=============================================================== == == == ----------- ALS INTEREST GROUP ----------- == == ALS Digest (#29, 18 MAR 1993) == == == == To subscribe, to unsubscribe, to request back issues, == == to contribute notes to ALS Digest, etc. please send == == e-mail to: == == bro@huey.met.fsu.edu (Bob Broedel) == == == == All interested people may "broadcast" messages to == == to ALS Digest subscribers by sending to: == == als@huey.met.fsu.edu == == == =============================================================== (1) ===== ------------------------------------- ALS INTEREST GROUP (18 March 1993) --------------------------------------------------------------- MTS@gnv.ifas.ufl.edu .......................... Tom Sanford murray@sumax.seattleu.edu ..................... Mary Anne Murray stever@tessi.com .............................. Steve Rentala SMIRNES@IMIHSRA.BITNET ........................ S. Palazzi PHIP@TEMPLEVM.BITNET .......................... Tina Phipps RRICCIUT@WCU.BITNET ........................... Rae Ricciuti andrew@uaneuro.uah.ualberta.ca ................ Andrew Penn IEQZ96M@TJUVM.BITNET .......................... Michele Lee sissi@tinman.gene.com ......................... Sissi Tchehrazi linda@nuhub.acs.northeastern.edu .............. Doug Hanson smith@alexia.lis.uiuc.edu ..................... Linda Smith Jim.Knox@um.cc.umich.edu ...................... Jim Knox Tom.Butts@um.cc.umich.edu ..................... Tom Butts Lori.Nelson@Forsythe.Stanford.edu ............. Lori Nelson E1.R17@STANFORD.BITNET ........................ Bob Hess Norm_Oliver%NINDS31%NIH@fedtcp.ninds.nih.gov .. Norman Oliver dlmc@med.unc.edu .............................. David McIlwain bro@huey.met.fsu.edu .......................... Bob Broedel ZINJMAN@uog.pacific.edu ....................... Gary Heathcote Paul.Herrling@PKFLTG.PHARMA.SANDOZ.CH ......... Paul Herrling ROSE@fsu1.cc.fsu.edu .......................... Kermit Rose moore@geomag.gly.fsu.edu ...................... Christie Moore gamyers@icaen.uiowa.edu ....................... Glenn Myers fischbeck@a1.mscf.upenn.edu ................... Kenneth Fischbeck rfabian@utmbeach.bitnet ....................... Rod Fabian M.Duncan@unsw.edu.au .......................... Mark Duncan lannyh@bcm.tmc.edu ............................ Lanny Haverkamp 72567.400@compuserve.com ...................... Mike Ward 72677.1211@compuserve.com ..................... Jonathan Licht springerj@hal.hahnemann.edu ................... Joe Springer wharriso@ccit.arizona.edu ..................... Lliam Harrison ronmoss@panix.com ............................. Ron Moss afc04@albnydh2.bitnet ......................... Alvaro Carrascal wl@u.washington.edu ........................... Will Longstreth icla@immoscow.gtc.de .......................... Erik Minsker mdcphdmd@ukanvm.bitnet ........................ Martin Donal Cunningham rlinden@brlncc.bitnet ......................... Rafael Linden jnayram@vtvm1.cc.vt.edu ....................... Mary Ann Johnson tolkin@ksr.com ................................ Steve Tolkin MDKRUPIN@PLKRCY11.BITNET ...................... Jerzy Krupinski britell@rch.edu ............................... Cathy Britell 70272.1034@compuserve.com ..................... Kathy Miller 75050.767@compuserve.com ...................... Armand Cajigal Chris_Oseto@mailhost.entm.purdue.edu .......... Chris Oseto mrusso@cartun.enet.dec.com .................... Mary Russo 71043.3705@compuserve.com ..................... Robert Shannon Doty (2) ===== RE: Regeneron, Synergen, CNTF Clinical Trials, etc. ========== Here is an example of the type of information that can be collected from the world of commerce. This particular example was retrieved from Dow Jones via MCI Mail. It is also available on several other commercial information utilities (i.e. Prodigy, etc.). ----- DOW JONES NEWS 02/17/93 TARRYTOWN, N.Y. -DJ- Regeneron Pharmaceuticals Inc. (REGN) said the U.S. Patent & Trademark Office has determined that claims in a Regeneron patent application involving the human ciliary neurotrophic factor (CNTF) protein and pharmaceutical compositions containing human CNTF protein are allowable. The company added that the patent office has suspended prosecution in view of a potential interference. No patent has yet been issued to any party concerning the human CNTF protein or pharmaceutical compositions containing the human CNTF protein, the company said. The patent office previously determined that Regeneron's patent claims relating to the human DNA sequence and the bacterial production of human CNTF were also allowable. Synergen Inc. (SYGN) has been granted patents covering the human DNA sequence of CNTF and production of CNTF. Regeneron was the first company to begin human trials of CNTF as a possible treatment of amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease. Regeneron initiated a Phase I clinical trial in April 1992 and began a Phase II clinical trial in the fourth quarter of last year. The company plans to start a Phase III trial by the end of the first half of 1993. The Food & Drug Administration designated the company's recombinant human CNTF for the treatment of ALS as an orphan drug. If it is the first to receive FDA approval for this purpose, Regeneron said it will have exclusive marketing rights and certain tax benefits. (END) DOW JONES NEWS 02-17-93 10:25 AM ----- DOW JONES NEWS 02/17/93 Synergen PaineWebber's Miller says the most recent patent announcement by Regeneron is likely to escalate market concerns about Synergen's CNTF patent status, or to at least create more confusion about which company is on a firmer intellectual property rights foundation. As reported, Regeneron said today that the U.S. Patent and Trademark Office has determined that claims in a Regeneron patent application involving human CNTF (ciliary neurotrophic growth factor) protein and pharmaceutical compositions containing human CNTF protein are allowable. Regeneron, she says, has made it clear that it is willing to enter into cross-licensing agreements regarding CNTF. ''I don't see (Synergen) likely to be shut out,'' Miller says. ''None of this seems to have dire consequences at this point.'' But the latest Regeneron filing, she says, would appear to increase the likelihood that a patent interference will be declared. Josephthal, Lyon & Ross biotechnology analyst Franklin Berger is recommending purchase of both Regeneron and Synergen, but he thinks the CNTF patent balance is swaying in Regeneron's favor. ''This is positive for Regeneron,'' Berger says, ''and the company's patent position looks much stronger than many people in the market had perceived.'' Today's announcement by Regeneron, he says, ''shows the depth of intellectual property rights at Regeneron.'' Regeneron's stock, Berger says, has languished in large part because of the patent cloud. ''I think that cloud is beginning to lift,'' he says. Berger also thinks a patent interference will be declared. Regeneron shares are up 1/2, or 3.8%, at 13 1/2 on 77,400 shares, compared with average daily volume of about 99,200. (END) DOW JONES NEWS 02-17-93 3:14 PM ----- DOW JONES NEWS 03/02/93 Regeneron By Phillip E. Nalbone, Dow Jones Staff Reporter NEW YORK -DJ- Despite concerns about pending changes in national health care policies and worries about the risks of the biotechnology sector in general, Dillon Read & Co. analyst Larry Bloom this morning reiterated his ''1,'' or ''buy,'' rating on Regeneron Pharmaceuticals Inc. (REGN) and said he still thinks the stock could run up to 32 this year. Bloom says he still considers Regeneron his No. 1 biotechnology pick for 1993, and he thinks Synergen Inc.'s (SYGN) recent stumble will be a boon to Regeneron's efforts to develop its lead product to treat Lou Gehrig's disease. In NASDAQ trading today, Regeneron is up 2 1/4, or 18.4%, at 14 1/2 on 153,900 shares, compared with average daily volume of 98,400. Lou Gehrig's disease, known clinically as amyotrophic lateral sclerosis, or ALS, is a life-threatening, degenerative disease characterized by the death of motor neurons. The condition afflicts roughly 25,000 to 30,000 people in the U.S. ''We doubt that any changes that come through with the new health care plan would impact a drug that would improve the quality of life of a patient suffering from ALS,'' Bloom wrote in a report this morning. DOW JONES NEWS 03-02-93, 11:25 AM ----- DOW JONES NEWS 03/02/93 Regeneron Regeneron is one of three companies working on a treatment for Lou Gehrig's disease using compounds known as neutrophic growth factors. Both Regeneron and Synergen are developing ciliary neurotrophic growth factor, or CNTF, while Cephalon Inc. (CEPH) is developing a distinct neurotrophic growth factor based on recombinant insulin-like growth factor-1, or IGF-1, called Myotrophin. A large body of scientific literature of the past six or seven years demonstrates that neurotrophic factors, which are naturally occurring proteins, are critical to the survival, growth and function of nerve tissue and promote nerve cell regeneration and prevent nerve cell death. Dillon's Bloom says he thinks Synergen's recent troubles with its lead product, Antril to treat sepsis infection, creates an opportunity for Regeneron with its lead product, CNTF. Synergen was behind Regeneron in clinical trials of CNTF for Lou Gehrig's disease at the time Synergen announced disappointing preliminary Phase III data on Antil, and Bloom thinks Synergen now won't have the resources to pursue CNTF with the same vigor it once had. ''Even Synergen would admit that it lacks the funds to do the appropriate testing to catch up with Regeneron in the pursuit of Orphan Drug status (for CNTF) exclusivity,'' Bloom asserts. DOW JONES NEWS 03-02-93, 11:36 AM ----- DOW JONES NEWS 03/02/93 Regeneron Regeneron, as reported, began Phase II clinical trials of CNTF in Lou Gehrig's disease patients during the fourth quarter of 1992, and the company has said it plans to start the pivotal Phase III clinical trial during the first half of this year. The Phase III study is expected to involve 500 patients in 30 ALS treatment centers across the U.S., Dillon's Bloom tells Dow Jones Professional Investor Report. Regeneron has said it expects the Phase III study to last about a year. Regeneron has also said it expects to report results of its Phase I clinical trial and preliminary data on the Phase II study of CNTF at a scientific forum sometime during the first half of the year. There are currently no effective treatments for Lou Gehrig's disease, Bloom says. ''Regeneron, therefore, doesn't have to be judged against any criteria'' in seeking FDA approval to market CNTF to treat the disease, Bloom says. ''That gives them a tremendous advantage, since all that is necessary to get approval is for Regeneron to show that it can improve the patients' quality of life.'' Bloom says he continues to forecast late 1994 marketing approval for CNTF, and he expects the company to break even or achieve slight profitability in 1995. ''Despite investors' merited caution for the biotechnology industry, we do not think that the company- specific good news is reflected in Regeneron's stock price,'' Bloom says. Synergen, which is developing CNTF in partnership with Syntex Corp. (SYN), has completed it Phase I safety study of CNTF and has been expected to begin a Phase II trial soon in Lou Gehrig's patients. In the meantime, Cephalon has already begun pivotal efficacy trials in the U.S. for Myotrophin to treat Lou Gehrig's disease. That study will incude about 200 patients in six treatment centers. Pivotal trials of the Cephalon neurotrophic factor in Europe are scheduled to begin before the end of the first quarter. That study will involve about 150 patients in at least four centers. Cephalon President and Chief Executive Frank Baldino Jr., as reported, has indicated in recent presentations to the investment community that the company expects to file its New Drug Application, or NDA, with the Food and Drug Administration for Myotrophin next year. He also has said the company plans to use the Phase I safety data to file an Investigational New Drug, or IND, application to begin a Phase II clinical study soon for Myotrophin to treat peripheral neuropathy caused by chemotherapy in cancer patients. Regeneron will focus on peripheral nerve system diseases with its second neurotrophic factor under development, brain- derived neurotrophic factor, or BDNF, which is part of a 50/50 joint venture with Amgen Inc. (AMGN). Regeneron has said it expects human trials of BDNF to start soon after mid-year. DOW JONES NEWS 03-02-93, 12:24 PM == end of als 29 ==