Bioniz Therapeutics, an Irvine-based medical research firm backed by prominent Orange County executives, has reached a deal with a Spanish pharmaceutical company that could ultimately result in a $540 million sale of one of its main drug products.
Barcelona-based Almirall S.A., a pharmaceutical company focused on dermatology, said last week it is making a $15 million upfront payment to Bioniz for exclusive global rights to BNZ-1, an inhibitor that is being tested for its ability to fight a type of lymphoma that manifests in skin.
If the data from ongoing trials proves successful later this year, Almirall can exercise its option to acquire the drug candidate BNZ-1 outright from Bioniz.
The BNZ-1 drug candidate alone has a value of more than $540 million when future royalties for the deal are factored in, according to Bioniz founder and Chief Executive Nazli Azimi.
“We are super excited,” said Azimi, who last year received a Business Journal’s Women in Business award.
“It’s a very sweet deal for the company and investors.”
Among those investors are Bioniz Chairman David Pyott, former CEO at Allergan Inc., and Joe Kiani, founder and chief executive of Irvine’s Masimo Corp.
It was Pyott who made the introductions to Almirall, Azimi said.
If Almirall takes over BNZ-1, Bioniz’s remaining assets will be spun into a new company.
Azimi said her company has other products in its pipeline called BNZ-2 and BNZ-3, which are aimed at stomach illnesses.
“The beauty of the deal that was very important was it didn’t require the full acquisition of our portfolio,” Azimi said. “We will continue with other programs.”
Dozen Patents
Azimi, a native of Iran who arrived in the U.S. in the early 1990s, spent a decade at the U.S. National Institutes of Health, where she completed her postdoctoral immunology program and was directed by Thomas Waldmann, who is a pioneer in the field of immune therapy and who is also listed as a Bioniz “collaborator.”
Her board of advisers includes Robert Gallo, who became famous in 1984 when he co-discovered HIV as the cause of AIDS.
Azimi has authored more than 40 peer-reviewed, scientific publications and holds more than a dozen patents, including the Bioniz intellectual property patent estate.
Through its platform, Bioniz has identified several product candidates that address immuno-inflammatory diseases and cancer.
Its drugs are designed to attack cytokines, the multiple proteins that block immune pathways and can lead to serious diseases.
Options
Almirall focuses on what it calls “immunodermatology.”
In 2018, Almirall acquired Allergan’s dermatology portfolio for $550 million upfront, with a conditional $100 million based on product performance thereafter. Among Allergan’s pharmaceuticals listed was the tetracycline antibiotic Seysara, which was the first of its kind in 40 years to be developed specifically for treating skin conditions.
Last June, Almirall inked an optional purchase plan with Menlo Park-based Dermira for its atopic dermatitis treatment as it was entering Phase 3 clinical trials at the time of purchase.
Bioniz’ BNZ-1 may be able to treat cutaneous T-cell lymphoma (CTCL), a type of cancer that affects the skin.
It’s “an orphan disease with high unmet medical need,” Almirall said in its statement.
BNZ-1 may also treat alopecia areata, “an autoimmune hair disorder with no approved treatments,” Almirall said.
Bioniz picked Almirall because it’s “committed to developing” BNZ-1 in a relatively short time frame, Azimi said.
