Norwegian biopharmaceutical company Clavis Pharma ASA (OSE: CLAVIS) has raised 163 million NOK in a private placement of 2.86 million+ shares for a price of 57 NOK per share, adding approximately 9.4% more shares into circulation. The placement was conducted through an accelerated bookbuilding process with a minimum of half a million NOK purchase required.
Largest shareholder Braganza AS added 118 200 shares, which was around half of the amount which would have kept its ownership proportionally the same. Prior to the placement Braganza owned 7.9% of shares and after the placement it will have 7.6% of the shares.
The company says that the financial flexibility from net proceeds will help the company to negotiate favourable out-licensing agreements with potential partners and flexibility to exploring new cancer product opportunities as well as extend the run-way. Clavis Pharma has stated it aims to commercialize its products first and foremost through strategic alliances and partnerships.
One day earlier, as the company was announcing the private placement, it provided an update on ongoing phase 3 CLAVELA trial with elacytarabine for late-stage acute myeloid leukaemia saying that 234 out of targeted 380 patients have been recruited. The guidance of full enrolment was pushed back from Q2 2012 the H2 2012 with top-line data expected in Q1 2013 vs. Q4 2012.
Clavis Pharma said that the delay is caused by temporary elacytarabine shortage as the current manufacturer Ben Venue Laboratories has been having factory-wide quality issues. This has been painfully evident from certain recently released European Medicines Agency recommendations and an FDA inspection report. Clavis Pharma says that Ben Venue has informed it cannot release the final two patches until an inspection has been completed later on in Q1. Regardless of that, Clavis Pharma has already agreed with another elacytarabine contract manufacturer Baxter Oncology GmbH, that Baxter will start supplying the drug to CLAVELA trial patents from Q2 2012.
Approximately one week ago the company provided news regarding ongoing pivotal LEAP trial with lipid-conjugated gemcitabine CP-4126 (CO-101) in 1st line setting in the treatment of metastatic pancreatic cancer, where the drug is being directly compared to gemcitabine, which is currently approved as a single agent for first-line treatmentof such patients, in regards to overall survival. Clavis Pharma’s Lipid Vector Technology is designed to create patentable new drug candidates by significantly improving well-established drug molecules. This is achieved by chemically binding unsaturated lipids to approved pharmaceuticals.
Independent Data Monitoring Committee informed that approximately 65 percent of the patients in the trial have been classified as human Equilibrative Nucleoside Transporter 1 (hENT1)-low, which was in line with expectations. The hypothesis forming the basis of this study is that gemcitabine needs to enter cancer cells via specific membrane transporters on the surface of the cells with hENT1 being the dominant transporter.
Tumour cells with low hENT1 expression were shown to be resistant for gemcitabine in vitro and in vivo and subsequently strong correlation has been found in retrospective (data mining) analysis of subsequent clinical studies in between overall survival and hENT1 expression. It is positioned that CP-4126 can enter cells in a transporter-independent manner due to the fatty acid conjugate. This is the first trial where such a hypothesis is tested.
CP-4126 has been licensed to Clovis Oncology on a deal worth a maximum of 585 million U.S. Dollars. This drug has never been manufacturer by Ben Venue and Clovis Pharma has sufficient supply and two contract manufacturers on hand. The enrolment is expected to be completed during this quarter with data expected on Q4 2012. The CP-4126 excitement has been pushing Clavis Pharma up nicely in the past two weeks. Today it closed down by 2% at 58.75 NOK per share.
No comments:
Post a Comment