Headline: Idenix should be able to keep the good news flowing Source: EP Vantage Company: Idenix Pharmaceuticals Related: GlaxoSmithKline Date: February 09, 2009
"Idenix Pharmaceuticals clinched a highly anticipated deal with GlaxoSmithKline over its novel phase II HIV candidate IDX-899 last week, pocketing $34m upfront, useful funds that will be put to good use this year.
The cash will be spent developing the group’s expansive hepatitis C programmes and if all goes well further positive headlines should emerge soon to keep investors interested. Novartis, which owns a 56% stake in the US-based company and two seats on the board, also has the right to first refusal over its entire pipeline. Considering the pharma giant’s clear commitment to the anti-infectives space Idenix has a ready made partner waiting in the wings for anything that does start to look promising.
Anticipation of a deal over IDX-899, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), helped make Idenix shares one of the best-performing healthcare stocks in 2008 (Emergent tops slim list of stock market winners for 2008, January 9, 2009). Despite suffering heavily in October when global stock markets went into meltdown, the shares managed to more than double last year.
Restructure and focus
In part, the company was bouncing back after a disastrous 2007, which saw its lead compound valopicitabine stall in a phase II trial for hepatitis C. The setback prompted a significant restructuring; its newly launched hepatitis B candidate Tyzeka was sold to Novartis in return for a royalty stream on sales, allowing the group to size down considerably and focus attention on its early stage hepatitis C and HIV programmes.
There can be little doubt that the refocusing helped usher in this deal with Glaxo. As well as the $34m upfront, split between a cash injection and stock purchase, Idenix could receive up to $416m in milestones, plus double-digit royalties. Glaxo, with its strong HIV franchise, was an obvious partner.
The move also means Idenix will be even more sharply focused on hepatitis C, an extremely hot area of both research and licensing deals (Bristol-Myers, Zymo deal shows interest in hep C remains high, January 13, 2009).
Broad pipeline
The group’s programme is impressively broad; it has two research projects, five preclinical candidates and a phase I compound, a nucleoside analogue called IDX-184, under investigation. A proof of concept study for the latter started last month, and by the end of the year Idenix hopes to become the first company to have innovative drugs from three major classes of direct-acting hepatitis C antivirals in clinical development.
With $46m in the bank at the end of 2008, plus the cash from Glaxo, Idenix should be able to make quick progress this year. That should be enough to keep shareholders interested, who will be looking for news on the pipeline to boost the stock back up to last year's levels. Shares in the company closed Friday at $6.14, and have not moved much on the Glaxo deal, possibly because it has been so well flagged. The stock touched $9.48 last September, an 18-month high.
With Novartis owning such a big chunk of the company and having first dibs on anything interesting, the chances of a buyout at this stage look fairly limited; a third party would not get involved and there is little reason for the Swiss company to consolidate its ownership just yet. However, there is no doubt Novartis will be watching closely, and if progress is made with the other candidates, Idenix should have no problems negotiating another licensing deal."
[Updated for blowout Copaxone sales by Teva and revised table of major shareholders.]
What is MNTA’s business all about? #msg-25473104 Capsule summary of proprietary technology #msg-35570668Transcript of 4Q08 conference call (2/12/09) #msg-35477216Webcast from BIO-CEO conference (2/10/09) #msg-28748329MNTA helps FDA with contaminated heparin #msg-33978205 Post-mortem on above story #msg-338670742003 article from Signals (still a good read) #msg-28865474 Characterizing a compound by “ruling out” structures #msg-26837144Salient FoB quote from MNTA’s CEO #msg-35477216Momenta’s Mantra on FoB’s #msg-34857329 Early-stage cancer program
News flow and miscellaneous tidbits #msg-354789592009-2010 news flow #msg-33498974 Tidbits from Nov 2008 DB webcast #msg-29053373 Tidbits from May 2008 DB webcast
Valuation and finances #msg-35548032 4Q08 financial results: $108.5M cash balance #msg-29008722 Musings on valuation (somewhat dated) #msg-3397119 2004 IPO at 6.50/sh #msg-8410708 Poison pill adopted (11/8/05) #msg-25377212 Standstill agreement with NVS expired on 7/25/08 #msg-35646213 Table of recent biotech buyouts
Generic Lovenox program #msg-35570519Lovenox sells $3.8B/yr, 60% in US #msg-35544866Single generic would be largest-selling of all time #msg-33862924Sandoz pays the freight #msg-33839164Profit split depends on # of generics #msg-33892399 Musings on MNTA’s slice of Lovenox pie #msg-33839413 Estimated royalty if multiple generics #msg-12685766 Royalty payable to MIT #msg-33857504 Musings on an AG launch by Sanofi (zipjet, bullish) #msg-34006751 Musings on an AG launch by Sanofi (BI, bearish) #msg-32449872Sandoz submits response to FDA #msg-35090820 Why the Lovenox ANDA’s have taken so long to process #msg-33858393What about ANDA’s from Teva and Amphastar? #msg-35170055 Amphastar’s 180-day ‘exclusivity’ expires on 3/31/09 #msg-33960572 HSP filed ANDA for vial only #msg-26739674 Lovenox US market share #msg-28936334 What indications do Lovenox sales come from? #msg-12222305 2006 agreement extends partnership to EU #msg-29728035 How generic Rx’s are written in EU
M118 (proprietary anticoagulant) program #msg-26897124 “Checklist” rationale for M118 program #msg-26900300M118 has blockbuster potential #msg-32382532 Program update from UBS webcast (9/23/08) #msg-29698599M118 vs new oral anticoagulants #msg-27272430 Meeting an unmet need #msg-26898084 How M118 binds both FIIa and FXa (graphic) #msg-32382585M118 clinical trials #msg-31029674 Musings on lack of drug interactions
Generic Copaxone program #msg-30621490FDA accepts Copaxone ANDA for review #msg-30938608MNTA/Sandoz have first-filer status #msg-33580867 MNTA/Sandoz allege inequitable conduct #msg-30960930 List of Copaxone patents being challenged #msg-12222305 Copaxone falls under 2006 collaboration #msg-30649453 Notes from 7/11/08 Copaxone conference call #msg-30647865 “Controlled chaos” and reverse engineering #msg-35647813Copaxone is cleaning Tysabri’s clock #msg-31152081Copaxone is world’s biggest-selling MS drug #msg-35326613 FDA approves Copaxone for CIS
Follow-on Biologics (FoB) programs #msg-27114485US FoB’s are a question of when not if #msg-35247466 Congressional action in 2009 unlikely, however #msg-26837144Salient FoB quote from MNTA’s CEO #msg-35477216Momenta’s Mantra on FoB’s #msg-35607204 Biogenerics vs biosimilars #msg-12222305 2006 PR announcing FoB deal with Sandoz #msg-34383144 $178M in remaining potential milestones #msg-34383579 What is M178? (table of biologic patent expirations) #msg-20699044 Largest-selling biologics by class #msg-33866262 Reference website for FoB’s
Competition: multiple sclerosis #msg-35065247Comparative efficacy of approved MS drugs #msg-35647813Copaxone is cleaning Tysabri’s clock #msg-31553565 Musings on MS drugs in development (genisi) #msg-35023606 Merck Serono’s phase-3 Cladribine data #msg-31515145 FTY720 runs into a safety setback… #msg-34138665 …but shows good results, all told, in first phase-3 trial #msg-31519342 MS drugs in phase-2 or phase-3 #msg-34832939 Musings on Campath (with another table of MS drugs) #msg-29902618 Mylan enters the Copaxone fray—sort of.
Competition: miscellaneous #msg-33839321 Procognia is not a serious competitor #msg-33597614 Also-ran companies in the FoB arena
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