"Boning Up" On Amgen's D-mab


While on the elliptical at the gym the other night I was watching one network newscast and the person on the machine next to me was watching another one. Both shows hit their commercial breaks around the same time.

On my monitor was a commercial for one osteoporosis drug, Reclast from Novartis, and at the very same moment on the monitor next to me there was Sally Field talking about Boniva from Roche and GlaxoSmithKline. It's a telling anecdote about the importance of the $7 billion osteoporosis drug market to the biopharma industry.

Perhaps, those companies are gearing up for a looming threat from Amgen. The big biotech company is getting ready to file for Food and Drug Administration approval of its twice-a-year osteoporosis treatment known as D-mab. So, it's no surprise that AMGN devoted a good portion of its analyst/investor day presentation in New York City this morning to the drug. I'm not there, but I watched the webcast. In fact, shares of Amgen spiked mid-morning right about the time that officials revealed that they're looking for a corporate partner on D-mab in Europe and that they think the "value proposition" (that's a euphemism for, "we think we can set the price pretty high") for the drug is strong. The news that the company might partner the drug outside the U.S. might have moved the stock because it means another company would pay Amgen cash for some of the rights to the drug. Amgen said it plans to have a U.S. D-mab sales force of between 500-1,000 reps and 800-1,500 people internationally.

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What's all that gonna cost the company? None of the execs would put a dollar figure on it. But in response to that question from Bernstein analyst Geoffrey Porges about the launch expense, Amgen Chairman and CEO Kevin Sharer said, "We will invest enough money to do this right and to do it aggressively." He added that he thinks they can pay for it with money from sales growth of existing products and possibly more cost cuts in other areas. But another executive suggested that we might not see Amgen do the typical type of marketing for a drug launch and that the company could borrow a page from Barack Obama's presidential campaign and what he called its "exquisite use of the internet". Interesting.

But the one thing analysts and investors really wanted to find out today is when Amgen plans to file for approval of D-mab. That's why it was kind of surprising that 20 minutes went by in the q. and a. period before Goldman Sach's May-Kin Ho finally, thankfully, asked that question. Sharer would only say they're aiming for the end of this year or early next. "We're working very, very hard to prepare a good file for the FDA," he said.

In his opening remarks Sharer stated, "I've never been more excited about Amgen's future than I am right now." He went on to say that he thinks D-mab has what he called "dual blockbuster status potential" in post-menopausal osteoporosis and in cancer patients who suffer bone loss. Employees, investors and patients hope he's right.

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