MY PICK IS ELN

[kingofthehill]

Elan (Buy, Current Price $29.8
Mouse patents squeaky clean
Elan and the Mayo Foundation announced this morning that they have reached agreement on a dispute over certain transgenic mice patents. The mice are being used to develop treatments for Alzheimer's disease and the agreement will allow both parties to use "an array of research tools" for such endeavours. The Elan patents on the mice have been acknowledged as valid and enforceable but under the agreement cross-licences will be provided to allow both parties continue their on-going research into the disease. Currently Elan has one drug candidate (AAB-001) in Phase I/II studies with data expected in mid-2005. It is also expected to file an Investigational New Drug (IND) request with the FDA for a second candidate in the first half of 2005 with a further two requests to bring candidate drugs from pre-clinical to human trials due late 2005 and/or 2006.

http://www.goodbody.ie/news/morn.html

Nice to see the Alzheimers effort getting a little more publicity

[kingofthehill]

The Sunday Times - Business



November 14, 2004

Judgment Day: Should you buy shares in Elan?
New drug is perfect cure for financial ills



ELAN shares reached an all-time high of $65 (€50) in 2001 before crashing to $1.05 a year later following a traumatic period that saw the American Securities and Exchange Commission (SEC) launch an investigation into the pharmaceutical company’s accounting policies and poor trial results from its hoped-for treatment for Alzheimer’s disease.
The pressure this placed on the company led to doubts about its ultimate survival.



But a rescue plan devised by Garo Armen, a main board director promoted to chairman and chief executive following the resignation of Donal Geaney, saw Elan unwind potentially devastating liabilities, deal with the SEC and, most important, get its drug pipeline back on track. With promising preliminary results from Antegren, the company’s treatment for multiple sclerosis, anticipation surrounding Elan has reached new heights in recent months.

Elan shares have been far and away the best performers on the Irish market in the year to date and, if all goes according to plan, have the capacity to increase substantially in 2005.

The two experts below have been selected for their skills in several investment areas. They, or the funds they manage, may hold shares in the companies or sectors discussed.

Kevin McConnell, head of equity research, Bloxham Stockbrokers

ANY shareholder sitting on an investment that has quadrupled in 11 months might be inclined to a profit. In the case of Elan, however, our view is that they should resist placing a sell order. We believe substantial upside remains for a company that over the next few weeks should see FDA approval of Antegren, its treatment for MS.

Biotech stocks such as Genentech and Imclone posted gains in excess of 50% after gaining FDA approval for drugs that had blockbuster potential. Antegren’s approval would validate Elan’s science and augurs well for its promising drug development pipeline.

Biotech investing is considered risky as it is based on assessing which pipelines can deliver supernormal profits. Next year should see substantial pipeline news flow from Elan, with clinical trial results expected for Antegren and its Alzheimer’s drug franchise. Elan should also become cash-flow positive next year and earnings positive in 2006.

By 2007 Antegren could be the leader in an MS market that is currently worth $4 billion (€3.1 billion). That could translate into earnings of $2 per share for Elan.

With standard biotech price-earning ratios running at 35-40 times earnings, the potential for a revaluation means the current price is compelling.

Events over the past few weeks have transformed the risk profile of Elan — a provisional SEC settlement; a $1.15 billion successful debt pricing; and the news that after one year of trials Antegren had hit its primary and secondary end points — drastically reduces that risk profile.

The re-rating resulting from Antegren approval should be supported by this expansion of Elan’s shareholder base.


Judgment: buy

David Marshall, equity analyst, NCB Stockbrokers

[kingofthehill]

copied from Forbes.com

If all goes as expected, Kelly Martin, CEO of Elan Pharmaceuticals (nyse: ELN - news - people ), and James Mullen, CEO of Biogen Idec (nasdaq: BIIB - news - people ), could receive a long-awaited green light from U.S. regulators for Antegren, a treatment for multiple sclerosis that the two companies are developing. Investors will be watching for data, yet to be released, on the drug. There could be a downside for Biogen if Antegren doesn't work well with the company's existing multiple sclerosis treatment, Avonex. If there are any warts, they are likely to be pointed out by Serono (nyse: SRA - news - people ), which makes a rival drug. Serono CEO Ernesto Bertarelli has been openly critical of Biogen Idec and Elan's decision to remain mum on their data until they get approval from the Food and Drug Administration. -- Matthew Herper

[Michaelk005]

I liked the sell of on Fri. Just the rookies getting scared and taking profits. My fingers are crossed for the announcement. Ill make a pretty penny and I bet you will to King.

We should be on the prowl for the next ELN.

[tokyojoeskid]

Is anyone buying the dec puts???

[RL]

Joe Kernen on cnbc said ELN drug was approved

[kingofthehill]

not yet maybe after the bell, the name change rumor seems correct as there is a drug with a similar name ..and http://www.fda.gov/cder/consumerinfo...fo/ANTAGON.htm it is also an injection


here is the latest info

BIIB Biogen Idec follow-up II (55.90 -1.24) -- Update --

As mentioned earlier (11:14 and 11:29), the Wall Street Journal reports that a Houston hospital prematurely issued a press release announcing the FDA had approved a new drug for multiple sclerosis from BIIB and ELN. A spokeswoman for The Methodist Hospital said FDA approval is expected as early as Tuesday, and the hospital is participating in the clinical trial of the drug, called Antegren. The spokeswoman said the director of the hospital's M.S. unit spoke to BIIB officials about FDA approval Monday. An FDA spokeswoman said the drug has not been approved. The hospital release indicates Antegren will have a new name when approved by the FDA, called Tysabri.

[kingofthehill]

APPROVED BABY ... http://www.fda.gov/bbs/topics/news/2004/NEW01141.html

[Websman]

APPROVED BABY ... http://www.fda.gov/bbs/topics/news/2004/NEW01141.html

Damn!!! I should have held it!!!

[kingofthehill]

23 November 2004
FDA Grants Accelerated Approval of TYSABRI, Formerly ANTEGREN, For the Treatment of Multiple Sclerosis
CAMBRIDGE, Mass. and SAN DIEGO, Calif. and DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 23, 2004--

Approval of TYSABRI Marks A Major Advancement in the Treatment of MS Phase III Trials at One Year Demonstrate New Level of Efficacy - 66% Reduction in Rate of Relapses Seen in AFFIRM Monotherapy Trial

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that the U.S. Food and Drug Administration (FDA) has approved TYSABRI(R) (natalizumab), formerly referred to as ANTEGREN(R), as treatment for relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical relapses. FDA granted Accelerated Approval for TYSABRI following Priority Review based on one-year data from two Phase III studies, the AFFIRM monotherapy trial and the SENTINEL add-on trial with AVONEX(R)(Interferon beta-1a).

TYSABRI, the first humanized monoclonal antibody approved for the treatment of MS, inhibits adhesion molecules on the surface of immune cells. Research suggests TYSABRI works by preventing immune cells from migrating from the bloodstream into the brain where they can cause inflammation and potentially damage nerve fibers and their insulation.

"TYSABRI is a powerful and innovative therapy that offers new hope for hundreds of thousands of people living with MS," said James C. Mullen, chief executive officer, Biogen Idec. "We believe TYSABRI will revolutionize the treatment of MS and become the leading choice for patients and physicians."

"TYSABRI is a significant breakthrough for patients with MS," said Kelly Martin, president and chief executive officer, Elan. "The approval of TYSABRI, with its unique mechanism of action and new level of efficacy, has the potential to make a genuine difference in the lives of patients and families who struggle with the debilitating effects of this disease."

Results of the AFFIRM Monotherapy Trial

AFFIRM is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide, in which patients were randomized to receive either a fixed 300 mg IV infusion dose of TYSABRI (n=627) or placebo (n=315) every four weeks. TYSABRI reduced the rate of clinical relapses by 66 percent relative to placebo (p<0.001), the primary endpoint at one-year. The annualized relapse rate was 0.25 for TYSABRI-treated patients versus 0.74 for placebo-treated patients.

AFFIRM also met all one-year secondary endpoints, including MRI measures. In the TYSABRI-treated group, 60 percent of patients developed no new or newly enlarging T2 hyperintense lesions compared to 22 percent of placebo-treated patients (p<0.001). On the one-year MRI scan, 96 percent of TYSABRI-treated patients had no gadolinium enhancing lesions compared to 68 percent of placebo-treated patients (p<0.001). The proportion of patients who remained relapse free was 76 percent in the TYSABRI-treated group compared to 53 percent in the placebo-treated group (p<0.001).

Results of SENTINEL Add-on Study

Approval was also based on the results of another Phase III clinical trial, SENTINEL. SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide.

In the SENTINEL trial, AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.

SENTINEL achieved its one-year primary endpoint. The addition of TYSABRI to AVONEX resulted in a 54 percent reduction in the rate of clinical relapses over the effect of AVONEX alone (p<0.001). The annualized relapse rate was 0.36 for patients receiving TYSABRI when added to AVONEX versus 0.78 with AVONEX plus placebo.

SENTINEL also met all secondary endpoints, including MRI measures. In the group treated with TYSABRI plus AVONEX, 67 percent of patients developed no new or newly enlarging T2 hyperintense lesions compared to 40 percent in the AVONEX plus placebo group (p<0.001). On the one-year MRI scan, 96 percent of TYSABRI plus AVONEX-treated patients had no gadolinium-enhancing lesions compared to 76 percent of AVONEX plus placebo-treated patients (p<0.001). The proportion of patients who remained relapse-free was 67 percent in the TYSABRI plus AVONEX-treated group compared to 46 percent in the AVONEX plus placebo-treated group (p<0.001).

"I believe TYSABRI will be an important therapeutic advance for patients with relapsing MS," said Richard Rudick, MD, lead investigator of the SENTINEL trial and director, Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation. "Patients who have discontinued therapy, are newly diagnosed with MS, or have persistent active disease despite being on a current therapy will benefit from TYSABRI."

Safety

Common adverse events associated with TYSABRI include headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, joint pain and abdominal discomfort. The rate of infection in both studies was approximately one per patient-year in both TYSABRI-treated patients and placebo-treated patients.

Serious infections occurred in 1.3 percent of placebo-treated patients and 2.1 percent of TYSABRI-treated patients. Serious infections included bacterial infections such as pneumonia and urinary tract infection, which responded appropriately to antibiotics. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions, which occurred at an incidence of less than 1 percent of patients.

Immunogenicity

All biologics have the potential to induce patient antibodies. Analysis of the one-year Phase III MS trials indicate a low level of immunogenicity associated with TYSABRI. Patients were tested for antibodies every 12 weeks in the AFFIRM and SENTINEL trials. Antibodies were detected in approximately 10 percent of patients at least once during treatment, with 6 percent of patients remaining persistently positive. Persistently positive antibodies were associated with a substantial decrease in efficacy and an increase in certain infusion-related adverse events. Almost all patients who tested positive for antibodies did so within the first 12 weeks of treatment.

Two-year Results

AFFIRM and SENTINEL are two-year trials. Two-year results are anticipated beginning in the first half of 2005. Patients who complete these trials are eligible for enrollment in a long-term safety extension study.

"The MS community is pleased that the FDA approval of TYSABRI provides an additional treatment option for people with relapsing forms of MS. There are many people living with MS who may benefit from this different treatment approach," said Stephen C. Reingold, PhD, vice president for research, the National MS Society.

About TYSABRI

Biogen Idec and Elan are collaborating equally on the development of TYSABRI in MS, Crohn's disease (CD), and rheumatoid arthritis (RA). In September 2004, a Marketing Authorisation Application (MAA) for CD was filed with the EMEA based on Phase III studies, and another Phase III induction trial for CD is ongoing. A Phase II trial is also underway to evaluate TYSABRI in RA. To date, more than 2,800 patients have received TYSABRI in clinical trials.

Information about TYSABRI, including prescribing information, and its comprehensive support services, will be available through a single toll-free number (1-800-456-2255), and via www.TYSABRI.com.

About Multiple Sclerosis

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

Webcast

The companies will host a joint webcast for the investment community tomorrow at 8:00 a.m. EST, 1:00 p.m. GMT, which can be accessed through the companies' websites. At the conclusion of this call, Elan will have a separate conference call to address any company-specific questions at 9:15 a.m EST, 2:15 p.m. GMT, which can be accessed through the company website.

About Biogen Idec

Biogen Idec creates new standards of care in oncology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.

About Elan

[rickg777]

Congratulations, ELN longs! Special thanks to KINGOFTHEHILL for all the positive posts and for hanging in through the emotional rollercoaster and for helping me hang in. What do you see happening next?

[Michaelk005]

Yahooooooooooo

[kingofthehill]

I love the stock, I will keep a great portion of my holdong for 2 more years this really should become a $100.00 stock.. now the shorts need 20 million shreas to cover, they will lie cheat and steal to do it so who know next week but on the longer term ..this stock is going way up !!!

HEALTH
MS Drug Receives FDA Approval

One-Year Results Prompt
Agency to Expedite Tysabri,
From Biogen Idec, Elan
By DAVID ARMSTRONG
Staff Reporter of THE WALL STREET JOURNAL
November 24, 2004

The Food and Drug Administration granted expedited approval to a new drug for multiple sclerosis that has produced impressive results in clinical trials.

The drug from Biogen Idec Inc. and Elan Corp. will be called Tysabri. It had been called Antegren, but the companies were required to change the name because Antegren resembled the name of another drug already on the market.

The stocks of both companies have soared since February when they announced the FDA would allow them to seek approval for the drug on the basis of just one-year results.

"This innovative treatment for multiple sclerosis represents a new approach to treating MS," said Lester M. Crawford, the acting FDA commissioner. "While we eagerly await long-term results from ongoing clinical trials, we have reason to believe that Tysabri will significantly reduce relapses in MS."

The companies said the drug will be available to patients next week.

How much of a boon to patients or the companies Tysabri will be is open to debate, but some analysts believe the drug could become the best-selling MS drug, with annual sales of more than $2 billion.

Tysabri reduced the rate of relapse in patients by 66% compared with a placebo group. That rate was almost double the reduction rate reported by the four MS drugs already on the market, including the best-selling Avonex, which is also made by Biogen. The other drugs are Rebif from Serono SA; Copaxone from Teva Pharmaceutical Industries Ltd. and Schering AG's Betaseron.

A second clinical trial was conducted to see if Tysabri reduced the relapse rate for patients taking Avonex, which had sales of $1.2 billion last year. For patients taking both drugs, there was a reduction in the relapse rate of 54% compared with the group taking Avonex and a placebo.

Biogen hopes those results will be good enough to convince some doctors that some Avonex patients should receive both drugs. Biogen receives all of the profits from Avonex but must split the profits from Tysabri with Elan.

The new drug generated buzz because it works differently than existing MS drugs. Tysabri binds to cells that are believed to damage brain tissue and cause inflammation, thereby preventing the cells from crossing from the blood stream into the brain. The other drugs regulate the immune system by, among other things, interfering with the production and migration of white blood cells thought to contribute to tissue damage and inflammation.

[billyjoe]

While this is great for ELN investors , it's even better news for those suffering from MS. How many times have their hopes been shattered by promising drugs that failed the trials . It makes me think of a couple friends that didn't live to see this breakthrough. I wish ELN has many more winners in the lab and in the market.
billyjoe

[New-born baby]

Congrats to the King

King,

Hearty and heartfelt congratulations to you for riding this thing out! Best wishes to you and ELN for many profitable years. I am not partaking of the profit. I left ELN a long time ago, as you once wrote, "ELN--Not for the faint of heart." My stomach couldn't take the ride. But I congratulate you on 'a full ride' (if you follow bullriding, you know what I mean).