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a little johnson & johnson story

  1. 5,330 Posts.
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    To anyone who may be a little concerned about the sp action I encourage you to read through the following and you may also come to understand exactly why management have never showed any hint of desperation or sugar coating in announcements, and have provided many indications over the past 2 years that our company have no need to raise any capital funding through s/holders...

    OBJ provides partnering services in the creation of next generation products in:
    •Transdermal and Intra-Dermal Drug Delivery
    •Therapeutic and Dermatological skincare
    •Cosmetic and non-medicinal active ingredient and peptide delivery
    •Oral Health strips,
    applicators and advanced technology tooth brushes
    •Haircare enhanced brushes and
    applicators
    •High Penetration surface hygiene technologies
    •Fabric and Carpet cleaning technologies
    •Advanced industrial surface interface systems


    OBJ operates as a technology partner providing IP opportunities, market exclusivity, magnetic array design, POC evaluations through to full manufacturing support.

    OBJ works closely with partner companies by providing knowledge and expertise in magnetic field design, POC and feasibility testing, technology integration, IP protection, product development and manufacturing support.

    jasetheace30 provided the following update with regards to the patent application OBJ's European Patent Attorney is working on:

    "A preliminary examination report in relation to OBJ's patent application in relation to invention "Method and Apparatus for Enhanced Diffusion" (listed as item #8 in the list of patent applications of OBJ at the beginning of this thread) was released by the European Patent Office on 1 June 2012. The relevant docs produced by the EPO in this regard can be accessed via the following link -
    Method and Apparatus for Enhanced Diffusion "As per usual, at the early stages of examination of most patent applications, the EPO has pointed out problems that need to be addressed by OBJ's patent attorneys. All good though, IMO ... the company is consistently prosecuting its patent applications for obvious commercial reasons."

    October 10, 2006
    Launch of Macroflux Corporation
    Macroflux Corporation has raised $75 million in an equity financing to create a new transdermal drug development company. Originally a group within ALZA Corporation, The Macroflux Corporation spin-out is being led by Nomura Phase4 Ventures, a specialist investor in healthcare. The syndicate includes significant investments from New Enterprise Associates (NEA) and funds managed by HBM Partners. The $75M financing will enable the company to progress several product opportunities through clinical development. ALZA Corporation, a wholly owned subsidiary of Johnson & Johnson, will retain an equity stake in the venture.



    Zosano’s lead clinical program is ready for Phase 3. ZP-PTH rapid delivery patch for the treatment of severe osteoporosis is being developed as an alternative to daily injections. The product delivers PTH 1-34, teriparatide (PTH), a compound that stimulates formation of new bone and reduces the risk of fractures. The ZP PTH product has also demonstrated greater than 2 year shelf-life without the need for refrigeration.

    23 November 2006
    Announces Power-Less Active Drug Patch
    OBJ Limited is pleased to announce the development of what is believed to be the first power-less active drug patch technology. The program was established to determine how OBJ’s expertise in non-contact active drug delivery techniques could be applied to create a new type of drug patch substrate with the ability to drive larger and more complex molecules through the skin. Traditional drug patches, such as those used in smoking cessation and hormone replacement, use a drug and adhesive matrix that relies on the slow migration of drug molecules from the matrix into the skin. This has restricted the commercial use of drug patches to simple molecules and low dose applications. The result is a novel biphasic material, the subject of a recently lodged patent application, that captures thermal energy from the body to create an active drug push. Unlike traditional drug patches it does not require the drug-adhesive matrix, and as a result can avoid the drug retention, disposal or adhesion problems currently facing traditional drug patches.

    09 January 2007
    "OBJ Limited is pleased to announce that Dr Ravi Kiron PhD, MBA, one of the authorities on drug delivery licensing and technology evaluation and former-Executive Director of ALZA Corporation, a division of the $200 billion US pharmaceutical company Johnson & Johnson, will advise OBJ on a consultancy basis to assist the growth of its transdermal drug delivery products and licensing business.
    Until recently, Dr Kiron was an Executive Director at ALZA Corporation where he was responsible for New Technology Assessment, Strategic Planning and Intellectual Property for the various ALZA delivery technologies supporting the Johnson & Johnson pipeline of compounds. ALZA has more than 30 products marketed in over 80 countries worldwide. Dr Kiron’s department brought in external complementary and innovative technologies to enhance ALZA’s own internal R&D delivery efforts. Dr Kiron was first introduced to OBJ’s novel non-contract drug delivery technology at the Drug Delivery and Licensing Conference in Singapore in June this year. He was in Perth recently to spend time with the OBJ management and development teams."

    September 27, 2007
    Macroflux Announces Name Change to Zosano Pharma, Inc.

    "Our name change reflects the positive evolutionary steps the company is taking to advance our innovative transdermal microprojection delivery system technology," said M. Cory Zwerling, CEO and president of Zosano Pharma. Zosano's Macroflux(R) transdermal microprojection delivery system provides unique benefits including convenient needle-free administration with room temperature stability for various therapeutic peptides, proteins, small molecules and vaccines. "Our transdermal system has been clinically tested in over 300 patients with four different peptides and a vaccine," said Peter Daddona, PhD, and chief scientific officer for Zosano. "In addition to product convenience and stability benefits, the system provides rapid and efficient drug delivery beyond existing injectable products."
    Zosano Pharma's lead program, Zosano(TM) PTH, is in Phase II development for osteoporosis. The trial is scheduled for completion in mid 2008. Zosano is also exploring other product opportunities for use with this delivery system. Based on demonstrated experience in prior clinical programs, the company is pursuing many therapeutic areas.

    30 September 2008
    In December 2007, the Company executed a new research collaboration agreement with a global healthcare company to evaluate its magnetic delivery platforms for OTC applications. The terms of the agreement and details of the feasibility project are subject to confidentiality; however the Company will receive payment for completion of the project. The agreement also deals with future collaboration and potential licensing rights that may arise following a successful feasibility. Should the technology achieve its success milestones, this project will provide significant industry validation of the OBJ delivery platforms.

    29 October 2008
    OBJ Signs Second Agreement
    OBJ Limited is pleased to announce that it has executed a second research collaboration agreement with a global Fast Moving Consumer Goods (FMCG) company to evaluate and optimise its proprietary DP and ETP drug delivery platforms for the transdermal delivery of an undisclosed compound. In December 2007, OBJ executed a research collaboration agreement with the same FMCG company to conduct an initial feasibility to evaluate the use of both the DP and ETP platforms for up to 2 compounds for over-the-counter (OTC) healthcare applications. The initial feasibility was successfully completed in March 2008. The FMCG company recently advised OBJ that it wished to conduct additional studies to further evaluate the magnetic delivery platforms for 1 of the previously tested OTC compounds.

    01 October 2009
    US Study Results
    OBJ Limited advises that it has now received the final report from Azopharma covering the Company’s research collaboration with a global Fast Moving Consumer Goods (FMCG) company. The study tested the delivery performance of OBJ’s Dermaportation and ETP technologies in a fully formulated patch format, when compared to an existing Over the Counter (OTC) drug product with significant international sales.

    09 November 2009
    Zosano Pharma, Inc. Announces Publication of Positive Phase 2 Study of its ZP-PTH Patch
    In the 165-patient study, the authors concluded that daily administration of ZP-PTH (teriparatide) for 24 weeks resulted in a significant gain in bone mineral density (BMD) of the lumbar spine over placebo (p<0.001) and that the 40 mcg coated transdermal patch increased total hip BMD compared to both placebo and FORTEO® 20 mcg subcutaneous injection (p<0.05).

    04 Nov 2009: Trading Halt

    04 Nov 2009: OBJ Enters into Materials Transfer Agreement with 3M
    OBJ wishes to advise shareholders that it has entered into a Materials Transfer Agreement (MTA) with 3M Corporation of St Paul, Minnesota USA, for the evaluation of the Company’s eM-patch® technologies as an approach to enhance transdermal drug delivery.

    2 December 2009
    Microneedle Patch System: Clinical Pharmacokinetics and Pharmacodynamics for Treatment of Osteoporosis
    ABSTRACT
    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 T1/2 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.

    Statistical Methods
    Pharmacokinetic parameters, AUC t, AUCinf, Cmax, Tmax, and t1/2 were calculated for each treatment and subject in the Phase 1 studies using non-compartmental analyses. The PK data of the Phase 1 and Phase 2 studies were also analyzed using a PK modeling approach. The data were analyzed using a subject-specific nonlinear regression model implemented in the NLME function in Splus 7.0 (Insightful Corp). The data were best described by a one-compartment disposition model with a biphasic slow and fast first-order absorption process for the ZP-PTH patch applications

    MATERIALS AND METHODS
    Titanium microprojection arrays were fabricated by photo/chemical etching and formed using a controlled manufacturing process. The ZP-PTH patch system consists of a 2 cm2 titanium microneedle array with 1,300 microneedles/2 cm2 arranged in a close-packed hexagonal design. Microneedles have an arrow-head shape with a length of 190 microns, maximum width of 115 microns, shaft width of 60 microns and thickness of 25 microns. The microneedle array is attached to an adhesive patch (Medical Tape 1523, 3M, St Paul, MN)
    Springerlink: Research Paper

    06 April 2010
    3M – Material Transfer Agreement
    The Company announced a Material Transfer Agreement (MTA) with 3M in November 2009 and a subsequent extension to the program in January 2010 to accommodate the broadening of the testing program. Following the completion of that initial phase, OBJ and 3M have agreed to extend the testing and to work closely with OBJ’s partners. 3M has granted permission to the release of the following commentary. “OBJ is pleased to announce that 3M has confirmed its interest in working with OBJ’s current or potential clients in patch development and/or contract manufacturing following testing performed by 3M Drug Delivery Systems’ laboratory in St Paul Minnesota.
    Pre-existing clinical program commitments at 3M Drug Delivery Systems facility will require the rescheduling of current testing. OBJ and 3M have agreed to a further 6 month extension of the MTA.

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    *Zosano Pharma: No announcements from November 2009 to October 2011
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    And no news from OBJ in regards to our FMCG#1 or 3M over the same period, although respectively Glyn did what he could to accomodate shareholders without placing any risk to confidentiality provisions of naming partner or major collaborator names...

    October 25 2010
    Material Transfer Agreement
    This program of work is now complete and the other party to agreement has reconfirmed its interest in OBJ continuing to recommend that party as a potential contract manufacturer for magnetic arrays to interested partners. The ongoing relationship remains important to OBJ as it provides an internationally respected GMP manufacturing capability for OBJ partners’ product requirements. Additionally, OBJ has agreed to share the results of a product performance enhancement program for two existing commercial patch products. This internal program will utilise the full magnetic micro-array development capabilities of OBJ's laboratory.
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    If it is indeed the granting of our patent application we await before any material deal is announced to the market, then we can only speculate on the timing, however if this ZP-PTH patch system from Zosano Pharma does indeed incorporate OBJ's technology then we can already confirm with 100% certainty the value a licensee is placing on it for the exclusive rights in only four countries - Japan, Korea, China, and Taiwan...

    10/10/2011
    Zosano Pharma & Asahi Kasei Pharma Enter Agreement for Transdermal Patch for Up to $132.5 Million
    Zosano Pharma, Inc. and Asahi Kasei Pharma Corporation recently announced they have entered into a long-term strategic collaboration for the development, commercialization, and supply of a weekly transdermal patch formulation of Teribone (teriparatide acetate), AKP's formulation of human parathyroid hormone (human PTH 1-34), for the treatment of osteoporosis patients with a high risk of fracture.
    Under the terms of the agreement, AKP has received exclusive rights to develop and commercialize the transdermal patch formulation of Teribone in Japan, Korea, China, and Taiwan. AKP is responsible for clinical and regulatory development and commercialization activities.
    The agreement was signed on February 22, 2011, although AKP and Zosano agreed not to disclose the agreement until the subcutaneous injection form of Teribone for osteoporosis patients was approved in Japan, which occurred on September 26, 2011. - Zosano Pharma & Asahi Kasei Pharma Enter Agreement for Transdermal Patch for Up to $132.5 Million

    Zosano Pharma






    Unique Delivery System
    Zosano's delivery system puts drug directly into skin for efficient drug delivery — benefits of an injection but without the needle





 
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