Bellus Health Press Releases

BELLUS Health Reports Results for First Quarter Ended March 31, 2013, and Provides Update on KIACTA(TM) Phase III Confirmatory Study

Wed, 15 May 2013 17:00:00 -0400

- Also announces voting results from Annual Meeting of Shareholders -

LAVAL, QC, May 15, 2013 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today reported its financial results for the first quarter ended March 31, 2013.

First Quarter 2013 Highlights

Recruitment continued for Phase III Confirmatory Study for KIACTA™ for the treatment of AA amyloidosis, with approximately 66% of patients recruited to date;
Recommendation of the Data Safety Monitoring Board to continue KIACTA™ Phase III Confirmatory Study as per protocol, based on its last review;
Concluded the quarter with a cash position of $17.6 million, enabling the Company to finance its operations through the end of KIACTA™ Phase III Confirmatory Study, expected in 2017;
Exercised put option to settle one of its credit facilities, leading to estimated savings of more than $200,000 in future interest payments.

"During this reporting period, we maintained our steady pace of enrolment for the Phase III Confirmatory Study for KIACTA™," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We also continued to evaluate responsible capital allocation opportunities to maximize our financial runway while strengthening our pipeline."

Phase III Confirmatory Study for KIACTA™ (eprodisate)

During the first quarter of 2013, recruitment continued for the Phase III Confirmatory Study for KIACTA™, for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. The study will involve approximately 230 patients enrolled from more than 70 sites and 30 countries worldwide.

As of May 15, 2013, there are 152 patients enrolled in the Phase III Confirmatory Study, and based on the current recruitment rate, BELLUS Health continues to expect that patient recruitment will be completed in the first half of 2014. The Phase III Confirmatory Study is an event-driven study that will end when 120 events linked to deterioration of kidney function have occurred, which is currently expected to be reached in 2017. BELLUS Health's partner, Auven Therapeutics (previously Celtic Therapeutics), is funding 100% of the development costs of KIACTA™, including the Phase III Confirmatory Study and other related activities, which are estimated to be in excess of US$50 million. Auven Therapeutics and BELLUS Health are expected to share the overall proceeds from potential future revenue of KIACTA™ approximately equally.

Patients completing the Phase III Confirmatory Study will be offered to continue in an extended program. The first patients are expected to be enrolled in the extended program in the second half of 2013.

As part of the Phase III Confirmatory Study, there are periodic meetings of the Data Safety Monitoring Board (DSMB), which independently assesses the safety of KIACTA™ throughout the study. Based on its last review on April 16, 2013, the DSMB recommended that the study continue as per protocol.

VIVIMIND™

VIVIMIND™, BELLUS Health's natural health product designed to protect memory function, was commercially launched in Greece in the first quarter of 2013 by the Company's marketing and distribution partner, Integris Pharma Ltd.

The Company currently has distribution agreements with partners in several countries, including Italy, Canada, Taiwan, Greece, certain countries in the Middle East, Israel and South Korea.

Management is currently exploring opportunities in order to expand its pipeline, including through acquisitions and/or in-licensing. In addition, the Company continues to pursue additional sources of funds including through asset sale and/or further arrangements relating to the distribution of VIVIMIND™.

Summary of Financial Results

All currency figures reported in this press release are in Canadian dollars, unless otherwise specified. Comparative per share data for 2012 have been retrospectively adjusted to reflect the consolidation of the Company's common shares in May 2012.

	Three-months ended March 31, 2013	Three-months ended March 31, 2012
	(in thousands of dollars, except per share data)
Revenues	599	568
Research and development expenses	(395)	(329)
General and administrative expenses	(966)	(1,278)
Finance income	256	734
Finance costs	(48)	(2,888)
Net loss	(554)	(3,193)
Net loss attributable to owners of the Company	(537)	(3,193)
Basic and diluted loss per share	(0.01)	(0.33)

The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three-month period ended March 31, 2013, will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

For the three-month period ended March 31, 2013, net loss attributable to owners of the Company amounted to $537,000 ($0.01 per share), compared to $3,193,000 ($0.33 per share) for the corresponding period the previous year. The decrease is primarily due to a reduction in accretion expense and change in fair value of embedded derivative on convertible notes following the settlement of convertible securities, as part of the strategic partnership, financing and capital reorganization that took place in May 2012.
Revenues amounted to $599,000 for the three-month period ended March 31, 2013, compared to $568,000 for the corresponding period the previous year. Revenues mainly consist of revenue recognized for accounting purposes from the asset sale and license agreement as well as the service agreement entered into with Auven Therapeutics in 2010 for KIACTA™. Revenues also include revenue recognized for accounting purposes from the agreement with Asclepios Bioresearch (UK) Limited, as well as revenue from distribution agreements in relation to VIVIMIND™.
General and administrative expenses amounted to $966,000 for the three-month period ended March 31, 2013, compared to $1,278,000 for the corresponding period the previous year. The decrease is mainly due to transaction costs recorded in the comparative period in relation to the strategic partnership, financing and capital reorganization that took place in May 2012.
Finance income amounted to $256,000 for the three-month period ended March 31, 2013, compared to $734,000 for the corresponding period the previous year. The decrease is mainly attributable to a lower increase in fair value of the New ABCP Notes recorded during the current quarter.
Finance costs amounted to $48,000 for the three-month period ended March 31, 2013, compared to $2,888,000 for the corresponding period the previous year. The decrease is primarily due to a reduction in accretion expense and change in fair value of embedded derivative on convertible notes following the settlement of convertible securities, as part of the strategic partnership, financing and capital reorganization that took place in May 2012.

As at March 31, 2013, the Company had available cash, cash equivalents and short-term investments totalling $17.6 million.

On March 28, 2013, effective April 19, 2013, the Company exercised the put option on one of its credit facilities, which reduced both the aggregate credit facilities and nominal value of the related New ABCP Notes by US$3,009,000. Upon the exercise of the put option, the Company transferred to the bank the ownership of the MAV3 IA Tracking Notes, and paid an amount of $1,282,000 (US$1,250,000) to settle the credit facility. This will enable the Company to save more than $200,000 in future interest payments.

BELLUS Health Announces Election of Directors and Independent Auditor at Annual Meeting

Each director nominee listed in the Management Information Circular dated March 19, 2013 was elected as Director of the Company during the Annual Meeting of the Holders of Common Shares held earlier today in Laval, Quebec.

The details of the election are as follows:

Director Nominee	Outcome	Votes For	% For	Votes Withheld	% Withheld
Dr. Francesco Bellini, O.C.	Elected	24,913,396	99.96%	9,440	0.04%
Roberto Bellini	Elected	24,913,423	99.96%	9,413	0.04%
Franklin M. Berger	Elected	24,913,946	99.96%	8,890	0.04%
Charles Cavell	Elected	24,907,355	99.94%	15,481	0.06%
Hélène F. Fortin, FCPA auditor, FCA	Elected	24,907,999	99.94%	14,837	0.06%
Pierre Larochelle	Elected	24,581,631	98.63%	341,205	1.37%
Donald Olds	Elected	24,908,725	99.94%	14,111	0.06%
Joseph Rus	Elected	24,908,736	99.94%	14,100	0.06%
Dr. Martin Tolar	Elected	24,907,794	99.94%	15,042	0.06%

The results of the final votes regarding all matters subject to a vote during the Annual Meeting that took place earlier today will be made available on SEDAR's site (www.sedar.com).

KPMG LLP, Chartered Accountants, have been appointed as the independent auditor of the Company until the next Annual Meeting of Shareholders. KPMG LLP has been the independent auditor of the Company since September 1995.

About BELLUS Health

BELLUS Health is a development-focused healthcare company concentrating on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

About AA Amyloidosis

AA amyloidosis is a deadly condition that progresses from chronic inflammatory diseases such as rheumatoid arthritis. The disease causes a protein called amyloid A to accumulate in major organs, particularly the kidneys, which leads to organ dysfunction, failure, and eventually death.

There is currently no available treatment for AA amyloidosis and it is estimated that approximately 35,000 to 50,000 patients are living with the disease in the United States, Europe and Japan. Independent research conducted by the Frankel Group in 2009 suggests that peak annual revenues of $400 million to $600 million are achievable.

Because patients diagnosed with AA amyloidosis tend to quickly progress to a costly regimen of dialysis, healthcare payers are anxious to find alternative treatments for this deadly condition. KIACTA™ has been granted Orphan Drug designation or its equivalent in the United States and Europe, which provide seven and ten years of market exclusivity, respectively, once the drug is approved, as well as a reduction in application and review fees.

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, 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 Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. The length of KIACTA^TM Phase III Confirmatory Study is dependent upon many factors including clinical sites activation, patient enrolment rate, patient drop-out rate and occurrence of clinical endpoint events. 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 Company and its business.

Adam Peeler
TMX Equicom
416-815-0700 ext. 225 | apeeler@tmxequicom.com

BELLUS Health to Present at Bloom Burton & Co. Healthcare Investor Conference

Thu, 09 May 2013 14:30:00 -0400

LAVAL, QC, May 9, 2013 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today announced that Roberto Bellini, President and Chief Executive Officer, will present at the second annual Bloom Burton & Co. Healthcare Investor Conference. The presentation will take place at 4:00 pm Eastern Time on Wednesday, May 22, 2013. The conference is being held at the Toronto Board of Trade in Toronto, Ontario.

Mr. Bellini will provide a corporate update, including information about the Phase III Confirmatory Study for KIACTA™, BELLUS Health's drug candidate for the treatment of AA amyloidosis.

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a development-focused healthcare company concentrating on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics (previously Celtic Therapeutics). AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

Adam Peeler
TMX Equicom
416-815-0700 ext. 225 | apeeler@tmxequicom.com

BELLUS Health Reports Results for Year Ended December 31, 2012

Wed, 27 Feb 2013 07:00:00 -0500

LAVAL, QC, Feb. 27, 2013 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today reported its financial results for the year ended December 31, 2012, and provided an update on its pipeline of products.

2012 Highlights

Recruitment continued for the Phase III Confirmatory Study for KIACTA™ for the treatment of AA amyloidosis, with more than 50% of patients recruited to date, and expected to be completed in the first half of 2014;
Completed a $17.25 million strategic partnership and financing with Pharmascience Inc., including $8.15 million in non-dilutive capital and a $9.1 million investment for a 10.4% ownership stake;

Settled all outstanding convertible securities principally through the issuance of common shares of the Company, and consolidated its common shares on the basis of one new post-consolidation common share for every 30 pre-consolidation common shares;

Entered into a partnership with Asclepios Bioresearch (UK) Limited for the development of BLU8499, BELLUS Health's drug candidate for the treatment of Alzheimer's disease;

Further expanded VIVIMIND™'s marketing and sales network through the conclusion of three new distribution agreements in Israel, Taiwan and South Korea; and
Concluded the year with a cash position of $18.6 million as of December 31, 2012.

"This past year marked a period of significant progress for the Company," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We now have sufficient funding to complete the ongoing Phase III Confirmatory Study for KIACTA™, and we have the financial resources to evaluate additional opportunities to strengthen our pipeline. We have also simplified our capital structure and, most importantly, our clinical assets are making consistent headway."

Phase III Confirmatory Study for KIACTA™ (eprodisate)

During the fourth quarter of 2012, recruitment continued for the Phase III Confirmatory Study for KIACTA™ for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. The study will involve approximately 230 patients enrolled from more than 70 sites and 30 countries worldwide.

It is expected that patient recruitment will be completed in the first half of 2014. The Phase III Confirmatory Study is an event-driven study that will end when 120 patients reach an event linked to deterioration of kidney function. It is currently projected that the study will reach 120 events in 2017. BELLUS Health is actively working with its partner Celtic Therapeutics Inc. (Celtic Therapeutics) on actions to accelerate patients' recruitment.

Celtic Therapeutics is funding 100% of the development costs of KIACTA™ including the Phase III Confirmatory Study and other related activities. The total cost of the development activities of KIACTA™ is currently estimated to be in excess of US$50 million. Celtic Therapeutics and BELLUS Health are expected to share the overall proceeds from potential future revenue of KIACTA™ approximately equally.

Patients completing the Phase III Confirmatory Study will be offered to continue in an open label extension study (OLES). The first patients are expected to be enrolled in the OLES in the first half of 2013.

BLU8499

During the third quarter of 2012, the Company entered into a partnership with Asclepios Bioresearch (UK) Limited (Asclepios) for the development of BLU8499, BELLUS Health's drug candidate for the treatment of Alzheimer's disease. Under the terms of the agreement, Asclepios will fund all Phase IIa enabling activities and has committed to a second tranche of additional capital for the conduct of a Phase IIa clinical trial in mild Alzheimer's disease patients. The total investment and commitment by Asclepios towards the development of BLU8499 is expected to be approximately $4 million. Under the terms of the agreement, BELLUS Health will earn study management fees equal to 15% of direct development costs and will also be reimbursed for certain intellectual property costs. According to the agreement, it is expected that the two parties will share the overall proceeds from the future monetization of BLU8499 approximately equally.

The Phase IIa clinical trial is currently expected to be initiated in the second half of 2014.

VIVIMIND™

In 2012, the Company entered into three new distribution agreements for VIVIMIND™ in Israel, Taiwan and South Korea.

Total revenues in relation to VIVIMIND™ distribution agreements amounted to $448,000 for the year ended December 31, 2012, an increase of 68% compared to 2011. VIVIMIND™ is a natural health product designed to protect memory function. The Company currently has distribution agreements with partners in several countries, including Italy, Canada, Taiwan, Greece, certain countries in the Middle East, Israel and South Korea.

Summary of Financial Results

All currency figures reported in this press release are in Canadian dollars, unless otherwise specified. Comparative per share data for 2011 have been retrospectively adjusted to reflect the consolidation of the Company's common shares.

	Year ended December 31, 2012	Year ended December 31, 2011
	(in thousands of dollars, except per share data)
Revenues	2,298	3,066
Research and development expenses, net	(954)	(1,315)
General and administrative expenses	(4,961)	(3,543)
Finance income	1,272	13,254
Finance costs	(19,625)	(8,038)
Gain on sale of unrecognized assets	8,150	-
Other income	650	-
Net (loss) income	(13,170)	3,424
Net (loss) income attributable to owners of the Company	(13,255)	3,424
Basic (loss) earnings per share	(0.41)	0.39
Diluted loss per share	(0.41)	(0.19)

The Company's full consolidated financial statements and accompanying management's
discussion and analysis for the year ended December 31, 2012, will be available shortly on
SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

For the year ended December 31, 2012, net loss attributable to owners of the Company amounted to $13,255,000 ($0.41 per share), compared to a net income of $3,424,000 ($0.39 per share) for the previous year. The increase in net loss is primarily due to items recorded in relation to the strategic partnership, financing and capital reorganization in the second quarter of 2012, namely a non-cash loss on settlement of convertible securities in the amount of $15,751,000 (including the change in fair value of the embedded conversion option liability on the 2009 Notes), partially offset by a gain on sale of unrecognized assets in the amount of $8,150,000. In addition, results for the year ended December 31, 2011, included finance income in relation to the decrease in the fair value of the embedded conversion option liability on the 2009 Notes in the amount of $13,105,000.
Revenues amounted to $2,298,000 for the year ended December 31, 2012, compared to $3,066,000 for the previous year. The decrease is primarily due to lower revenue recognized for accounting purposes in relation to the agreements entered into with Celtic Therapeutics for the development of KIACTA™.
Research and development expenses, net of research tax credits and grants, amounted to $954,000 for the year ended December 31, 2012, compared to $1,315,000 for the previous year. The decrease is mainly attributable to a reduction in expenses incurred in relation to the BLU8499 Phase I clinical trial for the treatment of Alzheimer's disease, which ended in the first quarter of 2011, and a reduction in the workforce and other cost reduction initiatives in 2011.
General and administrative expenses amounted to $4,961,000 for the year ended December 31, 2012, compared to $3,543,000 for the previous year. The increase is due to transaction costs incurred in relation to the strategic partnership, financing and capital reorganization.
Finance income amounted to $1,272,000 for the year ended December 31, 2012, compared to $13,254,000 for the previous year. The decrease is mainly attributable to finance income recorded in 2011 in relation to the decrease in the fair value of the embedded conversion option liability on the 2009 Notes in the amount of $13,105,000, mainly attributable to the decrease in the Company's share price, partially offset by an increase in fair value of the New ABCP Notes in the amount of $1,135,000 recorded in 2012.
Finance costs amounted to $19,625,000 for the year ended December 31, 2012, compared to $8,038,000 for the previous year. The increase is primarily due to a non-cash loss on the settlement of convertible securities (including the change in fair value of the embedded conversion option liability on the 2009 Notes) in the amount of $15,751,000, recorded in relation to the strategic partnership, financing and capital reorganization, partially offset by a reduction in accretion expense as a result of the settlement of convertible securities, as part of the same transaction.
Gain on sale of unrecognized assets amounted to $8,150,000 for the year ended December 31, 2012 (nil for the previous year), in relation to the non-dilutive capital payment received from Pharmascience Inc., as part of the strategic partnership and financing in 2012.
Other income amounted to $650,000 for the year ended December 31, 2012 (nil for the previous year), and represents a milestone payment received from Advanced Orthomolecular Research Inc. (AOR) during the second quarter of 2012 in relation to AOR's acquisition of BELLUS Health's wholly-owned Canadian subsidiary, OVOS Natural Health Inc., in December 2010.

As at December 31, 2012, the Company had available cash, cash equivalents and short-term investments totalling $18.6 million.

About BELLUS Health

BELLUS Health is a development-focused healthcare company concentrating on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Celtic Therapeutics. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

About AA Amyloidosis

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 BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of KIACTA^TM Phase III Confirmatory Study is dependent upon many factors including clinical sites activation, patients' enrollment rate, patients' drop-out rate and occurrence of worsening events. 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 BELLUS Health Inc.'s public fillings including the Annual Information Form for further risk factors that might affect BELLUS Health Inc. and its business.

Adam Peeler
TMX Equicom
416-815-0700 ext. 225 | apeeler@equicomgroup.com

BELLUS Health Reports Results for Third Quarter Ended September 30, 2012, and Provides an Update on KIACTA(TM) Phase III Confirmatory Study

Thu, 08 Nov 2012 07:00:00 -0500

LAVAL, QC, Nov. 8, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today reported its financial results for the third quarter ended September 30, 2012.

Third Quarter 2012 Highlights

Recruitment continued for the Phase III Confirmatory Study for KIACTA™ for the treatment of AA amyloidosis, with more than 50% of patients recruited to date;
Entered into a partnership with Asclepios Bioresearch (UK) Limited that is expected to provide approximately $4 million for the development of BLU8499, BELLUS Health's drug candidate for the treatment of Alzheimer's disease;
Entered into a licence and distribution agreement with Lifenergy Biotech Corp. for VIVIMIND™ in Taiwan.

"The progress we made with our commercial and clinical assets during the third quarter further diversifies and strengthens BELLUS Health," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "While KIACTA™ remains the focal point of our product pipeline, we believe we can also create additional shareholder value by advancing BLU8499 and VIVIMIND™ in the coming quarters."

Phase III Confirmatory Study for KIACTA™ (eprodisate)

During the third quarter of 2012, recruitment continued for the Phase III Confirmatory Study for KIACTA™, for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. The study will involve approximately 230 patients enrolled from more than 70 sites and 25 countries worldwide.

As of November 8, 2012, there are 119 patients enrolled in the Phase III Confirmatory Study, and based on the current recruitment rate, it is expected that patient recruitment will be completed in the first half of 2014. As the Phase III Confirmatory Study is an event-driven study that will end when 120 events linked to deterioration of kidney function have occurred, it is currently expected that the study will reach 120 events in 2017. BELLUS Health is actively working with its partner Celtic Therapeutics Inc. (Celtic Therapeutics) to explore means and actions to accelerate both recruitment and study end. Celtic Therapeutics is funding 100% of the ongoing development costs of KIACTA™ including the Phase III Confirmatory Study and other related activities. The total cost of the development activities of KIACTA™is currently estimated to be in excess of US$50 million. Celtic Therapeutics and BELLUS Health are expected to share the overall proceeds from the future revenues of KIACTA™ approximately equally.

The Data Safety Monitoring Board, which independently assesses the safety of KIACTA™ throughout the Phase III Confirmatory Study, met for a second time on October 19, 2012, and based on its review, recommended to continue the study as per protocol.

BLU8499

During the third quarter of 2012, the Company entered into a partnership with Asclepios Bioresearch (UK) Limited (Asclepios) for the development of BLU8499 (formerly named NRM8499), BELLUS Health's drug candidate for the treatment of Alzheimer's disease. Under the terms of the agreement, Asclepios will fund all Phase IIa enabling activities and has committed to a second tranche of additional capital for the conduct of a Phase IIa clinical trial in mild Alzheimer's disease patients. The total investment and commitment by Asclepios towards the development of BLU8499 is expected to be approximately $4 million. Under the terms of the agreement, BELLUS Health will earn study management fees equal to 15% of direct development costs and will also be reimbursed for certain intellectual property costs. During the third quarter of 2012, the Company received a payment of $201,000. According to the agreement, it is expected that the two parties will share the overall proceeds from the future monetization of BLU8499 approximately equally.

The Phase IIa clinical trial is currently expected to be initiated in the first half of 2014. The trial is expected to focus on patients with mild Alzheimer's disease and an apoE4 positive genotype. BELLUS Health will form a joint steering committee with Asclepios to oversee the program's development efforts.

VIVIMIND™

In September 2012, BELLUS Health entered into a licence and distribution agreement with Lifenergy Biotech Corp. (Lifenegy), pursuant to which BELLUS Health granted Lifenergy exclusive distribution rights for VIVIMIND™ in Taiwan. Lifenergy expects to launch VIVIMIND™ in 2013.

VIVIMIND™ is a natural health product designed to protect memory function. The Company currently has distribution agreements with partners in several countries, including Italy, Canada, Taiwan, Greece, and certain countries in the Middle East.

Summary of Financial Results
All currency figures reported in this press release are in Canadian dollars, unless otherwise specified. Comparative per share data for 2011 have been retrospectively adjusted to reflect the consolidation of the Company's common shares.

	Three-months ended September 30, 2012	Three-months ended September 30, 2011
	(in thousands of dollars, except per share data)
Revenues	484	745
Research and development expenses, net	(223)	(185)
General and administrative expenses	(768)	(718)
Finance income	281	3,065
Finance costs	(60)	(2,662)
Net (loss) income	(286)	245
Net (loss) income attributable to owners of the Company	(256)	245
Basic (loss) earnings per share	(0.01)	0.03
Diluted loss per share	(0.01)	(0.06)

The Company's full consolidated financial statements and accompanying management's
discussion and analysis for the three- and nine-month periods ended September 30, 2012,
will be available shortly on SEDAR at www.sedar.com and on the Company's web site at
www.bellushealth.com.

For the three-month period ended September 30, 2012, net loss attributable to the owners of the Company amounted to $256,000 ($0.01 per share), compared to a net income of $245,000 ($0.03 per share) for the corresponding period the previous year. The increase in net loss in the current quarter is primarily due to lower revenue recognized for accounting purposes in relation to the agreements entered into with Celtic Therapeutics in 2010 for the development of KIACTA™.
Revenues amounted to $484,000 for the three-month period ended September 30, 2012, compared to $745,000 for the corresponding period the previous year. Revenues mainly consist of revenue from the asset sale and license agreement as well as the service agreement entered into with Celtic Therapeutics for KIACTA™. The decrease in revenues is primarily due to lower revenue recognized for accounting purposes, as described above.
Finance income amounted to $281,000 for the three-month period ended September 30, 2012, compared to $3,065,000 for the corresponding period the previous year. The decrease is mainly attributable to finance income in relation to the decrease in the fair value of the embedded conversion option liability on the 2009 Notes in the amount of $3,034,000 recorded in the three-month period ended September 30, 2011.
Finance costs amounted to $60,000 for the three-month period ended September 30, 2012, compared to $2,662,000 for the corresponding period the previous year. The decrease is primarily due to a reduction in accretion expense following the settlement of convertible instruments as part of the strategic partnership, financing and capital reorganization that occurred in the second quarter of 2012.

As at September 30, 2012, the Company had available cash and cash equivalents of $19.1 million.

About BELLUS Health

BELLUS Health is a development-focused healthcare company focusing on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Celtic Therapeutics. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

About AA Amyloidosis

Because patients diagnosed with AA amyloidosis tend to quickly progress to a costly regimen of dialysis, healthcare payers are anxious to find alternative treatments for this deadly condition. KIACTA™ has been granted Orphan Drug designation or its equivalent in the United States and Europe, which would provide seven and ten years of market exclusivity, respectively, as well as a reduction in application and review fees.

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 Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of KIACTA^TM Phase III Confirmatory Study is dependent upon many factors including clinical sites activation, patients enrollment rate, patients drop-out rate and occurrence of worsening events. 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 Company and its business.

Adam Peeler
TMX Equicom
416-815-0700 ext. 225 | apeeler@equicomgroup.com

BELLUS Health to Present at BioContact in Québec City

Mon, 01 Oct 2012 13:30:00 -0400

LAVAL, QC, Oct. 1, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today announced that its President and Chief Executive Officer Roberto Bellini will deliver a corporate presentation at BioContact Québec on Thursday, October 4^th at 2:30 pm EST.

The Bellus presentation, in the Salle Grande-Allée at Château Laurier, Québec, will focus on KIACTA™, the Company's lead novel drug candidate that is currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis.

The presentation will also feature information about Bellus' development partnerships, and other product candidates in its pipeline.

The presentation will not be webcast, however the accompanying slides will appear in the `Investors' section of Bellus' website.

About BELLUS Health (www.bellushealth.com)
BELLUS Health is a development-focused healthcare company focusing on products that provide innovative health solutions and address critical unmet medical needs. KIACTA™, the Company's lead program, is a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Celtic Therapeutics Inc. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

Adam Peeler
TMX Equicom
416-815-0700 ext. 225 | apeeler@tmxequicom.com

Raising Orphans – Biotechnology Focus

Mon, 01 Oct 2012 09:00:00 -0400

Bellus champions partnering with funds – BioTuesdays

Tue, 18 Sep 2012 09:00:00 -0400

BELLUS Health Announces Partnership for the Development of BLU8499

Tue, 04 Sep 2012 07:00:00 -0400

- Asclepios Bioresearch to fund Phase IIa study in Alzheimer's disease -

LAVAL, QC, Sept. 4, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today announced that it has entered into a partnership with Asclepios Bioresearch (UK) Limited ("Asclepios") for the clinical development of BLU8499 (formerly named NRM8499), BELLUS Health's drug candidate for the treatment of Alzheimer's disease. Under the terms of the agreement, Asclepios will fund all Phase IIa enabling activities immediately and has committed to a second tranche of additional capital for the conduct of a Phase IIa clinical trial in mild Alzheimer's disease patients. The total investment and commitment by Asclepios towards the development of BLU8499 is at least US $4 million.

"We are very happy to be working with Asclepios Bioresearch to pursue the development of BLU8499 into a proof of concept study," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "This collaboration allows us to use non-dilutive capital while retaining significant upside for our shareholders."

"Alzheimer's is a devastating disease that affects both patients and their families," said Simon Conder, Director of Asclepios. "We are excited to partner with the team at BELLUS Health to advance BLU8499 into a Phase IIa study and hope that this compound will make a difference in the lives of those affected by this condition."

The Phase IIa study is expected to be initiated in the second half of 2013. The trial will focus exclusively on Alzheimer's disease patients with an apoE4 positive genotype, which is the subgroup where the greatest level of treatment effect was seen in a previous Phase III study conducted with tramiprosate, the parent compound of BLU8499.

BELLUS Health will form a joint steering committee with Asclepios to oversee the program's development efforts. Under the terms of the agreement, BELLUS Health will earn study management fees equal to 15% of the capital invested by Asclepios over the life of the partnership. According to the agreement, it is expected that the two parties will share the overall proceeds from the future monetization of BLU8499 approximately equally.

About BLU8499
Formerly named NRM8499, BLU8499 is a prodrug of tramiprosate, a candidate for the treatment of Alzheimer's disease. In January 2011, BELLUS Health announced the results of the phase I clinical trial for BLU8499, which investigated the safety, tolerability and pharmacokinetic profile of BLU8499 as compared to tramiprosate in a group of 67 young and elderly healthy subjects. The phase I clinical trial data demonstrated that BLU8499 was safe and well tolerated at the intended therapeutic dose. Moreover, the gastrointestinal tolerability and pharmacokinetic profile of tramiprosate were meaningfully improved with BLU8499.

About Asclepios Bioresearch (www.abioresearch.com)
Asclepios Bioresearch, a life sciences company based in the city of London (UK), provides private equity, pharmaceutical advisory and capital raising services for early-mid stage pharmaceutical candidates, medical devices and diagnostic technologies. Asclepios Bioresearch's multi-talented team is driven by the objective to increase the value of meaningful and credible technologies that advance human science. Since its inception in October 2009, Asclepios Bioresearch has successfully fundraised in excess of $100 million to advance trials for a number of clinical-stage candidates for Alzheimer's disease, Type 2 Diabetes and chronic wound healing.

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 Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, 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 Company and its business.

BELLUS Health Reports Results for Second Quarter Ended June 30, 2012

Wed, 08 Aug 2012 07:00:00 -0400

LAVAL, QC, Aug. 8, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today reported its financial results for the second quarter ended June 30, 2012.

Second Quarter 2012 Highlights

Completed a $17.25 million strategic partnership and financing with Pharmascience Inc. (Pharmascience), including $8.15 million in non-dilutive capital and a $9.1 million investment for a 10.4% ownership stake;
Concluded the quarter with a cash position of $21.2 million as of June 30, 2012;
Settled all outstanding convertible securities principally through the issuance of common shares of the Company;
Consolidated its common shares on the basis of one new post-consolidation common share for every 30 pre-consolidation common shares;
Presented an update on the KIACTA™ Phase III Confirmatory Study at the XIII International Symposium on Amyloidosis. Preliminary, blinded data demonstrates that demographics and baseline characteristics are similar to BELLUS Health's previous Phase II/III study for KIACTA™ and also confirm an effective trial design based on the strong results of that first Phase II/III study;
Received a $0.65 million payment from Advanced Orthomolecular Research Inc. (AOR) in relation to AOR's exclusive license of VIVIMIND™ for Canada and acquisition of BELLUS Health's wholly-owned Canadian subsidiary, OVOS Natural Health Inc., in December 2010;
Entered into a licence and distribution agreement with LevPharm Ltd. (LevPharm), pursuant to which BELLUS Health granted LevPharm exclusive distribution rights for VIVIMIND™ in Israel.

"Our actions in the second quarter, particularly the closing of the partnership with Pharmascience, provide us with the financial stability to complete the Phase III program for KIACTA™," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "In addition, BELLUS Health now has the resources to pursue other opportunities to add to its promising pipeline."

BELLUS Health is developing KIACTA™ as a potential treatment for AA amyloidosis, a fatal condition that progresses from chronic inflammatory diseases such as rheumatoid arthritis. The disease causes a protein called amyloid A to accumulate in major organs, particularly the kidneys, which leads to organ dysfunction, failure and eventually death.

There is currently no available treatment for AA amyloidosis and it is estimated that approximately 35,000 to 50,000 patients are living with the disease in the United States, Europe and Japan. KIACTA™ has been granted Orphan Drug designation or its equivalent in the United States and Europe, which would provide seven and ten years of market exclusivity, respectively, as well as a reduction in application and review fees.

	Three-months ended June 30, 2012	Three-months ended June 30, 2011
	(in thousands of dollars, except per share data)
Revenues	706	719
Research and development expenses, net	(343)	(305)
General and administrative expenses	(1,880)	(789)
Finance income	95	4,310
Finance costs	(16,800)	(1,832)
Gain on sale of unrecognized assets	8,150	-
Other income	650	-
Net (loss) income	(9,422)	2,103
Basic (loss) earnings per share	(0.39)	0.23
Diluted loss per share	(0.39)	(0.04)

The Company's full consolidated financial statements and accompanying management's discussion and
analysis for the three- and six-month periods ended June 30, 2012, will be available shortly on SEDAR
at www.sedar.com and on the Company's web site at www.bellushealth.com.

For the three-month period ended June 30, 2012, net loss amounted to $9,422,000 ($0.39 per share), compared to net income of $2,103,000 ($0.23 per share) for the corresponding period the previous year. The increase in net loss is primarily due to items recorded in the current quarter in relation to the strategic partnership, financing and capital reorganization namely a non-cash loss on settlement of convertible securities, partially offset by a gain on sale of unrecognized assets.
General and administrative expenses amounted to $1,880,000 for the three-month period ended June 30, 2012, compared to $789,000 for the corresponding period the previous year. The increase is due to transaction costs incurred in relation to the strategic partnership, financing and capital reorganization.
Finance income amounted to $95,000 for the three-month period ended June 30, 2012, compared to $4,310,000 for the corresponding period the previous year. The decrease is mainly attributable to finance income recorded in relation to the decrease in the fair value of the embedded conversion option liability on the 2009 Notes in the amount of $4,247,000 for the three-month period ended June 30, 2011.
Finance costs amounted to $16,800,000 for the three-month period ended June 30, 2012, compared to $1,832,000 for the corresponding period the previous year. The increase is primarily due to a non-cash loss on settlement of convertible securities in the amount of $15,084,000 (including the change in fair value of the embedded conversion option liability on the 2009 Notes) recorded in relation to the strategic partnership, financing and capital reorganization.
Gain on sale of unrecognized assets amounted to $8,150,000 for the three-month period ended June 30, 2012 (nil for the corresponding period the previous year), in relation to the non-dilutive capital payment received from Pharmascience.
Other income amounted to $650,000 for the three-month period ended June 30, 2012 (nil for the corresponding period the previous year), and represents a milestone payment received from AOR during the current quarter in relation to the achievement of a pre-established milestone.

Phase III Confirmatory Study for KIACTA™ (eprodisate)

The international, randomized, double-blind, placebo-controlled, event-driven study will involve approximately 230 patients diagnosed with AA amyloidosis recruited from more than 70 sites in 28 countries worldwide. Recruitment is ongoing and is expected to be completed in the second half of 2013. The Phase III Confirmatory Study is an event-driven trial which will conclude when 120 patients have reached worsening events linked to deterioration of kidney function. The completion of the study is expected in the second half of 2015.

About BELLUS Health

BELLUS Health is a development-focused healthcare company focusing on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is a novel drug candidate KIACTA™, which is currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Celtic Therapeutics Inc. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

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 Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, 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 Company and its business.

BELLUS Health Receives Milestone Payment from Advanced Orthomolecular Research

Thu, 21 Jun 2012 14:00:00 -0400

LAVAL, QC, June 21, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today announced that it had received a $650,000 payment from Advanced Orthomolecular Research (AOR). This payment relates to the achievement of a pre-established milestone set when AOR acquired BELLUS Health's wholly-owned Canadian subsidiary OVOS Natural Health Inc. in January 2011.

"Over the next few years, BELLUS Health has the opportunity to earn more than $8 million in regulatory and commercial milestone payments based on the five VIVIMIND™ distribution partnerships signed to date," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "Combined with upfront and pre-agreed minimum payments estimated in excess of $2 million thus far, the financial impact of these arrangements is substantial. Our strategy for VIVIMIND™ is to continue building a substantial cashflow positive business through strategic distribution partners while we also focus our efforts on progressing and expanding our pharmaceutical development portfolio."

In January 2011, BELLUS Health and AOR entered into a share purchase agreement with respect to OVOS Natural Health Inc. Concurrently, the companies entered into a Canadian license and supply agreement ("License and Supply Agreement") relating to BELLUS Health's product VIVIMIND™. Pursuant to the License and Supply Agreement, BELLUS Health granted AOR exclusive distribution rights for VIVIMIND™ in Canada and agreed to supply AOR with the product at a pre-agreed transfer price. AOR is responsible for all marketing, distribution and sales activities of VIVIMIND™ in Canada. The License and Supply Agreement also provides for up to $3 million in commercial milestone payments to BELLUS Health should certain mutually agreed upon sales targets be achieved.

About VIVIMIND™

VIVIMIND™ is scientifically proven to help support the specific area of the brain known as the hippocampus, a region responsible for memory and learning. The active ingredient of VIVIMIND™, homotaurine, is a naturally occurring amino acid with unique properties found in certain seaweed. VIVIMIND™ is intended to be used in normal aging adults.

VIVIMIND™ was subject to over 15 years of significant scientific research. In a large controlled clinical study, VIVIMIND™ was shown to reduce by 68% the hippocampus volume loss in Alzheimer's disease patients over 18 months.¹Regulatory approvals for the commercial sale of VIVIMIND™ have been obtained in Italy, Spain, Canada and certain countries in the Middle East.

¹ Gauthier S. et al, Journal Nutrition Health Aging, 2009; 13 (6): 550-7.

About Advanced Orthomolecular Research (www.aor.ca)

AOR has an established reputation as the most advanced supplement formulator in Canada. AOR consistently puts science-backed vitamin supplements and natural health products into the hands of health practitioners and into the lives of patients, insisting on solid science and real-world outcomes. AOR's portfolio of products includes over 160 vitamin supplements and natural health products.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a development-focused healthcare company concentrating on products that provide innovative health solutions and address critical unmet medical needs. The Company, in collaboration with its partner, Celtic Therapeutics Inc., is currently advancing its novel drug candidate KIACTA™, through a Phase III trial for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and eventually death. AA amyloidosis affects approximately 50,000 individuals in the United States, Europe and Japan.