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In close race with Amgen, Regeneron expands late-stage PCSK9 program

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Regeneron Pharmaceuticals and Sanofi have stepped up their Phase III push in the closely watched contest to advance LDL cholesterol-lowering drugs against PCSK9. After the partners announced more than 10 late-stage studies last year, Regeneron revealed plans Tuesday to take a shot at a trial to test less frequent dosing of the experimental therapy.

The Tarrytown, NY-based biotech company ($REGN) highlighted the study in which patients would take alirocumab every four weeks, providing the therapy less frequently than in the other 11 clinical trials in the late-stage program. Patients in the previous studies take alirocumab, also known as SAR236553 and REGN727, once every two weeks. Regeneron aims to launch the new study, called Odyssey Choice, by the end of 2013.  

Amgen ($AMGN), which has a similar drug called AMG 145 in Phase III development, has been running neck and neck with Regeneron and the Paris-based drug giant Sanofi ($SNY) in the race to bring PCSK9-targeting medicines to market. Yet Amgen has already made convenient monthly dosing of its therapy part of its late-stage development plan, giving the Thousand Oaks, CA-based company a potential edge on the dosing front. With more than $5 billion in potential sales of the drugs at stake, Regeneron and Sanofi seek to close any gaps in their late-stage plan.

"Given the competitive dynamics between Amgen and Regeneron to get their respective PCSK9 antibodies to market for hypercholesterolemia, today's announcement of Regeneron also moving to once-monthly dosing is neutral/slight positive for Amgen, who already has every 2 weeks and every 4 weeks dosing in development," RBC Capital Markets analyst Michael Yee wrote in a note this morning.

Regeneron/Sanofi and Amgen have the two most advanced therapies that block the protein PCSK9. Pfizer ($PFE), Novartis ($NVS) and Roche ($RHHBY) are among the companies trying to catch up with their own programs in the field, which could produce the most important new LDLc-lowering drugs since statins such as Zocor and Lipitor arrived in pharmacies in the 1990s.

Regeneron and Sanofi's alirocumab is the highest profile drug candidate in the two companies' long-term R&D collaboration, which began in 2007 and gave Sanofi a key ally in the fast-growing biologics business. The two companies are partnered on 7 antibodies in clinical development, including another late-stage contender called sarilumab for rheumatoid arthritis.

In the second quarter, Regeneron advanced two new antibody drugs into clinical development and ended work on another, the company said on Tuesday. The company scrapped development of the candidate, called REGN846, after initial studies of the antibody in patients with pruritus and atopic dermatitis, according to records from ClinicalTrials.gov.

Later this year Regeneron and Sanofi plan to provide the first glimpse of Phase III data from the PCSK9 program.

- here's Regeneron's release

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