Sebelius, Sharfstein address generics industry at GPhA conference
WASHINGTON —The Obama administration has stuck to its calls for seven years of market exclusivity for novel biologics for any regulatory approval pathway for follow-on biologics, Health and Human Services secretary Kathleen Sebelius told attendees of the Generic Pharmaceutical Association’s Annual Policy Conference in Washington last month.
Sebelius appeared alongside Food and Drug Administration principal deputy commissioner Joshua Sharfstein as a keynote speaker at the event, which took place from Sept. 17 to 18.
“The current battle which is under way is clearly with follow-on biologics, and I just want to tell you at the outset that you have allies in the president of the United States and in our department,” Sebelius said, following introductory speeches by GPhA president and CEO Kathleen Jaeger and William Marth, GPhA chairman and Teva North America president and CEO. “We very strongly believe that this initiative needs to move forward and give everyone access to these critical new drugs.”
In addition, Sebelius stated the administration’s rejection of pathway provisions allowing biotech companies to extend their exclusivity periods, a practice known as “evergreening,” which Sebelius said gave the companies exclusive rights to market their products “frankly, forever.” The FDA’s growing backlog of generic drug approval applications got attention as well, with Sebelius pledging to help reduce it to “help Americans get access quicker.”
She also took the opportunity to push the administration’s healthcare-reform agenda, emphasizing what she saw as generic drugs’ role.
“There are lots of folks who continue to say, ‘How in the world can you have higher quality and lower cost at the same time’ and ‘That just isn’t possible,’ but I think that the story of the generic drug industry is a great indication that it is very possible,” Sebelius said.
Sharfstein echoed many of Sebelius’ comments, adding a few anecdotes of his own about his experiences as a 25-year-old hospital resident, where some patients would visit the emergency room because they lacked the money to buy their drugs.
“I remember…my first clinical experiences meeting patients who could not afford their medications, and it was a common experience for me,” Sharfstein, a pediatrician and former Baltimore public health commissioner said. “I saw infections partially treated coming back resistant; I saw high blood pressure out of control.”
Like Sebelius, Sharfstein emphasized generics’ role in reducing healthcare costs. “I think, put in context, Hatch-Waxman is one of the most important pieces of public health legislation of our time,” Sharfstein said. “Many, many lives have been saved or improved by generic drugs, and much more can be accomplished.”
Late-stage clinical trial results: MS drug is effective
ALISO VIEJO, Calif. Patients taking an investigational drug for multiple sclerosis fared better than those taking placebo, according to late-stage clinical results presented Friday at a neurology conference.
Avanir Pharmaceuticals said MS patients taking Zenvia (dextromethorphan and quinidine) in 30 mg/10 mg doses experienced a 11.9% greater reduction in pseudobulbar effect – an MS-related condition also known as PBA that causes sudden, uncontrollable episodes of laughter, crying and other emotional outbursts – than those taking placebo in a 12-week phase 3 trial, results of which the company presented at the 3rd World Congress on Controversies in Neurology in Prague, Czech Republic. Patients taking the 20 mg/10 mg dose did not do better than the placebo group.
“PBA represents an area of high, unmet medical need with no FDA-approved treatments currently available,” study presenter and trial steering committee member Daniel Wynn of the Consultants in Neurology Multiple Sclerosis Center stated. “Although the involuntary emotional outbursts of PBA cause considerable impairment for millions of individuals in the United States, it is under-recognized and commonly misdiagnosed.”
New report projects 12.6% increase of probiotics market
NEW YORK The two takeaways from this story are “the [U.S.] market is expected to grow at a rate of almost 14%” and “the early movers in the industry will benefit in terms of market share.”
That about describes the opportunity in a probiotic nutshell.
The rising interest in probiotics can be credited in part to Dannon’s Activia brand, a line of yogurts and yogurt drinks, which has been heavily advertised to the American consumer with the message that not all bacteria is bad for you — and in fact some bacteria taken on a regular basis can impart some pretty significant health benefits. That advertising message — that probiotics can be an important piece in a healthier-for-you diet — has been all the more reinforced as Bayer supports its probiotic Phillips Colon Health, and as Procter & Gamble rolls out its Align probiotic.
And the consumers already are core drug store shoppers. The ratio of women to men in search of a product delivering digestive benefits is about 2-to-1, according to industry experts. When women hit their 30s and 40s, that’s the point in their lives when they’re looking for a strategy in life to help them manage their digestive issues.