Thanks Bio,
I had not seen that yet.
One of the interesting developments lately is from Roche. The following is from the RB ICN thread. Sig who wrote it is a staunch ICN advocate. I can't vouch for the accuracy of this but it does make sense:
ragingbull.lycos.com
Per ICN's CC yesterday, did you notice the question about Roche's comment made during their (Roche's)Annual Investor's Meeting held earlier in Basle (yesterday morning before ICN's CC)
Question to ICN :
"What do you think about Roche saying that they will file their own ribavirin?"
Today, I observed during Roche's US Investor's Meeting (REPEAT of yesterday but in NY) that they were VERY DIRECT in stating their intent to file with both US and EU regulatory authorities an application seeking to market "their ribavirin" in combination with their pegylated interferon product, PEGASUS. When asked directly during the Q&A section (many questions relating to Pegasus/combo...lot of "fishing") Roche stated that:
"We are an R&D bassed company and our patent counsel feels comfortable in filing our ribavirin product"
....or something to this effect.
What I found "enlightening" was the "fishing questions" about PEGASUS, HCV, etc and Roche's response since they obviously refused to discuss details of their patent challenge.
Let us review the facts:
While there is NO composition of matter patent on ribavirin
in the EU or US there exists patents which cover the use of ribavirin either as a single agent or in combination with interferon alfa (and pegylated) for use in the treatment of hepatitis.
In addition, the EU maintains that all data relating to the ribavirin/interferon applications are "exclusive" and cannot be used by other companies. The REBETRON NDA with the FDA is "protected in totum"(including all ribavirin data) for another 17 years (until all patents associated with the NDA expire!)
In Japan, ribavirin is protected by composition of matter patents.
Historically, "use patents" were of limited value in Europe because each country maintained separate patent offices and cetainly ALL pharmaceutical registrations were INDEPENDENTLY authorized at the state (country) level.
Today, the EMEA in London works with the European patent office in Barcelona and everything is coordinated pan-European.
The US, both issues AND RECOGNIZES "USE PATENTS" as "a reward" for invention.
The best I can "dig-up" is that Roche Management "missed the ball" in not licensing ribavirin back in 1995 (before SGP did), partly because the conservative Swiss Lawyers REFUSE to accept the concept of "use patents" and partly because they were still pis$ed at MP for "Green Mailing" Roche in the late 1980's.
After SGP launched REBETRON (standard interferon alfa/Rebetol capsules)they (Roche) lost ALL HCV marketshare in the US and maintain >20% in the EU, where they use to have +40% of the HCV market via their interferon (the ONLY reason Roche held ANY market share in the EU is because REBETOL Capsules have always been available separtely).
While REBETRON was being developed, both Roche and SGP had competing pegylated interferon programs as a Monotherapy to treat HCV.
SGP immediately started combination trials with PEG-INTRON/REBETOL capssules once REBETRON (standard interferon/rebetol) was FDA approved (CANNOT have two experimental drugs; i.e. non-approved being tested against an approved standard of therapy so SGP waited until AFTER approval!)
While Roche obtained a 2nd line HCV indication approval for PEGASUS in the EU as a monotherapy they COULD NOT market it as first line......thus, SGP "took over" the market with their 1st Line REBETRON combination therapy as the standard of treatment
In the US, Roche's PEGASUS application, also for 2nd line treatment of HCV, was "put on hold" last year by the FDA, due to manufacturing problems.
While this "battle of the pegylated interferons" was occuring in development/registration; in order to play "catch up" in this $4 BILLION market, Roche initiated combination trials using their Pegylated interferon, PEGASUS, with a toll/generic manufactured ribavirin. The trials were ex-US.
(Note: Since in the EU there was NO composition of matter patent, you can manufacture it;i.e. ribavirin.....since it was "given away" in clinical trials, thus, it was not being "commercialized" ...use patent violation is "grey area" in this type of scenario. However if Roche had decided to buy REBETOL Capsules for clinical trial use, SGP could "file an injuction" if Roche were "developing" SGP's product...thus "forcing" the use of a generic ribavirin!)
In the meantime, Roche's portfolio implods (remember Genetech is treated as a sister company) and their fat drug, Xenical is WAY BELOW expectations. (Roche sales were BAD last year and net profit is not good this year.) Roche cans their long time US team and "reinvents/prioritizes,etc" themselves amid their $500,000,000 EU fine for monopoly collusion in their Vitamins division.
What happens.......the $4 BILLION HCV market looks "real good" and very short term "attainable!"
In most of Roche's IR/PR releases both in the US and the EU, PEGASUS has been the ONLY mentioned drug as a $billion drug (stated again today!).
With ZERO US Market Share......heading toward ZERO Japanese marketshare because SGP has ribavirin "sewn up" over there and the EU (Home for Roche) being "locked out" of the 1st line HCV Market what do you do:
SIG's "Speculation:"
(1) Do not "shoot yourself in your left foot TOO;"i.e. license virimadine from ICN. If it is as effacious as ribavirin without the side affects$$$$$$$$$$$$$$$$$$$ in 3 years.
(2) Get in the game by........"Threatening" to challenge the ribavirin "use" patents. (not understood well by non-pharmaceutical patent attorneys)....and let's face it..........................................................SGP is on a two legged stool and
ICN is a monopod!
(3) When you meet with the FDA to "clarify" the PEGASUS manufacturing problems, try to "pressure, nice talk, whatever" the FDA to expand the PEGASUS indication to include a first line treatment for HCV in combination with:
(Plan A) Your ribavirin (Hey, FDA we can produce ALL the pegylated interferon you need, 60,000, 120,000, 240,000 patients you name it....something SGP CANNOT do this year...you know what I mean!)
(Plan B) REBETOL Capsules (already on the market....and you know what MD's will do anyway!)
In my opinion, the "use patents" will HOLD UP WELL for the next 3 years while they are challenged in court and ultimately prevail.
However, if ICN/SGP would like to reach an "agreement" involving *supplemental clinical/preclinical data which could help "support" a broader claim for PEGASUS;I.E. use in combination with ICN/SGP's REBETOL Capsules...........maybe the lawyers are not needed.
*(Note: I DOUBT Roche has enough pre-clinical/toxiciology, safety, clinical etc. data to support a separate NDA!)
Like Wolves, the Swiss "smell money" at 100 meters!
However, the Swiss prefer "Consensus vrs Confrontation".....SGP....with the manufacturing and OTC ISSUES "LOOMING" over Claritin/Clarinex....cannot afford to be their normal confrontational persona....ICN is only the tail on the dog in this fight.
By the way, if viramidine (ribavirin backup ICN licensed to Roche) does replace REBETOL capsules...SGP might be interested in combination with PEG-INTRON!
Wolfee, Flight23, my take is that, ultimately ribavirin will be a multi-billion dollar drug, replaced, perhaps by virimadine.....either way ICN will receive $$$$$.
Roche is simply wanting (and "needing to") share in HCV's $4 billion market.
Roche indicated today that they will address FDA's questions regarding PEGASUS's manufacturing problems in full in April and at the same time discuss combination filing.
I expect SGP will be prepared to "respond" to any inquiry, tomorrow, but as their stock drops BELOW $30 and ICN's below $25......SGP will issue a PR "defending their patent" at the same time the phone calls to Basle will take place!
So,I doubt that we will see a $3 Billion Ribapharma IPO as MP stated yesterday and I doubt he will even try "spinoff" Ribapharma until AFTER this point is clarified.
With the Annual Meeting in May and a "highly probable" PROXY fight for final control of ICN's BOD.......
The next few weeks are going to be "real interesting" but NOT for the faint oif heart.
Hope the facts and my personal opinion helps!
SIG
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I wish I knew enough about patent law to handicap this one - but I am not even close.
Ribavirin royalties are climbing nicely. It the patents hold - ICN has value. If the patents fall under the generic attack - ICN should drop under 10, IMO.
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