Deal activity dims in HIV

Analysis

If the level of partnering activity in the last year is anything to go by, Bionor might have trouble drumming up interest for its resurrected HIV vaccine programme (EP Vantage Interview – Bionor seeks backing for resuscitated HIV vaccine, November 26, 2010).

Only one deal has been struck in the space this year, an early stage research collaboration between Proximagen and Ligand Pharmaceuticals, a big drop off from 2009 and 2008, when ten products were licensed each year. In terms of which doors to knock on, big players in the field like GlaxoSmithKline and Johnson & Johnson have been notably active on the partnering front. Surprisingly, Gilead Sciences, a company that dominates the space and was founded on its HIV therapies, has licensed just two HIV drugs in the last decade (see analyses below). 

Number of HIV product deals
Year Count of products
2010 (YTD) 1
2009 10
2008 10
2007 8
2006 20
2005 9
2004 2
2003 14
2002 10
2001 11
2000 13
Total 108

The significant drop off in deals this year is hard to explain.

HIV therapy has certainly improved enormously over the last decade; for those with access to modern medicines the anti-retroviral therapies now available allow people infected with the virus to live full and almost normal lives.

However, there is certainly room for improvement, particularly in terms of lessening side effects, and research activity is still continuing. For example Gilead is investing huge amounts of money in its Quad pill – a new combination therapy that analysts expect to reach the market in 2012 and generate $1.38bn by 2016 – and a couple of sizeable deals have been struck over the last few years.

The biggest of these was GlaxoSmithKline’s licensing of Idenix’s non-nucleoside reverse transcriptase inhibitor (NNRTI), GSK2248761, in February 2009. The deal cost Glaxo $34m upfront, and is worth $450m in total. Idenix pocketed a $20m milestone payment this week, as the candidate moved into phase IIb trials. With impressive growth in the market for branded HIV drugs set to continue, it seems unlikely that this quiet spell on the deal front will become the new normal.

WW Market for HIV Branded Drugs
2004 2010 2016
Total market ($bn) 7.5 15.5 19.6

The Idenix compound is now being progressed by ViiV Healthcare, the HIV joint venture set up by Glaxo and Pfizer last year when the two pharma giants amalgamated their activities in this space (Glaxo and Pfizer to join forces on HIV, April 16, 2009).

Recognition of how competitive the HIV space no doubt had a lot to do with the creation of this entity. Although Glaxo brought one of the first modern HIV therapies to market, the area was no longer a core focus for the British pharma giant. And with Pfizer busy integrating Wyeth, hiving both their HIV operations off into an autonomous company was sold as an efficient use of resources.

Its formation, however, seems to have coincided with a notable drop in deal activity. As Glaxo has been the most active of companies on the partnering front over the last decade, it would be surprising if ViiV does not make an appearance on the scene soon. ViiV has yet to strike a licensing deal since its creation.

Most active in-licensing companies (2000 - 2010)
Company Count of products
GlaxoSmithKline 6
Avexa 4
Johnson & Johnson 4
Pharmexa 4
Arisyn Therapeutics 3
Presidio Pharmaceuticals 3
Progenics Pharmaceuticals 3
Roche 3
Valentis 3

The table below would appear to make more encouraging reading for Bionor, with HIV vaccines the most common type of therapy over which these deals have been struck in the last decade. However, many of these 31 deals are more specifically over a vaccine technology, and the majority of these transactions were struck at the research project stage. In fact, a previous analysis by EP Vantagefound that the majority of HIV drugs in development belong to well known and validated classes (Therapeutic focus – Novel HIV approaches continue to suffer lack of interest, July 19, 2010).

And with few therapeutic vaccines having made it into late-stage trials, in HIV or any other therapy area, and the technology far from validated, even the encouraging results revealed last week means Bionor will remain a high risk bet.

Product deals by pharma class (2000 - 2010)
Pharma class (most common types) Count of products
HIV vaccine 31
NRTI 8
Anti-HIV MAb 7
NNRTI 6
CCR5 antagonist 6
HIV integrase inhibitor 5
Fusion inhibitor 5
Protease inhibitor 4
CXCR4 antagonist 3

Bionor's Vacc-4x candidate is in phase II, the most common stage at which deals have been struck over clinical stage products, in keeping with wider trends in the industry. However, what is intriguing is the heavy bias towards deals over early stage research; 75% of deals struck over the decade have been for candidates yet to enter the clinic.

Product deals by phase (2000 - 2010)
Status on deal Count of products
Phase III 3
Phase II 15
Phase I 8
Pre-clinical 41
Research project 41
Total 108

The table below lists current partnering opportunities for clinical stage HIV products, identified by EvaluatePharma’s partnering service, where the company concerned has publicly stated it is seeking a partner for further development.

The chances of Pharmasset and Oncolys BioPharma finding homes for their NRTI candidates, Racivir and Festinavir respectively, seem slim given Avexa’s failure to secure a partner (Avexa’s partnering problems could be contagious in HIV space, May 14, 2010).

Alongside Bionor’s candidate, the only other HIV vaccine being actively touted around is Bavarian Nordic’s MVA-BN-Multiantigen candidate. Designed to be both a prophylactic and therapeutic vaccine, by expressing eight HIV antigens to elicit a broad immune response, the Danish group have completed phase I/II trials and are seeking a partner to conduct a full phase II study.

Partnering opportunities for clinical stage HIV products (companies actively seeking a partner)
Status Product Company Pharmacological Class Technology Originator
Phase II CYT 107/Recombinant Glycosylated Human IL-7 Cytheris IL-7 Recombinant product Cytheris
MPC-4326 Myrexis HIV maturation inhibitor Small molecule chemistry Panacos Pharmaceuticals
Racivir Pharmasset NRTI Small molecule chemistry Emory University
HIV Antibodies therapy Polymun Scientific Anti-HIV agent Monoclonal antibody Polymun Scientific
HIV Vaccine (MVA-BN-Multiantigen) Bavarian Nordic HIV vaccine Bioengineered vaccine Bavarian Nordic
Festinavir Oncolys BioPharma NRTI Small molecule chemistry Yale University
Phase I CYT 99 007 Cytheris IL-7 Recombinant product Cytheris

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