Two recent product launches perhaps demonstrate the occasional wisdom of Big Pharma, or perhaps the hubris of emerging biopharma companies. The products, Provenge (Dendreon) and Krystexxa (Savient), may be examples of fools rushing in where angels fear to tread.

Provenge and Krystexxa have both stumbled with their product launches. Despite addressing important clinical needs neither of the products are getting appreciable market acceptance. A back of the envelope calculation suggests that Provenge, for the treatment of advanced prostate cancer, is treating less than 300 new patients per month eighteen months after FDA approval. And Krystexxa, for the treatment of chronic gout, I generously estimate is being administered to less than 50 new patients per month. With very high treatment prices, $93,000 for a full course of treatment with Provenge, and $59,000 for Krystexxa, neither product is on an obvious path to success.

It can be argued these are novel products, only recently launched, and too little time has elapsed for them to gain traction. It is also worth noting that both products have only recently sorted out federal reimbursement issues.

The point worth noting is that neither company has a Big Pharma or Big Bio partnership. One might have thought Big Pharma would have been all over products like these that offer novel therapeutic benefits and an entrance to new markets. Perhaps Big Pharma has been all over them, and that is exactly why they are unpartnered. There was talk about Savient selling themselves to the higher bidder (with a reserve price of course) on the basis of Krystexxa’s pending approval. Obviously none of the bids met the reserve price. Provenge seemed an obvious partnering asset even if the company wasn’t ‘for sale’.

What derailed the partnering opportunity, and more obviously the commercial opportunity, for these two products?

Big Pharma seems to have properly assessed the potential for both products. The challenges were apparent even two years ago. The more obvious challenges ranged from limited target population, dosing logistics and manufacturing costs. An even bigger concern must have been competitors in later stage development that addressed a number of the challenges with Krystexxa and Provenge. In a recent post I recently discussed the challenges faced by Provenge and its competitors. In the case of Krystexxa, Ilaris (canakinumab) from Novartis may be a formidable competitor with a less onerous dosing regimen.

I’m pessimistic that either Provenge or Krystexxa will ever make it big. You only have one chance to make a good first impression, and the up and coming competition looks tough and ready to learn from these product’s mistakes.

Bottom-line: if Big Pharma is not interested in a product there is good reason believe there are more issues than are obvious to the investment bloggers pumping a stock. And please, let’s remember that benefits and prices need to be aligned. High prices will only fly if a product provides a life and death benefit for patients where there are no real alternatives.