# US 2013/0280302 A1 · Pharmaceutical product comprising mite allergen extract(s) and a method for the manufacture thereof

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- Number: US 2013/0280302 A1
- Document ID: US20130280302A1
- Status: Published application
- Kind: A1
- Application number: 13/701,614
- Filed: 2011-06-03
- Published: 2013-10-24
- Earliest claimed: 2010-06-03
- Assignees: ALK-Abello A/S
- Inventors: Heather Michelle Webster; Jason Daniel Frey; Trena Larissa Repp; Craig T. Grass; David Rowles; Gary Steven Smith; Domingo Barber Hernandez; Fernando Juan Vidales; Carmen Artega Vazquez; Juan Carlos Moreno Segura; Maria Jose Chamorro Salillas
- Web page: https://patentgrep.com/patent/US20130280302A1

## CPC

- A61K 39/35: Allergens
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 9/2063: {Proteins, e.g. gelatin}
- A61K 9/2095: {Tabletting processes}
- A61K 35/646: Arachnids, e.g. spiders, scorpions, ticks or mites
- A61P 11/06: Antiasthmatics
- A61P 33/14: Ectoparasiticides, e.g. scabicides
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61K 2039/515: {Animal cells}
- A61K 2039/54: {characterised by the route of administration}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to a pharmaceutical product comprising an allergen extract or an allergoid thereof for the treatment and/or prevention of allergy and allergic asthma caused by house dust mites, which extract comprises at least one extract of mite bodies selected from the following groups a)-b): a) An extract of Der p mite bodies, and b) An extract of Der f mite bodies, and at least one extract of mite cultures selected from the following groups c)-g): c) An extract of Der p faecal particles, d) An extract of Der f faecal particles, e) An extract of Der f whole mite culture, f) An extract of an Der p whole mite culture, and g) a combination of extracts c) to f).

## Claims

### Claim at position 1

1-73. (canceled)

### Claim 74

A pharmaceutical product comprising an allergen extract or an allergoid thereof, which comprises at least one extract of mite bodies selected from the following groups a)-b):
a) An extract of Der p mite bodies, wherein the extract of Der p mite bodies is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 70% v/v Der p mite bodies,
b) An extract of Der f mite bodies, wherein the extract of Der f mite bodies is prepared from one fraction or combined fraction(s) of mite cultures said fractions comprising more than 70% v/v Der f mite bodies,
and at least one extract of mite faecal particles selected from the following groups c)-d):
c) An extract of Der p faecal particles, wherein the extract of Der p faecal particles is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 70% v/v Der p faecal particles,
d) An extract of Der f faecal particles, wherein the extract of Der f faecal particles is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 70% v/v Der f faecal particles.

### Claim 75 (depends on 74)

The pharmaceutical product according to claim 74 comprising an extract of Der p mite bodies and an extract of Der p faecal particles.

### Claim 76 (depends on 74)

The pharmaceutical product according to claim 74 comprising an extract of Der f mite bodies and an extract of Der f faecal particles.

### Claim 77 (depends on 74)

The pharmaceutical product according to claim 74 comprising an extract of Der p mite bodies, an extract of Der p faecal particles, an extract of Der f mite bodies and an extract of Der f 2 faecal particles.

### Claim 78 (depends on 74)

The pharmaceutical product according to claim 74, wherein the extract of Der p mite bodies is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 95% v/v Der p mite bodies; and/or the extract of Der f mite bodies is prepared from one fraction or combined fraction(s) of mite cultures said fractions comprising more than 95% v/v Der f mite bodies; and/or the extract of Der p faecal particles is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 95% v/v Der p faecal particles; and/or the extract of Der f faecal particles is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 95% v/v Der f faecal particles.

### Claim 79 (depends on 74)

The pharmaceutical product according to claim 74, wherein the extract of Der p mite bodies is prepared from one Der p mite body fraction or combined Der p mite body fractions and where extraction of said fraction(s) of mite bodies results in an extract comprising by weight equal amounts of group 1 and group 2 allergen or more group 2 allergen than group 1 allergen and/or the extract of Der f mite bodies is prepared from one Der f mite body fraction or more combined Der f mite body fractions and where extraction of said fraction(s) of mite bodies results in an extract comprising by weight equal amounts by weight of group 1 and group 2 allergen or more group 2 allergen than group 1 allergen.

### Claim 80 (depends on 74)

The pharmaceutical product according to claim 74, wherein the extract of Der p mite bodies is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 95% v/v Der p mite bodies; the extract of Der f mite bodies is prepared from one fraction or combined fraction(s) of mite cultures said fractions comprising more than 95% v/v Der f mite bodies; the extract of Der p faecal particles is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 95% v/v Der p faecal particles; the extract of Der f faecal particles is prepared from one fraction or combined fraction(s) of mite cultures said fraction(s) comprising more than 95% v/v Der f faecal particles.

### Claim 81 (depends on 74)

The pharmaceutical product according to claim 74, wherein the pharmaceutical product is a sublingual tablet.

### Claim 82 (depends on 81)

The pharmaceutical product according to claim 81, wherein the sublingual tablet is a fast dissolving sublingual tablet.

### Claim 83

A mite body fraction comprising more than 70% v/v mite bodies.

### Claim 84 (depends on 83)

The mite body fraction according to claim 83, wherein the mite bodies are Der p mite bodies or Der f mite bodies.

### Claim 85

A mite faecal particle fraction comprising more than 70% v/v faecal particles.

### Claim 86 (depends on 85)

The mite faecal particle fraction according to claim 85, wherein the faecal particles is Der p faecal particles or Der f faecal particles.

### Claim 87 (depends on 74)

A method for the manufacture of a mite allergen allergen extract (I) or allergoids thereof for a pharmaceutical product according to claim 74, said allergen extract (I) having a predetermined and controlled amount by weight of allergens selected from Der f 1, Der f 2, Der p 1 and Der p 2 allergens and comprising the following steps:
a) Fractions of Der p mite bodies and/or fractions of Der p mite faecal particles are isolated from Der p cultures of mites, and/or fractions of Der f mite bodies and/or fractions of Der f mite faecal particles are isolated from Der f mite cultures;
b) Optionally combining several fractions of Der p mite bodies, optionally combining several fractions of Der p mite faecal particles, optionally combining several fractions of Der f mite bodies and optionally combining several fractions of Der f mite faecal particles;
c) Extracting allergens from mite body faction(s) obtained in a step a) or a step b) as above and/or extraction of allergens from mite faecal particle fraction(s) obtained in a step a) or a step b) as above; and thereafter
d) Measuring the concentration (w/v) of group 1 and group 2 allergen in mite allergen extracts obtained in a step c) as above; and optionally
e) Mixing one or more extract(s) of mite bodies with one or more extract(s) of faecal particles as obtained in a step c) as above to obtain a mixture of allergen extracts (I) with a predetermined amount by weight of group 1 to group 2 allergen and optionally
f) Converting the extract (I) to an allergoid thereof.

### Claim 88 (depends on 87)

The method according to claim 87, wherein one or more extract(s) of mite bodies and one or more extract(s) of faecal particles is mixed to obtain a mixture of allergen extracts (I).

### Claim 89 (depends on 87)

The method according to claim 87, wherein the mixture of mite allergen extract (I) comprises extract(s) of Der p mite bodies, extract(s) of Der p faecal particles, extract(s) of Der f mite bodies and extract(s) of Der f 2 faecal particles.

### Claim 90 (depends on 87)

The method according to claim 87, wherein the pharmaceutical product is a fast dissolving sublingual tablet.

### Claim 91 (depends on 74)

A method for treatment and/or prevention of allergy and allergic asthma caused by house dust mites which method comprises administering to a patient in need of such treatment an effective amount of a pharmaceutical product of claim 74.