Product sales in 2010: hits and misses

Analysis

With most Japanese companies having recently reported their fiscal full year results for 2010, the annual review of products that exceeded and missed sales expectations last year is complete. In contrast to huge volatility in 2009 when the swine flu pandemic caused global stockpiling of potential treatments and vaccines, 2010 saw more subtle but still significant swings in product performance (Product sales in 2009: hits and misses, March 30, 2010).

Star performer was Novo Nordisk’s anti-diabetic agent Victoza, sales of $400m being four times higher than was expected at the start of the year, boosted by a somewhat surprising FDA approval and rapid uptake. Other notable winners were Ambien CR, Vancocin and Protonix, which all benefited from a failure of expected generic competition to materialise. As for the misses, the list is dominated by newly launched products which have struggled to get off their blocks, including Savient’s Krystexxa, Cumberland’s Caldolor and NeurogesX’s Qutenza (see tables below).

The following analysis, extracted from EvaluatePharma, compares actual product sales in 2010, as disclosed by the relevant companies, to the expectations from a consensus of analysts prior to the start of the year. While this analysis provides valuable insight into a product's relative performance, it also says much about equity analysts' ability to predict demand, a notoriously difficult task especially for new product launches.

Above and beyond

Once-daily Victoza has certainly made impressive in-roads into twice-daily Byetta’s market share, and the wider diabetes market in general. Not only did sales last year easily surpass expectations, forecasts for 2016 now sit at $2.22bn, more than double what analysts had been estimating just 12 months ago.

Sanofi’s Ambien franchise continues to hold up remarkably well – global sales of both immediate release (IR) and controlled release (CR) formulations amounted to $1.47bn last year, despite losing patent protection some time ago. Sales of Ambien CR beat expectations as generic competitors only entered the US market towards the end of the year.

Products that exceeded expectations in 2010: actual vs. archive at Dec 2009  Sales in 2010 ($m)
Rank Product Company Therapeutic category Archive Actual Difference ($m) Difference %
 1   Victoza   Novo Nordisk   Anti-diabetics  103  413  +309  299%
 2   Ambien CR   Sanofi   Sedatives & hypnotics  137  498  +360  262%
 3   Vancocin   ViroPharma   Anti-bacterials  77  260  +183  237%
 4   Protonix   Pfizer   Antacids & anti-ulcerants  208  690  +482  231%
 5   Vpriv   Shire   Gaucher's disease agent  49  143  +94  191%
 6   Glactiv   Ono Pharmaceutical   Anti-diabetics  47  130  +83  178%
 7   Venofer   Galenica   Anti-anaemics  69  178  +109  158%
 8   Tyvaso   United Therapeutics   Cardiac therapy  64  152  +88  139%
 9   Ampyra   Acorda Therapeutics   MS Therapies  56  133  +77  138%
 10   Azilect   Lundbeck   Anti-Parkinson's agents  78  183  +105  136%

ViroPharma received a surprising boost last year when generic versions of Vancocin, which had been expected to flood the market in 2010, failed to emerge, leading to record sales in the US of $260m as the company took full advantage by pushing through some price increases.

Although current estimates for Vancocin sales of $162m this year suggest some expectation for generics to enter the US market in 2011, nearly half the year has gone and none have yet emerged. The company booked its best quarterly sales for the product in the first quarter at $69m, suggesting Vancocin is set to exceed expectations once again.

Pfizer managed to extract one last year of decent revenues for Protonix, before generics finally flooded the US market in January 2011 – sales of $690m were significantly higher than the $208m originally expected at the start of 2010.

As for Shire’s Vpriv, regulatory approvals in both the US and Europe last year helped to drive sales of the Gaucher's disease agent, which continued to benefit from Genzyme’s manufacturing woes with Cerezyme.

Misses

Gout drug Krystexxa, intravenous ibuprofen formulation, Caldolor, and post-herpetic neuralgia agent, Qutenza, have all struggled since gaining FDA approval. There are now serious questions marks over the commercial and clinical relevance of these products. Needless to say that long-term forecasts for each one have been slashed.

Products that missed expectations in 2010: actual vs. archive at Dec 2009  Sales in 2010 ($m)
Rank Product Company Therapeutic category Archive Actual Difference ($m) Difference %
 1   Krystexxa   Savient Pharmaceuticals   Anti-gout preparations  15  0  (15)  -100%
 2   Caldolor   Cumberland Pharmaceuticals   Non-steroidal anti-inflammatories  35  3  (32)  -91%
 3   Qutenza   NeurogesX   Non-narcotic analgesics  18  1  (17)  -96%
 4   Vibativ   Astellas Pharma   Anti-bacterials  70  8  (62)  -88%
 5   Relistor   Pfizer   Other gastro-intestinal agents  66  16  (50)  -75%
 6   Xiaflex   Auxilium Pharmaceuticals   Other musculoskeletal agents  53  14  (39)  -73%
 7   Firazyr   Shire   Immunosuppressants  37  11  (26)  -70%
 8   Promacta   GlaxoSmithKline   Other haematologicals  133  48  (85)  -64%
 9   Fabrazyme   Genzyme   Fabry disease agent  517  188  (329)  -64%
 10   Effient   Eli Lilly   Platelet aggregation inhibitors  308  115  (193)  -63%

Perennial underachievers, Pfizer’s opioid-related constipation drug Relistor and Eli Lilly’s anti-coagulant Effient, feature again. Indeed Pfizer has called time on Relistor, a product it inherited from Wyeth, handing back the rights to Progenics, although the biotech has since managed to secure a replacement partner in Salix.

Effient’s fall from grace appears complete, sales only just breached $100m last year, quite a shortfall compared to a few years ago when the product was projected to be a blockbuster by 2012.

Sales of Auxilium’s Dupuytren's contracture agent, Xiaflex, were somewhat disappointing last year, another sluggish launch following FDA approval in February 2010. The company is however predicting a sales ramp up in 2011, hoping to achieve $50m to $60m, while successful development of a follow-on indication, Peyronie's disease, could drive further sales growth in future years.

Genzyme’s manufacturing deficiencies accounted for Fabrazyme’s poor performance, while Glaxo’s idiopathic thrombocytopenia drug, Promacta, has struggled to gain acceptance and reimbursement, particularly in Europe.

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