The Medicines Co.
still seems to be playing by its own rules when it comes to making public disclosures about the regulatory status of its experimental hypertension drug Cleviprex.
At an investment conference last Thursday, Medicines Co. CEO Clive Meanwell disclosed for the first time that the U.S. Food and Drug Administration's review of Cleviprex was being delayed by three months because regulators asked the company to provide additional, preclinical data on Cleviprex.
The Medicines Co. has been
when it comes to doling out any meaningful morsels to investors on the timing of the FDA's Cleviprex review. If Thursday's update was an attempt by management to be more forthcoming in that regard, it didn't work very well, because Meanwell's disclosures actually raise more questions than they answer.
Like this one: The FDA asked for the new Cleviprex data in April -- two months ago -- so why did it take this long for The Medicines Co. to disclose the information to investors?
This question is particularly troubling since the company also knew, in April, that the FDA's request was going to delay any approval decision on Cleviprex by at least three months, if not more.
A Material Event
The Medicines Co. sells one drug, a blood thinner called Angiomax, which faces generic-drug competition in 2010. The company, therefore, needs Cleviprex's approval as quickly as possible in order to soften the coming loss of revenue from Angiomax.
In other words, the status of Cleviprex appears to be very much the definition of a material event for The Medicines Co. and its investors, yet the company chose to keep silent on an FDA request for more information and a delay in the drug's review time line.
Attempts to reach executives at The Medicines Co. for comments over two days were not successful. The company's stock closed Monday down 1.5% at $18.27.
Previously, however, The Medicines Co. investor relations chief Robyn Brown told me that the company had a deliberate policy to say nothing about the timing of the FDA's Cleviprex review because the company didn't want investors to fixate on a specific date.
When I asked Brown last week for an update (before the company's presentation at the Needham conference), she replied, "We have received no formal action from the FDA" on Cleviprex.
Technically true, I guess, because the FDA's decision date has been delayed, but then, she didn't offer an entirely forthright answer either.
A Question of Timing
Is The Medicines Co. deliberately misleading investors about Cleviprex? That's a serious charge, but not entirely out of bounds given the company's past statement about the drug.
Take a look at what President John Kelley said about Cleviprex on the company's first-quarter earnings conference call, held April 23. This quote is culled from a transcript of that call, provided by Thomson Financial StreetEvents.
"Now, turning to Cleviprex. The NDA new-drug application requires (inaudible) that we are progressing at the FDA. We've had active discussions with FDA on the review, including labeling discussions. We are continuing with our pre-launch activities and preparing for the launch of the product this year."
Kelley made it sound as if the FDA's review of Cleviprex was going smoothly and that there weren't any problems. He made these comments on April 23, the same month that the FDA asked for more information on Cleviprex from the company.
In his presentation last Thursday, The Medicines Co.'s CEO Meanwell didn't disclose the exact date of the FDA's Cleviprex preclinical data request, only saying that it was made in April. If the FDA request came before April 23, why wouldn't Kelley have disclosed that news to investors with his Cleviprex update on the first-quarter conference call?
If the FDA's request was received after April 23, wouldn't the company consider that to be a material change to its outlook, as provided on the April 23 conference call and decide that a public update was in order?
In fairness, it should be noted that even with a three-month delay in Cleviprex's approval, the drug could still be on the market this year, and this hasn't forced The Medicines Co. to alter its revenue forecast. That may partially explain the company's decision to stay mum about Cleviprex.
With that said, however, there is no guarantee that the FDA won't take even longer to complete its Cleviprex review, nor can you count out the possibility that the new data provided to the agency -- even if it is only data from animal or laboratory studies -- doesn't prompt more questions or concerns for regulators.
Longer-than-expected FDA drug reviews has been a problem plaguing drug makers this year, including
( CVTX) and
At the top of this column I said there were more questions raised than answers offered, so let me end with one final query:
Why hasn't The Medicines Co. filed an 8-K update with the
Securities and Exchange Commission
? Meanwell's comments Thursday on the FDA data request and the approval time-line delay were made during his presentation at an investor conference. His remarks were webcast, but still, it seems as if the company would be under some obligation to more widely disseminate the news.
To date, however, the company hasn't issued a press release or filed an 8-K with the SEC.
In the meantime, investors will wait a bit longer to hear if the FDA approves Cleviprex or not. Expect a decision to be announced by The Medicines Co. in August. An exact date is not known, because, well, the company isn't offering one.
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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