Biotech Values

[DewDiligence]

IDIX Inks HIV Partnership With GSK: $34M Up-Front, $416M in Potential Milestones

[Inasmuch as IDIX inked this deal before running the head-to-head trial of IDX899 vs Sustiva, the economic terms are at the high end of what I expected (#msg-28959639). The up-front cash of $34M, of which half comes from the sale of equity at $6.87/sh, is consistent with my expectation of at least $25M (#msg-34894217).

All told, this is a great deal for IDIX and a shrewd deal for GSK, IMO. GSK was once the worldwide leader in HIV, but it has slipped to also-ran status because of the colossal success of GILD’s Truvada and Atripla. What remains to be seen is how GSK incorporates IDX899 into a larger HIV strategy—merely combining IDX899 with GSK’s Epzicom or Combivir is not the answer, IMHO.

This is the big partnership deal IDIX originally promised to announce before the end of 2008. Hence, the deal is a month late, but it was well worth waiting for. With the up-front cash from this deal added to the $45M on hand as of 12/31/08, IDIX now has more than enough liquidity to continue or even accelerate its three-pronged development program in HCV. Moreover, IDIX remains an attractive buyout candidate for NVS, the majority owner.]

http://finance.yahoo.com/news/Idenix-Pharmaceuticals-and-prnews-14276124.html

›Idenix Pharmaceuticals and GlaxoSmithKline Sign Worldwide License Agreement for IDX899, a Novel NNRTI for the Treatment of HIV

Friday February 6, 2009, 7:00 am EST

CAMBRIDGE, Mass. and LONDON, Feb. 6 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) and GlaxoSmithKline (GSK) today announced the execution of a license agreement granting GSK exclusive worldwide rights to IDX899. IDX899 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) in Phase II clinical development being developed by Idenix for the treatment of HIV/AIDS. New NNRTIs are needed to address the increasing prevalence of viral resistance and side effects associated with this drug class. To date, IDX899 has demonstrated high potency with low milligram doses, a high barrier to drug resistance, favorable risk/benefit profile, and the convenience of once-a-day administration.

Under the terms of the agreement, GSK will assume all development responsibility and associated costs for IDX899, and Idenix will receive an upfront payment of $34 million and will be eligible to receive up to $416 million in development, regulatory and sales milestones. Furthermore, if IDX899 is successfully developed and commercialized, Idenix will receive double-digit, tiered worldwide royalties.

"GSK, with a well-established HIV franchise and substantial drug development experience, is the ideal collaborator to help maximize the potential of IDX899," said Jean-Pierre Sommadossi, Chief Executive Officer of Idenix. "For Idenix, the significant value created through the license of IDX899 enables us to focus all of our resources on advancing our core strategic HCV assets, which include drug candidates from the three major classes of direct-acting HCV antivirals."

"IDX899 may play a significant role in improving treatment options for people with HIV/AIDS," commented Zhi Hong, Senior Vice President of the Infectious Diseases Centre of Excellence for Drug Discovery (ID CEDD) at GSK. "A once-daily, lower-dose NNRTI that offers an improved drug resistance and pharmacokinetic profile would be valuable to HIV-treating physicians and patients. The preliminary clinical evidence of IDX899 supports this and warrants continued clinical study as part of GSK's growing drug pipeline in HIV."

The $34 million upfront payment by GSK to Idenix was split evenly between cash and the purchase of Idenix common stock at $6.87 per share. The effectiveness of these transactions is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended and other customary closing conditions.

About IDX899

IDX899 is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for the treatment of HIV-1. Idenix has advanced IDX899 through a Phase II proof-of-concept study in HIV-1 infected treatment-naive patients that was completed in 2008. In the proof-of-concept study, patients (n=32) receiving once-daily oral administration of IDX899 achieved mean viral load reductions of 1.8 log(10), after seven days of treatment as tested with the Roche Amplicor® 1.5 assay. In this study, no treatment-related serious adverse events were reported and no patients discontinued. The most common adverse events observed were dyspepsia, headache and nausea; the rate of these events was similar between IDX899-treated patients and those receiving placebo. Additionally, no patterns in laboratory abnormalities between treatment groups were observed during the treatment period.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus. For further information about Idenix, please refer to www.idenix.com.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.‹