The black-boxed approval as expected of Eli Lilly and Co.’s blood thinner Effient (prasugrel) last week did nothing to quell investor worries about the steep patent cliff faced by the big pharma firm, and attention stayed on would-be competitors in the antiplatelet space.

In line with FDA briefing documents disclosed earlier this year, Effient carries a warning against use in elderly patients and those likely to undergo coronary artery bypass graft surgery (an estimated 10 percent to 15 percent of angioplasty patients undergo CABG), though the label doesn’t mention cancer risk, as some had feared.

It all means that Effient likely will grab market share in acute coronary syndrome patients getting angioplasties, but the boxed proviso from regulators and limits on use by comparison hobbles Indianapolis-based Lilly’s chances against Plavix (clopidogrel, Sanofi-Aventis and Bristol-Myers Squibb Co.) – the second largest selling drug in the world, which chalked up about $5.6 billion last year.

“The situation is pretty serious for Lilly over the next seven years,” said Michael Latwis, analyst with Decision Resources.

Language on the label also warns about bleeding in some patients, recommending that physicians attempt to manage the condition rather than stop Effient altogether. Leerink Swann analyst Seamus Fernandez, in a July 13 research report, noted that the guidance overall “complicates prescribing choices.”

“Physicians aren’t going to have the same level of comfort as they do with Plavix, but to Lilly’s credit, they did a pretty good job of defining the bleeding risk when the data first came out,” Latwis told BioWorld Today.

Also due to crowd the antiplatelet field is London-based AstraZeneca plc’s ADP receptor antagonist Brilinta (ticagrelor), which yielded positive top-line data from a Phase III trial in May, and could reach the market in 2011. That’s the year when more than two-thirds of Lilly’s marketed drugs start losing patent protection – and the year when generic versions of Plavix, already for sale in Europe, are expected to hit shelves in the U.S.

Another possible heavyweight is elinogrel, also an ADP receptor antagonist, which earlier this year netted a deal with Basel, Switzerland-based Novartis AG for Portola Pharmaceuticals Inc., of South San Francisco, worth up to $575 million, when the compound had reached Phase II trials. (See BioWorld Today, Feb. 13, 2009.)

William Lis, Portola’s vice president of business and commercial development, pointed out that angioplasty patients represent about 25 percent of those eligible for antiplatelets for various reasons – and Effient addresses a subset of angioplasty patients. “It’s an important but modest” group, Lis said of the Effient patient segment.

Elinogrel, on the other hand, comes in intravenous and oral forms. Unlike Plavix, it is direct-acting and reversible, and requires no liver metabolism since it’s not a prodrug. “We plan to take advantage of each of these attributes,” Lis told BioWorld Today, so elinogrel can be developed for patients who need fast results from an I.V. version as well as those for whom effects can be less quick.

Lilly’s marketing partner for Effient is Tokyo-based Daiichi Sankyo Ltd.

Leerink Swann estimated that Effient could garner $1.9 billion in revenue in 2015, but Decision Resources’ Latwis said his firm is “a little more cautious than some others,” modeling just under $1 billion in sales by 2015.

“We think it’s going to initially be very much a niche product,” he said. “The market is contracting with generic

Plavix in 2012, and [Effient’s] pricing is going to pressure it in the out years.” Leerink assumes a 30 percent pricing premium over Plavix, but Latwis believes that, once Plavix goes generic, Lilly may end up selling Effient at a discount.

Lilly needs to do something for its pipeline soon, Latwis said, and the company may bring aboard assets that would be divested by merger partners Merck/Schering-Plough or Pfizer/Wyeth, such as those in the area of animal health.

Although Lilly “made a big bet on ImClone, that’s likely to be a longer-term contributor,” Latwis said. Last fall, Lilly disclosed a plan to buy New York-based ImClone Systems Inc. for $70 per share, or $6.5 billion. (See BioWorld Today, Oct. 7, 2008.)

Not all who’ve tried for a share of the lucrative antiplatelet market met with late-stage success. An example recently was The Medicines Co., of Parsippany, N.J., which halted two massive Phase III trials of the antiplatelet agent cangrelor. The move foiled plans for a 2010 product launch that would have offset revenue decline when the firm’s top-selling drug, Angiomax, goes off patent next year. (See BioWorld Today, May 14, 2009.)

In late-stage development as well is the thrombin receptor antagonist gained by Merck & Co. Inc. in its merger with Schering-Plough Corp. (See BioWorld Today, March 10, 2009.)

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