Biogen and AbbVie Receive Health Canada Approval of Once-Monthly ZINBRYTA™ (Daclizumab Beta) for Multiple Sclerosis

Approval Supported by Largest and Longest Head-to-Head Global Phase 3 Study Conducted in Multiple Sclerosis (MS)

ZINBRYTA™ Significantly Reduced Multiple Measures of Disease Activity in Patients with Relapsing Remitting MS

MISSISSAUGA, ON and MONTREAL, Dec. 9, 2016 /CNW/ - Health Canada has approved ZINBRYTA™ (daclizumab beta), a new once-monthly, self-administered, subcutaneous treatment for adult patients with active relapsing remitting multiple sclerosis (RRMS), who have had an inadequate response to, or are unable to tolerate, one or more therapies indicated for the treatment of multiple sclerosis, Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today.  

"ZINBRYTA™ is the first once-monthly, self-administered treatment for MS, and it demonstrated superior efficacy over a widely used interferon. Clinical data showed ZINBRYTA™ significantly reduced relapses and brain lesions for up to three years compared to AVONEX^® (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring," said Lisa Hickey, Vice President and Managing Director at Biogen Canada Inc. "Not only does the Health Canada approval reflect our long-term commitment to our patients, it provides people living with MS a further treatment choice to meet their diverse and evolving needs."

The Health Canada approval of ZINBRYTA™ is based on results from two clinical trials, including DECIDE, the largest and longest head-to-head global Phase 3 clinical trial conducted in MS. The Phase 2b SELECT and Phase 3 DECIDE studies were global, randomized, double-blind, controlled studies that involved approximately 2,400 people living with relapsing MS. Some patients in DECIDE were treated for up to three years.

In DECIDE and SELECT, ZINBRYTA™ significantly reduced the annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to AVONEX^® up to 144 weeks and by 54 percent compared to placebo at 52 weeks (both p<0.0001), respectively.

Results from DECIDE showed that ZINBRYTA™ demonstrated superior efficacy across multiple measures of MS disease activity (relapses and MRI) compared to AVONEX^®, including a significant reduction in the mean number of new or newly enlarging T2-hyperintense lesions by 54 percent compared to AVONEX^® at 96 weeks (p<0.0001).

The ZINBRYTA™ Product Monograph includes a Serious Warnings and Precautions box for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders such as skin reactions, lymphadenopathy, autoimmune hemolytic anemia and gastrointestinal disorders can occur in patients treated with ZINBRYTA™.¹  Because of these risks, access to ZINBRYTA™ in Canada is available through a controlled distribution program called Biogen ONE^® Support Program.  Only prescribers and pharmacies registered with the program are able to prescribe and dispense ZINBRYTA™.  In addition, ZINBRYTA™ can only be dispensed to patients who are registered in the Biogen ONE^® Support Program. Patients will be informed about the risks of ZINBRYTA™ and how to meet the conditions of the Biogen ONE^® Support Program, including compliance with monthly monitoring and assessment of liver enzymes before the next dose of ZINBRYTA™.

"MS affects each person differently, so having additional therapeutic options to address their needs throughout the course of this long term disease is very important news," said Marcelo Kremenchutzky, MD, FRCPC, FAAN, Chapman Chair in MS Clinical Research at London Health Sciences Centre and Associate Professor in Neurology at Western University, London, Ontario. "Daclizumab beta provides a meaningful new option for the treatment of people with MS, with demonstrated efficacy and convenient once-monthly dosing." 

ZINBRYTA™ is thought to work differently from other disease-modifying therapies by binding to CD25, a subunit of the interleukin-2 (IL-2) receptor found on activated lymphocytes, cells believed to underlie the biology of MS. Total lymphocyte, T and B cell counts decreased less than 10 percent from baseline during the first year of treatment. The effects on total lymphocyte counts returned to baseline within approximately eight to 12 weeks after the last dose of ZINBRYTA™.

"ZINBRYTA™ has a different target in the immune system compared to other MS therapies," said Dr. Marcelo Kremenchutzky. "ZINBRYTA™ provides both patients and clinicians an additional and distinct treatment option to consider. Having options is critical when the course of MS can be so different from patient to patient." 

The most common adverse reactions (incidence at least 1 percent higher incidence than comparator) that occurred in ZINBRYTA™-treated patients were nasopharyngitis (inflammation of the nose and a part of the throat), upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal (part of the throat) pain, bronchitis, eczema, and lymphadenopathy (enlargement of the lymph nodes) compared with AVONEX^®; and upper respiratory tract infection, depression, rash, pharyngitis (inflammation of part of the throat), and increased alanine aminotransferase (ALT; a type of liver enzyme) compared with placebo. The Canadian ZINBRYTA™ Product Monograph also includes warnings and precautions for hepatic injury, immune-mediated disorders, acute hypersensitivity (inflammatory reaction), infections, depression and suicide.¹ 

For more information on ZINBRYTA™, please consult the Canadian Product Monograph at www.biogen.ca. 

About the DECIDE Study
DECIDE was a two- to three-year, Phase 3, global, randomized, double-blind, multicenter study in patients with relapsing forms of multiple sclerosis (MS) designed to determine if ZINBRYTA™ would provide superior outcomes for certain clinical endpoints compared to treatment with AVONEX^® (interferon beta-1a) 30 mcg intramuscular (IM) injection. DECIDE was an active comparator study with two groups: 150 mg of subcutaneous (SC) ZINBRYTA™ every four weeks (n=919) was compared to AVONEX^® IM once weekly (n=922).

About the SELECT Study
SELECT was a multicenter, randomized, double-blind, Phase 2b study that evaluated the efficacy and safety of ZINBRYTA™ 150 mg (n=208) and 300 mg (n=209) subcutaneous every four weeks for one year versus placebo (n=204) in patients with relapsing remitting MS.

About ZINBRYTA™ (daclizumab beta)
ZINBRYTA™ is being developed globally for relapsing forms of multiple sclerosis (MS).  In Canada, ZINBRYTA™ is indicated for the treatment of adult patients with active relapsing remitting multiple sclerosis (RRMS) who have had an inadequate response to, or are unable to tolerate, one or more therapies indicated for the treatment of multiple sclerosis.   

The recommended dosage of ZINBRYTA™ is 150 mg, self-administered subcutaneously on a monthly basis. The U.S. Food and Drug Administration  (FDA) and European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the Australian Therapeutic Goods Administration (TGA) recently granted approval for ZINBRYTA™.  ZINBRYTA™ is also currently under regulatory review in Switzerland.

In clinical trials, ZINBRYTA™ demonstrated superior efficacy in reduction of annualized relapse rate and certain MRI endpoints, key measures of MS disease activity, compared to AVONEX^® (interferon beta-1a) IM injection and placebo.

ZINBRYTA™ is a humanized IgG1 monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25). CD25 is expressed at high levels on T-cells that become activated in people with MS.

The Canadian ZINBRYTA™ Product Monograph includes a Serious Warnings and Precautions box for a risk of hepatic injury including autoimmune hepatitis.¹ It also includes warnings and precautions for hepatic injury, immune-mediated disorders, acute hypersensitivity, depression and suicide, infections, vaccinations, and monitoring and laboratory tests.  The most common adverse reactions (incidence at least 5 percent and at least 2 percent higher incidence than comparator) that occurred in ZINBRYTA™-treated patients were nasopharyngitis, upper respiratory tract infection, rash, influenza, diarrhea oropharyngeal pain, back pain, arthralgia, bronchitis, oral herpes, dizziness, and lymphadenopathy compared with AVONEX^®; and upper respiratory tract infection,depression, rash, pharyngitis, and increased alanine aminotransferase (ALT) compared with placebo.

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves. Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. The progression, severity and specific symptoms of MS are unpredictable and vary from one person to another.² MS affects more than 2.3 million people worldwide³ and an estimated 100,000 Canadians.⁴ Relapsing MS is the most common form of the disease, accounting for 85 percent of cases, and is characterized by clearly defined acute attacks followed by partial or full recovery.⁵

Patient Support
As part of the companies' ongoing commitment to people living with MS, extra support will be provided through the Biogen ONE^® Support Program to patients being prescribed ZINBRYTA™.  

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world's oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis therapies. For more information, please visit www.biogen.ca. Follow us on Twitter.

Biogen Safe Harbor
This press release includes forward-looking statements, including statements about the potential therapeutic effects and benefits of ZINBRYTA™. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will," and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in commercialization of ZINBRYTA™, which may be impacted by, among other things, slower than anticipated acceptance of ZINBRYTA™ by patients and the medical community, competition in the MS market, the effectiveness of sales and marketing efforts, problems with the manufacturing process for ZINBRYTA™, the occurrence of adverse safety events, difficulties in obtaining or changes in the availability of reimbursement for ZINBRYTA™ and Biogen's other MS products, failure to obtain regulatory approvals in other jurisdictions, failure to protect intellectual property and other proprietary rights, product liability claims, third party collaboration risks, and the other risks and uncertainties that are described in the Risk Factors section of Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements speak only as of the date of this press release and Biogen assumes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @AbbVie on Twitter or view our Facebook and LinkedIn pages.

AbbVie Forward-Looking Statements 
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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¹ ZINBRYTA™ Product Monograph, December 8, 2016.
² National Multiple Sclerosis Society (NMSS). What is MS? Date accessed: May 27, 2016. http://www.nationalmssociety.org/What-is-MS.
³ NMSS. Who Gets MS? (Epidemiology). Date accessed: May 27, 2016.  http://www.nationalmssociety.org/What-is-MS/Who-Gets-MS.
⁴ Multiple Sclerosis Society of Canada.  What is MS? Date accessed: Nov 30, 2016. https://mssociety.ca/about-ms/what-is-ms.
⁵ NMSS. Types of MS. Date accessed: May 27, 2016. http://www.nationalmssociety.org/What-is-MS/Types-of-MS.

SOURCE Biogen

MEDIA CONTACT: Biogen: Philipp Epsworth, Ph: [phone], [email protected]; AbbVie: Jillian Griffin, Ph: [phone], [email protected]; INVESTOR CONTACT: Biogen: Mike Hencke, Ph: [phone], [email protected]; AbbVie: Liz Shea, Ph: [phone], [email protected]