Advancis Pharmaceutical Corp., of Germantown, Md., said the FDA is continuing to review the company s supplemental new drug application for additional Keflex (cephalexin capsules) products. The company, which said it drew no negative inference from the notification, is preparing for a July launch, assuming FDA approval. The company acquired rights to the antibiotic two years ago and has since begun development of a once-a-day Keflex that employs its Pulsys technology. Current Keflex products are dosed two to four times a day. In other news, Advancis said it was on schedule to complete its ongoing pivotal Phase III trial of Amoxicillin Pulsys for pharyngitis/tonsillitis by the end of this cold/flu season, and top-line trial results are coming next quarter.
Affymetrix Inc., of Santa Clara, Calif., watched its shares (NASDAQ:AFFX) plunge 14.3 percent Friday, or $4.85, to close at $29.03, after the company reported first-quarter earnings that were less than expected. The stock hit a 52-week low on news that net income reached $1.8 million, or 3 cents a share, compared with $16.2 million, or 24 cents a share, from the first quarter of 2005. Total revenue fell short of the $91 million expected by the company, which reported $86.4 million for the quarter. Product sales were $66 million, down from last year's $73.6 million, but operating costs grew from $69.8 million in the first quarter of 2005 to $89.4 million this year.
CombinatoRx Inc., of Cambridge, Mass., said its CombinatoRx (Singapore) Pte. Ltd. subsidiary received a grant from that country s Economic Development Board Biomedical Sciences Group to support infectious disease drug research and development. The award, which is intended to encourage the development of strategic technologies and capabilities there, covers a percentage of qualifying costs of the research and development project on a reimbursement basis.
Covance Inc., of Princeton, N.J., agreed to pay $65 million to acquire the eight early phase clinical development sites from Radiant Research Inc., of Bellevue, Wash. The sites currently generate about $25 million in annual revenue, and Covance, a drug development services company, said the deal would increase its Phase I/IIa capacity.
Cytori Therapeutics Inc., of San Diego, said preclinical data demonstrated that adipose stem and regenerative cell-based therapy following a heart attack in pigs is not associated with an increased risk of irregular heart rhythms, which can result in life threatening complications from heart attacks. The data indicated that adipose stem and regenerative cells may reduce the incidence of the potentially fatal arrhythmias. Results of the study, conducted in collaboration with Tulane University, were presented at the German Cardiac Society Annual Conference in Mannheim, Germany.
Digene Corp., of Gaithersburg, Md., and Asuragen Inc., of Austin, Texas, entered an exclusive, worldwide agreement for the marketing and distribution of Asuragen s cystic fibrosis screening products. Digene has made an up-front payment to Asuragen and will make additional payments based on regulatory milestones. Digene will have the exclusive rights to market and distribute Asuragen's Signature CF products worldwide, and Asuragen will develop a next-generation CF test.
Gene Logic Inc., of Gaithersburg, Md., entered a drug repositioning agreement to seek new therapeutic uses for discontinued compounds belonging to NV Organon, of Oss, the Netherlands. Should the arrangement lead to new therapeutic uses, both companies would become equal owners and could decide to jointly develop and commercialize the drug candidate. Gene Logic will receive a success-based milestone payment for each therapeutic candidate that Organon chooses to enter into clinical development. More specific financial terms were not disclosed. News of the deal did not soften the impact of bad earnings released by Gene Logic, which posted $11.8 million in net losses, a wider loss than a year ago that corresponded with less revenue. On Friday, the company's stock (NASDAQ:GLGC) fell $1.09 cents, or 26 percent, to $3.10.
Gen-Probe Inc., of San Diego, paid about $7 million to purchase preferred stock in privately held Qualigen Inc., of Carlsbad, Calif. The stock is convertible into about 19.5 percent of Qualigen s fully diluted common shares. The purchase was made in conjunction with Gen-Probe s decision to exercise an option to develop a nucleic acid testing platform based on Qualigen s FDA-approved FastPack immunoassay system. If developed, Gen-Probe said the new platform would use its nucleic acid testing technologies to detect harmful microorganisms and genetic mutations at the point of sample collection.
Inhibitex Inc., of Atlanta, is reducing its work force to 48 employees from 83 over the next several months in order to lower its expenses and align its operations with the current stage of development. The reduction is largely focused in areas related to the planned commercialization of Veronate, which failed to meet its primary and secondary endpoints in a pivotal Phase III trial for the prevention of hospital-associated infections in premature, low-birth-weight infants. Inhibitex anticipates recording a charge of $1.2 million in the second quarter related to the cost of one-time termination benefits, and it expects to reduce annual expenses associated with salaries and benefits by about $3.5 million. The company s stock fell 66 percent earlier this month when the Phase III data were released. (See BioWorld Today, April 4, 2006.)
Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and its partner Wyeth, of Madison, N.J., said they plan to submit by early 2007 a new drug application with the FDA for subcutaneous methylnaltrexone (MNTX) in a new room-temperature formulation. MNTX is a peripheral opioid receptor antagonist designed to treat the side effects of opioids without interfering with pain relief.
Scolr Pharma Inc., of Bellevue, Wash., closed its previously announced direct offering of about 2.4 million shares of common stock at $5 per share, resulting in gross proceeds of about $11.9 million. Net proceeds will be used for general corporate purposes, including working capital, product development and capital expenditures, as well as for other strategic purposes.
Serologicals Corp., of Atlanta, and the Australian Stem Cell Centre signed an agreement whereby Chemicon International Inc., Serologicals subsidiary, has obtained exclusive rights to commercialize, market and distribute stem cell reagents developed at the ASCC to scientists all over the world. Initial products to be available include a stem cell isolation kit, various proteins and antibodies. Chemicon will make an in-kind contribution of research tools for use by researchers in the ASCC laboratories, and it will contribute funds, products and technical expertise to the new stem cell training program recently launched by the ASCC.
Sirtris Pharmaceuticals Inc., of Cambridge, Mass., was awarded research funding from the ALS Association for a compound with potential to treat amyotrophic lateral sclerosis (ALS). By activating sirtuins, a recently discovered class of enzymes involved in the body s natural defense mechanisms, the compound has the potential to protect against damage to nerve fibers and inflammation. The preclinical testing will be performed in mutant mice with altered copper-zinc superoxide dismutase (SOD1), a commonly used model for ALS mimicking many aspects of the human disease.
Vanda Pharmaceuticals Inc., of Rockville, Md., said the underwriters have exercised an overallotment option to purchase an additional 214,188 shares of its common stock in connection with its initial public offering earlier this month. Including the overallotment shares, the offering will total nearly 6 million shares at $10 each, resulting in net proceeds of about $55.4 million. JP Morgan Securities and Banc of America Securities LLC are joint book-running managers, while Thomas Weisel Partners LLC is co-manager for the offering. Vanda has three product in clinical development: iloperidone, which is in a Phase III trial for schizophrenia; VEC-162, which is in a Phase III trial for insomnia; and VSF-173, which is ready to enter a Phase II trial for excessive sleepiness. (See BioWorld Today, April 13, 2006.)