Upcoming Events - Panel For Epogen Biosimilar And Ocaliva's Lipid Test For Nash

by: EP Vantage

Welcome to your weekly digest of approaching regulatory and clinical readouts. On May 25 Pfizer's (NYSE:PFE) Retacrit, an Epogen biosimilar, will go before the US regulators. Epogen's maker Amgen (NASDAQ:AMGN) has a backup plan in place but as more competition reaches the market the threat to sales will grow (see table below).

By mid-year results should emerge from a phase II trial of Intercept's (NASDAQ:ICPT) Ocaliva in nonalcoholic steatohepatitis. The drug is being given in combination with a statin as LDL elevations were seen in a previous trial, and the data are needed to allay any safety concerns.

Biosimilar adcom

Retacrit is a biosimilar of Amgen's epoetin alfa product Epogen, which is known as Procrit in certain markets. It was initially filed by Hospira (NYSE:HSP), now owned by Pfizer, at the end of 2014 and an approval decision is due in June.

An adcom will convene on May 25 to consider the proposed indications: anemia in kidney disease patients (on dialysis and not on dialysis), in HIV-infected patients, in people with non-myeloid malignancies and in patients at high risk of blood loss undergoing surgery. Galenica (OTCPK:GNHAF) (OTC:GNHAY) now owns the US rights in dialysis.

Retacrit has been on the market in Europe since 2008 but its path in the US hasn't been as straightforward, and two years ago it received a complete response letter. At the time few details were provided, though Pfizer did state that no additional clinical studies were required.

On Amgen's first quarter call in April it noted that Epogen sales had decreased 10% over the first quarter of last year. This decline was due to a renegotiation of the supply agreement with dialysis provider Davita through to 2022, in exchange for reductions on net selling prices.

Readying for further declines, Amgen has a backup product, Aranesp, already on the market. On its earnings call the company noted that dialysis centers are converting from Epogen to Aranesp, with the latter product now representing over 85% of usage.

According to consensus from EvaluatePharma Epogen sales will halve by 2022. Aranesp is expected to recover lost Epogen sales and be the top seller by 2022, but its growth is also in decline. As the threat from biosimilar competition intensifies sales will come under renewed pressure.

Biggest marketed erythropoietin products
Annual Sales WW ($m)
Product Company Patent Expiry 2016 2022 CAGR Markets
Marketed Aranesp Amgen May 2024 2,093 1,718 (3%) WW ex Japan, China, Taiwan, Korea, Greece, Cyprus & Israel; Greece, Cyprus & Israel (royalties)
Epogen Amgen Jun 2015 1,282 638 (11%) US (dialysis only)
Procrit Johnson & Johnson Aug 2013 1,105 603 (10%) WW ex Japan & China (US - excluding dialysis & diagnostics market)
Retacrit* Pfizer - 213 440 13% Europe ex Germany & Canada; US (royalties); Germany (co-promotion with STADA Arzneimittel)
Mircera Roche Nov 2021 520 350 (6%) WW ex US, Puerto Rico & Japan; US, Puerto Rico & Japan (royalties)
Mircera Galenica Nov 2021 334 333 (0%) US & Puerto Rico
Filed Retacrit* Galenica - - 44 n/a US
Source: EvaluatePharma. *Biosimilar

Lipid monitoring

Intercept's phase II Control study will report by the middle of the year. The trial tests Ocaliva, known generically as obeticholic acid, in 80 nonalcoholic steatohepatitis (Nash) patients. 5, 10, or 20mg of Ocaliva is being tested with 10mg atorvastatin titrated up to 20mg, versus placebo and atorvastatin. The primary endpoint is the change from baseline in LDL metabolism at 16 weeks.

Control was initiated because of worries over LDL elevations reported in another phase II study with Ocaliva. In the Flint trial the increase peaked at 12 weeks into treatment and then plateaued, and concerns over potential cardiovascular risks caused shares to fall 30% (Full Flint data make Intercept look normal, November 10, 2014).

The Control data will report ahead of a larger phase III trial called Regenerate, and could offer some insights into how lipids might be managed in the latter study, which is expected to report in 2019.

Ocaliva has been approved in primary biliary cirrhosis since last May but Nash is the bigger indication. 2022 sales are forecast to reach $1.5bn according to EvaluatePharma consensus, with $970m assigned to Nash. Intercept's shares are down 13% over the past year, but if the Control data can address any lingering LDL concerns the company's fortunes might turn around.

Trial name Trial ID
Flint NCT01265498
Control NCT02633956
Regenerate NCT02548351

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.