BELLUS Health Out-Licenses VIVIMIND, BLU8499 and Its Analogs
-VIVIMIND Rights Licensed to Specialty Pharma FB Health-
-BLU8499 and Tramiprosate Analog Platform Rights Licensed to Alzheon, Inc., a U.S. Biotechnology Company Focused on Alzheimer's Disease-
LAVAL, QC, Oct. 23, 2013 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a drug development company focused on rare diseases, today announced the divestiture of two non-core assets: VIVIMIND™, a natural health product for memory protection, and BLU8499, a drug candidate for the treatment of CNS diseases including Alzheimer's disease.
"VIVIMIND™ and BLU8499 are being divested to knowledgeable partners who can increase the potential of creating value for BELLUS Health's shareholders," said Roberto Bellini, Chief Executive Officer of BELLUS Health. "This transaction also allows us to focus entirely on the development of drugs for rare diseases, including KIACTA™ for AA amyloidosis, which is currently in a Phase 3 confirmatory study, and Shigamabs™, a clinical-stage product for the treatment of STEC-related Hemolytic Uremic Syndrome."
As part of the transactions, BELLUS Health will receive a cash consideration from FB Health, an equity stake in FB Health as well as royalties and a share of BLU8499 revenues from Alzheon.
As part of the transaction, BELLUS Health has licensed the worldwide rights to VIVIMIND™ to FB Health S.p.A. ("FB Health") for a cash consideration of more than $2 million representing a premium of four times VIVIMIND™ revenues generated in 2012. The consideration is to be paid over the next four years.
FB Health is an Italy-based distributor of specialty nutraceutical and pharmaceutical products targeting neurologists and geriatricians. FB Health has distributed VIVIMIND™ since 2010 and currently represents a majority of BELLUS Health's VIVIMIND™ revenues.
VIVIMIND™ is a natural health product for memory protection. It is currently being distributed by seven partners covering 17 countries.
BLU8499 and Tramiprosate Analog Platform Transaction
Alzheon, Inc. ("Alzheon") of Lexington, Massachusetts, USA, has entered into a worldwide license agreement for BLU8499 and a family of analogs, along with an associated platform of chemotypes and clinical datasets. BELLUS Health will receive a portion of all future payments received by Alzheon related to BLU8499 and royalties on net sales of BLU8499. Further terms of the license agreement are not disclosed.
"We believe that placing BLU8499 and the tramiprosate analog platform in the hands of a proven and experienced Alzheimer's drug development team at Alzheon will enable BELLUS Health to realize the full potential of this therapeutic asset and give us the option to derive significant future value," continued Roberto Bellini, Chief Executive Officer of BELLUS Health.
Alzheon is a clinical-stage biotechnology company focused on brain health, memory and aging, developing the next generation of medicines for Alzheimer's and other neurodegenerative diseases. Alzheon was founded in 2013 by Martin Tolar, MD, PhD. Previously, Dr. Tolar has held a number of executive positions in life sciences companies, where he has established and grown new companies, business areas and product opportunities. Most recently he served as President and CEO of Knome, Inc., President and CEO of NormOxys, Inc. and Chief Business Officer of CoMentis, Inc.
"We believe that BLU8499 is a very promising drug candidate for the treatment of Alzheimer's disease," said Dr. Martin Tolar, Chief Executive Officer of Alzheon. "Having completed a Phase 1 clinical study, we are excited to pursue the development of BLU8499, to be named ALZ-801, into a Phase 2 proof-of-concept study in patients with Alzheimer's disease, guided by the existing clinical data and subpopulation analyses in more than 2,000 Alzheimer's patients from Phase 3 studies conducted by BELLUS Health and its predecessor Neurochem, Inc."
As part of the agreements signed today, BELLUS Health has also terminated its agreement with Asclepios Bioresearch to develop BLU8499.
Related Party Transactions
FB Health is a company controlled by Dr. Francesco Bellini, the Chairman of the Board of Directors of BELLUS Health. Alzheon is a company controlled by Dr. Martin Tolar, a member of the Board of Directors of BELLUS Health.
An independent committee of the BELLUS Health Board of Directors was put in place to review and consider the transactions. The independent committee was formed of independent members of the BELLUS Health Board of Directors. It was chaired by Mr. Charles Cavell and also included Mr. Donald Olds and Mr. Pierre Larochelle. The independent committee found the transactions fair and unanimously recommended their approval to the BELLUS Health Board of Directors, which voted unanimously in favour of the transactions, excluding Dr. Bellini and Dr. Tolar who declared their interest and recused themselves.
The transactions may be considered to be "related party transactions" under Canadian securities laws. However, the transactions are exempt from the valuation and minority approval requirements provided under such laws, since the fair market value thereof, individually or in the aggregate, is less than 25 percent of the market capitalization of BELLUS Health. A material change report could not be filed earlier since the transactions had not yet been approved by the Board of Directors of BELLUS Health.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is developing a portfolio of drugs for rare diseases including Kiacta in Phase III for AA Amyloidosis and clinical stage Shigamabs for STEC-related Hemolytic Uremic Syndrome (sHUS). The Company's 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 FB Health (www.fb-health.com)
FB Health is an Italy-based specialty pharmaceutical company engaged in the commercialization of innovative products for the prevention and treatment of pathologies affecting elderly people, with a focus on neurology and geriatrics. FB Health's commitment to address elderly people's particular needs is embedded in its culture and reflected in activities undertaken by the company, from strategic development to operations.
About Alzheon (www.alzheon.com)
Alzheon Inc. is a clinical-stage biotechnology company focused on brain health, memory and aging, developing innovative treatments for Alzheimer's disease and other neurodegenerative disorders. Alzheon pursues drug development programs that have previously been tested in extensive efficacy studies in Alzheimer's disease patients and where new insights can be applied. Based on a drug development platform that yields diverse and novel compounds, the company is building a pipeline of innovative drugs to target the underlying pathogenesis of neurodegeneration in order to improve symptoms and slow the progression in these devastating disorders. Alzheon has world-leading capabilities in drug development for Alzheimer's and related diseases, and we apply state-of-the-art clinical development approaches to improve the likelihood of success with product candidates in our pipeline as well as additional therapeutic assets from in-licensing. Alzheon is located in Lexington, Massachussetts, USA. For more information, please visit www.alzheon.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 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, 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 KIACTATM 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.
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