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|U.S. Sponsor of Abortion Pill Encounters More Manufacturing Problems|
A Hungarian manufacturer that had been secretly lined up to do the initial raw chemical processing and manufacturing of RU 486 for the United States has backed out of its agreement with the Population Council, the U.S. patent holder for the abortion pill, according to several recent news reports.
Precisely what effect this will have on the American debut of the pill is not known. Danco Laboratories, the would-be U.S. distributor of RU 486, filed suit May 9, 1997, in New York Supreme Court against the manufacturer, Chemical Works of Gedeon Richter, Ltd., of Budapest, Hungary.
Danco calls Richter's decision to withdraw "a major and potentially ruinous setback" and alleges that even if another manufacturer is found, Richter's pull-out could delay the pill's introduction to the U.S. market by as many as three to five years.
However, Sandra Waldman, spokesperson for the Population Council, told the New York Times (6/13/97), "Three to five years, that really is the extreme ... it would be unfortunate to give the impression that that is the most likely pathway because I don't think it is." The pill had been scheduled for release this December.
Danco Laboratories is the entity selected by Advances/Neogen, the group given control over American marketing of the pill by the Population Council, to handle the pill's U.S. distribution.
In the June 11 Washington Post report that broke the story, Waldman confirmed the existence of a dispute with the manufacturer, but said, "We're continuing to talk to them." If the council can convince Richter to continue production, Waldman indicated the delays could be minor. She admitted, however, that "our commercial partners are very actively looking for other manufacturers."
According to press accounts of the suit, which surfaced a couple of days after the initial Post story, Gedeon Richter was supposed to have entered into a five-year agreement with the Population Council to manufacture bulk mifepristone (the generic name for RU 486) on May 15, 1996. Richter was to have manufactured the raw mifepristone and shipped it to the United States, where it would be made into tablets, packaged, and distributed. Whether Danco, or some other entity, would make and package the tablets was not entirely clear.
However, Richter abruptly canceled those arrangements early this year. On February 28, 1997, Gyorgy Thaler, Richter's director of development, sent a letter to Danco indicating that his company was terminating the manufacturing agreement and had "ceased all manufacturing activities with respect to the project."
Richter had worked with Danco Laboratories for more than a year before abruptly canceling its contract. It was unclear how much, if any, of the raw product Richter had produced or delivered.
If Richter holds firm, it might be difficult for the council to find another manufacturer. According to FDC Reports's "Pink Sheet" (6/18/97), Danco says it "has diligently looked, but has been unable to find another manufacturer capable of producing the identical bulk drug utilizing [Roussel Uclaf's] process and raw material for starting the synthesis." (Roussel Uclaf is the name of the French drug manufacturer that first developed the pill and is a subsidiary of Hoechst AG.)
Due to the controversy associated with the marketing of abortion drugs in the U.S., Danco says it has "experienced, and expects to continue to experience, difficulties in finding any substitute manufacturer."
The initial Washington Post article which broke the story did not include Gedeon Richter's name. A New York judge's June 2 refusal to seal the records resulted in the identification of Richter as the manufacturer. The story did mention that no major U.S. pharmaceutical company had been willing to market the drug in the U.S. for fear of "economic boycotts." The Post also noted that the identity of the European company that was to be involved in the manufacture of the pill had been kept secret because of "concerns about a backlash against it by abortion foes in this country."
The latest developments follow the decision last fall by the U.S. Food and Drug Administration (FDA) to give tentative approval to RU 486, declaring it "safe and effective." But the FDA withheld final approval pending additional information on "labeling and manufacturing" it was seeking from the sponsor.
While an FDA spokesman indicated to the Post (6/12197) that the Population Council had supplied the labeling information sought by the FDA, the FDA never received the additional data it required from Gedeon Richter to issue a final approval. The FDA accepted clinical data on the pill's use from Hoechst's French subsidiary Roussel Uclaf, which first developed and manufactured the pill, but had sought from Richter a "drug master file" which would demonstrate "the comparability of its manufacturing processes, and the bulk drug substances it produces" (FDC Reports, "The Pink Sheet," 6/18/97).
Other problems are apparently brewing for the Population Council. The company the Population Council set up to handle marketing of RU 486 in the U.S., Advances in Health Technology, has now undergone its second name change in as many years -- first to "Advances for Choice," now to "Advances/ Neogen."
Moreover, the status of Jack Van Hulst, the Dutch pharmaceutical executive hired to take over the marketing company after an embarrassing suit between the council and one of its business partners, is now unclear. Despite the close relationship Population Council has with Advances/Neogen, Waldman indicated to the Post that she is "not sure" what Van Hulst's current relationship is with the company.
Advances/Neogen indicated to FDC Reports that Van Hulst's relationship with the company "may be changing." Advances/Neogen was the company that contracted Danco to handle U.S. distribution.
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