Weekly Quick Hits (Research Triangle Park) – Week of July 17, 2023

Financial woes have taken their toll on two RTP biopharma companies. Both 9 Meters Biopharma and Novan, Inc. filed for Chapter 11 Bankruptcy Protection this week. Additionally, Iqvia is facing an uphill battle to acquire a digital media firm following concerns raised by the FTC.

By Alex Keown

July 21, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards, and Collaborations 

9 Meters Files for Chapter 11, Ceases Operation

Raleigh’s 9 Meters Biopharma, which was developing therapeutics for digestive and gastrointestinal diseases, filed for Chapter 11 bankruptcy and will cease operations, the company revealed in a filing with the U.S. Securities and Exchange Commission. In addition to financial woes, the filing revealed the departure of its interim CEO and CFO. As of July 17, 9 Meters has no officers, consultants, or employees, the filing shows. 

Novan to Sell Assets, including Berdazimer Gel, 10.3%, Files for Chapter 11

Durham-based Novan, Inc. and its wholly owned subsidiary, EPI Health, LLC, entered into a stalking horse asset purchase agreement with Ligand Pharmaceuticals, Inc. prior to filing voluntary petitions for relief under chapter 11 of title 11 of the United States Bankruptcy Code. The company continues to operate its business as a “debtor-in-possession.” The company also entered into a secured DIP credit facility with Ligand in the principal amount of $15 million, which, substantially governs the sale of all the assets of the company at closing. As the Chapter 11 Case progresses, Novan will continue to work with the FDA to progress towards potential approval of berdazimer gel, 10.3%, with a PDUFA goal date of January 5th, 2024. 

Premier, Inc. and Endo Partner to Address Pitocin Shortage

N.C.-based Premier, Inc. and Ireland’s Endo International plc forged a supply partnership for Pitocin (oxytocin injection, USP) vials, which are used to induce labor in pregnant women. The product is on the World Health Organization’s essential medications list and has a history of supply disruptions. The partnership involves a multifaceted approach aimed at providing a stable product supply through adequate safety stock on a long-term basis.

BioCryst Selects Er-Kim Pharmaceuticals as Commercial Partner in Turkey

BioCryst Pharmaceuticals entered into a collaboration with Er-Kim Pharmaceuticals to commercialize Orladeyo (berotralstat) in Turkey. Er-Kim is an international pharmaceutical company based in Istanbul, Turkey, which specializes in partnering with biopharmaceutical companies to commercialize new products in global markets. Orladeyo is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years and older. 

New Products

Leading U.S.Hospital Adopts Asensus Surgical System

Medical device company Asensus Surgical announced a leading United States-based hospital initiated a Senhance Surgical System program within their pediatric surgery department. The initiation of the Senhance program marks an important milestone as this represents the first system to be exclusively utilized by pediatric surgeons at a U.S. hospital, showcasing Senhance’s unique applicability for pediatric applications.

New Patents

Tenax Therapeutics Issued U.S. Patent for Oral Levosimendan in PH-HFpEF

Chapel Hill-based Tenax Therapeutics announced that the United States Patent and Trademark Office granted a new method of use patent for oral levosimendan (TNX-103) in the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The patent covers the use of oral levosimendan for the treatment of PH-HFpEF and provides exclusivity through December 2040. The ‘355 patent further builds upon the Company’s substantial IP, which also includes issued U.S. patents for the use of intravenous and subcutaneous formulations of levosimendan for the treatment of PH-HFpEF.

Real Estate

ProKidney Closes Purchase of N.C. Manufacturing Facility

ProKidney Corp. closed on its purchase of a 210,000-square-foot facility and approximately 22 acres of land in Greensboro, N.C. ProKidney paid approximately $25.5 million in cash for the facility and property. The company plans to make investments in the facility through 2028 to prepare for potential commercial-scale manufacturing of REACT, its proprietary REnal Autologous Cell Therapy, currently in Phase III development for the treatment of diabetic CKD. In connection with the purchase, the company is eligible to receive up to $33.7 million in various tax credits based upon the achievement of certain milestones, including the creation of at least 330 new jobs on or before December 31, 2028.

Research Roundup

NIH: Maternal Inflammation Risk Linked to Children’s Behavioral, Emotional Regulation

Maternal inflammation risk factors may be associated with dysregulation in children, according to a study funded by the Environmental Influences on Child Health Outcomes (ECHO) Program at the National Institutes of Health. “Dysregulation” refers to children’s attention, anxiety and depression, and aggression being measurably different from what is typically expected at their age. While inflammation is a normal bodily response to injury or infection, ECHO investigators wanted to learn whether factors linked to inflammation during pregnancy might be associated with dysregulation in children. More youth with dysregulation (35%) were born to mothers with prenatal infections compared with 28% of youth without dysregulation. Other maternal factors studied, including being overweight before pregnancy, attaining less education, and smoking during pregnancy, were associated with higher likelihoods of childhood dysregulation. Children and adolescents who had a parent or sibling with a mental health disorder were also more likely to experience dysregulation.

On the Hill – Regulatory and Advocacy

Feds Move to Block Iqvia’s Acquisition of Digital Media Firm

The Federal Trade Commission voted unanimously to block Durham-based Iqvia’s acquisition of Propel Media. The FTC said the deal will give Iqvia “a market-leading position in programmatic advertising for health care products, namely prescription drugs, to doctors and other health care professionals.” Additionally, the FTC said the merger will increase Iqvia’s incentive to withhold key information to prevent rival companies and potential entrants from effectively competing, the complaint states, according to reports. 

People on the Move

ProKidney Appoints Bruce Culleton as EVP Clinical Development and Commercialization

ProKidney Corp. named Bruce Culleton as Executive Vice President, Clinical Development and Commercialization. Culleton joins ProKidney after more than two decades in industry and academia with a primary focus on kidney health. Culleton joins ProKidney from CVS Kidney Care where he was most recently Vice President and General Manager. Previously, he was Vice President and Chief Medical Officer at CVS Kidney Care. Before that, he was Vice President, Global Clinical Development and World Wide Vice President, Medical Affairs, Medication, and Procedural Solutions at Becton Dickinson.