1/16/2013

BIND Biosciences & Amgen Sign Worldwide Development & Commercialization Agreement

BIND Biosciences recently announced it has entered into a global collaboration agreement with Amgen Inc. to develop and commercialize a kinase inhibitor nanomedicine for treating a range of solid tumors. The collaboration will develop a novel Accurin based on BIND’s platform for targeted and programmable nanomedicines and Amgen’s undisclosed proprietary kinase inhibitor. The collaboration aims to create a kinase inhibitor nanomedicine with optimized therapeutic properties, applying for the first time tissue targeting to molecularly targeted drugs.

Under the terms of the agreement, Amgen will have the exclusive right to pursue development and commercialization of the Accurin kinase inhibitor against solid tumor targets to be selected by Amgen. Both companies will work together on preclinical development, and Amgen will assume responsibility for future development and commercialization. BIND could receive up-front and development milestone payments totaling $46.5 million, and BIND could receive up to an additional $134 million in regulatory and sales milestone payments for the first therapeutic indication and is eligible for additional payments. BIND will receive tiered royalties on potential future sales.

“BIND’s technology is well aligned with Amgen’s focus on the development of highly targeted and selective oncology therapeutics,” said Joseph P. Miletich, MD, PhD, Senior Vice President of Research and Development at Amgen. “We look forward to collaborating with the BIND scientific team to leverage this technology to address unmet medical needs of cancer patients.”

“We are pleased to collaborate with Amgen, an industry leader with a proven track record of success in oncology, on extending our technology into molecularly targeted drugs, such as kinase inhibitors,” said Scott Minick, CEO of BIND. “Through this collaboration, Amgen has recognized the unique potential of BIND’s Medicinal Nanoengineering platform to create programmable oncology therapeutics that combine molecular and tissue targeting for unsurpassed selectivity and activity.”

BIND Biosciences is a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called Accurins. BIND’s Medicinal Nanoengineering platform enables the design, engineering, and manufacturing of Accurins with unprecedented control over drug properties to maximize trafficking to disease sites, dramatically enhancing efficacy while minimizing toxicities.

BIND is developing a pipeline of novel Accurins that hold extraordinary potential to become best-in-class drugs and improve patient outcomes in the areas of oncology, inflammatory diseases, and cardiovascular disorders. BIND’s lead product candidate, BIND-014, is currently in Phase I clinical testing in cancer patients and is designed to selectively target a surface protein upregulated in a broad range of solid tumors. BIND also develops Accurins in collaboration with pharmaceutical and biotechnology partners to enable promising pipeline candidates to achieve their full potential and to utilize selective targeting to transform the performance of important existing drug products.

BIND is backed by leading investors, Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension, DHK Investments, EndeavourVision, and Rusnano. BIND was founded on proprietary technology from the laboratories of two leaders in the field of nanomedicine, Professors Robert Langer, David H. Koch Institute Professor of the Massachusetts Institute of Technology (MIT) and Omid Farokhzad, Associate Professor of Harvard Medical School. For more information, visit www.bindbio.com.

Aptuit & Aegerion Sign Long-Term API Agreement

Stuart Needleman, President and Chief Operating Officer, Aptuit LLC, recently announced that Aptuit and Aegerion Pharmaceuticals, Cambridge, MA, have signed a long-term supply agreement for commercial quantities of the active pharmaceutical ingredient (API) lomitapide.

Lomitapide is Aegerion’s orphan drug that is targeted to the treatment of a rare disease caused by a genetic disorder. The drug received NDA approval in December 2012 and is expected to be launched commercially in January 2013. Previously, Aptuit scientists had established the chemistry for lomitapide, developed, and validated its analytical methods, delivered solid state form control and crystallization R&D, and supplied registration batches of material. Post-launch, Aptuit will continue to supply commercial quantities of lomitapide to Aegerion.

“Because of the drug’s orphan status and high unmet medical need of the patients, on time and in full delivery of the API is crucial,” said Mr. Needleman. “Collaboration across several Aptuit sites in the US and Europe has made this possible. By accessing the vast drug development expertise of our organization, we have been able to accelerate the delivery of materials, methods, solid state chemistry, and regulatory documentation and help the client win prompt NDA approval.”

Although the exact terms of the agreement were not disclosed, Mr. Needleman added, “The collaboration represents another good example of how Aptuit’s integrated, global drug development capabilities can have a direct, positive impact on the pharmaceutical industry.”

Aptuit LLC provides the most complete set of integrated early to mid-phase development services in the pharmaceutical industry. Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Drug Product Formulation Development & Manufacture, Sterile Fill Finish, Clinical Sciences, Consulting and Aptuit INDiGO (a program that accelerates drug development) are offered as stand-alone or integrated services. Fully integrated drug discovery and development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. For more information, visit www.aptuit.com.

Catalent Makes Major Inhalation Capabilities Investment

Catalent Pharma Solutions recently announced it will make a major investment to expand its industry-leading inhalation drug development, delivery, and supply capabilities by enhancing its Inhalation Center of Excellence in Research Triangle Park (RTP), NC. The $20-million planned investment will focus on expanding pressurized Metered Dose Inhaler (pMDI) clinical and commercial supply capabilities as well as other enhancements to the facility.

Catalent, one of world’s leading solution providers for inhaled drug product development, provides a broad range of inhalation services, including API optimization, pre-formulation, formulation, analytical testing, and manufacturing across all inhaled dosage forms at the RTP, NC, facility, and its advanced aseptic development and fill/finish supply solutions facility in Woodstock, IL.

“Pulmonary and nasal represents the second largest drug delivery market by delivery route. Catalent’s investment in commercial manufacturing at our Inhalation Center of Excellence not only fits with our advanced drug delivery growth strategy, but also positions us as a world leader supporting inhaled products,” said Scott Houlton, President of Catalent’s Development and Clinical Services business. “In addition to the introduction of scalable processes for micro-dosing inhalation powder formulations, and the recent commissioning of our new nasal filling suite, this $20-million investment will upgrade our pMDI manufacturing capacity and allow us to better support our customers from early development all the way through to commercialization; bringing more products and better treatments to market faster.”

For more information on Catalent’s Inhalation drug development services, please click the link: http://www.catalent.com/index.php/Delivery/inh/inhalation.

Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer health products. With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable product supply. For more information, visit www.catalent.com.

Novozymes Biopharma Aligns Recombinant Human Albumin Portfolio

Novozymes Biopharma recently announced the introduction of a new brand and visual identity for its recombinant human albumin (rAlbumin) portfolio. As part of the rebrand, Novozymes will bring both of the company’s rAlbumin products under its well-established Recombumin brand. Albucult will be renamed Recombumin Alpha, while Recombumin will now be known as Recombumin Prime in order to better synchronize the company’s product offering and create clarity for customers.

The newly announced changes are purely to the brand and visual identity of Novozymes’ rAlbumins. Customers can be reassured that the products themselves, as well as the product codes, will remain exactly the same. As part of the rebrand, customers will see the changes reflected on both marketing materials and product labeling.

The molecule in Novozymes’ two rAlbumin products is identical in respect of amino acid sequence and protein structure. They are both expressed in Novozymes’ proprietary Saccharomyces host and are manufactured in compliance with ICH Q7 cGMP guidelines. The products’ physic-chemical properties and customer applications are essentially identical and the name change has been introduced to allow Novozymes to market these two albumins under a single family name.

Novozymes’ rAlbumins provide a secure supply of batch-to-batch consistent materials and are supported by a strongly documented safety package and drug master file. With excellent purity profiles and offering an established pathway through the regulatory approval process, the products have earned a strong reputation in the industry for helping customers to facilitate the safe and successful commercialization of new products.

“Novozymes is delighted to announce that it is synchronizing the branding of its rAlbumin products under the Recombumin family name to enhance the clarity of the company’s product offering, while still providing customers with the same superior solutions”, said Dermot Pearson, Marketing Director, Novozymes Biopharma. “Since we launched our rAlbumins, the portfolio has gone from strength-to-strength helping Novozymes to become one of the fastest growing companies in the industry.”

Novozymes’ rAlbumins are compliant with the National Formulary (NF) rAlbumin human monograph published by the United States Pharmacopeia (USP) and have been optimized to deliver stable, safe and regulatory compliant ingredients for the medical device, drug delivery, and formulation markets. Manufactured without animal-derived materials the products can be used in a wide-range of applications including stabilization of drugs and vaccines, device coating, advanced cell therapy products, and in sealants and hemostats. For more information on Novozymes’ Recombumin Alpha and Recombumin Prime products, visit www.biopharma.novozymes.com.

ALS Therapy Development Institute & to-BBB Collaborate on Motor Neuron Disease

The ALS Therapy Development Institute (ALS TDI) recently announced it has entered into a new collaboration with to-BBB to investigate potential treatments for ALS Motor Neuron or Lou Gehrig’s disease).

“This partnership brings a new potential tool to safely enhance the delivery of drugs that may slow or stop the progression of ALS,” said Steve Perrin, PhD, CEO, and CSO of ALS TDI. “Being able to dose a drug systemically, but yet have it cross the blood-brain barrier, allows us to try things we weren’t able to do before. It enhances the arsenal of weapons we have available in our search for effective treatments for ALS.”

“We strongly believe that we can facilitate in creating treatment options for devastating brain diseases faster by providing sustained and enhanced delivery of known compounds to the Central Nervous System (CNS),” said Pieter Gaillard, PhD, Founder and Chief Scientific Officer of to-BBB. “It is a major acknowledgement from ALS TDI to partner with to-BBB in applying such a novel approach to ALS. This collaboration will provide to-BBB with the opportunity to jointly pursue several treatment options for ALS, and we look forward to collaborating with the experts of the Institute.”

Under the terms of the agreement, ALS TDI will use to-BBB’s CNS-targeted liposomal drug delivery system, the G-Technology, as a tool to safely enhance the transport of several different compounds to the brain across the blood-brain barrier. The Institute will screen compounds in a preclinical model of ALS to determine if the enhanced formulation of the proposed treatments have an improved effect on disease course. The collaborators have been working together since early in 2012, designing and completing proof-of-concept experiments confirming that to-BBB’s G-Technology indeed accomplishes sustained and effective delivery of drugs to the CNS in the SOD1 preclinical model of ALS.

The mission of ALS TDI is to develop effective therapeutics that slow or stop ALS as soon as possible for patients today. Focused on meeting this urgent unmet medical need, ALS TDI executes a robust target discovery program, while simultaneously operating the world’s largest efforts to preclinically validate potential therapeutics; including a pipeline of dozens of small molecules, protein biologics, gene therapies, and cell-based constructs. For more information, visit www.als.net.

to-BBBis a clinical-stage biotechnology company focusing on enhanced drug delivery across the blood-brain barrier. The company is developing novel treatments for devastating brain disorders, such as brain cancer, neurodegenerative diseases, and lysosomal storage diseases, by combining existing drugs with the G-Technology, to-BBB’s proprietary brain delivery platform. This technology combines the widely used drug delivery approach of pegylated liposomes with the endogenous tripeptide glutathione as targeting ligand in a novel and safe way. Together with several top tier pharma and biotech companies, to-BBB is investigating the versatility of the G-Technology for drugs that are unable to reach the brain at systemically tolerable therapeutic doses. For more information, visit www.toBBB.com.

UPM Pharmaceuticals Enhances Pre-Formulation Capabilities

UPM Pharmaceuticals recently announced it has purchased and qualified a TA Instruments Q20 Auto MDSC (Differential Scanning Calorimeter), and a TA Instruments Q50 TGA (Thermogravimetric Analyzer). These pieces of equipment greatly enhance UPM’s ability to provide comprehensive pre-formulation studies, as well as support analytical testing of challenging formulations such as poorly soluble compounds.

“UPM sees these new pieces of analytical equipment combined with our already highly qualified and experienced analytical team as a powerful combination for our clients who are trying to make the best and most cost-effective decisions about investment of precious research funds. And further is looking for a partner that can perform the latest and best analysis with the most reliable equipment available in the pre-formulation stage of development,” said UPM’s President, Jim Gregory.

UPM Pharmaceuticals, Inc. is a Baltimore-based contract development and manufacturing organization providing customized formulation development, manufacturing, and analytical services to pharmaceutical, biotechnology, academic, and veterinary clients. Fully appreciating that time-to-market is critical, UPM offers remarkably flexible, affordable, and rapid outsourcing services designed to meet clients’ specific development and manufacturing needs. Their clients represent both small and large companies within the pharmaceutical and biotechnology industries, and academic institutions who have a focus on clinical studies.

UPM provides high-quality pharmaceutical drug development services, including formulation development, cGMP manufacturing, analytical methods development, and stability testing. They are characterized by the quality, speed, and thoroughness with which they complete all their projects. UPM’s clients enjoy service that is customized and fast with total quality management characteristic of a customer-focused business. Their history includes successful collaborative interactions with virtual to multi-million dollar companies providing them with customized product development services and solutions. UPM focuses on drug development for dosages with oral routes of administration, in solid dosage forms such as capsules and tablets. To learn more about UPM, please visit www.upm-inc.com.