Clenil

Bramitob

Brexin

It is an HFA extra-fine solution formulation, delivered via a pressurised metered dose inhaler (pMDI). The combination is formulated using Modulite technology, adopts an HFA propellant, and is characterised by a simple, flexible dose regime: one or two puffs twice daily. Foster's unique feature is its extra-fine formulation, which guarantees high lung deposition and uniform drug distribution throughout the bronchial tree. The rationale behind the development of such a formulation with small particle size for both components relies on evidence that inflammation affects all parts of the airways in asthma, including the periphery. Therefore, the ideal drug delivery has to be targeted to central and peripheral airways.

Clinical studies have demonstrated Foster to be effective in improving lung function, clinical symptoms and asthma exacerbation in patients with moderate to severe asthma. In all studies, Foster showed a favourable safety profile in terms of adverse events and effects on cortisol plasma levels. Foster was launched in Germany in October 2006, by which time it had already been approved in fifteen European countries. A second wave Mutual recognition procedure was achieved in the first quarter 2008.

To date, Foster is marketed in Italy, France, United Kingdom, the Netherlands, Slovenia, Slovakia Hungary and Spain. More launches in other European countries are planned for 2008. Research into additional indications, such as COPD, and therapeutic use in adolescent and paediatric populations is currently ongoing.

Indicated for the treatment of asthma, Clenil is available in various formulations (PMDI, DPI and solution for nebulisation in UDV). The pMDI formulation adopts the Chiesi patented Modulite technology enabling Clenil to achieve significant results in European countries like the United Kingdom, with consistently increasing sales and market share during its first full year on the market.

Clenil (especially in the UDV formulation) performed well beyond expectations especially in Italy, where it generates most of its worldwide revenues. Clenil is still one of our most important assets to date, thanks to its remarkable therapeutic properties.

Considered the best overall LABA on the market, due to its remarkably fast onset of action associated with long duration (up to 12 hours), Atimos guarantees optimal lung deposition even in the peripheral airways with its unusually extra fine particle size, thus enabling the disease to be uniformly treated.

As a result, Atimos has a superior bronchodilating effect and is as effective as other formoterols in DPI formulation. Moreover, it is also safe and well-tolerated compared to other pMDI and DPI formoterol formulations. Licensing our technology to Novartis further underlines its efficacy.

The product is currently marketed in all of the major European countries, where it performed positively in 2007 on a Chiesi group basis.

Bramitob comes in single-dose vials containing 300mg of tobramycin (75 mg/4 ml), to be administered twice daily to patients on a 28 days off cycle regime.

Tobramycin solution administered by nebulisation has been investigated in several clinical trials, including large, multinational, double-blind, placebo controlled studies. It has been demonstrated to be effective in improving pulmonary function, reducing hospital stays and the need for intravenous antibiotics in CF patiens.

Bramitob represents Chiesi's first product in the Cystic Fibrosis area. It has been registered and marketed in Italy since 2006, and as of February 2008 has been available in Germany, Spain, Holland, Greece, Austria, the Czech Republic, Slovakia, Hungary, Poland and Portugal. Moreover, Bramitob is under registration in the UK, Ireland, Switzerland, Russia, Turkey, Croatia, Serbia, Bosnia, and Montenegro.

Clipper is available in gastro-resistant, prolonged release tablets containing 5 mg of beclometasone dipropionate (BDP).

Its unique drug delivery system ensures targeted delivery of the active ingredient (BDP) at the mucosa of the distal ileum and proximal colon, where the inflammatory process occurs, thus exerting local anti-inflammatory activity whilst minimising the systemic side effects of oral corticosteroids. It represents the first oral targeted release corticosteroid indicated for the treatment of Ulcerative Colitis. Clipper is currently registered and marketed in Italy, Belgium, Spain and the UK.

Piroxicam betadex (PBC) is mainly indicated for the treatment of painful conditions and inflammation in patients suffering from rheumatic diseases such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. After 18 years of success since its launch, PBC is marketed in 45 countries in Europe, South America, Asia and Africa.

Because of its vasodilating action, manidipine effectively decreases both systolic and diastolic blood pressure. In addition, manidipine, unlike other conventional calcium antagonists, exerts characteristic effects aimed at both reducing the overall cardiovascular risk and improving the quality of life of the hypertensive patient. In fact, manidipine can be distinguished 1) by improved renal protection, due to a more balanced dilation of afferent and efferent glomerular arterioles resulting in a more effective reduction of microalbuminuria and proteinuria; 2) by a superior metabolic profile, enhancing insulin sensitivity and adiponectin secretion; 3) by a lack of reflex sympathetic activation contributing to the improved tolerability of the compound because of a lower incidence of ankle oedema. Today, manidipine is commercialized under various brand names in the following countries: Italy, France, Tunisia, and Morocco - Iperten; Brazil - Manivasc; Greece and Germany - Manyper; Spain - Artedil.