Fast-Delivery Strategy Makes Zosano a Company to Watch
September 29, 2015
By Dan Emerson, BioSpace.com News
With a strategic focus on rapid drug delivery, Fremont, Calif.-based Zosano Pharma is transitioning from an R&D company to a commercially-focused entity, as it prepares to begin Phase III trials for its first product to reach that stage, ZP-Glucagon. Zosano develops drug-delivery systems using its proprietary microneedle patch technology.
This emphasis on rapid delivery should work in the company's favor as a business advantage, since trials of fast-onset drugs typically require less time to complete, than drugs trials in which clinical outcomes take more time to develop and measure.
On Monday, Zosano announced it is discontinuing development of its Daily ZP-PTH treatment for severe osteoporosis, and resuming development of its Weekly ZP-PTH product. Chief Executive Officer Vikram Lamba said the decision was driven by recent feedback from Japanese regulatory authorities, which would have required additional studies that would have likely delayed commercialization in Japan by approximately one year.
Terminated Lilly Agreement
Also, Zosano and Eli Lilly and Co. have terminated a collaboration agreement to develop Daily ZP-PTH, that they signed last year. Zosano will resume development of its Weekly ZP-PTH, Lamba said.
Later this month, Zosano expects to complete the Phase II study for its ZP-Glucagon product for hypoglycemic diabetics and plans to release results by mid-October. Sometime thereafter, company officials plan to hold Type C meetings with the FDA to discuss Phase III trials, which they hope to begin in 2016, according to Lamba.
ZP-Glucagon is Zosano's proprietary formulation of glucagon, a hormone which can quickly raise the concentration of glucose in the bloodstream. The company hopes to complete its ZP-Glucagon trials within 18 months, Lamba says. He estimates the current, global market for glucagon at $220 million per year.
Zosano's patented drug-delivery technology uses titanium microneedles to deliver drugs through a wearable patch. Patients do not feel the pain that they would with conventional, injectable drug delivery, Lamba notes. The technology has been tested in more than 400 patients with more than 30,000 patches successfully applied to humans in Phase I and Phase II clinical studies involving multiple types of therapeutics.
Developing Fast-delivery Products
Zosano is strategically focusing on developing drug-delivery products for conditions that are best treated with “fast onset” delivery, Lamba told BioSpace.com. Taking that approach has led Zosano to develop products for quick treatment of hypoglycemia (ZP-Glucagon), migraine headaches (ZP-Triptan) and osteoporosis (ZP-PTH). Zosano expects to complete a Phase I study for its ZP-Triptan product by the end of this year.
Zosano completed a Phase I study of Weekly ZP-PTH for the treatment of severe osteoporosis in 2014, and plans to conduct a Phase II trial in the first half of next year.
“Fast onset is a very relevant therapeutic advantage,” Lamba says. It's also an advantage in expediting the availability of trial data. Once glucagon, a peptide hormone that raises the concentration of glucose in the bloodstream, has been given to the patient, “within a few hours, you can start collecting samples to see how the glucose levels perform. So, theoretically, you can start collecting data the same day.” The same is true of triptan when it is given to migraine sufferers, Lamba says.
Since 2006, the company has tested its technology in 30 different compounds, but took none of them beyond Phase II trials. “Now, for the first time, we are headed for commercialization.”
Patent Protection to 2027
To date, the company has been granted 22 patents for its drug-delivery technology and proprietary formulations. “Every time we develop a new formulation, we file new patent applications,” Lamba explains. As a result, the minimum patent protection for any of its formulations in development extends to at least 2027, he says.
All of the active pharmaceutical ingredients contained in the compounds the company works with have been used clinically for multiple years, with well-established safety and efficacy profiles, Lamba notes. As a result, its research costs are relatively low, with most of its R&D costs concentrated in the clinical development phase.
In addition to Lamba, Zosano's management team also includes President and Chief Operating Officer Konstantinos Alataris; Chief Scientific Officer and Executive Vice President Peter Daddona; and Chief Medical Officer Thorsten Von Stein, M.D.
Zosano reported its second quarter financial results in August. Zosano reported a net loss for the second quarter of 2015 of $7.6 million, or $0.63 per share on a basic and diluted basis, compared with a net loss of $3.9 million, or $0.76 per share on a basic and diluted basis, for the second quarter of 2014. Research and development expenses for the second quarter of 2015 were $5.0 million, compared with $2.8 million in the second quarter of 2014. The increase was primarily due to higher production costs related to the manufacturing of clinical trial materials for its Daily ZP-PTH, ZP-Glucagon and ZP-Triptan product candidates, the company says.
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