Today, the biotech-vaccine company Intercell AG (VSE: ICLL) announced its financial results for Q1 and presented an update on the Company's development programs.
- EUR 4.8m revenues in Q1 2010 compared to EUR 5.4m in Q1 2009.
- IXIARO®/JESPECT® product sales in line with Q1 2009 reflecting low level of new product supplies in Q1 2010; new product supplies to marketing and distribution partners shifted from Q1 to Q2 2010 due to supply-planning and lot release timing.
- EUR 14.7m net loss for Q1 2010 compared to EUR 8.2m in Q1 2009.
- EUR 17.9m R&D expenses in Q1 2010 – up 19.1 percent compared to EUR 15.1m in Q1 2009 – mainly due to late-stage research and development costs for the TD vaccine patch.
- Strong cash position: EUR 158.2m in liquid funds at March 31, 2010.
A strong focus is given to the IXIARO®/JESPECT® vaccine business to grow sales in the traveler and military markets. After having received a broadened vaccination recommendation in the U.S. in 2009, the Joint Committee on Vaccination and Immunization (JCVI) in the UK has now also extended its Japanese Encephalitis immunization recommendation to include the Intercell vaccine. Additional recommendations are expected for other key countries in Europe. These recommendations are essential to continue advancing product awareness and market growth for the Intercell vaccine to prevent Japanese Encephalitis.
Product sales are expected to increase significantly in Q2 2010, supported by the upcoming travel season. Intercell had previously announced that new product supplies designated for marketing and distribution partners, shifted from Q1 to Q2 2010 due to supply-planning and lot release timing for European markets.
The development targeting the Asian endemic markets is progressing further. The Phase III start for the endemic Japanese Encephalitis vaccine produced by Intercell's partner Biological E. in India is expected to commence by the end of 2010 under a revised regulatory path to licensure by Indian authorities.
Good progress in development pipeline – clinical programs progressing according to plan
- In February 2010, Intercell announced results from a Phase I clinical trial for investigational Pneumococcus vaccine, demonstrating a good safety and immunogenicity profile.
- Next important data points expected from Phase II studies for investigational single-application Pandemic Influenza vaccine system in Q2 and for Pseudomonas vaccine in Q3 2010.
- The pivotal Phase III study for the investigational Traveler's Diarrhea (TD) Vaccine Patch is progressing – first data expected by the end of 2010 or beginning of 2011.
- Staphylococcus aureus vaccine (V710): Phase II/III study recruitment conducted by Merck & Co., Inc. in cardiothoracic surgery patients for the investigational S. aureus vaccine continues to progress, with the first critical interim analysis (surpassing futility) expected during the course of 2010.
- Tuberculosis vaccine: Phase I clinical programs are proceeding according to plan.
- Therapeutic vaccine candidate against Hepatitis C: Intercell anticipates that a partnership to conduct combination studies with its vaccine will be identified in 2010.
- Intercell has signed an agreement with Cytos Biotechnology Ltd. to acquire Cytos' platform technology for antibody discovery. The technology, which is based on human B-cells, enables the identification of anti-infective antibodies to prevent and treat infectious diseases. The Antibody Technology complements Intercell's existing technology platforms and opens novel medically and commercially relevant applications for Intercell's Antigen Identification Program (AIP®).
- Intercell and Boehringer Ingelheim Vetmedica entered into a worldwide Option and Exclusive License Agreement under which Boehringer Ingelheim Vetmedica has the right to use certain antigens derived from Intercell's Antigen Identification Program (AIP®) to develop animal vaccines.