Updates for: Novo Nordisk (NYSE:NVO), IntelGenx Corp. (OTC:IGXT), Cytomedix Inc. (AMEX:GTF), and Par Pharmaceutical Companies Inc. (NYSE:PRX)

Warner Chilcott PLC

(NYSE:NVO)

On 9/23/09, Novo Nordisk (NYSE: NVO) announced the delay until 4Q09 of formal feedback from the FDA for its pending Victoza (liraglutide is a once-daily human GLP-1 analogue) NDA seeking U.S. marketing approval for the treatment of type 2 diabetes in adults. On 7/3/09, NVO announced European Commission marketing authorization for (liraglutide) in the treatment of type 2 diabetes in adults. The original PDUFA action date for the Company’s pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending. Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors. Panelists were split, voting 6-6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8-5 in favor of the drug’s cardiovascular safety profile. On 12/30/09, NVO reported that it expects FDA feedback within weeks for liraglutide and would provide an update on the regulatory process along with financial results on 2/2/10 if formal feedback is not received from the Agency by that time.

IntelGenx Corp.

(OTC:IGXT)

On 8/21/09, IntelGenx (IGX.V) announced that as required in connection with the filing of the CPI-300 NDA, its development partner and NDA applicant, Cary Pharma, provided notice of the filing to Biovail on 6/29/09, which holds the patent for Wellbutrin XL since CPI-300 is a novel, 450 mg high-strength formulation of the active ingredient of Wellbutrin (bupropion). On 8/18/09, IntelGenx learned that Cary Pharma was named in a lawsuit filed by Biovail for patent infringement. Cary Pharma and IntelGenx believe that CPI-300 does not infringe Biovail’s patent and will vigorously assert their rights in order to achieve a favorable judgment ahead of the 1/3/12 patent expiration. On 4/3/09, IGXT.OB and privately-held Cary Pharma filed a NDA with the FDA under the 505(b)(2) pathway for their CPI-300 antidepressant, which represents a new strength and formulation of bupropion (450 mg) to provide a more convenient dosing option to patients with major depressive disorder. The NDA has been formally accepted by the FDA for a standard, 10-month review with a previous PDUFA action date of 2/6/10. IntelGenx reported in its most recent presentation that the P-IV complaint by Biovail was filed August 13 but not served and the request for data will be used to prove non-infringement with a strong case history against Biovail, which has lost three cases. As a result of a manufacturing site change announced 1/11/10, IntelGenx and Cary Pharma are in the process of discussing with FDA the preparation of an amendment to their NDA, which will be filed with FDA in due course and will likely result in a delay, but a new PDUFA action date has not yet been issued.

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