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Regeneron Pharmaceuticals, Inc. (REGN), Sanofi (France) (SAN.PA) Bag BioMarin Pharmaceutical Inc. (BMRN)'s Special FDA Priority Review Voucher For $67.5 Million


7/30/2014 3:51:46 PM

Regeneron Pharmaceuticals, Inc., Sanofi (France) Bag BioMarin Pharmaceutical Inc.'s Special FDA Priority Review Voucher For $67.5 Million
Regeneron, Sanofi Bag BioMarin's Special FDA Priority Review Voucher For $67.5 Million
July 31, 2014
By David Sohn, BioSpace.com Breaking News Staff

Regeneron Pharmaceuticals (REGN) and Sanofi (SAN.PA) have announced that they will obtain a special review voucher from California-based BioMarin (BMRN) at the cost of $67.5 million dollars in hopes of expediting FDA approval for their new cholesterol drug alirocumab.

The special review voucher is part of an FDA incentive program that allows pharmaceutical companies to shorten the required review process that all drugs must go through before entering the markets. BioMarin was originally awarded the voucher for its pediatric drug, Vimizin, a treatment for a very rare disease known as Morquio syndrome. Regulations currently allow for the transfer of the voucher to another company for use on another drug.

A study at Duke University showed that an expedited review process could save a company as much as $300 million dollars in total costs associated with the development of a drug. Use of the voucher can typically shorten the review period from a year to six months, allowing faster introduction of the drug to the markets. A significantly shorter review period offers both tangible and intangible benefits to the company developing the drug. Risk associated with the time spent in development is often reduced, lowering the overall cost of investment for the company who owns the voucher. Additionally, drugs that receive approval quicker spend more time on the markets before exclusivity rights granted by patents expire.

The FDA claims that the special review vouchers may also provide a “first mover advantage,” allowing the owner of such a voucher a time advantage when faced with competitors.
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"The priority review voucher program was established to provide incentives that would enhance innovation in key areas of unmet patient need," said Ned Braunstein, M.D., Vice President, Regulatory Affairs at Regeneron. "Our decision to acquire and leverage the voucher is clear evidence that this program is a valuable incentive for biopharmaceutical companies." Paris-based Sanofi and New York based Regeneron hope to submit reviews for their cholesterol drug to both US and EU regulatory commissions by the end of this year.

“We are very pleased that a patient population beyond BioMarin’s will potentially be able to benefit from a faster drug application review process,” stated Jean-Jacques Bienaimé, CEO of BioMarin.

The company reported Q2 earnings yesterday, exceeding analysts’ expectations for the quarter. The consensus earnings per share forecast of -$0.42 was beat by a large margin with a reported EPS of -$0.19. Shares in the California-based company traded 6.33 percent higher this morning, reading in at $64.96.

Shares in Regeneron were trading -2.78 percent lower while Sanofi traded higher at 1.20 percent this morning.

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