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To: DIVYA DUTTA who wrote (382)6/4/1997 6:45:00 AM
From: harkenman   of 998
 
I am long on CYTO (years that is is). My price target exceeds 4x multiples, timeline is no concern. I will sell chunks at n multiples intervals all the way to 10x.

I am no technical analyst but CEPH may hit the levels of $5-6. This is guestimated based on DRMD non approval for conjugated estrogens.

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To: harkenman who wrote (384)6/5/1997 3:59:00 PM
From: Boyce Burge   of 998
 
I have some opinions in this sector. I only own 50 shares CEPH so I can be objective. I also own a little CTII (Cytotherapeutics - they have a membrane based implant that allows delivery of growth factors directly into the ventricles).

It seems to me that people (investors) have given up on delivery of large biomolecules to the brain. Its tough to deliver them, and when you do, very little happens. Thus CTII from 18 to 5 in the last 18 months, and CEPH from 30+ to perhaps 5 to 10 in the next 6 months. Other sad stories of this kind include regeneron and several others in the distant past.

!! Unless you are working on SMALL molecules you are dead meat!!

I recently bought GLFD, because of their small molecule integrin work.
And, I do recognize that large biomolecules still have their uses outside the brain (Amgen, CBMI, Biogen etc).

I'm holding my few CEPH shares because they have a ton of cash and might do something surprising with it... but frankly I've been unimpressed with their vision. Do they have a small molecule program??

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To: Boyce Burge who wrote (385)6/5/1997 7:38:00 PM
From: NeuroInvestment   of 998
 
1) CEPH has two small molecule neurotrophin mimetic/stimulant programs:one is the receptor kinase program from which CEP1347 has sprung; the other is the NEM class which cause the production of NGF. They have plenty of competition, and I am particularly impressed with GLFD's neuroimmunophilin programs, but the CEPH molecules have promise.
2) It is true that companies emphasizing large molecule neurotrophins must diversify or die. That is why REGN has moved so strongly into non-CNS targets. I believe that the selloff of CTII is short-sighted; having the ability to deliver almost anything (including neurotrophic factors) to selected targets in the brain (and eye) is very appealing. We do not yet know what a general infusion of neurotrophic stimulants throughout the CNS means on a longterm basis. While receptor systems are location and function specific, one still runs the risk of unexpected trophic reactions. CTII's targetting is not dead by any means. NeuroInvestment

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To: NeuroInvestment who wrote (386)6/5/1997 8:15:00 PM
From: Boyce Burge   of 998
 
Thanks for the quick response. You make excellent points.

When a biotech holding gets cut in two, as CTII and CEPH have, I never sell (assuming I did my homework up front) because I know how many uncertainties there are, and I know how people like to n"punish" stocks that disapoint them. I do expect a CEPH rally at some point, and I particularly admire the work CTII is doing. There may be no better way to test the efficacy of a peptide ligand than with the CTII membrane approach. By the way, I believe thats why GNE values its collaboration with CTII.

On the other hand, I think BIG drug sales and earnings will come from small molecules -- since their are now so many ways to generate and test them efficiently. Thus the real question for the investor is, would you increase your holdings of CEPH or CTII... on that question, I'm definitely on the sidelines, for now.

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To: Boyce Burge who wrote (385)6/5/1997 10:49:00 PM
From: harkenman   of 998
 
Sell your shares with a discount broker and buy it when it tanks. CEPH does have a small molecule program and they are targeting orphan diseases. They are targeting narcolepsy with some non-narcotic samll molecule. The only caveat is that they are targeting diseases that already have approved therapies e.g. Narcolepsy (Ritalin), ALS (Rilutek).

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To: NeuroInvestment who wrote (386)6/6/1997 1:59:00 AM
From: Jeffers Hughes   of 998
 
When is CEPH going to finish this phase I study ?


Wednesday October 9 8:03 AM EDT

Cephalon And Tap Launch Phase I Cancer Study

WEST CHESTER, Pa., Oct. 9 /PRNewswire/ -- Cephalon Inc announced today that its
collaborator, TAP Holdings Inc., has begun a Phase I clinical trial of CEP-2563, a novel
compound discovered by Cephalon and being developed by both companies for the treatment of
various cancers, including prostate cancer. The objective of the multi-center study is to
examine the drug's pharmacokinetic and safety profile in patients with advanced cancer.

CEP-2563 belongs to a family of tyrosine kinase (enzyme) inhibitors that have been shown
in preclinical studies to slow the growth of malignant cells. Animal studies suggest that
these inhibitors induce programmed cell death of prostatic cancer cells and may cause
regression of certain prostate tumors.

"The challenge in cancer research is to develop an agent that will induce cell death,
independent of cell proliferation rate," said John T. Isaacs, Ph.D., professor of oncology
and urology at Johns Hopkins University School of Medicine and a preclinical investigator
for CEP-2563. "Cephalon's efforts with CEP-2563 represent real progress in the development
of drug therapies for prostate cancer, and an important advance for the field. We hope
that human clinical trials will confirm the potential for this compound, and bring us
closer to a cure for this disease."

"We are excited about the potential of this new class of receptor tyrosine kinase
inhibitors to treat prostate cancer, and are pleased to see application of our technology
beyond the field of neurology," said Frank Baldino, Jr., Ph.D., Cephalon's president and
chief executive officer. "The launch of human clinical studies of CEP-2563 is an important
milestone for our collaboration with TAP and for our tyrosine kinase inhibitor development
program."

Cephalon and TAP recently renewed their collaboration to include a new class of compounds,
discovered by Cephalon, that may have potential in treating a variety of cancers. The
expanded agreement also provides for additional research and development compensation to
Cephalon, as well as milestone payments for each product, and royalties on product sales.

Cephalon, Inc., headquartered in West Chester, PA, is an international biopharmaceutical
company that discovers, develops and markets products to treat neurological disorders. The
company is developing products for the treatment of ALS, narcolepsy, peripheral
neuropathies, Alzheimer's disease, head and spinal injury, and stroke, and currently
copromotes two products in the United States for the treatment of neurological conditions.

This news release may contain forward-looking statements that involve risks and
uncertainties. A full discussion of Cephalon's operations and financial condition,
including factors that may affect the company's business and future prospects, is
contained in documents the company files with the SEC, such as form 10-Q and 10-K reports.
These documents identify important factors that could cause the company's actual
performance to differ from current expectations. SOURCE Cephalon, Inc.

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To: NeuroInvestment who wrote (386)6/6/1997 2:04:00 AM
From: Jeffers Hughes   of 998
 
I think it is the time for FDA to schedule the advisary meetting for
modafinil. See the following news for detail. It should give CEPH a good lift. Thus, I personally think it is the bottom for CEPH. The stock will be back soon.



Tuesday December 31 8:01 AM EDT

Cephalon Submits New Drug Application For Modafinil
to U.S. Food and Drug Administration

WEST CHESTER, Pa., Dec. 31 /PRNewswire/ -- Cephalon Inc announced today that the company
has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for
clearance to market modafinil for use in treating excessive daytime sleepiness associated
with narcolepsy.

The NDA contains results of 14 clinical studies with modafinil conducted by Cephalon,
including two double-blind, placebo-controlled multicenter Phase 3 trials involving 558
patients with narcolepsy. The Phase 3 studies were conducted at 39 sleep centers in the
United States and were designed to assess the patient's ability to stay awake using a
number of laboratory and clinical measures. The studies also measured the patient's
overall well-being, as assessed by an independent clinician, and the patient's quality of
life.

"As our first NDA submission, this event marks an important milestone for Cephalon," said
Frank Baldino, Jr., Ph.D., Cephalon's president and chief executive officer. "To our
knowledge, this is the most comprehensive clinical investigation ever undertaken in the
study of narcolepsy. We are grateful to the patients who participated in these studies,
and appreciate the dedication of the physicians and Cephalon employees who are working to
improve the lives of patients with this chronic and debilitating disease."

Modafinil is a novel oral medication that is approved and marketed in France for the
treatment of narcolepsy and idiopathic hypersomnia. Cephalon received exclusive rights to
market modafinil in the United States, Japan, the United Kingdom, Ireland and Mexico from
Laboratoire L. Lafon, the French pharmaceutical company which developed and currently
markets the drug in France. If approved in the United States, modafinil would be the first
new chemical entity available to treat narcolepsy in more than 20 years.

Narcolepsy is a chronic, lifelong sleep disorder afflicting approximately 125,000 people
in the United States. The most common symptom is excessive daytime sleepiness. Narcolepsy
generally begins in young adulthood. Therapies to treat the excessive daytime sleepiness
associated with the disease have been limited to amphetamine and other stimulants. The FDA
designated modafinil an orphan drug in March 1993 for the treatment of excessive daytime
sleepiness in narcolepsy.

Cephalon is an international biopharmaceutical company that discovers, develops and
markets products to treat neurological disorders. The company is developing products for
the treatment of ALS, narcolepsy, peripheral neuropathies, Alzheimer's disease, head and
spinal injury, and stroke, and currently copromotes two products in the United States for
the treatment of neurological conditions.

This news release may contain forward-looking statements that involve risks and
uncertainties. The results of the modafinil clinical trials have not been reviewed by the
FDA and there can be no assurance that the FDA will consider that these results
demonstrate sufficient safety and efficacy data to allow the filing of an NDA to obtain
marketing clearance or if the filing is allowed, to obtain marketing clearance. A full
discussion of Cephalon's operations and financial condition, including factors that may
affect the company's business and future prospects, is contained in documents the company
files with the SEC, such as form 10-Q and 10-K reports. These documents identify important
factors that could cause the company's actual performance to differ from current
expectations. SOURCE Cephalon, Inc.

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To: Jeffers Hughes who wrote (390)6/7/1997 11:03:00 PM
From: NeuroInvestment   of 998
 
Modafinil's NDA has an excellent chance of approval..eventually. Since it is a novel chemical class for the treatment of narcolepsy, the FDA will most likely request that the Advisory Panel responsible for CNS drugs review it. Now there's the proverbial rub: that Advisory Panel, and Paul Leber, who is the FDA Division chief responsible for CNS, have no love lost for CEPH due to Myotrophin. My opinion regarding Myotrophin's prospects is well documented elsewhere and does not need to be repeated here. Since Modafinil is being presented for a non life threatening condition for which treatment, however imperfect, is available, there is absolutely no basis for any fasttracking of Modafinil. Indeed, I would expect to see all scheduling of regulatory reviews of Modafinil to occur with the same speed as the balancing of the federal budget (OK, that is a slight exaggeration). The FDA may well be forced to approve Myotrophin, and Modafinil's data may be sufficiently convincing that approval will have to be given. However, the speed of processing, and the amount of nitpicking hurdles thrown in the path, are variables that are firmly under FDA (and the advisory
panel) control. CEPH is going to be punished for having 'dissed' the agenda of the FDA, and this is where they will pay the price. If the Advisory Committee reviews this drug in 1997, I will consider that a minor miracle. No, a major miracle. NeuroInvestment

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To: NeuroInvestment who wrote (391)6/8/1997 8:50:00 AM
From: Jonathan Rothschild   of 998
 
Dear Neuro, I disagree with your contention that narcolepsy is "not a life-threatening illness." True, it's not life-threatening for the narcoleptic, but how about the other drivers on the road. There's a big movement of people lobbying for restrictions on mentally-impaired drivers, similar to Mothers Against Drunk Driving. Also, check out Monday's lead story on the FDA in Investors Business Daily, re: conflicts of interest between FDA Advisory Committee Meetings, Drug Companies, Competitors and the FDA itself. Especially interesting was the behind scenes ambush of Duramed by American Home Products. I agree that there's no love lost between Frank Baldino and Paul Leber and I've commented frequently on the personality nuances at these meetings in other biotech co. posts. Now Leber's on notice. I think things will change and settle down once they appoint a new commissioner. The easiest thing for a government worker to do with a ruderless helm, is to do nothing.

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To: Jonathan Rothschild who wrote (392)6/8/1997 1:25:00 PM
From: NeuroInvestment   of 998
 
While your point regarding risk to others is not incorrect, it does not fit the definition of a life threatening illness as viewed by the FDA, and thus is irrelevant to the issue of how fast Modafinil will be reviewed. Since the Advisory Committee has ignored the ALS patient lobby, I see no reason to think that they will respond to this concern; there is hardly a lobbying group like MADD arguing for sanctions against narcoleptic drivers.You are also correct that things will eventually improve with a new commissioner, but a selection has not been made, and even once installed, it takes a while for someone to learn the 'culture' of a bureaucracy and to plan a strategy for altering it. This will not be in time to hasten Modafinil's review.
NeuroInvestment

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