3/20/2012

Connell Brothers Signs Agreement With World’s Top Chemical Company

Connell Brothers Australasia recently announced it was appointed by BASF Australia, a subsidiary of BASF Corporation, the world’s leading chemical company, to distribute its human nutrition ingredients and pharmaceutical excipients across Australia and New Zealand. This includes performance food ingredients, functional food ingredients, and pharmacopoeia-certified excipients for the beverage, bakery, dessert, confectionary, dietary supplement, and related markets. Connell Brothers also currently has distribution agreements with BASF in Malaysia, Philippines, and Singapore.

“BASF’s ability to offer an extensive portfolio of ingredients makes them a very important supplier to the food and pharmaceutical markets in Australia and New Zealand,” said Carol Toft, Business Manager, Connell Brothers Australasia. “Our customers will benefit from the even more comprehensive product list we will offer them through this expanded partnership agreement.”

In addition to the product expansion, Connell Brothers will assist its customers in the formulation and development of finished products that address market challenges or meet new market trends. To this end, Connell Brothers will add a food applications facility based in Sydney to provide comprehensive technical and commercial support.

“To accelerate business development, responsiveness, and customer intimacy, we have started construction of a food applications facility where we will make and test baked goods and desserts,” said Ms. Toft.

Connell Brothers also has food ingredient application facilities in Malaysia, Philippines, and Thailand that service customers in the region.

“Partnering with Connell Brothers will allow BASF to improve its geographic and customer reach throughout the region,” said Simon Lord, Business Manager, BASF Australia and New Zealand. “The company’s technical support and knowledge of the local market in this highly regulated business makes them an excellent choice for BASF. We look forward to a fruitful business relationship with Connell Brothers and to all the new opportunities that this relationship will bring our company.”

Connell Brothers, a division of Wilbur-Ellis Company and the largest marketer and distributor of specialty chemicals and ingredients in Asia-Pacific, has over 29 employees in Australia and New Zealand. Their current product portfolio includes dietary fiber, fat replacers, modified starches, natural colors, natural mould inhibitors, and yeast extracts sold into baking, beverage, dairy, and small goods. A specialized range of active pharmaceuticals ingredients and excipients are also included in their offering.

BASF just completed the acquisition of Cognis, giving Connell Brothers customers in Australia and New Zealand, Malaysia, and Singapore access to additional product offerings.

DSM & Agennix Sign Commercial Manufacturing Agreement

DSM Pharmaceutical Products and Agennix recently announced they have signed a new contract under which DSM will manufacture the oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin for Agennix at commercial levels in anticipation of positive Phase III clinical data and product approval. DSM is currently manufacturing talactoferrin for use in ongoing clinical trials, including the FORTIS-M trial in non-small cell lung cancer (NSCLC), and will continue to supply talactoferrin for clinical trials as well as to support a potential commercial launch.

“This agreement recognizes intensive collaboration between DSM and Agennix,” said Villaume Kal, Vice President of DSM BioSolutions. “DSM’s process design for application in large-scale manufacturing largely contributed to this success, and we are delighted to continue our support of Agennix.”

“We are pleased to continue our productive relationship with DSM,” added Rajesh Malik, MD, Chief Medical Officer and Management Board member of Agennix. “Their long-term experience with talactoferrin will be invaluable as we work with them in preparation for a potential product approval and subsequent commercialization of talactoferrin. It is important for Agennix to put in place now the key elements of the talactoferrin supply chain, and expanding our contract with DSM is an important part of this process.”

The contract includes the manufacture of commercial supply of talactoferrin, process development to continue to optimize the manufacturing process, and the opportunity to significantly expand production capacity as needed.

Talactoferrin is a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI) currently being studied for the treatment of NSCLC. In randomized, double-blind, placebo-controlled Phase II studies in NSCLC, talactoferrin appeared to improve survival across a broad range of patients, including the difficult-to-treat refractory population, without many of the common toxicities seen with other cancer therapies. Two Phase III trials with talactoferrin in NSCLC are ongoing. The FORTIS-M trial, which completed enrollment in March 2011, is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. A second Phase III trial (FORTIS-C) is evaluating talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death. No financial terms were disclosed.

Royal DSM is a global science-based company active in health, nutrition, and materials. By connecting its unique competences in Life Sciences and Materials Sciences, DSM is driving economic prosperity, environmental progress, and social advances to create sustainable value for all stakeholders. More information can be found at www.dsmbiosolutions.com and www.dsm.com.

Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The company’s most advanced program is talactoferrin, a first-in class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for cancer, and a topical gel form of talactoferrin for diabetic foot ulcers. For additional information, please visit the Agennix Web site at www.agennix.com.

Bend Research Technology Helps Advance Promising Compound

Bend Research Inc. recently announced a licensing agreement with Affinium Pharmaceuticals, Ltd in which Bend has licensed its proprietary spray-dried dispersion (SDD) technology to the biotechnology firm. The SDD technology, which is used to improve the bioavailability of compounds with low aqueous solubility, has been instrumental in advancing oral formulations of Affinium’s promising novel antibiotic, AFN-1252, to Phase II human efficacy trials.

“We are excited about this opportunity to strengthen our relationship with Affinium, and we’d like to congratulate them on advancing AFN-1252 into Phase II clinical studies,” said Rod Ray, Bend Research CEO. “This is one more demonstration of the effectiveness of the technologies and tools Bend Research has developed to solve our clients’ toughest problems.”

In many cases, he said, the SDD technology has proven to be an enabling technology in developing oral dosage forms for difficult-to-formulate compounds.

The licensing agreement is the culmination of a body of work Bend Research performed to ready AFN-1252 oral dosage forms for clinical testing. Bend Research performed feasibility testing, formulation and dosage-form development, and process development, as well as manufacturing clinical supplies of SDD and tablets for the Phase II study.

AFN-1252 is the first of a new class of antibiotics being developed by Affinium for the treatment infections associated with Staphylococcus spp, including methicillin-resistant Staphylococcus aureus (MRSA). Affinium’s current Phase II study in acute bacterial skin and skin structure infections is the first human efficacy study of this new class of antibiotic. It follows recently completed Phase I trials, in which the oral formulation of AFN-1252 showed excellent safety, tolerability, and pharmacokinetics.

“AFN-1252 shows tremendous promise and fits well with our commitment to bring the best new medicines to patients,” said Jim Nightingale, Bend Research President.

Dr. Barry Hafkin, Chief Medical Officer of Affinium Pharmaceuticals, said “Bend‘s level of science and corporate commitment to produce an oral solid formulation is unsurpassed in my decades of experience working with formulation experts. Bend‘s contributions have allowed Affinium to achieve our corporate goal of starting the Phase II trial in January of this year. We are confident that the Phase II trial will confirm the effectiveness of the AFN-1252 SDD oral dosage form in combating staphylococcal infections.”

For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding. Bend Research provides numerous capabilities, including formulation and dosage-form support, assists in process development and optimization, manufactures clinical-trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in novel formulations, including SDDs and hot-melt extrusions, and controlled-release, inhalation, and biotherapeutics technologies. For more information about Bend Research, please contact Phoenix Ivers via email at phoenix.ivers@bendresearch.com, by phone at 541-382-4100 or 800-706-8655, or visit the Bend Research website at www.bendresearch.com.

Affinium is a specialty pharmaceutical company focused on the development of novel anti-infective medicines. The Affinium FASII antibacterial programs constitute a new antibiotic franchise with the potential for multiple products targeting the FASII pathway. AFN-1252, is Affinium’s first clinical candidate and is well positioned to meet the urgent medical need for a new, safe, potent, oral and IV therapeutic for staphylococcal infections, including multi drug-resistant and methicillin-resistant Staphylococcus aureus (MRSA). Affinium has offices in Austin, TX, and Toronto. For more information about Affinium, please contact Leisa Dennehy via email at ldennehy@afnm.com or visit the Affinium website at www.afnm.com.

ThromboGenics Enters Commercialization Agreement With Alcon

ThromboGenics NV recently announced it has entered into an agreement with Alcon (a division of Novartis), the global leader in eye care, for the commercialization of ocriplasmin in all markets outside the US. As a result of this important strategic deal, ThromboGenics will concentrate on commercializing ocriplasmin in the US, where it plans to build its commercial and medical organization to support the product’s anticipated launch within the next 12 months.

Under the terms of the agreement with Alcon, ThromboGenics will receive an up-front payment of $98 million. The company is also entitled to a further $118 million in potential near-term milestone payments. Additional milestones bring the potential total of up-fronts and milestones to $491 million.

In addition, ThromboGenics will receive royalties on net sales of ocriplasmin that are commensurate with a product that has successfully completed Phase III development and that has been filed for regulatory approval.

Under the agreement, ThromboGenics will have a strategic and focused operational role in the commercialization of ocriplasmin in the five largest European markets, enabling it to build the foundation for an expanding ophthalmology franchise.

In addition to the commercial introduction of ocriplasmin in markets outside the US, the agreement specifies that Alcon and ThromboGenics will work together, and share the costs, to further develop new clinical applications of the product that the companies will introduce in their respective territories.

ThromboGenics has completed an extensive clinical development program, including two successful Phase III studies that have shown that ocriplasmin could play an important role in treating symptomatic VMA, including macular hole. Symptomatic VMA is an increasingly recognized sight-threatening disease of the vitreoretinal interface. VMA may lead to symptoms such as distorted vision, decreased visual acuity, and central visual field defects. VMA can cause traction resulting in anatomical damage, including formation of a macular hole, which may lead to severe visual consequences and central blindness.

Members of the international retina community have already shown great interest in ocriplasmin, as it could for the first time provide them with a pharmacological option to treat patients with symptomatic VMA, including macular hole. The availability of ocriplasmin may also enable retina specialists to treat patients earlier than they do with surgery. This could address a significant unmet need as earlier intervention has been shown to limit the progress of the disease and its related complications. ThromboGenics is confident that ocriplasmin has significant commercial potential, given estimates that more than 300,000 patients in Europe alone could potentially benefit from this novel treatment.

Vascular Magnetics to Advance Magnetically Targeted Delivery System

Vascular Magnetics, Inc. recently announced it has raised $7 million in a Series A financing to advance the development of its proprietary, magnetically targeted drug delivery system for the treatment of peripheral artery disease (PAD). Devon Park Bioventures was the sole investor in the financing.

“This financing is an important endorsement of our highly innovative approach to treating peripheral artery disease, a major, growing clinical challenge that affects about 30 million in Europe and North America. At least 10 million patients live in the US,” said Vascular Magnetics Chairman Georges Gemayel, PhD. “Current treatments for PAD such as angioplasty, grafts, and stents, including drug-eluting stents, are not durable, with arterial re-obstruction (restenosis) occurring frequently. Vascular Magnetics’ innovative approach to enhance local drug delivery has great potential to transform PAD treatment by delivering anti-restenotic drugs specifically to diseased artery sites at higher concentrations than are possible with drug eluting stents.”

The company’s system, called Vascular Magnetic Intervention (VMI), combines biodegradable, magnetic drug-loaded particles, a magnetic targeting catheter, and an external device for creating a uniform magnetic field. The field generates high force magnetic gradients in the catheter, so that when the drug-loaded particles are administered, the gradients direct them to the arterial wall. The particles remain in the arterial wall after the catheter is removed and release the drug over a sustained period. The initial product Vascular Magnetics is developing employs paclitaxel, an established anti-restenosis drug that is a component of drug-eluting stents used primarily to treat coronary artery disease. The underlying technology has longer term potential for the targeted delivery of therapeutics to other areas of the body.

“The funds will allow us to complete the preclinical development of the system and conduct an initial clinical trial,” said Richard S. Woodward, PhD, Vascular Magnetics Co-founder and Chief Operating Officer. “We expect to begin the clinical trial in 2014.”

The system is based on research by Vascular Magnetics’ Co-founder and Founding scientist, Robert J. Levy, MD, who holds the William J. Rashkind Endowed Chair in Pediatric Cardiology at The Children’s Hospital of Philadelphia and is Director of the hospital’s Cardiology Research Laboratory. Dr. Levy and colleagues demonstrated the feasibility of the VMI approach in studies published in 2010 in the Proceedings of the National Academy of Sciences.

“VMI shows great promise for improving outcomes for PAD, and I am delighted that with Devon Park Bioventures’ support this concept is moving forward,” said Dr. Levy.

Vascular Magnetics is developing novel therapeutic products based on the magnetic targeting of drug-loaded biodegradable particles. The company’s first product in development is a treatment for peripheral artery disease that is designed to target anti-restenotic drugs specifically to diseased arterial sites and deliver doses not achievable with a drug eluting stent. The company’s approach, called Vascular Magnetic Intervention (VMI), combines a magnetic targeting catheter, and external magnetic device, along with drug-loaded biodegradable particles. Learn more at www.vascularmagnetics.com.

Pion Launches Modern, High Throughput Complement to Conventional Franz Cells

Pion Inc. recently introduced the Skin PAMPA Test System, specifically designed to predict the permeability of drugs and dermal formulations through the human skin. The Skin PAMPA Test System excels as a complementary screen prior to Franz Cell testing due to the lower cost, enhanced usability, higher throughpute and reduced sample requirements.

Pre-coated with a proprietary formulation, the 96 well plates are disposable, which completely eliminates cross contamination and the additional time and labor required for washing glass cells. The PAMPA Explorer Complete system includes STIRWELL plates (which provide optional, double-sided donor-receptor stirring), buffers, test compounds, hydration solutions, data collection/processing software, and a high-quality UV plate reader. Other options are provided, depending on the specific needs of the customer.

“We evaluated the Skin PAMPA Test System using a broad range of drugs against samples of dermatomed skin mounted in Franz cells,” explained Mr. Mike Kelly, President of Pion Inc. “We observed the two methods were highly correlated, thus ensuring that researchers and product developers can now confidently screen drug permeability unencumbered by the restrictions of Franz Cell testing. They will develop better dermal products and get them to market faster, due to the many advantages of our new high throughput system.”

The conventional Franz cell method employs skin from humans, rats, pigs, or cattle to evaluate the penetration of drugs through the epidermis. These systems require mounting the skin on individual, controlled-temperature, stirred glass cells. Purchase, cleaning, setup, and maintaining this equipment is expensive, labor intensive, and cumbersome. The growth of transdermal drug products is inhibited by the low throughput and high cost of Franz cell testing.

With over 15 years of research dedicated to drug absorption measurements, this new product builds upon Pion’s experience and success in development of the first commercial PAMPA system, invention of the Double-Sink PAMPA system, predicting permeability in the gastrointestinal tract (GIT) and in the blood brain barrier (BBB). Pion PAMPA systems bring new drugs to market faster and with fewer late-stage failures.