1/10/2012

Particle Sciences Expands Program With Additional Proprietary Modeling Capabilities

Particle Sciences recently announced it has added a third computational module to its DOSE program. The DOSE program uses a combination of empirical data and proprietary modeling tools to efficiently arrive at the optimal drug product for a given API and dosage form. Previously, Particle Sciences implemented software solutions for calculating and predicting solubilization systems for APIs and modeling the solubility of a given API in candidate polymers for drug-eluting polymeric devices.

A second module introduced in mid-2011 calculates inter-particle forces in dispersed systems, and leads to the design of stable nano- or microparticle suspensions. The third and latest addition accurately models the elution of a given API from a non-degrading polymeric device, such as an implant or an intravaginal ring. Based on well-established mathematics and a set of base measurements, this latest addition allows Particle Sciences to significantly reduce the time needed for prototyping drug-device combination products.

“These proprietary computational tools, combined with Particle Sciences’ industry-leading formulation and process capabilities, give our clients a true competitive advantage, allowing them to get to the right product faster,” said Dr. Andrew Loxley, Particle Sciences’ Director of New Technologies. “Particle Sciences has also institutionalized the use of Design of Experiments (DOE) in the product development process. While there is no replacement for actual prototyping and measurement, the systematic use of these modeling tools to guide the DOE approach streamlines our efforts, providing our clients with the most expedient path to clinically relevant products.”

Particle Sciences is an integrated provider of drug development services, focusing on BCS II/III/IV molecules, biologics, and highly potent compounds through a variety of technologies, including emulsions, gels, micro- and nanoparticulates, drug/device combination products, solid solutions, and others. Through a full range of formulation, analytic, and manufacturing services, it provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic.

Veloxis Pharmaceuticals & Athena Drug Delivery Solutions Announce Partnership

Veloxis Pharmaceuticals and Athena Drug Delivery Solutions recently announced an alliance in which Athena will obtain exclusive rights in certain emerging market territories to manufacture and, with third parties, develop, register, and commercialize Veloxis’ AtorFen (Fenofibrate Atorvastatin fixed-dose combination).

AtorFen will contain the lowest fully effective dose of fenofibrate and is a combination of two effective dyslipidemia treatments in one tablet, thereby potentially improving patient compliance. The product has been developed by Veloxis through Phase II in the US.

Results showed significant improvements in HDL-C, triglycerides, VLDL, and fibrinogen compared with atorvastatin alone (Lipitor 40 mg) as well as significantly greater effect on non-HDL-C, LDL-C, triglycerides, and total cholesterol compared with fenofibrate alone (Tricor 145 mg).

Under this alliance, Athena will establish and fund AtorFen manufacturing capabilities in India and through partnerships with regional and country level pharmaceutical companies develop and, once approved, commercialize the product. Veloxis will transfer its technology for manufacturing of AtorFen to Athena, with all expenses funded by Athena, and Veloxis will retain 70% of all revenues generated (subject to a minimum royalty rate). Veloxis will retain the right to reclaim major territories or regions where third-party distributors are not established by Athena within certain time intervals.

“This alliance will enable Veloxis to establish a competitive presence for AtorFen in emerging markets,” said William Polvino, MD, Chief Executive Officer of Veloxis. “Substantial future growth in the pharmaceutical industry is expected to come from this region where cardiovascular morbidity is on the rise. We’re delighted to have the opportunity to work with Athena, a company that is well positioned in emerging markets. This agreement is part of our strategy to out-license our cardiovascular portfolio to partners who can realize the full value of these assets.”

Based in Horsholm, Denmark, with an office in NJ, Veloxis Pharmaceuticals A/S is a specialty pharmaceutical company. Clinical development is the core of Veloxis’ efforts to develop a product portfolio that includes the company’s lead product candidate, LCPTacro, for immunosuppression, specifically organ transplantation, and products to combat certain cardiovascular diseases. Veloxis adapts new technologies on a fast commercial timetable. Veloxis’ unique, patented delivery technology, MeltDose, can improve absorption and bioavailability at low scale-up costs not only for a broad spectrum of drugs already on the market, but also for NCEs. Veloxis has a lipid-lowering product, Fenoglide, currently on the US market and a diversified near- and medium-term pipeline with three clinical-stage product candidates and a number of projects in preclinical development.

Isotechnika & Vifor Pharma Enter Development & Commercialization Agreement

Isotechnika Pharma Inc. recently announced it has signed a global development and commercialization license agreement with Vifor Pharma Ltd., the specialty pharma company of Switzerland-based Galenica Group. The agreement grants Vifor Pharma an exclusive license for the company’s lead drug, voclosporin, for the treatment of lupus and all proteinuric nephrology indications. The Vifor pharma license is for the US and other regions outside of Canada, South Africa, Israel, China, Taiwan, and Hong Kong.

While the details of the transaction are confidential, Isotechnika noted that it is eligible to receive significant up-front and milestone payments, as well as royalties on commercial sales. In connection with this agreement, Vifor Pharma will be purchasing voclosporin capsules from Isotechnika.

“While the successful development of voclosporin for the prevention of kidney transplant rejection remains our primary focus, we believe the expansion of our platform beyond that indication via partnerships like this may help to unlock the drug’s full medical and commercial potential,” said Dr. Robert Foster, CEO of Isotechnika. “Autoimmune diseases continue to represent a significant unmet medical need globally, and we are confident that the opportunity to advance voclosporin to provide much needed therapeutic choice in the treatment of lupus will be a benefit for patients suffering from this often debilitating disease.”

Pursuant to a development, distribution, and license agreement between the company and ILJIN Life Science Co., Ltd, ILJIN held an exclusive license to voclosporin for transplant and autoimmune indications for some of the same geographic areas that comprise the Vifor pharma territory. In order to facilitate the Vifor pharma license, ILJIN and Isotechnika have reached an agreement in which ILJIN has licensed back to Isotechnika the autoimmune indications in the countries that fall within the Vifor pharma territory.

Vifor Pharma is one of the world’s leaders in the discovery, development, manufacturing, and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as OTC products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.

Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of immunomodulating therapeutics designed to offer key safety advantages over currently available treatments. Its lead drug, voclosporin, is a calcineurin inhibitor, and is targeted at the estimated $3-billion market for this class of immunosuppressants.

Novavax Reports Significant Vaccine Development Progress

Novavax, Inc. recently announced that CPL Biologics (CPLB), its joint venture in India with Cadila Pharmaceuticals Ltd., has made significant progress with its vaccine development programs in 2011 and is preparing to initiate clinical studies of vaccine candidates to prevent influenza and rabies in 2012 and 2013, respectively.

Cadila is one of the largest private pharmaceutical companies in India. CPLB was established in 2009 to combine Novavax’s novel vaccine technology and Cadila’s product development and manufacturing expertise to develop vaccine candidates from both companies and manufacture and market them in India. Novavax retains rights to products developed for markets outside of India.

Among the joint venture’s recent achievements is the development of a rabies vaccine candidate engineered by Novavax, which has shown great promise in preclinical testing. Rabies remains a significant public health hazard in India where 36% of the world’s rabies deaths occur. According to the World Health Organization, the majority of these deaths are the result of children under the age of 15 coming in contact with infected dogs. CPLB completed positive preclinical immunogenicity studies of a rabies G-protein nanoparticle vaccine and has recently received approval from the Review Committee on Genetic Manipulation (RCGM) to begin toxicology studies of this vaccine prior to initiating human clinical trials. The RCGM is responsible for regulating preclinical and clinical testing of recombinant vaccines, diagnostics, and biologics in India.

In addition, CPLB has made rapid progress with the validation of its state-of-the-art manufacturing facility in Dholka, India, which is now operational and capable of producing a significant volume of novel vaccine doses every year. This facility utilizes the single-use vaccine bioprocessing system that Novavax employs at its pilot plant in Rockville, MD. The facility in Dholka will be used initially to produce clinical supplies of vaccine candidates to prevent influenza and rabies and will later be used to produce commercial product as well as clinical supplies for other undisclosed new vaccine candidates to meet critical medical needs.

CPLB is also now pursuing early development of undisclosed new vaccine candidates to prevent other diseases. The targets of these vaccine candidates will be identified as they progress into preclinical and clinical studies.

“CPLB has made great progress this year with its state-of-the-art manufacturing facility and vaccine pipeline. It continues to demonstrate the power of combining our technology with world-class research, clinical development, and manufacturing expertise to develop potential in-border vaccine solutions,” said Stanley Erck, President and CEO of Novavax. “I am particularly excited about the team’s accelerated vaccine development efforts this year and the approval by the RCGM to initiate the rabies toxicology studies, which is an important milestone. In addition to sharing directly in any success from CPLB’s efforts to commercialize vaccine products in India, Novavax can utilize CPLB’s development work on vaccine candidates like rabies to initiate similar efforts in other territories that would benefit from such a program. We see CPLB as a long-term strategic partner that expands Novavax’s vaccine development capability plus adds to our global manufacturing capacity. I look forward to reporting more about their current and new vaccine programs in 2012.”

“Our joint venture with Novavax is progressing well and remains on track to begin clinical testing of two new vaccine candidates,” added Indravadan A. Modi, Chairman of Cadila Pharmaceuticals Ltd. “In addition, we have continued to add talented new scientific and manufacturing staff as we prepare for the launch of our production facility and expand preclinical testing of new vaccine candidates for undisclosed targets.”

Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea.

Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the state of Gujarat. Throughout the past 5 decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in India and in over 50 countries around the world. Cadila Pharmaceuticals is an integrated healthcare solutions provider with a pharmaceutical product basket in therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics, and immunologicals. The state-of-the-art R&D facility at Cadila Pharmaceuticals is manned by more than 350 scientists and engineers from various disciplines, including biology, pharmacology, clinical research, chemistry, toxicology, phytochemistry, and different disciplines of engineering.

The company also participates in public-private partnerships for developing preventive and curative pharmaceutical and diagnostic products. Throughout the past decade, Cadila Pharmaceuticals has focused on novel approaches to cancer management and is the first Indian company to get multiple INDs cleared by USFDA. The company has state-of-the-art manufacturing facilities conforming to the most stringent international norms at Dholka, Ankleshwar, Kadi and Hirapur in Gujarat; Samba in Jammu and Kashmir, and Addis Ababa in Ethiopia. Cadila Pharmaceuticals has recently emerged on the world map with the development of Polycap – a novel and world’s first drug combination for primary prevention of cardiovascular heart disease.

Thermo Fisher Scientific Uses New Method to Determine Sialic Acids in Glycoproteins

Thermo Fisher Scientific recently announced a new method that uses high-performance anion-exchange chromatography with pulsed amperometric detection (HPAE-PAD) to determine sialic acids in glycoproteins. Application Update 181: Rapid Screening of Sialic Acids in Glycoproteins by HPAE-PAD demonstrates good recoveries, precision, and linear detection for N-acetylneuraminic acid (Neu5Ac) and N-glycolylneuraminic acid (Neu5Gc). Using the Thermo Scientific Dionex CarboPac PA20 Fast Sialic Acid column, this rapid method separates Neu5Ac and Neu5Gc with a total analysis time of < 5 minutes, providing high-throughput sample analysis while reducing eluent consumption and waste generation.

Glycoprotein sialylation is critical to bioavailability, stability, metabolism, and immunogenicity of therapeutic proteins. As a result, proteins such as Neu5Ac and Neu5Gc are routinely analyzed to determine sialylation amount and identity.

This application note and many others can be found at www.thermoscientific.com/dionex under the Documents tab.

Thermo Fisher Scientific Inc. is a world leader in serving science with a mission 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 serves 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.

Alexion Pharmaceuticals to Pay $1 Billion for Enobia Pharma

Alexion Pharmaceuticals, Inc. and Enobia Pharma Corp. recently announced the companies have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia. Enobia is a private biopharmaceutical company based in Montreal, Canada, and Cambridge, MA, focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders.

Enobia’s lead product candidate ENB-0040 (asfotase alfa), is a human recombinant targeted alkaline phosphatase enzyme-replacement therapy for patients suffering with hypophosphatasia (HPP), an ultra-rare, life-threatening, genetic metabolic disease for which there are no approved treatment options. Alexion will acquire full worldwide development and commercial rights to asfotase alfa. Asfotase alfa was awarded orphan drug designation in the US and EU in 2008 and Fast Track status in the US in 2009, and is currently in Phase II clinical development.

“Hypophosphatasia is an ultra-rare and life-threatening disease, and those patients who survive live with debilitating morbidities, including skeletal deformity, severe muscle weakness, and progressive damage to vital organs,” said Leonard Bell, MD, Chief Executive Officer of Alexion. “Asfotase alfa has shown very compelling Phase II clinical data in infants and juveniles with hypophosphatasia. The acquisition of Enobia is very well aligned with Alexion’s objective to develop and deliver life-transforming therapies for patients suffering with ultra-rare, severe, and life-threatening disorders.”

“Alexion has proven expertise in developing and commercializing therapies to transform the lives of patients with severe and ultra-rare disorders, making them the ideal partner to advance the work of the Enobia team and bring asfotase alfa to HPP patients around the world,” added Jonathan Silverstein, General Partner of OrbiMed and Enobia Chairman.

Alexion will acquire Enobia in an all-cash transaction. Under the terms of the agreement, Alexion has agreed to pay $610 million in cash upon consummation of the transaction, and up to $470 million in cash to be paid upon achievement of various regulatory and sales milestones. Alexion is not issuing equity in connection with the acquisition. The transaction is subject to customary conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The Boards of both companies have approved the transaction and the companies currently anticipate that the transaction will be completed in the first quarter of 2012. Alexion intends to finance the acquisition through cash on hand and $300 million of committed bank debt.

Goldman, Sachs & Co. is acting as financial advisor to Alexion. Ropes and Gray LLP is acting as legal counsel to Alexion. Bank of America Merrill Lynch is acting as financial advisor to Enobia. WilmerHale is acting as legal advisor to Enobia.

Asfotase alfa is an investigational, highly innovative, first-in-class recombinant protein that addresses the underlying cause of HPP by targeting replacement of the missing enzyme to the necessary body tissues. Asfotase alfa is designed to normalize the genetically defective metabolic process and prevent or reverse the severe and life-threatening complications of life-long dysregulated mineral metabolism in patients with HPP.

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 35 countries for the treatment of PNH, and in the US and the European Union for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development.