Event – Santarus needs Uceris approval to boost flagging pipeline

The Californian biotech Santarus might want to postpone its New Year celebrations to January 16, when its ulcerative colitis drug Uceris will come up for US approval. With a thin pipeline, Santarus needs Uceris to add an important source of revenue.

Despite a three-month PDUFA extension from October owing to issues relating to good clinical practices, the company has proposed launching the drug in the first quarter of next year. However, generic competition is right around the corner and Santarus will have to play a convincing game to prove that Uceris is the one to prescribe.

Company Santarus Cosmo Pharmaceuticals
Product Uceris
Market cap $707m $482m
Product NPV $251m $193m
% of market cap 35% 40%
Event type PDUFA
Date January 16, 2013

Positive results

Uceris, known generically as budesonide MMX, is a corticosteroid tablet indicated for the induction of remission of mild to moderate active ulcerative colitis.

In the 509-patient, pivotal, phase III Core 1 trial the primary endpoint was met. More patients achieved combined clinical and endoscopic remission at week 8 in the Uceris 9mg group than on placebo, at 17.4% and 7.4% respectively, with a p value of 0.0143. The reference agent Asacol gave a non-significant numerical increase, with 12.1% of patients on the drug versus 7.4% on placebo reaching remission at week 8.

Santarus will not have long to tap the important Uceris revenue stream as the patent set to expire in 2020. The company has suffered from generic competition on its diabetes drugs, and even a court ruling reinstating patent claims for its acid reflux product Zegerid has not helped revive flagging sales (Wockardt and Arena lead small-cap gainers through nine months, October 10, 2012).

Inflammation

Ulcerative colitis is a form of inflammatory bowel disease with patients suffering from inflammation and ulceration in the lining of the colon and rectum. The first option for patients is to use aminosalicylates (ASAs) like Asacol, after which steroids or immunosuppressants may be used.

Santarus has said that Uceris would be used after ASAs but before systemic steroids. It also states that as doctors become more familiar with the product they would probably use ASAs and Uceris at the same time in new patients; as the ulcerative colitis is brought under control the patient would be taken off Uceris but kept on the ASA.

In light of this a phase IIIb trial is recruiting 500 patients testing Uceris as an add-on therapy to ASAs. Enrolment should complete in the middle of next year, with data in the second half.

Minor delay

When news of the PDUFA date extension came in August Santarus shares fell nearly 4%. A similar fate befell Cosmo Pharmaceuticals, which had licensed the project to Santarus back in 2008 (Santarus deal de-risks Cosmo's world, December 17, 2008).

At the time analysts at Roth noted that the delay related to good clinical practice violations in the European study (Core 2), where some 100 patients were excluded for entry criteria violations/histology, versus approximately 20 in the US trial.

Santaruss confidence that the drug, if approved, will be launched in the first quarter of 2013 could signify that its gastrointestinal sales force is in place. EvaluatePharma forecasts sales of $169m in 2018, and analysts at Stifel Nicolaus believe that Uceris has an above average chance of approval given that budesonide is a well-understood steroid.

However, with generics already snapping at its heels the product will need to prove that it is better than the rest. Uceris is unlikely to make a huge dent in the ulcerative colitis market, but could help breathe life into Santarus's pipeline.

Study Details Trial ID
Core 1  North America and India, 509 patients. Asacol reference arm. NCT00679432
Core 2 Europe, Australia, Israel, and Russia, 511 patients. Entocort EC (budesonide) reference arm. NCT00679380
- Add-on therapy to ASA's, 500 patients. NCT01532648

To contact the writer of this story email Joanne Fagg in London at joannef@epvantage.com or follow @JoEPVantage on Twitter

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