REINACH, Switzerland, March 13 /PRNewswire-FirstCall/ -- Arpida Ltd announced today its financial results for the year ending 31 December 2007.
2007 highlights
Major pipeline progress:
- Second pivotal Phase III trial with intravenous iclaprim in cSSSI achieves its pre-specified primary endpoint, as did the first
- Submission of New Drug Application (NDA) for intravenous iclaprim in cSSSI initiated
- First patients enrolled in a Phase II trial with intravenous iclaprim in HAP/VAP/HCAP, an important potential second indication
- Late-stage antifungal therapy added to pipeline via acquisition of TLT Medical Ltd.
- Completion of patient enrolment in Phase II trial with oral iclaprim in cSSSI
- Completion of patient enrolment in Phase II trial with intravenous iclaprim in
HAP/VAP/HCAP
- Completion of patient enrolment in Phase III trial with TLT in onychomycosis
- Regulatory review of NDA for intravenous iclaprim in cSSSI in USA
- Submission of application for marketing authorisation in EU
Dr Khalid Islam, President and CEO, commented: “We’re tremendously proud of the progress we’ve achieved in the year under review. By early 2008, we have one product candidate in an NDA filing process, one product in a Phase III, and two additional Phase II development programs. We are expecting the filing of the NDA for intravenous iclaprim in cSSSI to be completed shortly. Marketing approval in the U.S. could potentially be forthcoming around the end of this year. In addition, we are expecting exciting developments in other areas during the course of the 2008. I would like to thank all those who contributed to our achievements and hope we can continue to count on your support as we enter this pivotal period.”
CFO Harry Welten, MBA, added: “In 2007, we maintained a tight financial control and spent CHF 57.1 million on operating activities, or CHF 4.8 million on average per month. We’ve ended the year with CHF 68.1 million worth of cash and financial investments. In 2008, spending on the large Phase III trials with intravenous iclaprim in cSSSI will not recur as this programme has been completed successfully. On the other hand, costs for the other clinical programmes as well as pre-marketing are set to increase. On balance, we’re forecasting that spending on operating activities will be around CHF 4.5 million on average per month in 2008. We’ll be providing an updated guidance when we publish the half-year results in August.”
Results
In 2007, revenues of CHF 0.2 million (2006: CHF 0.3 million) were generated, related to contract research carried out for third parties.
Research and development expenses amounted to CHF 45.0 million in 2007 (2006: CHF 57.4 million, excluding non-cash impairment charges of CHF 7.3 million). The main impacting factors were spending associated with Phase III clinical trials with intravenous iclaprim in complicated skin and skin structure infections, costs associated with pre-marketing activities for iclaprim as well as spending for research and development staff.
Management and general expenses were CHF 15.4 million in 2007 (2006: CHF 9.2 million). The increase relative to 2006 stems primarily from higher charges associated with the expense for stock options, higher costs for the premises in Reinach and increased IT spending.
Total operating expenses were CHF 60.4 million in 2007 (2006: CHF 73.9 million). Of these expenses CHF 5.2 million relate to IFRS 2 non-cash charges for options accounting whereas this charge was CHF 1.9 million in 2006.
Financial income rose from CHF 1.4 million in 2006 to CHF 2.0 million in 2007. This increase is mainly due to higher levels of cash invested. Financial expenses increased to CHF 0.7 million, mainly due to currency translation differences. On balance, the net financial result amounts to CHF 1.3 million (2006: CHF 1.1 million).
Balance sheet and cash flow
Cash and financial investments stood at CHF 68.1 million as per 31 December 2007, compared with CHF 72.8 million at year-end 2006. The funds are held in current and money market accounts with leading banks. Cash used in operating activities amounted to
CHF 57.1 million (2006: CHF 52.6 million), while investing activities required CHF 1.0 million, compared with CHF 4.3 million in 2006. Financing activities amounted to CHF 52.9 million, reflecting the proceeds from the payment of the strike price by employees exercising their options (CHF 3.3 million) as well as from the share issue of March 2007. In this secondary placing, 1.7 million registered common shares from authorised capital were sold to institutional investors via an accelerated bookbuilding transaction. The shares were placed at CHF 30.50 per share, resulting in net proceeds (after expenses and taxes) of CHF 49.8 million.
In July 2007, Arpida announced the acquisition of TLT Medical Ltd. The transaction regarding TLT’s onychomycosis treatment comprises an upfront payment as well as success-dependent future payments to the former shareholders of TLT Medical Ltd. which could total up to CHF 57 million. Up to CHF 5 million will be paid in Arpida shares with the remainder payable in cash. Some 40% of the share-based payment has taken place in 2007.
Pipeline Development
Arpida made significant progress in developing its portfolio of candidate products during 2007.
Intravenous iclaprim in cSSSI - NDA filing initiated
In March 2007, patient enrolment in ASSIST-2, the second pivotal Phase III trial with iclaprim in complicated skin and skin structure (cSSSI) was completed. Top-line results were published on 15 July 2007. These showed that the pre-specified primary endpoint of the second trial was achieved, as it was in the first.
After completion of the clinical programme, the next step is the filing of a New Drug Application (NDA) for intravenous iclaprim in cSSSI. The NDA forms the basis for the U.S. Food and Drug Administration (FDA) for its evaluation of a drug candidate’s eligibility for marketing approval.
Arpida has agreed with the U.S. FDA to file the NDA in a rolling process. Using a ‘rolling NDA’ allows the different modules within the overall package to be filed individually. Arpida has further agreed to file the NDA in an electronic format. Both the rolling NDA and the electronic format could greatly facilitate the review process.
The rolling submission of the NDA package got underway in 2007 and is expected to be completed shortly.
Intravenous iclaprim - moves into Phase II in HAP/VAP/HCAP
In June 2007, the U.S. FDA granted authorisation to initiate a Phase II trial with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.
Patient recruitment has started and is expected to be completed in 2008.
Oral iclaprim - good progress in clinical programme
In December 2007, Arpida announced results of a Phase I study with oral iclaprim. The primary aim of the study was to assess the safety and tolerability of single ascending doses of an oral capsule formulation of iclaprim in healthy volunteers.
Early in 2008, Arpida announced that it had received authorisation from the U.S. FDA to conduct a Phase II ‘intravenous-to-oral’ switch trial with iclaprim in patients with cSSSI. Patient enrolment is expected to start in the short term and complete by the end of 2008. In parallel, Phase I studies are ongoing, investigating the safety and tolerability of multiple administration of supra-therapeutic doses of oral iclaprim as well as slow-release administration at supra-therapeutic doses.
TLT - moves into Phase III
The TLT (Transungual Laser Therapy) proprietary technology was developed at Novartis Pharma AG by the founder of TLT Medical Ltd., Dr Alfredo E. Bruno. After signing an exclusive worldwide license agreement with Novartis, the company was spun-off in June 2004. Subsequently, TLT Medical Ltd. further developed the innovative therapy, initially aimed at combating onychomycosis. In July 2007, Arpida announced the acquisition of TLT Medical Ltd. The acquisition was finalised in August 2007.
Onychomycosis (OM) is a fungal infection affecting mainly toenails and, to a lesser extent, fingernails. It can cause pain, discomfort, and disfigurement and may produce serious physical and occupational limitations. It is one of the most common dermatological diseases, affecting an estimated 30 million people in the USA alone while prevalence is steadily increasing for various reasons, e.g. the aging of the population, diabetes etc.
The key potential benefits of the TLT treatment are:
- targeted topical therapy - avoids systemic exposure, bypassing potential side effects
- innovative laser pre-treatment - much better permeation through the nail plate than the traditional lacquers
- novel formulation exploiting a widely used antifungal active substance
European regulatory authorities have granted authorisation to initiate a pivotal Phase III clinical trial with the TLT therapy in mild to moderate OM. Approximately 220 patients in total will be enrolled in this study. A substantial number of patients had already expressed their interest to participate well in advance of the trial. Patient screening has been initiated and patient enrolment is expected to be completed in 2008.
AR-709 - promising results of “first-in-man” studies
AR-709 originates from Arpida’s own drug discovery efforts. It is a bactericidal antibiotic that is being developed for the treatment of upper and lower respiratory tract infections contracted in the community setting. The compound is a novel DHFR inhibitor with an outstanding microbiological activity against streptococci in general and, importantly, against multi-drug resistant Streptococcus pneumoniae, the most relevant pathogen in community-acquired pneumonia.
In March 2007, Arpida announced promising results of “first-in-man” studies with AR-709.
At the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), which took place in the USA in September 2007, Arpida presented five posters on AR-709. The posters contained preclinical data as well as the results of “first-in-man” studies.
Arpida is completing the appropriate studies in order to initiate tolerability studies in humans.
AR-2474 - positive preclinical results
AR-2474 originates from Arpida’s own drug discovery efforts. It is an antibiotic with a novel mechanism of action that has demonstrated, both in vitro and in vivo, to be highly effective in eradicating multi-drug resistant bacteria known to cause topical infections. AR-2474 has potential as a topical therapy for different applications, including infections of the skin and eye as well as nasal carriage of MRSA.
In March 2007, Arpida announced positive results of in vitro microbiological studies with AR-2474 against a large panel of clinical isolates, including those resistant to various current therapies. In addition, topical applications of AR-2474 were found to be highly effective in eradicating MRSA in preclinical models of skin infection and nasal carriage.
Arpida was invited to present preclinical data on AR-2474 at ICAAC. A total of eight posters on the compound were presented at the conference.
Additional preclinical studies are currently ongoing.
Early-stage research programmes
Arpida’s research efforts are focused on finding new chemical entities to address current and future needs. To this end Arpida employs an integrated, multidisciplinary discovery platform which includes a leading biostructural group.
Arpida has a number of programmes at earlier research stages. Efforts are focussed on a number of selected targets. Crystallisation and co-crystallisation of these target proteins and inhibitory molecules could open up new avenues for rational drug design. Increasingly, the focus moves towards Gram-negative pathogens and fungi.
The full press release, including financial tables, and the preliminary 2007 annual report (in English) are available from our website (http://www.arpida.com) starting 13 March 2008.
About Arpida Ltd.
Arpida is a biopharmaceutical company with research facilities in Reinach, Switzerland and in the USA. It focuses on the discovery and development of novel drugs that seek to overcome the growing problem of microbial resistance. The most advanced compounds include an antibacterial close to NDA-filing and an antifungal in Phase III.
Arpida’s leading product candidate is intravenous iclaprim, a potent late-stage antibiotic that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The clinical programme for the first indication, complicated skin and skin structure infections (cSSSI), has been completed. The NDA-filing process for intravenous iclaprim in this indication in the USA is ongoing and expected to be completed shortly.
In December 2007, Arpida announced the enrolment of the first patients in a Phase II clinical study with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP).
In January 2008, the US FDA granted authorisation to progress oral iclaprim into a Phase II ‘intravenous-to-oral’ switch trial. Iclaprim could be offered not only as an intravenous therapy for hospital use in acute situations, but also as an oral formulation, allowing early patient discharge followed by outpatient treatment. This switch should be a valuable instrument in reducing healthcare costs and enhancing patient comfort.
Arpida’s fourth most advanced antibiotic programme, AR-709, targets upper and lower respiratory tract infections acquired in the community setting. AR-709 exhibited potent activity against a large panel of pneumococcal clinical isolates including those resistant to currently used drugs. Promising results of “first-in-man” studies with AR-709 were published in March 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept. AR-2474 has been shown to be highly effective in eradicating pathogens in preclinical models of skin infection and nasal carriage.
Apart from the antibiotic programmes, Arpida has an innovative antifungal therapy (TLT) which is in Phase III clinical trials in Europe, targeting onychomycosis.
Moreover, the company has several other leads in optimisation and additional discovery programmes derived from its own discovery platform at various research stages.
CONTACT: Contacts: Arpida, Dr Khalid Islam, President and CEO, Tel:
+41-61-417-96-60; Harry Welten, MBA, CFO and Senior Vice President, Tel:
+41-61-417-96-65; Paul Verbraeken, Head of Corporate Communications, Tel:
+41-61-417-96-83
