EU go-ahead for major new growth therapy

The approval could give the company access to a market worth millions of Euros, nicely complementing its existing endocrinology franchise, comprised of Somatuline (lanreotide) and NutropinAq (somatropin).

The European Commission has granted marketing authorisation for Increlex 10mg/ml solution for injection, which was given orphan drug status in the EU in May this year.

The EC authorisation provides Ipsen with a 10-year marketing exclusivity for the treatment of severe primary IGFD.

Ipsen originally obtained development and commercialisation rights to the drug from US firm Tercica in October last year, allowing the company to sell the product in Europe and certain other territories.

Following the EU approval, Ipsen is now responsible for a €15m milestone payment to Tercica, and is aiming to launch the drug on the EU market in October this year.

Increlex is the first recombinant human insulin-like growth factor-1 therapy approved in Europe for the treatment of children and adolescents with severe primary IGFD.

Children who suffer from the deficiency do not respond to the presence of normal or elevated growth hormone levels because their IGF-1 levels are so low, and as such are unable to achieve normal height.

Increlex, injected twice-daily, is identical to the natural IG-1 hormone, and has been shown to successfully treat children with severely short stature that were previously considered untreatable.

The keys players in Ipsen's endocrinology portfolio at present are Somatuline and NutropinAq, both targeting abnormal growth hormone levels.

The addition of Increlex now allows the company to offer " end-to-end " solutions for growth hormone disorders, according to an Ipsen spokesperson.

Ipsen's supplies of the drug will be provided by Tercica's manufacturer, Lonza, who recently agreed to transfer production of the drug from its Baltimore facility to its Hopkinton, Massachusetts plant in the second half of 2009.

Increlex has been available in the US through Tercica since early 2006 and is performing well, with the company recently increasing its estimates for the drug's full year performance.

In the second quarter this year, Increlex sales increased 81 per cent compared to Q1, reaching $2m (€1.5m) and prompting the company to up its guidance for the drug with revenues for 2007 now expected to be in the $9-$10m range (up from previous estimates of $7-$8m).

However, according to an Ipsen spokesperson, it is important to note that there will be a very slow ramp up for the product, due to the nature of the disorder that it treats.

It may be many months between a child's initial visit to an endocrinologist and their eventual start on the Increlex treatment, but following this step patients will be on the drug for five to six years, resulting in a fairly stable market.

As such, although anticipating revenues of only $10m or so in 2007, by 2011 Tercica expects half of the company's anticipated $250-$300m in revenues to be generated by Increlex.

According to Tercica, around 6,000 children in the US have severe primary IGFD, with a similar number affected across the EU, but whether Ipsen will be able to match Tercica's sales figures will largely be dictated to by the eventual pricing of the drug.

Tercica is also in the midst of plans to expand the Increlex franchise with additional indications, having recently completed enrolment on two Phase IIIb clinical trials.

The first trial is to evaluate Increlex in treating a less severe form of primary IGFD (with a market approximately five times larger), and the second trial also looks at the less severe form but with a once-daily rather than twice-daily injection.

Ipsen intends to follow Tercica's lead and submit supplemental applications to the EU authorities when results from these trials are available next year.