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. <\/p>\n
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. <\/p>\n
Puma hopes for roaring approval <\/p>\n
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). <\/p>\n
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. <\/p>\n
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. <\/p>\n
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). <\/p>\n
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. <\/p>\n
Sustaining its position <\/p>\n
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. <\/p>\n
The primary measure was change in glycosylated hemoglobin, also known as HbA1c, at week 40; results are due in the third quarter. <\/p>\n
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. <\/p>\n
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. <\/p>\n
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). <\/p>\n
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. <\/p>\n
Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks. <\/p>\n
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See the original post: 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. Continue reading
\nPuma's FDA Decider And Semaglutide's Head-To-Head Battle - Seeking Alpha<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"