BELLUS HEALTH DELIVERING ON KEY STRATEGIC PARTNERSHIPS AND KIACTA™ PHASE III DEVELOPMENT

Updates provided at Annual and Special Meeting of Shareholders

LAVAL, QC, May 11 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") held its Annual Meeting of Shareholders today. President and Chief Executive Officer Roberto Bellini provided shareholders with updates on the progress in implementing the Company's business plan, on the status of its products, including the clinical progress of KIACTA™, its lead drug candidate for AA amyloidosis, as well as on BELLUS Health's strategy to continue building value for shareholders.

"Executing on the business plan that we presented to shareholders at the beginning of 2010 has been our focal point in the past year, and I am pleased to report that our efforts delivered results," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "In implementing our plan, we entered into several important partnerships for our products, including a strategic partnership with Celtic Therapeutics for our lead drug candidate KIACTA™ and several distribution partnerships for VIVIMIND™. We also continued to develop the products in our pipeline, particularly KIACTA™ which began its confirmatory phase III clinical trial in December, 2010. We also put in place a leaner organizational structure which is better adapted to our business model. BELLUS Health is today much more solidly positioned for the future," Mr. Bellini added.

Strategic Partnerships and Products Update
       KIACTA™ (eprodisate)

On April 29, 2010, BELLUS Health entered into an asset sale and licence agreement with global pharmaceutical fund Celtic Therapeutics regarding KIACTA™, an investigational product candidate being developed for the treatment of AA amyloidosis, a life-threatening orphan disease. Pursuant to the agreement, Celtic Therapeutics acquired and licensed worldwide rights related to KIACTA™ (eprodisate) for upfront payments of US$10 million, and is assuming all costs related to the confirmatory phase III clinical trial and other development activities, estimated at an additional US$25 million. Celtic Therapeutics intends to conduct an auction process for the commercialization rights of KIACTA™ upon completion of the confirmatory phase III clinical trial, the overall proceeds of which are expected to be shared equally between the parties.

The global confirmatory phase III clinical trial for KIACTA™ was initiated on December 14, 2010. 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. Enrolment has commenced and 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™

In September 2010, Health Canada issued a Natural Health Product Number for VIVIMIND™, thereby granting formal authorization for sale of VIVIMIND™ in Canada. VIVIMIND™ is BELLUS Health's patented nutraceutical product that has been shown to protect the hippocampus, the area of the brain associated with memory and learning.

In October, 2010, BELLUS Health and FB Health LLC ("FB Health") entered into a license and supply agreement pursuant to which the Company granted FB Health exclusive distribution rights for VIVIMIND™ in Italy. FB Health launched VIVIMIND™ and made the product available to Italian consumers in January, 2011.

In early January, 2011, BELLUS Health and Advanced Orthomolecular Research Inc. ("AOR") entered into a share purchase agreement with respect to BELLUS Health's wholly-owned subsidiary OVOS Natural Health Inc. ("OVOS"), whereby AOR acquired all issued and outstanding shares of OVOS. The Company and AOR also entered into a Canadian license and supply agreement pursuant to which the Company granted AOR exclusive distribution rights for VIVIMIND™ in Canada. AOR is responsible for all marketing, distribution and sales activities of VIVIMIND™ in Canada and is expecting to launch the product across the country in the summer of 2011.

Finally, in April, 2011, BELLUS Health signed an exclusive license and distribution agreement with Agahan Ayandeye Pars Inc. ("Agahan Group") pursuant to which 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. 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.

These three partnerships represent approximately $2 million in upfront and guaranteed payments to BELLUS Health and up to $7.5 million in potential milestone payments. All partnerships also provide for BELLUS Health to supply VIVIMIND™'s active ingredient in powder form at a pre-agreed transfer price, which represents approximately 15% of the sales value.

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, which affects more than 30 million patients worldwide. 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 solid 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.

Organizational Restructuring

Over the past year, BELLUS Health progressively focused its human and financial resources on supporting its existing partnerships and product pipeline. The Company's head count was gradually reduced by more than 75% and is expected to be at 10 full time employees by mid-year. In January, 2011, BELLUS Health also exercised its right to terminate the lease of its Laval, Quebec premises, thereby substantially reducing its operating costs. Finally, the Company completed a corporate reorganization to streamline its international structure and repatriate its intellectual property to Canada. Together, these initiatives are expected to decrease BELLUS Health's burn rate to approximately $0.35 million per month by the end of the second quarter of 2011.

As at February 22, 2011, the Company had available cash and cash equivalents of $8.4 million. Based on current projections, the Company does not expect any additional financing to be required until the end of the second quarter of 2013.

Plans for 2011

Mr. Roberto Bellini also provided shareholders with an update on the Company's objectives for the year to come. Patient enrolment for the global KIACTA™ confirmatory Phase III clinical trial will continue and is expected to be completed by mid-2012. BELLUS Health will also continue implementing its strategy of forming partnerships with strong regional industry players to build a worldwide distribution network for VIVIMIND™.

"These steps are part of our action plan to continue creating long-term value for our shareholders, including through the eventual auction of KIACTA™'s commercialization rights, the conclusion of a partnership to take NRM8499 further in its development process, and the potential sale or spin-off of our nutraceutical business," Roberto Bellini concluded.

Board of Directors

All members of BELLUS Health's Board of Directors were re-elected. Board members include Dr. Francesco Bellini, Chairman, Mr. Charles Cavell, Deputy Chairman, Mr. Roberto Bellini, Mr. Neil Flanzraich, Ms. Hélène F. Fortin, Mr. Pierre Larochelle, Mr. Joseph Rus, Mr. Franklin Berger and Dr. Martin Tolar.

Roberto Bellini expressed his thanks and appreciation to the members of the Board for their encouragement and counsel in the implementation of the Company's business plan, as well as to BELLUS Health's employees and management team for their support throughout the year.  He also thanked the Company's shareholders for believing in BELLUS Health's important potential.

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, please visit www.bellushealth.com.

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 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, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, as well as other risks disclosed in public filings of BELLUS Health Inc. 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 Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the BELLUS Health Group and its business.

 

 

SOURCE BELLUS HEALTH INC.

For further information:

Anne-Marie Durand
NATIONAL Public Relations
514-843-2319

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BELLUS HEALTH INC.

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