The tally of new drugs approved each year in the US is often used as a measure of R&D productivity in the industry. However, a look at the sales performance of each year’s cohort five years after launch paints another picture and suggests the measure for R&D success should focus on the quality of products approved, rather than just the quantity.
As the table below shows, collated from actual and forecast data by EvaluatePharma, the picture is not as gloomy as the downward trend seen in approvals, with 2008 promising a significant return to quality and quantity. It does confirm, however, that 2007, when only 22 NMEs and new biologics were approved, the lowest for two decades, was not one of the sector’s best attempts in terms of volumes or sales potential.
|Year||No. of NMEs Approved||No. of Biologicals Approved||Total NMEs + Biologicals||% Chg.||USA Sales 5th Post launch ($bn)||% Chg.|
Last year the most notable approvals, according to consensus forecasts, are Tekturna, the Novartis and Speedel treatment for pulmonary hypertension, and Shire’s ADHD drug Vyvanse. The two products are respectively forecast to be generating US sales of $1.31bn and $998m in 2012, five years down the line. However both have been subjected to significant downgrades since they were launched, and doubts remain over even these lowered expectations. The class of 2007 could therefore turn out to be even more of an underachiever.
|Top 10 New Molecular Entities in 2007: ranked on 2012 US sales|
|Rank||Product||Company||Approved||2007 US Sales ($m)||2012 US Sales ($m)|
|3||Letairis/Volibris||Gilead Sciences||Jun 2007||20||791|
|5||Bystolic||Forest Laboratories||Dec 2007||-||590|
|6||Isentress||Merck & Co||Oct 2007||29||506|
|7||Ixempra||Bristol-Myers Squibb||Oct 2007||15||404|
|8||Kuvan||BioMarin Pharmaceutical||Dec 2007||0||373|
|10||Soliris||Alexion Pharmaceuticals||Mar 2007||46||308|
In the last decade 1999 was definitely bottom of the class in terms of value added, despite bringing a healthy-looking 40 new drugs to the market. That year Vioxx, Actos and Avandia were launched, contributing to a relatively paltry total of $7.1bn five years post launch, impacted by the withdrawal of Vioxx in 2004 which lost about $700m in revenue that year.
In 1996, the bumper year of the last decade, saw the approval of Lipitor, Zyprexa and Allegra, while another lucrative 12 months was 2004, which saw Avastin, Cymbalta, Lyrica and Spiriva get the green light.
For all the criticisms of the last couple of years, which has seen a steady decline in approval numbers, 2006 stands out for its relatively low approval rate but high sales success.
Merck & Co’s Januvia and Gardasil shine in that class, and probably help explain the 39 % appreciation in the company’s share price since, even considering the recent fall out from Vytorin.
So far 2008 is showing encouraging signs of a significant improvement on 2007 both in terms of quantity and quality. Five year sales forecasts for the class of 2008 are expected to grow by 28% to $9.8bn, with a potential 35 new approvals. This however assumes that all new products currently filed with the FDA get the go-ahead, an unlikely scenario. Even risk-adjusting these figures by the industry standard of 5%, the industry's R&D productivity appears to have improved on last year, and could rank as the sixth most productive year in the last 13 years.
|Top 10 New Molecular Entities in 2008: ranked on 2013 US sales|
|Rank||Product||Company||Approved / Approval by||2008 US Sales ($m)||2013 US Sales ($m)|
|1||Actemra||Roche||19 Sep 08||21||809|
|2||Pristiq||Wyeth||29 Feb 08||44||727|
|3||Effient||Eli Lilly||26 Jun 08||16||642|
|4||Cordaptive||Merck & Co||30 Apr 08||77||636|
|5||Milnacipran||Forest Laboratories||31 Oct 08||3||625|
|6||Promacta/Revolade||GlaxoSmithKline||01 Jul 08||3||621|
|7||Cimzia||UCB||22 Apr 08||9||447|
|8||Fiapta||Vanda Pharmaceuticals||25 Jul 08||-||398|
|9||Bridion||Schering-Plough||02 Jul 08||24||359|
|10||Recothrom||ZymoGenetics||17 Jan 08||40||346|