Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (3359)	10/4/2002 12:23:58 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 10345

Elite Acquires All Rights in Oxycodone and Other Products Friday October 4, 12:14 pm ET NORTHVALE, N.J., Oct. 4 /PRNewswire-FirstCall/ -- Elite Pharmaceuticals, Inc. (Amex: ELI - News; "Elite") announced today that it has consummated an agreement with Elan Corporation, plc (NYSE: ELN - News) to acquire all of Elan's interest in a joint venture company, Elite Research Limited. The termination of the joint venture results from Elan's continuing restructuring efforts. Elite now owns 100 percent of the joint venture company and intends to expedite the development of the products that were developed within the collaboration. The joint venture has completed the initial Phase I study for its first product, a once-a-day Oxycodone formulation. The study compared the once a day formulation against the twice-daily reference product that is currently marketed. The data showed comparable bioavailability. Accordingly, Elite intends to proceed with the next stage of development. The US market for twice a day oxycodone products exceeds $1 billion. Currently there is no once a day formulation for this compound. The joint venture has also been developing a second product in the CNS therapeutic area to compete with a currently marketed product whose US sales exceed $1 billion. Dr. Atul Mehta, the President and CEO of Elite stated, "We are excited to have obtained the world-wide development and commercialization rights for these products. We anticipate commencing larger studies on the first product in the near future. As a result of this transaction, we have regained control over the products, and we are now in a position to make the strategic decisions that will most efficiently move them toward commercialization." Under the termination agreement, Elite acquired all proprietary, development and commercial rights for the worldwide markets for the products developed by the joint venture. In exchange for this assignment, Elite Research has agreed to pay Elan a royalty on certain revenues that may be realized from the once-a-day Oxycodone product only that has been developed by the joint venture. Elan and its transferees also retained Elite securities that were issued in connection with the joint venture, and those securities are being converted to Elite common stock at a significant premium. Elite Laboratories, a wholly owned subsidiary of Elite Pharmaceuticals, Inc. specializes in oral drug delivery, and applies its proprietary controlled release technology to the development of delayed release, sustained release, targeted release and pulse release products for NDA or ANDA submission. Elite has been issued several patents, and additional patent applications are pending. This release contains forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include outcomes of current or pending research and development activities, actions by the FDA and other regulatory authorities, changes in competitive or market conditions, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q, and 8K reports. FOR FURTHER INFORMATION, CONTACT: Jonathan Fassberg of The Trout Group Phone: (212) 477-9007 Ext. 16 Website: elitepharma.com

To: scaram(o)uche who wrote (3359)	10/8/2002 5:51:25 PM
From: Cacaito	Read Replies (2) \| Respond to of 10345

Schenk D., Opinion: Amyloid-beta immunotherapy for Alzheimer's disease: the end of the beginning. Nat Rev Neurosci 2002 Oct;3(10):824-8 From the full article (caveat, it is my summary): 1. The animal research is reviewed, lots of very good models 2. Basic biochemistry: Amloid Precursor protein is cleavage by beta-secretase one fragment is the beta-stub then cleavage by gamma?-secretase one fragment is the AmyloidBeta peptide42 (42 aminoacids legnth) this are the ones that forms the plaque and toxicity is triggered against the brain. 3. The Proposed Rx Immunological Approaches: a.Active immunization with the whole AB42 (from Elan, known as AN-1792) and the only human clinical trials so far)plus adjuvant QS-21 b.Active immunization with AB42 fragments (especially the first 16 amino terminal portion) plus a carrier protein conjugate (from Who?) c.Passive immunization with monoclonal antibodies against AB42 or its fragments (from Who?) 4. Mechanisms: a. T cell activation b. Microglia activation c. Antibodies d. one or all could work by: attacking/eliminating the plaque, decrease AB42 in serum, and/or preventing the fibrillar AB42 aggregation formation before becoming plaques... 5. Clinical Experience (human) with AN-1792: a. whole AB42 plus QS-21 adjuvant given to subjects from one to several times b. Phase I 24 subjects- preliminary safety c. Phase I 70 subjects- multidosing and safety d. Phase IIa, the main trial so far, 375 subjects recruited, 4:1 ratio then 300 got AN-1792 and 75 got placebo. This trial is trying to establish some efficacy evidence. c. 17 of 300 (5.6%) different degrees of severity of meningoencephalitis confirmed with MRI or Csf changes. Interestingly the author calls this a "small percentage", and apparently no deaths. Subjects got reaction from 1 to 3 doses. d. Antibody levels in the affected subjects DID NOT correlate with meningoencephalitis, some with no detectable levels. f. Therefore (caveat, this is the theory): AN-1792 strategy (active whole AB42 immunization) activation of T-cell and/or Microglia activation is/are the responsible mechanism/s for the side effect... g. Then...Fragment/conjugate active immunization strategy (that it is known to activates T-cell less) or Passive monoclonals (that obviates T-cells altogether) should give no meningoencephalitis. f. some evidence that direct brain or csf approach with monoclonals (just at the blood level) could work as fine (according to the peripheral-brain ration decrease levels idea). 6. AN-1792 trial is not dosing subjects anymore, BUT very importantly continues to follow up all the subject without breaking the "blind coding" for assesment of efficacy and it is expected to have the clinical results "into 2003". There are seemingly chances that the drug does shows that it works, and that the side effect is not a deterrent, or at the least this trial is the harbinger of a refined approach (fragment, monoclonal, even an improved AN-1792) that will provide a good treatment for this devastating disease.