Date: 2014-10-20
Type of information: Granting of a Market Authorisation in the EU
Product name: Cortiment® (Budesonide MMX®)/Uceris® (USA)
Compound: budesonide MMX®
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Digestive diseases
Action mechanism:
- corticosteroid. Budesonide MMX® is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes Cosmo’s proprietary MMX® multi-matrix system technology and is designed to result in the controlled release and distribution of Budesonide throughout the length of the colon. Budesonide has mainly topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids.
- Cortiment® has been developed by Cosmo Pharmaceuticals. Ferring is the licensee in the EU and Asia (excluding Japan), Australia, Canada, Latin America and Africa. In the United States, where the product is available as Uceris®, the licensee is Salix Pharmaceuticals.
Company: Cosmo Pharmaceuticals (Italy)
Disease: mild to moderate active ulcerative colitis
Latest news:
- • On October 20, 2014, Cosmo Pharmaceuticals announced that Ferring’s Cortiment® MMX® (budesonide) treatment for the induction of remission in patients with active, mild to moderate ulcerative colitis has received marketing approval from 27 European Union member states following the EU Mutual Recognition Procedure (MRP). Cortiment® has been commercially available in the Netherlands since November 2013. Ferring plans to begin launching the product in the 27 additional European countries in the coming months.
The approved dosing regimen for adult patients is one 9 mg tablet taken once daily for up to 8 weeks. In phase III studies, 2.4 to 3.9 times more patients achieved clinical remission and mucosal healing with Cortiment® compared to placebo, and no clinically significant glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment (CORE I study and CORE II study respectively).
- • On February 1, 2013, Cosmo Pharmaceuticals has announced that it was informed by the Dutch Regulatory Agency (MEB) that the Appeals Committee put in place to review the MEBs decision of August 8, 2012 has now approved Cortiment™ (budesonide with Cosmo’s MMX™ technology), indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis for marketing in the Netherlands. Cosmo Pharmaceuticals will now pursue the product registration in the other EU member states.
- • On January 15, 2013, Cosmo Pharmaceuticals has announced that its licensee in the USA, Santarus announced that the FDA has approved the New Drug Application (NDA) for Uceris® (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. Santarus expects the commercial launch of Uceris® to begin in March 2013. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks.
- • On August 14, 2012, Cosmo Pharmaceuticals has announced that its licensee in the USA, Santarus announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target date for the review of the new drug application of Uceris™ from October 16, 2012 to January 16, 2013 because the FDA needed additional time to review information provided on August 3, 2012 by Santarus. The FDA also indicated that, if no major deficiencies are identified during the review, it plans to communicate proposed labeling and if necessary, any postmarketing requirement/commitment request to Santarus by December 12, 2012. Assuming FDA approval, Santarus anticipates that it will be in a position to commence launch of Uceris™ approximately two months following determination of final product label.
- • On August 9, 2012, Cosmo Pharmaceuticals has announced that it has received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment® (budesonide with MMX™ technology), indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The reasons given for the decline were apparently on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons for this decision.
- • On February 15, 2012, Cosmo Pharmaceuticals announced that its licensee Santarus, has been notified by the FDA that it has accepted the submission of its New Drug Application (NDA) seeking market approval for Uceris™ (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis.
- • On December 21, 2011, Cosmo Pharmaceuticals announced that its licensee Santarus, has submitted a New Drug Application (NDA) to the FDA seeking market approval for Uceris® (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis. Upon acceptance for review of the NDA for Uceris® Tablets, $4 million is payable to Cosmo. The milestone is payable in cash or Santarus common stock, at Cosmo’s option.
- • On May 31, 2011, Cosmo Pharmaceuticals announced that, based on the successfully concluded clinical trials in the US and EU, it had filed the documentation required for the Marketing Authorization Application of Budesonide MMX® for induction of remission in patients with mild to moderate active ulcerative colitis. This MAA was filed with 15 EU countries with Dutch Regulatory Agency acting as reference member state. In late September 2010, Cosmo Pharmaceuticals and its partner Santarus announced positive top-line results from the phase III pivotal clinical study of Budesonide MMX® in North America and in India and in November 2010 Cosmo Pharmaceuticals and Santarus announced positive top-line results from the phase III pivotal clinical study of Budesonide MMX® in Europe and the rest of the world.
Patents:
- • On March 2, 2015, Cosmo Pharmaceuticals informs that Santarus, a wholly owned subsidiary of Salix Pharmaceuticals, and its subsidiary, Cosmo Technologies, the licensor, commenced a lawsuit against generic drug maker Alvogen Pine Brook,for Alvogens’ infringement of certain patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) covering Uceris® and its use. The lawsuit was filed in the United States District Court for the District of Delaware.Cosmo and Santarus filed this lawsuit in response to a notice letter, dated January 16, 2015, sent by Alvogen regarding its filing with the FDA of an Abbreviated New Drug Application No. 205556 seeking approval for Alvogen to manufacture and sell budesonide extended release tablets. This letter also stated that ANDA No. 205556 contained Paragraph IV certifications, under 21 U.S.C. Section 355(j) of the Federal Food, Drug, and Cosmetic Act, with respect to certain patents listed in the Orange Book on that date as covering Uceris®. Santarus and Cosmo are enforcing such patents. These patents are expected to expire on June 9, 2020. Cosmo and Santarus remain committed to protecting their intellectual property rights, including their patent protection for Uceris®.
- • On February 3, 2015, Cosmo Pharmaceuticals informs that Santarus, a wholly owned subsidiary of Salix Pharmaceuticals,d., and its subsidiary, Cosmo Technologies , the licensor, commenced a lawsuit against generic drug maker Par Pharmaceutical, Inc. for Par’s infringement of six patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) as covering Uceris® and its use. The lawsuit was filed in the United States District Court for the District of Delaware.Cosmo and Santarus filed this lawsuit in response to a notice letter, dated December 19, 2014, sent by Par regarding its filing with the FDA of an Abbreviated New Drug Application No. 206131 seeking approval for Par to manufacture and sell budesonide extended release tablets. This letter also stated that ANDA No. 206131 contained Paragraph IV certifications, under 21 U.S.C. Section 355(j) of the Federal Food, Drug, and Cosmetic Act, with respect to the six patents listed in the Orange Book on that date as covering Uceris®: U.S. Patent Nos. 7,410,651; 7,431,943; 8,293,273; 8,784,888; 8,895,064 (“the ‘064 patent”); and RE43799. These six patents are all expected to expire on June 9, 2020, with the exception of the ‘064 patent, which is expected to expire on September 7, 2031. Cosmo and Santarus remain committed to protecting their intellectual property rights, including their patent protection for Uceris®.
- • On October 8, 2014, Cosmo Pharmaceuticals announced that the US Patent Office had issued the notice of allowance of its patent application 13/226,758 for Uceris®. This patent covers the product with its pharmacokinetic profiles and shall grant Uceris® IP protection in the US until 2031.
Submission of marketing authorization application USA : 2011-12-21
Submission of marketing authorization application UE: 2011-05-30
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2013-01-14
UE authorization: 2013-02-01
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
