News
Intercell AG announces Q1 2008 results and update on development programs
Vaccine against Japanese Encephalitis moving towards global market approvals: US FDA inspection currently ongoing, Australia grants priority review – All development programs on track
Intercell's investigational Japanese Encephalitis vaccine expected to obtain market approval in global traveler markets in 2008 – commercial production started
- Intercell’s manufacturing facility in Livingston receives Manufacturer's License from MHRA for future commercial manufacturing of the vaccine against Japanese Encephalitis
- Day-80 review from EMEA (European Medicines Agency) received
- FDA waives VRPAC (Vaccines and Related Biological Products Advisory Committee) – Pre-approval inspection of the facilities started on time and is currently ongoing
- Licensure application submitted to Australian Therapeutic Goods Administration (TGA) – TGA grants priority review for Intercell's vaccine candidate
- Licensure application for approval in Switzerland to Swissmedic submitted via Novartis
- EU, US and Australian market approvals expected in 2008
- Vaccine shows excellent safety and immunogenicity in Phase II trials in children at "half dose"
Significant progress in vaccines against hospital-acquired infections
- S. aureus: Phase II results for vaccine designed by Intercell expected for end 2008 / early 2009 (conducted by Merck & Co., Inc.)
- Pseudomonas: Start of clinical Phase II/III trials expected for 2008
- Pneumococcus: Outstanding pre-clinical results on novel protein-based universal vaccine published in the Journal of Experimental Medicine; initiation of Phase I trials is planned for later in 2008
- Acceleration of pre-clinical candidates for further nosocomial vaccine and antibody product targets including Klebsiella and Enterococcus
Unique clinical data for therapeutic Hepatitis C vaccine
- Therapeutic Hepatitis C vaccine candidate meets primary endpoints in Phase II trials - data from 46 vaccinated chronic patients reveal statistically significant viral load reduction and favorable safety profile
- Intercell and Novartis initiated co-development; further clinical trials will include IC31®
- Intercell was awarded "The Vaccine Industry Excellence Award" in the category of "Best New Therapeutic Vaccine" for its therapeutic Hepatitis C vaccine candidate at the "World Vaccine Congress" in Washington D.C.
Adjuvant IC31® – Phase I Influenza trials with IC31® successfully completed – Collaboration on Malaria – Tuberculosis cooperation expanded
- Influenza: Intercell's adjuvant IC31® demonstrates a very good safety and tolerability profile in first Phase I Influenza vaccine clinical trial
- Malaria: ICLL and PATH Malaria Vaccine Initiative (MVI) initiated a new collaboration to evaluate adjuvant IC31® in combination with malaria antigens from the US National Institutes of Health (NIH)
- Tuberculosis: TB vaccine formulated with adjuvant IC31® and developed in a partnership between Statens Serum Institut (SSI) and Sanofi Pasteur enters a series of further clinical trials
Strong financial and strategic position – Costs under control, fully on track for strong increase in revenues and sustained profitability for the full year 2008
- EUR 4.6 m net loss for Q1 2008 compared to EUR 7.1 m in Q1 2007, a reduction of 35.2 percent
- Increase in aggregate revenues – EUR 8.6 m in Q1 2008 compared to EUR 1.5 m in Q1 2007, an increase of 473.3 percent
- EUR 10.4 m R&D expenses in Q1 2008 – up 41.0 percent compared to EUR 7.4 m in Q1 2007 following progress of development programs as planned
- Strong strategic cash position: EUR 272.2 m in liquid funds at March 31, 2008. Further EUR 40 m already unconditionally committed for 2008.
- Intercell will finance the cash component of the acquisition of Iomai Corporation, which was announced today, comfortably from existing reserves. Despite higher costs through the acquisition, Intercell also expects to maintain its target of profitability in 2008.
Vienna (Austria), May 13, 2008 – Today, vaccine company Intercell AG (VSE: ICLL) announced its financial results for the first quarter of 2008 and presented an update on the Company's development programs.
Strategy for rapid market introduction of investigational Japanese Encephalitis vaccine fully on track
Further progress can be reported towards market approval of the prophylactic Japanese Encephalitis vaccine. The commercial production started successfully at Intercell's manufacturing site (Intercell Biomedical Ltd. Livingston, Scotland). In January, Intercell Biomedical Ltd. received a Manufacturer's License for the commercial manufacturing of the vaccine. The issuance of the license followed a GMP (Good Manufacturing Practice) inspection performed by the British Medicines and Healthcare products Regulatory Agency (MHRA).
In February 2008 the Licensure application for the investigational Japanese Encephalitis vaccine was successfully submitted to the Australian Therapeutic Goods Administration (TGA). TGA approved Intercell´s request for a priority review which implies a faster market approval in Australia. This also proves the need for a new safe vaccine, as the production of the old vaccine (JE-VAX®) was discontinued in 2007. The submission process in Australia was initiated by Intercell's partner CSL Biotherapies Pty Ltd. CSL Biotherapies Pty Ltd. has the exclusive rights for marketing and distribution of Intercell's novel cell culture-based Japanese Encephalitis vaccine in Australia, New Zealand, Papua New Guinea and Pacific Islands.
The Marketing Authorization Application (MAA) for Europe and the Biological License Application (BLA) to the US Food and Drug Administration (FDA), were submitted in December of 2007. Both were accepted in early 2008. Intercell recently received EMEA's Day-80 review, in which EMEA waived the requirement for a separate facility inspection. The FDA's pre-approval inspection started on time and is currently ongoing. Intercell has been informed that the FDA is waiving a VRPAC (Vaccines and Related Biological Products Advisory Committee) meeting.
All current news from the European, US and Australian authorities support Intercell’s plans to obtain all three approvals during 2008. Licensure application for approval in Switzerland to Swissmedic was submitted via Intercell's partner Novartis.
In April 2008, Intercell and its partner Biological E. Ltd. (Hyderabad, India) announced Phase II data for its investigational pediatric vaccine against Japanese Encephalitis. The vaccine shows excellent safety and immunogenicity in Phase II trials in children. In summary the data suggest that IC51 in young children (one to three years of age) has a comparable excellent immunogenicity and safety profile to those in adults even if only half of the adult dose is applied. This allows Intercell and its partner Biological E. to enter into late-stage development towards the licensure of the vaccine for the use in children in India and other parts of South East Asia. Start of Phase III clinical trials in India are planned for end 2008/early 2009.
Programs to develop vaccines against hospital-acquired infections all moving as planned
S. aureus vaccine – Phase II results and initiation of Phase III expected for end 2008/early 2009
In December of 2007 the vaccine, developed in a collaborative program with Merck & Co., Inc., entered clinical Phase II trials in the US. The S. aureus vaccine is based on an antigen discovered by Intercell and licensed to partner Merck & Co., Inc., on an exclusive worldwide basis. Recruitment of this global program is ongoing and ramping up as planned. Intercell expects Phase II results during the end of 2008/ early 2009.
Pseudomonas vaccine – Start of clinical Phase II/III trials expected for 2008
Preparations for the start of clinical Phase II/III trials of our Pseudomonas vaccine in 2008 are on track.
Pneumococcal vaccine - Results on a novel vaccine published in the JEM
In January 2008, Intercell's results on a novel pneumococcal protein-based universal vaccine were published in the renowned Journal of Experimental Medicine. In the article the Intercell research team reported the identification of novel Pneumococcus vaccine antigens.
The two lead antigens forming the basis of Intercell's subunit Pneumococcal vaccine were found to be exceptionally conserved among clinical isolates (>99.5% identity), cross-protective against different serotypes in lethal sepsis and pneumonia models, and to play important non-redundant roles in bacterial multiplication. The initiation of Phase I clinical trials is planned for later in 2008.
Pre-clinical candidates accelerated
Pre-clinical candidates for further nosocomial vaccines and antibody product targets including Klebsiella and Enterococcus are being accelerated.
Hepatitis C (HCV) vaccine – Intercell and Novartis initiate co-development including IC31®
In February 2008 Intercell announced the analysis of Phase II data for its peptide-based therapeutic Hepatitis C vaccine (IC41) in an exploratory clinical study targeting treatment-naïve Hepatitis C patients. The analysis revealed a statistically significant viral load reduction and a favorable safety profile, and confirms findings from the interim analysis conducted in Q3 2007. The data also showed that the primary endpoint set for this study, namely a HCV-RNA decline that was statistically significant and sustained, had been met.
The Phase II data opens the door for therapeutic vaccination in the arena of existing and future treatment options. Further clinical trials in co-development with Novartis will also take advantage of an enlarged antigen portfolio and of IC31®, Intercell's second-generation adjuvant.
In April 2008, during the course of the World Vaccine Congress in Washington D.C., USA, Intercell was awarded "The Vaccine Industry Excellence Award" in the category "Best New Therapeutic Vaccine" for its therapeutic Hepatitis C (HCV) vaccine candidate.
Exellent progress in clinical programs with IC31® adjuvant
Phase I Flu trials with IC31® successfully completed
In February 2008 Intercell announced the completion of Phase I clinical trials of the Company's adjuvant IC31® in combination with the seasonal, trivalent influenza vaccine Agrippal® from Novartis. The IC31® adjuvanted vaccine showed an excellent safety and tolerability profile, which was comparable to the non-adjuvanted standard vaccine. Furthermore, in all study groups vaccination with the test vaccine led to the induction of virus specific T-cells and protective levels of antibody responses against the three included influenza strains.
Novartis initiated further steps in the clinical development of a flu vaccine formulated with IC31®, which will entitle Intercell to receive further milestone payments during 2008. As part of the agreement between Novartis and Intercell, signed in July 2007, Novartis has an exclusive license for development of Intercell's IC31® adjuvant in novel Influenza vaccines.
New collaboration for a vaccine against Malaria
In January 2008 Intercell and the PATH Malaria Vaccine Initiative announced a new collaboration to evaluate Intercell's novel proprietary adjuvant IC31® in combination with recombinant Malaria antigens from the US National Institutes of Health (NIH). The work will be performed at Intercell and funded by PATH. The aim of these studies is to demonstrate whether or not IC31®, in combination with NIH's antigens, triggers an immune response when evaluated in animals. First results of the studies are expected by the end of 2008.
Vaccine formulated with IC31® part of a broader collaboration to fight Tuberculosis
A Tuberculosis vaccine, which is currently being tested in clinical trials and which contains antigens discovered by Statens Serum Institut (SSI) formulated with IC31®, will be further developed in a partnership between Sanofi Pasteur and SSI. SSI and Intercell will continue their collaboration in the field of Tuberculosis research and vaccine development with Intercell's proprietary adjuvant IC31®. The involvement of Sanofi Pasteur extends the activities into more advanced phases aiming to make a new Tuberculosis vaccine widely available in the shortest possible time. The collaboration with SSI and Aeras Global TB Vaccine Foundation, which led to the initiation of a Phase I clinical trial in December 2007, will continue. Together, each of these parties represents the greatest range of technology and expertise necessary to solve this complex global health problem.
Q1 2007 Financial Review
Revenues
Aggregate revenues increased from EUR 1.5 m in the three months ended March 31, 2007 to EUR 8.6 m in the three months ended March 31, 2008. This increase was mainly attributable to the recognition of deferred option fees under the strategic partnership agreement with Novartis. Grant income increased from EUR 0.9 m in Q1 2007 to EUR 2.2 m in Q1 2008, mainly due to the recognition of grant income from PATH and NIH.
Results of Operations
Intercell’s net loss decreased from EUR 7.1 m in Q1 2007 to EUR 4.6 m in Q1 2008, or by 34.5 percent. This decrease was primarily due to an increase in revenues, which was partly offset by a decrease in other income and an increase in research and development expenses.
Net operating expenses increased from EUR 9.0 m in Q1 2007 to EUR 13.4 m, or by 54.3 percent. Research and development expenses increased by 41.0 percent and were EUR 10.4 m in Q1 2008, compared to EUR 7.4 m in Q1 2007. Intercell’s general, selling and administrative expenses were EUR 3.2 m in Q1 2008, which was flat compared to Q1 2007.
Net other operating income in Q1 2007 was EUR 1.7 m which compares to net operating expenses of EUR 0.2 m in Q1 2008. This change was due to lower R&D tax credits and changes in foreign exchange rates.
Finance income increased from EUR 0.7 m in Q1 2007 to EUR 2.1 m in Q1 2008, due to higher interest income on liquid funds, which was partly offset by an increase in finance expenses of EUR 1.5 m in Q1 2008, compared to EUR 0.3 m in Q1 2007. The increase in finance expenses resulted principally from the realization of book losses on marketable securities in the Company’s securities portfolio.
Cash Flow
Intercell’s net cash used in operating activities was EUR 12.8 m in Q1 2008, compared to EUR 9.6 m in Q1 2007. This increase was primarily due to higher research and development expenses. Revenues were mainly non-cash, resulting from payments already received in prior accounting periods.
Net cash used in investing activities of EUR 121.6 m in Q1 2008 resulted primarily from investments in short-term, available-for-sale financial assets for cash management purposes and compares to EUR 1.3 m in net cash generated from investing activities in Q1 2007. Without giving effect to investments in, and proceeds from the sale of securities, and acquisitions, net cash used in investing activities in Q1 2007 and Q1 2008 was EUR 1.1 m and EUR 0.8 m, respectively.
Intercell’s net cash used in financing activities was EUR 0.1 m in Q1 2008, compared to EUR 0.5 m in Q1 2007 and resulted primarily from repayments of loans.
As of March 31, 2008 Intercell had liquid funds of EUR 272.2 m, of which EUR 26.6 m was cash and EUR 245.6 m was available-for-sale financial assets. An additional EUR 40 m payment has been unconditionally committed by Novartis for 2008.
Key Financial Figures | |||
TEUR | 3 months ended | Year ended | |
| March 31, 2008 | March 31, 2007 | Dec. 31, 2007 |
Revenues | 8,625 | 1,502 | 53,349 |
Net profit / (loss) | (4,617) | (7,050) | 5,009 |
Net operating cash flow | (12,808) | (9,635) | (41,686) |
Cash and available-for-sale financial assets | 272,223 | 86,262 | 287,571
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