REINACH and BASEL, Switzerland, July 19 /PRNewswire-FirstCall/ -- Arpida Ltd. today announced the acquisition of TLT Medical Ltd., a Swiss privately-owned biopharmaceutical company with an innovative onychomycosis (OM) therapy. European regulatory authorities have granted authorisation to initiate a pivotal Phase III clinical trial that aims to demonstrate superiority of the TLT therapy compared to the standard of care topical treatment for mild to moderate OM. Enrolment is expected to start in the short term and filing for approval could be expected in late 2008 or early 2009.
Onychomycosis is a fungal infection that affects the toenails or fingernails of an estimated 30 million people in the USA alone. The global market for OM is currently estimated at USD 2 billion and is expected to grow at double-digit rates over the coming years. Novartis Lamisil (terbinafine) is the current market leader with sales of USD 978 million in 2006.
The TLT therapy is targeted to treat fungal infections of the nails of fingers and toes and combines a novel formulation of terbinafine (the active ingredient of Lamisil, which has already been used in over 20 million patients) with an innovative, proprietary, local treatment. This targeted approach could consequently offer significant advantages by providing effective therapy while at the same time avoiding systemic exposure and bypassing the potential side effects of oral treatments. The technology is licensed from Novartis, based on an unencumbered, exclusive worldwide agreement.
Dr Andr Lamotte, Chairman of the Board of Directors of Arpida Ltd., commented The acquisition once more reiterates Arpidas focus on the discovery and development of novel pharmaceutical products for the treatment of microbial infections. This innovative therapy provides an attractive point of entry into the growing antifungal market and creates synergy with Arpidas existing knowledge-base.
Dr Alfredo Bruno, the inventor of the therapy and founder of TLT Medical Ltd., added: We are excited about the opportunity offered by teaming up with Arpida. We get access to a large pool of expertise and experience in antimicrobial research and development. This should enable us to drive the development of our OM therapy with increased vigour.
Dr Khalid Islam, president and CEO of Arpida Ltd., added: The founders of TLT Medical Ltd. have done a splendid job in getting this therapy to an advanced stage of development. Considering the low risk associated with this late stage product and the high potential in the onychomycosis treatment we believe that it will significantly enhance the Arpida pipeline and provide additional near term market opportunities. We are looking forward to working with the TLT team in accelerating their progress.
The transaction regarding the 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 to be issued out of authorised capital, with the remainder payable in cash. The closing of the agreement is expected to occur by mid-August. Arpida will finance the remainder of the TLT development expenses which are expected to total a single digit amount in CHF million.
Additional information on this topic can be found in the TLT factsheet which is added to this press release and is also available on www.arpida.com under Download centre.
Conference Call
Arpida will host a conference call to discuss this acquisition on 19 July 2007, at 2 pm CET.
The dial-in numbers are: +41-(0)91-610-56-00 (Europe) +44-(0)207-107-0611 (UK) +1-866-291-4166 (USA)
The conference call (Call ID 389, followed by the #) will be available for play-back for 48 hours after the call by dialling:
+41-(0)91-612-43-30 (Europe) +44-(0)207-108-6233 (UK) +1-866-416-2558 (USA) About Arpida Ltd.
Arpida is a biopharmaceutical company with research facilities near Basel, 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.
Arpidas leading product candidate is intravenous iclaprim, a broad-spectrum antibiotic that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The US Food and Drug Administration has granted fast track status to intravenous iclaprim. In July 2007, Arpida reported the completion of the Phase III programme in complicated skin and skin structure infections. An NDA filing is expected to take place in the second half of 2007.
In June 2007, Arpida announced that it has received approval from the US FDA to initiate Phase II trials with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP).
An oral formulation of iclaprim has successfully completed three Phase I trials: an ADME study (absorption, distribution, metabolism and excretion) with radiolabelled compound, a Phase I bioavailability trial with a solution and one with a capsule formulation. 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.
Arpidas fourth most advanced 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.
Moreover, the company has several other leads in optimisation and additional discovery programmes derived from its own discovery platform at various research stages.
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
Arpida contacts: Dr Khalid Islam, President and CEO Harry Welten, MBA, CFO and Senior Vice President Paul Verbraeken, Head of Corporate Communications Tel: +41-61-417-96-60 Tel: +41-61-417-96-65 Tel: +41-61-417-96-83
ArpidaCONTACT: Arpida contacts: Dr Khalid Islam, President and CEO, HarryWelten, MBA, CFO and Senior Vice President, Paul Verbraeken, Head ofCorporate Communications, Tel: +41-61-417-96-60, Tel: +41-61-417-96-65,Tel: +41-61-417-96-83
