Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Express Scripts
Harvard Business School
Mallinckrodt
Dow

Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Claims for Patent: 9,994,642

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

Summary for Patent: 9,994,642
Title:Methods for treating progressive multiple sclerosis
Abstract: The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.
Inventor(s): Smith; Craig (Seattle, WA), Chin; Peter S. (San Francisco, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:15/597,021
Patent Claims:1. A method of treating multiple sclerosis in a patient comprising administering an effective amount of an anti-CD20 antibody to the patient to provide an initial antibody exposure of 0.6 grams followed by a second antibody exposure of 0.6 grams, the second exposure not being provided until from 24 weeks or 6 months from the initial exposure, and each of the antibody exposures is provided to the patient as one or two doses of antibody, wherein the anti-CD20 antibody comprises a VH domain comprising the amino acid set forth in SEQ ID NO: 8, a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2, and a human IgG1 constant region.

2. The method of claim 1, wherein the initial antibody exposure comprises a first dose and a second dose of anti-CD20 antibody, wherein the first dose and second dose of anti-CD20 antibody is 0.3 grams.

3. The method of claim 2, wherein the second dose is administered from 3 to 17 days from the time the first dose was administered.

4. The method of claim 2, wherein the second dose is administered from 6 to 16 days from the time the first dose was administered.

5. The method of claim 2, wherein the second dose is administered from 13 to 16 days from the time the first dose was administered.

6. The method of claim 2, wherein the second dose is administered 15 days from the time the first dose was administered.

7. The method of claim 2, wherein the second antibody exposure comprises a single dose of anti-CD20 antibody, wherein the single dose of anti-CD20 antibody is 0.6 grams.

8. The method of claim 1, further comprising providing a third antibody exposure.

9. The method of claim 8, wherein the third anti-CD20 antibody exposure is provided 24 weeks or 6 months from the second exposure.

10. The method of claim 8, further comprising providing a fourth antibody exposure.

11. The method of claim 10, wherein the fourth antibody exposure is provided 24 weeks or 6 months from the third exposure.

12. The method of claim 10, further comprising providing a fifth antibody exposure.

13. The method of claim 12, wherein the fifth antibody exposure is provided 24 weeks or 6 months from the fourth exposure.

14. The method of claim 12, wherein subsequent antibody exposures are administered at intervals of 24 weeks or 6 months.

15. The method of claim 1, wherein a second medicament is administered with the initial exposure or later exposures, wherein the anti-CD20 antibody is the first medicament.

16. The method of claim 15, wherein the second medicament is selected from the group consisting of an interferon, glatiramer acetate, a cytotoxic agent, a chemotherapeutic agent, mitoxantrone, methotrexate, cyclophosphamide, chlorambucil, azathioprine, gamma globulin, Campath, anti-CD4, cladribine, corticosteroid, mycophenolate mofetil (MMF), cyclosporine, a cholesterol-lowering drug of the statin class, estradiol, testosterone; a hormone replacement drug, a TNF inhibitor, a disease-modifying anti-rheumatic drug (DMARD), a non-steroidal anti-inflammatory drug (NSAID), levothyroxine, cyclosporin A, a somatastatin analogue, a cytokine or cytokine receptor antagonist, an anti-metabolite, an immunosuppressive agent, an integrin antagonist or antibody, an LF A-1 antibody, efalizumab, an alpha 4 integrin antibody, natalizumab, and another B-cell surface marker antibody.

17. The method of claim 1, wherein the multiple sclerosis is primary progressive multiple sclerosis (PPMS).

18. The method of claim 1, wherein the multiple sclerosis is relapsing remitting multiple sclerosis (RRMS).

19. The method of claim 1, wherein the subject has never been previously treated with an anti-CD20 antibody.

20. The method of claim 1, wherein the anti-CD20 antibody is administered intravenously.

21. The method of claim 1, wherein anti-CD20 antibody is the only medicament administered to the subject to treat multiple sclerosis.

22. The method of claim 1, wherein the subject has elevated anti-myelin basic protein (MBP), anti-myelin oligodendrocytic glycoprotein (MOG), anti-ganglioside and/or anti-neurofilament antibody levels.

23. The method of claim 1, wherein elevated levels of B cells are present in cerebrospinal fluid (CSF), multiple sclerosis lesion, or serum of the subject.

24. An article of manufacture comprising: (a) a container comprising an anti-CD20 antibody, which anti-CD20 antibody comprises a VH domain comprising the amino acid set forth in SEQ ID NO: 8, a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2, and a human IgG1 constant region; and (b) a package insert with instructions for treating multiple sclerosis in a patient, wherein the instructions indicate that an amount of anti-CD20 antibody is administered to the patient that is effective to provide an initial antibody exposure of 0.6 grams followed by a second antibody exposure of 0.6 grams, the second exposure not being administered until from 24 weeks or 6 months from the initial exposure, and each of the antibody exposures is provided to the patient as one or two doses of antibody.

25. A method of treating multiple sclerosis in a patient comprising administering an effective amount of an anti-CD20 antibody to the patient to provide an initial antibody exposure of about 0.6 grams followed by a second antibody exposure of about 0.6 grams, the second exposure not being provided until from about 6 months from the initial exposure, and each of the antibody exposures is provided to the patient as one or two doses of antibody, wherein the anti-CD20 antibody comprises a VH domain comprising the amino acid set forth in SEQ ID NO: 8, a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2, and a human IgG1 constant region.

26. The method of claim 25, wherein the initial antibody exposure comprises a first dose and a second dose of anti-CD20 antibody, wherein the first dose and second dose of anti-CD20 antibody about is 0.3 grams.

Details for Patent 9,994,642

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Genzyme CAMPATH alemtuzumab VIAL; INTRAVENOUS 103948 001 2001-05-07   Start Trial Genentech, Inc. (South San Francisco, CA) 2028-09-16 RX Orphan search
Genzyme CAMPATH alemtuzumab VIAL; INTRAVENOUS 103948 002 2001-05-07   Start Trial Genentech, Inc. (South San Francisco, CA) 2028-09-16 RX Orphan search
Genzyme LEMTRADA alemtuzumab INJECTABLE;INJECTION 103948 003 2001-05-07   Start Trial Genentech, Inc. (South San Francisco, CA) 2028-09-16 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Moodys
Colorcon
Johnson and Johnson
Merck

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 verifification 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.