After promising to deliver a deal before the end of the year Clavis Pharma made good on its word today by signing a deal worth up to $380m with private pharma newcomer, Clovis Oncology, over its second most advanced drug CP-4126, currently in phase II trials for pancreatic cancer. The deal will see Clavis receive a welcome $15m upfront fee (EP Vantage Interview - Clavis poised to deliver data and hopefully a deal, June 12, 2009).
What might surprise some observers is that the group has chosen to ally itself with Clovis, rather than a large pharma partner which might have been expected given that CP-4126 is a modified version of Eli Lilly’s Gemzar. However its novel lipid ester tail means that the drug could potentially work better than the blockbuster, which had sales of $1.72bn last year.
Proven track record
Clovis and its management team do, however, have an impressive pedigree. The team is the core Pharmion management including Patrick Mahaffy, chief executive, who was behind the commercialision of cancer drug Vidaza before Pharmion was sold to Celgene for $2.9bn last year.
Speaking today on a conference call Keith McCullagh, chairman of Clavis, said what had swung their decision to license the drug to Clovis was the group’s collected experience: “It is hard to find an oncology team that has more success in bringing valuable products to the market,” he said.
Mr McCullagh added that big companies did not tend to make decisions or move as quickly as smaller partners sometimes wanted.
Given the history of some collaborations, which have seen smaller partners become frustrated by the pace taken by big pharma partners, Clavis’s choice may ultimately be a sensible one.
The market appeared to favour the deal, and shares in Clavis had risen 55% in late afternoon trading to NKr50.75, a good return for investors given they started the year at NKr8.00.
History repeats itself?
The deal is Clovis’s first product deal and it could be the beginning of a process that sees the management team repeat the formula they used at Pharmion of not investing in drug discovery, but building a portfolio of oncology assets.
As to whether the group wants to have a slightly longer run at independence than nine years this time round, or the plan is once again to be bought by a larger group is unknown. Pharmion’s original investors, however, appear confident that whatever strategy is adopted it is one worth getting in on and have funded Clovis to the tune of $145m. This should enable the deals to come thick and fast.
Clovis is already making its influence felt at Clavis. The groups have amended the design of the current phase II trial for CP-4126; the number of patients has been increased to 250 and the primary endpoint changed to overall survival.
In terms of getting the drug commercialised as quickly as possible, this is a sensible strategy, because the groups could get accelerated approval if a clear survival benefit is shown even at this early stage, saving on development time and equally importantly costs.
If successful the market opportunity for the drug could be huge. Unlike the current standard of care, Gemzar, CP-4126 does not require the transporter protein, hENT1, to enter cancer cells. This is important because up to two thirds of pancreatic cancers have low levels of hENT1 and therefore do not respond well to Gemzar, as such CP-4126 could show good efficacy in this large group of patients.
Bigger and better
Having identified this protein Clovis and Clavis are wisely working on a biomarker, which would maximise the efficacy of CP-4126 and also ultimately play well with payers who are increasingly basing reimbursement on demonstrable results. Additionally, Gemzar is due to come off patent next year and the only way to compete will be by proving CP-4126 is not only more effective, but also can treat the patients who stand the best chance of responding in this notoriously hard to treat cancer.
Clovis, which is taking on all the development costs of CP-4126, is expected to release the data from the phase II trial in the first half of 2012. Although distant, this event will be eagerly watched to see if Clovis can indeed “do a Pharmion” this time round.