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Miles
Km80.5

   

Veloxis Pharmaceuticals A/S (VELO) Announces Financial Results for the First Half 2012, Anticipated Financing, Revised EU Regulatory Filing Strategy and Revised Outlook for 2012. Phase III Activities for LCP-Tacro™ Progressing According to Plan.


8/24/2012 10:12:46 AM

HORSHOLM, Denmark, Aug. 22, 2012 /PRNewswire/ --

Highlights:

  • Veloxis development activities for LCP-Tacro are proceeding in line with expectations. Enrollment has been completed in the pivotal LCP-Tacro 3002 Phase III study in de novo kidney transplant patients. The LCP-Tacro 3002 study is designed to demonstrate non-inferiority versus standard therapy Prograf® and 543 patients have been randomized at approximately 90 clinical sites around the world. Results are expected mid-2013.
  • Veloxis STRATO Study of LCP-Tacro in Kidney Transplant Recipients Experiencing Tremors is progressing according to plan. The study is designed to explore whether a conversion of patients who have symptomatic tremor from treatment with standard immediate release twice-daily tacrolimus capsules to extended release once-daily LCP-Tacro tablets leads to a measurable improvement in tremor.
  • The Company has met with EMA representatives to discuss the MAA filing for LCP-Tacro and have agreed to defer filing to 2013.
  • Veloxis is announcing its intent to obtain further financing through a rights issue, anticipated to be launched in the fourth quarter of 2012, to raise gross proceeds of approximately DKK 425 million. The Company's two largest shareholders, Lundbeckfond Invest A/S and Novo A/S, have expressed their intention to support the financing. Based on the support expressed by the major shareholders the Company expects that the share price of the offering will be no less than DKK 0.35.
  • The Company intends in late August to call an EGM for September to approve the proposed financing. Detailed information to shareholders will be included in the notice convening the EGM in late August.
  • Veloxis reported a net loss of DKK 160.6 million for the first half of 2012 compared to a net loss of DKK 141.2 million for the same period in 2011. Veloxis announces revised outlook for 2012.
  • For the first half of 2012, Veloxis' research and development costs amounted to DKK 119.5 million compared to DKK 117.2 million during the same period in 2011.
  • On 30 June, 2012, Veloxis had cash and cash equivalents of DKK 152.7 million.

Outlook for 2012
Veloxis changes its 2012 outlook from previously announced DKK 220 - 250 to DKK 240 270 million in operating loss due to restructuring cost incurred in the second quarter of 2012. The Company's cash and cash equivalents position as at 31 December, 2012 is maintained as announced in the annual report for 2011, and is expected to be in the range of DKK 4080 million. The outlook is without giving the effect to the planned financing anticipated during the fourth quarter 2012.

Financial calendar for 2013

6 March, 2013:

Release of Annual Report 2012.

17 April, 2013:

Annual General Meeting.

15 May, 2013:

Interim Report for the 1st Quarter for the period 1 January to 31 March, 2013.

21 August, 2013:

Interim Report for the 2nd Quarter for the period 1 January to 30 June, 2013.

13 November, 2013:

Interim Report for the 3rd Quarter for the period 1 January to 30 September, 2013.

Conference call
A conference call will be held tomorrow, 23 August, 2012 at 8:00 AM CET (Denmark); 7:00 AM GMT (London).

To access the live conference call, please dial one of the following numbers:
+45 32 72 76 25 (Denmark)
+44 (0) 1452 555 566 (UK)
+1 631 510 7498 (USA)
Access code 21465742

Following the conference call, a recording will be available on the company's website http://www.veloxis.com.

This company announcement does not constitute an offer to sell or the solicitation of an offer to buy, any securities. No offer or sale of any securities will be made in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any securities to be offered have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "US Securities Act"), or any applicable securities laws of any state of the United States, and may not be offered or sold in the United States absent such registration or an applicable exemption from such registration requirements. If the proposed rights issue is consummated, any preemptive rights and/or offer shares will be offered in the United States solely to Qualified Institutional Buyers in reliance on Rule 144A under the US Securities Act, and outside the United States in offshore transactions in reliance on Regulation S under the US Securities Act.

Research & development update
LCP-Tacro in kidney transplant patients
Veloxis has completed one Phase III study and has commenced a second Phase III study of LCP-Tacro in kidney transplant recipients as the basis for its development programme for LCP-Tacro as a once-daily agent for the prophylaxis of organ rejection in kidney transplantation. The first of these studies, the 3001 Study was a non-inferiority study performed in 326 stable kidney transplant recipients, and was successfully completed in 2011, meeting its primary efficacy and safety endpoints when compared to Prograf® (tacrolimus, Astellas Pharma Inc.). The second study, Study 3002 is being undertaken in de novo kidney transplant recipients. This study is a randomized, double-blind, multicenter study that compares once-daily LCP-Tacro against twice-daily Prograf® in de novo adult kidney transplant patients. The primary endpoint of the study, a composite endpoint (biopsy proven acute rejection, graft failure, loss to follow up or death), will be evaluated after a 12-month treatment period to demonstrate the non-inferiority of LCP-Tacro compared to Prograf®. Secondary endpoints will include safety, tolerability and renal function assessments. The study completed enrollment in March 2012 of 543 subjects at approximately 90 transplant centers, primarily in the U.S and Europe. Results from this study are expected mid-2013. Patients will participate in a 12-month extension period on treatment for follow-up safety assessments.

In addition to the pivotal Phase III studies, Veloxis is planning a series of Phase IIIb/IV studies to further evaluate potential differences in clinical profile provided by LCP-Tacro's unique PK profile. The first study initiated is the STRATO (Switching kidney TRAnsplant patients with Tremor to LCP-tacrO) study of LCP-Tacro in kidney transplant recipients experiencing drug-induced tremors. The STRATO study is designed to explore whether a conversion of patients who have symptomatic tremor from treatment with standard immediate release twice-daily tacrolimus capsules to extended release once-daily LCP-Tacro tablets leads to a measurable improvement in tremor.

LCP-Tacro Regulatory Strategy
The Company has met with EMA (European Medicines Agency) representatives to discuss the MAA (Marketing Authorization Application) filing for LCP-Tacro for the prophylaxis of organ rejection and based on these discussions the company has decided to defer filing to 2013. The revised timing will enable the Company to submit requested manufacturing data to the EMA in the initial MAA. These data have now been generated. The Company will seek EMA rapporteur advice to discuss the optimal timing for regulatory submission including consideration of timing the MAA submission relative to the availability of the 3002 de novo study data. The U.S. submission to the FDA (Food and Drug Administration) is planned for the second half of 2013.

Financing
The Board of Directors intends to proceed with an equity financing to support the Company through LCP-Tacro regulatory submissions, the estimated one-year regulatory review periods, and initial product launch in the US. In this regard, the Company will propose raising gross proceeds of approximately DKK 425 million through a rights issue. Lundbeckfond Invest A/S and Novo A/S, the Company's two largest shareholders have each expressed their intent to subscribe for their pro-rata amount of the financing and, beyond this, have expressed their intention to subscribe any unsubscribed portion. The two major shareholders have indicated that they will support a share price which is no less than DKK 0.35 for the rights offering. The Company will in late August call an EGM for September and request authorization to issue up to approximately 1,350,000,000 new Company shares, at the discretion of the Board.



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