UK-based speciality pharmaceutical group BTG saw its purchase of Protherics pay off in a strong set of six-month results that showed swelling sales and gross profit despite a backdrop of difficult economic conditions.

In the first full set of six-month results following its £218-million merger with Protherics last year BTG saw its total revenues rocket nearly 60% to £47.9 million, as figures were bolstered by the addition of new product sales totalling £16.1 million from Protherics’ rattlesnake antivenom CroFab (crotalidae polyvalent immune fab) and toxicity drug DigiFab (digoxin immune fab).

This sales increase helped boost gross profit growth to £32.3 million from £18.1 million for the first half of last year, although a massive 216% hike in operating expenses to £23.4 million and an 84% increase in R&D spend dragged on overall results.

Before acquisition adjustments and reorganisation costs (but including foreign exchange losses), BTG swung into the red with an operating loss of £1.2 million compared to profit of £4.1 million for the like, year-earlier period, and including these adjustments operating loss came in at £5.9 million.

Louise Makin, BTG’s chief executive, said the group had put in a “robust” financial performance in the first half of the year, adding that she was “delighted” at the speed at which Protherics has been integrated into the business and the progress the group has made in becoming a “self-sustaining specialty pharmaceuticals business”.

However, shares in the group took a downturn following the results release on shareholder concern over manufacturing issues with CroFab and DigiFab across the Atlantic, which took a bite out of the products’ usual sales, although BTG insists that it has resolved all issues with a third-party supplier and so expects to recover these shortfalls in the second half of the year.

Positive outlook
Looking forward, the company is now preparing to market CroFab and DigiFab itself in the US from October next year, following the end of a distribution arrangement with Nycomend, and says plans to establish a US sales force and associated commercial functions are “at an advanced stage”.

Things are also going well on the development side, with BTG now showcasing six active programmes in its internal development pipleline: varicose vein therapy Varisolve, which is on the verge of starting US Phase III trials; Voraxaze (glucarpidase), which continues to advance through a rolling Biologics Licence Application in the US for methotrexate-related toxicity; OncoGel (sustained-release paclitaxel), for which patient recruitment into a Phase IIb study in oesophageal cancer is progressing; Pleneva (BGC20-0134), due to be tested in a Phase IIa trial in multiple sclerosis shortly; BGC20-1531, which is nearing a planned Phase IIa study in migraine patients; and the novel adjuvant CoVaccine, a Phase I dose-ranging study of which is anticipated to finish in the first half of 2010, with a new Phase IIa study of the Angiotensin Therapeutic Vaccine planned for the second half.