June 23, 2015
By Alex Keown, BioSpace.com Breaking News Staff
Allen will remain with the company through August before departing to launch his company. During his last months, he will oversee a New Drug Application and marketing authorizations for rociletinib, an inhibitor of the cancer-causing mutant forms of epidermal growth factor receptor (EGFR) currently being studied for the treatment of non-small cell lung cancer (NSCLC).
Patrick J. Mahaffy, president and chief executive officer of Clovis Oncology, said in a statement he always knew Allen would depart to launch his own company. He said he’s loved working with Allen over the years.
“The submissions of the NDA and MAA for rociletinib planned in July represent a final accomplishment for his tenure with Clovis and a clean transition point for our organization. I wish him the very best, and am confident he will do a great job in his new venture,” Mahaffy said in a statement.
While Clovis announced Allen’s departure and his plans to launch a biotech startup, the company did not release any information regarding areas of immuno-oncology the new company will be focus on, initial funding, employment or where the company will be located.
Allen joined Clovis in 2009. Before Clovis, he served two years as chief medical officer at Pharmion, Inc. before that company was sold for $2.9 billion to launch Clovis.
Replacing Allen will be Lindsey Rolfe, a senior vice president of clinical development, who joined the company in 2010. Rolfe will be responsible for clinical development, preclinical development, clinical operations and pharmacovigilance and will also serve on the company’s executive committee.
She will be based in Clovis Oncology’s San Francisco office. Rolfe previously served in senior oncology development roles at Celgene Corporation (CELG), Pharmion Corporation, Cambridge Antibody Technology, UCB Group and Celltech Group plc.
She has specialist accreditation in pharmaceutical medicine. While at Clovis, Rolfe has led clinical development of rociletinib and rucaparib.
During the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago earlier this month Clovis revealed clinical study results that showed rucaparib shrank ovarian cancer tumors in 82 percent of the women it treated in a recent mid-stage trial. All of the patients treated with Clovis‘ rucaparib during the Phase II ARIEL2 had a mutated BRCA gene and 10 percent of patients had complete resolution of their tumors.
Median progression-free survival was 9.4 months. In addition, nearly half of those (45 percent) with “BRCA-like” saw response rates to rucaparib, with their median progression-free survival in these patients was 7.1 months.
The successes of its two drugs have fueled rumors that Clovis could be ripe for a takeover from a larger pharmaceutical company, especially with both drugs having received breakthrough status by the U.S. Food and Drug Administration (FDA).
Last year Clovis Clovis inked with GlaxoSmithKline (GSK) on a new Phase I/II trial of an experimental oral combination therapy targeting mutant epidermal growth factor receptor (EGFR) in non-small cell lung cancer.
Clovis’ trametinib has been approved by the U.S. Food and Drug Administration as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
Rumors are swirling that Swiss-based Roche (RHHBY) and U.S.-based Johnson & Johnson (JNJ) are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo.
Last month there was buzz that Pfizer Inc. (PFE) was considering acquiring Glaxo, a year after it failed to acquire AstraZeneca PLC (AZN). Just this month over a third of respondents in a poll conducted by BioSpace (DHX) believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK).
So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom?
Source: BioSpace Featured News