Best Performing Companies To Own For 2015

Best Performing Companies To Own For 2015: Clovis Oncology Inc (CLVS)

Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.

CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine

CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for t! he assessment of hENT1 levels.

CO-1686-an Oral EGFR Mutant-Selective ! Inhibitor

CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.

The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line trea tment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.

CO-338-a PARP Inhibitor

CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I ! monothera! py study of the oral formulation, to determine an appropriate dose and schedule.!

The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.

Advisors' Opinion:

• [By Brian Orelli]

  Plenty of data was presented at the American Society for Clinical Oncology meeting over the weekend, causing the first set of ASCO pops, but Clovis Oncology (NASDAQ: CLVS  ) looks like the clear winner, more than doubling today as the company presented data on its two cancer drugs rucaparib and CO-1686.

• [By Jake L'Ecuyer]

  Clovis Oncology (NASDAQ: CLVS) was also up, gaining 7.26 percent to $79.35 after the company announced 2014 objectives and financial outlook. The company projected to initiate three global registration studies for CO-1686.

• [By Lauren Pollock]

  Biotech company Clovis Oncology Inc.(CLVS), which was considering a sale, didn’t enter any deal talks and is no longer seeking bids, Bloomberg News reported, citing a person with knowledge of the matter. Shares dropped 14% to $63.51 premarket.

• [By Sean Williams]

  Clovis Oncology (NASDAQ: CLVS  ) certainly made a name for itself, more than doubling its share price, after reporting positive early stage data on CO-1686 for EGFR-mutant non-small cell lung cancer and rucaparib for solid tumors such as ovarian cancer. Rucaparib provided an 89% clinical benefit to patients with ovarian cancer while CO-1686 indicated a partial response in three out of four patients with the T790M resistance mutation. I would still urge caution among investors, though, as these are still early studies and Clovis lost its then lead drug, CO-101,! to a fai! led mid-stage pancreatic cancer trial in November.

source from Top Penny Stocks For 2015:http://www.topstocksforum.com/best-performing-companies-to-own-for-2015.html