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GlaxoSmithKline (NYSE:GSK) signaled its ongoing strong interest in the vaccines space Friday by announcing a deal with Intercell (OTC:INRLF), over the Austrian company’s portfolio of products delivered through a skin patch. The lead candidate is in phase III trials for travellers’ diarrhoea.

Sales of vaccines are forecast to grow 9% a year from 2008 to 2014 to be worth $28.76 billion and the UK pharma giant is definitely a dominant player, the tables below show. Still, this deal represents a big step towards innovation in vaccine delivery, with few advances having been made beyond injections and oral formulations.

Top 10 Therapeutic Categories WW annual sales ($m)
Rank Therapeutic Class 2008 2014 CAGR (08-14) Total Change (08-14)
1 Anti-diabetics 24,882 40,274 8% 15,391
2 Anti-neoplastic MAbs 17,093 29,870 10% 12,777
3 Anti-virals 20,004 29,582 7% 9,578
4 Vaccines 16,939 28,763 9% 11,824
5 Anti-rheumatics 16,352 28,630 10% 12,278
6 Anti-hyperlipidaemics 29,546 23,132 (4%) (6,415)
7 Other cytostatics 7,158 16,266 15% 9,109
8 Angiotensin II antagonists 20,792 14,366 (6%) (6,426)
9 MS Therapies 8,650 13,618 8% 4,968
10 Anti-bacterials 15,917 13,606 (3%) (2,311)

Under the deal, Glaxo will pay €33.6 million ($49.4 million) upfront and up to €84 million on top, through a staggered shareholding purchase option of up to 5% in Intercell, and gains global rights to the travellers' vaccine. Novartis (NYSE:NVS) already has a 15% stake in the company, so if Glaxo chooses to take up its equity option the company will be in the somewhat unique position of having two big pharma shareholders.

The deal covered the diarrhoea patch, a single application pandemic influenza vaccine in phase II, and other potential future patch vaccines.

The diarrhoea patch is designed with travellers and military personnel in mind, to protect against illness linked to enterotoxigenic E. coli (ETEC), the most common cause of diarrhoea. A phase III trial recently started which will recruit 1,800 people travelling from Europe to Mexico and Guatemala, and results should be available in 2011.

Analysts have pencilled in sales of $75 million for the product by 2014, following a launch in 2012, according to consensus data from EvaluatePharma.

Morgan Stanley analysts wrote recently that they believe the product has peak sales of €135 million, whilst Jefferies is even more optimistic, pencilling in €450m. Previously they were anticipating “conservative” €100 million deal terms.

Crucell (NASDAQ:CRXL) already has a similar vaccine on the market, Dukoral, indicated to prevent GI tract infections and cholera, and which comes in a drinkable form. Jefferies calculated this product achieved 15% penetration amongst Swedish and Norwegian travellers, and the analysts believe this sort of penetration is also likely for the Intercell product.

Still, the product is on the small size for Glaxo, therefore the move also highlights big pharma’s growing interest in niche offerings.

However, the deal is also largely about the broader applicability of the patch technology that Intercell has developed, called the vaccine enhancement patch (VE Patch) which has been shown to enhance the effect of injected vaccines.

For example, the VE Patch which came with the deal, designed to be used alongside a pandemic flu injection, enhanced the immune response after only a single dose, resulting in a seroconversion rate of 70 percent, meeting the FDA and EMEA standard for approval of a pandemic influenza vaccine.

The companies believe this holds the potential to expand limited vaccine supplies by allowing fewer or lower doses of vaccines. As one of the biggest makers of the shots being sent around the world in the current flu outbreak, Glaxo’s interest in the field is understandable.

Source: Glaxo-Intercell Deal Could Bring New Developments to Vaccine Market