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Biotech / Medical : Biotech Holdings -- Ignore unavailable to you. Want to Upgrade?

To: biffpincus who wrote (212)	4/18/2000 1:52:00 AM
From: biffpincus	Read Replies (1) \| Respond to of 224

My questions to and answers from BIOHF IR ... Mr. Rand: I just called the office in hopes with speaking with you personally, but was told that you had just left for the evening. I'm in New York so it is difficult for me to call during regular business hours. I thought it might be more convenient if I posed, via email, some questions that I have about the company rather than taking up too much of your time on the phone. Your posting on one of the Boards last night answered many of our questions but raised a few others. I really appreciate your taking the time to go through my questions, and if you have anything to add to my understanding of the company, you have my thanks. My questions in no particular order: Question (1): BIOHF has mentioned Phase III trials but nothing about the FDA application. Has the company applied for same? It is my understanding that an FDA application for approval takes at least a year. Even though you can make licensing deals without approval, what is the timeline for FDA/USA approval? Answer (1): An application in the US would require first having a major pharma licensee in place, which could be done, the President of Biotech has suggested, once the Brazilian approval has been achieved. Once a licensee is in place, it would reasonably take 3+ years to do the clinical work required by the FDA and get an FDA approval. An approval in Mexico, however, might be possible some time next year, if the Brazilian approval is achieved this year. Question (2): At this point, the manufacturers of Avandia and Actos seem to be the main beneficiaries of the withdrawal of Rexulin from the market especially with their corporate marketing muscle. From your posting on the boards, you suggested that DIABII marketing would be done by individual companies in their respective regions. Is there any possibility of licensing the drug to a single worldwide carrier with significant "muscle". And if marketing rights are given worldwide to a foreign company, would those rights include the United States when domestic approval is eventually given by the FDA? Are you even considering entering the U.S. market? Answer(2): A licensing agreement with a major pharma is likely for a market such as the US or Japan. Typically, though, the President of Biotech believes that he can get more sales and more money by working with strong, non-multi-national licensees. Question (3): Many diabetics are treated with more than one drug in order to achieve control but the majority, 70-80% need only a first line drug. In order to be complementary, a second line drug must have different mechanisms of action and be found to have no adverse interaction with other diabetic drugs. I've been told that only one new drug has come out in the past ten years that is a "first line" drug and that drug is "Metformin" (Glucophage). If Diab II is not a "first-line" drug the potential market drops. Does Diab II have interaction problems with any other drugs that could impair its "first line" status? Answer (3): Metformin is a well-established drug that is generic in many markets now. Avandia is first-line or monotherapy approved in the US but has been specifically refused the monotherapy label in Europe. The President of Biotech believes that DIAB II has an excellent chance of becoming a first line drug. Question (4): How many other drugs does BIOHF have in its pipeline? Answer (4): The President of Biotech is interested in various applications of DIAB II but to my knowledge there are no other drugs in the pipeline. Question (5): How many shares are authorized? Are there any plans for a secondary? What is the status of the company's convertible debentures? And, if they are in play, do they have a solid floor price? Answer (5) : Authorized shares: unlimited. It is unlikely that a secondary offering will be done. The President of Biotech has personally arranged all financings to date with offshore companies. Question (6): What accounted for the reduction in revenues for the the skin care line? And what are the company's plans to build up that part of the business? Answer (6): Personal care side of the business had reduced revenues due to some major customers deciding to not carry the line or to make it themselves. This part of the business is building and should do well in the year starting April 1/00. Question (7): It is my understanding that Colin Leech-Porter, the President of ImmuNis Corp. (IMMCE)(a company I can't find much information on) purchased a 25% interest in the commercial rights to DIAB II in 1998. Does he still hold those shares, and if so, is he an active partner in promoting the success of DIAB II and the company? What does IMMCE bring to the table? Answer (7): The President of Biotech has said that he would like to purchase, for Biotech, IMMC's 25% interest in the distribution profits of DIAB II outside East Asia. Question (8): Finally, and with all due respect, that Biotech is headquarted n Vancouver is seen by some as "red flag" due to some unfortunate scandals in the past. Can you offer and comment or reassurance that could address those fears i.e., professional associations that Biotech is a member of, Better Business Bureau type statistics, etc., et al. Answer (8): To my knowledge, Biotech does not belong to any trade or professional associations having to do with the biotech industry. The above are brief answers to some of your questions. I am generally in from about 10 a.m. NY time each weekday, so please call me again at your convenience. Austin Rand Information Officer, Biotech (Voluntary Disclosure: Position- Long)