High Value Licensing Opportunities Still Exist in Late Stage R&D

July 31, 2008 High value licensing opportunities still exist in late stage R&D

Evaluate Vantage

Following Amgen’s release this week of positive phase III data for osteoporosis drug denosumab, which have helped propel the US biotech’s shares to one-year high levels of around $63, speculation has increased over whether the company will seize the moment and sign a lucrative deal with a large marketing partner, or go it alone to retain future profits whilst incurring significant selling costs.

A review of the industry’s most valuable phase III and II products, according to EvaluatePharma’s NPV Analyzer, reveals the majority of the top ten drugs at each clinical stage have already been partnered, whilst highlighting some intriguing opportunities for big pharma to secure valuable drugs to fill ailing pipelines and fight the looming patent cliff.

Phase III opportunities

Four out of the top ten most valuable phase III drugs are yet to be partnered in the major regions of the US and Europe. Although Amgen licensed Japanese rights for denosumab to Daiichi Sankyo last year, the company is still thought to be assessing its commercial options for the potential blockbuster.

Top 10 phase III products ranked by NPV (aggregated across partners)

Generic Today's NPV Rank Product Company (s) Name ($m)

Denosumab (AMG 1 denosumab Amgen + Daiichi Sankyo (Japan) 7,726 162)

Bapineuzumab (AAB- 2 bapineuzumab Elan + Wyeth 7,289 001)

Vertex Pharmaceuticals + Johnson 3 VX-950 telaprevir 6,562 & Johnson

Amylin Pharmaceuticals, Alkermes + 4 Byetta LAR exenatide 6,422 Eli Lilly

5 HuMax-CD20 ofatumumab Genmab + GlaxoSmithKline 4,410

6 SCH 530348 - Schering-Plough 3,724

7 Apixaban apixaban Bristol-Myers Squibb + Pfizer 3,481

8 Axitinib (AG-13,736) axitinib Pfizer 3,077

9 HCT 3012 naproxcinod NicOx 2,926

ASA404/AS1404 10 - Antisoma + Novartis 2,925 (DMXAA)

Two other un-partnered candidates are being developed in-house by US majors, with Schering-Plough’s anti- coagulant SCH 530348 and Pfizer’s anti-angiogenic agent Axitinib.

Although this probably excludes these drugs as tangible licensing opportunities, deals between majors, previously unheard of, have become slightly more prevalent as even the big players look to spread developmental costs and risks; Bristol-Myers Squibb and AstraZeneca have struck a deal for anti-diabetic agent saxagliptin, whilst Pfizer and Bristol-Myers Squibb are collaborating over anti-coagulant Apixaban. Which leaves NicOx’s pain treatment naproxcinod as the only other potentially high value product available for licensing. The development of naproxcinod has been a roller-coaster ride for the French pharma group, with AstraZeneca handing back rights to the drug in 2003 after phase II data failed to convince.

NicOx has nevertheless continued the drug’s development through phase III trials, with pivotal results due in the second half of this year. A positive read out may therefore start to turn a few heads.

Phase II opportunities

Not surprisingly, phase II offers up a few more candidates which look riper for a deal, with four of the top ten products still in the hands of relatively small biotech companies.

Top 10 phase II products ranked by NPV (aggregated across partners)

Generic Today's NPV Rank Product Company (s) Name ($m)

iodofiltic I- 1 Zemiva Molecular Insight Pharmaceuticals 4,160 123

2 GSK159797 milveterol Theravance + GlaxoSmithKline 2,414

3 AS1411 - Antisoma 2,109

Alnylam Pharmaceuticals + Kyowa Hakko 4 ALN-RSV01 - 1,632 Kirin (Asia)

5 R406/R788 fostamatinib Rigel Pharmaceuticals 1,604

6 DU-176b - Daiichi Sankyo 1,324

Influenza Seasonal influenza 7 Crucell + Sanofi-Aventis 1,268 Vaccine vaccine

8 Juvista avotermin Renovo + Shire 1,191

9 Taspoglutide taspoglutide Ipsen + Roche 1,106

10 AZD3480 (TC-1734) ispronicline Targacept + AstraZeneca 1,064

Somewhat surprisingly top of the list is Molecular Insight Pharmaceuticals’ radiodiagnostic agent, Zemiva, for the diagnosis of cardiovascular disorders. Whilst analysts’ forecasts are probably on a “best-case” scenario, even reducing the estimates by 69% to include a more reasonable level of risk, the agent still looks like a good opportunity for a suitable partner with access to this specialist market.

Another candidate currently attracting a decent level of interest is Rigel Pharmaceuticals’ immunosuppressant drug fostamatinib. Positive phase II data released late last year propelled the biotech’s share price from $8 to $27 in one day. Given the potentially broad spectrum of activity for the drug, partners have no doubt started to circle around the Californian company.