Incivek unseats Celebrex as fastest-ever drug launch

Source EP Vantage
Company Vertex PharmaceuticalsCelgeneRegeneron PharmaceuticalsAmgenBristol-Myers SquibbGilead SciencesJohnson & JohnsonMerck & CoNovo NordiskRocheAstellas PharmaBiogenPfizer 
Tags Free Content, Analysis, Launches, Interim Results, Company Strategy, Immunology, Systemic Anti-Infectives, Sensory Organs, Oncology, Endocrine, Central Nervous System, Cardiovascular, Blood
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 Avastin. Victoza, 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 [email protected] or follow  @AmyEPVantage on Twitter

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