Aerial BioPharma LLC

ATLANTA — Two former executives of Eli Lilly’s diabetes unit are searching for the newest and best approaches to obesity treatment. Enrique Conterno, former president of Lilly Diabetes, and his colleague Meg Powell teamed up earlier this year to launch a venture capital firm called 501 Ventures. The firm plans to fund the science of next-generation metabolic health medicines. Conterno said at this year’s ObesityWeek conference that many more medicines will come to market over the next 20 years after blockbuster GLP-1s paved the way. “Some people believe that maybe the metabolic health story has been written. It’s still going to be written,” Conterno, 501’s executive chair, said in an interview with Endpoints News at ObesityWeek in Atlanta. Conterno was president of Lilly Diabetes and Lilly USA until the end of 2019, and then moved to the CEO post at FibroGen for a few years. He’s since joined the board of Zealand Pharma, one of the leading contenders in the amylin race. Powell was at Lilly during the 2000s before moving to roles at GSK, Aerial BioPharma and Target PharmaSolutions. She’s also on the board of trustees of Blue Cross North Carolina. They named 501 Ventures after the highway that connects the University of North Carolina and Duke University, the two institutions that Powell and Conterno went to, respectively. “We have a bit of a rivalry,” he joked. The firm aims to take large stakes in early-stage companies and play an active role in helping them design efficient experiments for new metabolic health medicines so they can quickly find out whether they truly have a differentiated program on their hands. “As soon as you figure out that they’re not [best-in-class], we’re advocating that you shelve them,” Powell said. The 501 leaders declined to disclose the amount of capital the firm is working with so far, but Powell noted they’re focused on courting biopharma companies to help support the fund. Strategic companies want additional avenues to “stay on top of the science as quickly as possible,” she said. “So much of biotech, you raise these $100 million Series A and so much of that is spent on overhead instead of doing the science, and we are really committed to advancing the science as quickly as we possibly can,” Powell said. The search for new medicines will be global, the 501 leaders said. Conterno listed off Boston, San Francisco, San Diego, Shanghai and Tokyo as examples of regions they could find biotech investment opportunities. Powell, sitting next to Conterno, chimed in to mention Copenhagen. Conterno then added their former adopted home of Indianapolis to the list. 501’s “sweet spot” would be projects that are a couple years away from the clinic, Conterno said. That could include helping form new companies. There have not been as many obesity-focused biotech launches this year, but activity has picked up in recent weeks. Pfizer won a bidding war over Novo Nordisk to buy Metsera, and AstraZeneca acted on its option to buy out SixPeaks Bio earlier this month. The field has “played some of the first innings,” Conterno said. “I don’t know if it’s going to go to 18 innings like in the World Series, but there’s a lot of innings to be played,” he said.

MORRISVILLE, N.C. (May 25, 2016) – Arrivo BioVentures today announces the launch of Arrivo BioVentures, LLC, a drug development company, with the closing of a preferred financing totaling $49 million in committed capital. Arrivo was founded by Steve Butts, Bill Wofford, Dr. Michael Ackermann and Dr. Jed Black, and located in North Carolina’s Research Triangle Park region. Mr. Butts and Mr. Wofford were members of the management team that led successful investor exits of privately-held start-up biopharmaceutical companies Aerial BioPharma LLC, Neuronex Inc. and Addrenex Pharmaceuticals, Inc. Dr. Black, therapeutic area head for sleep at Jazz Pharmaceuticals, will serve as a scientific advisor to Arrivo. Arrivo plans to use the funds to develop four to six new drug candidates over the next several years. Consistent with the management team’s previous companies, Arrivo’s team will source and acquire development candidates in or ready for the early stages of human clinical trials and move the projects through clinical proof-of-concept and the next significant valuation inflection point. “We are excited about the next evolution in our business model,” Butts said. “We will continue to look for development programs that improve patient care and provide opportunities to minimize the clinical development and regulatory risks. However, our new model with more drug candidates will give our investors greater diversification, and ultimately even more chances for development success.” Jazz Pharmaceuticals is the lead investor in the financing, with Solas BioVentures Fund I, L.P., Rex Health Ventures and private investors also participating. Committed capital will be accessed over the next five years to fund development projects as they are identified, in-licensed and initiated by Arrivo. “We are very pleased to continue our long standing relationship with this outstanding management team,” said Dr. David Adair, Managing Partner of Solas BioVentures. “The Arrivo operating team has a demonstrated track record of advancing valuable new treatments for patients through the drug development process.” The strategy for Arrivo, as with the previous companies, is to leverage the team’s clinical expertise and knowledge of the drug development process. The previous companies have replicated a successful process founded on identification of drug candidates with high probabilities of success and clear development and regulatory paths for approval. About Arrivo BioVentures, LLC Arrivo BioVentures, LLC is a privately held biopharmaceutical development company focused on identifying biologics and small molecules to improve patient care. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com. Media Contact Scott Yates OnPoint Communications Group LLC (for Arrivo) 919-649-6621 scott@onpointprgroup.com

Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration granted approval for Sunosi, a treatment for people with narcolepsy. Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration (FDA) granted approval for Sunosi , a treatment for people with narcolepsy. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Ireland-based Jazz said it anticipates Sunosi being commercially available in the United States following a final scheduling meeting with the FDA, which typically occurs within 90 days of approval. Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness, and the inability to regulate sleep-wake cycles normally. Obstructive sleep apnea is also associated with excessive daytime sleepiness. Excessive daytime sleepiness is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness. Bruce Cozadd, chairman and chief executive officer of Jazz, said excessive daytime sleepiness associated with these disorders negatively impacts the quality of lives of patients. “With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” Cozadd said in a statement. “The FDA approval of Sunosi also represents an important milestone for Jazz as we continue to offer new treatment options that address unmet needs for people living with chronic, and often debilitating, sleep disorders.” The FDA approved Sunosi based on Phase III data that included four randomized placebo-controlled studies that demonstrated the superior benefits of the medication in comparison to placebo. The data showed that after 12 weeks, approximately 68 to 74 percent of people taking Sunosi at the 75 mg dose and 78 to 90 percent who took the 150 mg dose reported improvement in their overall clinical condition, Jazz said. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize Sunosi from Aerial Biopharma. Sunosi was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea and was shown to maintain its effect relative to placebo after six months of use. Jazz was forced to wait three additional months for the FDA to review Sunosi after amendments were made to its New Drug Application. In December, the FDA determined that those amendments regarding draft labeling would require additional time for staff to study. “We’re excited about this new therapeutic option for patients, and we are pleased with the information included in the Sunosi label as we believe it will give physicians the information needed to appropriately manage the vast majority of obstructive sleep apnea and narcolepsy patients with excessive daytime sleepiness,” said Daniel Swisher, president and chief operating officer of Jazz Pharmaceuticals. Sunosi isn’t the only sleep-aid developed by Jazz that has been approved in the U.S. In October, the FDA approved a supplemental new drug application to revise labeling for Xyrem (sodium oxybate) oral solution, CIII. The medication was approved for a new indication to treat cataplexy or excessive daytime sleepiness (EDS) in pediatric patients with narcolepsy ages seven and older.