MY PICK IS ELN

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  • kingofthehill
    Senior Member
    • Nov 2003
    • 487

    today Elan talked about how the new drug Tysabri is seeing wide use, they talked about the future...!!!!!!!!

    READ THIS ......CAREFULLY ...YOU TELL ME WHAT YOU THINK ....

    Q. You touched on the Alzheimer’s program a little earlier. I am wondering if you can give us an update on the timing and the enrollment of the vaccine trial? When should we expect to see some of that data and then anything you might have going on small molecules?

    Kelly Martin ELAN CEO: O.K., I’ll frame that and Lars can go through where we are with the vaccine. We have four programs. Three of them are in pre-clinical: gamma and beta secretase and the active [vaccine – ACC 001] program are all in pre-clinical. We are making progress on all three. And the AAB program, Lars, perhaps you could go through those?

    Dr. Lars Ekman ELAN: Yeah, we're about to finish the extended Phase I study. You have to remember that in Alzheimer’s disease you do not do Phase I studies as you would do in other diseases. You do it in patients. So there, we will finish that study which has been ongoing for now almost 18 months. We have 18 months of data in patients. We will start the Phase II in the first quarter of the coming year [he means 2005]. That will actually be two studies, one with 180 patients, and one with 30 patients in which we will study the image of the brain with the binding of the antibody to the plaques in the brain, which we are doing together with General Electric. So there will be altogether 210 patients in the study at the start. That will be an 18 month study with a one year interim look.

    Question: [unclear] Is that ’05?

    KM: Yes.
    Question: Just a follow-up: is it reasonable to think that that may be sufficient for a regulatory filing or are you looking at having to do a full-blown Phase III?

    KM: I’ll scare Lars by answering this. You know, it’s clearly an area that has enormous pressure: political [and] patient pressure. It’s also an area, however, – unlike other areas in the FDA like oncology and other things – where the perception of risk, or the willingness to take risk is almost zero. It will depend on the data, number one. And it will depend on where the Agency is vis-à-vis risk. It’s going to be improper to speculate, but clearly our job to deliver what we think is going to be very, very strong data. And then work with the Agency on the best path forward, as we have done with Tysabri and Prialt. But clearly, you know, the dimensions of this disease are geometrically growing. And the pressure on all of us to get “there” is very significant. I think that that pressure is not going to subside; it is going to go up. I don’t know Lars if you want to …

    Q. When is the immunoconjugate [ACC-001] going to start Phase I?

    KM: Sometime, we’re hoping sometime within the first six months of this year. We have done a lot of work on that and we are progressing that through the process, again getting all the “t”s crossed and the “i”s dotted. But, sometime in the first six months of this year.
    // If you listen carefully to KM's remarks, and Lars' important comment about the one-year interim look, you see a path laid out before you

    Comment

    • kingofthehill
      Senior Member
      • Nov 2003
      • 487

      Financial Times London

      Pharmaceuticals Merck and Pfizer were two of the big busts in 2004, each shedding about a quarter of its value thanks to controversies surrounding blockbuster drugs Vioxx and Celebrex. While 2005 may not hold more such blowups, it is not likely to be a banner year because of several ill winds heading toward the healthcare industry.

      First, while Big Pharma companies have invested heavily in biotechnology, the pipelines for the next two years look woefully short on blockbuster drugs to boost earnings. Meanwhile, a lot of political pressure is about to be exerted to squeeze costs out of the healthcare system just as rising costs for individuals may constrain spending as well.

      In this inhospitable environment, few US pharmaceutical companies will perform strongly. As Larry Feinberg of Oracle Partners suggested in FT Wealth's recent 2005 outlook, the companies that will hold up are those offering "must have" drugs, such as Switzerland's Novartis and Ireland's Elan Pharmaceuticals.

      Elan's stock has soared this year after recovering from near-bankruptcy and with high hopes for Tysabri, its new multiple sclerosis drug.

      While the stock is consolidating after a big move, if Tysabri proves to be the blockbuster it appears to be Elan may well be a strong performer.

      Of course, these unfavourable comparisons do not mean US stocks must fall off a cliff in 2005 - they may underperform other markets but other sectors should hold up well. But the examples here have parallels in nearly every industry. In steel, for instance, US Steel has had a strong run and while it trades with a modest 10 P/E, it does not compare with, say, Korea's Posco, a well-run steel company with a forward P/E below 5.

      With these opportunities, to refrain from going overseas is the greater risk.

      Comment

      • kingofthehill
        Senior Member
        • Nov 2003
        • 487

        take a look at the latest info on competing MS drugs,

        go to http://www.tixx.com/elan.htm

        Comment

        • kingofthehill
          Senior Member
          • Nov 2003
          • 487

          last chance to place your bets..the word is getting out, and the play is ELN who own 50% of all Tysabri profits. I really dont care that Elan is not mention it makes for nice entry point for new dollars. the stock is only $5.00 above its April 2004 price

          Todays Barrons

          BIIB New MS drug may boost Biogen's fortunes - Barron's Online (67.11 )

          Barron's Online highlights Biogen Idec, suggesting its new multiple sclerosis (MS) drug Tysabri may bring happier times. "If we overcome barriers to treatment, we will be on our way to placing Tysabri as a number- one treatment," CEO James Mullen said. Meanwhile, Biogen's pipeline has several early-stage experimental cancer drugs. And it's trying to find more uses for Rituxan, the cancer drug Biogen markets with Genentech. "We believe Biogen will be one of the most compelling large-cap biotech stories of 2005," wrote Mike King, an analyst with BofA. At 67, the shares are just 3% below their 52-w high. But the stock "does not fully reflect the potential for Tysabri," says Sam Isaly, a principal at OrbiMed Advisors, which recently bought Biogen shares. At 41.5x projected profits over the next 4 quarters, Biogen hardly looks cheap by traditional standards. It just barely trades below its 5-year median of 43.7x forward profits. David Webber, an analyst with First Albany, says Biogen deserves a P/E multiple of 45x. Multiplied by his estd profits of $1.76 a share in 2005, that produces a tgt price of 79.

          Comment

          • Michaelk005

            Hey King, You posted a while back on IPXL, I am currently holding this stock. Whats your take on it, you like a $25 buy out.. I dont know if im soo sure your price is high enough..

            Comment

            • spikefader
              Senior Member
              • Apr 2004
              • 7175

              FYI King. Thought you'd want to know. Looking for short tomorrow.

              Comment

              • kingofthehill
                Senior Member
                • Nov 2003
                • 487

                someone will buy IPXL, many players need a good generic drug maker, im just holding it and buying it and good dips


                Thanks Spike for the headsup

                options week will be fun for ELN


                From the S.G. Cowen Multiple Sclerosis Physician Consulting Conference Call
                Some comments from Dr. Ellen Lathi, MD, member of the team at the MS Center at St. Elizabeth’s Medical Center,

                Tufts University School of Medicine, Brighton, Massachusetts.

                In this center they have already already infused about 50 patients. Some already on their 2nd dose. They are going to infuse another 10-15 between now and next Tuesday. She heard that in a very large MS center in the South they are going to have 1000 or more patients on Tysabri,

                The infusion process going extremely well, no big reactions. So mild that the patients wondering if they are gettting the drug or just water.

                "Everyone wants Tysabri, people are chomping at the bit for it because of the convenience, because of the once-a-month. They know there is not the flu-like symptoms. Even our people who don't have much flu-like symptoms think that they lose part of a day from the fatigue after the interferon. So people really want it. So I think most newly diagnosed patients are opting for it."
                ***
                all three MS physicians on the conference call expect that about half of their patients will be on Tysabri after a year.

                ***

                Comment

                • spikefader
                  Senior Member
                  • Apr 2004
                  • 7175

                  Another channel hit today - in your favor.
                  Attached Files

                  Comment

                  • kingofthehill
                    Senior Member
                    • Nov 2003
                    • 487

                    Tysabri Launch Proceeding On Plan
                    On Friday, we hosted a conference call with three multiple sclerosis (MS) experts to
                    discuss the ongoing launch of Biogen Idec’s and Elan’s Tysabri. None of our three
                    consultants (one academic, two community based) had prior experience with
                    Tysabri in clinical trials, yet all three were well aware of the drug’s attributes and
                    have begun prescribing Tysabri to their patients. Physicians noted that awareness of
                    Tysabri amongst physicians and patients was extremely high, that reimbursement
                    and infusion access have not been substantial barriers to uptake, and that they each
                    intend to use Tysabri in over 50% of their patients within 2 years time. Perhaps most
                    surprising is that physicians are keen to use Tysabri in combination with other MS
                    therapies (despite an absence of robust data supporting additive efficacy) and that
                    reimbursement has not put a damper on such use. We believe use of Tysabri in
                    combination with beta interferons is tracking well ahead of Street expectations and
                    could be a significant positive for Biogen Idec’s Avonex franchise. Overall, the
                    conference call increased our conviction that Tysabri will be a very substantial drug
                    in the long term and indicated Tysabri’s early launch may be proceeding better than
                    some expect. Results (expected shortly) from our monthly tracking survey of 39
                    multiple sclerosis physicians should provide a broader view of Tysabri’s early
                    launch.
                    Initial Impressions Of Tysabri Are Highly Positive
                    Physician sentiment towards Tysabri appears strongly positive. Our consultants
                    indicated that during the months before the drug’s launch, excitement had been
                    building, and that the release of one year results from the AFFIRM study in
                    November 2004 created substantial buzz in the MS community. Although we chose
                    to host a call with physicians who did not participate in Tysabri’s Phase III trials, all
                    three were very familiar with Tysabri’s attributes and admitted to watching the
                    drug’s development for the past 2+ years. Adding to their knowledge of Tysabri was
                    the fact that two of the three physicians had attended CME sessions sponsored by
                    Biogen Idec over the past 1-2 months. It was also clear from our conversations that
                    Tysabri is not a drug that will require substantial detailing on BIIB’s part. Each of the
                    physicians was a strong believer in Tysabri’s benefits versus other MS therapies and
                    each noted that the patient community had been galvanized by the drug’s launch.
                    Thus far, physicians indicated having prescribed Tysabri to 4, 6, and 50 patients,
                    although not all of these patients have started infusions.
                    Biogen Idec
                    January 17, 2005 3
                    Tysabri Versus The Competition
                    Our consultants shared similar views on the pros and cons for Tysabri versus other
                    existing treatments. Most cited higher efficacy, a clean side effect profile, less
                    frequent dosing, and the ability to combine Tysabri with other therapies as positive
                    factors driving uptake. In terms of the biggest perceived negatives associated with
                    Tysabri, physicians cited the lack of lack of long-term safety and efficacy data, the
                    need for infusion services, development of neutralizing antibodies in a minority
                    (roughly 10%) of patients, higher pricing, and the need for good patient compliance.
                    On this later point, physicians noted that due to Tysabri’s mechanism of action,
                    missing an infusion by more than a few days could leave a patient susceptible to
                    potential relapse. In contrast, patients who discontinue or delay beta interferon
                    treatment are thought to be “covered” by an efficacy tail that may last two to three
                    months. Hence at least one physician has put into place a new system to ensure
                    timely dosing of Tysabri. Given the relatively infrequent administration of Tysabri
                    (1x ever four weeks versus 1-7x per week for interferons or Copaxone), we believe
                    patient compliance is not a substantial concern.
                    Counter Marketing Efforts Have Left Little Impression On
                    Physicians
                    Our consultants indicate that Biogen Idec sales representatives have modestly
                    increased the frequency their details to 1-2 visits per month to promote the benefits
                    of Tysabri (and to a lesser extent Avonex). Biogen Idec was also praised for providing
                    good educational and financial support, particularly in helping physicians set up
                    infusion centers and tackle reimbursement concerns. Given our physicians highly
                    positive views on Tysabri, it may not be surprising that they view counter -
                    marketing measures by competitors as weak and misdirected. Our consultants note
                    that efforts by Serono have been fairly negative and primarily centered around petty
                    arguments which are largely irrelevant or untrue. Teva has chosen to focus on
                    Copaxone’s lower cost, and to downplay the importance of inflammatory processes
                    in the progression of MS (consultants were not receptive to either argument).
                    Meanwhile, Betaseron reps were termed “quiet” on the Tysabri issue. Representatives
                    of other products have also pushed physicians to continue treating stable and well
                    cared for patients with existing therapies as opposed to switching to Tysabri.
                    Although physicians report that some stable patients have asked to be switched,
                    they are not inclined to do so.
                    Early Dosing Experience Has Been Positive
                    Our consultants are in agreement that Tysabri (monotherapy) will be the treatment
                    of choice for the majority of treatment-naïve MS patients. Our consultant with the
                    most experience using Tysabri commercially (50 patients on drug) indicates that
                    after detailing the positives and negatives of the various available MS treatments, all
                    but one of her patients has chosen Tysabri. The patient who chose interferon
                    therapy did so because of Tysabri’s “unproven commercial track record”, but
                    nonetheless switched to Tysabri after 2 weeks of interferon therapy. One of our
                    consultants noted that a minority of naïve patients (those presenting with severe
                    disease) are candidates for starting therapy on Tysabri plus beta interferon.
                    Consultants have treated patients in a variety of settings. The consultant affiliated
                    with an academic center has extensive infusion capabilities in house which were
                    established in anticipation of strong demand for Tysabri. One community physician


                    FROM A VERY EXPENSIVE REPORT RELEASED THIS WEEK ...ON TYSABRI

                    Comment

                    • Websman
                      Senior Member
                      • Apr 2004
                      • 5545

                      Sounds like it may be time for me to buy and hold ELN

                      Comment


                      • Thanks

                        Boy, after all this I can feel like one of those drug reps that educates the doctors! Thanks for all your detailed posts, and I am rooting for ELN.
                        Bruce

                        Comment


                        • P.S. to kingofthehill

                          Sorry if this information is in an earlier post by someone else, kingofthehill, but I am a mutual fund aficionado and there is a very small fund called the Bruce Fund (no relation to me!-symbol BRUFX) that is starting to get more and more publicity---its managers are believers in Elan and it (Elan) has been mentioned in some articles about the fund and its holdings.
                          Bruce

                          Comment

                          • kingofthehill
                            Senior Member
                            • Nov 2003
                            • 487

                            Biogen & Elan give 4th quarter updates Feb 8th & 9th ..the latest down turn is just part of the Biotech turn, Tysabri will lead the way for these 2 companies

                            here is something posted on another board about Elan

                            4% and other thoughts
                            by: elanalum
                            Long-Term Sentiment: Strong Buy 01/24/05 04:38 pm
                            Msg: 523286 of 523397

                            Elanians,

                            As my prior posts indicate, I'm an ex-employee, over a decade at ELN. I thought a number of comments were worth reflecting:

                            1. Tixx's data indicates Tys has 4% of NRX in the MS market at the end of four weeks. That is simply awsome. It translates to at least $150M in sales. Consider further that our NRX is 25% of the vaunted Rebif...and Rebif has been out for how long???!!!

                            2. EDSS data, while us investors want the data now, I think the AAN in April in Miami is more likely. Why? Let's assume the data is on line with the one year? Then why put it out outside an appropriate medical setting? All you do is drive demand to a level where supply might be an issue. Why do I assume the data is in-line? If it was worse it would probably be material and forced disclosure by now because the data is in house. Beyond that, how much better could it be?

                            3. Future competition: They NVS drug may be interesting. Our P2 data was exciting too. But, it's a long way from here to there. We've all learned that.

                            4. AD...it remains the big bet and Dale and his team are the best in the business. I am personally cautiously optimistic that we will see some data that reflects the therapeutic affect of our compounds. If so, the future will be quite nice indeed for investors and patients.

                            So, the day to day may cause much agita, and I think some of the PPS projections may be bullish, but overall, I certainly can't think of a better investment and the initial MS scripts are backing that up!

                            Eric

                            the site refers to http://www.tixx.com/elan.htm

                            Comment

                            • kingofthehill
                              Senior Member
                              • Nov 2003
                              • 487

                              from NCB brokerage report this morning released in Ireland

                              Physician uptake points to strong Tysabri launch
                              * At an investor conference yesterday BiogenIdec management updated on the launch of Tysabri. It was reported that as of January 15th, 1,600 physicians had prescribed Tysabri to at least one of their patients, which is an increase of 300 physicians on the 1,300 clinicians reported the previous week. These physicians are reported to be within the targeted group of 6,000 neurologists who write the majority of scrips and are therefore likely to have written multiple prescriptions. Whilst there is likely to be a lag (likely to be several weeks in length) between prescribing and administration of the first Tysabri infusion to a new patient as the reimbursement process is navigated, the wide breath of clinician usage so soon after launch is indicative of a very strong launch.
                              * BiogenIdec targeted 1,000 infusions being achieved over the first 60 days post Tysabri launch, which should clearly be significantly beaten. Our forecasts for patients on Tysabri by end of January are 1,500, by end March 6,500 and 14,000 by end of June. We expect that both BiogenIdec and Elan management's will update at the upcoming Q4 results presentations (February 7th & 8th) on the number of patients on Tysabri as of the end of January and the number of prescriptions written.
                              * Given we are towards the top of the market for Tysabri expectations (and our early numbers appear too low) the strong launch bodes very well for upgrades to Tysabri forecasts. If the 2-year Tysabri data (disability and relapse data) due from late-February is positive (as we expect) the strong early traction of Tysabri should be amplified.
                              * Our forecasts for Tysabri in MS assume sales peaking in 2009 with 42% market penetration in the US by this time point and 36% penetration in the Rest of the World (RoW) markets. Our 2007 revenue forecasts drive EPS of $1.60 - suggesting that the stock is currently trading on 16.5x 2007 earnings. We reiterate our BUY rating and price target of $37, which is supported by both earnings and DCF based valuation analyses.

                              Summary of our Tysabri forecasts by MS patient subgroup (three main groups)
                              New MS sufferers presenting for treatment (c.10,000 per year)
                              * 3,000 take Tysabri in 2005 and 4,000 per year to 2009
                              Patients switching from other therapies (c.10-15% stop or switch each year)
                              * c.30% of patients have switched to Tysabri by 2008
                              Relapsing remitting MS sufferers currrently not treated
                              * 7,000 take Tysabri in 2005 and 9,000 in 2006-2008

                              Of our 2007 Tysabri forecast
                              - 47% of patients are new or currently untreated patients."

                              Comment

                              • kingofthehill
                                Senior Member
                                • Nov 2003
                                • 487

                                In a note on BIIB today SG Cowen raises sales estimates for Tysabri in 2006-2009 to $1,25Bill (0,6B), $2,4B(1,2B), $3,3B(1,7B) and $4,0B(2,4B) or around 100 % .
                                They recommend buying BIIB due to Tysabri

                                Comment

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