Excerpts from The Street:
Skip Irvine, director of communications for the joint venture, insists that neither company received any clues about ENHANCE until earlier this month. But skeptics, pointing to stock sales by Schering-Plough insiders, have some doubts.
Schering-Plough didn't respond to questions about its insider sales.
In May of 2006, just one month after EMBRACE came to an end, Carrie Cox, president of Schering-Plough's global pharmaceutical business, sold nearly $1 million worth of company stock. Cox would go on to execute even larger sales, clearing more than $5 million on two separate occasions, a year down the road.
Meanwhile, Schering-Plough's top executive had secured $2 million in a stock sale of his own. Hassan pocketed that money at the end of 2006, even as the company wrapped up a banner year that ensured tremendous bonuses.
"I must admit, I'm a bit concerned about this trial because you've set up an admittedly medically important endpoint but a challenging design and endpoint" all the same, Cowen analyst Steve Scala said during Schering-Plough's fourth-quarter conference call in January of 2007. "AstraZeneca's (AZN - Cramer's Take - Stockpickr - Rating) METEOR trial of Crestor, I believe, will report at around the same time, and its endpoint is likely much more achievable.
"So from a marketing standpoint, how would you deal with a situation where METEOR is successful but ENHANCE is not?"
Schering-Plough responded in a manner that would soon become routine. The company emphasized the complex nature of the specialized trial -- focused outside the mainstream population -- and warned that the results would take some time.
"We're in no rush to get a marketing thing out of this," Hassan assured.
Unlike Schering-Plough, The New York Times has since noted, AstraZeneca took just 10 months to report favorable results from its cholesterol drug trial.
Meanwhile, quarter after quarter, analysts kept asking Schering-Plough about ENHANCE. In response, Schering-Plough began downplaying the significance of that trial -- insisting that the value of lower LDL had already been proven -- and directing attention to the ongoing IMPROVE-IT instead.
Finally, in mid-December, Congress began demanding answers as well. And as the new year began, Schering-Plough found itself peppered with ENHANCE-related questions at a presentation hosted by Morgan Stanley.
In fact, that "CEO Unplugged" conference, with its question-and-answer format, brought ENHANCE to the forefront like never before.
"So let me just cut to the chase," Morgan Stanley analyst Jami Rubin began in one address. "What's the organization thinking embarking on this study and putting such an important franchise at risk given that you didn't have to do the study?
"But now you own the study, and it's yours, and you've got to continue to protect what is obviously the most important franchise" for the company.
Schering-Plough has always known about the high stakes involved. For 12 straight quarters, the company has managed to generate double-digit growth in adjusted sales. Strip out the contribution from its cholesterol franchise, however, and those double-digit gains fade away.
"Vytorin and Zetia are critical to the future of Merck (and) critical to the future of Schering-Plough as well," Merck CEO Richard Clark stressed back in June of 2006. "So we will do everything we must to maximize both of those products."