Incivek unseats Celebrex as fastest-ever drug launch

Source EP Vantage
Company Vertex PharmaceuticalsAmgenAstellas PharmaBiogenBristol-Myers SquibbCelgeneGilead SciencesJohnson & JohnsonMerck & CoNovo NordiskPfizerRegeneron PharmaceuticalsRoche 
Tags Analysis, Sensory Organs, Company Strategy, Interim Results, Launches, Systemic Anti-Infectives, Immunology, Oncology, Endocrine, Central Nervous System, Cardiovascular, Blood, Free Content
Date October 31, 2013

Rapid advances made in hepatitis C in the last couple of years might have cut short Incivek ’s commercial life span, but Vertex Pharmaceuticals  can point to one accolade for now. Its  protease inhibitor  ranks as the fastest-ever drug launch, narrowly unseating  Pfizer ’s Celebrex , which has held the record since 1999.

Only five products have ever achieved blockbuster status in their first full four quarters on the market, an EP Vantage analysis reveals. Kudos to any pharma geeks who can guess the other three candidates, coming behind  Incivek  and  Celebrex . But with great things forecast for Biogen  Idec ’s Tecfidera  and  Gilead ’s sofosbuvir , this exclusive club could soon swell (see tables).

The analysis below was conducted by taking EvaluatePharma’s historical record of company-disclosed quarterly US product sales, and aggregating the first four full quarters after launch in the region.

Owing to different market dynamics vaccines have been excluded, but it is worth noting that both Prevnar  13 and  Gardasil  would have made the top 10, with first-year US sales of $1.76bn and $823m respectively.

The analysis reveals a four-year gap between the launches of Lucentis  and  Atripla  in 2006 and  Victoza  in 2010, representing the fallow period of productivity that so concerned industry watchers. The recent successes and the prospect of two more on the way, in the shape of  sofosbuvir  and  Tecfidera , help to explain why optimism about the sector’s ability to discover top-selling new medicines has recovered. Whether this is warranted is another debate entirely.

Fastest new US product launches - sales in first full four quarters on the market 
Product  Company  Therapy category  US launch  US sales in first 4 qtrs ($m) 
Incivek   Vertex Pharmaceuticals   Hep C antiviral  30 May 2011  1,561 
Celebrex   Pharmacia   Non-steroidal anti-inflammatory  31 Jan 1999  1,553 
Victoza   Novo Nordisk   Antidiabetic  16 Feb 2010  1,112 
Vioxx   Merck & Co   Non-steroidal anti-inflammatory  20 May 1999  1,008 
Lipitor   Pfizer   Anti-hyperlipidaemic  28 Jan 1997  990 
Neulasta   Amgen   Neutropaenia therapy  15 Apr 2002  897 
Eylea   Regeneron   Macular disorders  21 Nov 2011  838 
Viagra   Pfizer   Erectile dysfunction  06 Apr 1998  808 
Lucentis   Roche   Macular disorders  30 Jun 2006  790 
Atripla   Gilead Sciences   HIV antiviral  19 Jul 2006  779 

Three new medicines have made it into the top 10 since EP Vantage last conducted this analysis in 2011 (Incivek set to break record for fastest product launch, November 3, 2011). As well as Incivek , both Victoza  and  Eylea  have generated hugely successful launches.

The commercial success enjoyed by Eylea  is particularly notable, considering that similar drugs were already available in the shape of  Lucentis  and off-label  AvastinVictoza , meanwhile, was the second GLP-1 to the market but had a once-a-day dosing advantage over twice-a-day incumbent Byetta , and a much improved tolerability profile.

High demand for Incivek  was long predicted, as the drug represented a clear advance in the treatment of hepatitis C. With an astonishing $420m in sales booked in its first full quarter on the market the drug holds another record, and this one at least looks hard to beat. Speculation is rife that patients are being warehoused once again, this time ahead of the arrival of  sofosbuvir , but forecasts do not point to such a huge ramp-up for the Gilead  pill.

However, with the price of the new antiviral still unknown, or the real level of demand, this record is there for the taking (All change in hep C as expectations shift dramatically to sofosbuvir, October 28, 2013).

On the horizon

The table below, which details the actual and expected US launches of several other new medicines that are being closely watched, reveals the huge expectations being pinned on sofosbuvir . With a PDUFA date of December 6 by this time next year its launch will be measurable, and few expect it to disappoint.

However, the most closely watched launch currently under way has to be Biogen  Idec ’s oral MS therapy Tecfidera . The company this week reported third-quarter sales of $284m, smashing expectations and putting the drug on track to become another first-year blockbuster.

Outside sofosbuvir  and  Tecfidera , no closely watched new approval looks likely to come close to achieving this level so soon. This of course does not mean they are failures, and many of these products have surpassed expectations and are projected to go on to greater things.

Xarelto , for example, is forecast to generate almost $2bn in sales by 2018 in the US alone – the launch of Eliquis , also in this table, has been sorely disappointing by contrast. And Stribild  is expected to become just as big a product as  Atripla  was for  Gilead  – with peak sales of around $3.5bn – despite not achieving such a remarkable launch.

As Incivek  demonstrates more than most, a fast launch is not everything.  Vertex  yesterday reported third-quarter sales of $86m. So with a demise as rapid as its ascendance, this drug will always be in the record books.

Progress of closely watched recent US launches - actual and estimated sales in first full four quarters on market 
Product  Company  Pharma class  US launch date  US sales in first 4 qtrs ($m)  Actual or Estimate  2014 US sales estimate ($m) 
Tecfidera   Biogen  Idec   Nrf2 pathway activator  31 Mar 2013  1,172  A+E  1,055 
Sofosbuvir   Gilead Sciences   Hepatitis C NS5B  polymerase inhibitor  Dec 2013 (Est)  1,115  1,115 
Yervoy   Bristol-Myers Squibb   Anti-CTLA4 MAb  14 Apr 2011  440  730 
Kadcyla   Roche   Antibody drug conjugate   22 Feb 2013  421  A+E  184 
Stribild   Gilead Sciences   NRTI, HIV integrase  inhibitor & CYP3A inhibitor  27 Aug 2012  364  953 
Xtandi   Astellas Pharma   Androgen receptor antagonist   13 Sep 2012  301  A+E  607 
Zytiga   Johnson & Johnson   17-alpha -hydroxylase/C17,20 lyase inhibitor  1 May 2011  291  978 
Xarelto   Johnson & Johnson   Factor Xa  inhibitor  31 Jul 2011  257  1,005 
Kyprolis   Amgen /Onyx Pharmaceuticals  Proteasome inhibitor   20 Jul 2012  229  A+E  442 
Pomalyst   Celgene   Immunomodulator  8 Feb 2013  177  A+E  306 
Perjeta   Roche   Anti-HER2  (ErbB -2) MAb  8 Jun 2012  147  281 
Xeljanz   Pfizer   Janus kinase (JAK)-3 inhibitor  19 Nov 2012  122  A+E  368 
Eliquis   Bristol-Myers Squibb   Factor Xa  inhibitor  28 Dec 2012  93  A+E  376 

To contact the writer of this story email Amy Brown in London at or follow  @AmyEPVantage on Twitter

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