Merck's Schering-Plough Consumer HealthCare Products division will launch Zegerid OTC in the first half of 2010 as the first dual-ingredient OTC proton pump inhibitor.

FDA approved the Rx-to-OTC switch of Zegerid (omeprazole 20 mg/sodium bicarbonate 1100 mg) for the treatment of frequent heartburn Dec. 1.

Zegerid OTC's sodium bicarbonate coating "allows absorption of" the PPI ingredient, according to the Drug Facts label. While the sodium bicarbonate is listed as an active ingredient, it is not indicated as an antacid in the case of Zegerid.

While its unique formulation could help differentiate it from Prilosec OTC and the just-launched Prevacid 24HR , Zegerid OTC's approved ¹ labeling states it is "not intended for immediate relief of heartburn" and may take one to four days to reach full effect - identical to labeling for the other nonprescription PPIs.

Gastroenterologists say head-to-head clinical data likely are forthcoming and may support stronger claim language for Zegerid OTC.

In the meantime, switch sponsor Merck/Schering-Plough and originator Santarus are playing up the product's uniqueness and dual-ingredient formulation.

The product's Web site calls the sodium bicarbonate buffer a "special ingredient that protects the omeprazole from acid in the stomach." It claims to treat consumers 18 years and older suffering from "frequent heartburn by controlling and suppressing acid for a full 24 hours" - also comparable to claims made for the other OTC PPIs.

Zegerid OTC will be available at retail in packs of 14, 28 and 42 capsules. A Merck spokeswoman did not give suggested retail prices and declined to say whether FDA has granted a period of market exclusivity. The firm has patent protection on Zegerid OTC into 2016.

Launching Zegerid likely will be a boon to Merck, which gained an already-strong consumer health portfolio and a degree of revenue diversification in its acquisition of Schering-Plough (² Also see "Schering-Plough Merger Offers Merck OTC Business, Zegerid Switch Rights" - Pink Sheet, 16 March, 2009.).

Meanwhile, Santarus earned $20 million from Merck upon Zegerid OTC's approval and is due for another $37.5 million in potential sales milestone payments.

Claim Games

The approval of Zegerid OTC with no apparent competitively advantageous claims offers a measure of relief to Procter & Gamble, whose Prilosec OTC (omeprazole 20 mg) has lost market share in recent years.

P&G asked FDA to specifically not allow Zegerid OTC to claim more rapid onset of effect than other PPIs. The firm's November 2008 ³ petition asserted consumers could confuse "immediate release" for "immediate relief" and reach a false conclusion about the drug's efficacy (⁴ Also see "P&G Says Zegerid Switch Proposal Should Drop “Immediate Release” Claim" - Pink Sheet, 8 December, 2008.).

The petition also requested, unsuccessfully, that Zegerid's sodium bicarbonate be labeled an excipient because listing two active ingredients "could result in inappropriate use of the product to the potential detriment of the consumer."

FDA denied that petition, as well as an April 2009 P&G ⁵ petition that sought class labeling for all OTC PPIs, noting that to accede to the requests would interfere with the review of Zegerid's switch application and preclude the possibility that the sponsor had submitted data backing stronger claims (⁶ Also see "FDA Denies P&G Petition For OTC Proton Pump Inhibitor Class Labeling" - Pink Sheet, 26 October, 2009.).

Assume The Positioning

The increasingly crowded OTC PPI space means firms must position creatively their products within the context of what is essentially, for now, class labeling.

Novartis gained FDA approval for Prevacid 24HR in May and introduced the lansoprazole 15 mg drug in mid-November, backed by an aggressive $200 million marketing campaign (⁷ Also see "Prevacid 24HR Hits Shelves, Targets Rx-Users And Fed-Up Heartburn Sufferers" - Pink Sheet, 16 November, 2009.). The firm estimates annual sales could range between $500 million and $1 billion.

To make Prevacid 24HR a top-five OTC brand, Novartis is targeting users of Takeda Pharmaceuticals' Rx Prevacid who also suffer from frequent heartburn, rather than focusing on gaining share from Prilosec OTC.

With Prilosec OTC, P&G has the advantage of first-to-market status and a large degree of brand loyalty. A spokesman said P&G is "aware of what's happening on the market" and has "plans in place to remain a strong choice" among consumers, retailers and health care providers.

Prilosec OTC, launched in 2003, dominates the branded heartburn remedy market, tallying sales of $285.7 million during the 52 weeks ended Oct. 4 in supermarkets, drugstores and mass merchandise outlets, excluding Walmart, according to data from Information Resources Inc.

That sales figure is down 16.6 percent from the prior year period. P&G has faced competition from generic omeprazole since early 2008 (⁸ Also see "P&G Health Care Unit Boosted By Oral Care, Prilosec Faces Competition" - Pink Sheet, 5 May, 2008.).

The overall U.S. market for OTC gastrointestinal remedies - including PPIs, antacids, laxatives and anti-diarrheals - is about $2.44 billion for 2009, according to an April forecast by Mintel. The market research firm projects the market will contract to about $2.27 billion in 2010, followed by relatively flat growth through 2013.

A September 2008 report by Mintel weighed in on the eventual significance of the expected Prevacid and Zegerid switches.

"While the impact of these new OTC PPIs may not be as great as Prilosec's, they will certainly help to strengthen the high end of the OTC heartburn market," Mintel said.

Additional Rx PPIs are expected to switch in the near future. Pfizer's Protonix (pantoprazole) could switch in 2010, while Eisai's AcipHex (rabeprazole) is slated for a possible switch in 2013 (⁹ Also see "OTC Switch Offers Firms Opportunities To Diversify Earnings – Morgan Stanley" - Pink Sheet, 4 February, 2008.).

Data With Destiny

Zegerid's sodium bicarbonate coating has yet to prove clinically relevant when it comes to formulating "time to full effect" claims.

Still, Zegerid may eventually gain a competitive advantage over single-ingredient PPIs, based on as-yet-unpublished data from head-to-head clinical studies.

Mark DeLegge, a gastroenterologist and professor at the Medical University of South Carolina, said he is aware of a study Schering-Plough conducted comparing Zegerid OTC and Prilosec OTC, and he expects results to be released soon.

Based on experiences in his medical practice, DeLegge said Zegerid's dual formulation "does give an advantage" to patients suffering intermittent and nighttime heartburn.

Santarus cited reduction of nocturnal gastric acidity as a possible indication for Zegerid OTC upon Schering-Plough's initial licensing of the drug (¹⁰ Also see "Zegerid May Bring Quick Heartburn Relief To Market Under Santarus/S-P deal" - Pink Sheet, 23 October, 2006.).

DeLegge said he expects Merck will aim for a claim of rapid onset of action, and added, "I feel like that's going to be absolutely true, but again, we obviously have to wait until the results are released."

Eastern Virginia Medical School gastroenterologist David Johnson said he also is aware of a drug comparison study, not yet begun, that will look at Zegerid OTC's pH effect in the stomach.

Such an endpoint could give the sodium bicarbonate formulation an advantage, said Johnson, former president of the American College of Gastroenterology. However, Zegerid has yet to show any true advantage in clinical efficacy over the other PPIs, he added.

"There were never head-to-head trials looking at really hard endpoints of esophagitis healing or symptom resolution with another PPI," said Johnson, who consulted with Novartis on Prevacid.

"It would be hard to imagine that we could expect [Zegerid] to be a better PPI without any data that suggests that from the prescription Rx market studies, or lack thereof."

Additionally, Johnson posited that Zegerid's relative lack of built-in brand awareness could pose an obstacle to consumer uptake.

"Zegerid's not going to have that carry-forward brand legacy because it's a fairly small percentage of the Rx market," Johnson said. "So I think that will still be an encumberment for them."

Santarus said recently it expects Zegerid OTC marketing to spill over and increase awareness of Rx Zegerid among health care providers (¹¹ 'The Tan Sheet' Nov. 23, 2009).

- Dan Schiff ( ¹² d.schiff@elsevier.com )

Zegerid OTC Approved, Limited To Touting Dual-Ingredient Formula For Now

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