Initially, BioClin started out providing bioanalytical support during preclinical and Phase I clinical development, including
both methodological development and analysis of pharmacokinetic data. "We have broadened that out to an integrated package
as well," Burke says. The company, which was profitable in its first year, now has a broad range of facilities for mass spectrometry,
chromatography, and immunochemistry. "We've invested back about €600,000 in upgrading our equipment," says Burke. BioClin
can offer trouble-shooting, and it is currently adding assay development services. Burke explains, "We're expanding into becoming
a broader contract development organization." That may involve an acquisition, she says, to enable the company to enter the
drug formulation area as well.
Ena Prosser, a former Elan executive, is now in the process of helping to create a dedicated biotech venture capital fund.
Colin Sainsbury, previously vice-president and general counsel at Elan, has set up a legal practice dedicated to life sciences
at BCM Hanby Wallace, one of Ireland's largest and best-known law firms. Sainsbury notes, "Working in Elan for 10 years enabled
me to gain huge experience in the legal and commercial aspects of the life sciences sector. It was also a great learning ground
for building and developing international long-term relationships, which are an imperative in the life sciences sector."
Elan's Drug Technologies division is performing very strongly, and its recently announced third-quarter revenue doubled for
2005 over 2004. The facility at Athlone has seen $178 million of investment in the past three years, including new sterile
fill–finish line and nanocrystal technology. Current employment levels are at approximately 540 onsite, including a large
team of scientists.
Elan's proprietary NanoCrystal technology is especially exciting. Elan is working with many pharmaceutical companies to help
them to manage their products' life cycles and also to reformulate products to deliver significant benefits to patients with
greatly increased bioavailability. As an example, Elan worked with Par Pharmaceutical Companies, Inc, to reformulate its Megace
product, which helps AIDS patients gain weight. Previously patients had to ingest 20 mL of a thick liquid, with food. Thanks
to Elan's NanoCrystal delivery system, Megace can now be taken on an empty stomach and is 16 times less viscous than it was
originally. In addition, patients need take only 5 mL instead of 20 mL.
To date, four pharmaceutical products have been commercialized that incorporate NanoCrystal technology. Several additional
NanoCrystal-related product launches are anticipated over the next two years. Elan is in negotiations with a number of additional
companies, and Elan scientists are investigating the NanoCrystal application across a large range of drugs.
Elan's Prialt (ziconotide intrathecal infusion) is the first innovation in the treatment of severe chronic pain in 25 years.
It was approved in the US in December 2004 and launched in the US in the first quarter of 2005. The drug was inspired by the
hunting ability of the tiny but deadly South Sea snail, conus magnus. The snail, though only inches long, uses its venom to paralyze its prey for hours, so it can feed at leisure. It was found
that one of the peptides in the snail's venom blocks N-type calcium channels and prevents pain signals from reaching the brain.
Elan has synthesized this peptide to produce Prialt, which as a non-opioid does not depress the respiratory system or result
in withdrawal effects. Reaction from physicians and patients using Prialt has been very positive.
Following the voluntary suspension of the multiple sclerosis medication Tysabri in February 2005 by Elan Pharmaceuticals and
Biogen Idec, the companies have completed a detailed safety evaluation and review. This investigation yielded no new confirmed
cases of progressive multifocal leukoencephalopathy. Among patients taking Tysabri, three cases had previously been identified,
of which, sadly, two were fatal. The companies have filed a supplemental biologic license application with the FDA and with
European authorities, and a decision on Tysabri's return to market will be made during 2006. Elan remains very confident about
the value of Tysabri, especially to patients with multiple sclerosis, which has a high unmet medical need.