Incivek set to break record for fastest product launch

Source EP Vantage
Company Vertex PharmaceuticalsAmgenBristol-Myers SquibbForest LaboratoriesGilead SciencesMerck & CoNovartisRocheAstraZenecaPharmaciaGlaxoSmithKlinePfizer 
Tags Free Content, Analysis, USA, Company Strategy, Launches
Date November 03, 2011

With Vertex Pharmaceuticals ’ new hepatitis C drug Incivek being touted as the fastest new product launch on record, try this pharmaceutical trivia question: only three products have achieved blockbuster sales in the US in their first 12 months on the market – what are they?

The answer is in the table below and Pfizer ’s Lipitor is one of those three but surprisingly does not top the chart – one of the few records it failed to take (Pfizer fights for last gasp as record breaking Lipitor expires, November 3, 2011). Incivek’s astonishing US sales of $420m in the third quarter, which blew consensus estimates out of the water, certainly put it on track to break the record for the fastest ever launch. Incivek has already earned one accolade, its first full quarter sales breaking Viagra’s quarterly record of $409m when it was launched in 1998. Yet the data below also show that Incivek is the exception that proves the rule that new products remain slow to get off the ground these days.

COX-2 breakthrough

The table below, taken from EvaluatePharma’s historical record of company disclosed quarterly product sales, shows the top ten products with the biggest aggregate US sales from the first four quarters after launch in the US, starting with the first full quarter of sales.

Vaccines such as Prevnar 13 and Gardasil, with first year US sales of $1.76bn and $823m respectively, would have made the top ten list but have been excluded as the dynamics of the vaccine market are so different from mainstream prescription drugs.

Fastest New US Product Launches - sales in first full 4 quarters on the market 
Rank  Product  Company  Pharma Class  Therapeutic Category  Launch in US  US sales in first 4 quarters ($m) 
 1  Celebrex  Pharmacia   COX-2 inhibitor  Non-steroidal anti-inflammatory   31-Jan-99   1,553 
 2  Vioxx  Merck & Co   COX-2 inhibitor  Non-steroidal anti-inflammatory   20-May-99   1,008 
 3  Lipitor  Pfizer   Statin  Anti-hyperlipidaemic   28-Jan-97   990 
 4  Neulasta  Amgen   Colony stimulating factor  Neutropaenia therapy   15-Apr-02   897 
 5  Viagra  Pfizer   PDE5 inhibitor  Erectile dysfunction   06-Apr-98   808 
 6  Lucentis  Roche   Anti-VEGF MAb  Macular disorders   30-Jun-06   790 
 7  Atripla  Gilead Sciences   NRTI & NNRTI  HIV anti-viral   19-Jul-06   779 
 8  Avastin  Roche   Anti-VEGF MAb  Anti-neoplastic MAb   26-Feb-04   714 
 9  Nexium  AstraZeneca   Proton pump inhibitor (PPI)  Antacid & anti-ulcerant   19-Mar-01   669 
 10  Lexapro  Forest Laboratories  SSRI  Anti-depressant   05-Sep-02   646 

Ahead of Lipitor – which with 12-month sales of $990m is still classified as achieving blockbuster status – are Celebrex and Vioxx, COX-2 inhibitors which revolutionised the treatment of chronic pain conditions such as rheumatoid arthritis and osteoarthritis.

Approved within months of each other in 1999, both products were heavily promoted by sales reps and direct-to-consumer (DTC) advertising as a breakthrough in pain management on the primary basis that they reduced the stomach and intestinal side effects associated with more traditional pain relievers, such as aspirin and ibuprofen.

The uptake of Celebrex in particular was dramatic and became one of the primary drivers behind Pfizer ’s $60bn purchase of Pharmacia  in 2003. This echoed  Pfizer ’s $90bn swoop on Warner Lambert in 2000 to gain full rights to Lipitor.

The subsequent withdrawal of Vioxx from the market in 2004, following overwhelming evidence the drug increased rates of heart attack, stroke and death, put a sudden brake on Celebrex sales although it is worth noting the drug still pulls in US annual sales in excess of $1.5bn.

Leg up

Of the other fastest product launches, Avastin – not ranked quite as high as some recent commentators have suggested - Lucentis and Neulasta were undoubtedly aided by their high price on account of being biological agents. 

Meanwhile Atripla - the combination of three previously approved HIV therapies - and Nexium and Lexapro – essentially re-worked molecules of prior blockbusters in Losec and Celexa respectively – certainly benefitted from such a clear headstart compared to completely new products.

The pent up demand, supported by intense marketing, for Viagra got the product off to a flying start with its hitherto record first quarter sales of $409m, although subsequent quarterly sales in the $125m range revealed the extent of stocking in the market.

New records

What the table above also shows is the absence of any rapid uptake for new products launched within the last five years. The Vioxx debacle, which led to a significantly more cautious and safety conscious regulatory environment and the introduction in 2008 of risk evaluation and mitigation strategies (REMS) for many new products, has clearly played a major role. As has the gradual evolution away from primary care drugs to treat widespread chronic disorders.

In this context the uptake of Incivek is all the more impressive. The table below lists some recently launched products in the US with historic or estimated quarterly sales, based on current run rates or analyst forecasts.

Even assuming relatively modest sales of $400m for the next three quarters – some analysts have pegged next quarter sales at $550m – Incivek should exceed $1.6bn, beating Celebrex’s existing record of $1.55bn.

Yet Incivek would be the only recently launched product to break into the top ten chart – even the relatively fast launching and high cost Yervoy may only just exceed $500m.

The rapid uptake of Incivek could also not contrast more with the slow start for Merck & Co 's Victrelis, a similar hepatitis C agent approved and launched around the same time - initial 12-month sales could struggle to breach $100m in the US.

Still, Vertex needs to make the most of its prize asset. With a swathe of more potent hepatitis C agents in development promising to supercede Incivek, the product is predicted a short life - US sales are seen peaking in 2014 at $2.5bn.

Recently Launched New US Product Launches - sales in first full 4 quarters on the market 
Product  Company  Pharma Class  Therapeutic Category  Launch in US  Estimated US sales in first 4 quarters ($m)  Comment  US sales in 2012 ($m) 
Incivek  Vertex Pharmaceuticals   Hepatitis C protease inhibitor  Hepatitis C anti-viral   30-May-11   1,620  projected sales - assume $400m in each of next three quarters   1,972 
Yervoy  Bristol-Myers Squibb  Anti-CTLA4 MAb  Anti-neoplastic MAb   15-Apr-11   520  projected sales   434 
Xgeva  Amgen   Anti-RANKL MAb  Bone calcium regulator   30-Nov-10   342  projected sales   641 
Gilenya  Novartis   S1P receptor modulator   MS Therapy   04-Oct-10   267  Estimated historic US sales (company not disclosed)   548 
Victoza  Novo Nordisk  GLP-1 agonist  Anti-diabetic   16-Feb-10   254  Estimated historic US sales (company not disclosed)   802 
Jevtana  Sanofi   Taxane  Alkaloid chemotherapy   19-Jul-10   220  projected sales   241 
Ampyra  Acorda Therapeutics   Potassium channel blocker  MS Therapy   01-Mar-10   177  Historic US sales   261 
Provenge  Dendreon   Prostate cancer vaccine  Cancer Vaccine   29-Apr-10   123  Historic US sales   375 
Victrelis  Merck & Co   Hepatitis C protease inhibitor  Hepatitis C anti-viral   20-May-11   102  projected sales   370 
Benlysta  Human Genome Sciences  Anti-BLyS MAb  Lupus therapy   09-Mar-11   97  projected sales   308 
Future launches              
Eliquis  Bristol-Myers Squibb  Factor Xa inhibitor  Anti-coagulants   30-Oct-12   ~400     
BG-12  Biogen  Idec  Fumarate  MS Therapy   31-Dec-12   ~300     

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