Small-molecule launches hold their own

Analysis

Already 2014 is shaping up to be a year that will see the most new drugs approved by the US FDA for over a decade, but it might come as a surprise to see that, despite the huge strides made by biologicals, small molecules are still holding their own.

Of the 29 additional US launches expected by the end of the year just nine will be biologicals, though this does include two of the top three drugs in order of consensus sales within five years of launch (see table below). Indeed, the revenue estimate analysis shows biologicals commanding the lion’s share of the most lucrative upcoming launches.

Thus the disparity between biologicals and small molecules only begins at the lower end of the list, with the two new drug categories taking an equal share of the top 14 remaining launches of 2014. 25 drugs having already been approved in the US this year, the year’s potential tally could hit 54 (Record US approval run sustains bull market hopes, July 21, 2014).

US approvals expected by the end of 2014
US sales ($m)
Product Biological? Company 2014e 2019e
Nivolumab Yes Bristol-Myers Squibb 15 3,119
Ledipasvir/sofosbuvir No Gilead Sciences 387 2,017
Pembrolizumab Yes Merck & Co 12 1,815
ABT-450/ABT-333/ABT-267 No AbbVie 84 1,296
Esbriet No InterMune 730
Plegridy Yes Biogen Idec 61 653
Idelalisib No Gilead Sciences 27 594
Secukinumab Yes Novartis 17 584
Jardiance No Boehringer Ingelheim 74 549
Trulicity Yes Eli Lilly 27 540
Ceftolozane/tazobactam No Cubist Pharmaceuticals 456
V503 Yes Merck & Co 73 393
Daclatasvir No Bristol-Myers Squibb 364
Natpara Yes NPS Pharmaceuticals 0 353
Orbactiv No The Medicines Company 4 295
Lynparza No AstraZeneca 11 287
Cerdelga No Sanofi 47 261
Suvorexant No Merck & Co 6 241
Farydak No Novartis 8 203
Movantik No AstraZeneca 8 120
Elonva Yes Merck & Co 15 87
Vitekta No Gilead Sciences 8 71
Tybost No Gilead Sciences 6 49
OBI-1 Yes Baxter International 21
Macrilen No Æterna Zentaris 20
Rapiacta No Biocryst Pharmaceuticals 8
Asunaprevir  No Bristol-Myers Squibb
Onexton No Valeant Pharmaceuticals
Striverdi Respimat No Boehringer Ingelheim

At least one of the biological launches – that of Bristol-Myers Squibb’s nivolumab – is debatable, and it will take a super-keen FDA to approve it this year. Meanwhile, the top-selling expected small-molecule launches are two combination hepatitis C antivirals and Esbriet, an idiopathic pulmonary fibrosis project that is already sold in Europe.

Esbriet recently secured US breakthrough therapy designation, matching Boehringer Ingelheim’s IPF competitor, nintedanib, which is thought to have a US action date next February. Two other Boehringer projects, the recently resubmitted empagliflozin for diabetes and olodaterol for COPD, could receive quick verdicts now that long-running manufacturing defects have been remedied.

Indeed, this could add clarity to the German group’s COPD combination strategy, within which olodaterol should make a far greater impact than as a standalone drug.

Other small molecules worth watching are idelalisib – Gilead’s foray into oncology, to be pitted against Pharmacyclics’ Imbruvica – and Bristol’s own hep C agent, daclatasvir.

Dubious

The list of 29 potential approvals is, of course, the result of sellside consensus expectations, some of which are unrealistic.

The dubious category is headed by AstraZeneca’s ovarian cancer project Lynparza, slapped with an 11-2 advisory panel vote against approval in June. Novartis’s anti-IL-17 MAb secukinumab is being pitched at a crowded psoriasis market, and has yet to negotiate an advisory panel review in October.

A decision on Merck & Co’s human papillomavirus vaccine V503, a Gardasil follow-on, could, like the verdict on nivolumab, slip into 2015; the PDUFA date for Cubist’s antibacterial combo of ceftolozane/tazobactam is December 19, while Aeterna Zentaris’s Macrilen has a November 5 action date.

Meanwhile, a six-month priority review for treating Gaucher’s disease put the expected PDUFA date for Sanofi’s Cerdelga at June 11, but so far no news has emerged about a decision. Sanofi told EP Vantage that it had not disclosed an action date, but expected a decision in the third quarter.

FDA action dates are clearly subject to change in both directions, but at this stage nothing can detract from the fact that 2014 should be a memorable year for US approvals of biologicals and small molecules alike.

To contact the writers of this story email Jacob Plieth or Joanne Fagg in London at news@epvantage.com or follow @JacobEPVantage or @JoEPVantage on Twitter

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