Fremont, CA, United States
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Daddona P.E.,Zosano Pharma | Matriano J.A.,Zosano Pharma | Mandema J.,Quantitative Solutions Inc. | Maa Y.-F.,Zosano Pharma
Pharmaceutical Research | Year: 2011

Objectives: To evaluate the clinical PK/PD of PTH(1-34) delivered by a novel transdermal drug-coated microneedle patch system (ZP-PTH) for the treatment of osteoporosis. Methods: Phase 1 PK studies evaluated the effect of site of administration, patch wear time and dose in normal volunteers, ages 40-85 yrs. Phase 2 was conducted in post-menopausal women with osteoporosis to determine the patch dose response compared to placebo patch and FORTEO® injection. Results: Phase 1 ZP-PTH patch delivery demonstrated a rapid PTH plasma pulse profile with Tmax 3 times shorter and apparent T 1/2 2 times shorter than FORTEO®. In Phase 2, ZP-PTH 20, 30 and 40 μg doses showed a proportional increase in plasma PTH AUC. Inter-subject and intra-subject AUC variability was similar for all patch doses and comparable to injection. All patch doses produced a significant increase in spine bone mineral density. Unexpectedly, ZP-PTH also produced an early increase in hip bone mineral density, an effect not observed with the injection. Conclusions: These studies suggest that this novel ZP-PTH patch system can deliver a consistent and therapeutically relevant PTH PK profile. Based on encouraging Phase 2 safety and efficacy data, the program is advancing into a pivotal Phase 3 clinical study. © 2010 Springer Science+Business Media, LLC.


Patent
Zosano Pharma | Date: 2014-08-22

There is provided glucagon formulations suitable for preparing coatings on microneedle patches for the transdermal delivery of glucagon. The coated patches may be used for the treatment of low blood sugar in diabetic patients. Also provided are glucagon loaded patches, methods for their preparation, and methods of their use.


Patent
Zosano Pharma | Date: 2014-07-30

A low-profile applicator, and a method of manufacturing and use thereof, for impacting microneedles against the stratum corneum of a person having a housing, a diaphragm member having the microneedles, a folding member having interlinking members that hinge-ably rotate with a force member, operatively attached thereto, between a resting position and an extended position. The folding member translates energy stored within the force member when release while retaining the force member in an energized state when in the resting position.


FREMONT, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), an emerging central nervous system company focused on providing symptom relief to patients using the Company's proprietary intracutaneous delivery system, today announced financial results for the fourth quarter and year ended December 31, 2016. “The past year was an important period of progress for the Company as we initiated and in the fourth quarter completed ZOTRIP, our pivotal efficacy trial in migraine,” commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. “Subsequent to the fiscal year end, we announced positive results from the ZOTRIP trial, which not only advances our lead migraine program towards FDA approval but also further validates the effectiveness of our technology platform. If approved, M207 could be an important new therapeutic option for migraine patients.” The ZOTRIP trial was designed to be a registration-enabling, pivotal efficacy trial of M207 as an acute treatment for migraine. The study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the United States. Dosing of ZOTRIP’s first subject was announced in July of 2016. This past November, the Company announced the completion of ZOTRIP’s enrollment. Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 30 million men, women and children in the United States suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States. M207 is our proprietary formulation of zolmitriptan coated onto our patented intracutaneous microneedle patch, which is then applied with our proprietary applicator to ensure uniform and consistent application. In a Phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society. Financial Results for the Year Ended December 31, 2016 Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications.  The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com. This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K.. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.


News Article | December 2, 2014
Site: www.fiercebiotech.com

Eli Lilly has stepped in to ink a worldwide license on Zosano Pharma's recipe for parathyroid hormone 1-34 dubbed ZP-PTH, which is delivered via its microneedle patch system to treat osteoporosis. The drug has wrapped Phase II and is now on the threshold of a late-stage program. Fremont, CA-based Zosano, a spinoff of J&J ($JNJ), gets a relatively small $15 million equity buy-in from Lilly ($LLY) when it completes the IPO it filed for last summer as well as up to $425 million in regulatory and sales milestones. If the therapy makes its way to an approval, Zosano will handle the manufacturing while Lilly will have the commercial sales rights. Zosano filed for a $65 million IPO in June. Earlier this year the biotech company inked a deal with Novo Nordisk ($NVO) to use its delivery tech on the diabetes drug semaglutide. "The treatment of osteoporosis has advanced significantly in recent years, and if approved Zosano's microneedle patch system could offer a potentially innovative way to deliver this important medicine," said David Ricks, president of Lilly Bio-Medicines. "Zosano shares our commitment to making life better for the tens of millions of people with osteoporosis around the world, and we look forward to helping advance this potential innovation to improve the patient's experience." Related Article: Biotechs queue up for $269M in fresh IPOs amid a sector rebound


DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/zxjf6n/global_insulin) has announced the addition of the "Global Insulin Patch Market Opportunity Analysis" report to their offering. Highly advanced technology like ultrasound and iontophoresis are being used for the development of modern insulin patches. Depending upon the type of technique, their prices may vary which may be out of reach of several patients. In long-term, it would be considered as inexpensive but high upfront cost may deter some diabetic patients. Benefits like greater control over blood glucose levels and ease of utilization are one of the most significant benefits of these technologies. It is expected that investigators would also explore the techniques like electroporation, thermal ablation and microdermabrasion for making insulin patches. These techniques are expected to increase the cost effectiveness due to which their market penetration would increase. In coming years, it is expected that investigators would be able to come forth with insulin patches having higher pharmacological benefits with lesser prices. Besides this, newer modalities are also expected to be developed due to which more sales are expected to be generated. Development of insulin patches are expected to pave the path for the development of large molecule based transdermal patches. This is going to be a major technological success due to which large number of patients would get more therapeutic benefits. Due to increased indications, more revenues are expected to generate from this field. Both molecules and formulations have to be revisited that will lead to new innovations. Moreover, pharmaceutical companies engaged in the production of insulin patches may venture in other diseases segment by using same technology. Insulin patches have yet not made place in global market but they will definitely encourage the other pharmaceutical companies to follow the lead. Pharmaceutical companies are expected to launch the first insulin patch in global market in next few years.


(http://www.researchandmarkets.com/research/7qn2gf/global_insulin) has announced the addition of the "Global Insulin Patch Market Opportunity Analysis" report to their offering. Highly advanced technology like ultrasound and iontophoresis are being used for the development of modern insulin patches. Depending upon the type of technique, their prices may vary which may be out of reach of several patients. In long-term, it would be considered as inexpensive but high upfront cost may deter some diabetic patients. Benefits like greater control over blood glucose levels and ease of utilization are one of the most significant benefits of these technologies. It is expected that investigators would also explore the techniques like electroporation, thermal ablation and microdermabrasion for making insulin patches. These techniques are expected to increase the cost effectiveness due to which their market penetration would increase. In coming years, it is expected that investigators would be able to come forth with insulin patches having higher pharmacological benefits with lesser prices. Besides this, newer modalities are also expected to be developed due to which more sales are expected to be generated. Development of insulin patches are expected to pave the path for the development of large molecule based transdermal patches. This is going to be a major technological success due to which large number of patients would get more therapeutic benefits. Due to increased indications, more revenues are expected to generate from this field. Both molecules and formulations have to be revisited that will lead to new innovations. Moreover, pharmaceutical companies engaged in the production of insulin patches may venture in other diseases segment by using same technology. Insulin patches have yet not made place in global market but they will definitely encourage the other pharmaceutical companies to follow the lead. Pharmaceutical companies are expected to launch the first insulin patch in global market in next few years. "Global Insulin Patch Market Opportunity Analysis" Report Highlights: - Introduction to Insulin Patch - Mechanism Iontophoresis, Ultrasonic & Microneedle Insulin Patch - Global Insulin Patch Market Analysis - Global Insulin Patch Clinical Pipeline by Company, Indication & Phase - Global Insulin Patch Clinical Pipeline: 9 Patches - Highest Phase of Insulin Patch Development: Phase-II - Insulin Patch Patent Analysis Key Topics Covered: 1. Introduction to Insulin Patch 2. Comparison between Insulin Patches & Other Insulin Modalities 3. Mechanism of Insulin Patches 4. Emerging Trends in Insulin Delivery 5. Global Insulin Patch Market Analysis 6. Global Insulin Patch Market Dynamics 7. Future Prospects of Insulin Patch Market 8. Global Insulin Patch Clinical Pipeline by Company, Indication & Phase 9. Discontinued Insulin Patch in Clinical Pipeline 10. Competitive Landscape - Dermisonics - Encapsulation Systems - Encapsulife - Mesoblast - NeurogesX - NOLabs AB - Novo Nordisk - Phosphagenics - Relmada Therapeutics - Zosano Pharma For more information visit http://www.researchandmarkets.com/research/7qn2gf/global_insulin


FREMONT, Calif., Nov. 08, 2016 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), an emerging CNS company focused on providing rapid symptom relief to patients using the Company's proprietary intracutaneous delivery system, today announced completion of enrollment in its registration-enabling, pivotal efficacy trial (the Zotrip trial), of M207 for the treatment of acute migraine. “The completion of enrollment in the Zotrip study is a major milestone for the Company and bolsters our confidence in the previously announced availability of trial data in the first quarter of 2017,” commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. “The enrollment pace is also indicative of the urgent need for improved treatment options for those suffering with acute migraine.” The pivotal efficacy trial is a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0 mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Patients were recruited and enrolled in the Zotrip trial at 36 centers across the United States. Subjects recruited into the Zotrip trial had a history of at least one year of episodic, acute migraines with or without aura. Upon recruitment, the subjects enter a run-in period that ensures they meet the key eligibility criteria of 2-8 migraine attacks per month, which is documented using an electronic diary. Successfully screened subjects are then randomized into the treatment/dosing period in which they have 8 weeks to confirm and receive blinded treatment for a single migraine attack. In regards to the Company’s discussions with the FDA and the FDA’s October 2014 Draft Guidance—“Migraine: Developing Drugs for Acute Treatment,” the co-primary endpoints of this study are: The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study, will be sufficient for approval under a 505(b)(2) pathway. The Company intends to conduct the safety study after completion of the Zotrip trial. M207 is Zosano’s proprietary zolmitriptan-coated microneedle patch that is designed to rapidly deliver zolmitriptan during a migraine attack. In a phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society. The Company believes M207’s injection-free mode of delivery has the potential to provide an attractive solution for acute migraine sufferers. Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications.  The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use.  The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies.  Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com. This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in our 2015 Annual Report on Form 10-K, as filed with the Securities Exchange Commission on March 29, 2016. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.


News Article | November 9, 2016
Site: globenewswire.com

FREMONT, Calif., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), an emerging central nervous system company focused on providing rapid symptom relief to patients using the Company's proprietary intracutaneous delivery system, today announced financial results for the third quarter ended September 30, 2016. “I'm extremely pleased with progress achieved during the period across clinical and corporate development fronts. The announcement of the first subject dosing in the Zotrip trial for the acute treatment of migraine was, of course, a key milestone and we remain on track to report results during the first quarter of 2017. Additionally, we improved our balance sheet by executing a private placement and strengthened the leadership team with the appointment of Georgia Erbez as Chief Business Officer,” commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. Ms. Erbez, who continues to serve as Zosano's Interim Chief Financial Officer, has provided financial and strategic advisory services as a consultant to multiple biotechnology companies and has extensive experience in senior management roles in the healthcare sector. In July, Zosano announced the dosing of its first subject in its registration-enabling pivotal efficacy trial (the Zotrip trial), of its M207 patch, formerly known as ZP-Triptan, for the acute treatment of migraine. The results from Zotrip are expected to be reported in the first quarter of 2017. Furthermore, Zosano has confirmed with the U.S. Food & Drug Administration (FDA) that a single, positive, pivotal efficacy study, in addition to a one-year safety study, will be sufficient to file for registration under the 505(b)(2) pathway. In August, Zosano announced the completion of a private placement that generated aggregate gross proceeds of approximately $7.5 million. Financial Results for the Third Quarter Ended September 30, 2016 Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications.  The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com. This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in our 2015 Annual Report on Form 10-K, as filed with the Securities Exchange Commission on March 29, 2016. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

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