Arbor Pharmaceuticals LLC

“At Santander Pharma Consulting, our mission is clear: to help our clients optimize their commercial success by leveraging our teams’ experience,” said Robert Yanez, the firm's co-founder and CEO. There’s a new life-sciences-focused consulting firm in town. Founded by a duo with about half a century’s worth of experience in biopharma and medtech between them, Santander Pharma Consulting—no relation to the major banking firm—stepped into the spotlight with a launch announcement Tuesday. The firm, based in Durham, North Carolina, will offer a range of support services to drug and devicemakers of all sizes, though its focus is on “small or emerging enterprises,” per Santander’s website. To those clients, it’ll offer guidance on commercial strategy development, team building, revenue generation, business planning and development, and financial management. Santander has pledged to provide “hands-on support” in each of those areas, with an aim of “delivering tailored solutions that drive growth, maximize efficiency, and ensure compliance,” according to Michelle Yanez, the firm’s co-founder and chief financial officer. “At Santander Pharma Consulting, our mission is clear: to help our clients optimize their commercial success by leveraging our teams’ experience,” Robert Yanez, another co-founder and the firm’s CEO, added in the announcement. Fierce Pharma Marketing has reached out to Santander for clarification on the relation, if any, between Michelle Yanez and Robert Yanez. Each of the founders arrives at the consultancy with more than two decades of experience in the life sciences industry. Michelle spent the bulk of her career—from 2002 to 2022—at specialty pharma BioDelivery Sciences International, including a stint as director of financial reporting through BDSI’s acquisition by Collegium Pharmaceutical in early 2022. She joined Mira Pharmaceuticals as financial controller and director in May of that year and was named its CFO a year later. Robert, meanwhile, got his start as a product manager at GSK, Valeant Pharmaceuticals—now Bausch Health—and Johnson & Johnson. From there, he spent about six years in increasingly senior marketing director roles at XenoPort, followed by stints as director of commercial operations at BDSI and as senior director first of marketing and global research sales, then of strategic partnerships within the Americas, for devicemaker Circassia, now known as NIOX Group. Since early 2021, he’s served as chief commercial officer of Bryn Pharma.

Zenzedi, a drug approved to treat ADHD and narcolepsy, is marketed by Arbor Pharmaceuticals, a subsidiary of Azurity. It’s one thing for a drugmaker to recall a product after a labeling mix-up, but it’s another situation entirely when the wrong drug turns up in a bottle of branded medicine. Azurity Pharmaceuticals is recalling one batch of Zenzedi 30mg tablets from U.S. shelves after it received a report from a pharmacist in Nebraska who opened a bottle of the narcolepsy treatment and instead found carbinoxamine maleate, an antihistamine drug. After receiving word of the mix-up, Azurity kicked off an investigation and is pulling one drug lot.  Zenzedi is indicated for both narcolepsy and ADHD and marketed under Azurity’s subsidiary Arbor Pharmaceuticals. The suspect batch was shipped to wholesalers between late August and late November of 2023. The lot was due to expire in June 2025. Since antihistamine drugs can cause drowsiness, narcolepsy patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, Azurity said in a notice posted on the FDA’s website. Patients who unknowingly consume the antihistamine drug could experience other side effects such as drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction and thyroid disorder. What’s more, patients who have both attention deficit hyperactivity disorder (ADHD) and narcolepsy have a “reasonable probability” of experiencing accidents or injuries thanks to the sedating effects of carbinoxamine, which could lead to ongoing disability or death in severe cases, Azurity said. As of Wednesday, Azurity hadn’t received any side effects or safety reports linked to the recall. Labeling mix-ups can have serious consequences for patients, but they happen more often than one might think. Back in December, Glenmark Pharmaceuticals issued two separate Class II recalls due to mislabeling issues involving indomethacin and naproxen. The company specifically pulled 37,200 bottles of indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms. Separately, the drugmaker recalled five lots of naproxen, which is used to reduce fever or relieve mild pain due to headaches, muscle aches and other minor maladies. Both products may have been mislabeled as the other, Glenmark said.

Media Contact: Liz Flynn, Director, Corporate Communications (781) 281-3225 FOR IMMEDIATE RELEASE – January 24, 2024 – Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed. Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery). To date, Azurity has not received any reports of serious adverse events related to this recall. Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand. Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc. For additional Zenzedi® safety information, please visit www.azurity.com Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side. Product was distributed nationwide through pharmacies. Product NDC No. Lot No. Exp. Date Ship Dates to Wholesalers Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg 24338-856-03 F230169A 2025-06 08/23/2023 – 11/29/2023 Azurity Pharmaceuticals, Inc. sent recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level. Consumers that have product which is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product. Azurity has enlisted the services of Inmar Intelligence to facilitate the recall. Inmar is located at 3845 Grand Lakes Way, Grand Prairie, TX 75050. All returns from wholesalers and retailers must go to Inmar at this address. For more information regarding this recall, please reference the following telephone numbers: – For information regarding the recall process, call Inmar Intelligence at 877-804-2069 (Monday through Friday, 9AM-5PM EST). – For medical or technical product information or to report a technical product complaint or adverse event please call 800-461-7449 (Monday through Friday, 9AM-5PM EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. An adverse event may also be reported to Azurity via email at aereports@azurity.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. – Complete and submit the report Online: www.fda.gov/medwatch/report.htm – Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. PP-ZEN-US-0099