Here is the story many of us have been holding our collective breaths for-- the one year data from the Antegren AFFIRM trial is now public. The results show a 66% reduction in relapses compared to those on placebo. Relapse rate was the primary endpoint, or test, of the trial. Even more promising is that Antegren hit all the secondary endpoints too (number of new T2 lesions, number of active lesions, and proportion of patients who were relapse-free). Side effects (headaches, fatigue and joint pain) were 2% more common for those on Antegren versus placebo. One more reassurance is that there were over 900 people on the trial, and over 600 of them were on Antegren, so it seems to be a good sample size.

With all this positive news, we still want to caution everyone that this is the one year data from a two year trial, so wisdom dictates that we approach this with reserved optimism until we see the longer-term results (upcoming shortly-- the trial is already over). One thing is for certain though: after many years of stagnation, a promising new treatment option is going to be available for MS'ers very soon.

"Biogen Idec and Elan Corporation, plc announced today that one-year data from the Phase III ANTEGREN® (natalizumab) AFFIRM trial met the primary endpoint of clinical relapse rate reduction. In this international study of 942 patients with relapsing-remitting multiple sclerosis (RRMS), natalizumab reduced the rate of relapses by 66 percent compared to placebo, a statistically significant result. All secondary endpoints were also met...

'These data demonstrate that natalizumab dramatically reduced the rate of relapses at one year,' said Burt Adelman, MD, executive vice president, Development, Biogen Idec. 'We believe natalizumab, with its novel mechanism of action, has the potential to be a significant step forward in the treatment of MS.'

'Natalizumab has the potential to make a real difference in the lives of MS patients,' said Lars Ekman, executive vice president and president, Research and Development, Elan. 'We are working closely with regulatory authorities to make natalizumab available to patients in need as soon as we can.'

Click "read more" for the full story...

Here it is folks, Elan and Biogen have gone through with their public promises and formally submitted Antegren to the FDA for approval as a Multiple Sclerosis therapy, based on the one-year data from their two-year trial. Note that the trial is still on-going and as such, they do not want to reveal the interim results. But it is quite obvious that they must be very good if they are trying to get approval one year early. In drug company time, one year is practically nothing so there must be an overwhelming reason to spend the money and effort trying to get the approval done ahead of schedule... this bodes very well for the MS-afflicted. Also reassuring is the sheer number of people in the trial, as this large group would clearly reveal the side effect profile (at least the short-term side effects).

We're another step closer to a brand-new treatment option for MS-patients!

"Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of ANTEGREN® (natalizumab) for the treatment of multiple sclerosis (MS)...

"Based on the one-year analysis from our Phase III studies, which include more than 2,100 patients, we believe that natalizumab has the potential to become an important new therapy for MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "Natalizumab's novel mechanism of action represents an innovative approach to treating MS."

"This submission represents a significant milestone for Elan and Biogen Idec and demonstrates our continued commitment to providing a new treatment option for the more than one million patients experiencing the debilitating effects of MS," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan."

Click "read more" for the full story...

You like our title? Because that's basically the information we're about to give you. This study, which was likely from the Phase II trials of Jan '03 but just posted today in PubMed, shows unquestionable efficacy for Antegren (natalizumab) in a novel measure: Preventing the worsening of new lesions. Note this: The study presumes that Antegren reduces the number of new lesions-- it is exploring what happens to the lesions that DO form when a patient is on Antegren.

Basically this means two things:

1) Antegren reduces lesions

2) When lesions do appear, they do not get as severe (in size/activity) as they would if not on treatment

No word on side effects or long term stability, but containing our enthusiasm for this new treatment which has multi-modal effects (especially compared to the limited efficacy of the CRABs), becomes harder with every story we publish. Let's hope no hidden secrets are going to come up and ruin our fun...but enough of the conservatism; read and enjoy-- a new ray of hope is around the corner. As previous stories have mentioned, Antegren is up for fast-track FDA approval and *may* be available by the end of this year or early next if the FDA permits.

"BACKGROUND: Natalizumab, a humanized monoclonal anti-adhesion molecule antibody, reduces the frequency of new gadolinium (Gd) enhancing lesions and relapses in multiple sclerosis (MS). Its effect on evolution of new Gd enhancing lesions to T1 hypointense lesions is unknown.

...

Please click "read more" to get the full abstract...

Elan just sold off two of its established drugs in favor of funding its pipeline-- in other words, they are collecting their cash to put the big bets on two drugs they think will be huge, particularly Antegren for MS. This is yet another positive for people hopeful that Antegren will be the next great MS treatment.

"DUBLIN, March 31 (Reuters) - Irish drugmaker Elan Corp has agreed to sell its North American and European interests in epilepsy treatment Zonegran to Japan's Eisai Co Ltd (for about $130 million, the company said on Wednesday.

Elan, which has hauled itself back from the brink of bankruptcy in 2002, said the deal would allow it to focus on the expected 2005 launch of two key drugs, Antegren for multiple sclerosis (MS) and Crohn's disease, and Prialt for severe pain...

"Elan is reverting to a pure play on its pipeline with the strategic disposal of Zonegran coming only hours after the sale of Frova," said Jack Gorman, analyst at Davy Stockbrokers, adding Elan was likely to use the cash to prepare its marketing infrastructure for the launch of Antegren and Prialt.

Some analysts estimate the MS market alone could be worth more than $6 billion by 2010 and that Elan's Antegren could take a 40 percent slice of it."

Sourced from: here

Great news... first we saw Elan and Biogen file with the FDA for early approval in the US, and now they have taken the same step with the European regulators-- this demonstrates continued confidence by the company in Antegren's efficacy as an MS therapy. We obviously view that as a huge positive.

"Irish drug company Elan (Irish:ELN.I - News) said on Tuesday it planned to submit Antegren, an experimental multiple sclerosis drug it is developing with Biogen Idec (NasdaqNM:BIIB - News), for approval by European regulators this summer.

"The decision to file was made after discussion with European regulatory officials, based on one-year data from the ongoing phase III trials in MS," Elan said in a statement. "The companies are committed to completing these two-year trials."

Click "read more" for the full article text...

NEW Antegren update

Biogen continues to outwardly express optimism about its new multiple sclerosis therapy, Antegren:

"Biogen Idec Inc. is in active planning mode ahead of making its mid-year marketing application for its experimental multiple sclerosis drug Antegren, Chief Operating Officer William Rohn said Tuesday.
 
Speaking on a conference call to discuss the biotech company's first period as a combined company, Rohn said that the company wants to "to make sure we are ready for an early product launch," which would be in 2005 at the earliest...

Company officials declined to say if they thought the FDA would grant it a fast six-month approval timeline.

In mid-February, the companies said they plan to file for U.S. approval of Antegren a year ahead of schedule based on discussions with the FDA about the first year of data from two Phase III Antegren trials. Biogen officials repeated again Wednesday that they plan to complete the two-year trials, and won't yet disclose the results of the one-year data. The stocks of both companies hit their year highs on the news last month."

Again and again, we're seeing  that all signs point to positives both for the early release of Antegren, and more importantly, for its efficacy towards treating MS.

DEVELOPING STORY

What we've all had our fingers crossed for-- it's happening! Antegren has proved itself so effective in Phase III trials that Biogen and Elan are filling for early FDA approval-- something that is almost unheard of! Stay tuned for further developments, we are keeping a strong set of eyes on this story.

"[Biogen and Elan] said they planned to file in mid-2004 for U.S. approval of Antegren, the multiple sclerosis therapy, based on the one-year results of late-stage clinical testing that is scheduled to run for two years. Although the companies didn't release details of the clinical data, investors saw the application plan as a positive sign because the results are presumed to be strong enough already to merit approval....

"This is the first MS treatment to be allowed to file after one year which ... points to very strong data," said Peter Frawley of Dublin-based Merrion Stockbrokers.

"This is huge news. The talk has always been that Antegren could be much better than anything that's currently out there and that if approved would become the gold standard in this area," said Bloxham Stockbroker analyst Peter Jackson. "

Click "read more" for the full story...

"Elan Corporation, plc and Biogen Idec today announced that the Phase III maintenance trial of ANTEGREN® (natalizumab) in Crohn's disease met the primary endpoint of maintenance of response...These natalizumab data also reinforce the importance of studying its novel mechanism of action in the treatment of other severe and chronic inflammatory diseases. We expect to share the data from this study at a major medical meeting in the first half of this year...Concurrently, two Phase III studies in multiple sclerosis (MS) are underway. AFFIRM (natalizumab safety and efficacy in relapsing-remitting MS) will evaluate the ability of natalizumab to slow the rate of disability in MS and reduce the rate of clinical relapses; SENTINEL (safety and efficacy of natalizumab in combination with AVONEX® (Interferon beta-1a) in patients with relapsing-remitting MS) will determine if the combination of natalizumab and AVONEX is more effective than treatment with AVONEX alone in slowing rate of disability and reducing rate of clinical relapses.

"We are confident in the potential of natalizumab as a therapeutic option for patients with chronic immunologic diseases," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to working with the regulatory agencies to determine the next steps."

Please click "read more" for the full story...

Note: Another press release notes: ""We are extremely encouraged by these findings," Elan said in a statement.

The market has high hopes for Antegren, which is being tested on both Crohn's Disease and multiple sclerosis.