If there was a common thread to coverage of the pharma and biotech industries in 2012, it was one of renewed enthusiasm. The stock market performance is convincing, and a review of the year’s expected launches provides additional evidence.
Nine of the 10 biggest small-molecule hopes for 2012 won approval, along with eight of 10 of the biggest projected biologicals, making last year the best since EP Vantage began tracking the fate of blockbuster prospects (Which of 2012's launches will be future blockbusters?, January 17, 2012). Some question marks hang over such products as Novo Nordisk’s Tresiba, Biogen Idec’s BG-12 and Amarin’s Vascepa; however, for others like Gilead Sciences’ Stribild and Astellas Pharma’s Xtandi, the outlook keeps improving (see table).
The quick rate of drug approvals last year has helped drive enthusiasm in the field, as the FDA returned to a pace not seen since the 1990s (Friendly FDA ups number of NMEs, January 10, 2013).
What might be even more impressive is how the consensus views have changed – five of the biotech products and six of the conventional pharma drugs have seen upgrades to their forecasts. In the aggregate, the 2016 forecasts for the top 10 biotech and small-molecule products have risen since January 2012 – another first for this analysis.
This should not be too surprising: Stribild and Xtandi have seen their 2016 forecasts treble in the past year, for example, and Onyx Pharmaceuticals’ Kyprolis has more than doubled, according to EvaluatePharma data. Xtandi in particular has been the beneficiary of an unusually quick approval and optimism about its use in pre-chemotherapy prostate cancer patients (Medivation gets surprise early approval for prostate cancer pill, September 3, 2012).
Two products that failed to leave the launch pad, Sanofi’s Lemtrada and Kynamro, have more than doubled, showing that a launch date miss does not necessarily result in disappointment – as long as you have a big pharma backer.
|Progress of biggest products forecast to have launched in 2012|
|Biotechnology||Rank||Product||Pharmacology class||Company||Status 2012||Current status||2016 sales consensus in Jan 2012 ($m)||Current 2016 sales consensus ($m)||Change|
|2||Perjeta||Anti-HER2 (ErbB-2) MAb||Roche||Filed||Marketed||1,073||1,683||57%|
|3||Bexsero||Meningococcal B vaccine||Novartis||Filed||Approved||997||610||(39%)|
|5||Menhibrix (HibMenCY-TT)||Hib & meningococcal C & Y vaccine||GlaxoSmithKline||Filed||Approved||359||282||(21%)|
|6||Zaltrap||VEGFr kinase inhibitor||Sanofi||Filed||Marketed||325||320||(1%)|
|7||Gattex||GLP-2 agonist||NPS Pharmaceuticals||Filed||Approved||201||216||7%|
|8||Kynamro||Apolipoprotein B-100 antisense||Sanofi||Filed||Filed||155||287||85%|
|9||Prochymal||Mesenchymal stem cell||Osiris Therapeutics||Filed||Marketed||145||25||(83%)|
|10||Lemtrada||Anti-CD52 MAb||Sanofi||Phase III||Filed||135||255||88%|
|Total biotech products||5,236||5,843||12%|
|Conventional||1||Vascepa||Omega-3 fatty acid||Amarin/undisclosed partner sales||Filed||Approved||2,042||845||(59%)|
|2||BG-12||Fumarate||Biogen Idec||Phase III||Filed||1,742||2,597||49%|
|4||Qsymia||Adrenoreceptor agonist & anti-convulsant||VIVUS||Filed||Marketed||1,134||478||(58%)|
|5||Kalydeco||CFTR potentiator||Vertex Pharmaceuticals||Filed||Marketed||982||1,118||14%|
|6||Stribild||Nucleoside reverse transcriptase inhibitor, HIV integrase inhibitor & CYP3A inhibitor||Gilead Sciences||Filed||Marketed||842||2,523||200%|
|7||Linzess/Constella||Guanylate cyclase type-C receptor agonist||Ironwood Pharmaceuticals/Forest Laboratories/Almirall||Filed||Approved/Marketed||813||819||1%|
|8||Xtandi||Androgen receptor antagonist||Astellas Pharma||Phase III||Marketed||630||1,918||205%|
|9||Forxiga||SGLT2 inhibitor||Bristol-Myers Squibb||Filed||Marketed||571||256||(55%)|
|10||Kyprolis||Proteasome inhibitor||Onyx Pharmaceuticals||Filed||Marketed||457||1,029||125%|
|Total conventional products||10,642||12,991||22%|
|*change in forecast reflects Thrombogenics licensing ex-US rights to Novartis|
Should it be launched, BG-12 is forecast as the biggest introduction of the year, at $2.6bn in forecast 2016 sales – although it missed being a 2012 launch only by dint of a regulatory delay. It has wowed specialists as an oral MS drug effective at preventing relapses, and is thought to become a first-line therapy.
And despite its difficulties with the FDA, Tresiba remains the biotech product with the healthiest 2016 forecast – $1.95bn, a number that has risen 35% in the past year. Approvals in Japan and Europe lend some confidence that the US regulator will nod Tresiba through, but cardiovascular concerns mean that this is not a sure thing (Doubts linger after Novo Nordisk insulins scrape through US adcom, November 9, 2012).
Approval in Europe has meant that Bristol-Myers Squibb and AstraZeneca’s diabetes pill Forxiga can enter a major market. However, cancer worries have been its downfall in the US, and a competing product, Johnson & Johnson’s canagliflozin, appears closer to the market – hence, the consensus has fallen 55% in the past year (Adcom backing gives canagliflozin a chance at an open diabetes field, January 11, 2013).
Two meningitis vaccines have seen forecasts fall, by 39% in the case of Novartis’s Bexsero and 21% in the case of GlaxoSmithKline’s Menhibrix, and there are worries about their place in the vaccination schedules, as well as concerns that the relative rarity of meningitis could lead to lower than expected uptake.
Looking bad is the forecast for Thrombogenics’ Jetrea. However, its 46% drop is reflective of the Belgian firm’s decision to license European rights to the eye drug to Novartis. No consensus has been calculated – however, Deutsche Bank analysts forecast 2016 sales of $272m, which when added to US sales of $220m brings total sales to $492m, higher than last year’s forecast.
If there is a counterweight to investor exuberance, it can be found in Vascepa and Qsymia, two drugs hyped as potential blockbusters.
It has been nearly six months since the FDA approved the former, Amarin’s purified fish oil pill, for dyslipidaemia; a parade of patents have done little to stoke market confidence in the absence of new chemical entity (NCE) status. Amarin appears to have given up on partnership and today announced that it would launch solo next week; thus the title blockbuster-in-waiting might no longer apply as it did a year ago, as forecasts have slipped by 59%.
Hopes for Vivus’s obesity pill Qsymia have fallen drastically with word that many patients were abandoning their prescriptions because of cash outlays, as well as a negative European opinion (Arena says the magic combo word as reality hits Vivus, November 7, 2012). Like Vascepa, this has fallen from blockbuster forecasts to a more modest $478m in 2016.
The biggest percentage drop in forecast sales belongs to Osiris Therapeutics’ stem cell therapy Prochymal. Approval of the treatment for graft vs host disease in Canada and New Zealand has not built confidence in its overall promise; the 2016 forecast now sits at a modest $25m, having fallen 83% in a year (Osiris' battles will continue despite landmark approval for Prochymal, May 21, 2012).
All data sourced to EvaluatePharma.