Oslo, Norway, 17 January 2012
Clavis Pharma ASA (OSE: CLAVIS) today provides an update on recruitment into and timelines for its Phase III CLAVELA trial in patients with late-stage acute myeloid leukemia. To date, 234 patients have been recruited into the trial at centres in Europe, Australia and North America. The Company now expects CLAVELA to be fully recruited (approximately 380 patients) during the second half of 2012, versus earlier guidance of the second quarter of 2012. Top line results are expected in the first quarter of 2013, one quarter delayed.
This timeline delay versus previous guidance is owing to a temporary shortage of elacytarabine as a result of factory-wide quality issues at Ben Venue Laboratories (BVL), Ohio, USA, the current manufacturer of elacytarabine. BVL is unable to release two final batches of elacytarabine until the investigation at its Ohio facility has been completed. Clavis Pharma has now been informed that these batches cannot be released for clinical use until later in the first quarter of 2012.
The investigations at BVL concern the quality systems for the manufacturing plant in general and are not related to elacytarabine. Clavis Pharma is tightly managing its remaining supplies to ensure that existing patients receive uninterrupted supplies of elacytarabine and to continue limited recruitment until the next batch is available for use. Clavis Pharma is committed to completing CLAVELA as fast as possible to the highest clinical and regulatory standards and in close cooperation with relevant regulatory bodies.
In 2011, Clavis Pharma signed an agreement with Baxter Oncology GmbH (Germany) as a second contract manufacturer for elacytarabine, with the intent to transfer manufacturing in the first quarter 2012. The companies have been working closely for some time to facilitate a smooth switchover so that patients on the CLAVELA trial will receive drug manufactured by Baxter in the second quarter 2012.
CP-4126 (also known as CO-101), which has been licensed to Clovis Oncology (Clovis) is not affected by this manufacturing issue. CP-4126 has never been manufactured by BVL and Clovis is already utilizing two manufacturers for its clinical trials and potential commercial supply. In addition, Clovis has sufficient supply on hand of both CP-4126 and the active control arm (gemcitabine) to complete its pivotal LEAP trial in metastatic pancreatic cancer. Clovis continues to expect to complete enrollment in the 360-patient LEAP trial at the end of the first quarter of 2012 and anticipates top line results from the LEAP trial in fourth quarter of 2012.
Olav Hellebø, Clavis Pharma CEO, commented: “The speed of recruitment into CLAVELA has been as planned and we are disappointed that the issues at BVL are now slowing down this progress. We are working closely with BVL and Baxter so that we can resume full-speed recruitment as quickly as possible and we now expect to complete the recruitment in this important study during the second half of 2012 and to have data available in the first quarter of 2013.”
For further information contact:
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
+44 783 390 4901
olav.hellebo@clavispharma.com
Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum@clavispharma.com
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma@citigatedr.co.uk
About Clavis Pharma
Clavis Pharma ASA is a late clinical stage oncology discovery and drug development company based in Oslo, Norway with a portfolio
of novel anti-cancer drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially
successful drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential
breakthrough products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater
tissue penetration, altered metabolism and, in certain cases, additional modes of action.
Clavis Pharma's has several drug candidates in formal development studies:
- Elacytarabine, a leukaemia drug, currently in a randomized, controlled Phase III study in late-stage acute myeloid leukaemia;
- CP-4126, is currently in a pivotal clinical study compared to gemcitabine for the 1st line treatment of pancreatic cancer and a Phase II trial for 2nd line treatment for pancreatic cancer in patients refractory to 1st line gemcitabine treatment;
- CP-4200, an azacitidine derivative, in preclinical development for myelodysplastic syndrome (MDS), a disease that is often a precursor to leukaemia.
Clavis Pharma intends to commercialise its products through strategic alliances and partnerships with experienced oncology businesses and, where and when commercially appropriate, by establishing its own sales and marketing capabilities.
Disclaimer
The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there
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prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
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