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Sunny Skyes as injectables business falls to earth

By Anna Lewcock, 29-Mar-2007

Related topics: Materials & Formulation, Drug delivery systems

UK firm SkyePharma has announced that it has finally completed the sale of its deadweight injectable business, freeing up the company to focus on the development of products that the company believes could rival those of the pharma big guns.

The sale to financial investment group Blue Acquisition finally plugs the cash-drain that the injectables business was causing at the company - in the six months running up to June last year the company suffered an operating loss of £11.7m (€17.4m) through the division, with revenues of just £3.9m.

The company announced its intentions to shed the injectable business after a review at the beginning of 2006, and in January this year announced the potential buyer and a possible $82m (€63m) heading SkyePharma's way as a result of the deal.

The sale included all manufacturing, R&D and office facilities at the company's site in San Diego California, an area of around 100,000square feet. All manufacturing facilities comply with US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) regulations.

The completion of the sale this week was one of the final steps in a major restructuring of the company, a combination of placements, financial restructuring and the injectables divestiture. On top this, cross-border issues as a result of having to coordinate with US agencies further added to the already complex restructuring and dragged out the time taken to complete the injectables sale.

The original price-tag of $20m forecast in January was realised, and the company will also receive contingency milestone and sales-related payments. The company's promising DepoBupivacaine (bupivacaine) product, a long-acting injectable formulation of local anaesthetic for post-surgical pain which is ready to enter Phase III trials, will also pass over to the new owners.

"SkyePharma will receive a percentage and milestones on successful marketing of DepoBupivacaine," chief operating officer Ken Cunningham told In-PharmaTechnologist.com.

"So we still have a financial interest in the product and hope it does well."

With the deal now complete, SkyePharma is now free to focus on its oral and inhalation products, homing in its key asthma product that the company believes could have a significant impact on the market. The big prospect in the current pipeline is the inhalable asthma treatment, Flutiform (fluticasone/formoterol), which is currently in Phase III development.

The product is a fixed dose combination of a long-acting bronchodilator (formoterol) with the inhaled steroid fluticasone, supplied in the company's proprietary non-CFC metered dose aerosol inhaler equipped with a dose counter.

The company has high hopes for the therapy, which is due to be submitted for approval in the US later this year and in Europe during 2008, with the product due to enter the market in 2009.

In May 2006 SkyePharma licensed Flutiform to Kos Pharmaceuticals to market in the US, with an option on the Canadian market. However, six months later US pharma Abbott Laboratories announced its intentions to acquire Kos for $3.7bn, and thus became the new marketing partner for SkyePharma's Flutiform.

Although currently not a major player in the asthma market, Cunningham told In-PharmaTechnologist that Abbott is keen to break into the sector, and is confident that Abbott's support for the product could mean big things for SkyePharma.

"Flutiform is a very significant product for the company, even more so since the acquisition of Kos by Abbott last year," said Cunningham.

"We now have a company that can really go up against the likes of GSK in the $10bn asthma market."

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