Innovative products improving healthcare

Our objective is to help physicians improving the management of patient illness and quality of life, by providing innovative treatments. Chiesi’s expertise is concentrated in four corporate therapeutic areas: respiratory, cardiovascular, musculoskeletal/inflammation and neonatology.

The respiratory area represents the core business franchise, with a market value of 195 million Euros in 2005 (35% of total turnover). The main targets are asthma and chronic obstructive pulmonary disease (COPD), areas where Chiesi has developed extensive intellectual property and innovative technology to improve the management of patients with significant medical requirements.

Modulite®: Chiesi’s innovative technology for the treatment of Asthma & COPD

Modulite® is an excellent example of turning creativity into an innovative technology with a responsible approach to business, in terms of environmental impact.
Starting from the idea of reducing global pollution by liminating CFC propellants which cause damage to the ozone layer in the stratosphere, Chiesi developed Modulite®, a proprietary technology platform, which is based on the use of ozone-friendly HFA propellants to prepare pressurised metered dose inhalers. In addition to the environmental aspect, the Modulite® technology offers additional benefits for physicians and patients since it allows the preparation of solution formulations with key advantages of stability, uniform dose delivery, and flexibility in tailoring the particle size distribution of the cloud generated on actuation. Through this original technology, Chiesi has already achieved important results, since it has been able to reformulate a number of products which are a mainstay in the therapy of asthmatic and COPD patients.

Beclometasone dipropionate HFA, approved in most European countries is also marketed in France, Italy, Germany, the Czech Republic, and Russia.

When Budesonide HFA was first launched in Germany in 2003, it was directly responsible for the phase out of existing CFC budesonide products in that market. The product has been launched in Slovakia, Spain and Italy (licensed to Novartis). Additionally, a number of marketing authorizations have been obtained in other European countries.

Atimos®/Forair® (formoterol HFA), already marketed in Italy and Germany, was launched in the UK and will soon be available in other European countries. Chiesi has an international licensing and supply agreement with Novartis Pharma for this innovative product.

New products with Modulite® technology
Using its original Modulite® technology, Chiesi is developing other innovative products that may contribute to significant improvement in the management of Asthma and COPD patients. Among these, the most promising ones are the combination beetween formoterol/beclometasone dipropionate, using the ozone-friendly HFA propellants, on going to be launch in the most important European countries, and carmoterol, a new, potential once-daily long-acting beta-2 agonist, which is also being developed in combination with an inhaled corticosteroid.

Cardiovascular Area

The cardiovascular area is the second largest business area, accounting for 22% of Chiesi’s turnover in 2005. The company portfolio in this segment is focused currently on hypertension, with the international launch of manidipine and the preparation of the market introduction of further antihypertensive products.

Manidipine: the driver of the hypertension franchise
Manidipine, a third-generation calcium channel blocker first launched in Italy (Iperten®) and Brazil (Manivasc®), is currently Chiesi’s main antihypertensive drug.

After the successful market introduction of manidipine in Spain and Greece in 2003, the product was launched in France and Germany in 2004, in Tunisia in 2005, and will be marketed also in Morocco during 2006.

Chiesi’s product portfolio in hypertension will be broadened further in 2006 with the delivery to the market of an innovative fixed combination: manidipine plus delapril (Vivace®, Hipertil®) which will be launched in Brazil, Germany, and Italy.

The rationale behind this new treatment, with complementary mechanisms of action in a single pill, is to meet the therapeutic need for tight blood pressure control and the improvement of compliance over existing agents, especially in complicated patients who often require multiple medications for concomitant pathologic conditions.

Muscolo-skeletal/inflammation Area

The musculoskeletal/inflammation franchise represents an area of excellence for Chiesi, based on the continued international success of piroxicam beta-cyclodextrin (Brexin®, Brexidol®, Cycladol®). Sales in this category represented 10.4% of Chiesi’s total turnover in 2005.

Brexin®: a continued international success
Piroxicam beta-cyclodextrin (Brexin®, Brexidol®, Cycladol®) is one of the Company’s flagship products. This non-steroidal anti-inflammatory drug (NSAID) was developed by Chiesi, and is marketed in more than fifty countries.
Sales in 2005 reached the record value of 65 million Euros.

Neonatology Area

In the last year, Chiesi further consolidated its leading position in neonatology, in particular in the treatment of respiratory distress syndrome which affects predominantly premature infants. Curosurf®, a natural surfactant, which reached over 60 million Euros of global sales in 2005, is the market leader in Europe, with over 80% market share, and has a global market share of over 40%. We are continuously devoting great efforts in making this critical care product available for the largest number of babies in need around the world.

Curosurf®: a life-saving treatment for preterm babies
Curosurf® (poractant alpha) is a natural surfactant of porcine origin indicated in the treatment of Neonatal Respiratory Distress Syndrome which is one of the major causes of morbidity and mortality in premature infants. Curosurf® is Chiesi’s proprietary product developed in cooperation with the Karolinska Institutet of Stockholm, and it is available in over 50 countries, including most of Europe and the US. Approximately 600,000 babies have been treated to date with Curosurf®, confirming it as the gold standard surfactant for many medical specialists. Market share is 80% in Europe and over 40% worldwide.

Other areas of interest

Business interests also exist in other therapeutic areas, such as the central nervous system, nutrition, and orphan diseases, where Chiesi is particularly committed to the treatment of beta-thalassemia. In each therapeutic area Chiesi’s portfolio is supported by high value institutional relationships, through partnerships with leading academic centers and premier international scientific leaders.