Claims for Patent: 9,676,860
✉ Email this page to a colleague
Summary for Patent: 9,676,860
Title: | DAC HYP compositions and methods |
Abstract: | The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof. |
Inventor(s): | Hartman; Taymar E. (Redwood City, CA), Sauer; Paul W. (Fremont, CA), Burky; John E. (Newark, CA), Wesson; Mark C. (San Ramon, CA), Huang; Ping Y. (Fremont, CA), Robinson; Thomas J. (San Mateo, CA), Partridge; Braeden D. (Sunnyvale, CA), Tso; J. Yun (Menlo Park, CA) |
Assignee: | AbbVie Biotherapeutics Inc. (Redwood City, CA) |
Application Number: | 14/601,909 |
Patent Claims: | 1. A method of treating a patient suffering from multiple sclerosis, comprising administering to the patient an amount of a daclizumab composition sufficient to provide
therapeutic benefit, wherein the daclizumab has two or more of the following: (a) an N-terminal isoform with one pyroglutamate residue and one glutamine residue that comprises 3%-17% of the total daclizumab: (b) an N-linked oligosaccharide profile
comprising two main peaks and a minor peak, wherein one of the two main peaks is GO-GlcNAc glycoform present in about 5% to about 20% of the AUC, the other main peak is GO glycoform present in about 70% to about 99.2% of the AUC, and the minor peak is G1
glycoform present in 1% to 9% of the AUC when determined according to the method described in Section 7.6.14, (c) <3% aggregates when formulated at a concentration of about 150 mg/mL.
2. The method of claim 1 in which the daclizumab composition is administered: (a) subcutaneously; (b) in an amount corresponding to about 1 mg/kg daclizumab, once every two weeks or in an amount corresponding to about 2 mg/kg daclizumab, once every month; (c) for a total of about 24 weeks; or (d) according to any combination of (a)-(c). 3. The method of claim 2, in which the daclizumab composition is administered in an amount corresponding to 75 mg to 300 mg daclizumab, or 150 mg, or 300 mg. 4. The method of claim 3 wherein the daclizumab composition is administered subcutaneously in an amount corresponding to 150 mg daclizumab once every month. 5. The method of claim 3 in which the daclizumab is administered as monotherapy, in which the patient has either failed to respond to prior treatment with interferon-beta or has discontinued prior treatment with interferon-beta. 6. The method of claim 3 in which the daclizumab is administered adjunctively to interferon-beta. 7. The method of claim 1 in which the daclizumab has an N-linked glycosylation profile determined according to the method described in Section 7.6.14, in which the total AUC of the peaks in the profile corresponding to non-fucosylated mannose glycosyls is less than about 6% of the total AUC of all peaks in the profile. 8. The method of claim 4 which is administered for a total of at least 48 weeks. |
Details for Patent 9,676,860
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Hoffmann-la Roche Inc. | ZENAPAX | daclizumab | Injection | 103749 | 12/10/1997 | ⤷ Try a Trial | 2031-05-27 |
Biogen Inc. | ZINBRYTA | daclizumab | Injection | 761029 | 05/27/2016 | ⤷ Try a Trial | 2031-05-27 |
Biogen Inc. | ZINBRYTA | daclizumab | Injection | 761029 | 05/26/2017 | ⤷ Try a Trial | 2031-05-27 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.