Norway's Clavis Pharma earlier this week won $15 million upfront from Clovis Oncology for partial rights to a Phase 2 analogue of a top-selling chemotherapy agent for pancreatic cancer.
The firm's modus operandi is to in-license clinical-stage cancer treatments and push them to commercialization. With Clavis's CP-4126, Clovis has found a reformulated version of Eli Lilly's Gemzar (gemcitabine) that might provide treatment to certain pancreatic cancer patients who fare poorly on gemcitabine.
They fare poorly, Clavis officials say, because gemcitabine enters cancer cells via the nucleoside transporter protein known as hENT1, but several studies show a significant percentage of pancreatic cancer patients, perhaps up to 67 percent, have low levels of hENT1 and thus poor uptake of gemcitabine.
For these low-hENT1 patients, one or two more months of life would be "meaningful and significant survival," said Clavis CEO Geir Christian Melen from his home in Norway.
Clovis will take over Phase 2 testing of intravenous CP-4126, boosting enrollment from 120 to 250 patients with newly diagnosed advanced pancreatic cancer. They will eventually be categorized as either high-hENT1 or low-hENT1 patients, and the companies will focus on comparative overall survival of the low-hENT1 patients. Data are due in the first half of 2012. The firms will also test the low-hENT1 hypothesis in other oncology indications.
With Clovis in the lead, development plans include a companion diagnostic that sorts out low- from high-hENT1 patients. The diagnostic could be "key to identifying the target group of patients included in the NDA filing," said Melen. In addition to its upfront fee, Clovis will pay up to $365 million in milestones and take on the full burden of clinical development and commercialization for North America, South America and Europe. The rest of the world remains unpartnered. Clavis can opt to co-develop and co-promote CP-4126 in Europe. It will earn tiered double-digit royalties from all sales. Rights to any diagnostics that emerge from the trials would be shared along the same regional lines as CP-4126
The deal is Clovis's first, and the development costs plus milestones due to Clavis will be a test of its ability to manage the impressive cash it raised. Clovis officials could not be reached for comment.
Clavis's platform, Lipid Vector Technology, was discovered at Norwegian industrial giant Norsk Hydro in the last decade. LVT chemically links a fatty acid to a parent drug. Added to gemcitabine, the molecule passes through the tumor cell membrane without using the hENT1 transport. Gemcitabine has been the subject of a running patent battle between owner Eli Lilly and several generic drug makers.
But Clavis says its altered compounds are new chemical entities. It has composition of matter patents in the United States and Europe and bears no infringement risk, said Melen. He also noted that CP-4126 will reach the market after Lilly's gemcitabine patents expire in 2013.
A U.S. court ruling this summer in the Lilly fight opened the door to generic competition next year, although Lilly said it plans to appeal. Meanwhile, the drug maker has begun to restructure as it looks ahead to the looming patent cliff (In Vivo, Oct. 1, 2009). Gemzar tallied $1.05 billion in worldwide sales the first nine months of 2009, down 19 percent from the same period in 2008.
-Alex Lash (a.lash@elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY –Nov 24, 2009
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