Avantor & Rubicon to Collaborate on Next-Generation Functional Excipients

Avantor Performance Materials recently announced it has signed a collaboration agreement with Rubicon Research Private LTD of Mumbai, aimed at combining the Indian company’s proprietary product technology with Avantor’s expertise in manufacturing and marketing to develop next-generation products for the functional excipient market.

The immediate goal of the partnership is to develop and market a novel gastro-retentive excipient that can enable the delivery of molecules having a window of absorption. Introduction of this novel excipient will enable the industry to develop more options in a niche segment where the benefit of targeted delivery will result in significant therapeutic advantage.

“We are delighted to be working with an exceptional partner like Rubicon in this development effort,” said Paul Smaltz, Executive Vice President of Pharmaceuticals and the Americas for Avantor. “The combination of Rubicon’s groundbreaking technology and our strong position in the global marketplace for functional excipients will result in outstanding products to help our pharmaceutical customers in their pursuit of patient dosage compliance and safety.”

The agreement calls for the companies to collaborate on key elements of the process of bringing new products to the pharmaceutical excipient market, including optimized commercial manufacturing and production, full regulatory registrations and approvals from the US Food and Drug Administration to move toward full commercialization and potential licensing of the excipient materials. The two companies said they would work to launch initial products resulting from the partnership in 2013.

“The Rubicon team is excited to work with Avantor in introducing this novel polymeric material as a functional excipient,” said Rubicon Research CEO Mrs. Pratibha Pilgaonkar. “This material will provide solutions to the global pharmaceutical industry for molecules with challenging therapeutic requirements, either from the pipelines of innovator companies or for life cycle management opportunities for already marketed products.”

Mr. Smaltz noted that the agreement is an example of Avantor’s commitment to seek innovative approaches to opportunities in the pharmaceutical area. “As we continue to be a trusted supplier of chemical compounds and materials, we’re also looking at similar arrangements to expand on our portfolio of drug delivery products and services, with the aim of providing even more value to our pharmaceutical customers in the future.”

Based in Center Valley, PA, Avantor Performance Materials manufactures and markets high-performance chemistries and materials around the world under several respected brand names, including the J.T.Baker, Macron Fine Chemicals, Rankem, BeneSphera, and POCH brands. For additional information please visit www.avantormaterials.com.

Rubicon Research, based in Mumbai, India, is a product development company recognized as a world-class outsourcing partner in pharmaceutical industry, serving Fortune 500 companies worldwide. For more information, visit www.rubicon.co.in.

Catalent Announces Drug Delivery Institute

Catalent Pharma Solutions recently announced the launch of its Catalent Applied Drug Delivery Institute at the 2012 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition, Chicago, IL.

The Catalent Applied Drug Delivery Institute aspires to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers and regulators to enhance understanding of available, emerging, and future drug delivery technologies and improve patient care.

“The mission of the Catalent Applied Drug Delivery Institute is to bring better treatments to market by advancing the development and adoption of applied drug delivery technologies,” stated Kurt Nielsen, PhD, Senior Vice President of Research and Development. “By harnessing the knowledge of some of the world’s leading experts in drug development, delivery, and formulation, the Institute will cultivate leadership and excellence in drug development through education, training, and innovation.”

As part of its mission, the Catalent Applied Drug Delivery Institute will serve as a link between industry and academia by providing guidance, counsel, and resources on major issues pertaining to drug development, delivery, and formulation. The Institute will develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory issues affecting drug developers and researchers. It also will pursue a multi-tiered approach of seed funding, strategic counsel, and educational programs to advance the adoption of emerging technologies.

Today is an exciting day for Catalent Pharma Solutions and the Catalent Applied Drug Delivery Institute, as well as for everyone working in the areas of drug delivery and development,” said Rao Tatapudy, Vice President of Scientific Affairs. “In launching the Institute at AAPS, we hope to start an informative and productive dialog between industry and academic experts that will spur innovation at the benchtop and in the marketplace. We look forward to a continuous series of successful collaborations as the Institute’s activities unfold.”

There will be a series of Institute-led initiatives designed to enhance understanding of drug delivery and inspire the next generation of science leaders. These initiatives, which will target both industry and academic audiences, will include:

-Applied Drug Delivery Events and Training Programs for Industry

-Innovation & Research Collaborations with Universities and Technology Companies

-Catalent Applied Drug Delivery Institute Scientific Journal

-Science Leaders of Tomorrow University Partnership Program

-Student Drug Delivery Guide

Annual Drug Delivery Landscape Technology Survey

-Scientific Communications

For more information about the Catalent Applied Drug Delivery Institute, visit www.drugdeliveryinstitute.com.

Unilife Develops Breakthrough Device Technologies

Unilife Corporationrecently announced the development of two new breakthrough platform technologies for targeted drug delivery that can enable and enhance patient outcomes for many acute and chronic conditions in which there are high rates of occurrence but limited treatment options available.

These proprietary device technologies for microliter doses and drug depot deployment have broad applicability for use across a number of important and fast-growing therapeutic areas, including targeted organ delivery to the eye, brain, ear, or liver, as well as the delivery of novel therapies, such as sirNA, microRNA, and gene therapy.

Unilife is pleased to announce the development of two distinct brand platforms that are ideally suited to the delivery of injectable therapies to the eye:

The Unilife Depot-Ject platform – enables a physician to precisely and intuitively implant a drug depot (solid or oil based substance) into a targeted region of the body, such as the eye, for the release of an active pharmaceutical compound in a consistent way over an extended duration of time.

The Unilife Ocu-Ject platform – enables the accurate, precise, and intuitive delivery of microliter-size doses to the eye. By significantly reducing the risk of over-dosing or under-dosing, Ocu-Ject devices can help maximize clinical outcomes, minimize patient pain, and enhance compliance with drug labeling.

Mr. Alan Shortall, CEO of Unilife, said: “Since commencing an ongoing collaboration with a global pharmaceutical company to develop a specialized device for targeted organ delivery, we have identified many additional areas where we have been able to leverage our proprietary technologies to address other unmet customer needs. There are many acute and chronic diseases that have been recognized by pharmaceutical companies as attractive areas for investment where the absence of a suitable delivery system has impeded the commercialization and widespread clinical adoption of promising injectable therapies. Our innovative device solutions for drug depot deployment and microliter dosing offer a wide range of opportunities to improve patient comfort and safety, optimize clinician convenience, and enable or enhance the commercialization of drugs designed for targeted or localized delivery to many areas of the body, including the eye. Having developed and patented these breakthrough platform technologies, we are pleased to advise that active discussions have already commenced with a number of interested pharmaceutical companies where we can enter into collaborations to address many of these fast-growing, high-value markets.”

Currently available device technologies for depot drug delivery have several challenges for clinicians and patients. Significant training is required for a clinician to deploy the drug into the target region of the body in a surgical environment. Conventional device technologies can potentially reduce clinical efficacy by damaging the drug, or harm and discomfort the patient, due to factors such as their non-intuitive steps of use, the precise angle at which the needle must be inserted and withdrawn, and the rapid velocity at which the drug is propelled into the target region of the body.

Unilife’s solution to these problems is the Unilife Depot-Ject platform, which leverages certain aspects of the Unifill system of automatic, user-controlled needle retraction technology. It allows pharmaceutical companies to supply their drug depot to clinicians in a ready-to-inject format, where they can intuitively and precisely implant the drug depot into the target region of the patient’s body using a standard one-handed technique. The ability for a clinician to accurately and precisely implant the depot can help to minimize the risk for internal injury to a target organ, and also reduce the risk of damage to the drug itself.

A video of the Depot-Ject can be seen at www.unilife.com. Certain aspects of the device have been blurred in the video for commercial purposes.

The Unilife Ocu-Ject platform enables the accurate delivery of microliter-size doses to the eye far more precisely than is currently possible with conventional devices. Under laboratory testing, the Ocu-Ject technology has been demonstrated to deliver a 10-microliter dose with a standard deviation of only 0.2 microliters (2% standard deviation) compared to a 1-mL tuberculin syringe of 2.9 microliters (31% standard deviation). This capacity to precisely delivery microliter doses can deliver a tenfold increase in compliance with drug labeling requirements.

To address specific customer, drug and patient requirements, each Ocu-Ject device can be customized in a variety of configurations including prefilled, with either an attachable or integrated retractable needle, or for filling at time of use. Unilife Ocu-Ject devices are designed for intuitive use by clinicians, employ ergonomic features and can help to minimize patient pain and safety.

Pharmaceutical and biotechnology companies seeking further information on the Unilife Ocu-Ject and Depot-Ject technology platforms are encouraged to contact Unilife at info@unilife.com, (717) 805 8607, or visit www.unilife.com.

EMD Millipore Announces Partnership With NIH Consortium

EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, recently announced it has entered into an agreement with an academic consortium funded by the NIH, to distribute more than 140 peer-validated neuroscience-specific monoclonal antibodies through its worldwide network.

This set of antibodies has been specifically requested by academic researchers for key targets in neuroscience research. The antibodies have been submitted and vetted through a formal process, led by academicians, and have been determined to be valuable and worthy of development in light of today’s neuroscience research priorities. These key targets in neurodevelopment, metabolism, oxidative stress, synaptic function, neurodegeneration, and disease have been tested in multiple species, including genetic knockout mice. In addition, the antibodies have been independently peer reviewed and research validated prior to being made available through EMD Millipore.

“EMD Millipore’s objective is to help our customers advance the study of neuroscience,” notes John Sweeney, Executive Vice President, EMD Millipore Bioscience Division. “We are excited about this partnership with the NIH consortium, one of the largest sources of medical research funding in the world. This partnership will enable us to provide access to this novel range of neuroscience antibodies in addition to others, allowing us to provide cutting-edge tools for researchers focused on metabolism, oxidative stress, synaptic function, neurodegeneration, and more.”

EMD Millipore is currently one of the top antibody manufacturers worldwide, with the majority of antibodies licensed and manufactured in California. A significant number of EMD Millipore’s antibody portfolio and technical expertise includes antibodies and research staff from Chemicon, Upstate, Linco, and Calbiochem, which were acquired by the company over the past several years. With its primary focus on quality and stringent validation, EMD Millipore’s antibodies are backed by its commitment to quality and a unique performance guarantee. For more information about EMD Millipore’s portfolio of antibodies visit www.emdmillipore.com/antibodies.

Foster Reports Increased Interest in Implantable Applications

Foster Corporation, a leader in custom medical polymers, recently reported increased interest in implantable medical device applications by polymer suppliers. While risk mitigation remains a primary concern, increased acceptance and application of polymers by device manufacturers for temporary and permanent implants presents opportunities for growth for performance polymers.

In the 1990s, there was an exodus of implant material suppliers following several high profile litigations, including breast and temporomandibular (TMJ) joint implants. Many material suppliers restricted supply for implant applications due to perceived risk and limited return. With the passage of the Biomaterials Access Assurance Act, created to protect implant material suppliers from civil liability, many suppliers have re-entered this growing market. Polyetheretherketone (PEEK), ethylene vinyl acetate (EVA), polyethylene (PE), and bioresorbable polymers are now considered the materials of choice for the implantable devices.

An increasingly common strategy by polymer companies for managing supply risk is to develop specific grades with enhanced manufacturing and testing standards for implant applications. Foster is increasingly collaborating with material suppliers to ensure applications are served with the appropriate grades. Foster estimates that 9 out of every 10 custom formulations require reporting of end use application to a material supplier for at least one of the constituents.

“The use of polymers in temporary and permanent implant devices is rapidly growing,” said Larry Acquarulo, Foster Chief Executive Officer. “Material suppliers who strategically positioned themselves for this market 10 years ago have benefited and paved the way for new suppliers and materials today. FDA 510(k) clearances of PEEK related devices are an excellent example. Companies introducing a new medical device for human use in the US market must first receive clearance from the FDA, the most common process is referred to as a 510(k). In 2001 there was only one FDA 510(k) clearance with PEEK polymer featured in the registered name of an implantable device. In 2011 there were 17 such clearances, and this year, there were 6 in the first quarter alone.”

“Another example is the explosion of medical implant applications using bioresorbable polymers,” continued Mr. Acquarulo. “According to the United States Patent and Trademark Office database, the number of patents issued referencing bioresorbable and medical grew from 48 in 2005 to 311 in 2011, a rise of 548%. In 2012, there have been 229 related patents issued year to date.”

For more than 2 decades, Foster has provided custom formulated polymer blends for medical applications, including minimally invasive and implantable devices. Similar to the dynamic growth of polymers and applications in minimally invasive devices at the end of the last century, Foster notes that the first decade of this century has seen similarly dynamic growth in polymers and applications for human implants. For more information, visit www.fostercomp.com.

Theravance & Merck Sign Major Cardiovascular Collaboration

Theravance, Inc.recently announced it has signed a collaboration agreement with Merck, known as MSD outside the United States and Canada, to discover, develop, and commercialize novel small molecule therapeutics directed toward a target being investigated for the treatment of hypertension and heart failure.

In exchange for granting Merck a worldwide, exclusive license to its therapeutic candidates, Theravance will receive a $5-million up-front payment, funding for research, and be eligible for milestone payments totaling up to $148 million for the first indication and royalties on worldwide net sales of any products derived from the collaboration.

“Despite years of medical advances, there remain significant unmet medical needs in the management of cardiovascular disease,” said Mathai Mammen, MD, PhD, Senior Vice President of Research and Early Clinical Development at Theravance. “Over the last several years, Theravance has gained significant insights into the design of novel molecules directed toward certain cardiovascular targets. We are pleased to be working with Merck, an industry leader in the development of innovative cardiovascular medicines, to bring new therapies to patients.”

“Merck remains committed to the discovery and development of new therapies for cardiovascular disease,” said Michael Mendelsohn, MD, Senior Vice President, Cardiovascular Research at Merck. “By combining Merck’s experience with the strengths of the Theravance team, we are well positioned to advance this new collaboration forward.”

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development, and commercialization of small molecule medicines across a number of therapeutic areas, including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. For more information, visi www.theravance.com.

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