A review of the biggest predicted product launches in 2011 reveals the extent to which this could be a breakthrough year for the major unmet needs of hepatitis C and lupus. Vertex Pharmaceuticals’ hepatitis C drug telaprevir is expected to be the star graduate from the class of 2011 with global sales predicted to exceed $4bn by 2016, while Human Genome Sciences stands on the threshold of bringing its first product to market with lupus therapy, Benlysta, sales of which could reach $2.8bn by 2016 (see table below).
In all, six of the 20 biggest product launches this year could achieve blockbuster status by 2016, although in a reversal of recent trends towards blockbuster biotech products, five are small molecule in origin; aside from Benlysta the biotech class of 2011 is looking decidedly thin. With the annual launch success rate around 50%, it will also be interesting to see how the 2011 class fare; with three approvals already in the bag, the chances of improving on this average look good (Failure to launch for 2010's big hopes, January 10, 2011).
Weak biotech class
Benlysta should finally gain FDA approval within the next couple of months; a positive advisory committee vote in November was followed by the FDA delaying its decision by three months until March 10. A European decision should also be imminent.
Prospects for the rest of the biotech products slated to launch this year are not quite so rosy. Bristol-Myers Squibb’s melanoma antibody, Yervoy (ipilimumab), holds most promise at this stage. The road to approval has been long and tortuous but should the FDA issue a positive verdict by the PDUFA date of March 26, it may just about be worth it; consensus estimates of $874m by 2016 suggest blockbuster potential.
Of the next biggest biotech candidates, BMS’ kidney transplant agent, Nulojix (belatacept) and GlaxoSmithKline’s meningococcal vaccine for infants, Menhibrix, were issued with complete response letters last year. BMS has responded and been granted a new PDUFA of June 15 while Glaxo will submit its response during the first half of the year.
Then there are a few relatively high-risk biotech products, such as Amsterdam Molecular Therapeutics’ gene therapy, Glybera, which could gain European approval this year, Protalix BioTherapeutics’ novel Gaucher’s disease agent, Uplyso (taliglucerase), and Osiris Therapeutics' stem cell therapy Prochymal. Sales forecasts remain understandably modest at this stage.
Small molecule to the fore
In contrast to a weak looking crop of biotech agents, a number of conventional small molecule drugs hold great promise.
Alongside telaprevir, Merck & Co’s similar hepatitis C agent, boceprevir, is also expected to reach the market this year, offering patients a ‘paradigm shift’ in their treatment options and disease prospects – an overused and commonly misplaced phrase but in this case entirely appropriate.
A couple of blockbuster anticoagulants should also gain market entry. Although uncertainty over FDA approval and subsequent commercial potential still surrounds AstraZeneca’s Brilinta, the drug gained approval in Europe in December and launches across the region are expected this year; most analysts still expect FDA approval by the middle of the year, although the need for extensive confirmatory post-marketing studies is likely.
Another BMS product, apixaban, being developed with Pfizer, could become the latest in a series of novel oral anticoagulant drugs, following in the footsteps of Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa, offering doctors and patients a range of options in contrast to decades restricted to warfarin.
Aside from Brilique, approvals are also in the bag for Clinical Data’s anti-depressant, Viibryd (vilazodone), and Dainippon Sumitomo’s anti-psychotic, Latuda (lurasidone). While Clinical Data weighs up its commercial options including whether to seek a partner, Dainippon will launch its biggest projected revenue driver this month.
While a number of other small molecule product launches hold great potential, it is touch-and-go whether they will make it off the ground in 2011. Technically, Incyte’s myelofibrosis drug, ruxolitinib, Bristol-Myers Squibb and AstraZeneca’s novel diabetes agent, dapagliflozin, and Gilead Sciences’s HIV combination drug, TMC278 + Truvada, could all gain approval this year but regulatory timelines could be tight.
|Biggest Expected Product Launches in 2011||WW annual sales ($m)|
|Biotechnology||1||Benlysta (belimumab)||Anti-B lymphocyte stimulator (BLyS) MAb||Human Genome Sciences + GlaxoSmithKline||Filed||156||2,845|
|2||Yervoy (ipilimumab)||Anti-CTLA4 MAb||Bristol-Myers Squibb||Filed||116||874|
|3||Nulojix (belatacept)||B7 integrin antagonist||Bristol-Myers Squibb||Filed||39||503|
|4||Menhibrix/HibMenCY-TT||Hib & meningococcal C & Y vaccine||GlaxoSmithKline||Filed||144||400|
|5||H1N1 VLP Vaccine||Influenza vaccine||Novavax||Filed||8||118|
|6||Uplyso (taliglucerase)||Glucocerebrosidase||Protalix BioTherapeutics||Filed||4||77|
|7||Glybera||Lipoprotein lipase gene therapy||Amsterdam Molecular Therapeutics||Filed||7||72|
|8||Rhucin||C1 esterase inhibitor||Santarus||Filed||-||50|
|9||Imojev||Japanese encephalitis vaccine||Sanofi-Aventis||Filed||3||49|
|10||Prochymal||Mesenchymal stem cell||Osiris Therapeutics||Filed||0.2||36|
|Total Biotech Products||478||5,024|
|Conventional||1||Telaprevir||Hepatitis C protease inhibitor||Vertex Pharmaceuticals + Johnson & Johnson||Filed||626||4,058|
|2||Brilinta (ticagrelor)||P2Y12 antagonist||AstraZeneca||Approved||348||2,527|
|3||Apixaban||Factor Xa inhibitor||Bristol-Myers Squibb + Pfizer||Filed||6||2,287|
|4||Viibryd (vilazodone)||SSRI & 5-HT1A (serotonin) partial agonist||Clinical Data||Approved||102||1,147|
|5||INC424 (ruxolitinib)||Janus kinase-1/2 (JAK-1/2) inhibitor||Incyte + Novartis||Phase III||7||1,069|
|6||TMC278 + Truvada||NNRTI & NRTI||Gilead Sciences + Johnson & Johnson||Filed||11||853|
|7||Boceprevir||Hepatitis C protease inhibitor||Merck & Co||Phase III||38||789|
|8||Latuda (lurasidone)||5-HT2A (serotonin) & D2 antagonist||Dainippon Sumitomo Pharma||Approved||96||770|
|9||Dapagliflozin||SGLT2 inhibitor||Bristol-Myers Squibb + AstraZeneca||Filed||-||724|
|10||TAK-491 (azilsartan)||Angiotensin II antagonist||Takeda||Filed||65||717|
|Total Conventional Products||1,293||14,940|
|Grand Total for class of 2011||1,771||19,965|