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Oxford Pharmascience in good heart after passing statin milestone

Drugs developer Oxford Pharmascience has completed the initial formulation development of the two most popular generic statins which aim to deliver the same level of cholesterol reduction but at a much lower dosage level.
Oxford Pharmascience in good heart after passing statin milestone

If you are one of the many people with high cholesterol who is unable to take medication to lower it because of unpleasant side effects, yesterday’s news from Oxford Pharmascience (LON:OXP) should get the pulse racing.

The group, which specialises in bringing out improved versions of off-patent and soon to be off-patent drugs, has completed the initial formulation development for its versions of generic cholesterol-lowering drugs, Atorvastatin and Simvastatin.

These two leading generic statins are widely prescribed by doctors to patients who have high cholesterol and for whom cholesterol reduction to a desirable level through a change of diet alone is insufficient.

One of the major problems with the statins, though, is that many users suffer unpleasant side effects such as inflammation and muscle damage.

A lower dosage would result in fewer side effects, but also, under normal circumstances, be less effective in lowering the patient’s cholesterol level.

However, Oxford Pharmascience’s Safestat development programme is working on a reformulation of atorvastatin and simvastatin to allow them to be accurately delivered to the colon where they are more effectively absorbed into the liver.

If you want to get “sciency” about it, the new formulation bypasses the gastro-intestinal tract, and this leads to higher levels of the drug reaching the liver, which is where all the cholesterol-inhibiting action goes on.

It’s this by-pass trick which means the same effect can be achieved at around a quarter of the dose, or at least it can under certain laboratory conditions.

As the company announcement put it, Oxford Pharmascience has “proven in-vitro release of its formulations under simulated human conditions.”

The statins market is a huge one, valued at more than US$29bn in 2009, but it could be a lot larger were it not for those pesky side effects.

Nigel Theobald, chief executive officer of Oxford Pharmascience, helpfully gave Proactive Investors an insight into how big the demand could be for its statin products.

“We usually quote figures from Their survey reveals that nearly three-quarters of new users stop taking their statins by the end of the first year of use. Of those, 62% cite side effects as the reason for doing so,” Theobald said.

Oxford Pharmascience’s versions of statins would initially be ideal for “second line intervention” for cholesterol reduction, Theobald explained.

This is when the initial prescription of statins has not worked out, due to the aforementioned side effects.

Monday’s announcement was the first important milestone on the march to market – a march which might not be as long as you would expect, as Theobald explained.

“We’re looking to get into production in 2015. Now, two years might seem like a long time ahead to some, but in the drug development world it is short.

“By working with an existing drug with a proven safety record, we can get it to market a lot quicker and a lot cheaper.”

“We are very happy with the formulations in the lab. The next stage is to move on to manufacture the products to allow us to undertake proof of concept clinical trials this year.”

Theobald stressed that the manufacturing, under good manufacturing practice (GMP) conditions, is just for in-house testing purposes, as the company works to determine what levels of dosage are required to deliver required amounts of the statin to the liver.

Nevertheless, the 26% rise in the share price on Monday to 3.375p indicates that the first hurdle has been successfully negotiated; the shares are up another couple of per cent today.

Further down the road, the company will be looking at the possibility of bringing in a partner to help navigate the path to market.


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