8M Through Private Placement
DOR BioPharma privately placed $3.8 million in securities with institutional investors, giving the company enough money to fund operations into 2006.
The Miami-based company plans to use the funds to further develop its biodefense vaccine programs for ricin and botulinum toxins, and for a new drug application filing for orBec (oral beclomethasone dipropionate) to treat graft-vs.-host disease. Proceeds also might cover acquisitions, in-licensing and general corporate purposes.
DOR issued 8.4 million shares and warrants to purchase 6.3 million shares. The warrants will be exercisable for five years and could bring DOR $3.3 million in additional gross proceeds.
DOR expects to have clinical data from a Phase I trial of RiVax, its recombinant ricin toxin vaccine, this year. The company's stock (AMEX:DOR) dropped 2 cents Thursday to close at 50 cents.