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Clovis closes in

Clovis Oncology plans big $130M IPO on top of drug-diagnostic strategy

Clovis closes in

Clovis Oncology Inc. is aiming for the largest IPO by a therapeutics company since the $215.6 million debut for gastrointestinal play Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) in February 2010.

Clovis began its road show last week and amended its S-1 to raise up to $160.4 million through the sale of 9.3 million shares at $13-$15. A $14 price would raise $130.2 million and value the biotech at $290.7 million. In June, it proposed to raise up to $149.5 million.

Clovis' two-pronged strategy is to in-license cancer candidates and then develop companion diagnostics for each compound via collaborations.

On the road show, Clovis President and CEO Patrick Mahaffy told investors: "In an era where reimbursement is becoming more and more of an issue, we think that outstanding results in a subset population will lead to outstanding reimbursement."

Clovis was founded in April 2009 by the management team from Pharmion Corp., which was acquired by Celgene Corp. (NASDAQ:CELG) for $2.9 billion. In November 2009, Clovis in-licensed a lipid-conjugated form of gemcitabine from Clavis Pharma ASA (OSE:CLAVIS).

The compound, CO-101, is in a pivotal Phase II trial for first-line treatment of metastatic pancreatic cancer. Top-line data on overall survival in a prespecified subset of patients who express low levels the transporter protein ENT1 are expected in 4Q12.

The entry of gemcitabine into tumor cells is dependent upon the expression of specific membrane transporter proteins, particularly ENT1. According to Mahaffy, at least 50% of gemcitabine patients are deficient in ENT1, thereby rendering the treatment ineffective.

CO-101 does not require specific transporter proteins to enter the cells.

Clovis hopes to submit regulatory applications to FDA and EMA by mid-2013, with a potential launch by the end of 2013 or by early 2014.

CO-101 also is in Phase II testing for second-line treatment of pancreatic cancer in patients with an absence of ENT1 expression. The trial is expected to complete enrollment in 4Q12. The compound has Orphan Drug designation in the U.S. and Europe for pancreatic cancer.

The biotech is partnered with the Ventana Medical Systems Inc. subsidiary of Roche (SIX:ROG; OTCQX:RHHBY) to develop a

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