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Biotech / Medical : IVAX Insider Trading -- Ignore unavailable to you. Want to Upgrade?

To: flickerful who wrote (239)	12/4/1997 11:07:00 PM
From: 5,17,37,5,101,...	Respond to of 756

<<Patent claims for this potential new use of Paclitaxel were recently allowed, as announced by the company on September 16, 1997>> I hope Ivax has such a patent that differentiates Paxene because we are going to need such a patent... I just read email from my FDA liaison: he intimated in more specific language that BM-S taxol orphan drug status will preclude availability of Paxene. I responded asking if FDA considered Paxene the same as Taxol under orphan drug law. Pending reply. I don't expect one. I suspect this is one of the issues the FDA is trying to resolve. Will there be reversal tomorrow to the upside? Please, Fortuna, spin my wheel upward! I supplicate thee with burning bones and fat! Jackson

To: flickerful who wrote (239)	12/5/1997 7:29:00 PM
From: 5,17,37,5,101,...	Read Replies (1) \| Respond to of 756

Here is another Taxol-derived anticancer drug. Surely Ivax will be allowed to sell Paxene. I say I don't really understand all of this nonsense. Jackson ++++++++++++++++++++++++++++++++++++???????????????????????????????? Thursday December 4, 9:34 pm Eastern Time Taxotere surpasses rival cancer drug - study SAN ANTONIO, Dec 4 (Reuters) - Taxotere, a cancer drug made by Rhone-Poulenc Rorer Inc (NYSE:RP - news), was found to outperform Adriamycin in reducing breast cancer tumors, a study said onThursday. Adriamycin, which was introduced in 1979, is the current first line of treatment for women with metastatic breast cancer. The results of the Phase III clinical trial, which were presented at the 20th Annual San Antonio Breast Cancer Symposium, confirms preliminary studies about Taxotere, Dr. John Crown of St. Vincent's Hospital in Dublin, Ireland, said in a statement. ''The results of this study would seem to indicate that Taxotere is more effective and safer than doxorubicin in patients with advanced breast cancer,'' Crown said. ''Because of the lack of overlapping toxicities, combining these two agents is likely to yield even greater efficacy and this is currently being studied in many settings,'' he added. Patients treated with Taxotere showed a 50 percent better overall response rate compared to patients treated with Adriamycin, which is made by Pharmacia & Upjohn Inc (NYSE:PNU - news), the study said. Among resistant patients, including those who had failed on previous regimens containing alkylating agents and those with liver metastases, the response rates from Taxotere were significantly higher than doxorubicin. Patients treated with Taxotere also showed a longer time to disease progression at 26 weeks than those treated with doxorubicin at 21 weeks, the study said. Also, the response to Taxotere was significantly faster at 12 weeks than the 23 weeks before a response to Adriamycin, the study said. A total of 326 women from 16 countries were entered into the study, all of whom had previous therapy with alkylating agents. One hundred sixty-one patients received Taxotere as a one-hour infusion given once every three weeks and 165 patients received a dose of doxorubicin as a short infusion every three weeks, the study said. Of the 161 Taxotere patients, approximately 41 percent had a partial response, shrinkage of the tumor by 50 percent or more, and 7 percent had a complete response. Of the 165 Adriamycin patients, 29 percent had a partial response rate and 4 percent had a complete response.

To: flickerful who wrote (239)	12/5/1997 10:26:00 PM
From: 5,17,37,5,101,...	Read Replies (2) \| Respond to of 756

Here are a few dates for the record: 4-1-97 Ivax will be seeking approval of Paxene in other countries "soon" per press release. 7-23-97 FDA panel accepts BM-S paclitaxel for consideration in use against K-S. 8-4-97 FDA accepts BM-S paclitaxel "efficacy supplement" (orphan drug status) for use against K-S [pretty quick acceptance, really] 9-19-97 FDA panel accepts Ivax's Paxene for futher consideration in use against K-S. 12-5-97 We are still waiting to hear of any kind of Paxene approval anywhere. Jackson