Incivek set to break record for fastest product launch

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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