With its compound, Stanate, for hyperbilirubinemia (jaundice) in late-stage development, InfaCare Pharmaceutical Corp. raised $30 million in a Series A financing.
Stanate (stannsoporfin) is being studied for severe neonatal jaundice and possible prevention of kernicterus, a condition attributed to high levels of bilirubin that some believe is on the rise in the U.S.
Ron Goldfuss, chief financial officer of privately held, Plymouth Meeting, Pa.-based InfaCare, said Stanate is in "mid-Phase II" development, and most of the funds raised will be used for continued work with it.
Scientists at the Rockefeller Institute in New York discovered stannsoporfin, and InfaCare licensed commercial rights from Rockefeller. In turn, InfaCare entered a sublicensing deal last June with Recordati SpA, of Milan, Italy, giving the latter rights to Stanate for jaundice in babies in Europe and certain territories of Northern Africa and the Middle East. Terms were not disclosed, though the deal was said to include milestone payments for InfaCare.
"They’re not just marketing but doing clinical development in Europe," Goldfuss said. "They’re going to depend a lot on the clinical work we’ve already done," so characterizing the exact stage of Recordati’s work is difficult, he added.
Goldfuss declined to comment on anything else in InfaCare’s pipeline, but the company’s website indicated the firm has bethanechol for infantile gastroesophageal reflux disease, which can result in regurgitation, colic, vomiting and poor weight gain. Though GERD is common in adults, and several therapies are available, none is approved for infants. Bethanechol has been cleared for marketing as a treatment of urinary retention in adults.
InfaCare plans to develop a novel liquid formulation and file for orphan drug status, the company said. Bethanechol "will require [a new drug application] filing, but it is expected that this program will be of lower risk and require less of a safety database given the long clinical history associated with the drug and its well-characterized pharmacologic profile."
A third InfaCare drug is sincalide for neonatal ileus, a failure of intestinal peristalsis. Sincalide is the C-terminal octapeptide of the naturally occurring gut hormone cholecystokinin, and also is approved for use in adults against a separate indication. It’s used to stimulate gall bladder contraction that aids in the diagnostic evaluation of bile physiology and gall bladder function. InfaCare also will ask for orphan drug status for sincalide, and expects a somewhat expedited regulatory process, given the compound’s history, according to the website.
Robert Vukovich, chairman of InfaCare, which has five employees, founded the firm in 2001. He formerly served as chairman and CEO of another company he founded, Roberts Pharmaceutical Corp., of Eatontown, N.J., which was taken over by the Shire Pharmaceutical Group, of Basingstoke, UK, in 1999.
The financing was led by new investors Atlas Ventures, of Waltham, Mass., and Pequot Ventures, of New York. Peter Barrett, senior partner at Atlas, is joining InfaCare’s board, along with Patrick Enright, managing director at Pequot. Leerink Swann & Co., of Boston, served as placement agent in the fund raising.
In other financing news:
• Acorda Therapeutics Inc., of Hawthorne, N.Y., said the underwriters of its initial public offering have exercised a portion of their overallotment option to purchase an additional 575,614 shares of common stock at $6 each. The exercise of the option increases the size of the IPO to about 6.08 million shares, and the gross proceeds to $36.5 million. Banc of America Securities LLC acted as the sole bookrunner, and Lazard Capital Markets, Piper Jaffray and SG Cowen & Co. acted as co-managers. (See BioWorld Today, Feb. 13, 2006.)
• Columbia Laboratories Inc., of Livingston, N.J., entered a securities purchase agreement with certain investors for the private placement of about 7.4 million shares of its common stock at a price of $4.04 per share, and warrants to purchase about 1.85 million shares of common stock with an exercise price of $5.39 per share. The closing of the sale of the shares is expected to occur on or about March 15. The warrants become exercisable 180 days after the closing and expire five years after the closing, unless exercised earlier or terminated, and the company expects gross proceeds of about $30 million. Columbia’s women’s health care product candidates deploy its polymer-based Bioadhesive Delivery System. Columbia’s stock (NASDAQ:CBRX) closed Monday at $4.30, down 19 cents.
• Egalet A/S, of Copenhagen, Denmark, closed a €23.5 million (US$27.6 million) financing in a private placement led jointly by new investors Atlas Ventures, of Waltham, Mass., and Index Ventures, of Geneva. Current investors Bio Fund, Dansk Kapitalanlaeg, Danske Bank and QueQuoin Holdings Ltd. also participated. Proceeds from the offering will enable Egalet to take its lead drug candidates in heart diseases and pain management through final pivotal studies, the company said.
• Helix BioMedix Inc., of Bothell, Wash., raised gross proceeds of about $2.6 million from a recent equity private placement. The company issued about 2.6 million shares of its common stock and warrants to purchase an additional 259,800 shares of its common stock to accredited investors. The warrants have a five-year term and a per share exercise price of $1. Proceeds will be used to continue ongoing research and development efforts, the out-licensing initiatives for the company’s peptides and for general corporate purposes.
• Neuralstem Inc., of Rockville, Md., raised $5 million in a private placement, and plans to file a registration statement with the SEC over the next 30 days to become a publicly traded company. The placement consisted of 5 million units priced at $1 per unit, with each one share of Neuralstem common stock, half A warrant to purchase a share of common stock at $1.50, and half B warrant for the purchase of common stock at $2 per share. TR Winston & Co., of Bedminster, N.J., acted as placement agent for the offering, with significant participation from S.W. Bach & Co., of Roslyn Heights, N.Y. Proceeds will be used to pursue the cure of central nervous system diseases using patented human neural stem cell technology developed by Neuralstem’s founding scientist Karl Johe.