Post by lakers on Dec 25, 2015 14:09:07 GMT -5
Sanofi takes an FDA shortcut with its diabetes combo, racing with Novo
Sanofi ($SNY) is using its $245 million coupon for a quick FDA review to speed up the approval process for a combination of its top-selling insulin and a new diabetes drug, angling to beat rival Novo Nordisk ($NVO) to the market.
The French drugmaker filed an FDA application for LixiLan, a fixed-dose injection that combines the blockbuster Lantus with lixisenatide, an investigational Type 2 diabetes treatment that works by boosting the hormone GLP-1 to increase natural insulin production. In tandem, the two therapies significantly reduced blood sugar in a Phase III program involving roughly 2,000 patients, Sanofi said.
To move things along with LixiLan, Sanofi redeemed an outstanding priority review voucher, which shortens the standard FDA review time for submitted drugs from 10 months to 6 months and will kick in once the agency accepts the company's application. Sanofi picked up its voucher earlier this year in a deal with Retrophin ($RTRX), paying $150 million up front and promising to disburse installments of $47.5 million in 2016 and 2017.
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The goal is to get to market before diabetes magnate Novo, which submitted a similar combo for FDA approval in September. That cocktail therapy, sold in Europe as Xultophy, pairs Novo's blockbuster GLP-1 treatment Victoza with the recently approved insulin Tresiba and has charted excellent clinical results over the past few years.
Sanofi is working to stay afloat in a changing diabetes market, preparing to face biosimilar competition for Lantus that will imperil the treatment's roughly $8 billion in annual revenue. Earlier this year, the company disappointed analysts with the revelation that diabetes sales are likely to slip about 7% in 2015 and decline well into 2018, as new products including the Lantus heir Toujeo have underperformed expectations.
Sanofi has used the priority review program to win a blockbuster race in the past, joining partner Regeneron Pharmaceuticals ($REGN) last year to trade $67.5 million for a voucher that helped the pair leapfrog Amgen ($AMGN) in the race to commercialize new treatments for high cholesterol.
The priority review voucher program, which allows any company to cut the line at the FDA for a price, has come under scrutiny over the past year.
Introduced in 2007, the system awards a coupon for quick review to any company that successfully develops a treatment for a rare pediatric disorder or neglected tropical disease, and that asset can be sold to the highest bidder. While that has proven lucrative for companies with vouchers--the last one sold for $350 million--it forces the FDA to interrupt its other public health work to fast-track new, possibly marginal treatments. And companies can obtain these increasingly valuable assets without inventing drugs on their own, a facet of the program that led the former Martin Shkreli-helmed KaloBios ($KBIO) to acquire an old antiviral treatment in hopes of winning FDA approval and picking up a sellable voucher.
www.fiercebiotech.com/story/sanofi-takes-fda-shortcut-its-diabetes-combo-racing-novo/2015-12-23
Sanofi is trying to gain approval ahead of competitor Novo Nordisk, which filed a new drug application in September for its experimental diabetes medication Xultophy, a combination of its insulin medicine Tresiba and its blockbuster GLP-1 agonist Victoza.
But Sanofi has the benefit of holding a priority review voucher, which it purchased from Baltimore-based Asklepion Pharmaceuticals for $245 million in May. Sanofi redeemed the voucher to shorten the review time to six months from 10.
It's a move the company has used before. In 2014 Sanofi and partner Regeneron bought a voucher from California-based BioMarin Pharmaceutical for $67 million. The companies then redeemed the voucher in order to fast-track review of its cholesterol-lowering drug Praluent, which won FDA approval a month ahead of rival Amgen's medication Repatha.
The FDA grants a voucher as a reward when a company develops and gets approval for a treatment of one of 17 tropical diseases or develops a therapy for a rare pediatric condition that affects more than 50% of those under the age of 18 and has fewer than 200,000 U.S. cases.
A voucher holder can either redeem it to expedite review of one of its other drugs or turn around and sell it to another company, which has created a secondary market that can yield hundreds of millions of dollars for the seller.
www.modernhealthcare.com/article/20151223/NEWS/151229941
[Mnkd should have started a tiny biz developing these drugs instead of some oncology to win FDA vouchers, then sell them to highest bidders ~ $0.5B each to realize Afrezza and TS pipeline fullest potential. Furthermore, Sanofi might want to negotiate bundle deals, T&A, and L&A w/ PBMs to preempt Novo's next gen. Exclusive deals would be great.]
Sanofi ($SNY) is using its $245 million coupon for a quick FDA review to speed up the approval process for a combination of its top-selling insulin and a new diabetes drug, angling to beat rival Novo Nordisk ($NVO) to the market.
The French drugmaker filed an FDA application for LixiLan, a fixed-dose injection that combines the blockbuster Lantus with lixisenatide, an investigational Type 2 diabetes treatment that works by boosting the hormone GLP-1 to increase natural insulin production. In tandem, the two therapies significantly reduced blood sugar in a Phase III program involving roughly 2,000 patients, Sanofi said.
To move things along with LixiLan, Sanofi redeemed an outstanding priority review voucher, which shortens the standard FDA review time for submitted drugs from 10 months to 6 months and will kick in once the agency accepts the company's application. Sanofi picked up its voucher earlier this year in a deal with Retrophin ($RTRX), paying $150 million up front and promising to disburse installments of $47.5 million in 2016 and 2017.
Sign up for our FREE newsletter for more news like this sent to your inbox!
The goal is to get to market before diabetes magnate Novo, which submitted a similar combo for FDA approval in September. That cocktail therapy, sold in Europe as Xultophy, pairs Novo's blockbuster GLP-1 treatment Victoza with the recently approved insulin Tresiba and has charted excellent clinical results over the past few years.
Sanofi is working to stay afloat in a changing diabetes market, preparing to face biosimilar competition for Lantus that will imperil the treatment's roughly $8 billion in annual revenue. Earlier this year, the company disappointed analysts with the revelation that diabetes sales are likely to slip about 7% in 2015 and decline well into 2018, as new products including the Lantus heir Toujeo have underperformed expectations.
Sanofi has used the priority review program to win a blockbuster race in the past, joining partner Regeneron Pharmaceuticals ($REGN) last year to trade $67.5 million for a voucher that helped the pair leapfrog Amgen ($AMGN) in the race to commercialize new treatments for high cholesterol.
The priority review voucher program, which allows any company to cut the line at the FDA for a price, has come under scrutiny over the past year.
Introduced in 2007, the system awards a coupon for quick review to any company that successfully develops a treatment for a rare pediatric disorder or neglected tropical disease, and that asset can be sold to the highest bidder. While that has proven lucrative for companies with vouchers--the last one sold for $350 million--it forces the FDA to interrupt its other public health work to fast-track new, possibly marginal treatments. And companies can obtain these increasingly valuable assets without inventing drugs on their own, a facet of the program that led the former Martin Shkreli-helmed KaloBios ($KBIO) to acquire an old antiviral treatment in hopes of winning FDA approval and picking up a sellable voucher.
www.fiercebiotech.com/story/sanofi-takes-fda-shortcut-its-diabetes-combo-racing-novo/2015-12-23
Sanofi is trying to gain approval ahead of competitor Novo Nordisk, which filed a new drug application in September for its experimental diabetes medication Xultophy, a combination of its insulin medicine Tresiba and its blockbuster GLP-1 agonist Victoza.
But Sanofi has the benefit of holding a priority review voucher, which it purchased from Baltimore-based Asklepion Pharmaceuticals for $245 million in May. Sanofi redeemed the voucher to shorten the review time to six months from 10.
It's a move the company has used before. In 2014 Sanofi and partner Regeneron bought a voucher from California-based BioMarin Pharmaceutical for $67 million. The companies then redeemed the voucher in order to fast-track review of its cholesterol-lowering drug Praluent, which won FDA approval a month ahead of rival Amgen's medication Repatha.
The FDA grants a voucher as a reward when a company develops and gets approval for a treatment of one of 17 tropical diseases or develops a therapy for a rare pediatric condition that affects more than 50% of those under the age of 18 and has fewer than 200,000 U.S. cases.
A voucher holder can either redeem it to expedite review of one of its other drugs or turn around and sell it to another company, which has created a secondary market that can yield hundreds of millions of dollars for the seller.
www.modernhealthcare.com/article/20151223/NEWS/151229941
[Mnkd should have started a tiny biz developing these drugs instead of some oncology to win FDA vouchers, then sell them to highest bidders ~ $0.5B each to realize Afrezza and TS pipeline fullest potential. Furthermore, Sanofi might want to negotiate bundle deals, T&A, and L&A w/ PBMs to preempt Novo's next gen. Exclusive deals would be great.]
