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Meda’s development function responsibilities are development, clinical trial programs, and drug registration; about 100 people work in drug development and clinical trial programs functions, and just over 100 work with the drug registration function.

As a specialty pharma company, Meda refrains from capital-intensive, risky early research. Resources are instead focused on development in the late clinical and registration phases, with efforts often based on known drug substances.

Using these substances, product characteristics are improved—for example, through a new method of drug delivery. Combined products based on well-established drug substances and new indications for existing drugs are other key components of Meda’s drug development.

Read more about Meda’s products in development below.

About Meda's products in development

Meda invested about SEK 346 million* (2.6% of sales) in drug development in 2009.

In recent years, Meda has built a strong pipeline of products in the late clinical phase for its key therapy areas. Meda’s most important development projects are presented below.

Respiratory

Meda has an active development strategy that includes new products and product life-cycle management, with the aim of maintaining and developing its solid position in the respiratory area. Consequently, Meda is developing several possible life-cycle initiatives based on azelastine: Astepro, Astepro oncedaily, and a new product combining azelastine and fluticasone (a steroid). Other products for the treatment of respiratory diseases are a combination product (fluticasone + salmeterol) for use with the Novolizer system, OX-NLA, and dexpirronium.

Astepro

Astepro contains azelastine, an active ingredient, and is a nasal spray approved for treatment of seasonal allergies. Following FDA approval, launch in the US market began in Q1 2009. Registration work is in progress in other key markets.

Astepro once-daily

Astepro once-daily is the first approved once-daily nasal antihistamine for patients with seasonal allergies. The launch of Astepro once-daily began in the US in October 2009. Registration work is in progress in other key markets.

New combines azelastine-fluticasone product

Meda is developing a new combined product that contains azelastine and fluticasone (a steroid) for patients with allergic rhinitis. Azelastine is an antihistamine and fluticasone a corticosteroid; both are indicated for nasal treatment of allergic rhinitis. As mono-substances, both are market leaders in the US on the antihistamine and corticosteroid markets, respectively.

This combination product may give patients with allergic rhinitis more effective treatment than current therapies.

The product is currently in phase III. The remaining clinical studies are expected to be completed in H2 2010.

Combination product in the Novolizer system

A combination product of salmeterol and fluticasone administered with the Novolizer device. Fluticasone is a corticosteroid that reduces swelling and irritation (inflammation) in the lungs. Salmeterol is a longacting bronchodilator that eases breathing. Meda already markets several Novolizer products: Novopulmon (budesonide), Formatris (formoterol), and Ventilastin (salbutamol).

Expanded market territory for the Novolizer system

Meda is working to gradually expand the market territory of the Novolizer system by registering its Novopulmon, Formatris, and Ventilastin products. Meda considers the US to be a key future market for the Novolizer system.

OX-NLA

OX-NLA is a patented nasal formulation that contains cetirizine (antihistamine). The liposomes in OXNLA give the product unique characteristics. OX-NLA is documented for treatment of allergic and non-allergic rhinitis.

Dexpirronium - A new substance for treatment of COPD

Dexpirronium is intended for treatment of chronic obstructive pulmonary disease (COPD), a common disease that inhibits respiratory tract air flow. Dexpirronium is an anti-cholergenic ingredient that expands airways. Meda has a portfolio of patents and patent applications that cover use of dexpirronium for COPD. The project is in phase I.

Pain and inflammation

Meda is working actively to develop new products for indications in the pain and inflammation therapy area. The FDA approved Onsolis in 2009, and registration in other key markets continues. Axorid (a combination ketoprofen and omeprazole product) is in the registration phase in several key markets. In addition, development continues on Onsolis for expanded indications and on new products based on Flupirtine’s characteristics.

Onsolis - New pain product

Onsolis is a patented pain product that consists of a thin, soluble disc that adheres to the inside of the cheek. The unique product contains fentanyl, and is an important step toward better treatment of severe bouts of breakthrough pain in seriously ill cancer patients. The FDA approved Onsolis in 2009, and the product is in registration in several other key markets.

Onsolis - Expanded indications

Meda is planning on expanding Onsolis’s indication for use outside the cancer area. Clinical trials are planned to support treatment of severe bouts of pain among patients who suffer from chronic pain, such as back pain, arthritis (joint inflammation), and neuropathic pain.

Ketoprofen-omeprazole - New combination drug

Ketoprofen is an NSAID for treating rheumatic diseases, and omeprazole is a proton pump inhibitor that reduces gastric acid. Both substances are widely known and used. The proprietary product uses a capsule formulation for ketoprofen (sustained-release granulate) and omeprazole (enteric-coated granulate). Registration applications were submitted in several European countries and approvals were granted in countries such as the UK, Italy, Spain, Portugal, and Poland.

Flupirtine - Development of new products

Flupirtine (back pain treatment) is currently sold in a few European markets. Besides pain relief, flupirtine Drug development | 2009 annual report also has neuroprotective properties. Meda is now developing new products for other indications based on flupirtine’s properties. Flupirtine belongs to a special class of pain-relieving drugs with unique mechanisms of action.

Dermatology

In the key dermatology therapy area, Meda is working on new formulations for Aldara, a product based on the active ingredient imiquimod. Meda is also developing a new product based on sotirimod—a follow-up substance to imiquimod.

Aldara - Development of new formulations

Meda has a portfolio of patents that include new formulations for imiquimod (the active ingredient in Aldara). New products and uses based on imiquimod are in development.

Sotirimod - Follow-up to Aldara

Sotirimod is intended for treatment of conditions such as actinic keratosis and is a follow-up to Aldara (active ingredient imiquimod). Sotirimod and imiquimod are immuno-modulating agents that activate the body’s own immune defenses through the skin and help counteract skin changes such as actinic keratosis. Sotirimod is a proprietary substance in a late phase of clinical development. Sotirimod is more potent than imiquimod, and human trials have shown that it is a more effective in treating actinic keratosis than Aldara. The product is currently in phase III.

Clindamycin-tretinoin combination product

A proprietary combination of active ingredients clindamycin and tretinoin for the treatment of acne is in the registration phase.

CNS

Retigabine

In October 2009 Meda’s partner for Retigabine, Valeant Pharmaceuticals, submitted a new drug application and marketing authorization application for Retigabine to the FDA and EMEA, respectively. The applications were accepted for further review.

Retigabine is a new way of affecting potassium channels in the central nervous system. Retigabine has been documented for the treatment of epilepsy and has a different mechanism of action than current antiepileptic therapies. Its mechanism of action is based on affecting potassium channels in the central nervous system. GlaxoSmithKline, the pharmaceutical company, has a global collaboration agreement with Valeant Pharmaceuticals for Retigabine. Meda is entitled to substantial royalty payments on sales and milestone payments when certain milestones are achieved.

Edluar

Edluar contains zolpidem, a well-documented active ingredient that is one of the world’s most used drugs for treating sleep disorders. Edluar has a patented sublingual tablet formulation with clear patient advantages. The FDA approved Edluar in March 2009, and the registration process is underway in other key markets.

Oncology ceplene

Ceplene is indicated for remission maintenance therapy and prevention of relapse in adult patients with acute myeloid leukemia (AML). AML is one of four main types of leukemia. Each year about 16,000 new cases of AML are diagnosed in Europe. Most patients suffer from relapse after initial treatment. There is currently no alternative treatment, and the medical need is substantial. Ceplene is approved by the European Commission as an orphan drug, and registration in other key markets is underway. Ceplene is also being investigated for other indications such as myelodysplastic syndrome (MDS) and chronic myelogenous leukemia (CML).