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Waxman, Hatch debate fate of follow-on biologics

BY Alaric DeArment

WASHINGTON —Rep. Henry Waxman, D-Calif., and Sen. Orrin Hatch, R-Utah, disagree on just about every major issue, but party lines didn’t prevent them from coming together on Sept. 18 at the Generic Pharmaceutical Association’s Annual Policy Conference.

Twenty-five years ago, the two sponsored the Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act, which created a regulatory approval pathway for generic pharmaceutical drugs. That law spawned an industry that now provides 72% of all the prescription drugs that American patients take, but accounts for 17% of drug spending, according to GPhA statistics.

But Hatch and Waxman lately have parted on the issue of creating an abbreviated regulatory approval pathway for follow-on biologics, specifically data exclusivity periods, with Waxman supporting a five-year model similar to the Hatch-Waxman Act and Hatch supporting the 12-year model in the amendment to the healthcare-reform bill added by Rep. Anna Eshoo, D-Calif.

“If follow-on biologics enter the market too early, investors will be hesitant to invest heavily in future products for fear of a limited rate of return on their investment,” Hatch said, noting the biotech industry’s strong reliance upon venture capital. “And it is like rolling a dice sometimes. As a result, investment incentives will be skewed away from biotechnology.”

Waxman, whose speech followed Hatch’s, disagreed. “If that amendment becomes law, I believe it will pose almost insurmountable barriers to real competition in the biologics marketplace,” Waxman said. “With the guarantee of 12 years of exclusivity and unlimited opportunity for evergreening—that is, allowing companies to make minor changes in products and obtain 12-year extensions of the exclusivity—the Eshoo amendment is everything a monopolist could hope for.”

Both agreed, however, that the Food and Drug Administration’s Office of Generic Drugs needed more funding. “As patents on brand-name drugs expire, there is a tremendous increase in submissions of generic-drug applications, and the Office of Generic Drugs does not have the funding to keep up with its current workload,” Hatch said.

The workload has multiplied in recent years. In 2003, the office had a backlog of 515 pending approval applications for generic drugs, according to published reports. By last year, that number had increased to about 1,500.

In addition to the more than $70 million in funding that the office received for this year, Hatch and Waxman expressed support for a user-fee program, whereby generic drug companies would pay a fee to expedite reviews. Similar programs already exist for branded drug companies and device makers.

“We would rather have an important government function supported by government appropriations—that’s clearly got to be our preference—but in an era of staggering budget deficits, we’ve all come to realize that user fees may be necessary in exchange for subsidizing the generic-drug review process,” Waxman said. “The industry is entitled to accountability from FDA on such things as the length of the review process and the transparency of decisions.”

Another topic on which the two Congressmen disagreed was reverse payments, also known as “pay-for-delay” settlements. The settlements, whereby branded drug companies pay generics companies to delay launching generic versions of their drugs for a certain period of time, have come under criticism from the Federal Trade Commission, which considers them anticompetitive. According to an FTC report released in June, banning such settlements would save consumers $3.5 billion a year. Earlier in June, the House Subcommittee on Commerce, Trade and Consumer Protection passed a bill, H.R. 1706, the Protecting Consumer Access to Generic Drugs Act of 2009, to prohibit reverse payments. Waxman signed on as a co-sponsor of the bill, though Hatch continues to support the settlements.

Despite their differences, however, both received a warm welcome from the organization. “We were honored to have our industry’s founding fathers with us as we celebrate the 25th anniversary of the Hatch-Waxman Act,” GPhA president and CEO Kathleen Jaeger said. “We thank both Sen. Hatch and chairman Waxman for their long-standing commitment to increasing access to generic medicines.”

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Late-stage clinical trial results: MS drug is effective

BY Alaric DeArment

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.”

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New report projects 12.6% increase of probiotics market

BY DSN STAFF

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.

 

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