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Cipher reports third quarter fiscal 2007 results
Date:11/7/2007

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, Nov. 7 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced its financial and operational results for the three and nine months ended September 30, 2007.

Q3 2007 Summary

---------------

- Entered into a licensing and distribution agreement with ProEthic

Pharmaceuticals under which ProEthic was granted the exclusive right

to market, sell and distribute CIP-FENOFIBRATE (approved and marketed

in U.S. under the label Lipofen(TM))

- Successfully completed commercial scale-up and delivery of finished

packaged product to ProEthic on schedule

- Lipofen launched in U.S. market toward the end of the third quarter

- Continued dialogue and correspondence with the U.S. Food and Drug

Administration (FDA) on CIP-ISOTRETINOIN and CIP-TRAMADOL ER

- Recorded commercial revenue of $149,000

- Cash and cash equivalents of $12.1 million at quarter end

"We reached important company milestones in the third quarter with the signing of our first commercial distribution agreement in the U.S. market and, toward the end of the quarter, the launch of Lipofen in the large and growing U.S. fenofibrate market," said Larry Andrews, President and CEO of Cipher. "These successes validate our core business strategy and our transition to a commercial, specialty pharmaceutical company. During the quarter, we also continued our dialogue and correspondence with the FDA on CIP-ISOTRETINOIN and CIP-TRAMADOL ER as we work diligently to advance these two products through the remaining milestones on the path to final approval."

Financial Review

----------------

In the third quarter of 2007, the Company recorded total revenue of $149,000, compared with nil in the same period last year. Revenue for the third quarter of 2007 includes an amortized portion of the US$2 million 98

Exercise of stock

options settled

in cash - (286) - -

---------------------------------------------- --------------------------

(2,878) (11,245) (83) (2,214)

---------------------------------------------- --------------------------

Investing activities

Purchase of property

and equipment (143) (28) (10) (17)

Increase in

intangible assets - (277) - (277)

Proceeds from

loan receivable - 800 - -

---------------------------------------------- --------------------------

(143) 495 (10) (294)

---------------------------------------------- --------------------------

Financing activities

Issuance of

share capital - 10,907 - -

Proceeds from

exercise of

stock options - 201 - -

---------------------------------------------- --------------------------

- 11,108 - -

---------------------------------------------- --------------------------

Increase (decrease)

in cash and cash

equivalents (3,021) 358 (93) (2,508)

Cash and cash

equivalents,

beginning of period 15,077 16,616 12,149 19,482

---------------------------------------------- --------------------------

---------------------------------------------- --------------------------

Cash and cash

equivalents,

end of period $ 12,056 $ 16,974 $ 12,056 $ 16,974

---------------------------------------------- --------------------------

---------------------------------------------- --------------------------

The accompanying notes are an integral part of these unaudited

consolidated financial statements

Cipher Pharmaceuticals Inc.

Notes to Unaudited Consolidated Financial Statements

September 30, 2007

(in thousands of dollars, except per share amounts)

1 Summary of significant accounting policies

Basis of presentation

The accompanying unaudited interim consolidated financial statements

of the Company have been prepared in accordance with accounting

principles generally accepted in Canada for interim reporting.

Accordingly, these financial statements do not include all of the

disclosures required by generally accepted accounting principles for

annual financial statements and should be read in conjunction with

the annual financial statements of the Company. In the opinion of

management, all adjustments considered necessary for fair

presentation have been included. All such adjustments are of a normal

recurring nature. Operating results for the nine months ended

September 30, 2007 are not necessarily indicative of the results that

may be expected for the fiscal year ending December 31, 2007.

There have been no changes to the accounting policies as described in

Note 1 to the consolidated financial statements for the year ended

December 31, 2006, except as explained in the following paragraph and

in Note 2 below.

Revenue recognition

The Company recognizes revenue from product sales contracts and

licensing and distribution agreements, which may include multiple

elements. The individual elements of each agreement are divided into

separate units of accounting, if certain criteria are met. The

applicable revenue recognition approach is then applied to each unit.

Otherwise, the applicable revenue recognition criteria are applied to

combined elements as a single unit of accounting.

Product sales - revenue from product sales contracts is recognized

when the product is shipped to the Company's customers, at which time

ownership is transferred.

Licensing revenues - for up-front licensing payments, revenue is

deferred and recognized on a straight line basis during the estimated

term over which the Company maintains substantive contractual

obligations. Milestone payments are recognized as revenue when the

underlying condition is met, the milestone is not a condition to

future deliverables and collectibility is reasonably assured.

Otherwise, milestone payments are recognized as revenue over the

remaining term of the underlying agreement or the term over which the

Company maintains substantive contractual obligations. Royalty

revenue is recognized in the period in which the Company earns the

royalty. Amounts received in advance of recognition as revenue are

included in deferred revenue. Revenue from licensing and distribution

agreements is presented on a net basis.

2 Changes in accounting policies

Effective January 1, 2007 the Company adopted the CICA Handbook

Section 1530, "Comprehensive income" and CICA Handbook section 3855,

"Financial instruments - recognition and measurement".

Comprehensive income

Comprehensive income introduces a new requirement to present, among

other things, certain unrealized gains and losses outside of net

income or loss. Section 1530 defines comprehensive income as a change

in net assets arising from transactions and other events and

circumstances from non-owner sources. The new standard requires

presentation of a statement of comprehensive income (loss), which has

been combined with the former statement of operations.

Financial instruments

The new standard for financial instruments prescribes when a

financial instrument is to be recognized on the balance sheet and at

what amount. It also specifies how gains and losses on financial

instruments are to be presented. Upon adoption of this new standard,

the Company has classified its cash and cash equivalents as held-for-

trading financial assets, other receivables and loan receivable as

loans and receivables; accounts payable and accrued liabilities and

due to related party as other financial liabilities.

The adoption of these standards had no substantive impact on the

Company's interim consolidated financial statements.

3 Loan receivable

On February 28, 2005, the Company completed the sale of its wholly-

owned pharmaceutical research services business, Pharma Medica

Research Inc. (Pharma Medica). Consideration consisted of a cash

payment of $14,000 and a deferred payment of $4,000.

The deferred payment is non-interest bearing and is repayable in

annual instalments of $800 over a five year period. As the deferred

payment is non-interest bearing, it was recorded at its fair value of

$3,112 based on a discount rate of 9%. Imputed interest of $145 has

been recorded on this deferred payment during the nine months ended

September 30, 2007 ($207 during the nine months ended September 30,

2006). The first instalment of $800 related to this deferred payment

was collected on January 30, 2006. In accordance with the terms of

the deferred payment agreement, $800 of clinical services purchased

from Pharma Medica during the year ended December 31, 2006 were

offset against the annual payment that was due on January 30, 2007.

During the nine months ended September 30, 2007, $800 of clinical

services purchased from Pharma Medica were offset against the next

annual payment, which would have been due on January 30, 2008.

4 Intangible Assets

During fiscal 2001, the Company entered into certain agreements with

Galephar Pharmaceutical Research Inc. ("Galephar") for the rights to

package, test, obtain regulatory approvals and market certain

products in various countries around the world. In accordance with

the terms of the agreements, the Company has acquired these

intangible rights through an investment in three separate series of

preferred shares of Galephar. The Company may be required to pay

additional amounts to Galephar in respect of the CIP-ISOTRETINOIN and

CIP-TRAMADOL intangible rights of up to $1,494 (US $1,500) if certain

future milestones are achieved as defined in the agreements. These

additional payments will be made in the form of additional Galephar

preferred share purchases. The recoverability of these intangible

rights is dependant upon sufficient revenues being generated from the

related products currently under development and commercialization.

Upon receipt of FDA approval in January 2006, the Company began

amortizing the intangible rights related to CIP-FENOFIBRATE.

Currently, no other products have received FDA approval.

A summary of 2007 developments related to the products currently

under development/commercialization follows:

CIP-FENOFIBRATE

In April 2007, the Company completed its first sale of CIP-

FENOFIBRATE in Canada under an agreement with Oryx Pharmaceuticals

Inc.

In July 2007, the Company entered into a licensing and

distribution agreement with ProEthic Pharmaceuticals Inc.

("ProEthic") under which ProEthic was granted the exclusive right

to market, sell and distribute Lipofen in the United States. Under

the terms of the agreement, the Company receives an up-front

licensing fee of US $2 million, US $1 million of which was

received on signing. The balance will be received 180 days after

the first commercial sale of the product, which occurred on

September 11, 2007 and is included in accounts receivable at the

end of the third quarter. In addition, under the terms of the

agreement, the Company could receive additional milestone payments

of up to US $20 million based on the achievement of certain net

sales targets and will also receive a royalty based on a

percentage of net sales. These elements are reflected in net

revenue, which also incorporates direct product-related expenses

and amounts due to Galephar, the Company's technology partner.

After direct product-related expenses are deducted, including

payments to Galephar, the Company anticipates that it will retain

approximately 50% of total revenue under the agreement. In late

September 2007, ProEthic launched Lipofen in the U.S. market.

The Company's US $2 million investment in Galephar preferred

shares will be repaid by Galephar in US $350 quarterly payments,

beginning in the fourth quarter of 2007. These payments will be

included in net revenue based on the remaining amortization period

of the related intangible asset.

CIP-ISOTRETINOIN

On April 27, 2007, the Company received a second approvable letter

from the U.S. Food and Drug Administration ("FDA") pertaining to

its New Drug Application ("NDA") for CIP-ISOTRETINOIN. The FDA

indicated that the Company's application is approvable subject to

the resolution of two remaining issues. In addition to one

question related to chemistry, manufacturing and controls, the FDA

has requested that the Company provide additional safety data. The

Company believes that the clinical question raised has been

adequately addressed in the NDA submission and has appealed the

position taken by the FDA in its approvable letter using the

formal dispute resolution process. The appeal is ongoing.

CIP-TRAMADOL

On May 3, 2007, the Company received an approvable letter from the

FDA pertaining to its NDA for CIP-TRAMADOL. The FDA indicated that

the Company's application is approvable subject to the resolution

of certain issues, including a request for an additional adequate

clinical trial to provide further efficacy data.

In subsequent discussions with the FDA, the Company has obtained

clarification on the question of efficacy. The FDA has indicated

that the statistical methods used to analyze data from the

Company's clinical trials did not adequately address missing data

relating to subjects who dropped out of the trials. The Company

believes its submission includes sufficient efficacy data to

support regulatory approval.

The Company has a meeting scheduled with the FDA in November 2007

to obtain further clarification on the issues raised in the action

letter. The outcome of these discussions will help the Company

determine the most appropriate path forward to achieve final

regulatory approval in the U.S. market.

5 Due to related party

The Company and a related party have in common a majority of their

respective boards. There is no balance owing to the related party at

September 30, 2007. At December 31, 2006 the amount due was $123, for

management and payroll services.

6 Share capital

Authorized share capital

The authorized share capital consists of an unlimited number of

preference shares, issuable in series, and an unlimited number of

voting common shares.

Issued share capital

The following is a summary of the changes in share capital from

December 31, 2005 to September 30, 2007:

Number of

common shares Amount

(in thousands) $

Balance outstanding - December 31, 2005 21,336 38,783

Options exercised during 2006 200 201

March 14, 2006 public offering(a) 2,500 10,907

---------------------------

Balance outstanding - December 31, 2006 24,036 49,891

---------------------------

Options exercised during the

three months ended June 30, 2007(b) 19 57

---------------------------

Balance outstanding - September 30, 2007 24,055 49,948

---------------------------

(a) On March 14, 2006, the Company issued 2.5 million common shares

pursuant to the completion of a public offering. Net proceeds

from the offering after considering share issuance costs of

$1,093 amounted to $10,907.

(b) During the three months ended June 30, 2007, 19,277 shares were

issued as a result of the exercise of 37,500 options. The

Company's stock option plan provides that an option holder may

elect to receive an amount of shares equivalent to the growth

value of vested options, which is the difference between the

market price and the exercise price of the options. There is no

cash consideration for the shares issued when this election is

chosen by an option holder.

Stock option plan

The following is a summary of the changes in the stock options

outstanding from December 31, 2005 to September 30, 2007:

Weighted

average

Number of exercise

options price

(in thousands) $

Balance outstanding - December 31, 2005 725 1.67

Options granted during 2006 489 3.91

Options exercised in exchange for

common shares during 2006 (200) 1.00

Options exercised in exchange for

cash consideration during 2006(a) (125) 2.35

--------------

Balance outstanding - December 31, 2006 889 2.96

Options granted during the

three months ended March 31, 2007(b) 274 3.90

Options exercised during the

three months ended June 30, 2007(c) (38) 1.90

Options cancelled during the

three months ended June 30, 2007(c) (112) 1.90

Options cancelled during the

three months ended September 30, 2007(d) (15) 4.12

--------------

Balance outstanding - September 30, 2007 998 3.36

--------------

--------------

At September 30, 2007, 309,741 options were fully vested and

exercisable.

(a) During 2006, 125,000 stock options were exercised in exchange

for cash consideration of $286 representing the difference

between the exercise price of the options and the market value

of the related common shares on the exercise date. The cash

consideration of $286 represents stock option compensation

expense of which $48 was expensed during 2006 and $238 was

expensed in prior years. Subsequent to March 31, 2006, the

Company no longer intends to make cash payments on the exercise

of stock options.

(b) During the three months ended March 31, 2007, the Company

issued 274,000 stock options under the employee and director

stock option plan, which have an exercise price of $3.90, 25%

of which vest on March 9 of each year, commencing in 2008, and

expire in 2017. Total compensation cost for these stock options

is estimated to be $921. This cost will be recognized over the

vesting period of the stock options.

The stock options issued during the three months ended

March 31, 2007 were valued using the Black-Scholes option

pricing model with tup-front licensing fee from ProEthic. Cipher received the initial payment of US$1 million in the third quarter of 2007 and expects to receive the second payment of US$1 million in March 2008. Revenue is presented on a net basis and reflects the elements of the ProEthic licensing and distribution agreement, as well as direct product-related expenses and amounts due to Galephar, the Company's technology partner.

Research and development (R&D) expenses for the third quarter of 2007 were $0.2 million, compared with $1.4 million in the third quarter of 2006. The decrease in R&D spending reflects the advanced stage of development of the Company's current products. Operating, general and administrative (OG&A) expenses for the third quarter of 2007 were $1.1 million, compared with $0.9 million in the same period last year. The increase in OG&A is due to higher compensation expense resulting from an increase in personnel to support current growth plans, as well as stock-based compensation expense. Net loss for the three months ended September 30, 2007 was $1.1 million ($0.04 per basic and diluted share), compared with a net loss of $2.0 million ($0.08 per basic and diluted share) in the same period last year.

As at September 30, 2007, Cipher had cash and cash equivalents of $12.1 million, compared with $12.1 million as at June 30, 2007 and $15.1 million as at December 31, 2006.

Product Update

--------------

In July 2007, Cipher entered into a licensing and distribution agreement with ProEthic Pharmaceuticals under which ProEthic was granted the exclusive right to market, sell and distribute Lipofen in the United States. The agreement with ProEthic is for a period of ten years and they have the right to extend the term for additional two-year periods. In late September 2007, ProEthic launched Lipofen 150 mg and 50 mg capsules in the U.S. market with the full effort of its sales and marketing teams. Lipofen is the lead product for ProEthic as it she following assumptions:

Risk-free interest rate 3.96%

Expected life 10 years

Expected volatility 87%

Expected dividend Nil

(c) During the three months ended June 30, 2007, 37,500 stock

options were exercised in exchange for 19,277 common shares.

The Company's stock option plan provides that an option holder

may elect to receive an amount of shares equivalent to the

growth value of vested options, which is the difference between

the market price and the exercise price of the options. As a

result of the departure of an employee during the three months

ended June 30, 2007, 112,500 options were cancelled.

(d) During the three months ended September 30, 2007, 15,000 stock

options were cancelled as a result of the death of a Board

member.

7 Loss per share Loss per share is calculated using the weighted

average number of shares outstanding. The weighted average number of

shares outstanding for the nine and three month periods ended

September 30, 2007 was 24,047,252 and 24,054,878 respectively (for

the nine and three month periods ended September 30, 2006

respectively 23,304,649 and 24,035,601).

As the Company had a loss for each of the periods presented, basic

and diluted loss per share are the same because the exercise of all

stock options would have an anti-dilutive effect.

eeks to build its presence in the important primary care space.

During the second quarter of 2007, Cipher received a second approvable letter from the FDA pertaining to its CIP-ISOTRETINOIN NDA. In the letter, the FDA indicated that Cipher's application is approvable subject to the resolution of two remaining issues. In addition to one question related to chemistry, manufacturing and controls, which the Company has responded to, the FDA has requested that Cipher provide additional clinical safety data. The Company appealed the position taken by the FDA in its approvable letter using the formal dispute resolution process. Cipher submitted its appeal and met with the FDA on July 11, 2007. In August 2007, the Company received a response from the FDA to its request for formal dispute resolution. In the letter to Cipher, the representative from the FDA agreed with the Division of Dermatology and Dental Product's view that a clinical study is needed to further demonstrate the safety of CIP-ISOTRETINOIN. Subsequently, Cipher has had further discussions with the FDA on the issues raised in its response letter. Cipher continues to believe that the clinical questions raised by the FDA have been addressed in the NDA submission. The appeal process is ongoing.

During the second quarter of 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's once-daily formulation of tramadol. In its letter, the FDA indicated that Cipher's application is approvable subject to the resolution of certain issues, including a request for an additional adequate clinical trial to provide further efficacy data. In subsequent discussions with the FDA, Cipher has obtained clarification on the question of efficacy. The FDA has indicated that the statistical methods used to analyze data from Cipher's clinical trials did not adequately address missing data relating to subjects who dropped out of the trials. The Company has a meeting scheduled with the FDA in November 2007 to further discuss the issues raised in the action letter. The Company will determine the most appropriate path forward to achieve final regulatory approval based in part on the outcome of these discussions with the FDA. Cipher continues to believe its submission includes sufficient efficacy data to support regulatory approval.

Notice of Conference Call

-------------------------

Cipher will hold a conference call today, November 7, 2007, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial 416-644-3424 or 1-800-732-1073. A live audio webcast of the call will be available at http://www.cipherpharma.com. The webcast will be archived for 90 days.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by ProEthic Pharmaceuticals under the label Lipofen(TM). In addition, Cipher is developing formulations of the pain reliever tramadol and the acne treatment isotretinoin.

Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit http://www.cipherpharma.com.

Forward-Looking Statements

Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. The Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.

Cipher Pharmaceuticals Inc.

Unaudited Consolidated Balance Sheets

(in thousands of dollars)

As at

September 30, December 31,

2007 2006

ASSETS

Current assets

Cash and cash equivalents $ 12,056 $ 15,077

Accounts receivable (note 4) 1,377 -

Other receivables 97 160

Income taxes receivable 98 95

Other current assets 83 32

-------------------------------------------------------------------------

13,711 15,364

Property and equipment 210 99

Intangible assets (note 4) 4,708 5,058

Loan receivable (note 3) 1,331 1,986

-------------------------------------------------------------------------

-------------------------------------------------------------------------

$ 19,960 $ 22,507

-------------------------------------------------------------------------

-------------------------------------------------------------------------

LIABILITIES

Current liabilities

Accounts payable and accrued liabilities $ 905 $ 921

Deferred revenue 601 -

Due to related party (note 5) - 123

-------------------------------------------------------------------------

1,506 1,044

Deferred revenue 1,341 -

-------------------------------------------------------------------------

2,847 1,044

-------------------------------------------------------------------------

SHAREHOLDERS' EQUITY

Share capital (note 6) 49,948 49,891

Contributed surplus 30,846 30,430

Deficit (63,681) (58,858)

-------------------------------------------------------------------------

17,113 21,463

-------------------------------------------------------------------------

-------------------------------------------------------------------------

-------------------------------------------------------------------------

$ 19,960 $ 22,507

-------------------------------------------------------------------------

-------------------------------------------------------------------------

The accompanying notes are an integral part of these unaudited

consolidated financial statements

Cipher Pharmaceuticals Inc.

Unaudited Consolidated Statements of Operations and Comprehensive Loss

(in thousands of dollars, except per share amounts)

For the nine For the three

months ended months ended

September 30 September 30

2007 2006 2007 2006

Revenues

Licensing revenue $ 149 $ - $ 149 $ -

Product sales 227 - - -

-------------------------------------------------------------------------

376 - 149 -

-------------------------------------------------------------------------

Expenses

Cost of goods sold 177 - - -

Research and

development 1,535 8,111 231 1,370

Operating, general

and administrative 3,739 2,648 1,102 897

Amortization of

property and

equipment 32 17 16 5

Amortization of

intangible assets 350 - 117 -

Interest income (634) (695) (267) (240)

-------------------------------------------------------------------------

5,199 10,081 1,199 2,032

-------------------------------------------------------------------------

Loss and

comprehensive loss

for the period $ (4,823) $ (10,081) $ (1,050) $ (2,032)

-------------------------------------------------------------------------

-------------------------------------------------------------------------

Basic and diluted

loss per share

(note 7) $ (0.20) $ (0.43) $ (0.04) $ (0.08)

-------------------------------------------------------------------------

-------------------------------------------------------------------------

Cipher Pharmaceuticals Inc.

Unaudited Consolidated Statements of Deficit

(in thousands of dollars)

For the nine For the three

months ended months ended

September 30 September 30

2007 2006 2007 2006

Deficit, beginning

of period $ (58,858) $ (46,795) $ (62,631) $ (54,844)

Loss for the period (4,823) (10,081) (1,050) (2,032)

-------------------------------------------------------------------------

Deficit, end of

period $ (63,681) $ (56,876) $ (63,681) $ (56,876)

-------------------------------------------------------------------------

-------------------------------------------------------------------------

The accompanying notes are an integral part of these unaudited

consolidated financial statements

Cipher Pharmaceuticals Inc.

Unaudited Consolidated Statements of Cash Flows

(in thousands of dollars)

For the nine For the three

months ended months ended

September 30 September 30

2007 2006 2007 2006

Cash provided by

(used in)

Operating activities

Loss for the

period $ (4,823) $ (10,081) $ (1,050) $ (2,032)

Items not affecting

cash

Amortization of

property and

equipment 32 17 16 5

Amortization of

intangible

assets 350 - 117 -

Stock-based

compensation

expense 473 292 170 136

Imputed interest

(note 3) (145) (207) (45) (82)

---------------------------------------------- --------------------------

(4,113) (9,979) (792) (1,973)

Net change in non-

cash operating items 435 (1,780) 709 (339)

Drawdown of loan

receivable (note 3) 800 800 -
'/>"/>

SOURCE Cipher Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
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