- Also announces voting results from Annual Meeting of Shareholders -
LAVAL, QC, May 7, 2014 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a drug development company focused on rare diseases, today reported its financial and operating results for the first quarter ended March 31, 2014.
- Recruitment nearly completed for Phase III Confirmatory Study for KIACTA™ for the treatment of AA amyloidosis, with 227 patients out of 230 recruited as of April 28, 2014;
- KIACTA™ Phase III Confirmatory Study on track to conclude in 2016. As of April 28, 2014, 55 patients out of 120 have experienced an event linked to the deterioration of kidney function;
- Recommendation of the Data and Safety Monitoring Board to continue KIACTA™ Phase III Confirmatory Study as per protocol, based on last review on April 15, 2014;
- Initiated Shigamab™'s proof-of-concept testing for treatment of sHUS in mouse and primate models;
- Concluded the quarter with a cash position of $14.0 million, which should enable the Company to finance its operations beyond the end of the Phase III Confirmatory Study for KIACTA™.
- Subsequent to quarter end, announced an amendment to the KIACTA™ asset sale and license agreement in relation to the share of proceeds from a potential divestiture of KIACTA™. In addition, BELLUS Health's clinical development partner, Auven Therapeutics, hired Lazard as a financial advisor to explore sale of KIACTA™. This new direction and amended agreement provide more flexibility to divest KIACTA™ at the most opportune moment for stakeholders, whether that proves to be this year or after the conclusion of the KIACTA™ Phase III Confirmatory Study;
- Subsequent to quarter end, announced that Auven Therapeutics entered into a license agreement with Mount Sinai Hospital for the development of KIACTA™ in sarcoidosis, a rare inflammatory condition that affects the lungs.
"Recruitment for the Phase III study that is evaluating KIACTA™ as a potentially safe and efficacious treatment for AA amyloidosis is almost complete, and this rare disease asset is now also moving forward into a Phase II study for sarcoidosis," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "In the coming quarters, we will maintain our focus on advancing our pipeline of rare disease projects towards greater shareholder value-creating events."
Phase III Confirmatory Study for KIACTA™
Recruitment for the KIACTA™ Phase III Confirmatory Study is on track with target, and it is expected that it will be completed in the second quarter of 2014. On April 28, 2014, Auven Therapeutics and Company presented an update on the study's progress at the XIVth International Symposium on Amyloidosis in Indianapolis. It was announced that as of that date, the Phase III Confirmatory Study had enrolled 227 patients, and that 55 patients have had an event. Based on the current recruitment and event rates, the KIACTA™ Phase III Confirmatory Study is expected to conclude in 2016.
The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis. The Phase III Confirmatory Study is the last key step before applications for regulatory approval for KIACTA™ can be filed. The study is expected to enroll approximately 230 patients from more than 70 sites and 30 countries worldwide.
The Phase III Confirmatory Study is an event-driven trial which will conclude when 120 patients have experienced an event linked to deterioration of kidney function. An event is counted when a patient's kidney function has deteriorated as measured by a persistent 80 per cent increase in serum creatinine, a persistent 40 percent decrease in creatinine clearance or reaching end stage renal disease.
KIACTA™ is partnered with global private equity firm Auven Therapeutics. Auven Therapeutics is conducting the KIACTA™ study and funding 100% of the development costs of KIACTA™, including the Phase III Confirmatory Study and other related activities, which total costs are currently estimated to be in excess of US$50 million.
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 15, 2014, the DSMB recommended that the study continue as per protocol.
Patients completing the Phase III Confirmatory Study will be offered to continue in an extended program, for which the first patients are expected to be enrolled in the coming weeks.
Amendment to the KIACTA™ asset sale and license agreement
Earlier today, Auven Therapeutics and BELLUS Health announced that they have agreed upon modified terms to the KIACTA™ asset sale and license agreement in relation to the share of proceeds from a potential divestiture of KIACTA™, particularly in the now-envisaged scenario of a KIACTA™ sale before the completion of its Phase III study. Assuming that total divestiture transaction proceeds reach a pre-determined threshold, the parties will share aggregate proceeds equally. Auven Therapeutics retains certain preference rights on exit proceeds related to Auven Therapeutics' aggregate investment in KIACTA™ up to the date of the sale.
Engagement of financial advisor to explore the sale of KIACTA™
Earlier today, Auven Therapeutics and BELLUS Health announced that Auven Therapeutics has engaged Lazard as financial advisor to explore the sale of KIACTA™. As the Phase III KIACTA™ study in AA Amyloidosis nears completion of its enrollment, it was determined that a potential sale prior to the completion of the study would provide the acquirer with the opportunity to have input into the regulatory process for approval of KIACTA™ worldwide, and would facilitate the manufacturing, marketing and sales preparations for a global launch of the drug.
License Agreement with Mount Sinai for KIACTATM in Sarcoidosis
On May 2, 2014, Auven Therapeutics and BELLUS Health announced that Auven Therapeutics has entered into a license agreement with Icahn School of Medicine at Mount Sinai Hospital, New York, under which Auven Therapeutics obtained rights to develop KIACTA™ (eprodisate) as a treatment for chronic sarcoidosis.
Auven Therapeutics intends to conduct a Phase II (proof-of-concept) clinical trial to evaluate KIACTA™'s effectiveness and safety to treat certain medical manifestations of sarcoidosis. Auven Therapeutics expects to finalize a study protocol by mid-year and anticipates that the trial will start dosing patients in the fourth quarter of 2014. The Phase II trial is expected to be completed within approximately 18 months of the time the first patient is enrolled. All costs in relation to the development of KIACTA™ in sarcoidosis will be borne by Auven Therapeutics. Proceeds from potential future revenue of KIACTA™, including the rights to KIACTA™ for sarcoidosis, are subject to the proceeds sharing agreement between Auven Therapeutics and BELLUS Health.
Sarcoidosis is a rare condition that causes small patches of red and swollen tissue - called granulomas - that can develop in multiple organs in the body, but mostly in the lungs and skin. The disease affects approximately 120,000 patients in the US alone and identification of an effective treatment is a major unmet medical need. Most patients with sarcoidosis recover, but approximately 30% develop chronic, debilitating disease. Mortality occurs in 1-5% of patients. There is no cure for sarcoidosis, and treatment options are limited and can have serious adverse effects. Obtaining the rights to move KIACTA™ into a second indication further expands its commercial potential and may help patients with this sometimes debilitating chronic disease.
Shigamab™'s proof of concept testing for treatment of sHUS in mouse and primate models is currently underway. Once completed, the Company then intends to meet with regulators to agree on a development plan and seek a partner to pursue the development of Shigamab™.
Shigamab™ is a monoclonal antibody therapy being developed for the treatment of Hemolytic Uremic Syndrome related to Shiga toxin-producing E. coli ("STEC") bacterial infections ("sHUS"), which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children.
Summary of Financial Results
All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.
| Three months ended
March 31, 2014
| Three months ended
March 31, 2013
|(in thousands of dollars, except per share data)|
|Research and development expenses||(464)||(395)|
|General and administrative expenses||(890)||(966)|
|Net loss attributable to owners of the Company||(680)||(537)|
|Basic and diluted loss per share||(0.01)||(0.01)|
The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three-month period ended March 31, 2014, 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, 2014, net loss attributable to owners of the Company amounted to $680,000 ($0.01 per share), compared to $537,000 ($0.01 per share) for the corresponding period the previous year. The increase in net loss is primarily due lower revenue recorded in the current quarter compared to the corresponding quarter the previous year, mainly in relation to VIVIMIND™.
- Research and development expenses amounted to $464,000 for the three-month period ended March 31, 2014, compared to $395,000 for the corresponding period the previous year. The increase is mainly attributable to expenses incurred in relation to the development of Shigamab™, which drug candidate was acquired through the acquisition of Thallion Pharmaceuticals Inc. in August 2013.
- General and administrative expenses amounted to $890,000 for the three-month period ended March 31, 2014, compared to $966,000 for the corresponding period the previous year. The decrease is mainly attributable to an expense reduction in relation to VIVIMIND™ operations following its divestiture in October 2013.
As at March 31, 2014, the Company had available cash, cash equivalents and short-term investments totalling $14,031,000, compared to $15,297,000 as at December 31, 2013. Based on management's estimate, the current cash position should enable the Company to finance its operations beyond the end of the KIACTA™ Phase III Confirmatory Study.
BELLUS Health Announces Election of Directors and Independent Auditor at Annual Meeting
Each director nominee listed in the Management Information Circular dated March 18, 2014 was elected as Director of the Company during the Annual Meeting of the Holders of Common Shares held today in Laval, Quebec.
The details of the election are as follows:
|Director Nominee||Outcome||Votes For||% For|| Votes
|Dr. Francesco Bellini, O.C.||Elected||33,406,645||99.95%||16,634||0.05%|
|Franklin M. Berger||Elected||33,381,852||99.88%||41,427||0.12%|
|Hélène F. Fortin||Elected||33,374,759||99.85%||48,520||0.15%|
|Dr. Martin Tolar||Elected||33,390,656||99.90%||32,623||0.10%|
The results of the final votes regarding all matters subject to a vote during the Annual Meeting that took place 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.
BELLUS Health Announces Renewal of Stock Option Plan at Annual Meeting
In addition, all unallocated options under the Stock Option Plan of BELLUS Health were approved, and the Company was granted the ability to continue granting options under the Stock Option Plan until May 7, 2017.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a drug development company focused on rare diseases. It has a portfolio of rare disease projects including KIACTA™ in Phase III for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage ShigamabTM for sHUS and a research-stage project for AL amyloidosis. The lead program KIACTA™ 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 Auven Therapeutics.
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. A recent commercial assessment study conducted for Auven Therapeutics and BELLUS Health indicated that there are approximately 13,000 diagnosed and addressable patients with AA Amyloidosis worldwide, of which an estimated 10,300 are in the U.S. and the EU5.
KIACTA™ has been granted Orphan Drug designation or its equivalent in the United States, Europe and Japan, which provide seven, ten 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 industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments in relation to indemnity agreements, 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 the KIACTATM Phase III Confirmatory Study is dependent upon many factors, including clinical sites activation, patient enrollment rate, patient drop-out rate and occurrence of clinical endpoint events, and the sharing of proceeds between Auven Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ is dependent upon a number of factors, including the quantum of proceeds. 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.
SOURCE: BELLUS Health Inc.
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