Monday, June 20, 2011
Positive Phase 2 data move Curis toward milestone payment
By Lori Valigra, Mass High Tech correspondent
Curis Inc. of Lexington received positive data from a pivotal Phase 2 trial of its GDC-0449 drug candidate for advanced basal cell carcinoma (BCC), a disfiguring and debilitating skin cancer, that will allow its partner Genentech to file for a new drug application (NDA) in the second half of this year, triggering a milestone payment for Curis.
“The response rate in this trial is significant enough to be compelling. This is a pivotal Phase 2 trial,” said Daniel Passeri, president and CEO of Curis. “There is no alternative for this patient population. They have tried other therapies, but they weren’t effective.” The data will be presented on June 21 at the Seventh European Association of Dermato-Oncology Congress in Nantes, France.
He said the NDA will trigger a milestone payment that will be higher than the $6 million the company got when it launched the Phase 2 trial. There will be additional milestone payments when the drug is approved and upon filing in the European Union, plus royalties in the mid to high single digits, Passeri said. The company has $97 million remaining on its milestone payment schedule.
Passeri said there are upwards of two million new cases of BCC in the United States each year, about 20,000 of which fall into the advanced disease category, where the cancer is no longer operable. He said Genentech has not yet revealed the price of the drug.
Passeri also said the Phase 2 trial and move toward the NDA submission is a “substantial derisking of the company.” Curis currently has two programs with partners that are monetized: The GDC-0449 program with Genentech and the Debio 0932 program with Debiopharm Group. The Debio 0932 will likely trigger a milestone payment from Debiopharm in 2012, when the fifth patient in a Phase 2 trial is treated, Passeri said. The drug candidate currently is in Phase 1 testing and is an Hsp90 inhibitor.
Curis, which recently moved to Lexington from Cambridge, employs about 40 people. It also has access to 30 dedicated medical chemists that it trained at Medinoah, a company in Suzhou, China.
Here's another tidbit for a new guessing game:
When has Dan ever indicated the milestone payment before? See the 3rd paragraph above: "He said the NDA will trigger a milestone payment that will be higher than the $6 million the company got when it launched the Phase 2 trial." Is that the writer saying this or did Dan actually say this to the reporter? I wonder how much higher? My guess is we receive $10 million upon submission, what is everyone else's?
from a different article:
"In order to provide people with advanced BCC (who are appropriate candidates) access to vismodegib while Roche discusses next steps with the European Medicines Agency, the company is conducting a phase II safety study in the EU and other countries. "
This formal announcement puts Curis in a different class and at a significantly lower investment risk level. The company has locked in another set of milestone payments ($7 million or so for the trial results, and additional payments when the NDA is filed and more when the drug is approved) and $60 to $80 million anually in royalties when the drug hits the market. Furthermore, this should validate Curis' platform .... but the market yawns............?????????????
I would also expect considerably more take-over interest/potential .... but ........ the market yawns......??????
This has been written before, but I am amazed by the low milestone payment that is estimated on this board (and reported in PR's) for an *NDA application*. I have owned smaller biotechs who have had relationships with GSK and Pfizer and have never seen less than $20MM for an NDA submission. I was not around when these deals were made, so I don't know if they were made because the company would have failed without them.