International Biotechnology Trust (IBT) 22 sept 2003 Page 13
products but with a more favourable side effect profile. Indevus licensed the US rights to
Trospium from Madaus who market the product in Europe. Trospium was filed for approval in
the US in April 2003 and the search for a marketing partner is underway.
Progenics Pharmaceuticals (£0.4m investment)
Progenics is a US-based company. Its most advanced product candidate is
methylnaltrexone, a compound in Phase III trials designed to reduce the side effects of
currently marketed opioids used for pain relief. Progenics is developing the compound in
three parallel clinical programs. A Phase III trial is underway for opioid-induced bowel
dysfunction in advanced medical illness, a Phase II trial has started in post-surgical
constipation and finally a Phase I study in patients taking opioids chronically is planned for
later this year. The compound is currently unpartnered.
The final three new investments were discussed in detail in the 2003 Interim Report.
Galen Holdings (£0.5m investment)
Galen is a speciality pharmaceutical company focused on women's health, dermatology and
urology. During the year under review, the company significantly broadened its product
portfolio. Galen strengthened its position in the dermatology market through a co-promotion
agreement with Bristol-Myers Squibb and development agreement with Leo Pharma in the
area of psoriasis. In June 2003, Galen's Femring was launched in the USA. Femring is the
first vaginal estrogen product indicated to treat both the hot flushes and vaginal symptoms
associated with menopause. Galen also bolstered its position in women's health through the
acquisition of the rights to three marketed products from Pfizer.
Inspire Therapeutics (£0.3m investment)
Inspire's lead drug candidate, diquafasol, is for the treatment of dry eye, and was filed for
approval in the USA in mid 2003. In May 2003, Inspire announced data from a PIII trial for
allergic rhinitis, which did not meet its primary endpoint. Although this was a large potential
market, the dry eye compound and potential size of the dry eye market mean that this
remains an interesting investment.
XOMA (£1.0m investment)
XOMA's lead drug candidate is Raptiva, an antibody for moderate to severe psoriasis
partnered with Genentech in the US, and Serono in Europe. Raptiva has been filed for
approval in both areas and an FDA Advisory panel in September 2003 unanimously
recommended its approval. Although the FDA is not bound by the recommendation of its
advisory committees it generally follows their advice.
A further £0.4m was invested in Adolor (total investment £0.8m) and a net investment of
£0.4m was made in Esperion Therapeutics (total investment £0.5m).
Adolor's lead compound, Alvimopan is in Phase III clinical trials for post-surgical constipation
resulting from the use of opioids for pain relief. Data from the first of these three trials was
reported in April 2003 and was mixed the primary endpoint of recovery of gastrointestinal
function was met in one of the dosage groups but the time to hospital discharge did not show
as much of a reduction as anticipated. Data from the other two trials is expected later this
year or early next and should allow a better evaluation of the clinical profile of the compound.
The positive initial Phase II data announced by Esperion has been described and more
details are expected in the coming months. The company's pipeline continues to progress
with two product candidates in Phase II, and another two in Phase I. However, the
inadvertent acquisition by a shareholder of a third of the company has resulted in an
overhang of stock in the market which will need to be carefully managed.
The holdings in Arqule, Aspect Medical, Corvas International, 3 Dimensional
Pharmaceuticals and Weston Medical were sold in their entirety.
