UK company SkyePharma, which generates revenues through the development of novel formulations of established drugs, is expecting to achieve turnover of £100 million (€139m) in 2003, which would represent a rise of around 40 per cent over last year. However, the company has warned that the lion's share of this total would come in the second half of the year, and that it may post a loss in the first half.
SkyePharma's drug delivery technologies have attracted a number of major pharmaceutical players, including GlaxoSmithKline, the largest European drugmaker. GSK contracted the firm to develop a once-daily formulation of its blockbuster antidepressant paroxetine (Paxil CR), using its Geomatrix technology, which was launched in April 2002. However, the bulk of the firm's revenues have to date come from milestone payments, and SkyePharma feels it is now in a position to improve the quality of its earnings by bringing in more from royalties, according to chief executive Michael Ashton.
He told the Friedman Billings Ramsey 7th Annual Technology and Growth Investor Conference in New York, USA, that Paxil CR will be a significant contributor to this, with sales tipped to reach $1 billion; SkyePharma will receive a low single-digit royalty on its turnover.
Other marketed products that will play a role include Solaraze (hyaluronic acid and diclofenac) for actinic keratosis (partnered with Quintiles), the benign prostatic hyperplasia drug Xatral OD (alfuzosin; with Sanofi-Synthelabo) and DepoCyt (cytarabine) for lymphomatous meningitis (with Enzon, Elan and Nippon Shinyaku).
By 2005, analysts expect royalties to represent about half of SkyePharma's revenues, compared with 10 per cent in 2002, according to comments made at the firm's 28 May annual general meeting by chairman Ian Gowrie-Smith.
Commenting on Skyepharma's R&D pipeline, Ashton said the dry powder inhaler formulation of the asthma drug Foradil (formoterol) should reach the market in 2004, after the company's partner Novartis filed for approval for the drug in the US and Europe in December. The product makes use of SkyePharma's proprietary Certihaler technology.
The post-surgery pain relief drug DepoMorphine, Skyepharma's most important product in development (as it will receive a 20 to 60 per cent share of revenues), is due to be submitted for approval in the USA in June, and in Europe in September. Market approvals of the product, which is based on SkyePharma's DepoFoam technology, are expected next year.
Ashton also said that Propofol IDD-D, an improved formulation of the widely-used sedative/anaesthetic propofol, has completed Phase II testing and is expected to enter Phase III clinical trials in the second half of this year, with marketing applications to be filed by the end of 2004.
Results from clinical trials of DepoMorphine and Propofol IDD-D will be disclosed at the company's R&D Day for analysts on 11 June.