5/9/2012
Caisson Biotech Enters Potential $100 Million Agreement
Caisson Biotech, L.L.C. recently announced it has entered into a development and license agreement with Novo Nordisk A/S. The agreement gives Novo Nordisk the exclusive rights to use Caisson’s proprietary heparosan-based drug delivery technology to engineer and develop compounds within undisclosed therapeutic areas.
Under the terms of the agreement, Caisson will receive an undisclosed upfront payment and contract research and manufacturing payments. In addition, Caisson will be eligible to receive milestone payments upon achievement of certain predefined clinical, regulatory, and commercial targets plus royalties on the global sales of the therapeutic products developed under the agreement, representing a total deal value potentially in excess of $100 million.
“We recently completed feasibility studies with Novo Nordisk that we believe validate Caisson’s heparosan-based drug delivery technology for product pharmacokinetics and enhanced half-life in relation to an undisclosed therapy area,” said Dr. Paul DeAngelis, Chief Scientist of Caisson. “Our technology utilizes a naturally occurring sugar polymer that is stable and inert in the bloodstream, but is biodegradable inside cells for the purpose of cloaking, enlarging, and/or protecting drug cargo. We can customize heparosan with respect to polymer size and conjugation chemistry thus providing flexibility to enhance a variety of therapeutic proteins, peptides, delivery platforms (eg, liposomes, viruses, or nanoparticles), and small molecules.”
“This agreement with Novo Nordisk is significant, and we are extremely pleased to closely collaborate with a leader in the development of therapeutic proteins,” added Thomas Harlan, CEO of Caisson. “Besides advancements within our own internal research programs, we have now established a pivotal technology access agreement we believe can further validate the application of Caisson’s heparosan-based drug delivery technology. We look forward to the rapid advancement of the Caisson clinical pipeline and the opportunity to work with additional industry partners to bring novel therapeutics to patients in need.”
“We are delighted to continue working with Caisson and their promising heparosan technology,” said Per Falk, Novo Nordisk Senior Vice President, Biopharmaceutical Research Unit. “This technology is an interesting approach for generating novel therapeutics with prolonged half-lives.”
Caisson Biotech is a wholly owned subsidiary of Heparinex, L.L.C. Caisson uses novel, heparosan-based conjugates to enhance the therapeutic properties of pharmaceuticals by increasing product half-life, reducing immunogenicity, and increasing stability. This newly invented drug delivery platform was developed by Chief Scientist and Professor Dr. Paul L. DeAngelis at the University of Oklahoma Health Sciences Center.
Caisson is funded and managed by Emergent Technologies, Inc. a leading life sciences technology investment and management firm headquartered in
Emergent Technologies, Inc. (ETI) is a life sciences technology investment and management company that provides early stage funding and development for scientific discoveries originating at universities and research institutions. The company creates value by transforming scientific breakthroughs into technology platforms with multiple applications. ETI’s unique innovation process enables the company to select promising scientific discoveries for development, maximize the value of intellectual property and manage both cost and risk associated with the commercial development of early stage technologies. ETI is dedicated to turning research into revenue and, in the process, introducing compelling solutions to meet important market needs. For more information, visit www.etibio.com.
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy. and hormone replacement therapy.
Celsion & Focused Ultrasound to Explore ThermoDox Combined With Focused Ultrasound
Celsion Corporation and the Focused Ultrasound Foundation recently announced their support for preclinical studies designed to explore the use of ThermoDox, Celsion’s Phase III, proprietary, heat-activated liposomal encapsulation of doxorubicin, in combination with MR-guided high intensity focused ultrasound (HIFU) for the treatment of pancreatic cancer. The studies are being conducted at the University of Washington School of Medicine by Joo Ha Hwang, MD, PhD, Director, Endoscopic Research, Associate Professor of Medicine and Adjunct Associate Professor of Bioengineering and Radiology.
Celsion is supporting Dr. Hwang’s research with ThermoDox supplies, and the Foundation is funding the preclinical study, MR-Guided HIFU Enhanced Targeted Drug Delivery for Treatment of Pancreatic Cancer.
A healthcare research and advocacy organization, the Focused Ultrasound Foundation solicits research proposals to address areas of unmet medical needs in which HIFU may provide benefit. Before awarding funding to Dr. Hwang, the Foundation had identified pancreatic and liver cancers as potential clinical applications for HIFU and designed a research roadmap to address a set of preclinical, mechanistic, and technical questions for the development of these applications.
“We are excited about Dr. Hwang’s research and the new treatments he is pioneering. As always, our goal is to save and improve lives by supporting the development of new focused ultrasound therapies for many of today’s most deadly and debilitating conditions,” said
The University of Washington School of Medicine research is expected to include in vitro experiments to confirm the ability of HIFU to target high concentrations of doxorubicin in proprietary pancreatic cancer cell lines, and in vivo studies to assess the response to these tumors treated using ThermoDox with and without HIFU-induced hyperthermia. The optimal HIFU exposure duration needed to maximize doxorubicin concentration will also be evaluated, where ThermoDox will be compared against other chemotherapeutic agents used in combination with HIFU in mouse tumor models.
“Focused ultrasound has the potential to make an enormous impact on the treatment of pancreatic cancer, both as a means of ablating tumors and for the enhancement of therapeutic drug delivery to these tumors,” said Dr. Hwang. “The thermal drug-targeting capability of ThermoDox makes it the ideal candidate for a combination treatment approach, one drawing from the benefits of both treatment modalities to provide what may be an innovative option for this large and urgent unmet medical need.
I look forward to studying the combination in a unique animal model, one which effectively recapitulates the human disease, then moving rapidly into the clinic.”
“We are pleased and excited to support Dr. Hwang’s research and to study ThermoDox’s potential in a disease with a staggering rate of mortality and few treatment options,” said Michael H. Tardugno, Celsion’s President and CEO. “In preclinical models, ThermoDox combined with HIFU has already demonstrated strong proof-of-concept, rationale, and support for clinical studies in certain cancers, including bone cancer. This further illustrates ThermoDox’s broad potential to enhance the benefit of multiple heat-based therapies, including HIFU and radiofrequency ablation, across a spectrum of cancers.”
Through a joint research agreement, Celsion is also working with Philips Healthcare, a division of Royal Philips Electronics, to develop treatments for bone cancer using ThermoDox and HIFU.
ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. Localized mild hyperthermia (39.5°C to 42°C) created by focused heat energy releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox is being evaluated in a 700-patient global Phase III study at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox in combination with radio frequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. Additional information on the company’s ThermoDox clinical studies may be found at www.clinicaltrials.gov.
An early-stage medical technology with the potential to revolutionize the treatment of many life-threatening and disabling conditions, focused ultrasound uses concentrated acoustic energy to treat tissue deep in the body while leaving surrounding healthy areas intact. Potentially, focused ultrasound could be a breakthrough in non-invasive surgery, serve as an alternative or complement to radiation therapy and enable the delivery of chemotherapeutics and other drugs at higher concentrations to precise targets with less toxicity. Researchers around the world are investigating the technology’s use in treating many forms of cancer – including bone, brain, breast, liver, pancreas, prostate, and thyroid – and neurological conditions, such as essential tremor, Parkinson’s disease, epilepsy, obsessive compulsive disorder, and stroke. In the
Based in
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license, or commercialization agreements with leading institutions, including the National Institutes of Health,
Novozymes’ rAlbumin Supports Faster Time-to-Market for Neomend Adhesion Barrier Sealant
Novozymes Biopharma recently announced that its recombinant human albumin (rAlbumin), Albucult, is being used by Neomend in the company’s Progel Adhesion Barrier Sealant product, which has recently received the European Union CE mark. Albucult, used as a key component in medical device applications, helps to facilitate regulatory compliance and enables a faster time-to-market due to its stable, safe, and animal-free composition. The product’s high purity can help manufacturers manage and reduce both commercial and regulatory risk where source variability and safety profile are important considerations in the commercialization of drug and medical device products.
“Novozymes has an extensive understanding of the regulatory pressures its customers are facing and its quality-assured, consistent biopharmaceutical components make the company an ideal partner for Neomend,” said David Renzi, Neomend’s President and CEO. “The Progel Adhesion Barrier Sealant CE mark is a vital milestone as it will enable us to help surgeons in
Neomend uses Novozymes’ Albucult in its Progel Adhesion Barrier Sealant, a product that has been developed as a hydrogel adhesion barrier sealant that can be sprayed onto general visceral organs during open and laparoscopic surgery to help prevent post-operative adhesions. The addition of a CE mark will help Neomend to expand the distribution of its latest sealant across
“Novozymes is delighted that Albucult is being used as a key component in another CE-marked medical device”, said Dermot Pearson, Marketing Director, Novozymes Biopharma. “It is a testament to the unique advantages conferred by the product and demonstrates our commitment to supporting customers throughout their regulatory process. We have a dedicated regulatory affairs team that monitors regulatory changes and trends, while working closely with relevant trade organizations to offer customers current, fast and efficient support for product registration.”
The use of Albucult as a key ingredient in medical devices offers a range of performance and quality benefits for medical applications not possible with animal-derived ingredients, including an exceptional purity profile and sustainability of supply. Novozymes’ Albucult also ensures batch-to-batch consistency to reduce processing and testing times to drive product efficiency for customers looking for a compliant albumin alternative. To learn more about Novozymes’ Albucult, visit www.biopharma.novozymes.com.
Neomend, based in
Novozymes is a world leader in bioinnovation, and together with customers across a broad array of industries, it creates tomorrow’s industrial biosolutions, improving customers’ business and the use of the planet’s resources. With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. For more information, visit www.novozymes.com.
Prosonix Demonstrates Improved Delivery & Co-Localization of Respiratory Medicines
Prosonix recently announced the publication of a new review paper describing how its novel particle-engineering-led approach to respiratory medicines is enabling the development of “smart” excipient-free, drug-only Multi-component Particles (MCPs) that offer the potential of more effective inhaled combination therapies.
Since their introduction, inhaled combination therapies have improved the management of major respiratory diseases, such as asthma and chronic obstructive pulmonary disease (COPD). There is compelling evidence that combination therapies acts synergistically to reduce inflammation and constriction of the airways, preventing disease progression, providing symptomatic relief and improving quality of life by providing treatment for complications and exacerbations. Drug combinations form the basis of several blockbuster respiratory medicines, such as GlaxoSmithKline’s Advair/Seretide and AstraZeneca’s Symbicort. Both of these products are based on combinations of an inhaled corticosteroid (ICS) plus a long-acting beta-agonist (LABA). Combinations of a LABA with a long-acting muscarinic antagonist (LAMA) and triple ICS/LABA/LAMA combinations are also being developed.
In the new review, published in the Spring 2012 issue of European Respiratory Disease, the authors highlight the advantages of combining two or more APIs in exact and consistent ratios in a single, excipient-free, drug-only particle (known as Multi-component Particles or MCPs) compared with mixed powder formulations. This is particularly beneficial when there is a synergistic action between the APIs, which ideally should be delivered and deposited together at the targeted site of action in the lung.
Going into more depth, the authors describe the use of Prosonix’ unique ultrasonic particle engineering approach to creating MCPs comprising equivalent ratios of fluticasone propionate (FP) and salmeterol xinafoate (SX) as in Advair/Seretide, and of budesonide (BDS) and formoterol fumarate dehydrate (FFD) as in Symbicort. These MCPs were found to retain the ratio of APIs of the originator products in both formulation and delivered dose via pMDI. Co-association of respiratory APIs in the form of MCPs was consistent throughout the process chain of manufacturing, formulation, and delivered dose, offering the promise of achieving true synergy, optimal therapeutic efficacy and reduced dosing.
In developing respiratory MCPs, Prosonix believes it is overcoming the main challenge faced by the companies developing combination products of maintaining consistent ratio of the APIs during formulation and upon re-dispersion and deposition in the lung. The excipient-free, drug-only nature of the MCPs is particularly advantageous. The majority of combination products on the market and in development are based on dry powder “blends” of APIs, which once aerosolized and inhaled are co-deposited randomly and therefore reduce the opportunity for a synergistic effect. Furthermore, current manufacturing methods – primarily jet milling large particles into smaller particles – change the chemical and physical stability of the particles. As a result, this creates little, if any, co-association among the actives.
“The treatment of respiratory disease remains a high unmet need, despite the recent development of new therapies,” said David Hipkiss, Prosonix’s CEO. “The effective production and delivery of combination medicines in a consistent, stable, and co-localized manner are lacking, given inefficiencies in current manufacturing and formulation processes. This paper highlights the potential for our engineered excipient-free, drug-only Multi-component Particles to deliver more effective and better tolerated respiratory medicines for patients.”
Prosonix is a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines enabled by its state-of-the-art particle engineering technology. Prosonix’ drug development is based on a novel ultrasonic particle engineering approach. Its proprietary technology enables Prosonix to develop “smart” excipient-free, drug-only inhalable particles that are specifically designed to optimally target the site of action in the lung, precisely and consistently, delivering maximum clinical effect. For more information, visit www.prosonix.co.uk.
Midatech & MonoSol Rx Announce Positive Results for Transbuccal Oral Insulin Film
Midatech Ltd. and MonoSol Rx LLC recently announced positive bioavailability and pharmacokinetic results from a first-in-human Phase I clinical study of their Midaform Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.
Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase I study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in
“These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics following administration of Midaform Insulin Pharmfilm,” said A. Mark Schobel, Co-President and CEO of MonoSol Rx. “The rapid onset of action surpassed our expectations, and we look forward to further clinical development of this exciting and new groundbreaking product. Based on the success of this in-man study, which unequivocally validates the utility of our diverse preclinical animal models, we look forward to accelerating the entire product development program.”
“The success of Midaform Insulin PharmFilm demonstrates its safety, tolerability, and potential use in treating diabetes, particularly meal-dependent hyperglycemia,” added Professor Thomas Rademacher, CEO and Chairman of Midatech. “This study is a significant step forward for the commercialization of this novel, non-injectable insulin formulation. This trial shows the success of the MidaSol Therapeutics LLC joint venture between Midatech and MonoSol, and brings us closer to using nanomedicines in clinical practice.”
MidaSol Therapeutics LLC. is a joint venture formed by Midatech Ltd. of
Midatech Ltd.,
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm technology to deliver drugs in films. PharmFilm is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription drug products, a pipeline of prescription formulations based on PharmFilm technology, and two recent FDA approvals – Zuplenz, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone sublingual film, the first combination sublingual film product for the treatment of opioid dependence. For more information visit www.monosolrx.com.
Royalty Pharma Buys an Interest in Fumaderm for $761 Million
Royalty Pharma recently announced it had acquired an interest in the earn-out payable to the former shareholders of Fumapharm AG for $761 million in cash. The Fumapharm earn-out primarily represents an indirect interest in Biogen Idec’s BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of relapsing-remitting multiple sclerosis (RRMS). The earn-out also includes an interest in Fumaderm, a therapeutic approved in
Recently, Biogen Idec presented positive data on BG-12 from the Phase III CONFIRM trial, the second positive Phase III study of BG-12 in the treatment of RRMS, at the 64th Annual Meeting of the
“We are pleased to acquire an interest in one of the most promising new therapies addressing the needs of patients with relapsing-remitting multiple sclerosis,” said Pablo Legorreta, Chief Executive Officer of Royalty Pharma. “The combination of efficacy, safety, and tolerability of BG-12 shown in the DEFINE and CONFIRM Phase III trials, the oral dosing regimen and Biogen Idec’s deep commitment to this disease category, leads us to believe that BG-12 has blockbuster potential.”
“The management and shareholders of Fumapharm AG deserve credit for identifying this breakthrough therapy that has the potential to improve the lives of thousands of patients with relapsing-remitting multiple sclerosis,” Mr. Legorreta added. “We are also pleased to have been able to offer the former Fumapharm shareholders an opportunity to realize immediate liquidity for a portion of their interest in the Fumapharm earn-out, and to mitigate the risks associated with owning such a concentrated financial asset.”
Royalty Pharma is the industry leader in acquiring royalty interests in marketed and late-stage biopharmaceutical products, with royalty interests in 30 products valued at over $7 billion. Royalty Pharma has a 16-year history of providing value to royalty holders, including its $400-million purchase of 80% of Memorial Sloan-Kettering Cancer Center’s Neupogen/Neulasta royalty, its $700-million acquisition of AstraZeneca’s Humira royalty, its $700-million purchase of a portion of Northwestern University’s Lyrica royalty, its $650-million purchase of NYU’s Remicade royalty, its joint $525-million acquisition with Gilead Sciences of Emory University’s emtricitabine royalty, and most recently its $609-million acquisition of Astellas’ patent estate and associated royalty stream relating to the use of dipeptidyl peptidase IV (DPP-IV) inhibitors for the treatment of type 2 diabetes.
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