Event - Glaxo's new anti-emetic pill nearing FDA decision

GlaxoSmithKline should hear by the end of March whether the FDA has granted marketing approval for Rezonic, an emesis treatment that is seen capturing a quarter of the market by 2014, to become the best selling product in the field (see table below).

Consensus forecasts from EvaluatePharma reveal that analysts have pencilled in sales of $647m by 2014. This makes the drug the group's fifth biggest growth driver over the next six years and with a net present value of $1.63bn Rezonic is the most valuable product in the company’s pipeline, meaning a green light would come as a helpful boost.

Top 10 anti-emetic products in 2014 Annual Sales WW - Sales
Product Company Pharmacological Class Patent Expiry 2007 2014 CAGR (07 - 14)  Phase (Current)
Anti-emetics Rezonic GlaxoSmithKline Neurokinin-1 antagonist - - 647 n/a Filed
Aloxi Eisai 5HT3 (serotonin) antagonist Apr 2015 293* 595 40% Marketed
Emend Merck & Co Neurokinin-1 antagonist Apr 2015 204 355 8% Marketed
IV Emend Merck & Co Neurokinin-1 antagonist Mar 2019 - 240 n/a Marketed
Navoban Novartis 5HT3 (serotonin) antagonist Dec 2005 143 147 0% Marketed
Nasea Astellas Pharma 5HT3 (serotonin) antagonist - 41 120 16% Marketed
Sancuso ProStrakan 5HT3 (serotonin) antagonist - - 106 n/a Marketed
Kytril Roche 5HT3 (serotonin) antagonist Dec 2007 355 96 (17%) Marketed
Zofran GlaxoSmithKline 5HT3 (serotonin) antagonist Dec 2006 392 80 (20%) Marketed
Cesamet Valeant Pharmaceuticals  Cannabinoid - 30 79 15% Marketed
  Other 446 186 (12%)
 Total 1,669 2,651 7%

* pro-forma Aloxi sales in 2007 to include MGI Pharma sales prior to Eisai acquisition

Rezonic is a neurokinin-1 antagonist, and would be the second of its class to reach the market; Merck & Co’s Emend was launched in 2003. The fact that regulators are familiar with the class of drug should improve the chance of approval straight off.

Glaxo announced the drug was filed on May 29 last year; a 10-month review period would give a PDUFA date of the end of March. Approval is being sought to prevent post-operative and chemotherapy-induced nausea and vomiting. It would be used as an add-on therapy to 5HT3 antagonists, such as Glaxo’s Zofran and Roche’s Kytril, which are now both off-patent, and dexamethasone.

Zofran achieved sales of $1.56bn in 2006, Glaxo's fourth biggest-selling product that year, before patent expiry in December 2006 led to significant generic erosion.

There is little else in the late-stage R&D pipeline coming through for emesis, save a handful of smaller products such as a phase III dopamine D2 antagonist being developed by Accentia Biopharmaceuticals, which has not been assigned any value by analysts. Therefore, any delay to approval for Rezonic would mostly affect drugs on the market, mostly positive for Merck’s Emend.

Rezonic was in-licensed from Japan’s Tanabe Seiyaku in 2001, as part of a six-product deal. It has been by far the most successful project, as the table below reveals. Although how much Glaxo paid was never revealed, all the products were early stage so the sum was probably not substantial; if Rezonic makes it to market it is likely to have paid off handsomely.

Products in-licensed from Tanabe Seiyaku (Sep 2001)
Product Pharmacological Class Status on Deal Date Phase (Current) Termination date 2014 WW sales ($m) Lead indication
Rezonic Neurokinin-1 antagonist Phase I Phase III - 647 Emesis, chemotherapy-induced [Phase III]; Emesis, surgery-induced [Phase III]
683699 VLA-4 antagonist Phase I Phase II - 46 Multiple sclerosis (MS) [Phase II]
815541 Dipeptidyl peptidase IV (DPP-IV) inhibitor Phase I Phase II - - Diabetes, type II (maturity onset) [Phase II]
SB 683698 (TR 14035) VLA-4 antagonist Phase I Abandoned - Phase I Dec 2002 - Arthritis, rheumatoid [Abandoned in R&D]
TA-1702 BK channel opener Pre-clinical Abandoned - Phase I Nov 2007 - Urinary incontinence (UI) [Abandoned in R&D]
SK Channel Blocker SK channel blocker Pre-clinical Abandoned - Pre-clinical Unclassified - Constipation [Abandoned in R&D]

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