Patient recruitment on-going for KIACTA Confirmatory Phase III Clinical Trial

LAVAL, QC, June 8, 2011 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") reported today its financial results for the first quarter ended March 31, 2011.

These financial results were prepared in accordance with International Financial Reporting Standards ("IFRS"), as issued by the International Accounting Standards Board. Comparative figures for 2010 that were previously reported in accordance with Canadian Generally Accepted Accounting Principles have been restated to conform to IFRS. For more information regarding the conversion to IFRS, please refer to note 14 of the Company's Consolidated Financial Statements for the three-month period ended March 31, 2011. All currency figures reported in this press release, including comparative figures, are in Canadian dollars, unless otherwise specified.

"During the first quarter, we continued to implement our business plan including the initiation of patient recruitment for the confirmatory phase III clinical trial for KIACTA™, our lead drug candidate." said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We also concluded our corporate reorganization enabling us to significantly reduce our burn rate and extend our cash resources to end of the second quarter of 2013," Mr. Bellini added.

Financial Results

For the three-month period ended March 31, 2011, net income amounted to $3,299,000 ($0.01 per share), compared to a net loss of $3,769,000 ($0.02 per share) for the corresponding period in the previous year. The increase in net income is primarily due to the decrease in the fair value of the embedded derivative liability on the 2009 Notes conversion option as well as a decrease in research and development expenses and general and administrative expenses.

As at March 31, 2011, the Company had available cash and cash equivalents of $7,100,000, compared to $10,257,000 at December 31, 2010. The decrease is primarily due to funds used in operating activities as well as to severance payments made in connection with the previously announced restructuring. The Company's burn rate is expected to run at approximately $350,000 per month by the end of the second quarter of Fiscal 2011. The burn rate of the upcoming quarters is dependent upon the level of development activities in relation to the Company's product candidates.

The Company's consolidated financial statements and accompanying Management's Discussion and Analysis for the three-month period ended March 31, 2011, will be available shortly on SEDAR at and on the Company's web site at

2011 First Quarter Highlights:


During the quarter, BELLUS Health and its strategic partner Celtic Therapeutics commenced recruitment for the global confirmatory phase III clinical trial for KIACTA™. The trial is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis. It will involve approximately 230 patients enrolled from approximately 72 sites in 30 countries worldwide. Patient recruitment is estimated to be completed in mid-2012. The confirmatory phase III clinical trial is the last key step before applications for regulatory approval for KIACTA™ can be filed. It is currently estimated that the trial will be completed in 2014.

VIVIMIND™ License and Distribution Agreement

In April 2011, the Company signed an exclusive license and distribution agreement with Agahan Ayandeye Pars Inc. ("Agahan Group") regarding VIVIMIND™ (the "Agreement"). Pursuant to the Agreement, the Company granted the Agahan Group exclusive distribution rights for VIVIMIND™ in Egypt, United Arab Emirates, Pakistan, Iran and certain other Gulf states of strategic importance to the Agahan Group for a consideration consisting primarily of up to US$1.5 million in commercial milestone payments, should certain mutually agreed upon sales targets be achieved, and a tiered royalty rate of 15 to 17 percent, depending on sales levels. The Agreement also provides for BELLUS Health to supply the product to the Agahan Group at a pre-agreed transfer price The Agahan Group intends to proceed rapidly with obtaining regulatory approval for VIVIMIND™ in the countries where it has exclusive distribution rights, following which it will move quickly to launch the product through prescribing physicians and direct-to-consumer pharmacy sales. The Agahan Group expects to launch VIVIMIND™ in the first half of 2012.

BELLUS Health continues to actively pursue arrangements to distribute VIVIMIND™ in other markets.

NRM8499 Prodrug Candidate

In January, 2011, BELLUS Health completed the phase I clinical trial for NRM8499, a prodrug of tramiprosate intended for the treatment of Alzheimer's disease. The phase I clinical trial investigated the safety, tolerability and pharmacokinetic profile of NRM8499 as compared to tramiprosate in a group of 67 young and elderly healthy subjects. Results of the trial showed a potential for pursuing NRM8499 for the treatment of Alzheimer's disease. The phase I clinical trial data demonstrated that NRM8499 was safe and well tolerated at the intended therapeutic dose. Moreover, the gastrointestinal tolerability and pharmacokinetic profile of tramiprosate, with regards to the inter-individual variability in drug systemic exposure, were meaningfully improved with NRM8499 when compared to the administration of an equivalent dose of tramiprosate. The Company is currently seeking a potential partnership to pursue the development process of NRM8499.

In addition, the Company is currently exploring opportunities in order to expand its pipeline, including through acquisitions and/or in-licensing.

Strategic Initiatives to Reduce Burn Rate

On January 14, 2011, the Company exercised its right to terminate the lease of its Laval, Quebec premises as of April 7, 2011, as provided in the amended lease agreement dated March 31, 2009 (the "Amended Lease") with A.R.E. Quebec No. 2, Inc. ("A.R.E."), the landlord of such premises. On January 21, 2011, in consideration for the exercise of the termination option, BELLUS Health issued 20,656,320 common shares from treasury to A.R.E. at a price of $0.29 per share (rounded to the second decimal point), for an aggregate value of $6 million. In addition, on April 7, 2011, the Company issued 34,242,911 common shares at a price of approximately $0.125 per share, as final payment for the deferred rent of approximately $4.3 million payable to the landlord. As provided in the Amended Lease, the Company deferred payment of base rent by $167,000 per month minus any sublease revenue from April 1, 2009 to April 7, 2011. The early termination of the lease is expected to result in annual savings of approximately $4.5 million for the Company, representing a total of approximately $43 million in aggregate savings over the remainder of the original lease term. The Company has signed a new one-year lease that begun on April 8, 2011 at the same premises, for less space.

On March 31, 2011, BELLUS Health completed a corporate reorganization whereby the Company streamlined its international structure by liquidating its subsidiaries in Europe and the United States, which resulted in the repatriation of BELLUS Health's intellectual property to Canada.

As announced in August 2010, the Company's head count was gradually reduced by more than 75 percent and is expected to be at 10 full-time employees by mid-year. Together, these initiatives reduce the Company's fixed-cost base and extend its financial resources.

Going Concern

As at March 31, 2011, the Company's committed sources of funds, and the cash and cash equivalents on hand is expected, in management's view, to be sufficient to meet its committed cash obligations and expected level of expenditures over the next twelve months. However, beyond that , the ability of the Company to continue as a going concern is dependent upon raising additional financing through borrowings, share issuances, receiving funds through sale of assets, supply agreements or product licensing agreements, and from obtaining regulatory approval in various jurisdictions to market and sell its product candidates and ultimately achieving future profitable operations. The outcome of these matters is dependent on a number of factors outside of the Company's control. These factors continue to raise significant doubt about the Company's ability to continue as a going concern in the foreseeable future.

About BELLUS Health

BELLUS Health is a development-focused health company concentrating on the development of products that provide innovative health solutions and address critical unmet medical needs. For further information on BELLUS Health, please visit

Forward Looking Statements

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks include but are not limited to: the ability to obtain financing immediately in current markets, the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Group does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see the Company's public fillings including the Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the BELLUS Health Group and its business.


For further information:

Anne-Marie Durand
NATIONAL Public Relations

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