Thermo Fisher Scientific Introduces New Imaging ATR Accessory

Thermo Fisher Scientific Inc., a world leader in serving science, recently announced the launch of a new imaging attenuated total reflectance (ATR) accessory offering enhanced spatial resolution and high-speed data acquisition capabilities for Fourier transform infrared (FT-IR) chemical imaging applications. The Thermo Scientific imaging ATR accessory has been designed to seamlessly and effortlessly integrate with the Thermo Scientific range of FT-IR microscopes to enable efficient, fast, and reliable chemical imaging of challenging samples. This is of particular benefit to manufacturers of composite structures, paper products, pharmaceutical dosage forms, biological tissues, polymer films, and coatings. The product was showcased recently at the JAIMA Expo 2011 in Makuhrai Messe, Japan.

ATR is a popular sampling technique for infrared spectroscopy, allowing direct contact sampling of solids and liquids without further preparation. When coupled with an FT-IR microscope, ATR provides a unique capability for exploring the microscopic structure of heterogeneous samples. Single point ATR mapping, while more flexible in terms of total image size and dimensions, requires many separate contact points to build up the imaging data set. The Thermo Scientific imaging ATR accessory provides a more rapid method because it requires the sample to be compressed only once against an extended area of contact. Data collection may then proceed at the same speed as normal transmission or external reflectance experiments.

The new imaging ATR accessory greatly simplifies the task of obtaining high-quality infrared spectra in cases of samples that are difficult to prepare for transmission analysis. Observable features in specimens, such as defects, particles, fibers, or inks, may be effectively analyzed with spatial resolution improved by a factor of four relative to transmission measurements. The accessory quickly snaps into the sample holder feature of Thermo Scientific Nicolet iN10, Nicolet iN10 MX, and Nicolet Continuµm microscopes in a matter of seconds without the need of tools. All standard microscope optics remain available, thus avoiding any concerns of alignment or down time when switching between sampling modes. Transmission, external reflection, micro-ATR, and imaging-ATR capabilities are all immediately available to address the requirements of any FT-IR microscopy application.

For more information about the new Thermo Scientific imaging ATR accessory, please call (800) 532-4752, e-mail analyze@thermofisher.com, or visit www.thermoscientific.com/ftir.

Thermo Fisher Scientific Inc.’s mission is to enable its customers to make the world healthier, cleaner, and safer. With revenues of nearly $11 billion, it has approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. The company creates value for its key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Its products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

Ambrx & BMS Announce $24-Million Collaboration for Novel Biologics Programs

Ambrx, Inc. and Bristol-Myers Squibb Company recently announced a collaboration under which Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop, and commercialize biologics based on Ambrx’s research surrounding the Fibroblast Growth Factor 21 (FGF-21) protein, for potential use in treating type 2 diabetes, and the Relaxin hormone, for potential use in treating heart failure. Derivatives of FGF-21 and Relaxin were developed using Ambrx’s unique ReCODE platform technology to modify the native proteins with amino acid building blocks beyond the common 20 to engineer enhanced versions for investigation for therapeutic use.

Under the terms of the agreement, Bristol-Myers Squibb will make an up-front payment of $24 million to Ambrx. In addition, Bristol-Myers Squibb will make potential milestone payments and royalty payments on worldwide sales for both programs. Bristol-Myers Squibb and Ambrx will also enter research collaborations for both programs.

FGF-21 is a naturally occurring protein that has been characterized as a potent metabolic regulator, and has been shown to lower blood glucose, elevate good cholesterol, and promote weight loss in preclinical studies. The lead compound in this program, ARX618, or PEG-FGF-21, is in the final stages of preclinical development.

Relaxin is a naturally occurring hormone known for its role in pregnancy and childbirth. Preclinical studies suggest Relaxin may aid in the treatment of heart failure by improving cardiac function. This program is in preclinical development.

“Bristol-Myers Squibb has a strong heritage discovering, developing, and delivering medicines to treat diabetes and cardiovascular disease,” said Francis Cuss, Senior Vice President, Research, Bristol-Myers Squibb. “As part of our String of Pearls strategy, we seek to build relationships with companies that have innovative programs and capabilities that complement our own internal efforts. We are excited to be working with Ambrx, which has used its unique ReCODE technology to create precisely engineered investigational biologics in both of these therapeutic areas. Our combined expertise will provide the best chance of bringing these innovative medicines to patients.”

“These programs have shown tremendous potential in preclinical studies, and we believe that Bristol-Myers Squibb has the necessary expertise to best lead their continued development,” added Added Simon Allen, Chief Business Officer of Ambrx. “We look forward to using the revenues from this partnership to continue to grow our internal pipeline, which includes our promising antibody drug conjugate programs.”

Ambrx Inc. is a clinical-stage biopharmaceutical company using its broad biologics platform to create best-in-class therapeutics, including antibody drug conjugates and proteins with improved pharmacologic properties. The company has validated its biologics platform through additional partnerships with Pfizer and Merck & Co Inc. Ambrx is advancing a robust portfolio of product candidates that are optimized for efficacy, safety and ease of use in multiple therapeutic areas.

Loxbridge & Dr. Kary Mullis Announce the Formation of Altermune Technologies

Dr. Kary Mullis, the Nobel Prize-winning inventor of the Polymerase Chain Reaction (PCR), the cornerstone of much of today’s DNA science, has entered a new joint venture with Loxbridge Research LLP to form Altermune Technologies LLC, focused on the development of novel therapeutics to combat resistant pathogens such as MRSA, C. difficile, pseudomonas, and pandemic influenza.

Dr. Mullis takes on the role of Chief Scientific Officer while Dr. Charles Roberts, CEO of Loxbridge, becomes President of Altermune for the initial developmental period. Loxbridge will provide a milestone-based seed-funding funding package worth US $7 million.

Altermune is pioneering the use of “programmable immunity.” This involves re-tasking antibodies that are ubiquitous in all humans, present at a high background level, and which are ordinarily not tasked by the body in fighting infections.

Altermune uses “linker” molecules to redirect these antibodies to selected pathogens. The linker molecules work through having two distinct ends. One end binds a consistent cell-surface target on the pathogen using an aptamer (a single stranded oligonucleotide), and the other end presents specific epitopes that attract the circulating antibodies.

Once attached to the pathogen, via the Altermune linker, the antibodies then activate a full immune response, heightened because they are the individual’s own endogenous antibodies, not synthetic administered ones. The approach therefore harnesses the power of the immune system, yet circumvents the disadvantages of administering monoclonal antibodies, such as immunogenicity and high costs.

Altermune has a strong team of in-house scientists, and a wide network of partnerships, including collaborative research arrangements with a number of leading Universities in the US and Europe and corporate relationships with leading companies in oligonucleotide synthesis and aptamer selection.

“We are very excited about entering a joint venture with an innovator with such an awe-inspiring track record,” said Dr. Roberts. “The initial priority is to build on the compelling proof of concept of the Altermune platform, demonstrated in vivo against influenza – and against anthrax by US Air Force scientists – into a broad pipeline of compounds against clinically and commercially relevant pathogens, to undergo FDA approval.”

“We chose to proceed with Loxbridge over other suitors because, unlike our other potential funders, the investment is smart money that comes with project management and hands-on commercial expertise,” added Dr. Mullis. “It seems to work very well that the investor is also the entrepreneur, able to pilot the project. This structure frees me from ongoing business administration, and enables me to focus on the science.”

Unigene Divests Non-Core Asset & Focuses Resources on High Valuation Drug Development & Peptide Delivery

Unigene Laboratories, Inc. recently announced it has divested its non-core asset, Site Directed Bone Growth (SDBG) by assigning seven patent applications to Kieran Murphy, LLC. In addition, Unigene terminated an Exclusive License Agreement and Consulting Agreement with Kieran Murphy, LLC, as well as a License Option Agreement and Research Agreement with Yale University. In exchange for the assignment of the patents, Unigene will receive sales royalties in excess of 7% and will receive 40% of any future licensing revenue and/or 40% of all considerations received upon the subsequent sale of the SDBG patent portfolio by Kieran Murphy, LLC.

Kieran Murphy, LLC is a development-stage company founded by the internationally renowned clinical key opinion leader Dr. Kieran Murphy. Dr. Murphy is the Vice Chair and Chief of Medical Imaging at the University of Toronto in Toronto, Ontario. He recently left Johns Hopkins Hospital, where he was the Director of Interventional Neuroradiology from 1998 to 2008. He has published over 100 peer-reviewed articles and has over 50 patents pending or issued worldwide. He is considered to be one of the most innovative specialists in the use of radiology guidance in the treatment of vascular brain and spinal disorders.

“I recognize the tremendous value in the Site Directed Bone Growth Program and also recognized Unigene’s need to focus on the strength of its oral delivery platform and cleanly exit the collaboration we began several years ago,” said Dr. Murphy. “With the IP necessary to exploit this invention squarely in the hands of my company, we will quickly be able to move SDBG into a proof-of-concept study in a target population investigating the effect of bone compatible cements in combination with a bone anabolic agent on new bone growth in vertebral body adjacent to a vertebra undergoing vertebroplasty. Once the relevance and superiority of this approach is established, our intent is to identify and license potential partners within the medical device space who recognize how important the addition of a biologic is to the surgical outcome.”

“SDBG was the one remaining non-core asset that did not fit Unigene’s high-valuation drug development and oral peptide drug delivery strategy,” added Greg Mayes, Vice President of Corporate Development and General Counsel of Unigene. “We have now found an excellent home for this otherwise valuable asset. We have every confidence that Dr. Murphy will apply the right resources and expertise to quickly demonstrate proof of concept and license out the opportunity to one or more competent commercialization partners. With more than 7% royalties and 40% of any licensing or sales proceeds, Unigene will more than recoup what it has invested in the SDBG program to date and should ultimately secure a satisfactory return on its investment. We wish Dr. Murphy every success with the Program.”

In divesting its SDBG patent portfolio, Unigene also terminated its License Option Agreement and Research Agreement (which expired May 31, 2010) with Yale University. Unigene had previously been working with Yale Professor Agnes Vignery and filed a number of patent applications covering the SDBG Patent Portfolio. Unigene has terminated these agreements and returned a number of patent applications to Yale University.

First Application of Haselmeier’s Injection Pen Launched

Haselmeier recently announced that the first application of its Axis-D pen platform has been launched. Commissioned by its client Merck Serono, a division of Merck KGaA, Germany, the new injection device has been designed to allow self-injection by patients of a ready-to-use biopharmaceutical solution for injection.

“With the Axis pen platform, it is easy to tailor the injection device to various needs. Following our client’s specifications, we have developed a device that enables users to adjust the volume of the injection and reuse the pen several times until the cartridge is empty. For security reasons, we added a function to the pen to immediately confirm that a complete dose was delivered, or to indicate the missing amount if an incomplete dose is injected,” said Volker Wirth, Director Business Development & Marketing at Haselmeier. “We are proud of this successful collaboration with Merck Serono, and we look forward to continuing our business relationship in the future.”

The Axis pen platform is available as a reusable or disposable multi-use pen, which features adjustable dosing. The pen design is based on an innovative technology featuring a sliding dose window that allows easy reading of the dose and provides reduced risk of incorrect dosing. Available in metal or plastic, the Axis pen is compatible with 3-ml cartridges, all fill volumes, and can be customized to meet any patient needs.

Haselmeier is a leading designer and manufacturer of pen and auto-injection systems. The company’s devices feature unique function, design, and technology and are marketed by leading pharmaceutical and biotechnology companies around the world.

Kythera Biopharmaceuticals Raises $37.4-Million Financing

KYTHERA Biopharmaceuticals, Inc. recently announced the closing of a $37.4-million Series D financing. The round featured significant new investments as well as participation from all existing institutional investors. Proceeds from this financing are slated to be used for conducting US Phase III trials for KYTHERA’s lead product, ATX-101, a first-in-class, injectable drug that is under investigation for the reduction of submental (under the chin) fat.

“We are delighted to once again have attracted the support of top flight investors in pursuit of our vision of building a premiere science-based aesthetic medicine company,” said Keith Leonard, KYTHERA’s President and CEO. “We also appreciate the continued support and commitment from our existing investors.”

KYTHERA’s investors include Versant Ventures, ARCH Venture Partners, Prospect Venture Partners, JAFCO, Partner Funds Management (PFM), INVUS Financial Advisors, BBT Capital Management/Apothecary Capital, and Altitude Life Science Ventures. Also joining the syndicate were Foley Ventures and Latham and Watkins. KYTHERA has now raised more than $108 million in four rounds of private financing.

“These new investments are a further powerful validation of KYTHERA’s novel, biotechnology-based approach to aesthetic medicine,” added Mr. Leonard. “We believe this new round of financing in today’s volatile economy is a testament to the robust scientific foundation of our lead product candidate and the promise of its future potential.”

KYTHERA has completed extensive development work on ATX-101 for the reduction of submental fat, completing seven clinical trials with more than 350 subjects. European Phase III studies of ATX-101 were initiated in late 2010 (enrolled more than 700 subjects) in collaboration with Bayer HealthCare’s dermatology unit Intendis, which has licensed rights to ATX-101 outside of the US and Canada.

KYTHERA Biopharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel prescription products for the aesthetic market. KYTHERA has an innovative pipeline, with its lead program in adipolysis (ATX-101) projected to start US Phase III trials late in 2011 or early 2012. The company also has active research programs with focused interest in hair and fat biology, pigmentation modulation, and facial contouring.