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Biotech / Medical : Sugen (SUGN) -- Ignore unavailable to you. Want to Upgrade?


To: John McCarthy who wrote (471)6/12/1999 11:41:00 PM
From: gao seng  Read Replies (1) | Respond to of 550
 
Wild guess here - check out ISIP

Isis and CIBA Vision Announce European CPMP Recommends Approval of Vitravene for Patients with Both Newly Diagnosed and Advanced CMV Retinitis
CARLSBAD, Calif., April 28 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) and CIBA Vision Corporation, the eye care unit of world life sciences leader, Novartis AG, have been informed that the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) have issued a positive opinion to approve the Marketing Authorization Application (MAA) of Vitravene(TM) (fomivirsen) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The MAA was filed by CIBA Vision in April, 1998.

The Committee recommended that until further experience is gained, Vitravene(TM) be approved for use in the local treatment of CMV retinitis in newly diagnosed or advanced CMV retinitis when other therapies are considered unsuitable or have been ineffective.

Vitravene(TM) is an antisense inhibitor of CMV replication, the virus that causes retinitis. CMV retinitis is a degenerative opportunistic infection that affects people with AIDS and results in blindness. Vitravene(TM) is the first antisense drug to be filed for commercial marketing review. Vitravene(TM) received approval for marketing in the United States in August, 1998.

''We are pleased that the committee recognizes the benefits of Vitravene(TM) in providing patients with an additional treatment option for CMV retinitis and especially pleased that the committee recommended Vitravene(TM) for both newly diagnosed and advanced patients,'' said Stanley T. Crooke, Chairman and CEO of Isis Pharmaceuticals. ''Assuming that the European Commission follows the CPMP recommendation, it will provide European patients and physicians with a new therapy with proven effectiveness against this disease.''

CIBA Vision holds exclusive worldwide distribution rights to Vitravene(TM).

This press release contains forward-looking statements pertaining to the therapeutic potential of Vitravene(TM), an antisense drug in development as a treatment for CMV retinitis in AIDS patients. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Actual results could differ materially from those projected in this release. As a result, the reader is cautioned not to rely on these forward-looking statements. These and other risks concerning the therapeutic potential of Vitravene(TM) are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1997 which is on file with the U.S. Securities Exchange Commission, copies of which are available from the company.

Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and development of novel human therapeutic compounds. Isis has six compounds in human clinical trials: Vitravene(TM) (fomivirsen), to treat CMV-induced retinitis in AIDS patients, has been approved for marketing by the FDA and has recently received a positive recommendation by the EMEA for European marketing; ISIS 2302, an inhibitor of ICAM-1, is in a pivotal quality trial for Crohn's disease, Phase II clinical trials for renal transplant rejection and is being explored as an enema formulation for ulcerative colitis, a topical administration for psoriasis and an aerosol administration for asthma; ISIS 3521 is in Phase II trials as a treatment for cancer; ISIS 5132 is in Phase II clinical trials as a treatment for cancer: ISIS 2503 has entered Phase II trials as a treatment for cancer and ISIS 13312 is in Phase I/II clinical trials for the treatment of CMV retinitis in AIDS patients. The company also has several additional compounds in preclinical development. ISIS' broad medical chemistry and biology research



To: John McCarthy who wrote (471)6/13/1999 2:35:00 PM
From: Miljenko Zuanic  Read Replies (2) | Respond to of 550
 
John and others:
You are all welcome.

I am well aware of QLTI (as well as PCYC and MRVT) work with photo-chemicals as drug-therapy for cancers and AMD. Also, QLTI stock price rise ~300% (in last few months) after positive AMD PIII data.

Regards the PKC 412, it is Novartis oral experimental drug (CGP 41251), currently in initial PI cancer trials. Probably CIBA Vision will explore further 41251-derivative for MD.

So, what this have to do with SUGN????

To be successful bt sector investor, one have to constantly look ahead few steps with wide angle. To *jump in* or *bail out* before the next guy.

Regards the SUGN, at this point, I do not see even slight sign for *bail out*. However there are still signs to *jump in*. On sign is this discussion on anti-angiogenesis approach for MD therapy. Novartis preclinical results with 41251 (however, dose of 300-600 mg/kg in MD model are several fold higher than regular dose, 10-20 mg/kg, which were acceptable as safety range in animal cancer model) indicate that TKs target is good one. Also, NXTR have VEGF-aptamer in AMD PI trial and AGPH have MMPs inhibitor AG3340 in PII MD trial.

In my last conversation with SUGN IR (Mrs. K. Susan) I asked did Allergan-SUGN selected lead anti-angio compound for MD. The answer was NO! I guess here that SUGN can't license to AGN SU xxxx class compounds (indolinone derivatives) because it will be conflict of interest/drug indications. However, I do not know does SUGN have any restriction on their cancer candidates in regards the other indications (and in connection with ALG collaboration), like AMD. They are free to explore candidates for inflammatory indications.

ALL IN ALL, I do not see any reason why SUGN will not explore SU6668 (if safety results are positive) for MD.

Miljenko



To: John McCarthy who wrote (471)6/13/1999 6:24:00 PM
From: David Bogdanoff  Respond to of 550
 
JM;
Thanks for article. To answer your question about which company, you could probably email the author of the article and ask him! :)

David