BOULDER, Colo.—Clovis Oncology has announced the acquisition of privately held Ethical Oncology Science (EOS) S.p.A., a pharmaceutical company based in Italy that is working on the development of a novel targeted cancer therapy. The company holds exclusive global rights (with the exception of China) for development and commercialization of lucitanib, an oral, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor (FGF) receptors 1 and 2 and vascular endothelial growth factor receptors (VEGF) 1 through 3. EOS sublicensed rights to the drug in Europe and rest of the world markets (excluding China) to Les Laboratoires Servier in 2012.
Per the terms of the transaction, Clovis will acquire EOS for $200 million up front, which consists of 3,713,731 shares, or $190 million, in Clovis common stock and $10 million in cash. Upon receiving U.S. Food and Drug Administration approval for lucitanib, Clovis will pay an additional $65 million is cash. In conjunction with the license agreement with Servier, Clovis stands to receive up to 350 million euros (approximately $470 million) if certain development and commercial milestones are met, in addition to royalties on sales of the drug in Servier territories. The agreement also stipulates that Clovis will pay up to an additional 115 million euros (approximately $155 million) in cash to EOS shareholders once Clovis receives certain of the milestone payments tied to the Servier agreement.
Clovis holds exclusive rights for lucitanib in the United States and Japan, and will work together with Servier on global clinical development of the therapy. The companies will be working together under a global development plan which makes Servier responsible for the initial 80 million euros (approximately $108 million) of costs under the plan, with all costs above that number to be shared equally between Servier and Clovis.
“We have been interested in lucitanib for some time and are pleased to have acquired EOS to add this program to our portfolio,” Patrick J. Mahaffy, president and CEO of Clovis, commented in a statement. “It is highly consistent with our focus on developing targeted therapies that provide meaningful benefit to specific patient populations. We are extremely encouraged with lucitanib’s 50 percent response rate seen to date in heavily pre-treated targeted patients and we intend to develop it aggressively, in collaboration with our partner Servier.”
The first clinical trial for lucitanib, which is ongoing, launched in July 2010 in Europe as an open-label, dose-escalation, Phase I/IIa study seeking to determine the maximum tolerated dose, recommended Phase II dose, efficacy, pharmacokinetics and pharmacodynamics of the drug in adult patients with advanced solid tumors. Thus far, observed adverse events consist of hypertension, proteinuria, asthenia and subclinical hypothyroidism, as well as gastrointestinal symptoms.
The drug has demonstrated objective responses in FGF-aberrant breast cancer patients as well as in patients with tumors that often display sensitivity to angiogenesis inhibitors. As such, the initial development program for lucitanib will focus on the roughly 25 percent of women with breast cancer who present with FGF-aberrant disease.
A broad Phase II program is being launched to explore the drug in several indications, including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with metastatic squamous non-small cell lung cancer. Both studies will be sponsored by Clovis, while Servier will be sponsoring a Phase II study of lucitanib monotherapy in patients with advanced breast cancer. If the monotherapy studies are successful, the companies plan to further develop lucitanib as a monotherapy and/or in conjunction with estrogen antagonists.