-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, ODrHKr+e/QhYDPRGIN2wwAC85DbuWLjdzK1tTJKpmAj0RT6M6VZq4K/gvrKc47dG pV4I6t8PK7jUAEgFLTdTJg== 0000921895-09-001276.txt : 20090504 0000921895-09-001276.hdr.sgml : 20090504 20090504141731 ACCESSION NUMBER: 0000921895-09-001276 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090430 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090504 DATE AS OF CHANGE: 20090504 FILER: COMPANY DATA: COMPANY CONFORMED NAME: QUIGLEY CORP CENTRAL INDEX KEY: 0000868278 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232577138 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21617 FILM NUMBER: 09792846 BUSINESS ADDRESS: STREET 1: KELLS BUILDING STREET 2: 621 SHADY RETREAT RD CITY: DOYLESTOWN STATE: PA ZIP: 18901 BUSINESS PHONE: 2153450919 MAIL ADDRESS: STREET 1: PO BOX 1349 STREET 2: LANDMARK BLDG, 10 S CLINTON ST CITY: DOYLESTOWN STATE: PA ZIP: 18901 8-K 1 form8k03814_04302009.htm form8k03814_04302009.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 30, 2009

 
THE QUIGLEY CORPORATION
(Exact name of registrant as specified in its charter)
     
Nevada
0-21617
23-2577138
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
     
Kells Building, 621 Shady Retreat Road, P.O. Box 1349, Doylestown, PA
18901
(Address of principal executive offices)
(Zip Code)

Registrant’s telephone number, including area code: xxx

N/A
(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 
Item 8.01                      Other Events.
 
On April 30, 2009, Quigley Pharma Inc., a wholly-owned subsidiary of The Quigley Corporation, issued a press release announcing that their recently completed Phase 2 double-blinded, placebo-controlled, clinical trial of diabetic peripheral neuropathy, demonstrated a significant improvement in two key measures of distal sensory nerve function in the group treated with their QR333 drug.  The full text of the press release is attached hereto as Exhibit 99.1.
 
Item 9.01                      Financial Statements and Exhibits.
 
(d) Exhibits.
 
  Exhibit No.   Description   
  99.1  Press Release issued on April 30, 2009  
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 

 
   
THE QUIGLEY CORPORATION
   
(Registrant)
       
Date: May 4, 2009
     
   
By:
/s/ Gerard M. Gleeson
   
Name:
Gerard M. Gleeson
   
Title:
Vice President and Chief Financial Officer


 
INDEX TO EXHIBITS
 
Exhibit 99.1                            Press Release issued on April 30, 2009
 

 
EX-99.1 2 ex991to8k03814_04302009.htm ex991to8k03814_04302009.htm
Exhibit 99.1
 
 
 
FOR IMMEDIATE RELEASE

CONTACT:
Media
Investor Relations
 
Karen Pineman
Carl Hymans
 
G.S. Schwartz & Co.
G.S. Schwartz & Co.
 
212.725.4500
212.725.4500
 
kpineman@schwartz.com
carlh@schwartz.com
 
 
Unexpected positive finding expands potential for
Quigley QR333 drug for Diabetic Neuropathy

Findings suggest possible disease modification

Doylestown, PA (April 30, 2009) Quigley Pharma Inc., www.quigleyco.com,  a wholly-owned subsidiary of The Quigley Corporation (NASDAQ: QGLY) announced today that their recently completed Phase 2 double-blinded, placebo-controlled, clinical trial of diabetic peripheral neuropathy, demonstrated a significant improvement in two key measures of distal sensory nerve function in the group treated with QR333.  The compound was applied topically to the feet of subjects suffering from painful diabetic neuropathy and over the course of 12 weeks, it significantly improved both maximal conduction velocity (p=0.05) and compound sensory amplitude (p=0.05) in the sural nerve.  These are well established, validated and objective electrophysiologic measures of the onset and progression of diabetic nerve damage.  The mean improvement in nerve conduction velocity was 1.5 m/sec, which exceeds the change considered by thought leaders to be “clinically meaningful” in clinical studies.  The sural nerve carries sensation from the feet and its pathology is the fundamental cause of foot pain and ultimately foot ulcers and amputation in some diabetic subjects.

The positive findings were detected in compliant patients (approximately 50% of the original intent to treat population) who had measurable nerve activity at both the beginning and end of the study.  A more conservative analysis involving approximately 65% of the randomized subjects showed a strong, but non-significant, trend toward benefit for the QR333 treated group. Other nerves evaluated for safety purposes were unaffected.  The electrophysiology testing was done as a safety measure and was of interest because of the topical application of the study drug to the area of the sural nerve.

These findings necessitate a change in the potential outlook for this investigational new drug. The Diabetic Peripheral Neuropathy market has significant unmet need for rational, mechanism-based drugs.  These clinically significant findings suggest disease modification in this (12 week) phase II (b) study.  The Company is aware that this is a finding in a subset of the patient population.
 


Since the observations obtained from the study relate to positive effect on nerve functioning, we may, in the future, be focusing on a broader therapeutic area.

About The Quigley Corporation
The Quigley Corporation (NASDAQ: QGLY, http://www.Quigleyco.com) is a diversified natural health medical science company.   Its Cold Remedy segment is a leading marketer and manufacturer of the COLD-EEZE® family of lozenges, gums and sugar free tablets clinically proven to cut the common cold nearly in half.  COLD-EEZE customers include leading national wholesalers and distributors, as well as independent and chain food, drug and mass merchandise stores and pharmacies.   The Quigley Corporation has several wholly owned subsidiaries; Quigley Manufacturing Inc. consists of an FDA approved facility to manufacture COLD- EEZE® lozenges as well as fulfill other contract manufacturing opportunities. Quigley Pharma Inc. (http://www.QuigleyPharma.com) conducts research in order to develop and commercialize a pipeline of patented botanical and naturally derived potential prescription drugs.

Forward-Looking Statements
Certain statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and involve known and unknown risk, uncertainties and other factors that may cause the Company's actual performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statement. Factors that impact such forward-looking statements include, among others, changes in worldwide general economic conditions, changes in interest rates, government regulations, and worldwide competition.
 
Important Additional Information
The Quigley Corporation (“Quigley” or the “Company”) filed a definitive proxy statement with the Securities and Exchange Commission (the “SEC”) on April 2, 2009 in connection with the 2009 Annual Meeting of Stockholders and began the process of mailing the definitive proxy statement and a WHITE proxy card to stockholders. The Company’s stockholders are strongly advised to read Quigley’s proxy statement as it contains important information. Stockholders may obtain an additional copy of Quigley’s definitive proxy statement and any other documents filed by the Company with the SEC for free at the SEC’s website at http://www.sec.gov. Copies of the definitive proxy statement are available for free at http://www.amstock.com/Proxy Services/ViewMaterial.asp?Co Number=07814. In addition, copies of the Company’s proxy materials may be requested at no charge by contacting MacKenzie Partners, Inc. at 1-800-322-2885 or via email at quigley@mackenziepartners.com. Detailed information regarding the names, affiliations and interests of individuals who are participants in the solicitation of proxies of Quigley’s stockholders is available in Quigley’s definitive proxy statement filed with SEC on April 2, 2009.

GRAPHIC 3 quigley_logo.jpg begin 644 quigley_logo.jpg M_]C_X``02D9)1@`!``$`8`!@``#__@`?3$5!1"!496-H;F]L;V=I97,@26YC M+B!6,2XP,0#_VP"$``@%!@<&!0@'!@<)"`@)#!0-#`L+#!@1$@X4'1D>'AP9 M'!L@)"XG("(K(AL<*#8H*R\Q,S0S'R8X/#@R/"XR,S$!"`D)#`H,%PT-%S$A M'"$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q,3$Q M,3$Q,3$Q,?_$`:(```$%`0$!`0$!```````````!`@,$!08'"`D*"P$``P$! M`0$!`0$!`0````````$"`P0%!@<("0H+$``"`0,#`@0#!04$!````7T!`@,` M!!$%$B$Q008346$'(G$4,H&1H0@C0K'!%5+1\"0S8G*""0H6%Q@9&B4F)R@I M*C0U-CH.$A8:' MB(F*DI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4U=;7 MV-G:X>+CY.7FY^CIZO'R\_3U]O?X^?H1``(!`@0$`P0'!00$``$"=P`!`@,1 M!`4A,08205$'87$3(C*!"!1"D:&QP0DC,U+P%6)RT0H6)#3A)?$7&!D:)BH*#A(6& MAXB)BI*3E)66EYB9FJ*CI*6FIZBIJK*SM+6VM[BYNL+#Q,7&Q\C)RM+3U-76 MU]C9VN+CY.7FY^CIZO+S]/7V]_CY^O_``!$(`%$`^@,!$0`"$0$#$0'_V@`, M`P$``A$#$0`_`/?Z`"@`H`*`"@`H`*`"@`H`*`"@`H`1F"#+$`#N:-@V(;R\ MM[&U>YNYDAAC&6=C@`5,I**NR924%S-Z'(V/Q'L-1\0VVEZ?:22QSOL^T.VP M#CLN,G]*XXXR,ZBA%?,X(X^$ZJIQ6_4[6NX]$*`"@`H`*`"@`H`*`"@`H`*` M"@`H`*`"@`H`*`"@`H`*`"@`H`*`"@`H`*`"@`H`RM:\1:9HEQ;0:C<"%[DX M3(X'N?05C4K0IM*3W,:E>%)I2>YP/QEUFZ5[33;>0I:31^:Y4\2)XDX/XC.:S]JZ]%PZK\C+ MVSQ%!T^J_%&3X,T>XAU>QU2^DCTZRAD$OG7#A-X'90>3FLG/Z5Y6/I2DU)'C9C1G)J<5 M='*^![4Z[K,&BZF)9K,([!=Q!A.,Y4]N<<=.:Y,/'VDU3EL<6%C[6:I3V_(U MKC2K;0O%.*V=.-.JZ<=?ZV-W2C2JNG# M7OW]#&U/POK\NH%M2^SQ32G/[Z[B7'MC=P*QG0JN7O?FC">&JN7OVOZH]"^' MOA^S\+P/->:A:27EWA/EE&T#LH]237HX:C&CJWJSU,'0CAU>4E=GQ:TT3_9$:YF$SN`V0FW&1TQ50O;4N M%[:LQK77KIK*_=[.:1X)ID1XT&W"DXSD_G6*K/E;MM MC6=U-CS)H$D;'`R5!-;0DW!,WIR[>YR.K?#KQ,+Z1MJ7Q=LF<2C+>YW5U1%ZLQ MP!2;2W$W8SO[=MI6*V,4]X1U,,>5'_`C@5E[5/X=2/:+IJ12ZU+$ZC7V6.T[Q)IM_((HYC%*3C9*-IIPKPEH@C5C+0UZV-3'U_5 M+.TBEM]1M+A[:0;&8)E&!'3.:PJ5(QTDM#*I**5I+0CL/$5M=1@6-E>RHORY M6(8'MG-*-92^%,4:B:]U&I#96\4$D4<02.8LSKZENOYULHJUC1025DBO/<1: M7#%;Q6ES)$B!56"/<%4<`5+DH*UB=())(Q=%O]&2<)I5C?%H_EVJ&*IGV+8% M84YTT[03T,:?LT_=3-V_U%;'!>VN91C),4>X+]:WE/DZ&\I:A8B+=K:DJLKVL;EQ-Y$#2%'?:/NHN6/T%=#=E7GV2%9#;SR[OX8DW$?6M92Y5>QHY65[&3%XOT^:80PPW M;RDX""+G^=8K$Q;LD9*M&]D;EO+YT*2&-X]PSM<88?6NA.ZN;)Z%35=5BTM0 M\\,[1XR7C3(7ZFHG45/[U)B+*%L M+"IPI/I_]>N.FI5Y7EL-V>A^M<.*II+F1RUX*W,C2\$:A+?Z/^_8M)`_E[CU M(P"/YUKAIN4->AI1DY1U,[XCW>VWMK-3R[%V'L.!_,UGBY:*)GB'HD;_`(=L MQ8Z-:P8PP0,W^\>3712CR02-Z<>6*1HUJ607TXM;*:=N!$A;\A4R?+%L3=E< MQ/`EIY.CFYBR:PPU36G:=6/[N-CP??'I[5A1I.I[\S&G3Y M_>D=E&BQH$C4*HX``P!7=L=>PZ@#-O=%@NM4M;_.R6W.3@??],UE*DI24NQF MZ:?R(-5\>E2-T<-5./,R`6 M-SKLBS:DK060.8[7."_H7_PJ>1U7>6W8GE=1WEL;D4:0QK'$BHBC`51@"NA) M+1&Z5MA],#COB4[BWL4&?+9G+?4`8_F:X<9>R.7$;(U?!*(GAVVV8^;<6^N3 M6V'_`(:-*.D$;E=!L%`'(?$2_46L-A&=TDC!V`[`=/S/\JXL5/111RXB6G*C M5\'Z<^F:,B2C;+*?,<>F<8'Y"MJ%/DAJ:48/]I>-HK8_<1TC_``ZG M^9KDJ>_6L83]ZK8[\#`P*])':+0!@^,YR-,6RAYGO'$:J.N,\_Y]ZY\0_=Y5 MNS&L_=LNIL65NMI:0VZ?=B0*/P%;17*DC6*Y58Y[XAW7E:3'`IP9I!^0Y_GB MN;%2M"QAB':-B_X/M?LOA^V4C#.#(?Q.?Y8K3#QY::+HJT$:F*]&'PJQV1V18JBC(UFWNXX;F[@ MU2:`(A<1[$*C`]QFL*D9)-J5C*::NTS!\*WVL:U<2B;47CBA`)VQIDDGIT^M M<]"=2H]]#&E*3"VM)IV.!$A8_@*[9/E39U-V5SC/AY"9]1O+UQR!C/ MNQR?Y5PX57DY')AU>3D=S7H'8%`&3XLNOLF@W3@X+KY8_P"!<5C7ERTVS.J^ M6#,#P7HKS:<]T;NYM_-;`$+;<@=S^.:YL/2;CS7L84:=XWO8W)=!=U(&JZ@# M_P!=?_K5T>Q?\S-O9^;&>$=.FT^RG%V")Y)F)9CDL.@-*A!P3N*E!Q6IN5T& MQG>(VC30[QI@"GE'@^O;]<5E5LH.YG4^!W.6^'NFQ3R37DR!_*(6//0-U)^O M2N3"P3O)G/AX7U9W6*]`[`H`*`*&N:7#JUBUO-\IZHX'*GUK.I352-F1."FK M'.Z0-6\-%K>YM'NK(MD/#\Q4^N/Z5S4^>CHU=&$>>EHUH;*^*-(VDO=>4PZH MZ,&'X8K95Z?W1+-Y=W2>4;(Q[\\FAU7+^&A<[?P(CTGPRL M-V;[4YOM=X3G)'RJ?:IA0L^:6K%"E9\TMSH*Z3\U>^C-M8W7D1 M)A=T1&23R?Y5Y]=RJ2T6AQU;S>B.QTB\CN(1%%#/"(E`Q+&5KNIR35DCJA)- M616\2:#%K,"_-Y4\?W'Q^A]JBK151>9-2FIHR=*N-:T&,6M[8275LGW'A.XJ M/\/K6,'4I:25T9QC6AKQ>(K)@-Z7,3>CV[_T%;JO$T56)E^)]8>\TY[33 M;2ZD,O#.864`?B*QK57*/+%,SJSO&T46_`^GRV&DDW$9CEF0[6;R6``SSU%37J-QY8H56;<>6**_@^ M?^R;"2&ZLKQ97D+$B$D8P,5%!^SC9IDTGR*S1L3>(88U)2SOG/8"`C^=;NLE MT9JZJ71D&B/?:E?R:A>)+:PQCRX8"2,^K$=ZFFY3ESO04.:3YGH9/C.\EU** M*UL;:Y=$4P!(X';ZUCB).:Y8HRK-R5HHT=!U1++2K>VDL+U'C3#8A)!/ MY]:BFYSES/1(4'*!71LC8Y/Q9J,NHZ=]D ML+*[;>P+L82!@<_SKCKSAKFKT.?5;F M%6ESZKSMM/ZUU*M3?4Z%5@^I.;;UV-G%:1G&6S*4D]BKJ&KQVMVM MG##-=7;+O\F$#*KZL20%'U-3*HHOE2NR)U5%\J5V26-Y<33-%HV^F6XFN"WS,$1$7BJ.YHE-05V.QP`9+*4=E'J5#9_+-1[22U<78S=62U<78TK6XAN[:.XMI%D MBD4,K+T(-:1DI*Z-8R4E=&/=^)XK66^WV5RT%@X6>9-I"Y`.<9R1@^E8NLHW MTT1A+$*+EH[+A&170=)A'Q3"OGR265REK!X^0J&#;M;WMJ=+=M3)AUN6[C\[3],NK MBW/*RY2,./50Q!(]^*R55RUC'0P59R5X1;1;TO4X-1$HB#Q2PMMEAE7:\9[9 M'OZ]#50FI;&E.HI[="+5=6%A>6MJEK-A!'8@\40FIQ M4D%.:J14D5-;UA](42/8SS0EE3?&R8W,<`8)!ZD5%2HZ>MC.K5]EKRZ%^TED MF@#RV[V[G/R.02/R)%:1;:U5C6+;6JL0V6HQ7=[>VJ(RO9NJ.3T)*YX_.IC- M2DUV)C44I./8;J>J0:>T4;+)-/,2(H(ER[XZ\=@/4\42FH674)U%!I=7T*LV MN/9)YFI:=_2H=5QUDK(S=9PUG&R-@$,H(.01P16YT&3H M_B&QU2::"%FBGAD=#'(,%MK%25]1D=JQIUHS=D84Z\*C:6Y:MM1BGU2ZL%1Q M):JC,QZ'=G&/RJU-.3CV+C43FX=B[5F@4`%`!0`4`%`#717&&4$>A%%@(A96 MH.1;0@^OEBIY8]B>5=B5$5.$4*/88JK6*2L8]UI]Y;:U+JFFB*4SQK'/!*VW M=MSM*M@X/)XQS6$H24^>)SRA*,^>'7EK?,ERJM644OG_P"WHNFII.E6]C M$Y=85QN/5CG)/YDUI3A[.*BNAI3IJG!170YZ\\*W,VI7^H+Y3RM<++%#(Q,4 MJA%!5UZ`Y'![5RRP[K"H1)EF\K<`,#7FH7SH;J\V`I%G9&J@X4$]>IR:JG!Q;E M+=E4Z;C)SENRKXFT"36K^Q)D:*"%90[QR%74L!M(Q[BHJT74DOF17H>UE'LK ME[P]:SV.G+:W,,$;1$@-`,+(/[V.Q/<>M:4HN,;,UHQ<(\K7W%75M(NM6U6$ MS3M;V5J!)'Y1!9Y?4@@C`'3W/M4U*;G)7=DC.I2E4FKNR7YAI.D76D:K.89V MN+&Z'F2>:0&27U```P1U]Q[T4Z;IR=GHPITI4YNST?YECQ-I\VI::MO;;0XG MBD^8X&%<$_H*JM!SC9>1=>#G&R[HTQP*U-C,TK3YK35M5N9=OEWSEL6M8+"*92DDIF\TA3UVJ`.?<_E4S52HG&UB)J MI4BXVM^)M6\*V]O'#$"$C4*N3V`Q6Z5E9'2ERJR,/3?#B?V9+;:B@\PW4T\4 MD38>/>HZTZ=.4)MR=[V'2I3A.3D[WL;U=!TA0`4`%`!0`4`%`!0`4`%`!0` L4`%`!0`4`%`!0`4`%`!0`4`%`!0`4`%`!0`4`%`!0`4`%`!0`4`%`!0!_]D_ ` end
-----END PRIVACY-ENHANCED MESSAGE-----