GSK Aims Flonase Sensimist To Counter Generic Nasal Allergy Competition

GlaxoSmithKline PLC expects its Flonase SensimistAllergy Relief (fluticasone furoate/27.5mcg spray) to build upon the success of the original Flonase OTC line and help counter recent private label competitive activity in the intranasal corticosteroid category.

“We’re very optimistic that we can follow the huge success of Flonase,” said CEO Andrew Witty on Feb. 8 during GSK's year-end earnings briefing.

Witty said Flonase OTC (fluticasone propionate/0.05mg) delivered high single-digit growth in 2016 after a strong performance in the first half was dragged down in the second half by increasing private label competition.

Competition for OTC fluticasone nasal sprays heated up in mid-2016 as Perrigo Co. PLCdistributed a generic equivalent of Flonase. Perrigo licensed the product from West-Ward Pharmaceuticals Corp., which received FDA approval for an abbreviated new drug application for the fluticasone propionate/0.05mg per spray product. (Also see "Fluticasone Spray Competition Grows With Perrigo Launch Of West-Ward Product" - Pink Sheet, 6 Jun, 2016.)

The CVS pharmacy chain also sells a store brand fluticasone propionate/0.05mg spray Apotex Technologies Inc. manufactured under an ANDA FDA approved in February 2016. Sales for Flonase and its generic equivalents reached $343m for the 12 months through May 2016, prior to the rollout of Perrigo's product, it said at the launch.

Glaxo expects its Flonase Sensimist Allergy Relief to build on the success of the original Flonase OTC line and help counter recent private label competitive activity in the intranasal corticosteroid category.

GSK Consumer Healthcare

Witty said the Flonase Sensimist launch “bodes well for GSK going forward and reflects our strategy to create a group that can both access growth opportunities from new innovation and navigate changes both in our portfolio and the challenges we face in today’s operating environment.”

Despite the drag from competition late in the year, the Flonase OTC brand helped drive Glaxo's total consumer health care sales in the US up 9% to £1.76bn ($2.2bn) on a reported basis and 5% on a pro-forma basis for the year, according to GSK’s same-day earnings release.

The briefing was Witty’s last presentation as CEO as he will be replaced April 1 by Emma Walmsley, former head of GSK’s consumer healthcare division. (Also see "GSK Management Shake Up Ahead Of New CEO Sees Hussain Out, AZ's Miels In" - Scrip, 19 Jan, 2017.) “I’ve been working closely with Emma as she transitions into the CEO role and as we enter a new period of leadership for the company,” he said. “And I believe GSK’s well-positioned to deliver long-term performance for its shareholders.”

'Gentle, Yet Powerful' Spray

In a separate release on the Sensimist launch, GSK said MistPro spray technology in the product "delivers a fine, gentle, yet powerful mist spray" for non-drowsy, 24-hour relief of allergy symptoms including itchy watery eyes, nasal congestion, runny or itchy nose and sneezing caused by triggers including pollen, mold, dust and pets.

Flonase Sensimist debuts following FDA’s approval Aug. 3 of GSK’s supplemental new drug application to market its previously Rx product Veramyst over-the-counter. The product, marketed by GSK Consumer Healthcare LP, Glaxo and Novartis AG's OTC and consumer health joint venture, hit US shelves Feb. 8 and is slated for launch in Puerto Rico. (Also see "GSK's Flonase Sensimist (Veramyst) Switches Name On Way To OTC" - Pink Sheet, 16 Aug, 2016.)

Sensimist shares an indication with Flonase Allergy – once-daily use for temporary relief of nose- and eye-related allergy – but the original Flonase OTC is approved for use in children age 4 and up, the lower dose Flonase Sensimist is approved for children 2 and up.

Most OTC allergy pills act on histamine alone, but Flonase Sensimist helps block six inflammatory substances, GSK says. The firm also says the product has been found to be 40% stronger than a leading, unnamed, non-drowsy allergy pill.

Sensimist has “unique” ergonomic design features, including little or no drip, a “less-invasive” design with a short nozzle, and a formula that is scent- and alcohol-free, according to GSK. The formula retails on Walgreens.com for $15.99 for a .34oz spray and $26.49 for a .54oz spray.

Sensodyne, Excedrin Growth In Double Digits

GSK said oral care sales helped drive 3% growth in US consumer sales to £467m ($585m) in the fourth quarter while OTC drug sales were slowed by private label competition in the allergy category.

European consumer health sales in the October-December period were up 4% to £565m ($707.3m) and international sales were flat at £842m ($1.05bn).

Strong US consumer health care sales in 2016 also benefited from double-digit growth of the Sensodyne oral care line on the launch of True White toothpaste in the first quarter and continued strong sales of Repair and Protect toothpastes, GSK said. The Sensodyne Pronamel line achieved distribution gains on the launch of Strong & Bright.

GSK also reported a good performance by the Tums antacid brand and double-digit growth of the Excedrin (acetaminophen, aspirin, caffeine) brandon the launch of its Gel-tab product, but said the strength of is consumer health care brands partly were offset by a decline in Aquafresh oral care brand sales due to increased competition.

The European consumer division sales grew 4% on a pro-forma basis to £2.19bn ($2.74bn) for the year. The firm noted momentum in Germany, Scandinavia and Italy, driven primarily by wellness product and oral health sales, was partly offset by "challenging economic conditions” in Russia and countries previously part of the Soviet Union.

Among European OTC brands, the Voltaren nonsteroidal anti-inflammatory drug line grew double-digits on sales of the 12-hour variant across the region, particularly in Germany, Italy and Central and Eastern Europe, the firm said. In oral care, Sensodyne recorded strong growth on innovations and targeted promotional support, the firm said.

International sales of £3.24bn ($4.05bn) represented 5% pro-forma growth and were impacted by the sale of the Nigeria beverages business in September and the effective cessation of trade in Venezuela at the end of 2015, the firm said. Another international influence was the combined impact on GSK's Indian business from the country's demonetization implemented in November and a general slowing of the health food drink category there.

Global sales for GSK consumer wellness products grew 6% pro-forma basis for the year to £3.73bn ($4.67bn); oral health sales grew 8% to £2.22bn ($2.78bn); and nutrition sales slumped 9% to £674m ($843.7m).

Net consumer health sales globally for 2016 advanced 5% pro-forma to £7.19bn ($9bn). The performance reflected sales of Novartis brands. (Also see "Glaxo In Charge, And The World Is GSK/Novartis Consumer Product JV’s Oyster" - Pink Sheet, 8 Jun, 2015.)

GSK Chief Financial Officer Simon Dingemans commented that the 2016 consumer business results were consistent with the firm's medium-term outlook. “Accelerating the delivery of the targeted benefits of the integration and restructuring program was a key objective when we closed the Novartis transaction, and we’re very pleased with the progress we’ve made through a sustained focus across the company on executing the program,” Dingemans said.

GSK’s net sales, including its pharmaceutical business, grew 5% on a pro-forma basis for the year to £27.9bn ($34.9bn).

From the editors of the Tan Sheet.