HEALTH

Switch products drive dollar growth

BY Michael Johnsen

There has been a lot of hope placed in the ability of recently switched products to drive significant growth within the OTC sector, and with good reason. Recently switched products Nexium and Flonase brought in a combined $520.4 million for the 52 weeks ended Oct. 4, according to IRI.

(To view the full Category Review, click here.)

Having first hit the market in 2014, Pfizer’s Nexium 24HR has become the best-selling heartburn remedy on the market with more than $292.5 million in annualized sales. And early in 2015, GlaxoSmithKline’s Flonase rocketed to the top of the best-selling lists across cough, cold, allergy and sinus with the introduction of its nasal corticosteroid, bringing $227.9 million in almost purely incremental dollars to the category.

But after Pfizer this summer pulled the plug on its Rx-to-OTC switch of Lipitor, the question has to be asked, is switch dead?

“[Lipitor] was a linchpin for a lot of these chronic conditions and more complicated switches,” said Laura Mahecha, industry manager health care at Kline Group. “A lot of people in the industry, even if they didn’t have a cholesterol-lowering drug, were waiting to see if [Pfizer] could get a statin approved.”

As a failed investment, that might stifle future switches, Mahecha suggested. “It makes companies really conservative in terms of investing resources.”

“There is still a lot of interest,” countered Robert Sanders, EVP healthcare practice leader at IRI. “[But] there has to be a different business model to get after switches. It’s going to require either diagnostics or some other mechanism for the Food and Drug Administration to feel more comfortable that people can self select.”

But switch is certainly not going to be the same growth driver in the near term, at least in 2016, as it has been in recent history. “Certainly nothing like we saw with Nexium and Flonase,” he said.

Longer term, switch will remain a viable growth engine. In 2012, the FDA established the Non-Prescription Drug Safe Use Regulatory Expansion Initiative, and since that time the FDA has created two new categories with its switch approvals. “Back in 2013, they switched Oxytrol, which actually created a new category for overactive bladder within the OTC marketplace,” noted David Montfort, director of insights for the Edgewood Consulting Group, during a recent GMDC Connect presentation on switch. “[And] in 2013, they also approved Nasacort, which is actually the first nasal steroid product approved to be sold OTC.”

Montfort outlined six factors that help drive every switch success story. From the manufacturer’s perspective, there is having a strong heritage as a prescription brand, speed to market and consumer marketing. A strong heritage is especially important — as much as half of year-one sales volume can be attributed to prior prescription patients, Montfort said.

And from a retailer’s perspective, key factors are preparing for launch beforehand, speed to shelf and in-store execution. “What Edgewood would recommend is a preemptive category management approach whereby a lot of this best practice analysis work is done prior to the product launching, such as shopper insights, speed to shelf and ensuring impactful retail execution,” he said.

“Speed to shelf really does effect trial and repeat rates for a switch product,” Montfort added. “Those retailers able to get the product to market quickly, actually have higher initial trial rates, and those higher trial rates ultimately result in higher repeat rates. Ultimately, they’re able to build a much bigger business more quickly based on getting the product to the shelf in an expedited fashion.”

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HEALTH

VMS industry requests FDA dedicate greater resources to regulating industry

BY Michael Johnsen

WASHINGTON – Six associations representing the dietary supplement industry last week requested that the Division of Dietary Supplement Programs be elevated to an “Office” within the Food and Drug Administration. 
 
“We believe that the elevation of DDSP to an 'office' would provide appropriate regulatory attention to the growing industry and increase FDA’s enforcement activities and priorities,” the trade associations said. “In addition, we believe such a reorganization would enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency.”
 
The trade associations also expressed their concern over “blatant” criminal activity in the supplement industry. “We believe that elevating DDSP’s status to an Office would help increase FDA’s abilities to take more aggressive enforcement action; raise the visibility and attention for dietary supplement safety and compliance measures at FDA; and better utilize CFSAN’s enforcement resources.”
 
The six associations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance. 
 
 
 
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Over-the-counter home conception kit proven efficacious

BY Michael Johnsen

PITTSBURGH — A clinical study demonstrates that The Stork OTC is more effective at delivering sperm to the cervix than natural intercourse when trying to get pregnant. The peer-reviewed, post-coital sperm assessment study was performed over a 10-month period by study author Michael Pelekanos, and is published in the Surgical Technology International
 
The Stork OTC, the only FDA-cleared, over-the-counter home conception kit using cervical cap insemination, is clinically shown to deliver a higher concentration of sperm directly to the cervix compared to natural intercourse.
 
The study was an efficacy study designed to compare the number of sperm in the cervical mucus both with the use of The Stork OTC home conception kit and natural intercourse. Post-coital test data was collected after participants used both the Stork OTC home conception kit and the natural intercourse method to evaluate concentrations of sperm in the cervical mucus.
 
The results are promising for the one-in-six U.S. couples having difficulty conceiving with intercourse alone. “We were very excited to see the study results confirm that The Stork OTC delivers a significantly higher sperm concentration to the cervix,” said Stephen Bollinger, president and CEO of Rinovum Women’s Health. “With the new data demonstrating the efficacy of the Stork OTC in aiding conception compared to natural intercourse, couples trying to get pregnant now have a safe, clinically validated option to optimize their chances with the Stork OTC.”
 
In 85% of study subjects, the Stork OTC delivered a 3.23x higher value of sperm concentration at the cervix compared to the value of sperm concentration with natural intercourse.
 
The remaining 15% of study subjects saw no change in sperm concentration between The Stork OTC and natural intercourse.
 
The kit provides a way for the user to collect, insert and deliver the sperm directly at the opening of the cervix, and keeps it at the cervix for longer, giving sperm the opportunity to enter into the uterus. Considering most sperm never make it through the vaginal tract, the Stork OTC’s applicator provides a simple and safe way for the user to bypass the normally unfavorable vaginal environment, to deliver the sperm. Cervical cap insemination has documented success rates between 10% and 20%, similar to in-clinic intrauterine insemination success rates (16%-21%).
 
 
 
 
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