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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

To: Izzy who wrote (4577)	6/28/1998 4:21:00 PM
From: Gary L. Kepler	Respond to of 6136

Here is the SD Union Tribune article. LOCAL STOCKS Immune Response, Agouron Pharmaceuticals pact has potential By Don Bauder June 28, 1998 Earlier this month, two biotechs, Immune Response and Agouron Pharmaceuticals, announced a collaboration to commercialize the former's Remune as an AIDS treatment. "We believe that this deal serves as a major validation for the Remune technology by a leading player (Agouron) focused on the HIV market," says Caroline L. Copithorne of Prudential Securities. "In addition, it provides a needed source of funds to Immune Response for the completion of Remune development." Immune Response's losses should be pared, Copithorne says. She expects the 1998 loss to drop to 25 cents from her earlier expectation of $1.33. For 1999, she expects the loss will be 28 cents, down from the earlier forecast of 79 cents. She expects a profit in the year 2001: $1.43 a share, up from her earlier estimate of $1.24. Copithorne has a buy on the stock, but warns that it carries high risk. Merrill Lynch points out that Remune "has to date not been able to demonstrate convincing clinical efficacy," either because the clinical trials have not been conducted properly, or the drug doesn't work. "This profile of the drug may change," says Merrill Lynch, saying the drug has blockbuster potential. The collaboration will dilute Agouron's earnings per share by 20 cents this year and 30 cents next year, says Merrill Lynch, although it believes the transaction is a good one. It has its second-best (accumulate) rating on Agouron stock. However, James McCamant, editor of the Medical Technology Stock Letter in Berkeley, says Agouron stock is "woefully undervalued," in part because of a Merrill Lynch prediction that the annual growth of the HIV market will slow. That estimate is in error, McCamant says. Agouron, which has been trading in the low $30s, is a buy under $40, he says. Copyright 1998 Union-Tribune Publishing Co.

To: Izzy who wrote (4577)	6/29/1998 12:45:00 AM
From: margie	Read Replies (2) \| Respond to of 6136

As far as "those" analysts, I don't think they have factored in the growth in sales that will result from Viracept sales in Europe nor the upcoming approval in Canada and Mexico as well as other countries, nor data from Geneva that should give more support for choosing Viracept first, based on data showing it's durability, potency, convenient dosing, favorable cross-resistance profile, and mild side effects, and of course Remune. SOME NEWS EXPECTED AT GENEVA: There will be about 60 abstracts presented with information involving Viracept. Preliminary twenty week data from one of two Phase II studies on REMUNE plus HAART vs HAART alone has been accepted for a late-breaking session in Geneva. Data in approximately 40 patients using an ultra-sensitive assay<50 copies/ml) is expected to be presented. "Agouron was successful in licensing Remune against what we believe was rather formidable competition (i.e. major pharmaceutical companies) due to its demonstrated success." (from a PW report on June 12). I wonder who the major pharma were??? Dupont will present data on Sustiva, a potent non-nucleoside reverse transcriptase (NRTI) that requires only once a day dosing. Dupont submitted an NDA to the FDA on June 11, 1998. Some key interaction data between Sustiva and protease inhibitors have been found and is supposed to be discussed at Geneva showing that: Sustiva lowers the concentration of Fortovase by 60%; Sustiva lowers Crixivan levels by ~35%; Sustiva lowers Amprenavir ~35% (Vertex's VX141 levels by Sustiva increases the levels of Viracept ~20%, and no dosing changes are recommended. natap.org Dupont will present some data on the Phase III combination of Sustiva with Viracept, and some Phase II/III where Sustiva is combined with a higher dose of Crixivan. Glaxo says that patients should not take Fortovase in combination with Sustiva until more is known, although some physicians are doubling the dosage of Fortavase when it is used with Sustiva. Ritonavir increases Fortovase levels significantly, but Sustiva lowers Fortovase levels significantly. The interaction of all three is unknown and under study. I would imagine if data shows that Sustiva in combination with Nelfinavir is as effective as Sustiva in combination with Crixivan, Nelfinavir would be preferable because increasing the dose of crixivan is expected to lead to an increased incidence of side effects including more kidney stones. Nelfinavir can be taken BID and Sustiva once a day, making it an attractive combination. More data is expected to be released in Geneva to support nelfinavir BID. There are many who think that Crixivan BID does not produce adequate drug levels in between doses. thebody.com Glaxo is expected to report results in Geneva using Ziagen (Abacavir) in both treatment na‹ve and experienced patients. 3% to 5% of patients on Abacavir experience a severe hypersensitivity reaction which can be fatal if the drug is not stopped immediately and two patients have died from it. Data is expected to be released on Ziagen in combination with the protease inhibitors. Some 16 week open label data comparing Abacavir in combination with the 5 PI's is available at:http://www.aegis.com/aegis/pubs/aidswkly/aw1998/aw980301.html Both Sustiva and Abacavir are expected to have significant cross resistance to the two other nnrti's, delavirdine and nevirapine, and resistance to any one of the nnrti's will result in high levels of cross resistance to the other drugs in this class. Resistance to nrti's is thought to develop more quickly than to protease inhibitors. Although some are hoping that Sustiva or Abacavir will be able to be used in protease sparing regimens, there is not sufficient data to support this at present. Gilead is expected to present data on Preveon, PMEA or GS-840, a non-nucleoTide reverse transcriptase. Preliminary data has indicated that Preveon lowers viral load when used in combination with a PI and an NRTI. It does not show cross-resistance to other non-nucleoSide reverse transcriptase inhibitors and will be useful for salvage therapy. Amprenavir: As far as rumors claims that Amprenavir -141W94- is superior to Viracept, I don't think there is data to support those claims either. There are claims that Amprenavir will not show cross-resistance to other protease inhibitors but not all agree. The pivotal clinical data for Amprenavir is not expected to be released in Geneva, according to PW. D'Aquila et al found that the most common mutation (in >75% of patients failing amprenavir monotherapy) was at 50; but additional mutations seen at 10,36,77, and 84 are associated with cross resistance to crixivan, fortovase, and ritonavir. They also found mutations at p7/p1 and p1/p6. They said clinical correlation of resistance is necessary. Amprenavir is administered twice daily and does not require food but it does require taking 16 pills daily. The results of a very small Phase II study released 6/5/98 by Vertex showed VX141 was able to cross the blood/brain barrier in 8/9 patients at 32 weeks. But a small phase I/II study reported at the same time showed that only 1 out 5 patients had VL <400 copies/ml at 32 weeks. This was among treatment experienced patients, i.e. with prior monotherapy of VX141 for one month, then switched to rti's, and then VX141was added back. A different Phase II reported on 6/5/98 showed that 4/4 patients had VL loads<400 at 32 weeks. So the results have been variable so far. One small study was reported by Kost at the 5th Retroviral meeting where all four of Glaxo/Vertex drugs were used in combination: Abacavir, Amprenavir, AZT and 3TC (Combivir) in a twice daily regimen. There were 25 subjects: 13 subjects had acute infections (AI<90 days) and 12 subjects had chronic infections (CI>6 months). All were PI na‹ve. 14/20 subjects were undetectable at week 8 <100 copies/ml 8/12 subjects were undetectable at week 12 <100 copies/ml 5/8 subjects were undetectable at week 20 <100 copies/ml Rash (grade II or less) occurred in 7; Predominant side effects were nausea, vomiting, fatigue. Mean change in CD4-at week 12 for AI was +172 (n=7) +126 in CI (n=6) Note: The study started with 25 subjects and at week 20, data was reported for only 5 patients. aegis.com So....there is no data to support the analyst's claims that Abacavir, Sustiva, or Amprenavir will be equally as effective as Viracept, certainly not from any studies to date. This is another topic, but so far only ~10 cases of lipodystrophy on Viracept have been reported among the various 1000 to 1500 patients, na‹ve to protease inhibitors currently in clinical trials. And as we have heard, there will be several studies showing that some patients on other PI's who developed lipodystropy showed lessening of symptoms or at least no progression on Viracept.