2010 DDP Awards: Technology Innovation Nominee: Topi-Click

Technology: The patented Topi-Click topical dosing applicator (TDA)

“Dose it easy and quick with Topi-Click.”

"We don’t put deodorant on with our hands so why do we ask patients to put topical meds on with their hands." The patented Topi-Click topical dosing applicator (TDA) provides a pill bottle’s ease of use with the dosing precision of syringes to solve this problem. Topi-Click provides an integrated applicator pad with a metered dosing clicker to overcome the non-compliance procedure of having to rub topical meds onto treatment areas with the hands. We know the hand is a great absorber of topicals; therefore, the patient is using the treatment area to rub a large percentage of the medicine into their hands. Using the hands can also increase chances of others accidentally being exposed to someone else’s prescription when holding or shaking hands. Very recently, a male topical testosterone drug was delayed approval by the FDA due to the concern of transference of prescription topicals to others. The Topi-Click directly addresses these concerns with needed innovation.

In addition, the audible clicker and tactile dosing feedback features of the Topi-Click allow patients to dispense a metered dose in a matter of seconds…even in complete darkness. The Topi-Click TDA protects the public and the drugs’ success with features that help promote and attain compliance. With easier compliance comes more treatment success, thus also protecting profitability. Next, by combining patented dosing applicator technology with custom designer bottle shapes, pharmaceuticals are differentiated and pipelines are guarded. Custom Rx TDA deserves to win because they help solve the growing topical dosing challenges with Topi-Click’s laser focused innovation of features: 1.Applicator Pad; 2. Audible & Tactile Feedback of Metered Dosing; 3. Innovative Shape and Design for Recognition. See clips of highlights from Oprah, Dr. Phil and The Doctors that demonstrate its use with hormone prescriptions at www.Topi-Click.com

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2010 DDP Awards: Pipeline Value Creation Nominee: Zogenix

DosePro™- the world’s first & only single use, easy to use, disposable, needle free injection system that removes the anxiety associated with a fear of needles Zogenix is a showcase example of a Specialty Phama Co with a foundation in Drug Delivery. Since inception in late 2006, Zogenix has raised $170MM in private capital, acquired and developed a unique drug delivery technology in combination with a drug product through full clinical development, NDA approval and U.S. launch. Zogenix drug delivery technology is called – DosePro™- the world’s first & only single use, easy to use, disposable, needle free injection system that removes the anxiety associated with a fear of needles. Zogenix made history in July 2009 when the U.S. FDA-approved the company’s NDA for the very first product ever that utilizes a pre-filled needle-free injection technology for the treatment of migraine and cluster headaches; SUMAVEL DosePro (sumatriptan for injection). A brief list of Zogenix achievements are below:

• Acquired and completed development of the DosePro single use, needle free injection technology.
• In licensed a single entity oral Hydrocodone product for pain that utilizes Elan’s SODAS controlled release drug delivery technology – Phase 3 initiation in Q1 2010.
• Licensed SUMAVEL DosePro to Desitin Pharma for commercialization in Europe. Desitin completed the pivotal registration study for SUMAVEL DosePro and filed for approval in Europe in October 09.
• July 09, the U.S. FDA approved the NDA for SUMAVEL DosePro
• August 09, signed U.S. co-promotion agreement with Astellas Pharma U.S.
• January 2010 U.S. launched SUMAVEL DosePro with Zogenix Neurology Sales force and Astellas Pharma Primary Care Physician Sales force.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Partnering Excellence Nominee: Ranbaxy Labs

Partnership: Excellence in company partnering strategies

The in-licensing team headed by Dr. Harvinder Popli has entered into 44 agreements in the last 5 years of operation. In-licensing as a function started in Ranbaxy in 2005. The agreements have been signed with innovation/technology driven companies from US, Europe and Asia. The deals were done primarily for the Indian market along with markets like Singapore, Malaysia, Vietnam, Cambodia, Myanmar, Philippines, Sri Lanka & in the Middle East region. The deals were signed in therapy areas of Clinical Dermatology, Asthetic Dermatology, CNS, Urology, Oncology, Pain Management, Neutraceuticals, Dental products, Respiratory etc. The in-licensing team is also responsible for pre-launch and project management activities for launching the licensed products within stipulated timelines. As a recognition to her unmatched passion and hard work, recently Dr. Harvinder Popli has been nominated as one of the top 20 business development professionals in the reputed European Business Development newsletter, EuroPlx Business Developer Nov/Dec'2009 edition; weblink.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Technology Innovation Nominee: Wallace H. Coulter Center for Translational Research, University of Miami

Technology: a novel Nanoparticle which offers unique targeted in vivo delivery of nucleic acids into Antigen Presenting Cells (APC) resulting in robust / protective immune responses.

The platform is not only ideal for “Genetic Vaccination” as it targets APC and activates helper T cells, it, incidentally, may be used as delivery of nucleic acids including siRNA into such mononuclear cells which has broad therapeutic applications. Wallace H. Coulter Center of the University of Miami is a technology development center for biomedical innovation. WHCC is unique in acting as a catalyst for moving innovative University of Miami research with commercial potential from the bench to industry.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Technology Innovation Nominee: Pradama, Inc.

Technology: Novel bone-targeting drug delivery technology

Pradama Inc. is a pharmaceutical company that creates multiple products for bone diseases and disorders using its novel bone-targeting drug delivery technology. Bone tissue is distinguished from other tissues by the presence of bone mineral, mainly hydroxyapatite. Pradama's bone-targeting agents have significant affinity for hydroxyapatite. Pradama’s bone-targeting agents have several advantages over other bone-targeting approaches, including; oral availability, therapeutic inactivity, stability and flexibility.


The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Technology Innovation Nominee: Isis Biopolymer

Technology: IsisIQ™ Patch

Isis Biopolymer, Inc., founded in 2006, is led by a team of experienced scientists and entrepreneurs accomplished at successful development and commercialization of medical devices, materials and systems design. The company has developed a major advance in intelligent non-invasive transdermal drug delivery, the IsisIQ™ Patch. The patch is a fully programmable, single-use, “band-aid-like” active patch that controls and monitors transdermal drug delivery; ensuring safe and accurate administration through the skin using iontophoresis. An innovative solution to the challenges of today’s transdermal drug delivery systems, the IsisIQ™ Patch features a proprietary selective barrier membrane that facilitates the transport or complete cessation of drug molecules through the skin. Drug transport can be modulated for up to three drugs per patch and is fully programmable for customized delivery and monitoring via an integrated wireless communication platform. The unique single electrode design eliminates variability in drug delivery that can occur with changes in the skin due to temperature, moisture and movement; preventing inadvertent or over delivery of drug. The IsisIQ™ Patch is also a biosensor that can detect skin emanations, which may be indications of medical events such as heart attached, shock or diabetic reactions. Breakthroughs in pliable polyester substrate and hydrogels support lower cost development and manufacturing, as well as a more diverse range of delivery of drugs than is currently available. Moving forward, Isis Biopolymer technology will expand the worldwide multi-billion dollar market for transdermal delivery of existing and drugs in development for pain management, oncology, neurology, endocrinology, cardiovascular, CNS disorders, as well as therapies for chronic and acute conditions. Isis Biopolymer has developed not only the technology to revolutionize transdermal drug delivery, but also make it affordable as a result of our materials and manufacturing processes based here in the United States. Isis is focused on providing revolutionary (and cost-effective) transdermal drug delivery and biosensors to improve patient compliance and generate better health care outcomes.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Pipeline Value Creation Nominee: Halozyme Therapeutics

Value Creation: Halozyme’s EnhanzeTM Technology for improvements patient-centric dosing

Halozyme’s EnhanzeTM Technology is a novel drug delivery platform designed to increase the subcutaneous absorption of biologics and to convert biologics from intravenous to subcutaneous route of administration. Two products utilizing EnhanzeTM Technology entered Phase III studies in 2009, creating significant value for the pipelines of Halozyme’s partners. As part of the Halozyme-Roche collaboration, subcutaneous formulation of HERCEPTIN® (trastuzumab) with EnhanzeTM entered a Phase III study in 2009. HERCEPTIN® is currently administered intravenously. EnhanzeTM Technology is anticipated to allow patients with HER2-positive breast cancer to administer HERCEPTIN® themselves with or without the support of a healthcare professional via a simple subcutaneous injection.

As part of the Halozyme-Baxter collaboration, subcutaneous GAMMAGARD® Liquid [Immune Globulin Intravenous] 10% (IGIV) with EnhanzeTM Technology entered a Phase III study in 2009. GAMMAGARD® is currently administered intravenously. Subcutaneous administration of GAMMAGARD® with EnhanzeTM could allow patients to receive a full monthly dose in a single injection site in their home setting, in contrast to other subcutaneously administered immune globulin products that require weekly administration at multiple injections sites simultaneously.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Partnering Excellence Nominee: Partners in Care

Partnership: Partnering across the health value chain

Partners in Care has used technology to identify gaps in care, communicate the adherence/persistence needs in chronic care to providers and suppliers, and produce exemplary results in total health management. Where others thought disease management could deliver, Partners in Care showed that patient centered care, through PCMH as well as Care Coordination Entities (expanded care teams armed with data and solutions), could deliver a better dividend that mattered to the patient, the employer and the health plan. They can create these replicable and sustainable results to drive value and increase financial strength across the entire supply chain. That drives value to the demand side of the chain, and THAT drives value across the whole health value chain--promoting individual health, physician competence, and community health.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Partnering Excellence Nominee: Dicerna Therapeutics

Partnership: Harnessing Second Generation RNAi Therapeutics using Dicer Substrates (DsiRNA)- $1.4B Oncology Partnership with Kyowa Hakko Kirin, Japan

Dicerna's patented Dicer Substrate technology is a "second-generation approach" to small interfering RNA (siRNA). DsiRNAs enter the pathway at an upstream point compared to a siRNA. While siRNAs are generally 21 nucleotide base pairs, DsiRNA molecules are 25 base pairs or longer. The combination of properties of extraordinary potency (multiple single-digit picomolar DsiRNAs against the target of choice), duration of action and ability to manipulate the molecule for delivery purposes is what distinguishes DsiRNAs from other siRNA molecules. Dicerna has validated two approaches for delivery: nanoparticle systems, and a second approach of integrated DsiRNA delivery systems, which are "double-punch” molecules with a payload and a targeting moiety attached that would be injected as a molecule without the need for formulating in particles for delivery.

On January 4th, 2010 Dicerna and Kyowa Hakko Kirin announced their partnership to discover, develop and commercialize drug delivery systems and siRNA medications using Dicerna's Dicer Substrate Technology for undisclosed oncology targets. The deal potentially could garner Dicerna more than $1.4 billion and is the largest target-based RNAi deal to date. Under its partnership with KHK, Dicerna stands to gain $4 million up-front cash payment and up to $120 million in research funding and development and commercial milestones for the exclusive rights to one oncology target, with the firms having the option to expand the collaboration for up to 10 targets under similar terms. The partnership also includes a 50-50 co-promotional and profit-sharing option for the initial target in the U.S.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Technology Innovation Nominee: University of California at San Francisco

Electron tomography and image reconstruction technology to field monitor and determine the structure of highly dynamic proteins, such as antibodies, high-density lipoproteins and low-density lipoproteins Antibodies have been used as a drug delivery vehicle for years. With the drugs bonding to antibodies as the conjugated antibody, some conjugated antibodies may lose their function to bond to the target cell. To discover the reason for improving the drug delivery efficiencies, the structure of the conjugate is usually needed. However, structural determination of the dynamic antibody is not available by current technology, so we developed the electron tomography and image reconstruction technology which allow us to determine each individual antibody structure at about 10A resolution. By using this technology, we have discovered the conformational change of the antibodies after being bound to drug. Thus, this method has a general impact to field monitor and determine the structure of highly dynamic proteins, such as antibodies, high-density lipoproteins and low-density lipoproteins.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards Nominee: Technology Innovation Nominee: Elan Drug Technologies

Elan Drug Technologies’ NanoCrystal® technology is truly one of the most successful drug delivery technology innovations in the past ten years. Designed to overcome issues associated with poor water solubility, ten years since its first filing with the FDA, it has gone on to achieve product in-market sales for clients in excess of $7.8B.

Five products are now launched in over 100 territories worldwide incorporating this technology. Rapamune® (Wyeth) immunosuppressant, which was launched in 2001, eliminated need for refrigeration of tablet product and provided a 23% improvement in bioavailability. Emend® (Merck) was launched in 2003 for the treatment of nausea and vomiting with a 600% improvement in bioavailability, the product was successfully launched in Japan at end of 2009. TriCor® 145, which provided improved bioavailability and minimal food effect, was launched by Abbott in 2004. Megace ES®,, for cachexia in AIDS patients, was launched in 2005 with a 28% improvement in bioavailability, with a free from food effect. In August 2009, the first once- monthly schizophrenic injectable depot formulation, INVEGA® Sustenna™, was launched by Janssen using this technology.

Since 2001, 11 products using our technologies have been launched for our clients in over 100 countries worldwide, making us the most successful drug delivery company in the past decade. We believe more than any other drug delivery company we have developed superior, commercially successful technologies for our clients.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Partnering Excellence Nominee: Genzyme

Genzyme Pharmaceuticals has built several strong strategic relationships with companies such as SurModics Pharmaceuticals and Pharmidex Pharmaceuticals in the area of drug delivery. The collaborations span functional areas from business development to science to marketing and draw upon available strengths and resources in an innovative way. This year for example, Genzyme Pharmaceuticals and SurModics Pharmaceuticals hosted an educational webinar on the collaborative service technology Design for Peptide DeliverySM (www.d4pd.com) with scientists from each company speaking on the scientific background and benefit of the service. The processes of communication and follow up within the strategic relationships are exemplary examples of how collaborations do work to create more value and business for both parties in the long term.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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2010 DDP Awards: Partnering Excellence Nominee: Altea Therapeutics

The Altea Therapeutics PassPort® System is a breakthrough transdermal technology for the convenient and painless delivery of currently injected biologics from a small skin patch.

Altea Therapeutics is developing and commercializing initial products with leading pharmaceutical companies and has partnered with Amylin Pharmaceuticals, Inc. and Eli Lilly and Company to develop and commercialize a novel daily transdermal patch delivering sustained levels of exenatide (currently marketed as Byetta®). The Company also has a partnership with Hospira, Inc. to develop and commercialize a transdermal patch for delivering enoxaparin sodium (currently marketed as Lovenox®) utilizing the PassPort® Transdermal Delivery System.

Most recently, Altea Therapeutics announced a partnership with KAI Pharmaceuticals, Inc. for the preclinical and clinical development of certain KAI proprietary peptides utilizing Altea’s proprietary transdermal technology. Additionally, Altea Therapeutics is partnered with several pharmaceutical companies to conduct feasibility studies on certain proprietary compounds.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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