Mergers and Acquisitions

* On December 2, 2013, Clovis Oncology has announced that certain selling stockholders have commenced an underwritten public offering of 2,000,000 shares of the Company’s common stock which they recently acquired as consideration in connection with the acquisition of EOS. All net proceeds from the sale of the common stock will be received by the selling stockholders. The Company will not receive any of the proceeds, and the total number of shares of its outstanding common stock will not change as a result of the offering. 
* On November 19, 2013, Sofinnova Partners, an independent venture capital firm based in Paris, has announced  the sale of portfolio company Ethical Oncology Science (EOS), to Clovis Oncology for up to $420 million (€310M). EOS is a privately-held Italian biopharmaceutical company developing a novel targeted therapy to treat cancer, lucitanib (oral, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 and 2 (FGFR 1/2) and vascular endothelial growth factor (VEGF) receptors 1-3 (VEGFR1-3)). In 2012, EOS sublicensed lucitanib rights in Europe and the rest-of-world (ROW) markets, excluding China, to Les Laboratoires Servier (Servier). Clovis holds exclusive rights for lucitanib in the U.S. and Japan, and will collaborate with Servier on the global clinical development of lucitanib.

A broad Phase II program is being initiated to explore lucitanib in multiple indications including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with metastatic squamous NSCLC. In parallel with these planned Clovis-sponsored studies, a Servier-sponsored Phase II study of lucitanib monotherapy in patients with advanced breast cancer will begin enrolling this month. This ex-US study is expected to enroll approximately 120 patients and will seek to determine whether the activity of lucitanib is limited to a defined population of breast cancer tumors with FGF-aberrations or if a more broadly defined population may benefit as well.

If these Phase II monotherapy studies in breast cancer are successfully completed, Clovis and Servier intend to pursue future development of lucitanib as monotherapy and/or in combination with estrogen antagonists. Other potential indications that may be considered for development include squamous NSCLC, bladder, head and neck cancer, and other solid tumors with FGF-aberrancies.

Clinical development of lucitanib in patients with FGF-aberrant tumors will be accompanied by development of a diagnostic test designed to identify a selected patient population most likely to benefit.

Under the terms of the deal, Clovis is acquiring EOS for an up-front payment of $200 million, which includes $190 million in Clovis common stock (3,713,731 shares) and $10 million in cash. Clovis will pay an additional $65 million in cash upon the initial approval of lucitanib by the FDA. Pursuant to the license agreement with Servier, Clovis is entitled to receive up to €350 million (approximately $470 million) upon the achievement of development and commercial milestones, as well as royalties on sales of lucitanib in the Servier territories. Clovis will also pay the EOS shareholders up to an additional €115 million in cash (approximately $155 million) upon the receipt by Clovis of certain of the milestone payments pursuant to the Servier license agreement.

Clovis and Servier will collaborate on the development of lucitanib pursuant to a mutually-agreed upon global development plan. Servier is responsible for the initial €80 million (approximately $108 million) of costs under the global development plan and costs above €80 million will be shared equally between the companies.

EOS owns the exclusive global (excluding China) development and commercialization rights for lucitanib, an oral, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor (FGF) receptors 1 and 2 (FGFR1/2) and vascular endothelial growth factor (VEGF) receptors 1-3 (VEGFR1-3).

In an ongoing Phase I/IIa clinical study, lucitanib has demonstrated multiple objective responses in FGF-aberrant breast cancer patients, and objective responses have also been observed in patients with tumors often sensitive to angiogenesis inhibitors, such as renal cell and thyroid cancer. FGF-aberrations include amplification of the FGFR1 gene as well as amplification of a region of chromosome 11q that contains several FGF ligands, specifically FGF-3, -4 and -19. The initial development program for lucitanib will focus on the approximately 25 percent of women with breast cancer who have FGF-aberrant disease.

The first clinical trial of lucitanib was initiated in Europe in July 2010 and is currently ongoing at Institute Gustave-Roussy in Paris with Professor Jean-Charles Soria and at Vall d’Hebron Institute of Oncology in Barcelona with Professor Josep Tabernero. This trial is an open-label, dose-escalation, Phase I/IIa study to determine the maximum tolerated dose (MTD), recommended Phase II dose, efficacy, pharmacokinetics and pharmacodynamics of lucitanib in adult patients with advanced solid tumors. Doses evaluated in the study ranged from 5mg to 30mg given once per day. Twenty milligrams once per day was identified as the MTD. Overall, the toxicity profile observed to date is consistent with what was expected from preclinical studies and with VEGF inhibitors generally, with hypertension, proteinuria, asthenia and subclinical hypothyroidism being commonly observed. Other common treatment-related adverse events include gastrointestinal symptoms such as diarrhea, abdominal pain, nausea and vomiting.