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that pump out Acceleron’s protein drugs in disposable plastic bags that can be kept in a controlled environment with just the right temperature, oxygen, and acidity levels. Getting all these manufacturing parameters just right is one of the key pieces of value Acceleron sees in its products, and it would like to keep that part proprietary, and in-house, Ertel says.
The advances in manufacturing, which some other bigger biotechs are also using, make it far cheaper to build and operate this sort of facility than the traditional stainless-steel vats you’ll see at facilities like those from Amgen and Biogen. These sometimes can be as big 10,000 liters, with the extensive piping systems necessary to keep them properly supplied.
While making this bet on manufacturing, Acceleron plans to fully exploit it. The company doesn’t plan to make just one drug, but it has a pipeline of five treatments it wants to make for clinical trials. With that many projects to juggle simultaneously, Acceleron wants the flexibility and control over its own production schedule, Ertel says. If one drug fails, all the investment in infrastructure won’t go down the drain.
“It only makes sense to do this if you have multiple products,” Ertel says.
This isn’t to say that Acceleron will never use contractors. It is likely to turn in that direction if and when it ever develops an FDA-approved product that will require larger scale production than it can handle alone. But if Acceleron ends up developing products for small patient populations, it’s possible it could meet demand from its own facility. “It’s not inconceivable,” Ertel says.
So what does Acceleron really want to make? The lead product candidate in clinical trials, ACE-011, is being developed with Celgene as a treatment for bone loss and, surprisingly, anemia, which I wrote about back in September. The second, ACE-031, is for increasing muscle mass and decreasing fat mass. The third, ACE-041, is designed to block the formation of new blood vessels in tumors (and is supposed to work differently than other drugs in the class).
Plus, just last week, Cambridge, MA-based Alkermes said it agreed to pay $2 million upfront and invest $8 million in Acceleron for the right to co-develop a longer-lasting drug for rheumatoid arthritis that could compete with Amgen’s blockbuster, etanercept (Enbrel). That drug is slated to enter clinical trials in 2010.
Most biotechs have plenty to worry about with getting the science right, raising enough capital, and running clinical trials that are good enough to convince the FDA and physicians that they have a product worth prescribing to patients. Manufacturing often gets short shrift until later in the game. In the case of etanercept, that drug was such a huge hit that the company that created it, Seattle-based Immunex, failed to manufacture enough of it in its early years on the market. That failure to invest big enough, and early enough, in manufacturing is the main reason why that company got taken over by Amgen in 2002.
But given the difficulty of convincing investors to spend money on brick and mortar, the Immunex lesson is one that a few companies seem to take to heart.
“We want to control our own destiny. Part of that is producing our own drugs,” Ertel says.
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