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BTG reports robust trading postmerger

This article was originally published in Scrip

BTG expects its fiscal 2008 revenues to exceed those of 2007 and announced that the integration of its Protherics acquisition was proceeding to schedule.

It forecasts higher annualised sales revenues from its crotalid antivenom CroFab and DigiFab, a digoxin antidote, for the year ended March 31st, and greater recurring royalty revenues from licensed products. This includes the licensing of its anticancer BGC-945 to Onyx Pharmaceuticals (scripnews.com, November 11th, 2008).

As a result BTG expects to report cash of more than £70 million for its financial year ended March 31st. The company had almost £60 million in reserves at the end of September.

Operating and R&D expenses are expected to decrease, in line with previously announced plans to reduce the company's cash burn.

Shares in the UK's largest speciality company closed at 138.75 pence yesterday, having peaked at 141.50 pence at 10.30am, up from its opening price of 136 pence.

savings on track

BTG confirmed that it was on track to save £10 million per year by 2010-11. It is laying off 75 staff, reducing the total headcount by 20% to 290 employees, and is closing offices in London and Protherics' manufacturing facility in Salt lake City later this year.

CEO Dr Louise Makin said that half of the cuts were a result of the Salt Lake City facility closure. Most the restructuring associated with the merger was complete, she said, and the company was looking to create positions to build its US commercial operations.

The company will regain the US rights to CroFab and DigiFab from Nycomed next October and plans to expand its presence in the US speciality hospital business.

It reported £20.5 million in sales from these products for the year ended March 31st, 2008, and believes that these revenues will have more than doubled in the year just ended.

In addition, BTG has reorganised manufacturing facilities in Australia and Wales to improve operational efficiencies, it says.

portfolio review

The company has completed a review of the company's enlarged portfolio since the Protherics acquisition and has decided to continue developing Voraxaze (glucarpidase).

Although it has not been approved in any indication, Voraxaze is currently available in the US under a treatment protocol and cost recovery programme for patients receiving high-dose methotrexate and at risk of methotrexate toxicity.

BTG plans to market the product itself in the US if approved, which could be at the end of next year.

It plans to start a pivotal Phase III study for Varisolve (polidocanol microfoam) in the second half of this year and is in discussions with potential partners. The FDA confirmed that right-to-left cardiac shunts were no longer required in the study protocol, boosting the product's safety profile.

The company will complete ongoing trials of OncoGel, a sustained release formulation of paclitaxel, Prolarix (co-administered tretazicar prodrug and caricotamide enzyme co-substrate) and Acadra (acadesine), for B-cell chronic lymphocytic leukaemia, before seeking licensing partners.

It is planning Phase IIa trials for BGC20-1531 for migraine and BGC20-0134 for MS before seeking partners, but will discontinue development of BGC20-1259, a potential Alzheimer's disease treatment.

Dr Makin said that the company would continue to review its portfolio every six months or so and would consider licensing in more products.

There is speculation that AstraZeneca has given a grant to the Rhode Island Hospital to co-ordinate a second larger Phase II trial for CytoFab (TNF alpha Immune Fab (ovine)), for severe sepsis. However, this is still unclear until the release of the current Phase II trial data, which are expected in the mid-year, BTG said.

team changes

BTG has made several changes to its board and management team as it prepares to establish its US commercial operations.

It has appointed Matthew Gantz general manager US with overall responsibility for BTG's commercial operations there. Dr Guenter Janhofer becomes head of development and Dr Richard Mason head of business development. Dr Mason will be responsible for in- and out-licensing activities.

Christine Soden, BTG's chief financial and chief operating officer, is retiring and will leave BTG in June, and Willam James O'Shea becomes non-executive director from today.

* BTG's shares rose by 10% on April 1st to close at 136 pence following news that its co-development partner Genzyme will take responsibility for Campath (alemtuzumab) in MS (scripnews.com, April 1st, 2009).

Analysts at Piper Jaffray estimate that BTG will earn an 8% royalty on topline sales of Campath, around £6.9 million, for the financial year just ended.

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