Neotherapeutics Receives Patent For The Use Of Neotrofin(TM) And Other Related Compounds In Stimulating Nerve Regeneration

pecla · 09-25-2001, 06:56 AM

Tuesday September 25, 9:27 am Eastern Time
Press Release
SOURCE: NeoTherapeutics, Inc.

IRVINE, Calif., Sept. 25 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT - news, NEOTW - news) announced today that the Company has been issued a U.S. patent covering the use of Neotrofin (and related compounds to stimulate regeneration of both motor and sensory neurons. Neotrofin is currently being tested in a 521-patient pivotal clinical study for Alzheimer's disease, as well as phase 2 studies for Parkinson's disease and spinal cord injury. The Company recently announced that it will shortly begin phase 2 human studies of Neotrofin in chemotherapy-induced neuropathy.

Neotrofin is a small molecule that crosses the blood-brain barrier, enhances memory and causes the production of neurotrophic factors, including nerve growth factor, which are believed to lead to nerve regeneration. One of the aspects of this regeneration may occur through the proliferation of stem cells, which are then expected to grow into new nerve cells that replace damaged or dead cells.

``The issuance of this patent further strengthens the intellectual property behind our purine-based technology platform, which includes our lead drug, Neotrofin,'' said Michelle S. Glasky, Ph.D., Vice President, Scientific Affairs of NeoTherapeutics. ``Just as we have succeeded in expanding the indications in which we are testing Neotrofin this year, we continue to expand patent coverage to protect the value of our leading drug and technology foundation.''

``The clinical trials of Neotrofin are proceeding well, and Neotrofin and this technology may be the first practical alternative to embryonic stem cell therapy for neurodegenerative diseases,'' stated Alvin J. Glasky, Chairman and Chief Scientific Officer of NeoTherapeutics.

Previously, the United States Patent and Trademark Office has issued or allowed NeoTherapeutics eight patents covering the Company's technology platform, which includes NeoTherapeutics' lead drug candidate, Neotrofin. NeoTherapeutics has 15 additional patent applications pending in the U.S., as well as patent applications in development for additional technologies. NeoTherapeutics has also filed, and in some cases received, international patent applications corresponding to its U.S. patents to further expand its technology base.

NeoTherapeutics seeks to create value for stockholders through the discovery and development of central nervous system drugs, in-licensing and development of anti-cancer drugs and the licensing out of new drug targets discovered through genomics research. The Company has two drugs addressing major medical needs in pivotal/phase 3 human clinical trials: Neotrofin for Alzheimer's disease and satraplatin for prostate cancer. Additional neurology and anti-cancer drugs are in phase 1 and 2 human clinical trials and the Company has a rich pipeline of pre-clinical drug candidates. For additional information visit the Company's web site at www.neotherapeutics.com.
This press release may contain forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission.

Contacts:
MEDIA RELATIONS
Jon Siegal
Ronald Trahan Associates (RTA) Inc.
(508) 647-9782, ext. 15
INVESTOR RELATIONS
John McManus
NeoTherapeutics Inc.
(949) 788-6700, ext. 247
SOURCE: NeoTherapeutics, Inc.

Wise Young · 09-25-2001, 09:59 AM

It really doesn't matter what the first indications are for FDA approval of neotrofin. If it is approved, this means the doctors can prescribe the drug for off-label use. Neotherapeutics is already conducting clinical trials of the drug for subacute spinal cord injury and, if the trial results are positive, it will lead to rapid inclusion of spinal cord injury as an indication. This is really moving faster than I had thought. That is good. Wise.

andrea · 09-25-2001, 10:19 AM

Doc Young,
I wonder if you have an idea of how much they can charge for this drug once it will reach to the market ?
One more thing, could it be possible buy it from outside United States like a lot of people has done with 4-ap and overall could it be a treatmant that someone can do on it's own with resonable risk ?

thanks

giambjj · 09-25-2001, 01:43 PM

What does chemotherapy-induced nueropathy mean?
The chemo therpay caused the neuropathy?

Wise Young · 09-25-2001, 02:38 PM

jgiambro, One of the complications of chemotherapy for cancer is that they kill dorsal root sensory ganglia. This is called chemotherapy induced neuropathy.

Andrea, I have no idea what the cost will be. It is not likely that you or anybody will be able to get this particular drug from a generic provider since this is a novel drug and also one that is covered by extensive patents. In any case, I can't imagine that it will be all that expensive. It is a guanosine analog that has been around for a long time. This is a small molecule that will not be very expensive to make. It should probably cost about what 4-AP costs.

Wise

Carl R · 09-25-2001, 04:23 PM

what are they using as a delivery mechanism? Can it just be taken orally?

pecla · 09-25-2001, 05:07 PM

Carl R, yes it can be taken orally.

antiquity · 09-26-2001, 03:05 AM

This is great news. I wonder how many doctors would be willing to met out this drug on a compassionate basis for SCI once it's approved for Alzeimers.

Sue Pendleton · 09-26-2001, 01:49 PM

I think what Andrea and others are asking is whether they will be able to buy this drug in Europe if it approved for Alzheimers here. The EU commission that approves drugs for use there almost always seems to rapidly approve drugs aprroved by the US's FDA. I do not know how Europe's system works now for drugs approved for one problem like alzheimers but someone wants prescribed for them for another reason like SCI. Wise? Do you know how this works in Europe for approved drugs?

pecla · 09-26-2001, 04:36 PM

I am also very curious if I can order it in the USA and let's ship it to Europe or do I have to see an American doctor to write a prescript for me?(I think that's also what Andrea wants to know).I understand that it can't be ordered at a compounding pharmacy,like 4-AP, because of the patents.
Btw;Sue, I am not so sure the Netherlands will approve the drug soon after the FDA approves it. Propecia(to prevent male baldness) for example is approved in the USA for about 4 years and still not approved here unless very less side-effects.So I don't want to wait for approval in Europe

09-25-2001, 06:56 AM	#1
pecla Senior Member Join Date: Jul 2001 Location: The Netherlands Posts: 191	Neotherapeutics Receives Patent For The Use Of Neotrofin(TM) And Other Related Compounds In Stimulating Nerve Regeneration Tuesday September 25, 9:27 am Eastern Time Press Release SOURCE: NeoTherapeutics, Inc. IRVINE, Calif., Sept. 25 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT - news, NEOTW - news) announced today that the Company has been issued a U.S. patent covering the use of Neotrofin (and related compounds to stimulate regeneration of both motor and sensory neurons. Neotrofin is currently being tested in a 521-patient pivotal clinical study for Alzheimer's disease, as well as phase 2 studies for Parkinson's disease and spinal cord injury. The Company recently announced that it will shortly begin phase 2 human studies of Neotrofin in chemotherapy-induced neuropathy. Neotrofin is a small molecule that crosses the blood-brain barrier, enhances memory and causes the production of neurotrophic factors, including nerve growth factor, which are believed to lead to nerve regeneration. One of the aspects of this regeneration may occur through the proliferation of stem cells, which are then expected to grow into new nerve cells that replace damaged or dead cells. ``The issuance of this patent further strengthens the intellectual property behind our purine-based technology platform, which includes our lead drug, Neotrofin,'' said Michelle S. Glasky, Ph.D., Vice President, Scientific Affairs of NeoTherapeutics. ``Just as we have succeeded in expanding the indications in which we are testing Neotrofin this year, we continue to expand patent coverage to protect the value of our leading drug and technology foundation.'' ``The clinical trials of Neotrofin are proceeding well, and Neotrofin and this technology may be the first practical alternative to embryonic stem cell therapy for neurodegenerative diseases,'' stated Alvin J. Glasky, Chairman and Chief Scientific Officer of NeoTherapeutics. Previously, the United States Patent and Trademark Office has issued or allowed NeoTherapeutics eight patents covering the Company's technology platform, which includes NeoTherapeutics' lead drug candidate, Neotrofin. NeoTherapeutics has 15 additional patent applications pending in the U.S., as well as patent applications in development for additional technologies. NeoTherapeutics has also filed, and in some cases received, international patent applications corresponding to its U.S. patents to further expand its technology base. NeoTherapeutics seeks to create value for stockholders through the discovery and development of central nervous system drugs, in-licensing and development of anti-cancer drugs and the licensing out of new drug targets discovered through genomics research. The Company has two drugs addressing major medical needs in pivotal/phase 3 human clinical trials: Neotrofin for Alzheimer's disease and satraplatin for prostate cancer. Additional neurology and anti-cancer drugs are in phase 1 and 2 human clinical trials and the Company has a rich pipeline of pre-clinical drug candidates. For additional information visit the Company's web site at www.neotherapeutics.com. This press release may contain forward-looking statements regarding future events and the future performance of NeoTherapeutics that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission. Contacts: MEDIA RELATIONS Jon Siegal Ronald Trahan Associates (RTA) Inc. (508) 647-9782, ext. 15 INVESTOR RELATIONS John McManus NeoTherapeutics Inc. (949) 788-6700, ext. 247 SOURCE: NeoTherapeutics, Inc.

09-25-2001, 10:19 AM	#3
andrea Member Join Date: Aug 2001 Location: Reggio Emilia, Italy Posts: 83	Whatta a news ! Doc Young, I wonder if you have an idea of how much they can charge for this drug once it will reach to the market ? One more thing, could it be possible buy it from outside United States like a lot of people has done with 4-ap and overall could it be a treatmant that someone can do on it's own with resonable risk ? thanks

09-25-2001, 01:43 PM	#4
giambjj Senior Member Join Date: Jul 2001 Location: Auburn, AL,USA Posts: 1,866	chemotherapy-induced neuropathy What does chemotherapy-induced nueropathy mean? The chemo therpay caused the neuropathy?

09-26-2001, 01:49 PM	#9
Sue Pendleton Moderator Join Date: Jul 2001 Location: Wisconsin USA Posts: 9,114	Wise, do you know? I think what Andrea and others are asking is whether they will be able to buy this drug in Europe if it approved for Alzheimers here. The EU commission that approves drugs for use there almost always seems to rapidly approve drugs aprroved by the US's FDA. I do not know how Europe's system works now for drugs approved for one problem like alzheimers but someone wants prescribed for them for another reason like SCI. Wise? Do you know how this works in Europe for approved drugs?

09-26-2001, 04:36 PM	#10
pecla Senior Member Join Date: Jul 2001 Location: The Netherlands Posts: 191	Dr.Young I am also very curious if I can order it in the USA and let's ship it to Europe or do I have to see an American doctor to write a prescript for me?(I think that's also what Andrea wants to know).I understand that it can't be ordered at a compounding pharmacy,like 4-AP, because of the patents. Btw;Sue, I am not so sure the Netherlands will approve the drug soon after the FDA approves it. Propecia(to prevent male baldness) for example is approved in the USA for about 4 years and still not approved here unless very less side-effects.So I don't want to wait for approval in Europe

09-25-2001, 09:59 AM	#2
Wise Young Administrator Join Date: Jul 2001 Location: New Brunswick, NJ, USA Posts: 37,975	It really doesn't matter what the first indications are for FDA approval of neotrofin. If it is approved, this means the doctors can prescribe the drug for off-label use. Neotherapeutics is already conducting clinical trials of the drug for subacute spinal cord injury and, if the trial results are positive, it will lead to rapid inclusion of spinal cord injury as an indication. This is really moving faster than I had thought. That is good. Wise.

09-25-2001, 02:38 PM	#5
Wise Young Administrator Join Date: Jul 2001 Location: New Brunswick, NJ, USA Posts: 37,975	jgiambro, One of the complications of chemotherapy for cancer is that they kill dorsal root sensory ganglia. This is called chemotherapy induced neuropathy. Andrea, I have no idea what the cost will be. It is not likely that you or anybody will be able to get this particular drug from a generic provider since this is a novel drug and also one that is covered by extensive patents. In any case, I can't imagine that it will be all that expensive. It is a guanosine analog that has been around for a long time. This is a small molecule that will not be very expensive to make. It should probably cost about what 4-AP costs. Wise

09-25-2001, 04:23 PM	#6
Carl R Senior Member Join Date: Jul 2001 Location: Houston, Tx. USA Posts: 1,888	what are they using as a delivery mechanism? Can it just be taken orally?

09-25-2001, 05:07 PM	#7
pecla Senior Member Join Date: Jul 2001 Location: The Netherlands Posts: 191	Carl R, yes it can be taken orally.

09-26-2001, 03:05 AM	#8
antiquity Moderator Join Date: Jul 2001 Posts: 14,540	This is great news. I wonder how many doctors would be willing to met out this drug on a compassionate basis for SCI once it's approved for Alzeimers.

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