Alector Opts for Lonza’s Ibex™ Develop to Secure Future Manufacturing for Neurodegeneration Therapies

  • Alector and Lonza Pharma & Biotech extend their partnership to cover future manufacturing needs of two of Alector’s clinical stage product candidates
  • Access to Lonza’s expertise in expedited programs and BLA filings will accelerate Alector’s market readiness

Quote from Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech:

“Ibex Develop was launched in 2018, with the goal of giving our customers access to technology and assets in sync with their journey, as well as the agility to respond as their needs develop. With biotech customers like Alector who want to commercialize their drug candidate, we offer a rapid and simplified path to transition from clinical to launch which allows them to focus on bringing their therapies to patients.”

Quote from Robert King, Chief Development Officer, Alector:

”Lonza continues to be an innovator in the space and their flexible solutions and product offerings enable Alector to focus on drug development and bringing therapeutics to market to address the severe unmet need in neurodegeneration as efficiently as possible. Lonza’s considerable knowledge and experience make them an attractive long-term partner.”

San Francisco, USA and Basel, Switzerland – Alector (NASDAQ:ALEC) and Lonza (SWX:LONN) announced an agreement to secure manufacturing capacity for two of Alector’s drug candidates currently in Phase 1 development for neurodegenerative diseases. The California-based biotech chose Lonza’s IbexTM Solutions to ensure drug supply and accelerate market-readiness.

The two companies have been working together since 2016 on the early phases of development for Alector’s lead candidates.  Based on the potential product needs of these candidates, Lonza’s GS Xceed® Gene Expression System was used to create high-producing cell lines.  The programs have also included clinical manufacturing of drug substance and drug product across the Lonza network. Alector is now looking to secure supply for current and future trials with the ability to scale up rapidly.

The Ibex Develop offering in Visp, Switzerland was a compelling choice for Alector, who was looking for a simplified tech transfer from Lonza’s clinical assets in Slough (UK) and Hayward, CA (US) into a scalable solution with clinical and commercial production under the same roof. Under the agreement, Alector will have the flexibility to move molecules from their pipeline in and out of production as needed, to match the pace of their clinical trials and assure the quantities required are available. Ibex Develop is based on flexible single-use technology that allows management of forecast volatility and scale-up or -out within the same facility or in the wider Lonza network.

In addition, Alector will be able to leverage Lonza’s experience in expedited regulatory pathways and in bringing biologics successfully through BLA submissions as well as the option of drug substance and drug product manufacturing under one roof.

The Visp, CH facility, from which Ibex Solutions is offered, will be operational from 2020 onward, with planned start of operations for Alector in Q3 2020.


About IbexTM Solutions

Ibex™ Solutions consist of three innovative CDMO offerings that span the complete product lifecycle of a biopharmaceutical – from preclinical to commercial stages, from drug substance to drug product, all in one location.

The three offerings Ibex™ Design, Ibex™ Develop, and Ibex™ Dedicate have been developed as a response to a dynamic market with evolving needs: To help take drug candidates to market quickly, flexibility to manage the unknown, streamline supply and increase predictability.

The home for Ibex™ Solutions is the Lonza biopark in Visp (CH), which leverages Lonza's existing infrastructure, support networks and a stable and highly skilled workforce. Further information can be found at https://ibex.lonza.com/

About Lonza

Lonza is an integrated solutions provider that creates value along the Healthcare Continuum®. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.

Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. Further information can be found at www.lonza.com.

About Alector

Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders.

Alector is developing a broad portfolio of programs designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. The Company’s product candidates are supported by biomarkers and target genetically defined patient populations. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

Lonza Contact Details Dirk Oehlers Investor Relations Officer

Lonza Group Ltd

Tel +41 61 316 8540

dirk.oehlers@lonza.com

Dr. Sanna Fowler Head of Public Relations

Lonza Pharma & Biotech

Tel +41 61 316 8929

sanna.fowler@lonza.com

Constance Ward Head External Communications

Lonza Group Ltd

Tel +41 61 316 8840

constance.ward@lonza.com

Alector Contact Details

ir@alector.com

Additional Information and Disclaimer

Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd and/or Alector, Inc., at the time of this news release, although neither party can give assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd and Alector, Inc. disclaim any intention or obligation to update the statements contained in this news release. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports Lonza Group Ltd or Alector, Inc. file with the governmental or regulatory agencies, including with respect to Alector, the Securities and Exchange Commission.

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Lonza

Lonza is an integrated solutions provider that creates value along the Healthcare Continuum®. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.