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Puma’s FDA Decider And Semaglutide’s Head-To-Head Battle – Seeking Alpha

Posted: July 7, 2017 at 2:44 pm

Welcome to your weekly digest of approaching regulatory and clinical readouts. Puma's (NYSE:PBYI) neratinib, or Nerlynx, has a PDUFA date set for July 21, and with a positive panel review behind it the focus turns to its potential label and commercial outlook. Its market could be disrupted by Roche's (OTCQX:RHHBY) Perjeta.

Meanwhile, the next test for Novo Nordisk's (NYSE:NVO) semaglutide will be its head-to-head trial against Lilly's Trulicty, the prospective market leader. The data could help differentiate the GLP-1 market, and with semaglutide boasting a cardiovascular benefit it could carve out some market share.

Puma hopes for roaring approval

Nerlynx's May panel meeting resulted in a 12-4 vote - a strong but not overwhelming endorsement. The project was filed for adjuvant treatment of Her2-positive breast cancer, but its diarrhoea side effect is well known, and many panel members urged a narrower patient population than Puma's application seeks (Puma pulls within sight of FDA OK, May 24, 2017).

Should the regulators follow the panel recommendation Nerlynx still faces a big commercial challenge in the shape of Roche's Perjeta, though ultimately the Aphinity study of the Swiss company's drug disappointed. Aphinity data unveiled at Asco showed Perjeta plus Herceptin giving a statistically significant but unimpressive one percentage point reduction in risk of progression over Herceptin alone in adjuvant use.

However, as Perjeta is already on the market for treatment and neoadjuvant use in combination with Herceptin, oncologists could begin prescribing it off-label in the adjuvant setting.

With Perjeta's own FDA decision for adjuvant use still months away, Roche's sales representatives are not allowed to talk about it until approval, unless doctors ask them (Asco - Aphinity and Roche's 1% solution, June 5, 2017).

Puma will therefore have to think hard about its pricing strategy, but as a small molecule Nerlynx could come in cheaper than Roche's combination of two biologicals. However, associated costs of Nerlynx's diarrhoea side effect will have to be taken into consideration.

Sustaining its position

The phase III Sustain 7 trial of semaglutide tests the Novo Nordisk project versus Trulicity as an add-on to metformin in 1,201 type 2 diabetics. Two subcutaneous doses of each were tested: 0.5mg or 1.0mg of semaglutide per week, versus Trulicity at 0.75mg or 1.5mg per week.

The primary measure was change in glycosylated hemoglobin, also known as HbA1c, at week 40; results are due in the third quarter.

Novo will be going for superiority, and judging by previous studies with the two drugs it has a chance of getting it. Looking across trials semaglutide has shown slightly greater reductions in HbA1c than those achieved by Trulicity in similar add-on settings.

Sustain 7 results are important as they could differentiate the weekly GLP-1s. Trulicity is set to be the leader by 2022, according to consensus from EvaluatePharma, while injectable Semaglutide sits in third place.

Semaglutide could claw back some market share as it has shown a cardiovascular benefit, something that Trulicity has yet to do, at least until results from Trulicity's Rewind cardiovascular outcomes study come out next year (Semaglutide heart data spice up once-weekly GLP-1 race, April 28, 2016).

Injectable Semaglutide was filed in the US last December, so FDA action could come at the end of the year; an oral version is in phase III trials, with data due in 2018.

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Puma's FDA Decider And Semaglutide's Head-To-Head Battle - Seeking Alpha

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