EP Vantage Interview – Jazz making progress in licensing talks

US specialty pharma company Jazz Pharmaceuticals is making good progress in talks to find ex-US licensing partners for three of its R&D programmes, Willie Quinn, senior director for licensing and acquisitions, told EP Vantage at BioPartnering Europe conference in London today.

He also said that pending positive phase III results from the group’s lead compound, JZP-6 in fibromyalgia, a partner is likely to be sought next year to help promote the drug in the US. Some good news on the partnering front is needed. Jazz’s share price has performed badly this year, down 68% to date, in the wake of disappointing take up of lead drug Luvox CR and after stretched finances forced the company to lay off staff and put a brake on earlier stage research projects.

Up for grabs currently is ex-US marketing rights to three compounds. JZP-4 is for epilepsy and bipolar disorder and completed phase I trials, JZP-8 for seizures and JZP-7 for restless leg syndrome are in phase II.

“We’re pretty far along in discussions,” Mr Quinn said, declining to say whether deals could emerge this year. Although JZP-4 is the least advanced project, it probably has the most value, he believes, while the others are more niche offerings.

Most valuable

Jazz’s most valuable project, however, is JZP-6 in fibromyalgia, a chronic condition characterised by pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. But unlike other rheumatological disorders it is not caused by inflammation, thought instead to be down to abnormal pain processing within the central nervous system, commonly triggered by physical trauma, emotional stress or infection.

As such, it is a fairly recently recognised ailment, and so far only two drugs have been approved to treat the condition, Eli Lilly’s SNRI Cymbalta and Pfizer’s anti-epileptic Lyrica. It also means that many types of doctors diagnose and treat sufferers, including primary care physicians, rheumatologists and psychiatrists.

Through its existing sales force Jazz can cover psychiatrists, and maybe rheumatologists, but to compete with the blockbusters Cymbalta and Lyrica and their substantial sales forces, help will be required to reach the primary care doctors, Mr Quinn said.

Plus, as the table below shows, competition is due to grow in the field. Fibromyalgia is a very attractive-looking market, with an estimated 5 million sufferers in the US alone, and prescriptions are also expected to increase as awareness grows. Therefore it will almost certainly be in Jazz’s interest to get a bigger partner on board and compete effectively with the growing number of products set to reach the market.

Tenterhooks

Mr Quinn said the company is on tenterhooks waiting for the phase III results, and looking at the NPV of the product it’s not hard to see why. The product is valued at $420m, according to EvaluatePharma’s NPV Analyzer, making it by far the company’s most valuable R&D project, and second most valuable asset behind Luvox CR, for compulsive obsessive disorder and social anxiety disorder.

Phase II results were highly encouraging, the first set of phase III results are due in the final quarter of this year, while the second set are due early next year. A filing is anticipated at the end of 2009. UCB has ex-US rights to the drug.

Compared to the company’s current market cap of only $137m, the potential value of the fibromyalgia opportunity looks substantial. Jazz’s valuation has of course been affected by the recent market rout, exacerbated by concerns about Luvox CR. Positive results from JZP-6 will be needed for confidence to start returning.

Long-Term Outlook for Fibromyalgia products: includes aggregated product sales across ALL INDICATIONS WW annual sales ($m)
Market status Product Company (s) Pharmacological Class Lead Indication Summary 2007 2014
Marketed Lyrica Pfizer Alpha 2 delta ligand Pain, neuropathic [Marketed]; Diabetic neuropathy [Marketed]; Epilepsy [Marketed]; Generalised anxiety [Marketed]; Fibromyalgia [Marketed]; Pain, post-operative [Phase III]; Restless legs syndrome [Phase II] 1,829 4,582
  Cymbalta/Xeristar Eli Lilly + Boehringer Ingelheim SNRI Depression [Marketed]; Pain, neuropathic [Marketed]; Generalised anxiety [Marketed]; Fibromyalgia [Marketed]; Pain, chronic [Filed] 2,103 1,385
             
Filed Milnacipran Forest Laboratories + Cypress Bioscience Noradrenaline & 5HT reuptake inhibitor Fibromyalgia [Filed] - 690
             
Phase III Pristiq Wyeth SNRI Depression [Marketed]; Menopause [Phase III]; Fibromyalgia [Phase III] - 975
  JZP-6 Jazz Pharmaceuticals + UCB CNS depressant Fibromyalgia [Phase III] - 286
  Intratect Biotest Immunoglobulin Immunoglobulin deficiency [Marketed]; HIV treatment [Marketed]; Other immune indications [Marketed]; Fibromyalgia [Phase III] 85 242
  S,S-Reboxetine Pfizer SNRI Fibromyalgia [Phase III]; Post-herpetic neuralgia [Phase II]; Diabetic neuropathy [Phase II] - 98
             
Phase II Vimpat UCB Collapsin-response mediator protein 2 (CRMP-2) modulator Epilepsy [Approved]; Pain, neuropathic [Filed]; Migraine [Phase II]; Fibromyalgia [Phase II] - 979
  Neupro UCB Dopamine D2 & D3 agonist Parkinson's disease [Marketed]; Restless legs syndrome [Filed]; Fibromyalgia [Phase II] 71 670
  Eplivanserin Sanofi-Aventis 5HT2A antagonist Insomnia [Phase III]; Fibromyalgia [Phase II] - 386
  S-flurbiprofen Patch Taisho Pharmaceutical NSAID Osteoarthritis [Phase II]; Arthritis, general [Phase II]; Fibromyalgia [Phase II] - 27

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