Emerging biopharma Outlook Therapeutics shares the benefits of Cencora's international commercialization support

Recognizing the chance to reach more physicians while saving, internal resources, Outlook Therapeutics turned to an established integrated commercialization services partner for experienced, external help: Cencora. The resulting strategic collaboration has helped prepare Outlook Therapeutics for its expected launch of Lytenava™ in European markets in early 2025.

Cencora is helping Outlook Therapeutics launch Lytenava™ in the EU (expected in early 2025).  Cencora will also help support the potential launch of ONS-5010 in the UK (expected in Q1 2025 pending approval), in the United States (expected mid-2025 pending FDA approval), and potentially in other global markets. Utilizing Cencora’s end-to-end commercialization solutions, Outlook Therapeutics will be able to reach more Retina specialists and Ophthalmologists without having to strain or expand its internal resources.

Executives from Outlook Therapeutics, Joel Prieve and Jedd Comiskey, discussed the transformative impact of their collaboration efforts with Cencora on the company's commercialization journey.

Delve into this exclusive conversation to discover how a shared vision for innovation and seamless collaboration can reshape the future of biopharmaceutical commercialization. In it, industry experts offer firsthand insights on building successful partnerships, overcoming key challenges, and unlocking new possibilities in bringing life-changing therapies worldwide.

At what point in the commercialization journey does biopharma typically consider market expansion?

Jedd Comiskey: Most companies start thinking about filing in the European Union after they have made their filing with the FDA (U.S. Food and Drug Administration). They think about the EU more when they feel very comfortable about getting approval from the FDA and start building out in the United States. Success in the United States can provide the necessary platform to support an EU launch.

People sometimes start later in Europe because of the significant time, effort and resources they must invest in the related process. Also, Europe is not like the United States. A biopharma could get regulatory approval, but would need to get market access for each country it wanted to enter one-by-one. That’s a big lift and takes lots of people.

If a biopharma worked with an experienced commercialization provider like Cencora though, it has knowledgeable team members who work on these issues every day in the targeted markets. So, the biopharma doesn't have to put multiple feet on the ground in every country. It could have an experienced executive in Zurich managing from his office relying on Cencora to look after everything else.

What key challenges do emerging biopharmas face in their product journeys?

Jedd Comiskey: Regulatory approval, and all the responsibilities that come with it, was challenging us in 2023, but it is less so now because I know that Cencora and PharmaLex, part of Cencora, are there to support us. There are a lot of responsibilities with being the marketing authorization holder in Europe. You can’t just say that you’re the marketing authorization holder and then sit back. You have to demonstrate that you meet all the requirements at a regional and local level. That’s where we trust the Cencora and PharmaLex teams. Collaborating with them gives us confidence that we are less likely to overlook anything.

Our focus now has very much turned to market access and commercialization. Cencora and Xcenda, part of Cencora, are supporting us through the health technology assessment (HTA) process and price negotiations in our European launch markets. In addition, Cencora is supporting us to ensure we are ready to commercialize and drive rapid uptake by physicians once we have achieved market access.

How has working with Cencora as an integrated commercialization services partner helped you? And how do integrated services differ from using multiple point solutions providers?

Jedd Comiskey: We wouldn’t be able to do what we’re doing if we had multiple vendors. If you have multiple vendors, you need more resources on your side of the table to manage them and we currently have limited employees worldwide. With Cencora, we can just tell them what we need without having an additional resource managing the relationship. It doesn’t mean we don’t need anyone, but we need fewer people on our side because we work with an all-in-one shop.

And it goes beyond bodies. We don’t necessarily need as much infrastructure or buildings up front in each country we expand to either, which is more cost efficient.

Could you describe your collaboration with Cencora? 

Joel Prieve: Designing, building, and operationalizing the commercial infrastructure is critical to the long-term success at Outlook Therapeutics.  As a small company with limited resources, there are multiple projects we need to complete, and we recognized that Cencora can partner and collaborate efficiently and effectively to achieve our goals.  Cencora has many focused companies and business units that can support small, emerging manufacturers like us to commercialize their first asset. Ultimately, Outlook Therapeutics can access tenured industry experts for whatever we need and leverage their experience to successfully commercialize and launch ONS-5010 in targeted markets around the globe.

We have made tremendous progress with our commercialization planning and are on track with our launch preparations.  We would not be at this place without the dedicated support of Cencora and their integrated commercialization services model. It provides Outlook Therapeutics the backing and resources of a Fortune 11 company.  We take full advantage of Cencora’s size and scale by leveraging their infrastructure and resources to outsource as much as possible.

What differentiates Cencora from competitors? 

Joel Prieve: Cencora has an end-to-end solution to help companies launch and commercialize pharmaceuticals and biologics worldwide.  Their infrastructure is massive and their legacy and experience with Specialty drugs is deep.  Most people know about Cencora’s distribution and 3PL capabilities, but they might not know much about the pharmaceutical services they provide.  Specifically, all of the pre-commercialization support from evidence generation to market research, patient services and HUB offerings, pharmacovigilance, market access consulting, HTA support, regulatory and quality offerings, outsourced payer teams, field reimbursement experts, and physician GPO services.  On top of having those best-in-class offerings, Cencora is a recognized market leader in Retina.  It was obvious to us that Cencora was the ideal partner.  Outlook is able to utilize all of the external Cencora services and resources that most big biopharmas would build and operate internally. Taking all of that on internally is very expensive and requires many full-time employees. Emerging biopharmas don't have those kind of resources or time. What sets Cencora apart from competitors is that it offers emerging companies like Outlook Therapeutics access to market leading infrastructure without the same level of investment that a large corporation would make.

We trust Cencora to assist us with everything we need to do in Europe without expanding our internal resources.  They make the entire process seamless.

We’re a little company and have not launched Lytenava™ yet in the EU, but we have direct access to Cencora's leadership and have their full support. On top of that, we truly enjoy working with the Cencora associates, specifically the EU, UK and US teams.  Everyone is on the same page, and it really feels like we are operating as one company, not two companies working together.  It is an amazing dynamic, and we are very happy with the partnership.  It’s available to other pharma companies, regardless of size, to explore Cencora’s commercialization offerings. This can be replicated.

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The strategic collaboration between Outlook Therapeutics and Cencora has succeeded because of their shared vision and meaningful collaboration. Together, they pursue the opportunity to help more patients globally and to do it as effectively and efficiently as possible.

Cencora helps emerging biopharma companies along all phases of the commercialization journey. We can help you commercialize and launch your specialty product in markets around the world without expanding your internal resources.

Contact us to learn more about how we can help you successfully launch your product globally as your integrated commercialization services partner.