LONDON--Last Thursday's FDA approval for Amgen's PCSK9 competitor, Repatha, kicked off a head-to-head contest between that med and recently green-lighted Praluent from Sanofi and Regeneron. And with the newcomers bearing similar labels, both Sanofi and Amgen are counting on their legacies to give them a leg up in the marketplace.
|Sanofi's Jay Edelberg|
Sanofi ($SNY), for one, is leaning on injectables experience--and it has used that know-how to help develop My Praluent, a support program for patients and their physicians that the drugmaker's global head for the therapy, Jay Edelberg, called "very comprehensive."
"Sanofi produces more injectables than any other company in the world, between our diabetes franchise and Lovenox, as well as of course our vaccines, so this is a space we know," he told FiercePharma in an interview at the European Society of Cardiology Congress.
The program, whose web page was live by the Monday following Praluent's Friday approval, includes video tutorials on how to inject the product's pre-filled pens and syringes, plus as-needed self-injection training and on-call nurse support.
"It was a really cross-functional, collaborative effort to make sure we were meeting all the needs and making sure it was easy to use for patients and so forth, and we also drew upon experience from our legacy products as well--Lantus injections, things like that--so some of our heritage, if you will," Elizabeth Baxter, Sanofi's PCSK9 global communications head, told FiercePharma.
Of course, Amgen ($AMGN) has its own patient assistance program underway in RepathaReady, which offers one-on-one injection training and support from registered nurses, among other services. But the company has another sticking point for Repatha that it hopes will set it apart, too--and that's the treatment's thermostability.
|Amgen's Scott Wasserman|
Unlike Praluent--which Regeneron ($REGN) says in its prescribing information highlights shouldn't spend more than 24 hours outside a refrigerator--Repatha can be stored at room temperature for up to 30 days, a convenience factor Amgen's Repatha development lead, Scott Wasserman, believes will "make a difference in the marketplace," he told FiercePharma in an interview.
"Amgen's been doing protein therapies and manufacturing and formulation for 35 years, and I would say that we anticipated some of the important things as we developed this for the marketplace," he said. "That was one of the areas that we anticipated being important."
As the PCSK9 drugmakers look to get ahead, they'll need ways to differentiate themselves--especially since Repatha and Praluent bear similar labels. Both drugs have the FDA's blessing to treat patients who don't respond to maximally tolerated statins.
And the two bear similar wholesale prices, too. Amgen intends to price Repatha at $14,100 a year, just $1.36 less per day than the $14,600-per-year Praluent.
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