PCT. ANTIGENICITY LOSS OF 13vPnC WITH AIP04

Transcription

1 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date (10) International Publication Number 8 November 2007 ( ) PCT WO 2007/ A3 (51) International Patent Classification: River, NY (US). YANG, Xudong [CN/US]; 6 A61K 47/12 ( ) A61K ( ) Lanram Road, Tappan, NY (US). (21) International Application Number: (74) Agents: CASH, David, E. et al; Alston & Bird LLP, Bank PCT/US2007/ Of America Plaza, 101 South Tryon Street, Suite 4000, (22) International Filing Date: 19 April 2007 ( ) Charlotte, NC (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (26) Publication Language: English AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, (30) Priority Data: FT, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, 60/795, April 2006 ( ) US IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY,MA, MD, MG, MK, MN, MW, MX, MY, (71) Applicant (for all designated States except US): WYETH MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, [US/US]; 5 Giralda Farms, Madison, NJ (US). RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, TJ, TM, TN, (72) Inventors; and TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW (75) Inventors/Applicants (for US only): KHANDKE, Lak- (84) Designated States (unless otherwise indicated, for every shmi [US/US]; 120 East Allison Avenue, Nanuet, NY kind of regional protection available): ARIPO (BW, GH, (US). CHEN, Ying [CN/US]; 1005 Edinburgh GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, Downs Lane, Apex, NC (US). HAN, Hanyoung ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), [US/US]; 2400 Hudson Terrace, Apt. 5H, Fort Lee, NJ European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, (US). SEID, Robert, Chancey, Jr. [US/US]; 913 FR, GB, GR, HU, IE, IS, IT, LT, LU, LV,MC, MT, NL, PL, Beacon Square Court, Apt. #349, Gaithersburg, MD PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, (US). JIN, Zhaowei [CN/US]; 202 Barons Glenn GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). Way, Cary, NC (US). LOOK, Jee, Loon [US/US]; 50 Orchard Drive, Gaithersburg, MD (US). MAL- Published: ONE, Ronald [US/US]; 401 N. Middletown Road, Pearl with international search report [Continued on next page] (54) Title: NOVEL FORMULATIONS WHICH STABILIZE AND INHIBIT PRECIPITATION OF IMMUNOGENIC COMPO SITIONS E - 2 HRS AGITATION 8 HRS AGITATION 24 HRS AGITATION ANTIGENICITY LOSS OF 13vPnC WITH AIP04 IN TYPE 1 GLASS SYRINGE/4432 STOPPERS (57) Abstract: The present invention addresses an ongoing need in the art to improve the stability of immunogenic compositions such as polysaccharide-protein conjugates and protein immunogens. The invention broadly relates to novel formulations which stabilize and inhibit precipitation of immunogenic compositions. More particularly, the invention described hereinafter, addresses a need in the art for formulations which stabilize and inhibit particulate formation (e.g., aggregation, precipitation) of immunogenic compositions which are processed, developed, formulated, manufactured and/or stored in container means such as fermentors, bioreactors, vials, flasks, bags, syringes, rubber stoppers, tubing and the like.

2 (88) Date of publication of the international search report: 13 November 2008

3 A. CLASSIFICATION OF SUBJECT MATTER INV. A61K47/12 A61K47/48 According to International Patent Classification (IPC) or to both national classification and IPC B. FIELDS SEARCHED Minimum documentation searched A61K (classification system followed by classification symbols) Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic data base consulted during the international search (name of data base and, where practical, search terms used) EPO-Internal, WPI Data, PAJ C. DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where approp πate, of the relevant passages Relevant to claim No WO 02/05846 A (GREEN CROSS VACCINE CO LTD 1-13 [KR]; BAE CHEON SOON [KR]; LIM GWAN YEUL [K) 24 January 2002 ( ) page 2, line 14 - line 20 page 3, line 13 - line 20 page 4, line 6 - line 13 page 13, line 14 claims; examples WO 01/41800 A (CHIRON CORP [US]; ESIKOVA 1-13 IRINA [US]; WOLFE SIDNEY [US]; THOMSON JAMES) 14 June 2001 ( ) page 4 line 8 - line 11 page 7 line page 8, line 6 page 9 line 18 - line 27 claims examples -/-- Further documents are listed in the continuation of Box C See patent family annex * Special categories of cited documents 1 T' later document published after the international filing date or priority date and not in conflict with the application but 1 A 1 document defining the general state of the art which is not cited to understand the principle or theory considered to be of particular relevance invention underlying the 1 E' earlier document but published on or after the international "X" document of particular relevance, the claimed invention filing date cannot be considered novel or cannot be considered to 1 L" document which may throw doubts on pnoπty claιm(s) or involve an inventive step when the document is taken alone which is cited to establish the publication date of another 1 Y" document of particular relevance, the claimed invention citation or other special reason (as specified) cannot be considered to involve an inventive step when the O " document referring to an oral disclosure, use, exhibition or document is combined with one or more other such docu other means ments, such combination being obvious to a person skilled "P" document published prior to the international filing date but in the art later than the priority date claimed "& document member of the same patent family Date of the actual completion of the international search Date of mailing of the international search report 8 Apri l /07/2008 Name and mailing address of the ISA/ European Patent Office, P B 5818 Patentlaan 2 NL HV Rl SWI k TeI (+31-70) , Tx epo nl, Fax (+31-70) Authorized officer Bouloi s, Deni s

4 C(Contlnuation). DOCUMENTS CONSIDERED TO BE RELEVANT Category * Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. WO 2005/ A (HEXAL BIOTECH FORSCHUNGS 1-13 GMBH [DE]; SKUFCA PETER [DE]; SEIBERT. FABIAN) 6 May 2005 ( ) page 8, line 15 - line 26 page 9, line 26 - page 10, line 7 ; examples WO 03/ A (PROTEIN DESIGN LABS [US]; 1-13 KAISHEVA ELIZABET A [US]; GUPTA SUPRIYA [US]) 15 May 2003 ( ) page 1, line 12 - line 17 page 2, line 1 - line 31 page 3, line 5 - line 18 page 11, line 8 - line 29 claims; examples US 2004/ A l (BROEKER MICHAEL [DE]) 1,2,5-9, 11 March 2004 ( ) 12 paragraph [0013] claims EP A (AMERICAN CYANAMID CO [US] 1,2 WYETH CORP [US]) 15 September 1999 ( ) paragraph [0053] US B l (CHAN CHRISTINA Y [US] ET 1,2 AL) 1 May 2001 ( ) claims; examples Form PCT/ISA/210 (continuation of second sheet) (April 2005)

5 Box No. Il Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet) This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons: 1. Claims Nos.: because they relate to subject matter not required to be searched by this Authority, namely: 2. Claims Nos.: because they relate to parts of the international application that do not comply with the prescribed requirements to such an extent that no meaningful international search can be carried out, specifically: 3. I I Claims Nos.: because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a). Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet) This International Searching Authority found multiple inventions in this international application, as follows: see additional sheet As all required additional search fees were timely paid by the applicant, this international search report covers allsearchable claims. 2. As all searchable claims could be searched without effort justifying an additional fees, this Authority did not invite payment of additional fees. 3. As only some of the required additional search fees were timely paid by the applicant, this international search reportcovers only those claims for which fees were paid, specifically claims Nos.: 4. _γ _ No required additional search fees were timely paid by the applicant. Consequently, this international search report is restricted to the invention first mentioned in the claims; it is covered by claims Nos.: 1-13 Remark on Protest The additional search fees were accompanied by the applicant's protest and, where applicable, the payment of a protest fee. The additional search fees were accompanied by the applicant's protest but the applicable protest fee was not paid within the time limit specified in the invitation. No protest accompanied the payment of additional search fees. Form PCT/ISA/21 0 (continuation of first sheet (2)) (April 2005)

6 FURTHERINFORMATION CONTINUED FROM PCT/ISA/ 210 Thi s Internati onal Searchi ng Authority found multiple (groups of) inventions i n thi s i nternational appl ication, as fol l ows : 1. cl aims : 1-13 a surfactant (iii) a polysacchari de-protein conjugate 2. claims: wherein the buffer has a pka of about 3.5 to about 6.5 (ii) a surfactant (iii) a streptococcal C5a peptidase 3. claims: an aluminium salt (iii) a polysacchari de-protein conjugate 4. claims: wherein the buffer has a pka of about 3.5 to about 6.5 (ii) an aluminium salt (iii) a streptococcal C5a peptidase 5. claims: a surfactant (iii) a N. meningitidis 2086 protein 6. claim: 40 an aluminium salt (iii) a N. meningitidis 2086 protein

7 Patent document Publication Patent family Publication cited in search report date member(s) date WO A AU A CN A K R A WO A AT T CA Al EP A J P T WO A DE Al EP Al J P T US Al WO A CA Al CN A EP A HK Al J P T KR A NZ A US Al AU A CA Al DE Al WO A EP A J P T EP A AT T AU B AU A BR A CA Al DE Dl DE T ES T J P A PT T US Bl NONE Form PCT/ISA/210 (patent family annex) (April 2005)