NovaBay Pharmaceuticals reports Q4 and year-end earnings
EMERYVILLE, Calif. NovaBay Pharmaceuticals reported that its revenue increased in the fourth quarter and overall year, ended Dec. 31, 2008.
With license and collaboration revenue for the fourth quarter 2008 increased 44% to $2.2 million from $1.5 million, for the full year 2008, license and collaboration revenue totaled $6.7 million, compared with $5.9 for the year 2007.
Net loss for the fourth quarter of 2008 was $1.5 million, or $0.07 per share, compared with a net loss of $1.4 million, or $0.09 per share, reported for the fourth quarter of 2007.
Meanwhile, NovaBay reported a net loss for the full year of $8.1 million, or $0.38 per share, compared with a net loss of $5.4 million, or $0.60 per share, for the full year 2007.
License and collaboration revenue consists of the amortization of the upfront technology access fees previously paid, and reimbursements for the funding of research and development activities.
NovaBay ended the quarter and year with $12.1 million in cash and cash equivalents.
Research and development expenses increased for the quarter and full year, which NovaBay contributed to the timing of pre-clinical and clinical trials, development/clinical expenses and increase of employees.
NovaBay Pharmaceuticals is a mid-stage biopharmaceutical company developing first-in-class anti-infective products for the treatment and prevention of a wide range of infections without causing resistance.
Pharmaxis announces completion of phase 3 trial for CF drug
SYDNEY, Australia An Australian company announced Tuesday that it had finished the first part of an international phase 3 trial of a drug for cystic fibrosis.
Pharmaxis said the final patient in the trial of the inhaled drug Bronchitol (mannitol) had finished a final clinical visit, and the trial was running on time and on budget. Results of the trial are expected to be available later this month.
“We are very pleased to announce this major milestone for Pharmaxis and look forward to the results of the study with great interest,” Pharmaxis CEO Alan Robertson said. “It is hoped that Bronchitol will change the therapeutic landscape for people living with cystic fibrosis and provide a new therapeutic regimen that helps to prolong life.”
A second phase 3 clinical trial is recruiting in the United States, Canada, Argentina, Germany, Belgium and France, Pharmaxis said. The Food and Drug Administration and European Medicines Agency have given Bronchitol orphan drug designation due to the lack of effective treatments for cystic fibrosis.
Court finds that Watson’s ADHD drug patent is valid
CORONA, Calif. The U.S. District Court for the District of Delaware ruled Monday that Watson Pharmaceuticals’ generic version of an ADHD drug does not infringe the branded drug maker’s patent.
Watson announced the court ruling Tuesday, saying judge Joseph Farnan found that the ‘373 patent for Concerta (methylphenidate hydrochloride extended-release tablets), by ALZA Corp. and McNeil-PPC, is invalid. The ruling applies to Watson’s versions of Concerta in the 18 mg, 27 mg, 36 mg and 54 mg strengths.
“We are very pleased that the court has ruled in our favor, and we will continue to evaluate the court’s opinion as we contemplate next steps,” Watson president and CEO Paul Bisaro said. “We are currently pursuing final FDA approval of this important product.”
The two branded companies originally sued Andrx Corp. in 2005 over the drug; Watson acquired Andrx the next year.