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Cipher reports second quarter fiscal 2008 results
Toronto Stock Exchange Symbol: DND MISSISSAUGA, ON, Aug. 13 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced its financial and operational results for the three and six months ended June 30, 2008.Q2 2008 Summary --------------- - Submitted revised New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, extended-release tramadol formulation; NDA subsequently accepted for review by FDA - Recorded licensing revenue of $277,000 from Lipofen(R) - Net loss decreased to $1.8 million, or $0.08 per share, compared with $2.1 million, or $0.09 per share, in the second quarter of 2007 - Cash of $9.9 million at quarter end, compared with $11.0 million at the end of fiscal 2007 - Subsequent to quarter end, entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("RPI"), for CIP-ISOTRETINOIN in the United States."A key product development highlight during the quarter was the submission of our revised NDA for extended-release tramadol, which we believe provides the most expeditious path to final regulatory approval," said Larry Andrews, President and CEO of Cipher. "We also achieved a major milestone recently with the completion of the agreement with Ranbaxy for CIP-ISOTRETINOIN. This agreement provides us with the financial resources to complete CIP-ISOTRETINOIN's clinical development program while also achieving attractive commercialization terms post-FDA approval. Sales of Lipofen, our first commercial product, grew solidly during the quarter and we expect this product to provide a steadily increasing revenue stream to offset some of our operating costs and support our continued growth."Financial Review ----------------In Q2 2008, Cipher recorded total revenue of $277,000, an increase of 22% over the same period last year. Research and development expenses increased from $0.8 million in Q2 2007 to $1.1 million in Q2 2008, as a result of completion of additional pharmacokinetic studies for CIP-TRAMADOL ER during Q2 2008. Operating, general and administrative (OG&A) expenses for Q2 2008 were $1.0 million, compared with $1.4 million in Q2 2007. The year-over-year decrease reflects certain non-recurring expenses incurred in Q2 2007 related to the move to new premises and the departure of a senior employee. OG&A expenses are expected to increase moderately over the balance of the year as select resources are added to the management team. Net loss for the three months ended June 30, 2008 was $1.8 million ($0.08 per basic and diluted share), compared with a net loss of $2.1 million ($0.09 per basic and diluted share) in the same period last year. As at June 30, 2008, Cipher had cash of $9.9 million, compared with $11.0 million at December 31, 2007.Drug Development 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. In late September 2007, ProEthic launched Lipofen in the U.S. market with the full effort of its sales and marketing teams. Since launch, weekly prescriptions have shown steady growth and Cipher expects this trend to continue as ProEthic increases penetration of the primary care physicians in its targeted regions and expands its sales force. Subsequent to quarter end, ProEthic was acquired by Kowa Company Ltd. ("Kowa"), a multinational Japanese company actively engaged in manufacturing and trading activities in various fields, including pharmaceuticals and life sciences. Kowa has indicated that it is committed to supporting Lipofen and will accelerate the planned expansion of ProEthic's sales force, particularly in regions where ProEthic does not have coverage currently. Effective September 1, 2008, ProEthic will change its name to Kowa Pharmaceuticals America. 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 responded to, the FDA 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. After subsequent discussions, the representative from the FDA agreed with the Division of Dermatology and Dental Product's original view that a Phase III safety study was needed to further demonstrate the safety of CIP-ISOTRETINOIN. Cipher and its advisors are currently in discussions with the Division regarding the appropriate design of a safety trial. The study protocol has been submitted for FDA review under a Special Protocol Assessment ("SPA"). Subsequent to quarter end, the Company entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("RPI"), a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher has granted RPI the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States. Under the terms of the agreement with RPI, Cipher received an initial upfront milestone payment of US$1 million. The agreement includes additional pre- and post-commercialization milestone payments of up to US$23 million, contingent upon the achievement of certain milestone targets. Once the product is successfully commercialized, Cipher will also receive a royalty in the mid-teens on net sales. In addition, RPI will reimburse Cipher for all costs associated with any remaining clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally. Cipher is responsible for all product development activities, including management of the clinical studies required by the FDA to secure NDA approval. Cipher is also responsible for product supply and manufacturing, which would be fulfilled by its partner, Galephar Pharmaceutical Research. After product-related expenses are deducted, approximately 50% of all milestone and royalty payments received by Cipher under the agreement will be paid to Galephar. In May 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's extended-release 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, the FDA 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. In December 2007, Cipher announced that it had appealed the position taken by the FDA using the FDA's formal dispute resolution process. In the written response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the original approvable action. In a subsequent discussion, the FDA suggested an additional statistical sensitivity analysis of existing clinical data on CIP-TRAMADOL ER as a means to potentially satisfy the requirements for approval. As a consequence, the Company suspended its appeal and conducted the additional statistical analysis. During the second quarter of 2008, Cipher submitted a revised NDA to the FDA. After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis, Cipher and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER. The revised NDA was accepted for review, which the Company expects to be completed by October 2008. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. Out-licensing discussions with potential commercial partners are ongoing.Notice of Conference Call -------------------------Cipher will hold a conference call today, August 13, 2008, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial 416-644-3431 or 1-800-814-4860. A live audio webcast of the call will be available at 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(R). In addition, Cipher is developing formulations of the pain reliever tramadol (FDA approvable letter in May 2007) and the acne treatment isotretinoin (FDA approvable letter in April 2007). Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit 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. Except as required by Canadian securities laws, 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 June 30, December 31, 2008 2007 ASSETS Current assets Cash $ 9,851 $ 10,961 Accounts receivable 182 1,396 Income taxes receivable 22 128 Prepaid expenses and other current assets 93 56 Current portion of loan receivable (note 4) 655 - 10,803 12,541 ------------------------------------------------------------------------- Property and equipment, net 176 208 Loan receivable (note 4) 684 1,377 Intangible assets, net (note 5) 4,359 4,592 ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ 16,022 $ 18,718 ------------------------------------------------------------------------- ------------------------------------------------------------------------- LIABILITIES Current liabilities Accounts payable and accrued liabilities $ 1,121 $ 1,059 Deferred revenue 935 790 ------------------------------------------------------------------------- 2,056 1,849 Deferred revenue 894 1,192 ------------------------------------------------------------------------- 2,950 3,041 ------------------------------------------------------------------------- SHAREHOLDERS' EQUITY Share capital (note 6) 49,948 49,948 Contributed surplus 31,310 31,032 Deficit (68,186) (65,303) ------------------------------------------------------------------------- 13,072 15,677 ------------------------------------------------------------------------- ------------------------------------------------------------------------- ------------------------------------------------------------------------- $ 16,022 $ 18,718 ------------------------------------------------------------------------- ------------------------------------------------------------------------- The accompanying notes are an integral part of these consolidated financial statements Cipher Pharmaceuticals Inc. Unaudited Consolidated Statements of Operations and Comprehensive Loss (in thousands of dollars, except per share amounts) For the three For the six months ended months ended June 30 June 30 2008 2007 2008 2007 Revenues Licensing revenue $ 277 $ - $ 454 $ - Product sales - 227 - 227 ------------------------------------------------------------------------- 277 227 454 227 ------------------------------------------------------------------------- Expenses Cost of goods sold - 177 - 177 Research and development 1,092 826 1,542 1,670 Operating, general and administrative 967 1,354 1,778 2,271 Amortization of property and equipment 18 11 35 16 Amortization of intangible assets 116 117 233 233 Interest income (113) (180) (251) (367) ------------------------------------------------------------------------- 2,080 2,305 3,337 4,000 ------------------------------------------------------------------------- Loss and comprehensive loss for the period $(1,803) $(2,078) $(2,883) $(3,773) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per share (note 7) $ (0.08) $ (0.09) $ (0.12) $ (0.16) ------------------------------------------------------------------------- ------------------------------------------------------------------------- The accompanying notes are an integral part of these unaudited consolidated financial statements Cipher Pharmaceuticals Inc. Unaudited Consolidated Statements of Deficit (in thousands of dollars) For the three For the six months ended months ended June 30 June 30 2008 2007 2008 2007 Deficit, beginning of period $ (66,383) $ (60,553) $ (65,303) $ (58,858) Loss for the period (1,803) (2,078) (2,883) (3,773) ------------------------------------------------------------------------- Deficit, end of period $ (68,186) $ (62,631) $ (68,186) $ (62,631) ------------------------------------------------------------------------- ------------------------------------------------------------------------- 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 three For the six months ended months ended June 30 June 30 2008 2007 2008 2007 Cash provided by (used in) Operating activities Loss $ (1,803) $ (2,078) $ (2,883) $ (3,773) Items not affecting cash Amortization of property and equipment 18 11 35 16 Amortization of intangible assets 116 117 233 233 Stock-based compensation expense 161 144 278 303 Imputed interest (note 4) (32) (46) (73) (100) ------------------------------------------------------------------------- (1,540) (1,852) (2,410) (3,321) Net change in non-cash operating items 1,013 266 1,192 (274) Drawdown of loan receivable (note 4) 111 223 111 800 ------------------------------------------------------------------------- (416) (1,363) (1,107) (2,795) ------------------------------------------------------------------------- Investing activities Purchase of property and equipment (3) (127) (3) (133) ------------------------------------------------------------------------- Decrease in cash (419) (1,490) (1,110) (2,928) Cash, beginning of period 10,270 13,639 10,961 15,077 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Cash, end of period $ 9,851 $ 12,149 $ 9,851 $ 12,149 ------------------------------------------------------------------------- ------------------------------------------------------------------------- The accompanying notes are an integral part of these unaudited consolidated financial statements Cipher Pharmaceuticals Inc. Notes to Unaudited Consolidated Financial Statements June 30, 2008 (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 six months ended June 30, 2008 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2008. There have been no changes to the accounting policies as described in Note 1 and Note 2 to the consolidated financial statements for the year ended December 31, 2007, except as explained in Note 2 below. Basis of consolidation These consolidated financial statements include the accounts of Cipher Pharmaceuticals Inc. (the "Company") and its subsidiaries. All intercompany balances with subsidiaries have been eliminated. As part of the simplification of its corporate structure, the Company's wholly-owned subsidiaries Cipher Canada Inc., Cipher Holdings (Barbados) Ltd. and Cipher Pharmaceuticals Ltd. are in the process of being wound up by way of voluntary dissolution. 2 ADOPTION OF NEW ACCOUNTING POLICIES Effective January 1, 2008 the Company adopted the following new CICA accounting standards: Section 3862, Financial Instruments - Disclosures and Section 1535, Capital Disclosures. CICA Section 3862, Financial Instruments - Disclosures, establishes standards for the disclosure of financial instruments including disclosing the significance of financial instruments and the nature and extent of risks arising from financial instruments. CICA Section 1535, Capital Disclosures, establishes standards for disclosing aspects of the entity's capital management strategy. This standard requires disclosure of both quantitative and qualitative disclosures around the entity's objectives, policies and processes for managing capital requirements and the consequences of non- compliance. The adoption of these new standards had no impact on the Company's financial position or results of operations. 3 RISK MANAGEMENT Financial risk management In the normal course of business, the Company is exposed to a number of financial risks that can affect its operating performance. These risks are: credit risk, liquidity risk and market risk. The Company's overall risk management program and prudent business practices seek to minimize any potential adverse affects on the Company's financial performance. (i) Credit risk Cash - the Company places its cash with Canadian Schedule I banks. Accounts receivable - the Company licenses its products to distribution partners in major markets. The credit risk associated with the accounts receivable pursuant to these agreements is evaluated during initial negotiations and on an ongoing basis. There have been no events of default under these agreements. As of June 30, 2008, no accounts receivable balances were considered impaired, nor past due. Loan receivable - the loan receivable is payable in annual instalments over a five year period, with two payments remaining as at June 30, 2008. All prior instalments have been received on schedule and there have been no events of default under the loan agreement. (ii) Liquidity risk The Company has no long term debt with specified repayment terms. Accounts payable and accrued liabilities are settled in the regular course of business, based on negotiated terms with trade suppliers. All components of the balance of $1,121 as at June 30, 2008 will be settled in less than one year. The carrying value of the balances approximate their fair value as the impact of discounting is not significant. (iii) Market risk Currency risk - the majority of the Company's revenue and a portion of its expenses are denominated in US currency. At June 30, 2008 the accounts receivable balance included a total of US$132 and accounts payable and accrued liabilities included a total of US$223. There is no active hedging program currently in place due to the relatively short time frame for settlement of these balances. A 10% change in the US/CDN exchange rate on the June 30, 2008 balances would not have a significant impact on net income. Interest rate risk - the fair value of the loan receivable is based upon a discounted cash flow method, whereby a risk premium is added to the Bank of Canada risk-free interest rate. A 10% change in the risk-free interest rate would not have a significant impact on imputed interest. Capital risk management Shareholders' equity is managed as the capital of the Company. The Company's objective when managing capital is to safeguard the Company's ability to continue as a going concern in order to provide returns for shareholders and to maintain an optimal capital structure to minimize the cost of capital. In order to maintain or adjust the capital structure, the Company may issue new common shares from time to time. 4 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 $73 has been recorded on this deferred payment during the six months ended June 30, 2008 ($100 during the six months ended June 30, 2007). In accordance with the terms of the deferred payment agreement, $800 of clinical services purchased from Pharma Medica during 2007 were offset against the annual payment that was due on January 30, 2008. During the six months ended June 30, 2008, $111 of clinical services purchased from Pharma Medica were offset against the next annual payment, which is due on January 30, 2009. 5 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 ER intangible rights of up to $1,528 (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. With regard to CIP-FENOFIBRATE, 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. The Company has received an up-front licensing fee of US$2 million. 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. The Company also receives a royalty based on a percentage of net sales. These elements are reflected in licensing revenue, which also incorporates direct product-related expenses and amounts due to Galephar, the Company's technology partner. Revenue from licensing and distribution agreements is presented on a net basis. Over the term of the Galephar agreement, after product-related expenses are deducted and including payments to Galephar, the Company anticipates that it will retain approximately 50% of revenue. In late September 2007, ProEthic launched Lipofen in the U.S. market. The Company's US$2 million investment in Galephar preferred shares related to CIP-FENOFIBRATE is being repaid by Galephar in a series of quarterly payments. The first payment of US$350 was received in December 2007. Subsequent to year-end, the repayment schedule was amended and payments of US$225 were received in March and June 2008. The next quarterly payment will be in the amount of US$225. These payments are included in revenue based on the remaining amortization period of the related intangible asset. On August 6, 2008, the Company entered into a distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("RPI") under which RPI was granted the exclusive right to market, sell and distribute CIP- ISOTRETINOIN in the United States. Under the terms of the agreement, the Company will receive an up-front milestone payment of US$1 million and could receive additional pre- and post- commercialization milestone payments of up to US$23 million, based on the achievement of certain milestone targets. Once the product is successfully commercialized, the Company will also receive a royalty based on a percentage of net sales. In addition, RPI will reimburse the Company for all costs associated with the clinical studies required by the FDA to secure NDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally. The Company is responsible for all product development activities, including management of the clinical studies required by the FDA to secure NDA approval and is also responsible for product supply and manufacturing, which will be fulfilled by Galephar. After product-related expenses are deducted, approximately 50% of all milestone and royalty payments received by the Company under the agreement will be paid to Galephar. 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, 2006 to June 30, 2008: Number of common shares Amount (in thousands) $ Balance outstanding - December 31, 2006 24,036 49,891 Options exercised during 2007 19 57 ------------------------ Balance outstanding - December 31, 2007 and June 30, 2008 24,055 49,948 ------------------------ ------------------------ During 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, 2006 to June 30, 2008: Weighted average Number of exercise options price (in thousands) $ Balance outstanding - December 31, 2006 889 2.96 Options granted during 2007 274 3.90 Options exercised during 2007 (38) 1.90 Options cancelled during 2007 (127) 2.16 --------------- Balance outstanding - December 31, 2007 998 3.36 Options granted during the three months ended March 31, 2008 263 1.05 Options cancelled during the three months ended March 31, 2008 (50) 3.90 --------------- Balance outstanding - June 30, 2008 1,211 2.83 --------------- --------------- At June 30, 2008, 545,482 options were fully vested and exercisable. During the three months ended March 31, 2008, the Company issued 263,000 stock options under the employee and director stock option plan, which have an exercise price of $1.05, 25% of which vest on February 28 of each year, commencing in 2009, and expire in 2018. Total compensation cost for these stock options is estimated to be $242. This cost will be recognized over the vesting period of the stock options. The stock options issued during the three months ended March 31, 2008 were valued using the Black-Scholes option pricing model with the following assumptions: Risk-free interest rate 3.14% Expected life 10 years Expected volatility 93% Expected dividend Nil 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 six and three month periods ended June 30, 2008 was 24,054,878 (for the six and three month periods ended June 30, 2007 respectively 24,043,376 and 24,051,065). 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. 8 COMPARATIVE FIGURES Certain comparative figures for the previous year have been reclassified to conform to current financial statement presentation.%SEDAR: 00020415E
For further information:
For further information: Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, carmitage@equicomgroup.com; Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext 324, fax (905) 602-0628 fax, landrews@cipherpharma.com