BioMed News Bytes: AstraZeneca, Delcath, Unilife Print E-mail
Thursday, 19 November 2009 10:43

On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the FDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).

 

The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. This submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. The mode of action involves inhibiting the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic (blood clot) events.

On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death. In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the Phase 2 studies.

On 11/19/09, Delcath Systems (NASDAQ: DCTH) provided the following corporate updates. Active negotiations continue with several international entities to provide exclusive geographic market rights for the PHP System. In October, the pivotal Phase 3 Metastatic Melanoma Trial met its goal of 92 patients and was fully enrolled. This clinical study is evaluating the Delcath PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver. Enrollment in the Phase 2 clinical study of the Delcath PHP System with melphalan for patients with inoperable liver metastases from neuroendocrine tumors has now reached 25 patients and continues to enroll patients with data expected in the coming months. Established a low cost operations facility in Queensbury, New York in which Delcath plans to locate manufacturing of its PHP System.

DCTH expects to submit the application to the FDA seeking approval of the PHP System with melphalan by the end of 1H10 and is optimistic about its ability to gain CE mark approval in Europe in early 2010 with commercial sales in the European markets starting shortly thereafter. The Company recently closed a public common stock offering for proceeds of about $32.4 million. The Percutaneous Hepatic Perfusion (PHP) System results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of approved anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body.

On 11/19/09, Unilife Medical Solutions (OTC: UNIFF.PK) (ASX: UNI.AX) announced the appointment of Mikron Group as its contracted supply partner for the development and supply of automated assembly systems to support the commercial production of the Unifill ready-to-fill syringe. Unilife is targeting initial annual commercial production of about 60 million units of the Unifill syringe with development expected to begin next month for installation in the Company's Central Pennsylvania manufacturing facility slated for 4Q10 in conjunction with industrialization partner Sanofi-Aventis (NYSE: SNY), which is a major customer for safety syringes to deliver injectable products such as the flu vaccine and blood thinner Lovenox.

Last week Unilife announced a lodgement of an Information Memorandum with respect to its proposed relocation to the US and primary stock listing on the NASDAQ with a shareholder meeting / vote scheduled for 2010. Click here for the ProActive News Room landing pages for Unilife Medical Solutions and Delcath Systems, which contain a compilation of digital media coverage links, videos, news feeds, articles, and report downloads.

The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

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