# US 11,439,686 B2 · Recombinant FSH composition for treatment of infertility

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- Number: US 11,439,686 B2
- Document ID: US11439686B2
- Status: Granted
- Kind: B2
- Application number: 16/881,163
- Filed: 2020-05-22
- Published: 2020-11-12
- Granted: 2022-09-13
- Earliest claimed: 2015-04-17
- Assignees: Ferring B.V.
- Applicants: Ferring B.V.
- Inventors: Joan Carles Arce Saez; Lisbeth Helmgaard; Bjarke Mirner Klein
- Web page: https://patentgrep.com/patent/US11439686B2

## CPC

- A61K 38/24: Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
- A61P 5/06: of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
- A61P 5/24: of the sex hormones
- 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

Preparations including FSH, for example recombinant FSH, for use in the treatment of infertility.

## Claims

### Claim 1

A method of treating infertility, comprising administering a follicle stimulating hormone (FSH) composition at a dose of or equivalent to from 9 to 24 μg FSH to a patient identified prior to treatment as having (i) variant Ser/Ser at position 680 of the FSH receptor and (ii) a serum AMH level of 15.0 to 44.9 pmol/L.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method comprises daily administration of the FSH composition.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method comprises administering the FSH composition at a dose of or equivalent to from greater than 12 to 24 μg FSH.

### Claim 4 (depends on 1)

The method of claim 1, wherein the FSH composition is administered starting on day one of treatment and continuing for from six to sixteen days.

### Claim 5 (depends on 1)

The method of claim 1, wherein the FSH is recombinant FSH.

### Claim 6 (depends on 1)

The method of claim 1, wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation.

### Claim 7 (depends on 1)

The method of claim 1, wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation, wherein from 1 to 99% of the total sialylation is α2,6-sialylation and from 99% to 1% of the total sialylation is α2,3-sialylation.

### Claim 8 (depends on 1)

The method of claim 1, wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation, wherein from 1 to 50% of the total sialylation is α2,6-sialylation and from 50% to 99% of the total sialylation is α2,3-sialylation.

### Claim 9

A method of treating infertility, comprising administering a follicle stimulating hormone (FSH) composition at a dose of or equivalent to from 10 to 12 μg FSH to a patient identified prior to treatment as having (i) variant Asn/Asn or variant Asn/Ser at position 680 of the FSH receptor and (ii) a serum AMR level of 15.0 to 44.9 pmol/L.

### Claim 10 (depends on 9)

The method of claim 9, wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation, wherein from 1 to 50% of the total sialylation is α2,6-sialylation and from 50% to 99% of the total sialylation is α2,3-sialylation.