{"id":4653,"date":"2015-08-19T11:20:00","date_gmt":"2015-08-19T19:20:00","guid":{"rendered":"http:\/\/associatednews.info\/content\/price-rises-for-ticket-to-a-quicker-drug-review-by-fda\/4653\/"},"modified":"2015-08-19T11:20:00","modified_gmt":"2015-08-19T19:20:00","slug":"price-rises-for-ticket-to-a-quicker-drug-review-by-fda","status":"publish","type":"post","link":"https:\/\/associatednews.info\/content\/price-rises-for-ticket-to-a-quicker-drug-review-by-fda\/","title":{"rendered":"Price Rises For Ticket To A Quicker Drug Review By FDA"},"content":{"rendered":"

By Scott Hensley<\/a><\/span> <\/p>\n

\"A<\/a><\/div>\n
\n
<\/div>\n
\n
<\/div>\n

Drew Kilb\/Duke University’s Fuqua School of Business<\/span><\/div>\n<\/div>\n

A deal struck between drugmakers AbbVie and United Therapeutics Wednesday set a record price for a voucher that can be redeemed for a fast-track review of a new medicine by the Food and Drug Administration.<\/p>\n

AbbVie, marketer of Humira and AndroGel, has agreed to pay $350 million<\/a> to United Therapeutics, a company specializing in treatments for rare diseases, for a ticket to the regulatory fast lane.<\/p>\n

The tickets, or priority review vouchers as they’re known, were created by Congress in 2007 to encourage the development of drugs for neglected tropical disease and rare illnesses affecting children.<\/p>\n

Drugs like those aren’t usually lucrative for companies. The priority review voucher was conceived of as a prize that would be given to companies that brought medicines for certain overlooked diseases to market.<\/p>\n

The voucher entitles its holder to move a drug through the review line faster. FDA has to make a decision about a voucher drug in about six months rather than the 10 or so for a drug submitted without one.<\/p>\n

There’s no guarantee the FDA’s decision will be an approval; the agency could just reject a drug faster<\/a>.<\/p>\n

Oh, there’s one other important feature of the vouchers: They can be kept by the companies that won them or they can be sold to the highest bidder.<\/p>\n

United Therapeutics got its voucher in March when the FDA approved a drug called Unituxin<\/a> to treat pediatric neuroblastoma, a rare cancer in kids. Rather than keep the ticket, the company sold it. “We are very pleased to monetize our [voucher], and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases,” Roger Jeffs, president and co-CEO of United Therapeutics, said in a statement.<\/p>\n

AbbVie, for its part, confirmed the terms of the deal in an email to Shots but declined to say what the company’s plans are for the voucher.<\/p>\n

\n
\n
<\/div>\n<\/div>\n<\/div>\n

Duke University’s David Ridley, whose academic work<\/a> with two colleagues helped lay the foundation for the vouchers, told Shots in an email that the prices fetched by vouchers in 2015 “were in line with our expectations.” A 2006 paper<\/a> co-authored by Ridley pegged the value of a voucher at more than $300 million for a drug with the potential for blockbuster sales.<\/p>\n

In May, French drugmaker Sanofi paid $245 million<\/a> for a voucher. Last November, Gilead Sciences paid $125 million<\/a> to Knight Therapeutics for a voucher that was awarded for the approval of a drug to treat leishmaniasis. All told, four vouchers have been sold.<\/p>\n

Ridley said that “while the value of some vouchers might be around $300 million, the price might be lower if there are many sellers.” He added, “United Therapeutics was lucky and\/or smart that it was the only seller at a time when a buyer was eager to have a voucher.”<\/p>\n

On a related note, the FDA is expanding the illnesses<\/a> that can earn companies a voucher. Chagas’ disease<\/a> and neurocysticercosis<\/a>, a parasitic infection that can lead to epilepsy, have been added to the list of eligible conditions.<\/p>\n

This entry passed through the Full-Text RSS service – if this is your content and you’re reading it on someone else’s site, please read the FAQ at fivefilters.org\/content-only\/faq.php#publishers.<\/em><\/p>\n

Source:: http:\/\/www.npr.org\/sections\/health-shots\/2015\/08\/19\/432887081\/price-rises-for-ticket-to-a-quicker-drug-review-by-fda?utm_medium=RSS&utm_campaign=healthcare<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\"A<\/a><\/div>\n
\n
<\/div>\n
\n
<\/div>\n

Drew Kilb\/Duke University’s Fuqua School of Business<\/span><\/div>\n<\/div>\n

A deal struck between drugmakers AbbVie and United Therapeutics Wednesday set a record price for a voucher that can be redeemed for a fast-track review of a new medicine by the Food and Drug Administration.<\/p>\n

AbbVie, marketer of Humira and AndroGel, has agreed to pay $350 million<\/a> to United Therapeutics, a company specializing in treatments for rare diseases, for a ticket to the regulatory fast lane.<\/p>\n

The tickets, or priority review vouchers as they’re known, were created by Congress in 2007 to encourage the development of drugs for neglected tropical disease and rare illnesses affecting children.<\/p>\n

Drugs like those aren’t usually lucrative for companies. The priority review voucher was conceived of as a prize that would be given to companies that brought medicines for certain overlooked diseases to market.<\/p>\n

The voucher entitles its holder to move a drug through the review line faster. FDA has to make a decision about a voucher drug in about six months rather than the 10 or so for a drug submitted without one.<\/p>\n

There’s no guarantee the FDA’s decision will be an approval; the agency could just reject a drug faster<\/a>.<\/p>\n

Oh, there’s one other important feature of the vouchers: They can be kept by the companies that won them or they can be sold to the highest bidder.<\/p>\n

United Therapeutics got its voucher in March when the FDA approved a drug called Unituxin<\/a> to treat pediatric neuroblastoma, a rare cancer in kids. Rather than keep the ticket, the company sold it. “We are very pleased to monetize our [voucher], and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases,” Roger Jeffs, president and co-CEO of United Therapeutics, said in a statement.<\/p>\n

AbbVie, for its part, confirmed the terms of the deal in an email to Shots but declined to say what the company’s plans are for the voucher.<\/p>\n

\n
\n
<\/div>\n<\/div>\n<\/div>\n

Duke University’s David Ridley, whose academic work<\/a> with two colleagues helped lay the foundation for the vouchers, told Shots in an email that the prices fetched by vouchers in 2015 “were in line with our expectations.” A 2006 paper<\/a> co-authored by Ridley pegged the value of a voucher at more than $300 million for a drug with the potential for blockbuster sales.<\/p>\n

In May, French drugmaker Sanofi paid $245 million<\/a> for a voucher. Last November, Gilead Sciences paid $125 million<\/a> to Knight Therapeutics for a voucher that was awarded for the approval of a drug to treat leishmaniasis. All told, four vouchers have been sold.<\/p>\n

Ridley said that “while the value of some vouchers might be around $300 million, the price might be lower if there are many sellers.” He added, “United Therapeutics was lucky and\/or smart that it was the only seller at a time when a buyer was eager to have a voucher.”<\/p>\n

On a related note, the FDA is expanding the illnesses<\/a> that can earn companies a voucher. Chagas’ disease<\/a> and neurocysticercosis<\/a>, a parasitic infection that can lead to epilepsy, have been added to the list of eligible conditions.<\/p>\n

This entry passed through the Full-Text RSS service – if this is your content and you’re reading it on someone else’s site, please read the FAQ at fivefilters.org\/content-only\/faq.php#publishers.<\/em><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-4653","post","type-post","status-publish","format-standard","hentry","category-health"],"_links":{"self":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/posts\/4653","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/comments?post=4653"}],"version-history":[{"count":0,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/posts\/4653\/revisions"}],"wp:attachment":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/media?parent=4653"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/categories?post=4653"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/tags?post=4653"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}