Pharmaceutical

Approval is based on the Phase 3 KEYNOTE-716 Trial

Melanoma is the most serious of all skin cancers, with over 5,000 Canadians diagnosed each year. 1,2

Merck (NYSE: MRK), known as MSD outside the United States and Canada announced that Health Canada has granted approval for KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. 3 This approval is based on the results from the Phase 3 KEYNOTE-716 trial, which demonstrated a statistically significant improvement in recurrence-free survival (RFS). 3

Merck Canada (CNW Group/Merck Canada)

In 2022, an estimated 9,000 Canadians will be diagnosed with melanoma, 4 a form of cancer that takes place when melanocytes, the cells responsible for melanin production, start to grow uncontrollably and develop into a tumour. 5 Although it is the least common of all skin cancers, melanoma is the most serious type and early diagnosis and treatment are critical. 1 , 5

"We welcome the news of a new treatment option for Canadians living with this disease as the incidence of melanoma continues to rise across the country," 6 , 8 said Kathy Barnard , Founder/President of Save Your Skin Foundation. "Having options available right after surgery can help take action against a disease that moves quickly if not caught."

"Melanoma can affect anyone, including children, for whom, although rare, this is the most common amongst pediatric skin cancer types," 7 said Falyn Katz , Executive Director, Melanoma Canada. "Having options available, like this one, can help to make a difference for Canadians facing this particular type of skin cancer, helping them navigate the disease."

About KEYNOTE-716 Trial
Health Canada's approval is based on findings from KEYNOTE-716, a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients (n=976) with completely resected stage IIB or IIC melanoma. 3 Only patients that had not been previously treated for melanoma beyond complete surgical resection for their melanoma prior to study entry were included in the trial. 3 Patients were randomized to KEYTRUDA ® 200 mg or the pediatric (≥12 years old) dose of KEYTRUDA ® 2 mg/kg intravenously (up to a maximum of 200 mg) every three weeks (n=487) or placebo (n=489) for up to one year until disease recurrence or unacceptable toxicity. 3 The primary efficacy outcome was investigator-assessed recurrence-free survival (RFS). RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first. 3

The results of KEYNOTE-716 demonstrated a statistically significant improvement in RFS for patients randomized to receive KEYTRUDA ® compared with patients randomized to placebo at the first pre-specified interim analysis. 3 At the time of median follow-up (14.3 months), 11% (n=54/487) of patients who received KEYTRUDA ® had a recurrence or died compared to 17% (n=82/489) of patients who received placebo.

In the study, the safety profile of KEYTRUDA ® was consistent with previously reported studies in patients with solid tumors. The most common treatment-related adverse events (reported in at least 15% of patients) were pruritis, fatigue, diarrhea, and rash. KEYTRUDA ® was discontinued for treatment-related adverse events in 15% of patients in KEYNOTE-716. Refer to the product monograph for complete information. 3

"This approval is important for people living with melanoma and for all of us at Merck," said Marwan Akar , President, and Managing Director, Merck Canada. "With this new indication, KEYTRUDA ® is the first checkpoint inhibitor approved in Canada in the adjuvant space in Stage IIB or IIC melanoma, meaning it can be considered for patients earlier in their journey. We are proud to continue to pursue our passion to save and improve lives as well as reinforce our commitment to finding innovative and effective options for more patients with melanoma."

About Melanoma
Melanoma is a form of skin cancer that starts in the melanocyte cells of the skin. 5 Although less common than other forms of skin cancer, melanoma is the most serious type. 5 Incidences of melanoma are higher in men than in women, and the risk tends to increase with age. 8 Major causes include chronic exposure to ultraviolet radiation from sunlight or other artificial sources. 1

About KEYTRUDA ®
KEYTRUDA ® is an anti-PD-1 therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells. 3 KEYTRUDA ® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. 3

KEYTRUDA ® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma. 3

Our Focus on Cancer
Our goal is to translate progressive science into innovative oncology medicines to help people with cancer worldwide. At Merck Canada, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in oncology, and we are accelerating every step in the journey — from lab to clinic — to potentially bring new hope to people with cancer.

About Merck
At Merck, known as MSD outside of the United States and Canada , we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information about our operations in Canada , visit www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.

Forward-Looking Statement of Merck & Co. Inc., Rahway, NJ , USA
This news release of Merck & Co., Inc., Rahway, N.J. , USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2021 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Please see the product monograph for KEYTRUDA ® (pembrolizumab) at: https://www.merck.ca/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf

References

__________________________________

1 Canadian Skin Cancer Foundation. Malignant Melanoma. Taken from: https://www.canadianskincancerfoundation.com/skin-cancer/malignant-melanoma/ . Accessed on July 7, 2022.
2 Canadian Skin Cancer Foundation. Skin Cancer. Taken from: https://www.canadianskincancerfoundation.com/skin-cancer/ . Accessed on July 8, 2022.
3 KEYTRUDA ® Product Monograph. Merck Canada Inc. Updated August 18, 2022. Available at: https://www.merck.ca/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf
4 Canadian Cancer Society. Melanoma Skin Cancer Statistics. Taken from: https://cancer.ca/en/cancer-information/cancer-types/skin-melanoma/statistics . Accessed on July 7, 2022.
5 Government of Canada . Melanoma Skin Cancer. Taken from: https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/melanoma-skin-cancer.html . Accessed on July 7, 2022.
6 Conte et al. Population-Based Study Detailing Cutaneous Melanoma Incidence and Mortality Trends in Canada. Taken from: https://www.frontiersin.org/articles/10.3389/fmed.2022.830254/full . Accessed on July 7, 2022.
7 St. Jude Children's Research Hospital. Melanoma. Taken from: https://www.stjude.org/disease/melanoma.html . Accessed on July 7, 2022.
8 Canadian Cancer Society. Risk Factors for Melanoma Skin Cancer . Taken from: https://cancer.ca/en/cancer-information/cancer-types/skin-melanoma/risks . Accessed on July 7, 2022.

®Merck Sharp & Dohme LLC, used under license.

SOURCE Merck Canada

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Albert Labs International Corp. ( Albert Labs (CSE: ABRT) (FSE: VB50), the "Company"), a pharmaceutical drug development company focused on gaining regulatory approval for novel medicines to treat various mental health conditions, signs a Letter of Intent (LOI) with full-service Contract-Research Organisation (CRO), iNGENū, to carry out the Company's first in-human study of its primary drug target, KRN-101.

Albert Labs Inc. logo (CNW Group/Albert Labs International Corp.)

This randomised, double-blind study will evaluate the safety and tolerability of KRN-101 in study participants and determine its full pharmacokinetic characterization. As a unique, natural medicine containing a range of bioactives, KRN-101 is required to have its own pharmacokinetic profile despite an extensive background of safety data to support psilocybin-based medicines. Profiling KRN-101 through this study will allow the Company to reap the long-term potential of having a differentiated product through extensive opportunities for intellectual property protection.

This study will take place in Melbourne, Australia , and including the collection of all clinical outputs, will be carried out over 8 weeks with an expected completion in Q3 2023. Upon completion, KRN-101 will be available for use in late-stage clinical trials, allowing the Company to proceed with its Real World Evidence trial in the United Kingdom , which will establish the efficacy of the treatment for cancer-related distress. This first in-human study also allows the Company to collect valuable data which will enable a future Investigational New Drug (IND) Application to be filed with the FDA, thus taking KRN-101 to the largest pharmaceutical market in the world.

The Company will also benefit from the Australian Federal Government's Research & Development incentive programme which will provide cash rebates for 43.5% of all eligible costs relating to the study.

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Dr. Sud Agarwal , CEO of iNGENū: "It's a privilege to have been selected as the CRO by Albert Labs' team of highly credentialed research experts to take the KRN-101 investigational product into first-in-human studies in Australia ."

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Dr. Michael Raymont , CEO of Albert Labs : "We have carefully considered a range of partners for our first in-human study and are delighted to come to this agreement with iNGENū. We have been impressed by their capabilities and see a strong alignment with our core values as a company. We also greatly appreciate the assistance of the Australian Government for carrying out this research.  Through this partnership we will provide the highest standard of clinical due diligence, and risk mitigation for planned late-stage trials in the UK through expansion into the United States . We feel that this is a significant step forward in value creation for our shareholders."

Business of Albert Labs International Corp.

Albert Labs is a pharmaceutical drug development company, focused on gaining regulatory approval for novel medicines for the treatment of mental health, and providing rapid access to effective prescription medicines for people suffering from mental health disorders. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which the needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast track clinical pathway focusing on Real World Evidence (RWE). RWE studies are an increasingly recognized clinical route, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.

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Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .

You can find more details about Albert Labs on our website here .

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs International Corp.

Dr. Michael Raymont

Chief Executive Officer & Chairman

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.

The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.

Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs International Corp.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2022/17/c3259.html

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