-----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, QPiI6mLnpnW+97ZTLxnAoebTqtf2sQGQvmgh/NPChoGqwQjawdKOxL0vcyVmQb/F zBRHltGar9PB3bnAzcbeUw== 0001193125-05-191894.txt : 20050927 0001193125-05-191894.hdr.sgml : 20050927 20050927091217 ACCESSION NUMBER: 0001193125-05-191894 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050927 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050927 DATE AS OF CHANGE: 20050927 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NPS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000890465 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 870439579 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23272 FILM NUMBER: 051104136 BUSINESS ADDRESS: STREET 1: 420 CHIPETA WAY STE 240 CITY: SALT LAKE CITY STATE: UT ZIP: 84108-1256 BUSINESS PHONE: 8015834939 8-K 1 d8k.htm FORM 8-K Form 8-K

 

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

 

September 27, 2005

Date of Report (Date of earliest event reported)

 

NPS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   0-23272   87-0439579

(State or other jurisdiction of

incorporation)

  (Commission File Number)  

(I.R.S. Employer

Identification Number)

 

383 Colorow Drive

Salt Lake City, Utah 84108

(Address of principal executive offices)

 

(801) 583-4939

(Registrant’s telephone number, including area code)

 

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:

 

¨ 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 September 27, 2005, NPS Pharmaceuticals, Inc. issued a press release announcing the release of additional data regarding PREOS®. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(c) Exhibits

 

99.1   Press Release issued by the Company on September 27, 2005.


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.

 

Date: September 27, 2005       NPS PHARMACEUTICALS, INC.
        By:   /s/ KEVIN J. ONTIVEROS
               

Kevin J. Ontiveros

Assistant General Counsel


EXHIBIT INDEX

 

Exhibit
Number


 

Description    


99.1   Press Release issued by NPS Pharmaceuticals, Inc. on September 27, 2005.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO

 

For Immediate Release        

Contact: David L. Clark

Vice President, Corporate Affairs

NPS Pharmaceuticals, Inc.

(801) 583-4939

 

NEW ANALYSES SHOW PREOS® IMPROVES BONE STRENGTH AND REDUCES FRACTURE RISK

IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS

 

Salt Lake City — September 27, 2005— NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today announced the results of several studies that demonstrate treatment with PREOS®, parathyroid hormone [rDNA origin] for injection, improves bone strength and architecture as well as reduces the risk of vertebral fracture in patients with osteoporosis. Data were presented in oral and poster presentations at the American Society for Bone and Mineral Research (ASBMR) 27th Annual Meeting in Nashville. The New Drug Application for PREOS is currently under review by the U.S. Food and Drug Administration. The European Medicines Agency is also reviewing the market authorization application for Preotact™, the European equivalent to PREOS, which will be marketed in Europe by Nycomed, an NPS partner.

 

“New analyses and studies are giving us greater insight into how PREOS reduces vertebral fracture risk in postmenopausal women with osteoporosis,” said David Dempster, Ph.D., professor of Clinical Pathology at Columbia University and director of the Helen Hayes Hospital Regional Bone Center in New York. “With these studies, we’re seeing more than just increases in bone mass, we’re seeing changes indicative of improved skeletal architecture that more closely resembles strong, healthy bone.”

 

New PaTH Study Analyses

 

In two separate analyses, Dennis M. Black, Ph.D., Department of Epidemiology and Biostatistics, University of California, San Francisco, Mary L. Bouxsein, Ph.D., Beth Israel Deaconess Medical Center, Boston, and their colleagues studied a subset of postmenopausal osteoporotic women, who received daily injections of PREOS for one year as part of the “Parathyroid hormone (PTH) and alendronate” (PaTH) study, which compared PREOS, alendronate, and their combination.

 

Dr. Black evaluated the effects of treatment with PREOS on vertebral strength with biomechanical computed tomography (BCT). BCT provides a more detailed picture of bone strength than that which can be obtained from quantitative computed tomography (QCT) alone. The BCT analysis showed that treatment with PREOS for one year increased vertebral strength indices by almost 30%. Further analyses indicated that the overall increase in vertebral strength is attributed to both an increase in the amount of bone and to alterations in the distribution of bone within the vertebra.

 

Dr. Bouxsein used BCT in combination with a biomechanical model of the spine to assess the effects of treatment with PREOS on the factor of risk for vertebral fracture (F), which was computed as the ratio of spinal load to vertebral strength. Following treatment with PREOS, the mean factor of risk for vertebral fracture was reduced from 0.73 to 0.58; fracture theoretically occurs when F >1.0. Using Dr. Bouxsein’s methodology, four patients (21%) were at high risk for fracture (F > 0.90) prior to treatment with PREOS, but none were at high risk for fracture after administration of PREOS.

 

New TOP Study Analyses

 

Two separate analyses by David Dempster, Ph.D., professor of Clinical Pathology at Columbia University and director of the Helen Hayes Hospital Regional Bone Center in New York and Cesar Bogado, Ph.D., Instituto de Investigaciones Metabolicas, Buenos Aires, Argentina, and their colleagues studied subsets of postmenopausal osteoporotic women, who received either daily injections of PREOS or placebo as part of the 18-month “Treatment of Osteoporosis with Parathyroid Hormone (TOP)” study. Dr. Dempster used high-resolution micro-computed


tomography (micro-CT) imaging to examine trabecular bone architecture in biopsies of the hip, and Dr. Bogado used QCT to compare the effects of PREOS and placebo at the hip.

 

The micro-CT analyses of iliac crest biopsies showed significant improvements in trabecular microarchitecture in patients treated with PREOS versus placebo. Mean trabecular bone volume was 45% higher as a result of increases in trabecular number and thickness (12% and 17%, respectively). In addition, the trabecular separation was 10% lower, the mean connectivity density was 22% higher, and the structure model index (SMI) was 55% lower in PREOS-treated women. A lower SMI indicates a change in trabecular architecture from a more rod-like structure to a more plate-like structure.

 

“In our study, PREOS clearly improved bone structure. Patients had increased trabecular bone volume, better trabecular connectivity and a more plate-like trabecular architecture,” said Dr. Dempster. “We suspect that improved bone structure and strength is the reason that PREOS-treated patients had a reduced incidence of fracture in Phase 3 clinical trials.”

 

After 18 months of treatment with PREOS, QCT scans showed significant increases in volumetric trabecular bone mineral density (vTbBMD) and bone mineral content (TbBMC), as well as cortical bone volume (CtBV), at both the total hip and femoral neck. The PREOS group also had a modest but statistically significant decrease in volumetric cortical BMD (vCtBMD) at the total hip, but not at the femoral neck. These results are consistent with changes observed in PTH-treated osteopenic Rhesus monkeys.

 

About NPS Pharmaceuticals

 

NPS discovers, develops and commercializes small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company has drug candidates in various stages of clinical development backed by a strong discovery research effort. Additional information is available on the company’s website, http://www.npsp.com.

 

Safe Harbor Statement

 

Note: Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements include those regarding the likelihood that PREOS®, which is pending FDA approval, will be an appropriate therapy for patients who have osteoporosis. These statements are based on management’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include: our product candidates may not prove to be safe or efficacious; the FDA may delay approval or may not approve any of our product candidates; current collaborators or partners may not devote adequate resources to the development and commercialization of our licensed drug candidates which would prevent or delay introduction of drug candidates to the market; we may be unable to generate adequate sales and marketing capabilities to effectively market and sell our products; failure to secure adequate manufacturing and storage sources for our products could result in disruption or cessation of our clinical trials and eventual commercialization of such products; and we may not have or be able to secure sufficient capital to fund development and commercialization of our product candidates. All information in this press release is as of September 27, 2005, and we undertake no duty to update this information. A more complete description of these risks can be found in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K, as amended, for the year ended 2004, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2005. NPS, the NPS logo, and PREOS are registered trademarks of NPS Pharmaceuticals, Inc.

GRAPHIC 3 g10988ex99_1.jpg GRAPHIC begin 644 g10988ex99_1.jpg M_]C_X``02D9)1@`!`0$`8`!@``#_X0!X17AI9@``24DJ``@````&`#$!`@`1 M````5@````$#!0`!````:`````,#`0`!`````OME`1!1`0`!`````0```!%1 M!``!````Q`X``!)1!``!````Q`X```````!-:6-R;W-O9G0@3V9F:6-E`/^@ MA@$`C[$``/_;`$,`"`8&!P8%"`<'!PD)"`H,%`T,"PL,&1(3#Q0=&A\>'1H< M'"`D+B<@(BPC'!PH-RDL,#$T-#0?)SD].#(\+C,T,O_;`$,!"0D)#`L,&`T- M&#(A'"$R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R M,C(R,C(R,C(R,O_``!$(`#(`F`,!(@`"$0$#$0'_Q``?```!!0$!`0$!`0`` M`````````0(#!`4&!P@)"@O_Q`"U$``"`0,#`@0#!04$!````7T!`@,`!!$% M$B$Q008346$'(G$4,H&1H0@C0K'!%5+1\"0S8G*""0H6%Q@9&B4F)R@I*C0U M-CH.$A8:'B(F* MDI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4U=;7V-G: MX>+CY.7FY^CIZO'R\_3U]O?X^?K_Q``?`0`#`0$!`0$!`0$!`````````0(# M!`4&!P@)"@O_Q`"U$0`"`0($!`,$!P4$!``!`G<``0(#$00%(3$&$D%1!V%Q M$R(R@0@40I&AL<$)(S-2\!5B7J"@X2%AH>(B8J2DY25EI>8 MF9JBHZ2EIJ>HJ:JRL[2UMK>XN;K"P\3%QL?(RKR\_3U]O?X^?K_V@`,`P$``A$#$0`_`/-_$'Q$\8CQ)J83Q)J<2+=2JJ17 M#(J@,0``#@"E\.?$3QB?$VEJ_B34I4:[B5HY;AG5@6`((/!&*Y?Q!_R,FJ?] M?DO_`*&:=XPX`_P!\4`?3/QW\0ZMX>\'6K&\D+; M7V[&.`>HY`Z5\\_\+$\9_P#0TZO_`.!;_P"->Z?M'@GP3IA`.!J`R?3]V]?, MM`'TW\`/$>L^(-,UL:OJ5S?&":+RFN'+LNX-D9/..!74_$'P_/)HFK:Y9^(M MO6/''_(A>(/^P=/_ M`.@&@#YY\%?%SQ+X5U>W?Q-<7VH:3?('_P!(8NZKD@21D]>0*]>^#'BJ7P]XAADDTEWW/&O(&>DT1[CCD=_8B@#Z@KS3XC^&[VQ\, M:QKVE>*-?M+NW1KD1+?N82`;P[HNNW_`(CUZ]N[BW2X>.:^8PY89V[. MA'/?-5?B1X9>R\(:UK=CXA\0VUY!&UP@34Y?+!SDKLS@#J..E=-\//\`DG/A MS_L'0_\`H`JO\4/^28^(O^O-J`/,O@=;R>+]/U>?7M1U6]DMYHTB+ZE.-H() M/W7'I7HNK?#[S+=Y-!\0:YI5ZJDQ$:A++$6[;TI/MU\PG?_`(2?]H$2Z2/. MCDUE'1DZ%(V&Y_IA2-],W-;SS+,DP7<(90`"K^Q[>N2. MU`'LT'PU\/QVWEROJEQ,?O74VI3F4GUR&&#]!7(ZYI/BCP3XCT&]M/$NI7WA MA]0AANH+N;S)(=[;!EL99/FQST..O6MSP%\6]"\:0QV\DJ6&KX`>UF8`2-_T MS)^\/;K[5Z`Z*Z[74,OH1D4`<-I,7B1?$[M-)=^3O&X3;O+QQO\`]GDYV;>W M7'.KB>89BCU-G<'N!+DU]3:];+)XGCO/L=K)%<0$0 MW#W14ME"``,^XZ>M7!)O4RJR<8Z#M4UB'6]-:TU;08;O3Y`K31/(I.TD@,.> MH('Y\&OG[XK_``^@\&:G;7FER^;HVHAFM\G)B(QE">XY&#_A7LWV:);*1CI] M@%^Q*G_']QDR9"_>Z<$Y]JY/XX,EE\._#.FS0I#=-<-*L2ONV*%.>23_`'UJ MJD4EH9T9RD[,M?LT_P#(-\1?]=H/Y/7K'CC_`)$+Q!_V#I__`$`UY/\`LT_\ M@WQ%_P!=H/Y/7K'CC_D0O$'_`&#I_P#T`UD=)D?"'_DE.@?]<6_]&-5SQWX$ MTSQWHALKQ1','(0$_ZZ(]QZCO[$5[=X\O[74_A-KE]8W$=Q:SZ=(\\$:O`SV MEY`\8C9SM0L#B6(]U/<=_8B@#Z7^'G_).?#G_8.A_P#0!5?XH?\`),?$7_7F MU6/AY_R3GPY_V#H?_0!5?XH?\DQ\1?\`7F]`'DOP`N=:MM'UPZ5IMK>J9XMX MFNS"0=IZ?(P->A>(=.^(WBFUDTZ%])\/V,JE9I8YWN)V4\$`[%`'Z^]`?C!K/AC5QX M=\:^>]LCB$S7"D36IZ?-W9>G7GOD]*^D*\#_`&DM,TY+?1M35434I)'A8C@R M1@9R?7:]HZR(KHP9&`*L#D$>M%8G@N"ZMO!&AP7Q/VJ.QA63=U!V# M@T4`>3ZM^SG'?ZO>7D/B1HH[B9Y1&]IN*[B3C.X9Z^E>@^%/!=]HNAQZ)K.J MQ:Q8P8^S,]N8Y8<=`&W'@=NX^E6_#-WKU]-%6DW#:4"65]"-2:^DO)%9F,7EA0H(``R?4 MU:\9>&?$/BBQN],M?$%OIVG7*;'5;(O*5QR"^\#!]ATXJ_X=O]0N-1U:UO\` MS5%L\7E).$\P!DR22GRD$]._!S7+'Q?KJ(;5G1KI]4RD@AX6R%QY1!'3=GY< M^^:0RSX.\$>)O!NF1Z7:^)[2ZL(W+)%<:>2R`G)"L)!QG)YSUKT"N>\7:I?V M%A#!I0 MJ\Y'^R:`-ZN2\?>`=,\>:,;6Z`AO(@3:W:KEHF]#ZJ>X_K6IHMXL]W>01ZN- M2CC6-@PC7Y":5%KUI8Z; M=`*RK9%Y=O!*EB^.2.PZ5/X@U^XTMM:C2XCBECL8Y;%'49>4F0$*/XN0G'O[ MU?\`%=S>6/A:_O;*X>"YMH&E0JBMD@=""#Q0!P7@SX3Z[X$NIYM(\60M'<`" M:">P+(^.AXD!!&3R/6O3M/COH[0+J-Q!/<9.7@B,:X[<%C_.J.NW-UI/A/4+ MJ"=I+JWMG=)9%4DL`2"0`!^E,\2:A<6%K8^5.+:.XNTAGNBH(A0@G//`R0%R M>!NH`VZ\XUCX6W-WXXN_%ND^);C2M0E";%B@#IE5"D."?G!P.*[32KQ'T^:5 MM1%Y##(X^TE`HVCGJ.&QTW#@XK'\)^(;_5[V\CO[:>".51=67G0B/,))&WK\ MV,*<_P#33':@"DZ?%&(>5%+X4G'07#I.A^I0$C\C5*P^&$FH>(XO$?C35?[9 MU"'_`%%LD>RV@[@!3UP>>?QS76:7JQGU?5[.XN(@\%V(X(R0&V>5&W3J>6;F MLKQ1KEWI>HYCO/+@CBC$PF M$PQF(YRFT;3SGI]:**`'"-%D:0(H=L!F`Y..F:C^QVV<_9X<_P"X/[V[^?/U MYHHH`D,:-(LA12Z@A6(Y`/7!_`?E2)#%''Y:1HJ<_*%`'/7BBB@".ULK6PA\ MFSMH;>+);9#&$7)[X%(EA9QW1NDM(%N&SF41@.<]><9HHH`)[&SN9H9KBU@E MEA.8GDC#-&?52>GX5-)&DL;1R(KHPPRL,@CW%%%``\:2QM'(BNC#!5AD$?2F MS00W,+PSQ)+$XPR.H96'H0>M%%`"1VMO#;"VB@B2W"[1$J`*!Z8Z8IPBC#*P MC4%5VJ<=!QP/;@?E110!%]@L_M?VO[)!]I_Y[>6-_3'WL9Z43V-G
-----END PRIVACY-ENHANCED MESSAGE-----