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Finally, my notes from the Annual Meeting:
Adcon-L is available in 29 counties outside of the US and more than 12,000 patients have been treated without an adverse reaction. US launch will be via independent sales agents who sell to spinal surgeons. There are 29 agencies with a total of 140 representatives who will provide total coverage of the 50 states. The marketing will be targeted to the 4,000 neurosurgeons and 2,500 orthopedic surgeons who perform 80-85% of lumbar spinal surgery done in this country. The Company believes that there is a 200 million dollar market opportunity. Analysts are projecting that the company will get 5-10% penetration in 1st 12 months (i.e. 5-10% of 400,000 surgeries done here)
Adcon-TN--Sales are increasing in Europe but units sold lag behind Adcon-L. The number of procedures is less and the "clinical support package" for all the possible clinical indications is not as strong with T/N as it is with Adcon-L. Pivotal trial in US is progressing and the target for US PMA submission is 1999.
Adcon-P--Data analysis from the pilot trial should be completed by the end of June. The pivotal trial is targeted to begin in the 3rd quarter of 1998. Adcon P is a resorbable coating solution. The Company believes that it has good mucoadesive properties (attaches to all the tissues in the lower peritoneal cavity). The product should be useful to prevent both primary and de novo adhesions. Primary adhesions are those that occur in the area that the surgery was performed and de novo adhesions are those that occur away from the area of the surgery and are thought to result from unavoidable touching of the tissue by the surgeon's hand or an instrument. The product will be applicable to both open and laproscopic procedures. It will be easy to administer thru the laproscope.
Adcon A is "close to the beginning of clinical testing".
Cognition Modulation Program-- The focus is on the H3 histamine receptor which is located primarily in brain and remainder of the central nervous system. The H3 receptor controls levels of awareness and alertness. The lead compound is identified, patented and undergoing formalized animal safety testing. Human clinical testing is targeted to begin in the 4th quarter of 1998.
Alzheimer's program-- The Company is now in the 4th year of a good working relationship with Johnson and Johnson. The objective of the program is to develop drugs to stop the progression of the disease. They are very close to selecting a lead compound. The "rule of thumb" is that human clinical testing could be expected to begin about 1 year after the compound is selected. A milestone payment from J&J will be triggered when a lead is selected for human testing. This is expected "in the latter part of this year".
Other Notes:
Resale rate to existing accounts in Europe is increasing.
Since the company has a CE mark for Adcon technology, Adcon-L and Adcon-TN, introducing additional Adcon products to the European market should be an easier process. Having Adcon-L on the market in the US probably will not affect any FDA deliberations on Adcon-P since A and P will be reviewed by separate portions of the Agency.
Efficacy Study in Germany-all 400 patients have been enrolled. Code will not be broken till all have had their 6month followup. The result of the data analysis will not be available till late fall/4th quarter of 1998. Even though this data is not available, sales in Germany are improving.
FDA approval in the US should have a beneficial effect on sales all in non US markets.
Japanese approval of Adcon-L and Adcon-T/N--may occur late this year or sometime next year.
J&J Development Corporation, a subsidiary of J&J has about 3% of the Company. It is customary for J&J to take an equity position in small companies that they have partnerships with.
Sorry if this is repetitive, but I needed time to get though my tape. |
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