Amgen and Wyeth respond to FDA’s requirement of stronger warnings on TNF blockers
THOUSAND OAKS, Calif. Two companies that developed a biotech drug for treating autoimmune disorders said the product is safe, after the Food and Drug Administration recently announced a requirement to include its strongest warning on the drugs.
Amgen and Wyeth, which market the drug Enbrel (etanercept), said in a statement Wednesday that believed Enbrel was still a safe and effective treatment for the autoimmune diseases it treats, including juvenile idiopathic arthritis.
On Tuesday, the FDA announced that it would require TNF blockers – a drug class that includes Enbrel – to carry a boxed warning following reports of children and adolescents developing cancer while using the drugs. Other drugs affected by the FDA’s action include Abbott’s Humira (adalimumab), UCB’s Cimzia (certolizumab pegol) and Johnson & Johnson’s Simponi (golimumab).
Par reports increase in revenue, income and EPS for Q2
WOODCLIFF LAKE, N.J. Generic drug maker Par Pharmaceutical Cos. got a jump in revenues and net income during second quarter 2009, the company announced in an earnings report Tuesday.
Par reported total revenues of $404 million, net income of $23.8 million and diluted earnings per share of 71 cents. This compared with reported revenues of $112.9 million, a net loss of $21.2 million and diluted earnings per share of 64 cents during second quarter 2008.
The company also saw increases in product sales. Sales of the heart disease drug metoprolol succinate – an authorized generic version of AstraZeneca’s Toprol XL – were $306 million during the quarter, a 173% increase over first quarter 2009. The injected migraine headache drug sumatriptan, a generic version of GlaxoSmithKline’s Imitrex, had sales of $21.8 million, compared to $16 million during the first quarter.
Meanwhile, the antihistamine meclizine, a generic version of Pfizer’s Antivert, was $8.9 million, compared with $9.8 million during first quarter, the decrease resulting primarily from trade buying patterns.
FlavorX Flavoring System helps the medicine go down
BOSTON Mary Poppins may have observed a spoonful of sugar’s ability to help wash medicine down, but a mouthful of bitter syrup continues to be an unpleasant experience for any child.
FlavorX, a company based in the Baltimore and Washington area, has designed an automation dispensing aid designed to improve the palatability of medicines for children.
The FlavorX Flavoring System uses a bitterness suppressor and sweetness enhancer to allow pharmacists to mask the taste of many prescription and OTC medications in a wide variety of flavors, speeding up the flavoring process while giving the pharmacist complete control of the process.
According to some research, 86% of parents found that flavoring by the pharmacist influenced children’s success in taking the asthma drug prednisone, while 40% of children completed their therapies without flavoring.
“These figures clearly illustrate that flavoring medications promotes better patient compliance and increases positive clinical outcomes,” FlavorX president and CEO Stuart Amos said in a statement. “We wanted to help pharmacists fill a flavored prescription faster and meet the increasing demand as well as help patients get well.”