ATAC Drug Development Committee

AIDS TREATMENT ACTIVISTS COALITION

DRUG DEVELOPMENT COMMITTEE

ATAC’s Drug Development Committee (DDC) works with government, academia and the pharmaceutical industry to provide a community perspective into the development of new HIV drugs and the utilization of HIV therapies.

Join the DDC! To become a DDC member, you must apply to ATAC and be accepted for associate member status. Also, you must fill out the Financial Disclosure Form and send it to ATAC, attention DDC:

ATAC
P.O. Box 1514
Old Chelsea Station
New York, NY 10113

FAX: 212-367-1235

E-MAIL: [email protected]

NEW/NOTEWORTHY

June 2004 meeting with the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA)
- Notes (Microsoft Word or Adobe PDF)
- Slide sets
  - Opening presentation: Distinction Between Biologics and Standard Chemical Drug Products, and Regulatory Issues for Marketing Approval
  - Gene Therapy
  - Preventive Vaccines for HIV
  - Therapeutic Vaccines for HIV
  - Other Vaccines - e.g., HPV
  - Immune-based therapies
  - Review and Approval Issues Related to Testing Assays for HIV and Hepatitis
  - Critical Path Initiative
Letter to FDA re: Disclosing Risk Information in Consumer-Directed Print Advertisements, DRAFT GUIDANCE, Docket no. 2004D-0042 (5/17/04)

REFERENCE MATERIALS

Chart of Drugs in Development
General Resources on Antiretroviral Drugs
Glossaries
DDC Letterhead

BASIC INFORMATION ON PHARMACEUTICAL COMPANIES

There is a web page for each company. Follow the links below. (Note: if there's no link, the company page has not yet been set up.)

Abbott Laboratories (ritonavir, lopinavir/ritonavir)
Agouron/Pfizer Pharmaceuticals (delavirdine, capravirine*, nelfinavir, CCR5 antagonist*)
Boehringer Ingelheim (nevirapine, tipranavir*)
Bristol-Myers Squibb (ddI, d4T, efavirenz, atazanavir, entry/adhesion inhibitor*)
Chiron Corporation (interleukin-2)
Gilead Sciences (tenofovir, emtricitabine)
GlaxoSmithKline (AZT, 3TC, abacavir, amprenavir, fosamprenavir, entry inhibitors*, CCR5 anatgonist*, integrase inhibitor*)
Merck & Co. (indinavir, vaccines*, integrase inhibitor*)
Roche (ddC, saquinavir, enfuvirtide, pegylated interferon for Hep C)
Serono (Human Growth Hormone)
Schering-Plough (Schering C and D fusion inhibitors*, pegylated interferon for Hep C)
Tibotec (TMC125*, TMC114*; genotypic and phenotypic testing; drug level testing)
*under investigation

Reference Materials:

A. General Resources on Antiretroviral Drugs
1. Drugs in Development. Source: Rob Camp, Treatment Action Group.
2. New Mexico AIDS InfoNet fact sheet #402, Antiviral Drug Names. Includes HIV drugs approved or in clinical trials. Listed by class with generic name, trade name, other names, and manufacturer.

B. Glossaries

Acronyms
AmfAR Treatment Directory Glossary http://www.amfar.org/cgi-bin/iowa/bridge.html?table=AMFAR_GLOSSARY
CPCRA Glossary of Medical, Statistical, and Clinical Trials Terminology
http://sdmc.cpcra.org/gloss.html
HIV/AIDS Medical Glossary from Gay Men's Health Crisis
http://www.gmhc.org/living/treatment/glossary.html
San Francisco AIDS Foundation Glossary of HIV/AIDS Related Terms
http://www.sfaf.org/treatment/glossary/
HIV Therapeutic Development. An issue of "Research Initiative/Treatment Action!" (RITA!), published by The Center for AIDS: Hope & Remembrance Project.

Drugs in Development (Source: Rob Camp, Treatment Action Group)

Chart as of 5/19/04, Most recent version available at: www.aidsinfonyc.org/tag/tx/pipeline2004.html

Phase of Development NRTI NNRTI PI EI* Other
Preclinical SPD-754, Shire Biochem Diarylpyrimidines, Tibotec GS-9005, Gilead Benzothiepine and Benzazepine derivatives, CCR5 antagonists, Takeda RWJ67567, p38 inhibitor, U Penn / J&J

NVP C-8 derivatives, BI
Betulinic Acid Derivatives (BAD), Entry (& Maturation) Inhibitors, U North Carolina ACH-CIP, capsid inhibitor, Achillion

Tricyclic NNRTI, BMS
KRH-2731, X4 antagonist, Kureha α TRIM5, capsid inhibitor, Dana Farber, NIAID

PRO-140, monoclonal antibody (MAb), Progenics Chloroquine, viral maturation inhibitor, Catholic U, Rome

CDK inhibitor, Gilead

Mifepristone, glucocorticoid antagonist, U Pittsburgh

PA-457, Budding inhibitor, Panacos

RSC-1838, GSK/Shionogi

V-165, integrase inhibitor, Rega Institute
Phase I

AMD-070, X4 antagonist, Anormed HGTV43, gene regulation/editing inhibitor, Enzo

AMD-887, CCRS antagonist, Anormed Mycophenylate, T-cell reducer, Independent

GSK-873140, GSK

Phase I/II or Phase IB MIV-210 (FGV), Medivir/GSK

BMS-043, BMS BAY 50-4798, IL2 selective agonist, Bayer

Reverset (D-D4FC), Pharmasset/Incyte

SCH D, CCR5 antagonist, Schering Plough

SN-1212/1461, mutagenic deoxyribonucleoside, Koronis

SP-01A, Entry Inhibitor, Samaritan Pharma

TNX-355, Anti-CD4 MAB, Tanox/Biogen

UK-427,857, CCR5 antagonist, Pfizer

Phase II Elvucitabine (ACH-126), Achillion Calanolide A, Advanced Life Sciences TMC-114/r, Tibotec/J&J PRO-542, attachment inhibitor, Progenics

Amdoxovir (DAPD), Emory University TMC-125, Tibotec/J&J

Alovudine (MIV-310), Medivir/BI

Phase III
Capravirine/r, Pfizer/Agouron Tipranavir/r, Boehringer Ingelheim

Notes: EI = entry inhibitors, including CCR5 and CXCR4 receptor binding antagonists and CD4 monoclonal antibodies directed at binding, fusion, and entry.
possibly on hold
Recent news from the XIth Conference on Retroviruses and Opportunistic Infections, San Francisco, 8-11 February, 2004

Phase of Development	NRTI	NNRTI	PI	EI*	Other
Preclinical	SPD-754, Shire Biochem	Diarylpyrimidines, Tibotec	GS-9005, Gilead	Benzothiepine and Benzazepine derivatives, CCR5 antagonists, Takeda	RWJ67567, p38 inhibitor, U Penn / J&J
		NVP C-8 derivatives, BI		Betulinic Acid Derivatives (BAD), Entry (& Maturation) Inhibitors, U North Carolina	ACH-CIP, capsid inhibitor, Achillion
		Tricyclic NNRTI, BMS		KRH-2731, X4 antagonist, Kureha	α TRIM5, capsid inhibitor, Dana Farber, NIAID
				PRO-140, monoclonal antibody (MAb), Progenics	Chloroquine, viral maturation inhibitor, Catholic U, Rome
					CDK inhibitor, Gilead
					Mifepristone, glucocorticoid antagonist, U Pittsburgh
					PA-457, Budding inhibitor, Panacos
					RSC-1838, GSK/Shionogi
					V-165, integrase inhibitor, Rega Institute
Phase I				AMD-070, X4 antagonist, Anormed	HGTV43, gene regulation/editing inhibitor, Enzo
				AMD-887, CCRS antagonist, Anormed	Mycophenylate, T-cell reducer, Independent
				GSK-873140, GSK
Phase I/II or Phase IB	MIV-210 (FGV), Medivir/GSK			BMS-043, BMS	BAY 50-4798, IL2 selective agonist, Bayer
	Reverset (D-D4FC), Pharmasset/Incyte			SCH D, CCR5 antagonist, Schering Plough
	SN-1212/1461, mutagenic deoxyribonucleoside, Koronis			SP-01A, Entry Inhibitor, Samaritan Pharma
				TNX-355, Anti-CD4 MAB, Tanox/Biogen
				UK-427,857, CCR5 antagonist, Pfizer
Phase II	Elvucitabine (ACH-126), Achillion	Calanolide A, Advanced Life Sciences	TMC-114/r, Tibotec/J&J	PRO-542, attachment inhibitor, Progenics
	Amdoxovir (DAPD), Emory University	TMC-125, Tibotec/J&J
	Alovudine (MIV-310), Medivir/BI
Phase III		Capravirine/r, Pfizer/Agouron	Tipranavir/r, Boehringer Ingelheim
Notes: EI = entry inhibitors, including CCR5 and CXCR4 receptor binding antagonists and CD4 monoclonal antibodies directed at binding, fusion, and entry. possibly on hold Recent news from the XIth Conference on Retroviruses and Opportunistic Infections, San Francisco, 8-11 February, 2004