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Intermune/Roche HCV Protease Joins HCV Protease Battle
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Roche, InterMune In HCV Deal With $530M Potential
http://www.therapeuticsdaily.com
Another kernel popped in the sizzling pan of protease inhibitors for hepatitis C virus, as F. Hoffmann-La Roche Ltd. signed a potential $530 million deal with InterMune Inc. for a program led by preclinical ITMN-191.
InterMune's stock (NASDAQ:ITMN) jumped 25.5 percent on the news, closing Tuesday at $21.12, up $4.29. The payout from Roche includes $60 million up front and another $35 million that InterMune could pocket in the next 12 months.
Larry Blatt, the Brisbane, Calif.-based firm's chief scientific officer, partly credited the potency of ITMN-191 for the handsome terms. In early work, the drug's strength proved at least two orders of magnitude [greater] than other protease inhibitors in clinical testing by other firms, he told BioWorld Today, referring to VX-950, from Vertex Pharmaceuticals Inc., and Schering-Plough Corp.'s SCH 503034, both in Phase II.
What's more, ITMN-191, which InterMune and Roche plan to put in Phase I trials before the end of this year, can be dosed every 12 hours, or about twice per day, whereas others must be given at least three times per day, Blatt said.
In the deal with InterMune, Basel, Switzerland-based Roche is paying 67 percent of worldwide expenses. The firms will work on commercialization together and split costs in the U.S.; outside, InterMune will get royalties in the mid-teens to high-teens, depending on sales levels.
Manufacture of ITMN-191 (originally developed by InterMune with Array BioPharma Inc.), and any other drugs that might emerge from the collaboration, is up to Roche, and InterMune may opt out of either co-development or co-commercialization for the drug, which would mean higher royalties on ex-U.S. sales and royalties instead of profits in the States.
Roche already stands tall in HCV with Pegasys (pegylated interferon alfa-2) the drug with which Vertex combined its VX-950 for a comparison Phase II trial with Schering-Plough's SCH 503034. Vertex came out the winner in data disclosed earlier this year at the 41st annual meeting of the European Association for the Study of the Liver in Vienna, Austria.
Vertex's advanced position in the protease race ?doesn?t mean they will ultimately be the most important product out there,? Blatt noted.
For chronic HCV, first-line therapy is Pegasys plus ribavirin, but about half of all patients treated fail to respond. Protease inhibitors, which proved strong against HIV, could hold major hopes for HCV, as well, since HCV needs them to copy itself. Also, HCV proteases interfere with the host?s defenses by interacting with proteins that otherwise would fight off the virus.
The HCV market could be worth as much as $9 billion, and has drawn plenty of players. Gilead Sciences Inc. and Achillion Pharmaceuticals Inc. have inhibitor GS 9132 in Phase I trials. Others doing early research include Medivir AB, Bristol-Myers Squibb Co., GlaxoSmithKline plc and Novartis AG.
InterMune has a program for idiopathic pulmonary fibrosis (IPF), as well. The company is trying Actimmune, approved for chronic granulomatous disease and severe, malignant osteopetrosis, in a Phase III trial called INSPIRE. Although the first Phase III study with Actimmune (interferon gamma-1b) against IPF failed to hit statistical significance, and the drug didn't work against ovarian cancer, hopes are higher for INSPIRE. InterMune completed patient enrollment in April, and Wall Street expects to see data in the first quarter of 2008. (See BioWorld Today, Feb. 6, 2006.)
There's nothing approved for this disease, which affects four or five times the number of patients than pulmonary arterial hypertension, subject of the Myogen-Gilead deal, for example, said InterMune's president and CEO, Dan Welch. Earlier this month, Gilead Sciences Inc. disclosed a plan to buy Myogen Inc. for about $2.5 billion, a takeover that would give Gilead the Phase III compound ambrisentan PAH. (See BioWorld Today, Oct. 3. 2006.)
For IPF, the five-year survival rate is ?around 20 percent, which is worse than every cancer you know about, with the exception of lung cancer, Welch told BioWorld Today. If INSPIRE works, it's going to be a huge upside to our company's future. Already, doctors are prescribing about $75 million to $100 million per year of Actimmune off label for the condition.
CIBC World Markets, which Tuesday initiated coverage of InterMune with a sector outperform rating, estimated that peak sales of Actimmune for IPF could exceed $700 million. Sales of ITMN-191 could go beyond $1 billion, according to CIBC?s report.
GEN News Highlights
Roche will exclusively license InterMune's lead candidate compound, ITMN-191, according to a collaboration agreement between the two firms. The companies will also collaborate on a research program to identify, develop, and commercialize second-generation HCV protease inhibitors.
InterMune will conduct Phase I studies on ITMN-191, expected to start at the end of 2006. Thereafter, Roche will lead clinical development and commercialization.
Upon closing, InterMune will receive from Roche an upfront payment of $60 million. In addition, assuming the successful development and commercialization of ITMN-191 in the U.S. and other countries, InterMune could potentially receive up to $470 million in milestones, including $35 million within the next 12 months.
Roche will fund 67% of the global development costs for ITMN-191 and the companies will co-commercialize the product in the U.S. and share profits on a 50-50 basis. InterMune will receive royalties outside the U.S. The economic terms for ITMN-191 could also apply to additional compounds that InterMune and Roche develop and commercialize.
Roche Snaps up InterMune Treatment
San Mateo County Times - Oct. 17, 2006
Small Bay Area biotech company InterMune Inc. scored a $60 million payment Monday from pharmaceutical giant Roche to collaborate on treatments for hepatitis C.
The deal is centered on Brisbane-based InterMune's leading protease inhibitor ITMN-191, a drug that has yet to enter the first phase of trials. A protease inhibitor keeps the body from replicating viruses in the body. In this case it will target hepatitis C, referred to as HCV.
In addition to the $60 million upfront payment, InterMune could receive up to $470 million in milestone payments. A more telling factor of Roche's belief in ITMN-191 is that it will share profits if the drug is commercialized.
"That is an extremely big deal if you are willing to give up 50/50 profit share on something this early," said John McCamant, editor of Berkeley-based Medical Technology Newsletter. "HCV is a huge chronic market opportunity that pharmaceutical companies like Roche are salivating to try to get at, so I'm not surprised at the deal at all."
"It's a huge deal for us," said Dan Welch, president and chief executive of InterMune. "If we didn't have this, we would have had to raise huge amounts of money on our own, which could have been very difficult to do."
The deal also aligns InterMune with Roche, instead of having to later compete with Roche. It may not be the first protease inhibitor for hepatitis C to reach the market, but Welch believes it will be the "best of class."
Spending money on a deal like this before any clinical trials have been conducted may seem unusual, but Welch says it's the kind of compound that favors a good prediction of potency at the pre-clinical level.
"Roche is willing to take a big $60 million gamble, and possibly more, that these test-tube studies now will translate into human results later," Welch said.
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