LAST Monday Dr Jim Pickard, managing director of Controlled
Therapeutics (Scotland), received an important letter. From the
Department of Health's Medicines Control Agency, it offered the East
Kilbride company conditional approval to market its first product line.
The product is a polymer pessary designed to deliver precise amounts
of prostaglandin over an eight-hour period directly to the cervix of
pregnant women in labour. The hormone, which relaxes the opening to the
womb, helps ease delivery.
Controlled Therapeutics' product should reduce the incidence of
Caesarean sections by offering a more targeted delivery of precise
amounts of prostaglandin throughout labour. The system's other great
virtue is that treatment can be interrupted by the simple expedient of
removing the pessary. It will be launched within two months.
The official green light for this sophisticated drug delivery system
is a significant milestone in a complex story, involving the research
skills of Scottish academics, the market vision of an American
entrepreneur, and investment support from the Scottish Development
Agency.
Today, less than three years after setting up in East Kilbride,
Controlled Therapeutics is a 75-strong company -- two-thirds qualified
scientists who might otherwise have been forced to emigrate to deploy
their skills fully -- with three more products already heading for
launch and ambitions to build a major presence in a highly profitable
pharmaceutical niche.
In an industry where development programmes stretch over decades,
risks run into mega-bucks, and the small player is always in danger of
being trampled by the big boys, this is a start-up of real promise.
The story, in more ways than one, starts at Strathclyde University.
That was where Jim Pickard trained as a pharmacist before going off to
work for the mighty Sandoz corporation in Switzerland and for a
Norwegian pharmaceuticals group in Oslo. Strathclyde is also the
university where Professor Neil Graham developed hydrogels, polymers
related to the substances used to make soft contact lenses, which can
absorb drugs or human biomolecules and release them later within the
body at precisely designed rates and without adverse tissue reactions or
toxic side effects.
Professor Graham's work was carried out under the auspices of the
British Technology Group, and the market potential of the patent BTG
held was seized on by an American, Dr Art Michaelis, working at the time
for SmithKline Beckman.
He persuaded SmithKline to undertake a market evaluation of the
delivery system's potential. ''Great little product,'' the
multinational's analysts concluded, but not big enough to breach the
minimum profit boundaries pharmaceutical giants like SmithKline work to.
That was in 1984, and according to Dr Pickard that boundary could be
as high as $25m even then. But if $25m was a fleabite to the kind of
profits that would stir the SmithKline boardroom, it was more than
enough for Dr Michaelis to sign up the BTG patent rights for himself.
He also decided, early on, to put the operations base of his start-up
company as close as possible to where the concept had originated. So he
came looking for Dr Pickard, with whom he had worked in Switzerland, to
help get the company launched.
By this time Jim Pickard was back in the UK. He was, he says, paying
the mortgage by working as a consultant, designing pharmaceutical
plants, and, at the same time, trying to get his own niche business off
the ground in Durham.
Dr Pickard was torn by the offer to join Dr Michaelis in the new
venture. He had invested a lot of effort and considerable amounts of
money in his own fledgling venture. Eventually he agreed to roll his own
company into Controlled Therapeutics, maintaining development of one
particular product with strong commercial promise -- a simple-to-use,
tablet-based technique for caring for contact lenses.
Dr Michaelis won funding support from Montgomery Medical Ventures, the
Californian backers who are also behind the planned private hospital at
Clydebank. The SDA put their money where their mouth is, to the tune of
some #556,000.
The size of that investment, the sixth biggest in the agency's
last-published portfolio, is all the more daring when you realise that
Controlled Therapeutics' corporate headquarters, from the start, was
based in Philadelphia. But its first product development and
manufacturing base, as Dr Michaelis had always intended, is on East
Kilbride's Peel Park campus.
Dr Pickard has signed up the rights to further patents flowing from
Professor Graham's work at Strathclyde. Apart from the prostaglandin
pessary and lens care product (which is about to be launched in Ireland
and should be available in the UK by the beginning of next year),
Controlled Therapeutics is developing a morphine suppository for pain
management in terminally ill cancer patients and a wound care product
which will exploit the polymer's ability to absorb large quantities of
fluid to clean up bedsores and other wounds.
The way Dr Pickard describes it, Controlled Therapeutics is trying to
chart a profitable middle way in a very competitive industry. The Glaxos
and SmithKlines of this world invest vast sums in the search for new
wonder drugs. The rewards for success are high. But the cost of entry to
new players is now prohibitive.
At the other end of the pharmaceutical industry is the easily accessed
generic business, where margins are cutthroat and success depends on
achieving high volume.
Controlled Therapeutics cannot afford the former and has no interest
in the latter. Drs Michaelis and Pickard see their opportunity in taking
established drugs that are out of patent and human biomolecules, which
cannot be patented, and designing patent-protected delivery systems that
increase efficacy or reduce toxicity or in other ways improve their
impact.
The development costs are high. But if they succeed the rates of
return Controlled Therapeutics can command will rival those of the
majors.
Sensibly, the company has decided to concentrate its energies and take
its return from the development and manufacture of its product range.
Established pharmaceutical players -- the French-owned Roussel
Laboratories in the case of the pessary and Bausch & Lomb from the US
for the lens care product -- are being signed up as trading partners to
market each successive product.
There are, in fact, two group factories at Peel Park. One, Polysystems
Healthcare, is jointly owned by Controlled Therapeutics, the SDA, and
Polysystems, Professor Graham's own university spin-off business. It
makes the delivery polymers.
The Controlled Therapeutics plant, just up the road, refines them
(delivery rates are, in part, a function of geometry) and adds the drug,
hormone, or other treatment.
This unusual start-up has itself been undergoing something of a
corporate shake-up recently. At Easter the Controlled Therapeutics
holding company in the US and a quoted American shell company, Fidata
Corporation, were backed into a new vehicle, Advanced Medical
Technologies.
So the SDA is now a significant shareholder in a business with an
American listing. That means the wisdom of this particular healthcare
initiative is measurable, on a daily basis. Judging by the optimism at
East Kilbride, that share price is set to rise.
Why are you making commenting on The Herald only available to subscribers?
It should have been a safe space for informed debate, somewhere for readers to discuss issues around the biggest stories of the day, but all too often the below the line comments on most websites have become bogged down by off-topic discussions and abuse.
heraldscotland.com is tackling this problem by allowing only subscribers to comment.
We are doing this to improve the experience for our loyal readers and we believe it will reduce the ability of trolls and troublemakers, who occasionally find their way onto our site, to abuse our journalists and readers. We also hope it will help the comments section fulfil its promise as a part of Scotland's conversation with itself.
We are lucky at The Herald. We are read by an informed, educated readership who can add their knowledge and insights to our stories.
That is invaluable.
We are making the subscriber-only change to support our valued readers, who tell us they don't want the site cluttered up with irrelevant comments, untruths and abuse.
In the past, the journalist’s job was to collect and distribute information to the audience. Technology means that readers can shape a discussion. We look forward to hearing from you on heraldscotland.com
Comments & Moderation
Readers’ comments: You are personally liable for the content of any comments you upload to this website, so please act responsibly. We do not pre-moderate or monitor readers’ comments appearing on our websites, but we do post-moderate in response to complaints we receive or otherwise when a potential problem comes to our attention. You can make a complaint by using the ‘report this post’ link . We may then apply our discretion under the user terms to amend or delete comments.
Post moderation is undertaken full-time 9am-6pm on weekdays, and on a part-time basis outwith those hours.
Read the rules hereComments are closed on this article