This week's pharmaceuticals and life sciences industry news includes items on a Chester County pharma firm's skin disease medicine, a local drug that made it on the federal government's initial Medicare drug price negotiation list, an academic-industry partnership, and more.
Here's the roundup:
Verrica Pharmaceuticals
The West Chester dermatology therapeutics company has come out in support of the Food and Drug Administration's crackdown against retailers and manufacturers of unapproved products for the treatment of molluscum contagiosum.
The support is hardly surprising given that Verrica (NASDAQ: VRCA) in late July received approval for Ycanth, the only treatment cleared by the FDA to treat the skin disease. The company expects its drug-device combination product will be available for use by licensed health care providers later this month. The company announced earlier this week its first commercial sale of Ycanth to its exclusive distributor, FFF Enterprises.
Ted White, Verrica's CEO, said his company is pleased that the FDA is taking "additional measures" against the makers of the unapproved products — issuing direct warnings to Amazon and Walmart and four other companies marketing or distributing unapproved, over-the-counter products for the condition — following the federal agency's June 1 warning directly to consumers urging them not to use such products.
“It is clear that the FDA views molluscum as a serious health problem that requires medical intervention with therapies that have been rigorously tested and properly reviewed," White said.
Molluscum is a highly contagious viral skin disease that affects about 6 million people, primarily children in the United States. It is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through objects that carry the disease such as toys, towels or wet surfaces.
Janssen Biotech
The Horsham-based Johnson & Johnson subsidiary's immunosuppressive medicine Stelara is on the Health and Human Services' list of the first set of drugs selected for Medicare price negotiations.
The Inflation Reduction Act initiative — opposed by the pharmaceutical industry, which is challenging the law in court — is a key part of the Biden Administration's efforts to lower drug costs.
Negotiations for the first group of selected drugs are scheduled to begin later this year, with negotiated prices going into effect in 2026.
Stelara, which is Johnson & Johnson's (NYSE: JNJ) top-selling medicine with sales of $9.7 billion last year, is approved as a treatment for a variety of autoimmune disorders including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The Medicare program spent more than $2.6 billion on Stelara from June 2022 to May 2023.
Drexel University
The Philadelphia university’s School of Biomedical Engineering, Science and Health Systems, in collaboration with Drexel’s College of Medicine, has received grants from Bristol Myers Squibb totaling nearly $1 million to support the education and training of diverse and talented students interested in careers in cell and gene therapy.
The funds will be used by Drexel for its Cell and Gene Therapy Technology, Engineering, Analytics, Manufacturing, & Science academic program — known as CGT-TEAMS — that the university launched this summer for undergraduate and graduate students enrolled in its biomedical engineering and medical schools.
The program will allow Drexel students to pursue cooperative education experiences during six-month rotations at Bristol Myers Squibb, which is based in New York and has operations in Princeton and Lawrence Township in New Jersey. The funding will also support outreach and scientific educational programming for high school students, and professional development for high school teachers in Philadelphia.
Paul W. Brandt-Rauf, dean of Drexel's School of Biomedical Engineering, Science and Health System, said the grant support will "strengthen the pipeline between education and career" for many of the university's diverse students.
Lynelle Hoch, senior vice president and the global cell therapy franchise lead at Bristol Myers Squibb, said the partnership will support education and training programs for "prospective diverse talent who will drive next generation approaches in the growing cell therapy field."
Quick hits
Proscia, a Philadelphia digital and computational pathology services company, has entered into a partnership with DoMore Diagnostic of Oslo, Norway, to predict outcomes for colorectal cancer patients. Financial terms of the deal are being kept confidential. … NRx Pharmaceuticals (NASDAQ: NRXP) filed an investigational new drug application that, if approved, will allow the Radnor biopharmaceutical company to begin human testing of its new drug candidate NRX-101 as a treatment for chronic pain. NRx also entered into a definitive purchase agreement with a group of accredited long-term investors covering the purchase of 3 million shares of preferred stock at 40 cents per share, which will convert after six months into 3 million common shares and 3 million warrants to purchase common stock at the same 40 cents per share price. The biopharmaceutical company will use the proceeds to advance the development of NRX-101, which is also being studied as a potential treatment for suicidal bipolar depression. … Warrington-based Windtree Therapeutics (NASDAQ: WINT) said it was issued a patent from the U.S. Patent and Trademark Office that provides patent protection through late 2039 for its drug candidates being developed to improve cardiac function in heart failure patients. The new composition of matter patent is titled: “17beta-heterocyclyl-digitalis like compounds for the treatment of heart failure.” Windtree received similar patent protection from the European Patent Office in April.
