Norsk Hydro, the largest Norwegian producer from that nation's rich North Sea
petroleum products, was among the first companies to recognize the pharmaceutical potential ofomega-3 fatty acids. Danish
researcher Jan Dyerberg isolated
dietary omega-3 fatty acids as the likely reason why Greenland eskimos had
low serum lipids and low coronary disease despite a high percentage of calories from seal blubber. Norsk Hydro was exploring
the potential of developing very concentrated omega-3 oils from fish wastes, and using that concentrate as a treatment for
hypertriglyceridemia.
Norsk Hydro developed what may be the most highly concentrated extract of the two essential
fatty acids, EPA and DHA. That 80%/20% EPA/DHA formulation enabled Norsk Hydro investigators to use EPA/DHA to treat hypertriglyceridemia
without the unwanted load of saturated fatty acids that comprise most over-the-counter omega-3 "fish oil" capsules.
It was at that point I met Jon Aulie of Norsk Hydro on a shuttle flight. Due
to ProClinica's extensive experience in both cardiology (nuclear stress testing, angioplasty, beta blockade) and intravenous
and infant nutrition, we had a lot of knowledge and contacts that would be useful to a company starting up a pharma operation.
One of the first efforts was a search for partners. Japan seemed a promising source,
because Mochida was already selling a prescription DHA concentrate for reductions of coronary risk. ProClinica arranged
for one of the Norsk Hydro chemical engineers to address a special meeting of the Japan Bioindustry Association, and then,
company meetings with several JBA members.
Norsk Hydro formed the wholly-owned subsidiary Pronova, which licensed three
Italian companies to assist in registering and marketing the company's 80%EPA/20% DHA formulation in that country.
However, the product was approved only for "C" reimbursement, which meant patients had to pay for it out of pocket -- not
a popular option in countries with national health plans. C reimbursement can imply the regulatory authorities don't regard
such products very highly. Pronova hired ProClinica to help its Italian partners change that.