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Compositions for the Control of Parasitic Infestations in Fish

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Compositions for the Control of Parasitic Infestations in Fish (19) TZZ_¥ZZ_T (11) EP 1 306 084 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: A61K 31/17 (2006.01) A01N 47/34 (2006.01) of the grant of the patent: A61P 33/14 (2006.01) 21.08.2013 Bulletin 2013/34 (21) Application number: 03075182.0 (22) Date of filing: 31.05.1999 (54) Compositions for the control of parasitic infestations in fish Zusammensetzungen zur Bekämpfung von parasitischen Befallen in Fischen Compositions pour la lutte contre les infections parasitaires des poissons (84) Designated Contracting States: • Evensen, Oystein AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU 0198 Oslo (NO) MC NL PT SE • Syvertsen, Christian 1900 Fetsund (NO) (30) Priority: 09.06.1998 NO 982650 • Martinsen, Bernt 1386 Asker (NO) (43) Date of publication of application: 02.05.2003 Bulletin 2003/18 (74) Representative: Plougmann & Vingtoft A/S Rued Langgaards Vej 8 (62) Document number(s) of the earlier application(s) in 2300 Copenhagen S (DK) accordance with Art. 76 EPC: 99921041.2 / 1 083 907 (56) References cited: WO-A-96/11707 WO-A-96/41536 (73) Proprietor: Pharmaq AS WO-A-97/40826 WO-A-97/45017 7863 Overhalla (NO) WO-A-97/46204 WO-A-99/44425 FR-A- 2 720 898 (72) Inventors: • Alexander, Svein 4024 Stavanger (NO) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 306 084 B1 Printed by Jouve, 75001 PARIS (FR) 1 EP 1 306 084 B1 2 Description [0005] Substances that are effective against parasitic infestations for oral administration have also been tested FIELD OF INVENTION in fish. Substances such as chitin synthesis inhibitors, diflubenzuron and teflubenzuron, and ivermectin are ex- [0001] The present invention pertains in its broadest 5 amples of substances, which, if administered orally, can aspect to the field of controlling diseases in fish and in be effective against parasitic diseases in fish. In addition particular there are provided means for controlling para- to the substances mentioned above, wrasse (Labridae) sitic infestations in fish such as farmed fish and more has been used extensively to keep sea lice infestations specifically, novel compositions for treating and/or pre- under control. venting infestations with sealice and other crustacean 10 [0006] Substances for bath treatment of parasitically fish parasites are provided, including injectable compo- infestated fish, such as sea lice infestations, must be sitions for such treatment and/or prevention. mixed into the water where the fish normally swims. Some of the substances that are used are water- soluble TECHNICAL BACKGROUND AND PRIOR ART (azamethiphos), while others are not (cypermethrin, del- 15 tamethrin) and therefore, the latter group of substances [0002] Parasitic infestations constitute considerable remain as a suspension or emulsion in water. For fish problems in the fish farming industry as well as in wild that are kept in tanks, the bath treatment can be carried fish. This applies especially to farmed fish in fresh water out by adding the substance formulations directly into the and seawater. Damages due to parasitic infestations re- tank where the fish are kept. For treatment of fish that sult in considerable losses and increased workloads for 20 are kept in sea cages, the bottom of the cage is raised the fish farmers. Infestation with sea lice ( Lepeophtheirus manually to reduce the treatment volume. A tarpaulin is salmonis and Caligus elongatus) is considered to be one placed around the cage so that the fish are completely of the most important disease problems in the farming of enclosed, whereupon the treatment substance is added salmonids, especially in Atlantic salmon (Salmo Salar) to the cage. The fish swim in the solution for 20-60 min- and rainbow trout ( Oncorhynchus mykiss). In addition to 25 utes, depending on the treatment substance. Oxygen the costs that are associated with treatment, lower clas- must be supplied to the cage in which the fish are treated. sification ratings of slaughtered fish and reduced growth Treatment with a bottomless tarpaulin, the so- called skirt rate due to reduced feed intake contribute to the eco- treatment, is also used to a large extent. Since the treat- nomic losses for the fish farmer. ment volume in such cases can not be defined exactly, [0003] In addition to the damages caused in farmed 30 a larger amount of active substance will have to be used fish, recent research has shown that sea lice could be in this route of administration than is the case when a the most important single cause leading to weakening of closed tarpaulin is used. It is also becoming more com- several wild salmon stocks. The emigration of salmon mon to carry out bath treatments in well boats. smolt from river systems is often coincidental with rising [0007] Organophosphates and hydrogen peroxide are seawater temperatures in the fjord and coastal areas, 35 only effective against the pre-adult and adult stages of which leads to a massive attack of copepodites (sea lice sea lice (the last 3 stages of the total of 8 stages which larvae) on the smolt. An attack of 40 or more sea lice on exist on the skin of salmonids), while pyrethroids and salmon smolt is fatal to fish weighing less than 25 grams, ivermectin also have a more or less well-defined effect and in several regions in Norway premature return of against the other 5 stages. None of these substances post-smolt sea trout has been observed. The decline in 40 protect against new infestations after the treatment has the stock of salmonids that have been documented in been completed. several Norwegian salmon rivers over the past few years, [0008] Hydrogen peroxide is corrosive, and must could be related to the fact that the amount of sea lice in therefore be handled with great care. Transport of hydro- connection with fish farming has increased. gen peroxide requires certain precautionary measures, [0004] Up till now, the most common treatment of fish 45 as it is defined as hazardous goods in great quantities. parasites involves bathing or immersing the fish in a treat- The organophosphates are toxic to humans and must ment solution comprising an antiparasitically active com- therefore be treated with caution. The organophosphates pound. This includes both skin and gill parasites. Bathing couldbe absorbed throughthe skin and lead topoisoning. in formalin is a widespread treatment against many par- The therapeutic margin for organophosphates and hy- asites, especially in fresh water, while bathing in organ- 50 drogen peroxide is small. Fish mortality has been report- ophosphates (metrifonate, dichlorvos, azamethiphos), ed on several occasions, due to overdosing of such pyrethroids (pyrethrum, cypermethrin, deltamethrin) or drugs. hydrogen peroxide are the most common bath treat- [0009] Pyrethroids have, in addition to their effect ments against e.g. sea lice Lepeophtheirus( salmonis, against pre-adult and adult lice, also an effect against Caligus elongatus). These substances act directly on the 55 the attached stages. They are not acutely toxic to the parasites via the water, and a possible absorption of the user, but is a drug group that is toxic to fish, especially active substance into the fish itself is unimportant for the small fish. Possible overdosing and increased mortality effect of the active substances on the parasite. is thus possible. 2 3 EP 1 306 084 B1 4 [0010] All drug groups mentioned above are adminis- after the treatment has been completed. This also tered via bath treatments. This is labourintensive and means, however, that the treatment involves a long with- might also be a stress factor to the fish. drawal period before the fish may be slaughtered and [0011] In addition to bath treatments, oral treatments consumed. Ivermectin has not been documented and ap- for parasite control in fish have been developed. Two 5 proved for use on fish in any country. Sufficient docu- chitin synthesis inhibitors, diflubenzuron and tefluben- mentation about withdrawal periods, toxicity to fish and zuron, have been documented for use against sea lice to the marine environment is therefore not available. in salmon. The macrocyclical lactone, ivermectin, is also [0014] As it appears from the above summary of the being used against parasites in salmonids in Chile, Ire- state-of-the-art, there is an industrial need for improved land and Scotland. 10 means of controlling parasitic infestations in fish, which [0012] Diflubenzuron and teflubenzuron, which belong are antiparasitically effective and non- toxic to the fish and to the same substance group as hexaflumuron, act by can be administered in an industrialty convenient manner inhibiting the production of chitin which is an important and which protect the fish for an extended period of time part of the cuticle of insects and crustaceans. At each after administration. Such improvement that are provided moulting or ectdysis, a new synthesis of chitin is required 15 by the invention is the treatment of fish to cure or prevent for development. If this synthesis is inhibited, the devel- parasitic infestations by administering hexaflumuron and opment of the insect or crustacean will be halted, and the administration of antiparasitically active substances the animal under development will die. In principle, chitin by injection. Such an administration route has not been synthesis inhibitors will be effective against all organisms used previused previously, as it has hitherto been con- containing chitin.
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