Aurinia Pharmaceuticals Inc. (AUPH)

Aurinia Pharmaceuticals Prepares for Commercial Launch from New Maryland Site on the Heels of 2020 Hiring Spree

Aurinia Pharmaceuticals (Aurinia) is a late-stage clinical biopharmaceutical company (Toronto Stock Exchange (TSX:AUP); NASDAQ (NASDAQ:AUPH) focused on commercializing therapies for rare autoimmune and inflammatory conditions. Headquartered in Vancouver, British Columbia, the company announced in March 2020 that it had established its U.S. commercial center of operations in Rockville, Maryland, which is actively staffing up with key personnel. Among the key leaders, Aurinia attracted were two veteran industry executives with deep ties to the region: former top MedImmune executives Peter Greenleaf and Max Donley are the company’s CEO and EVP, Internal Operations and Strategy, respectively. They both joined Aurinia’s leadership team in 2019

The company’s lead product candidate, voclosporin, is a potential best-in-class, first-in-class therapy for lupus nephritis (LN) in the U.S. and the European Union (EU). Aurinia just recently received Priority Review status from the U.S. Food & Drug Administration (FDA) and voclosporin has a Prescription Drug User Fee Act (PDUFA) date of January 22, 2021, making this an exciting and important time for the organization as it prepares for the potential commercialization of its first product.

“Peter and I are back together with Aurinia and we’re very excited about this opportunity to build another vertically integrated company around outstanding technology,” stated Donley. “At the end of the day what’s exciting is the patient community we are serving. We still have to get through an important gate, but this could be a meaningful medical intervention for patients that don’t currently have a lot of options.”

“When Aurinia made an announcement around voclosporin’s positive Phase III data, many major advocacy groups, unprompted by us, issued their own press releases thanking us and spurring us on to get the best label possible to the patients,” he added. “Lupus Nephritis (LN) is a nasty disease and the next progression of the lupus disease state that presents dramatic, life- altering outcomes for patients. To bring a medical intervention forward is not an opportunity, it is an obligation for us.”  

Donley is no stranger to a patient-focused mission. He joined MedImmune in its earlier days when they were building a company around its eventual flagship product Synagis. Donley learned about MedImmune from the Neonatal Intensive Care Unit (NICU) staff after the birth of his daughter, who was born premature. She received Respigam, the precursor to Synagis, which protected her against respiratory syncytial virus, known as RSV.

“My daughter was a patient. When we got to a point where MedImmune was quite big, we took our leaders to an offsite in Boston. We wanted our leaders to understand why they were here…The capstone speaker was my 13 year old daughter. She told her story and how she’s a happy, healthy, successful kid and said it’s because of you. It’s still kind of hard to tell this story,” shared Donley.

“Patients and science have to be at the center of all we do and that’s at the core of Aurinia’s culture,” he added.  

Aurinia’s MedImmune ties are just the latest example of the influential BioHealth Capital Region (BHCR) company’s lasting legacy. MedImmune’s impact keeps reverberating throughout the BHCR and the wider global biopharmaceutical industry.

In March 2019, BioBuzz asserted that the BHCR was entering a period of creative destruction, signalled by AstraZeneca’s (AZ) announcement that it was retiring the MedImmune brand. AZ’s announcement essentially ended a remarkable run by one of the most important and influential BHCR life science companies of the last twenty years.

The scientific creative force unleashed by MedImmune and its subsequent dissolution has never been more evident than now. Former MedImmune executives have gone on to lead numerous successful BCHR companies. Key former MedImmune leaders and scientists have created scores of new life science startups across the region that have increased the vitality and fertility of the Maryland, Virginia and Washington, D.C. life science ecosystem.

“I remember the early days of biotech along the I-270 corridor. It was a little dicey. We didn’t know if we could attract talent to the region. We didn’t know if biotech could work here or if we’d have to move up to Boston. At MedImmune, we were able to create our own gravity. It’s been fun to watch over time people that came through the organization go on to do bigger and better things. The diaspora is telling a pretty cool story. The new wave and next generation is doing some pretty cool things across the region and the globe,” stated Donley.  “At Medi, we invested in people and we were going to do what’s best to develop our people even if that meant they eventually left the company.”

Feeding the life science diaspora was the right strategy then as it is now. 

One doesn’t have to look too hard to find former MedImmune team members at scores of companies in the region, including Emergent Biosolutions, Viela Bio, Autolus Therapeutics, Immunocore, Novavax, Neximmune and Kite Pharma, to just name a few. Even Greenleaf and Donley, after leaving MedImmune when AstraZeneca decided to more forcefully integrate the two companies, stayed in the region as executive leaders of Rockville’s Sucampo until it was purchased in 2017. 

“We know that Montgomery County, Maryland has a wealth of talent. We have the FDA, National Institutes of Health (NIH) and an amazing university system right in our backyard. This is a fantastic place to do business. The state of Maryland has done a consistent job supporting biopharma, which has been beneficial to businesses that Peter and I have worked with…the support has been smart and timely and has allowed us to focus on developing our people and products,” Donley stated. 

Aurinia is currently preparing for its January 2021 PDUFA date. In preparation for voclosporin’s potential approval, Greenleaf, Donley and the Aurinia team are building out the company’s commercial infrastructure at the Rockville, Maryland location. Much of the growth at Aurinia over the last year has been focused in the U.S. where voclosporin will be launched first. The company has grown from 38 to 260 employees across the last year, adding world-class talent along the way, with many of these hires tied to the commercial function at the Rockville site.

Aurinia is in the final stages of construction for the Aurinia U.S. headquarters, which will be a 30,000 square foot facility right off of Shady Grove Road in Rockville once completed. The company is looking forward to its grand opening in October 2020, should COVID-19 regulations make that possible. 

Aurinia is also in the final stages of lease negotiations for a new headquarters in British Columbia, Canada, that will continue to house its CMC, manufacturing, clinical and business development functions. Its financial and back office functionality is located in Edmonton, Canada. The company was founded to bring the benefits of the voclosporin molecule to patients. The original Canada-based voclosporin team is still part of Aurinia’s core leadership group and board. Aurinia has a remarkable, long and compelling history in Canada. 

“We have many compelling stories to tell at Aurinia. We have excellent data and a great program and we have a patient population in need that is enthusiastic about what we’re doing. These are good signs,” stated Donley. “And we have strong leadership. Peter’s positive reputation is well-deserved and is complemented by great leadership within all the company’s verticals and across the organization.”

Donley added, “We have a really robust culture here, too. There is a level of organic passion for our culture…Our ‘We CARE’ tagline is not just a plaque on the wall or a catchy-buzz phrase, it’s really the way we behave. It’s about how we show up, how we cover one another’s backs and how we execute for patients.” 

‘We CARE’ stands for (C)reating Opportunity, (A)cting Responsibly, (R)relentlessly Persevering and (E)xecuting with Integrity.

“There should always be a straight line between us and the patient….This gives our team the context they need to make the decisions necessary to move the business forward in an aligned way,” said Donley.

Donley shared that the company is in an advantageous financial position and is laser focused on the potential regulatory approval and commercial launch of voclosporin, while keeping an eye on expanding the molecule’s indication into a treatment for dry eye syndrome (DES) eventually.

“We’re in the process of finalizing our plans for Phase IV activity for LN and we have some differentiation programs we’re contemplating. We do think this molecule has a lot to offer. There’s more to come,” he added. “We started in August 2019 with a leverage capability in clinical development and we’re ending that rolling 12-month period with a leverageable commercial capability. We feel that’s pretty remarkable,” shared Donley.

But the work is not done, by any means. 

Aurinia is actively recruiting new talent to help bring voclosporin to LN patients in need. Some estimates have the company adding 500 new, well-paying jobs to Montgomery County in the near future.

“We’re very transparent about who we are and what we’re about. We’ll share the good, the bad and the ugly in the interview process. If we have successful interviews, people will tend to want to run towards us or run away from us,” shared Donley. “We’re looking for talent that isn’t just coming to do work but is looking to get better. We invest in people’s development and this shows up in how they experience Aurinia. This goes back to what we did at Sucampo and MedImmune…this investment-in-people mentality leads to a healthy and well-characterized community that represents your legacy. This is central to what Aurinia stands for.”

Donley shared, “I recently drove my son cross-country back to school. We were driving on I-270 and there’s a level of pride seeing the former MedImmune campus…When we built out the MedImmune campus we weren’t sure we could make it in Montgomery County. We didn’t have a built biopharma structure to lean in to. And now we do. We are proud of whatever part we played in helping to build out this biopharma hub along with many, many other talented people.”

“Peter and I have great confidence that as we strive to build out another vertically integrated biopharma around an exciting technology, we’re going to find the talent and critical infrastructure here to help us be successful. This is the right place for us to be in the U.S. and there’s a unique feeling of confidence and pride to be part of it,” he added.

With a strong focus on employee development, an authentic patient-centric approach and promising technology, Aurinia is a perfect fit for the region and is a fantastic addition to the fabric of a thriving BHCR diaspora that will have a positive impact on the region for years to come.

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