Nycomed, Forest Labs enter agreement to develop, commercialize COPD treatment
NEW YORK Nycomed and Forest Labs announced that they have entered into an exclusive development, manufacturing and commercialization agreement in the United States for Daxas(roflumilast), a once-daily oral treatment for patients suffering from symptomatic chronic obstructive pulmonary disease.
Nycomed will retain marketing rights to Daxas in Europe and the rest of the world.
Under the terms of the agreement, Forest Labs will make an upfront payment of $100 million and additional milestone payments to Nycomed based on defined regulatory and commercialization achievements. Nycomed will also receive royalties on U.S. net sales typical for a product, which is in registration. Forest will assume responsibility for the U.S. regulatory approval and commercialization of Daxas and the companies will collaborate on future development programs. Other details of the financial terms of the agreement were not disclosed.
Daxas is an orally-administered phosphodiesterase 4 enzyme inhibitor targeting cells and mediators in the body believed to be important in the COPD disease process. A new drug application was filed with the Food and Drug Administration in July.
No comments found
Washington, Mo., considers repealing recently passed PSE legislation
NEW YORK The objective here is closing down clandestine methamphetamine labs. The question is: Who is going to bear the cost? And the answer, ultimately, is the consumer.
It seems that one of the primary reasons behind legislation like this, which is also under consideration by the California state legislature as well as several local municipalities throughout Missouri, is cost shifting.
Indeed, one solution that would prevent the practice of “smurfing,” a practice whereby meth addicts exceed their legal purchase limits in pseudoephedrine products by buying across several nearby pharmacies, is electronic logbooking. By granting access to PSE logbooks to law enforcement in real time, law enforcement officers would not only be made aware of a “smurfer” as they were driving between pharmacies, but would also identify who that smurfer was and where they lived.
Setting up that comprehensive electronic logbooking system requires resources, however. State coffers have traditionally been tapped for that purpose, and at least in the case of California, the Consumer Healthcare Products Association has offered to help defray that cost. In the case of Missouri, more than $500,000 has already been earmarked for the implementation of an electronic logbooking system at the state level.
However, a not-as-much-talked-about cost is also borne by law enforcement, as pointed out by Franklin County Sgt. Jason Grellner in Missouri. After all, it requires additional resources to actually apprehend and prosecute those criminals, he suggested. And a system that better defines who those criminals may be, by his estimation, could cost the state as much as $350,000 per criminal per year.
Therefore, Grellner argues, it’s a fiscal responsibility to take PSE off the OTC market altogether, and require a prescription for the popular decongestant.
That, in a nutshell, is cost-shifting. Because reverse switching PSE translates into less revenue for retailers (and consequently less taxable revenue, as well) for those consumers who choose to forego PSE-provided relief, and for those who don’t, it’s a greater healthcare cost because now consumers have to schedule an appointment with their primary care practitioner and pay the co-pay for that doctor’s visit on top of the cost of the PSE product.
Regardless of how the consumer ultimately pays for the elimination of meth labs — whether through increased taxes to cover escalating law enforcement budgets or through increased personal healthcare costs — there is another argument to be made here. Switching PSE to prescription-only status may result in fewer meth labs busted, but it’s not going to do anything about those meth addicts still on the street. Necessity is the mother of invention, and for addicts, that simply means sourcing their meth from somewhere else.
No comments found