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DRUG DEVELOPMENT COMMITTEE'S SPECIAL PAGE RE FUZEON APPROVAL, PRICING, AND RELATED ISSUES
The Committee also requested claroification of a number of issues in a letter to Roche shortly after Fuzeon's approval. See the Roche page.
Chart on Drugs in Development (source: Ben Cheng, Project Inform)
Research Presentations and Related Materials
The Research, Development and Access Committee is working in two areas:
October 29, 2001 Teleconference
Notes from the 10/29 RDA Call:
PRESENT:
Bob Munk
Lynda Dee
David Pieribone
Tracy Swan
Jeff Gustavson
Yvette Delph
Gregg Gonsalves
Brian Klein
Robert Reinhard
There was a mentoring/drug company meetings event suggested
for the weekend leading into the 9th Conference on Retroviruses
and Opportunistic Infections in Seattle, WA. On Friday, February
22, we would have a mentoring program
on basics of working with drug companies, clinical trials 101,
etc. for new ATAC activists (9AM-11AM), followed by a teach-in
on new targets with Ben Cheng and Gregg Gonsalves and perhaps
Mario Stevenson from University of
Massachusetts Medical School and/or Daria Hazuda from Merck (11AM-1PM),
followed by a strategy session about the drug company meetings
the next day (2-5PM). The next day, Saturday, February 23, we
propose to meet with Tibotec (Bob M. and Ben C. will speak to
them), Progenics (Gregg G. will speak to them) and Shiongi (Bob
Munk, David P).
Tracy went over the comments on the bylaws from the RDA committee members (i.e. Mark Milano, Lynda Dee, Jeff Gustavson), but she thought that there should be a specific query around different options for leadership, decision making and membership. Tracy will send out a survey to RDA committee members.
RDA Committee needs to know from the Mentoring Committee what
they want from these two days of continuing education/drug company
meetings, but also from the Retrovirus conference itself. Are
we going to, as John James, suggested
set up community meetings for advocates in attendance....What
do RDA Committee members need to do for the Mentoring Committee
and vice-versa.
NEXT CALL: 4PM, TUES. 11/20, YVETTE DELPH TO SET UP.
Gregg
On 10-15-01 the Research, Development & Access Committee(RDA) had a call. Carlton Hogan, Bob Munk, Tracy Swan, Linda Grinberg, Gregg Gonsalves, Ben Cheng, Mark Harrington, Yvette Delph, Mark Milano, Brian Klein and Robert Reinhard were present. (Robert Reinhard is new to our group. Welcome, Bob. We hope you will continue to participate.)
After a very brief history of ATAC was presented, we discussed a number of points.
We decided that Mark Harrington from the by-laws committee would circulate the latest iteration of the by-laws. We agreed to make comments to the RDA list by the close of business on October 22, 2001. Bob Munk will create a Yahoo e-group for the RDA. Mark and Tracy Swan will review the bylaws comments and will present them to the group on our next call.
We discussed coordination of our group and collaboration with other groups. Although we could offer no firm process for dealing with other groups until the by-laws have been ratified and one overall policy has been defined by the larger group, the consensus was that we should try to be cognizant of the activities of other groups, like the Coaltion for Salvage Therapy (CST) and Hepatitis C Activist and Advocacy Coaltion (HAAC). To that end, Linda Grinberg will keep the group informed about CST activities and Brian Klein will do the same for HAAC. There was also consensus decribed eloquently by Carlton Hogan and Mark Milano on how important it is to speak with one voice and for the left hand to know what the right hand is doing both among ourselves and in our interactions with other groups. Further, we agreed that it was not our intention to gobble up other groups, instead we wish to support their efforts and work collaboratively with them.
There was also discussion of a method of conflict resolution so that minority opinions would be heard and a method devised for them to be expressed. The CST model for majority and disssenting opinions was discussed. All recommendations for conflict resolution among ourselves and with other groups should also be submitted to the RDA list for Mark and Tracy to collate. The consensus was that open, inclusive discussion should be fostered.
We decided to defer creating specific working groups or formulating a scientific agenda at this time. Ideas for scientific priorities and for the group endeavors should also be forwarded to the RDA list by close of business on October 22, 2001. Linda Grinberg and Gregg Gonsalves will collate these suggestions and present them on the next call.
We will attempt to devise an agenda for a "pilot"
larger community meeting with a drug company meeting immediately
thereafter in February or March. The date is still to be determined.
Ben Cheng indicated that he is still wiliing to conduct a co-receptor
teach-in. There seemed to be consensus that this was an important
topic of interest. This will be determined once we review
suggestions for the larger meeting.
Yvette Delph is our temporary Steering Committee (SC) representative. She informed us that the SC thought that a uniform system of chairs and vice chairs across ATAC was advisable. The SC consensus is that the Vice Chair of each committee should be that committee's representative to the SC in order to divide the workload more evenly across the group.
The RDA consensus was that we should rotate our chair until further notice. There were a number of opinions about how we should handle this in the future. Suggestions ranged from always rotating the chair to not calling the position "the chair" and different ways for individuals to be nominated. All were deferred for the present time.
Gregg Gonsalves and Linda Grinberg will chair the next call. They will set up the call and forward an agenda as well as take minutes which will be thereafter be distributed to the RDA list. Our next call will take place on Monday, October 29, 2001 from 4-5pm ET.
Thanks to everybody who participated for a very productive call. We're off to an excellent start.
Lynda Dee
October 1, 2001 Teleconference Notes
The RDA Committee had a conference call on 10-1-01. Ben Cheng,
Lynda Dee, Yvette Delph, Gregg Gonsalves, Linda Grinberg, and
Paul Simmons were present. Several issues were discussed. The
group decided not to divide the RDA
Committee into smaller working groups until we know who all our
members are going to be and what issues they wish to work on.
There was no opposition to breaking RDA down into a series of
smaller groups in the future. Consensus was that the RDA should
be the umbrella committee so as to facilitate coordination and
collaboration.
Mentoring Issues
Consensus was that the RDA Committee needs to be intricately involved with the Mentoring Committee. A number of suggestions for the Mentoring Committee were discussed. The Mentoring Committee should Identify and refer interested new comers to the RDA Committee. The RDA Committee will assign the mentoree to an RDA member of group as an "apprentice".
There was also consensus that the European AIDS Treatment Group (EATG) model for mentoring and meeting a day before a drug company meeting was an excellent idea. RDA felt that it was essential that we work with the Mentoring Committee to set up a meeting agenda for the first day's meeting. The group also felt that 101, 201 and 501 curriculum strata are necessary. Thus, the old timers could mentor new comers; and, we could also arrange for scientists to provide all of us with cutting edge continuing education.
Gregg will work on a draft proposal for a preliminary meeting to be held sometime after the Retrovirus Meeting in February. This proposed meeting might have a mentoring component followed by an FDA/regulatory component. We look forward to the draft from Gregg.
Membership Issues
The group discussed what the criteria would be for "graduation" from mentoree to voting member of the RDA Committee. Consensus was that the mentoree must participate with his mentor or group for at least one year. Three full jamborees and three separate stand alone drug company meetings were discussed as minimum requirements. Of course, this cannot be set in stone at this juncture since we do not know how many jamborees or independent drug company meetings will occur annually. The group stressed that this is not a final recommendation for that reason and noted that flexibilty was important.
The process for "graduation" would be an affirmative recommendation from the mentor or group with ratification by the RDA Committee to the Steering Committee.
Yvette brought up the need for a joint call with both the Mentoring Committee and the Steering Committee. We hoped that these minutes would suffice for the present. If there are additional questions or other points to be clarified, Yvette will ask the relevant people to participate in our next call.
We also began a discussion of the substantive work to be done. Ben Cheng agreed to forward his latest "drugs in the pipeline" chart to the group. We will begin to formulate a division of work/agenda on our next call if possible.
Consensus was that Lynda Dee would act as Chair of the RDA until we could have a face to face meeting and a vote with as many members as possible.
Our next call is scheduled for Monday, October 15, 2001 from 3-4 pm EDT. Please mark your calendars. Call information will be forwarded in the near future.
Thanks.
Lynda Dee
Note: in this version, compounds are in alphabetical order. In the original version they were grouped by class of compound.
| Compound | Class of Compound | Phase of Development | Pharmaceutical Company |
| 3TC | nucleoside analogue RT inhibitor | Approved | Glaxo SmithKline |
| Abacavir | nucleoside analogue RT inhibitor | Approved | Glaxo SmithKline |
| ACH-126,443 (L-Fd4C) | nucleoside analogue RT inhibitor | Phase I | Achilleon |
| ADA | zinc finger | Phase I/II | Hubriphar |
| AMD-3465° | CXCR4 antagonist | Preclinical | AnorMed |
| AMD-8445° | entry inhibitor | Preclinical | AnorMed |
| Amprenavir | protease inhibitor | Approved | Vertex/Glaxo SmithKline |
| AZT | nucleoside analogue RT inhibitor | Approved | Glaxo SmithKline |
| BCH-10618 (DOTC) | nucleoside analogue RT inhibitor | Preclinical | Shire Biochem |
| BEA-005° | nucleoside analogue RT inhibitor | Preclinical | Medivir |
| Beta-D-Fd4C° | nucleoside analogue RT inhibitor | Preclinical | Vion |
| Beta-L-Fd4C° | nucleoside analogue RT inhibitor | Preclinical | Vion |
| BMS-232623 | protease inhibitor | Phase II/III | Bristol-Myers Squibb |
| Calanolide A | non-nucleoside RT inhibitor | Phase II | Sarawak Medichem |
| Capravirine | non-nucleoside RT inhibitor | Phase II | Agouron |
| d4T | nucleoside analogue RT inhibitor | Approved | Bristol-Myers Squibb |
| DAPD | nucleoside analogue RT inhibitor | Phase I/II | Triangle Pharmaceuticals |
| ddC | nucleoside analogue RT inhibitor | Approved | Hoffman-La Roche |
| ddI | nucleoside analogue RT inhibitor | Approved | Bristol-Myers Squibb |
| DEHSPM | inhibits hypusin/eIF-5A | Phase I | SunPharm |
| Delavirdine | non-nucleoside RT inhibitor | Approved | Agouron |
| DPC 083 | non-nucleoside RT inhibitor | Phase I | DuPont Pharmaceuticals |
| DPC 681 | protease inhibitor | Preclinical | Dupont Pharmaceuticals |
| DPC 684 | protease inhibitor | Preclinical | Dupont Pharmaceuticals |
| DPC 961 | non-nucleoside RT inhibitor | Phase I | DuPont Pharmaceuticals |
| Efavirenz | non-nucleoside RT inhibitor | Approved | DuPont Pharmaceuticals |
| Emivirine (MKC-442) | non-nucleoside RT inhibitor | Phase III | Triangle Pharmaceuticals |
| Emtricitabine (FTC) | nucleoside analogue RT inhibitor | Phase III | Triangle Pharmaceuticals |
| HI-236° | non-nucleoside RT inhibitor | Preclinical | Wayne Hughes Institute |
| Hu5A8° | binding inhibitor | Preclinical | Tanox |
| Hydroxyurea | inhibits cellular factors | Phase II/III | Bristol-Myers Squibb |
| Indinavir | protease inhibitor | Approved | Merck |
| LB-71350° | protease inhibitor | Preclinical | LG Chemical |
| Lopinavir (ABT-378) | protease inhibitor | Approved | Abbott |
| Mycophenlate | inhibits cellular factors | Phase I/II | Hoffman-La Roche |
| Nelfinavir | protease inhibitor | Approved | Agouron |
| Nevirapine | non-nucleoside RT inhibitor | Approved | Boehringer Ingelheim |
| Peldesine | inhibits cellular factors | Phase I | Biocryst |
| Pentfuside (T-20) | fusion inhibitor | Phase III | Trimeris/Roche |
| Phosphazid° | nucleoside analogue RT inhibitor | Preclinical | Viscount |
| PNU142721 | non-nucleoside RT inhibitor | Preclinical | Pharmacia |
| PRO 140 | CCR5 antagonist | Preclinical | Progenics |
| PRO 367 | entry inhibitor | Phase I | Progenics |
| PRO 542 | attachment inhibitor | Phase I/II | Progenics |
| RD4-2217° | non-nucleoside RT inhibitor | Preclinical | Tosoh |
| Resveratrol | inhibits cellular factors | Phase I | Pharmascience |
| Ritonavir | protease inhibitor | Approved | Abbott |
| S1360 | integrase inhibitor | Phase I/II | Shionogi Pharmaceuticals |
| Saquinavir | protease inhibitor | Approved | Hoffman-La Roche |
| SCH C | CCR5 antagonist | Phase I | Schering Plough |
| SCH D | CCR5 antagonist | Preclinical | Schering Plough |
| SJ-3366° | non-nucleoside RT inhibitor | Preclinical | Samjin |
| T-1249 | fusion inhibitor | Phase I | Trimeris/Roche |
| TAK 449 | CCR5 antagonist | Preclinical | Takeda |
| Tenofovir | nucleotide analogue RT inhibitor | Phase III* | Gilead Sciences |
| Tipranavir | protease inhibitor | Phase I/II | Boehringer Ingelheim |
| TMC 125 | non-nucleoside RT inhibitor | Phase II | Tibotec |
| TMC120 | non-nucleoside RT inhibitor | Phase II | Tibotec |
| TMC126 | protease inhibitor | Phase I | Tibotec |
| UC-781° | non-nucleoside RT inhibitor | Preclinical | Uniroyal |
| UK-427,857 | CCR5 antagonist | Preclinical | Pfizer |
| VX-175/ GW433908 (amprenavir prodrug) | protease inhibitor | Phase II/III | Vertex/Glaxo SmithKline |
* Available in expanded access
° No information available
Meeting Attendance:
Ken Fornataro NY
Rich Arenschieldt (Center For AIDS) Houston
Precious Jackson LA, CA
Bob Huff GMHC
Rob Camp NY
Daren or Baron Margolin, Boston (I'm not sure if this is correct)
Charles Clifton, Chicago
Mark Milano, NY
Lei Chou, NY
Nelson Vergel, Houston
Fred Schaich, Portland, OR
Matt Sharp, Chicago
Lynda Dee, Baltimore
Rolf Christiansen, Seattle
Cathy Olufs, LA
Dave Gilden, NY
Matt Sharp gave a quick overview of the Roche Fuzeon issues, including price and possible access issues post FDA approval; i.e., will there be enough drug to go around after approval. He indicated that he believed Roche called this meeting because we asked to meet with the Roche execs responsible for pricing whether from Basel, Switzerland or the Nutley, New Jersey. He did not have high hopes for Roche attendees being the ones we wanted or much movement on the actual price.
Suggestions ranged from boycotting the meeting (Mark Milano), to attending the meeting (Matt Sharp & Bob Huff), to walking out of the meeting (Lynda Dee).
We agreed that Lynda would contact Roche to obtain time, place, agenda and a list of Roche participants, stressing that we required Roche execs in a position to address and effect pricing issues.
There was some discussion of whether or not the Fair Pricing Coalition/Marty had arranged another Roche meeting with Roche and some ADAP Directors. Nobody had knowledge of this meeting and there were questions as to whether other community reps would be present.
We agreed on a number of things. Mark will contact us if ACT UP decides to boycott the meeting or conduct an action at the end of the meeting or when we walk out. We will listen to the access plan, save the pricing discussion until the end, and walk out if pricing discussions were unsatisfactory.
Regarding the access distribution opinions ranged from give the drug that will be available (12,000-15,000 the first year) away for free (Rob Camp) to make 1/3 free to those who cannot afford it (Lei Chou & Ken Fornataro). Consensus was that that we would request that Roche provide drug to anybody who can't afford it. (Dave Gilden).
We also agreed that Roche's Patient Assistance Program should administer the program, using ADAP type guidelines ala NY, CA, MA and NJ. (Lei), and Roche should cover all those who are still ineligible. This would serve as an incentive to Roche to keep the price low enough for ADAPs to actually cover T-20. (Mark). Lei will provide any data he has to show the strain T-20 costs will provide to ADAPs.
Regarding access we all agreed that in the event of access
problems the medical criteria should be that T-20 should be available
to all who "cannot construct a viable regimen". Nobody
favored CD4 restrictions, but everyone also agreed that in no
instance should CD4s requirements be below 200 if Roche insists
on such a categorization. Ken felt strongly that toxicities,
including elevated liver functions, should be given special consideration.
Most people felt that toxicities were included in "cannot
construct a viable regimen" approach.
We also agreed that we would request that Roche work with Boehringer to provide access to T-20 for patients who have access to Tipranavir (TPV) and be sure that drug is provided to study participants indefinitely if they are unable to access the drug by other means.
We also will be requesting the number of clinic/Medicaid doctors who participated in Roche's educational program in an effort to ascertain if their patients were in fact able to access T-20 via the Expanded Access Program and the amount of drug that will be available as well as the number of patients that Roche anticipates will have access to the drug after it is approved. Rob was interested in the breakdown of patients between the US and Europe.
We had a discussion of whether in fact there would be a rush of patients to T-20. Consensus was that there would not be. Some felt strongly that there might even be enough drug and that Roche was hyping it up in order to create T-20 supply/demand frenzy. We all agreed that we do our best in our newsletters, etc. to warn people that T-20 was not a panacea and that side effects are to be expected.
Lynda provided a quick Tipranavir (TPV) update from our recent Boehringer Ingelheim (BI) call.
Trials are proceeding with 500Tipranavir/200Lopinavir BID in experienced patients. BI will be studying 500/100 in naive patients. The 500/200 was better tolerated with better PK data and had less variations which was better for toxicity.
The two arms on the phase III trial are:
Lopinavir/Tipranavir + viable nucleoside background treatments
and any Expanded Access drugs.
VS. Ritonavir+ comparative PI history and the same type of nucleoside
background regimen. (PI and all nucleoside regimens will be determined
by geno and phentypic testing).
Lynda explained this trial design was quite open and not restrictive.
There is enough drug for 1,600 people for the first year. 1,300
will be used for the trials and 300 for anybody who does not qualify
for the trials in a restrictive expanded access program that would
require patients to have below 50 CD4s until more drug could be
manufactured in about one year. The
expanded access program should start in February of 2003. Sites
should be identified by BI by the Retrovirus Conference. There
are going to be between 30 to 200 sites by 2004.They are going
to try to work with T-20 sites. These Phase III trials, known
as Resistance 1 and Resistance 2 will roll over people from their
Phase II trials.
BI claimed that the reason for the 1300/300 is due to drug supply issues. BI claims that the two years is required to ramp up production. Many remembered that BI had previously stated that drug supply was not an issue. We need clarification on this.
Mark voiced concern about the 200BID Lopinavir dose, expressing toxcity concerns. We will have more data and a chance to speak to BI at their Retrovirus meeting. Matt suggested after the data is seen at CROI we should have another call.
Drug Development Committee Process
Lynda asked Rob to send her the E-CAB by-laws for review.
She will work something up and discuss it with an interested
group. They may have a conference call to discuss it. (Matt,
Rob, Lynda, Bob Munk). It will then be sent to the entire group
for review by the entire group. This process can continue while
the substantive work goes on. Maybe, the term "facilitator"
or "secretary" could be utilized instead of a chair
and vice chair. Lynda and Matt (reluctantly) will operate with
Lynda as the co-facilitator on the committee in the interim.
Mentoring Discussion
We discussed how to initiate the mentoring process. New people were warmly encouraged to contact anyone on them call or on the list to help them in any way or answer any questions they may have. Some old timers volunteered to be mentors. Some new people indicated that they did actually have a mentoree relationship with old timers on the call.
Matt suggested that people on the call should try to enlist people in their own orgs or in their cities in an effort to expand the group. Lynda suggested a self-selected buddy system between new people and old-timers on the call. Lynda suggested that we try this approach for a time to see if it works before mandating a plan.
We will have another call after the Retrovirus Conference. Thanks for a very successful call with a good mix of naive and experienced activists. Hope we can continue to work together so successfully.
Thanks also to Fred Schaich for providing explicit notes for these minutes. We're going to have to begin volunteering to share such responsibilities if we are going to be able to continue our work succesfully. I look forward to people jumping in to share the work.
Lynda Dee