SAN FRANCISCO (
(ONXX) pre-announced strong fourth quarter net sales of at least $43.4 million for its newly launched multiple myeloma drug Kyprolis.
Tacked on to previously reported third-quarter sales of $18.6 million, Kyprolis closed out 2012 with net sales exceeding $62 million, Onyx said during its presentation at the J.P. Morgan Healthcare Conference.
At this pace, Kyprolis is already well on it way towards topping Wall Street's 2013 consensus sales estimate of approximately $200 million. The FDA approved Kyprolis in July for the treatment of patients with relapsed or refractory multiple myeloma.
I got a chance to speak with Onyx CEO Tony Coles before his J.P. Morgan presentation. Here's some of what he had to say:
On the Kyprolis launch and goals for 2013:
"We're really pleased with the U.S. launch. It's got off to a good start with rapid penetration in patients and accounts in the third quarter and that's continued through the end of the year. The next question for us is what we do in Europe and the rest-of-world markets.
"In Europe, approval is contingent on the FOCUS and ASPIRE trials... We could file on either one of these studies. We should have interim results in the second half of the year from the FOCUS trial and results from ASPIRE as early as the fourth quarter."
The FOCUS trial is evaluating single-agent Kyprolis in relapsed/refractory multiple myeloma patients. The ASPIRE trial compares Kyprolis,
(CELG - Get Report) Revlimid and low-dose dexamethasone against Revlimid and low-dose dex, also in relapsed/refractory multiple myeloma patients.
On the possibility of compendia listing for Kyprolis in front-line multiple myeloma:
"It's probably too early. We have good phase II data
in front-line multiple myeloma
but to date, we've had no conversations about compendia listing. It may be too early to have those conversations based just on phase II data. But with that said, investigators are really excited about the role Kyprolis may play in the front-line setting.
On R&D priorities and the potential for expanding the company's pipeline:
"The key to Onyx's success has been maintaining an optionality in the pipeline. We've done this through acquisitions, in-licensing and option agreements since we don't have internal development capabilities. Looking forward, I think people can continue to expect us to look at a range of transactions to expand our pipeline.