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If there is a "weapon" that can shorten the market review time of an innovative drug by 4 months, how much is it worth? The answer from Dutch star Biotech Argenx was $102 million
.
November 30, Argenx
Announced the acquisition of a U.
S.
FDA Priority Review Voucher for $102 million, which is expected to be used for the marketing application
of the neonatal Fc receptor blocker efgartigimod.
For a long time, "only fast and not broken" is the truth
that innovative drugs stand out.
However, how valuable "fast" is is impossible to measure
.
Priority review of the trading price of the coupon may give us a reference angle
.
In fact, a few years earlier, accelerated review coupons were even more "expensive", with historical transaction records reaching a maximum of US$350 million, equivalent to RMB 2.
4 billion
.
What is this concept? In 2021, there were only 8 pharmaceutical companies with R&D investment of more than 2.
4 billion yuan
.
Obviously, overseas big pharmaceutical companies are serious about "speculating" priority review
coupons.
/ 01 /
/ 01 /Have the privilege of cutting the queue,
Have the privilege of cutting the queue,Hyped priority review coupons
Hyped priority review couponsThe birth of priority review coupons can be described as a miracle stroke of the FDA
.
As we all know, due to the small number of patients, the difficulty of research and development, and the low input-output ratio, there are few entrants in the field of research and development of some pediatric rare diseases and tropical diseases
.
In order to encourage more pharmaceutical companies to enter no-man's land, the FDA has introduced a series of incentives, including the issuance of priority review vouchers
.
The so-called priority review coupons, or listing "acceleration coupons", can shorten the market review time of drugs from 10 months to 6 months
.
While approving relevant innovative drugs for rare diseases, FDA may award developers a "priority review voucher" as a reward
.
Developers can use the voucher for the review of other drugs to shorten the time to
market.
In the development of innovative drugs, time is money
.
The "buy one get one free" measure can naturally play a stimulating role
.
More importantly, the FDA "recognizes the coupon but does not recognize the person", and the priority review coupon can be freely bought and sold
.
In this context, priority review vouchers may become an important means
for pharmaceutical companies to generate revenue.
In July 2014, Sanofi opened its trading history
of priority review coupons for $67.
5 million.
After Sanofi's pioneering decision, the market for the buying and selling of priority review bonds continued to heat up
.
When Sanofi bought its second senior review note in May 2015, the price had risen to $245 million
.
In just one year, the price of priority review vouchers quadrupled
.
But this is not the most exaggerated
.
Sanofi's record was soon broken by AbbVie
.
In August 2015, AbbVie set a new record for the sale price of priority review securities for US$350 million, which has remained so far
.
Over the past few years, although the number of priority review coupons approved has increased, the price is still not cheap, and the transaction price has remained at about
100 million US dollars.
For example, in February this year, BioMarin sold its priority review certificates for $110 million; In December, Blue Bird sold the senior review note for $102 million
.
/ 02 /
/ 02 /4 months,
4 months,What can it bring?
What can it bring?Seeing this, you may wonder, is it worth spending hundreds of millions of dollars to save just four months?
The answer is probably yes
.
Because for innovative drugs, first-mover advantage is crucial
.
《Nature Reviews Drug
An article published in Discovery analyzes 50 innovative drugs, and in just 4 months, the leader may be able to open a 2% market share gap
with the latecomers.
In some highly competitive areas, multiple drug marketing nodes are approaching
.
At critical moments, priority review tickets may become victorious soldiers
.
Sanofi has the right
to speak on this.
In the competition for PCSK9 inhibitors, Sanofi is in a position
to lag behind Amgen.
In the European market, Sanofi's Praluent was approved 2 months
later than Amgen's Repatha.
However, in the US market, Sanofi reversed the unfavorable situation
of lagging behind with priority review coupons.
Originally, Praluent expected to be approved a few months later than Repatha; However, Sanofi came out on top with the "acceleration coupon", turning Praluent's approval time in the United States ahead of Repatha and into a 1-month
lead.
Although approved one month in advance, it may not bring significant advantages; But if it lags too far, whether it is market layout or medical insurance negotiations, Sanofi will be at a disadvantage
.
Even in areas where competition is not fierce, the "acceleration" advantage of preferential vouchers is equally valuable
.
For some potential "blockbuster" drugs, monthly sales peak in the hundreds of millions of dollars, so the value of approval 4 months in advance far exceeds the cost
of purchasing priority review tickets.
On September 20, 2019, Novo Nordisk's oral somaglutide Rybelsus was approved for marketing through priority review bonds, 4 months
ahead of the original plan.
In the first three quarters of 2022, Rybelsus sales were $962 million, equivalent to $330 million in a single quarter
.
It is clear that Novo Nordisk will "settle the score"
.
Perhaps tasting the sweetness, in July this year, Novo Nordisk "hoarded" a priority review ticket
for $110 million.
"Accelerating" Buff can bring various benefits, and it is not difficult to understand that priority review coupons will be hyped by pharmaceutical companies
.
/ 03 /
/ 03 /Speed is key,
Speed is key,But not the only one
But not the only oneHowever, pharmaceutical companies spending hundreds of millions of dollars to buy an acceleration coupon can also be regarded as a dangerous move and a sword that goes sideways
.
Getting an FDA Priority Review Voucher doesn't mean "everything is fine.
"
Because priority review vouchers only speed up the review, and have nothing to do with
the results.
If the clinical data is suboptimal, speeding up approval is simply accelerating the time to death
.
Novartis has suffered such a tragic experience
.
In 2011, Novartis used a priority review voucher to submit a marketing application
for Ilaris for the treatment of gouty arthritis to the FDA.
However, due to the problem of too many side effects of the drug, Ilaris' listing application was rejected, and a valuable priority review voucher was lost
.
Even worse is Sanofi
.
In 2015, it submitted a marketing application for iGlarLixi, a fixed-dose combination of "insulin + GLP-1 receptor agonist", with priority review vouchers
purchased for $245 million.
Tragically, the FDA then asked Sanofi to supplement the drug's information about the drug delivery device, thus extending the scheduled approval period by 3 months, and the buff of the sky-high priority review coupon was canceled
.
For big pharmaceutical companies, the loss of a sky-high price coupon is not a big problem; But for small pharmaceutical companies, it may be a disaster
.
Taking a step back, even if a drug is approved expeditiously, there is no guarantee of invincibility
.
Sanofi may be the big pharmaceutical company
that has stepped on the most pits in the field of priority review vouchers.
As mentioned above, in the US market, Sanofi came out on top through the priority review coupon and took the lead in the battle for PCKS9 monoclonal antibodies
.
Unfortunately, Praluent failed to play the first-mover advantage
because of the patent dispute.
Since its listing, Sanofi's Praluent sales have been lower than Amgen's Repatha
.
In 2021, their sales were US$421 million and US$1.
117 billion, respectively.
All in all, whether an innovative drug can stand out is determined by many factors such as the speed of drug development, clinical performance, and the commercialization ability of pharmaceutical companies
.
In this multidimensional war, only if you have the advantage in every link, you can have the last
laugh.
