This Is MS Multiple Sclerosis Community: Knowledge & Support

Some of you may find this interesting.

In talking about Antegren, and pharmas, etc., I mentioned SEC filings. So........I took a quick look at SEC filings for Biogen Idec. This is ALL public record and can be found on their website, not to mention on the Securities and Exchange Commission website.

I'm going to highlight what I found a little "surprising" in a way. Not very "diversified" are they? That's a little risky in my opinion, but who is to say?

The following are excerpts from their 10Q and 8Ks. It appears that there is a lot at stake riding on the success of Antegren.

Remember, none of this is "unusual" whatsoever, and is common practice, etc. for the most part. I just found it interesting and thought some of you might also.

Deb

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Our Revenues Rely Significantly on a Limited Number of Products

Our current and future revenues depend substantially upon continued sales of our commercial products. Revenues related to sales of two of our products, AVONEX and RITUXAN, represented approximately 92% of our total revenues in the second quarter of 2004. We cannot assure you that these products will continue to be accepted in the U.S. or in any foreign markets or that sales of either of these products will not decline in the future. A number of factors may affect the rate and level of market acceptance of these products, including:

•the perception of physicians and other members of the health care community of their safety and efficacy relative to that of competing products;

•patient and physician satisfaction with these products;

•the effectiveness of our sales and marketing efforts and those of our marketing partners and licensees in the U.S., the EU and other foreign markets;

•the size of the markets for these products;

•unfavorable publicity concerning these products or similar drugs;

•the introduction, availability and acceptance of competing treatments, including therapies that we may bring to the market in the future;

•the availability and level of third-party reimbursement;

•the success of ongoing development work on these products;

•new data and adverse event information relating to any of these products;

•the continued accessibility of third parties to vial, label, and distribute these products on acceptable terms;

•the unfavorable outcome of patent litigation related to any of these products;

•the ability to manufacture commercial lots of products successfully and on a timely basis; and

•regulatory developments related to the manufacture or continued use of these products.

Given our current reliance on these products as the principal sources of our revenue, any material adverse developments with respect to the commercialization of either of these products may cause our revenue to grow at a slower than expected rate, or even decrease, in the future.

Our Long-Term Success Depends Upon the Successful Development and Commercialization of ANTEGREN and Other Products from Our Research and Development Activities and Collaborations, and Increased Acceptance of ZEVALIN and AMEVIVE.

Our long-term viability and growth will depend upon the successful development and commercialization of ANTEGREN and other products from our research and development activities and collaborations, and, to a lesser extent, increased acceptance of ZEVALIN and AMEVIVE. We continue to expand our marketing of ZEVALIN and AMEVIVE, our development and commercialization efforts related to ANTEGREN, and our development efforts related to other potential products in our pipeline. The expansion of our pipeline may include increases in spending on internal projects, the acquisition of third-party technologies or products or other types of investments. Product development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Many important factors affect our ability to successfully develop and commercialize other products, including the ability to:

•obtain and maintain necessary patents and licenses;

•demonstrate safety and efficacy of drug candidates at each stage of the clinical trial process;

•enroll patients in our clinical trials and to complete clinical trials;
•overcome technical hurdles that may arise;

•successful manufacture of products in sufficient quantities to meet demand;

•meet applicable regulatory standards;

•obtain reimbursement coverage for the products;

•receive required regulatory approvals;

•produce drug candidates in commercial quantities at reasonable costs; and

•compete successfully against other products and to market products successfully.

Success in early stage clinical trials or preclinical work does not ensure that later stage or larger scale clinical trials will be successful. Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from additional data or analysis or that obstacles may arise or issues be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with our view of the data or require additional data or information or additional studies.

We have submitted applications for approval of ANTEGREN in the U.S. and EU as a treatment for MS. The FDA has designated ANTEGREN for Priority Review and Accelerated Approval as a treatment for MS in June 2004 and formally accepted the application for approval in July 2004. Our efforts to achieve the approvals necessary to launch ANTEGREN could be hindered if unexpected new data arises or if we encounter difficulties in our discussions with the FDA or other regulatory authorities, or if other hurdles arise.

************************************************
Our long-term growth will depend on the successful development and commercialization of new products such as ANTEGREN. Drug development involves a high degree of risk. For example, our plans to launch ANTEGREN as a treatment for MS could be negatively affected if unexpected concerns arise from additional data or analysis, if regulatory authorities require additional information or further studies, or if we were to encounter other unexpected hurdles.

For more detailed information on the risks and uncertainties associated with these forward looking statements and the Company’s other activities see the periodic reports filed by the Company with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

*******************************************

In July 2004, we and our collaboration partner, Elan Corporation, plc, entered into a license agreement with Genentech for a non-exclusive license to certain Genentech patents related to the manufacture of licensed products, including ANTEGREN. As a part of the agreement, we and Elan will each pay a $1 million license grant fee upon execution of the agreement and an additional $1 million on the first anniversary of the agreement. In addition, we and Elan may each have to pay a development milestone fee of $2.5 million, half of which would be paid upon the first marketing approval of a licensed product from the FDA and half of which would be paid on the anniversary of such approval. The agreement also requires that we and Elan pay royalties on net sales of ANTEGREN and other licensed products.

Looks like it's sh*t or bust for Elan as well...



http://www.timesonline.co.uk/newspaper/0,,2769-1336875,00.html

Wonder if they'll release the trial results after Nov 25th?

Robin

Awwwww.............geez!

WHY in the world (and how) did they put all their eggs in one basket? And go into such debt? They don't even have all of the neuros "on board" yet, either! I know at least ONE high profile neuro here indicates that he isn't that impressed with Antegren (yet, anyway) and is telling his patients that Antegren (in his opinion) is not suitable as monotherapy, and is used mainly as an "add on" drug therapy (this is according to what a patient said she was told. She was surprised at his advice because she had been anxiously awaiting Antegren.)

But then again, man..............how in the world can you weed out all of the overwhelming probable "influence" ploys (marketing, investor relations, etc.) that is being spread around right now, as opposed to the actual clinical efficacy?

And I've been watching the FDA applications. Nothing yet filed on Antegren here. I think I read where they were going to get approval in Canada first, though. Am I correct in that assumption?

Still................how much of these built-up "reveal" strategies are to influence stock prices?

And what's up with Biogen recently leasing a HUGE office building in the Netherlands? I investigated to be sure it wasn't going to be for manufacturing, and it's not. The lease is restricted to building occupancy being strictly for office use. There's something up with them and Denmark, but from a cursory review, I couldn't tell what exactly.

This almost feels like an "all or nothing" move on their part. Either they are thinking of a quick "strike and make it rich" short-term viewpoint, or they have something else up their sleeve. Is Antegren just a "take off" point? Man.........still.........risky business they are up to.

WHY do I get a feeling that it isn't Antegren that they have up their sleeve, so to speak. Something else is in their pipeline somewhere.........under wraps. I could be wrong, but I've seen this "quick strike" tactic used before. In order to infuse funds quickly.

Getting interesting, huh? As far as from a patient's viewpoint? There is way too much business maneuvering behind the scenes in connection with Antegren for it to feel real "secure" to me. But that's just SOLELY my opinion.

Still, I'd take a cautious wait-and-see approach before jumping on the Antegren bandwagon.

Deb

EDIT: Oh, yea, and their big-wigs have been moving around stock like crazy. That much inside stock activity doesn't bode well. Whenever you see that, you can bet there's a hidden agenda going on. Check out the amount of SEC form 4 filings they've been doing lately.

Oh, TOO funny! I just now went back and took another look at their 10Q. All last year they were fighting RICO charges against them! (That's racketeering, by the way.) They settled, but I had to laugh.

You know, they say they submitted application to the FDA in the second quarter of 2004, but the FDA doesn't show record of it (yet). Weird.

Ok...here it is:

" In July 2004, we announced that we will be restarting construction of our large-scale biologic manufacturing facility in Hillerød, Denmark to be used to manufacture products in the pipeline and will expand our global large-scale manufacturing capacity to 270,000 liters. The estimated cost of the project is estimated to be $340.0 million. As of June 30, 2004, we had committed approximately $0.4 million to the project. The facility is expected to be substantially complete in 2007 and available for commercial production in 2008."

Yea, they are into all kinds of stuff, but for some reason, I found this next item particularly interesting. I was JUST going to say that it almost looks like they are setting themselves up as venture capitalists! And then I came across this! HAH!

" In May 2004, we entered into a limited partnership agreement as a limited partner with MPM Bioventures III GP, LP, to create MPM Bioventures Strategic Fund, L.P, or the Strategic Fund. The purpose of the Strategic Fund is to make, manage, and supervise investments in relevant biotechnology companies with novel products or technologies that fit strategically with Biogen Idec. The Strategic Fund takes only minority positions in the equity of its investments, and does not seek to engage in day-to-day management of the entities. We have committed $65.0 million to the Strategic Fund over a three-year period. Through June 30, 2004, we have contributed $2.1 million to the Strategic Fund. We have consolidated the Strategic Fund in our consolidated financial statements at June 30, 2004. There were no significant expenses related to the Strategic Fund included in our operating results through June 30, 2004."

Hey! Maybe these ARE the guys I should send my research to!!!

In any event, these guys are interesting!

Deb

EDIT: Oh, it looks like their Netherlands thing is in connection to their "packaging" operations.

Ok...last post. I'm dying laughing, though!!!

Harry!! Get this - from the management team of Biogen Idec:

"Thomas J. Bucknum, Esq., Executive Vice President and General Counsel

Thomas J. Bucknum was previously Executive Vice President and General Counsel at Biogen. He joined Biogen in 1996 as Chief Corporate Counsel and was appointed Vice President and General Counsel in 1999. Previously, he was Senior Vice President and General Counsel for DuPont Merck Pharmaceutical Company from 1990-95, responsible for Legal, Government and Public Affairs. Mr. Bucknum held a number of positions with E.I. DuPont de Nemours and Company, including Director of Regulatory Affairs and Quality Assurance for Medical Products; Marketing Director for Agricultural Products, Europe, Middle East and Africa; European Counsel; and Patent Counsel for Pharmaceuticals and Agricultural Products. He holds a B.S. in Pharmacy, an M.S. in Pharmacology, and a J.D. from Temple University."

Small world, isn't it? I have no comment, of course. The above is just coincidental, of course, and has no bearing on anything other than just that.

Shoot, as a matter of fact, I still say maybe I should send my research to Biogen and see what they say about it, if anything. hmmmmmmmmmm..........

Deb

Guess he's still in the fertiliser business then....

Sorry, I couldn't resist...
Robin

Oh, TOO good!!!! (I think we have the same sense of humor, Robin!)

Deb

hmmm, sure seems like the ole diversification action, yet its very vague on what exactly is being diversified, and yes, that sure seems like a venture capital operation.

And they are certainly spreading themselves in many areas with lots of non specific baseline, lots of If's , and's, and maybe's.

Speculative subjection of non specific capital investment?

LOL..........Philip!!!

Well, on a different note, that I saw throughout but didn't post, was Biogen's repeating phrase of their interest in "novel pharmaceutics".

Like I said, I got going looking at them and found them really interesting, actually! Talk about some people with momentum!

Deb

You know what just hit me? An underlying "theme" that kept sort of hitting me in the back of my mind during my Biogen reading was "biological replication". Since I can't believe they are lining up to be a forerunner in CLONING, I then thought "stem cell"?

hmmmmmmmmm.....If Biogen is aligning themselves up to be "ready" and/or an active player in stem cell research, a lot of this makes sense.

Smart guys, if so.................. gotta hand it to 'em!

Deb

Oh my God! I shock myself sometimes!!

Each time I post something, I then head back out to the web and investigate further each new "direction" my mind has taken itself.

Get this! This is an excerpt of this man's biography:

"William R. Rohn, Chief Operating Officer of Biogen Idec

Currently, Mr. Rohn serves on the Board of Directors of Pharmacyclics, a pharmaceutical company developing energy-potentiating drugs to improve radiation therapy and chemotherapy of cancer, and to enable or improve the photodynamic therapy of certain cancers and atherosclerotic cardiovascular disease. In April 2002, Mr. Rohn joined the Board of Directors of Cerus Corporation. Cerus is developing medical systems and therapeutics based on its proprietary Helinx® technology for controlling biological replication.

So, I think...........ok......why join Cerus? Who are THEY?

Well............ Here's an article I found right off the bat.

http://www.findarticles.com/p/articles/ ... _109160273

"Cerus Corporation and the National Marrow Donor Program Initiate a Phase IB Clinical Trial for Stem Cell Transplants
Business Wire, Oct 23, 2003"

Stem cell..........And their theme is "novel technologies"!

But THEN I find this from the Stanford Law School Securities Class Action Clearinghouse! Oh, no!!:

"Cerus Corporation

Summary: According to a press release dated December 8, 2003, the complaint charges Cerus and certain of its officers and directors with violations of the Securities Exchange Act of 1934. The complaint alleges that during the Class Period, defendants artificially inflated the price of Cerus stock by issuing a series of materially false and misleading statements about the company's development programme for the Intercept Blood System for Red Blood Cells (Intercept RBC), a system that applies Helinx technology for the treatment of red blood cell concentrates.

The complaint further alleges that Cerus claimed that its Helinx technology for the treatment of RBC concentrates was represented by a family of novel small molecules that could target and crosslink nucleic acids of pathogens. The complaint alleges that Cerus claimed that when S-303, one of the novel Helinx compounds, was added to blood or blood components, it would cross through cell walls or viral membranes, and then bind to and crosslink these foreign nucleic acids (DNA or RNA). Cerus claimed that this action prevented the replication of the undesired viruses, bacteria and other pathogens, cutting off their capacity to cause infection. Cerus claimed that since red blood cells do not contain nuclear DNA or RNA, S-303 and other Helinx compounds could be safely added to RBC concentrates. Cerus also stated that its Helinx technology represented a selective and targeted approach to the inactivation of the undesired viruses, bacteria and other pathogens and a way to assure the safety of the blood supply. As a result of the defendants' false statements, Cerus stock traded at inflated prices during the Class Period, causing millions of dollars of damages to the Class. On 17 May 2001, just as Cerus stock had inflated to a price of $59/share, the company sold $78 M of its own securities via a secondary offering. On 6 Jun 2003, the company again sold an additional $54.3 M worth of its own securities. The individual defendants also took advantage of the inflated value of Cerus stock to sell their own shares for proceeds of over $5.8 M.

--------------------------------------------------------------------------------
INDUSTRY CLASSIFICATION:
SIC Code: 2836
Sector: Healthcare
Industry: Biotechnology & Drugs"


I live in the twilight zone..........LOL I guess this is why I get the requests I get [in my worklife - i.e. "hey, Deb.....go check out these guys. Tell me what you think they might be up to. (?)] GAWD!

Deb

EDIT: Well, this is MY guess as to what is "under wraps". Stem cell. They will be interesting to follow. Oh, what I meant exactly earlier by saying they weren't very diversified, was relating to "revenue stream". They are mainly investing, with very little "apparent" diversified revenue stream.

Deb.

>Harry!! Get this - from the management team of Biogen Idec:

Like I've said from the beginning....the whole scenario around Antegren simply makes me uncomfortable!

Harry

OddDuck,

Who is this neuro? Has he gone public with his impressions? I'd be interested to know what he is getting his hands on, since the rest of the stuff out there is so positive...

Just trying to prepare myself for best and worst case senarios!

[quote="OddDuck"]Awwwww.............geez!

WHY in the world (and how) did they put all their eggs in one basket? And go into such debt? They don't even have all of the neuros "on board" yet, either! I know at least ONE high profile neuro here indicates that he isn't that impressed with Antegren (yet, anyway) and is telling his patients that Antegren (in his opinion) is not suitable as monotherapy, and is used mainly as an "add on" drug therapy (this is according to what a patient said she was told. She was surprised at his advice because she had been anxiously awaiting Antegren.)

Does any doctor go "public" with their individual advice to their patients?

It's public knowledge that they are testing Antegren in combination with Avonex. No secret there. They aren't doing that for the fun of it.

Deb

EDIT: Go to Biogen's website and research like I did. Even they don't say a whole lot "positive" just yet. Like Philip said before - lots of "ifs" and "maybes", and "we hope so".

Besides, nobody is claiming Antegren won't be "good", just that it simply has ONE mechanism of action. Common sense will tell a person that you need to balance several things at once to effectively treat MS. Most immunotherapists will naturally lean toward combination therapy with Antegren.

Antegren doesn't affect the immune system much. Hence why the combo with Avonex.

Deb

EDIT: "Natalizumab [AN 100226, anti-alpha4 integrin monoclonal antibody, Antegren] is a humanised monoclonal antibody that blocks alpha4beta1 integrin-mediated leukocyte migration."

Also, you don't have to have "specific" media results from Biogen in order to research a VLA-4 antagonist. You can research what a VLA-4 antagonist does exactly, and what possible benefits having such a drug would be, what it would do, etc. The same way Biogen did in order to create Antegren in the first place. See what I mean? Research what and/or how blocking VLA-4 might help (or hinder) certain medical conditions, etc. Do some correlations. A person doesn't need to wait for a corporation's claims in order to research something themselves. Most clinical researchers/immunotherapists do just what I just said. Their own research and make up their own minds. (Or at least the good ones do.) The clinical trial results are only a small part of how they make up their own minds.