Agilent to Acquire Cancer Diagnostic Company for $2.2 Billion

Agilent Technologies Inc. and EQT, the Sweden-based private equity group, recently announced the execution of a definitive agreement for Agilent to acquire Dako, the Denmark-based cancer diagnostic company. The $2.2-billion acquisition (on a debt-free basis) is the largest in Agilent’s history.

“In the rapidly growing diagnostics market, Dako’s products and capabilities are a strategic complement to Agilent’s existing offerings,” said Bill Sullivan, Agilent President and Chief Executive Officer. “Dako is one of the world’s leading providers of cancer diagnostics tools, and together we will be able to develop a wider range of products that help in the fight against cancer.”

“Agilent’s strategy in acquiring Dako is about strengthening the company’s presence in life science and about revenue growth,” continued Mr. Sullivan. “Dako employs extremely talented people with specialized expertise that we highly value. Their knowledge and experience will be very important as we move forward together.”

Dako provides antibodies, reagents, scientific instruments, and software primarily to customers in pathology laboratories to raise the standards for fast and accurate diagnostic answers for cancer patients. Dako also collaborates with a number of major pharmaceutical companies to develop new potential pharmacodiagnostics, also called companion diagnostics, which may be used to identify patients most likely to benefit from a specific targeted therapy. Dako’s products are sold in more than 100 countries, and in 2010 its annual revenue was approximately $340 million. The company employs more than 1,000 people, primarily in Denmark, in Carpinteria, CA, and other parts of the world.

The acquisition is expected to close within the next 60 days, subject to the satisfaction of customary closing conditions.

Agilent’s bio-analytical measurement business provides application-focused solutions that include instruments, software, consumables, and services that enable customers to identify, quantify, and analyze the physical and biological properties of substances and products. Agilent is a global leader in gas chromatography and gas chromatography/mass spectrometry, and liquid chromatography and liquid chromatography/mass spectrometry used to analyze the composition of air, water, food, drugs, industrial process streams, and forensic evidence.

Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako’s know-how, reagents, instruments, and software to make accurate diagnoses and determine the most effective treatment for patients suffering from cancer. Employing more than 1,000 people and being present in more than 100 countries, Dako covers essentially all of the anatomic pathology markets globally. Information about Dako is available at www.dako.com.

Agilent Technologies Inc. is the world’s premier measurement company and a technology leader in chemical analysis, life sciences, electronics, and communications. The company’s 18,700 employees serve customers in more than 100 countries. Agilent had net revenues of $6.6 billion in fiscal 2011. Information about Agilent is available at www.agilent.com.

Newron & Zambon Enter Strategic Collaboration & License Agreement

Newron Pharmaceuticals S.p.A. recently announced it has executed with Zambon a strategic collaboration and license agreement for Newron’s lead compound safinamide. In aggregate, the total Zambon investment in Newron will be $25.5 million as defined further, also covering the completion of safinamide’s clinical development and the preparation of the application for marketing approval in Europe and the US.

Zambon has already made an investment of $6.38 million in Newron equity and an option fee, which was announced on April 5, 2012. In addition, Zambon will make a down payment to Newron of $6.38 million for the agreement that has now been executed, covering the license for safinamide research, development, manufacturing, and marketing in all territories of the world with the exclusion of those covered by the recently announced license agreement with Meiji Seika Pharma (Japan and key Asian territories). Furthermore, Zambon will meet the costs incurred by Newron to complete the development of safinamide and prepare the applications and file for marketing approval in Europe and the US. Zambon qualifies for one seat on the board of directors of Newron, at the upcoming Annual General Meeting.

Newron will receive significant success-based regulatory milestone payments as well as customary double-digit royalty payments on future sales of safinamide in the licensed territories.

“The strategic agreement with Zambon is of immense importance to Newron, as it provides us with a strong partner to support the completion of safinamide’s development,” said Rolf Stahel, Newron’s Chairman. “Additionally, the disclosed payments to Newron and the take-on of development cost by Zambon provides us with the means to broaden Newron´s strategic options.”

“Zambon has always been strongly committed to improve the Quality of Life of patients and bring innovative treatments to the market,” added Roberto Consonni, Zambon Pharma’s CEO. “We believe the closing of the agreement on safinamide and our competences in the pharma area and in fine-chemical processes represents a significant opportunity in the add-on treatment of Parkinson’s disease.”

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Phase III trials of safinamide are currently ongoing for the treatment of Parkinson’s disease (PD). Newron is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases. Newron’s additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection, NW-3509 for the treatment of schizophrenia, as well as pruvanserin and sarizotan for treatment of CNS diseases. Newron is headquartered in Bresso, near Milan, Italy. For more information, visit www.newron.com.

Zambon is an Italian pharmaceutical and fine-chemical multinational company, earning a strong reputation over the years for high-quality products and services. Zambon was established in 1906 in Vicenza, where are based the Italian fine-chemical and pharma plants. The other manufacturing units are in Switzerland, France, China, and Brazil. Zambon is present in 15 countries with more than 2,500 employees. Zambon Company S.p.A. is the industrial holding of the group, with Zach (Zambon Chemicals), which is a preferred partner for API, custom synthesis, and generics products for big pharma companies; with Zambon S.p.A., the pharma business, which mainly operates in respiratory, pain, and women healthcare; with Z-Cube, the corporate research venture, scouting new technologies and drug delivery system opportunities. For more information, visit www.zamboncompany.com.

IntelliCap Provides Reliable & Accurate Delivery

Medimetrics, recently certified to ISO 13485, has successfully developed the IntelliCap system, specifically designed to target delivery of small molecule drugs and biologics to the GI tract. The technology is capable of achieving controlled release of drugs to specific GI sites in a fast, cost-effective and convenient manner. This electronic capsule has the added capability of measuring quantitative data, such as temperature and pH throughout GI transit.

The idea of a swallowable device with sufficient electronic capability to deliver a drug in a programmed manner has turned from fiction to fact in recent years. There are various types of electronics-based capsules currently in development or in common use. This approach to drug delivery offers many exciting possibilities and, on the flip side, several challenges. It is tempting to utilize this technology for therapeutic purposes; however, regulatory hurdles abound and significant patient education on the usage of the capsules is envisaged. It is believed that the ideal application of these electronic capsules is in the area of early stage drug development.

The drug development process is extremely high risk, commanding significant amounts of time, energy and cost. It is essential to be efficient and accurate in determining whether drug candidates should be moved ahead for further development or discarded from the development pipeline.

Early stage development, which includes preclinical and first-in-man clinical studies, is an extremely critical step in the overall development process as major go/no-go decisions need to be made. These key decisions require a significant amount of reliable data as major financial and human resource investments will be committed. Nevertheless, failures of drug candidates in the late stages are very common.

Clinical failures are usually a result of lack of efficacy, high toxicity, and unfavorable pharmacokinetic (PK) properties. These parameters are often poorly understood and difficult to predict. The oral route is by far the preferred method of drug delivery; hence, it is critical to have a clear understanding of how a drug distributes and is absorbed following dispensing into the GI tract.

The value of a drug candidate is greatly enhanced if it shows propensity for being formulated into a controlled-release dosage form, but investigating this characteristic is usually neglected during the development process. The ability to accurately control the delivery of drug in the GI tract, to measure the GI transit parameters, and to evaluate the environment in which drug is released will greatly enhance the value of PK studies.

The IntelliCap consists of a microprocessor, battery, pH sensor, temperature sensor, RF wireless transceiver, fluid pump, and drug reservoir. The capsule has two main subunits, the electronics body and the drug reservoir. This modular design ensures the drug comes into contact only with the reservoir, which is made from inert polymer materials. The drug payload can be in the form of a liquid solution, suspension, or gel.

The capsule communicates via a wireless transceiver to an external control unit worn by the test subject. This real-time wireless data recording, in addition to wireless remote control of dose delivery, enables researchers to monitor a capsule’s progress through the GI tract and direct the delivery profile “on the fly.”

The capsule measures pH and temperature every 10 seconds and reports the data immediately for display on a control station computer. The pH data is useful on two fronts. First, it provides an indication of the pH environment in which the test drug is released. This information is valuable because the local pH can have a strong influence on the compound’s solubility.

Second, the pH profile gives information on the site of the capsule within the GI tract. Typically, there is a sharp rise in pH as the capsule passes from the acidic environment of the stomach into the near neutral environment of the duodenum. Subsequently, a fall in pH accompanies the passage of the capsule from the small bowel into the colon.

These landmark pH shifts are used by the SmartPill system (SmartPill Corp., Buffalo, N.Y.) to measure and diagnose motility disorders. In an IntelliCap study, these pH shifts can be used to determine capsule location in order to target drug delivery to a specific region and to better analyse PK data.

While the pH profile has been effectively used to determine regional location, there are some cases where finer detail on capsule location is required. For example, researchers interested in tracking the distribution of the drug after it is released from the capsule can do so by adding an imaging component to the study.

Gamma scintigraphy, a nuclear imaging technique, allows non-invasive in vivo imaging of gamma-emitting radioisotopes. These scintigraphic images confirm that the drug reservoir is clearly intact in the stomach, and upon triggering drug release, the subsequent release of radiolabel in the transverse colon confirms the successful deposition of the drug at the target site.

Knowing the exact transit behavior and pH environment of a delivery capsule in each subject is extremely valuable. The importance of understanding transit on an individual basis is illustrated by an example from an IntelliCap study in dogs. In this study, the IntelliCap capsule delivered a test compound in a zero-order release profile for 6 hours. Of the four subjects studied, the gastric residence varied between 1 minute and 98 minutes. Average gastric residence time in dogs was found to be approximately 84 minutes.

The subject with the anomalous gastric residence data (1 minute) had a PK profile that showed an instant rise in plasma drug concentration, which then started to decay after 93 minutes. It was evident that data from this subject could not have been correctly interpreted without the accompanying transit data supplied by IntelliCap.

Merging the transit data with the plasma PK data allowed the portrayal of a consistent picture with regard to drug absorption. In each subject, the compound was poorly absorbed when released in the stomach or colon, and well absorbed when released throughout the small intestine. Plasma concentration rose rapidly as the drug was delivered in the small intestine and fell after the capsule reached the caecum.

Application of IntelliCap to early stage drug development enables in vivo studies to be conducted with minimal formulation work, generating enhanced data that gives definitive results. PK studies that incorporate accurate controlled release and individual location data provide greater value to a development program.

Application of this newly developed electronic drug delivery capsule has been put to immediate use in the area of early stage drug development. With greater usage, many potential applications may be explored. Electronic control and incorporation of sensor or external data brings great promise for the development of personalized drug delivery.

Relay Technology Launches Intelligence & Data Visualization Solution

Relay Technology Management recently announced the official launch of Business Development Live (BD Live!) – a new unified, real-time data visualization, comparative asset analysis and tracking platform for the life sciences industry. Relay TM supports life science business development, and licensing professionals validate opportunities and discover new assets.

“BD Live! provides access to a comprehensive information repository on biopharma assets and other relevant entities and utilizes cutting-edge data visualization technologies to create interactive dashboards that dramatically improve the user experience,” said David Greenwald PhD, Relay TM’s Co-founder and Managing Director. “We are excited to open the platform more broadly after having successfully tested our innovative approach with a number of leading pharmaceutical and biotech companies. We look forward to working with customers to fulfill their business intelligence needs.”

“Identifying and evaluating assets, and finding the most appropriate partners for pharmaceutical companies is time-consuming, resource-intensive, and often based on partial information,” shares Peter Collins, Business Intelligence Director at the Nature Publishing Group, which created a collaborative partnership with Relay and made a strategic investment in the company in 2011. “Relay is uniquely positioned to bring much needed objective data aggregation and analysis to speed up the drug development process.”

Relay TM complements competitive intelligence by assessing the relative attractiveness of life science assets – drugs, targets, researchers, and institutions, historically and in real time, from one screen. For more information, visit www.relaytm.com.

Piramal Healthcare to Buy US Drug Data Firm for $635 Million

Piramal Healthcare Limited recently announced it has agreed to acquire Decision Resources Group for a consideration of approximately $635 million. Decision Resources Group provides high-quality, web-enabled research, predictive analytics via proprietary databases and consulting services to the global healthcare industry. With 20% CAGR for the last 5 years, it is one of the fastest growing companies in the $5.7-billion global healthcare information industry. DRG projects revenues of $160 million for 2012. Forty-eight of the top 50 global pharmaceutical companies are its customers, and it has an overall customer retention rate of 95%.

DRG is focused on three market segments: (1) the biopharma business unit provides reports, databases, and advisory services on drug utilization trends and forecasting in a variety of therapeutic areas; (2) the market access business provides database and analytical services that healthcare companies use to assess the current and future opportunity of their products’ acceptance into a market; and (3) the medical technology business provides actionable insights and data on the medical device markets.

DRG’s products include detailed market assessments based on a specialized network of over 125,000 healthcare professionals (primarily physicians), proprietary databases of market information, and detailed analytical reports on specific therapeutic areas. The three market segments that DRG covers are worth approximately $ 2.5 billion, leaving considerable room for DRG to continue to grow its revenues.

After the sale of its healthcare solutions business to Abbott Laboratories in May 2010 for $3.8 billion, Piramal Healthcare has embarked on a strategy to acquire global growth businesses with sustainable returns.

“The global healthcare industry is facing several challenges, including rising research costs, lower drug approval rates, mounting regulatory pressures, and increasingly complex reimbursement models,” said Ajay Piramal, Chairman of Piramal Healthcare. “The need for specialist information is critical and the demand is growing. DRG’s portfolio of products is widely regarded as the gold standard of information. We will leverage our longstanding reputation and relationships with global pharma companies, our knowledge of emerging markets, as well as our track record of successful acquisitions as we continue to grow further DRG’s leadership position in the healthcare information and analytics industry. We’re very pleased to add the expertise of a world-class management team with deep understanding of this sector and nearly 300 analysts with a strong track record in their field.”

“This is an excellent opportunity for our business, customers, and employees,” added Peter Hoenigsberg, Chief Executive Officer of Decision Resources Group. “My team and I are excited to be part of the Piramal Group and are confident that its expertise in acquiring, integrating, and growing businesses will support our continued growth. Our customers have indicated that independent, objective, indispensable information from emerging markets is one of their greatest needs and Piramal’s experience in emerging markets is important since these markets are the primary avenues for growth in the pharma industry.”

Following the completion of the DRG acquisition, Piramal will operate DRG as a stand-alone business. DRG will remain headquartered in Burlington, MA. The company will continue to be led by Mr. Hoenigsberg and the existing senior management team. The transaction is expected to close by the June 30, 2012, subject to customary regulatory approvals and closing conditions.

Ra Pharma Closes $8.6-Million Second Tranche of $27 Million Series A

Ra Pharmaceuticals recently announced it is pursuing hereditary angioedema (HAE) as a lead program, leveraging the company’s proprietary Cyclomimetic drug discovery and development platform. HAE is a rare, but serious and often fatal disorder of the innate immune system that causes intermittent attacks characterized by swelling and pain of the face, airways, and intestinal tract. Ra Pharma has discovered HAE drug candidates designed to prevent these attacks by inhibiting plasma kallikrein, which controls the release of bradykinin, a mediator of swelling and pain associated with HAE attacks. Cyclomimetics are a new drug class with the diversity and specificity of antibodies, coupled with the beneficial properties of small molecules.

“Ra Pharmaceuticals is developing Cyclomimetics to address diseases with significant unmet medical need, such as HAE,” said Doug Treco, PhD, Co-founder, President, and CEO, Ra Pharmaceuticals. “The only FDA-approved treatment for the prevention of HAE attacks is delivered intravenously every 3 to 4 days and produced from human blood. Our synthetic Cyclomimetics are easily produced, and could offer a stable, highly potent option for patients suffering from HAE. In addition, Cyclomimetics have the potential to be orally available, which would significantly increase the quality of life for patients with HAE. “We will continue to build out our pipeline using our high-diversity drug discovery platform capable of generating optimized lead candidates in a matter of weeks, but also hope to secure discovery and development partnerships as we gain momentum with our internal programs. The company is on sturdy ground with the recent second tranche closing of our $27-million series A financing and a strong IP portfolio covering our lead candidates, display technologies, and the ability to generate peptidomimetic libraries with multiple non-natural amino acids.”

Cyclomimetics are peptide-like molecules characterized by their cyclic structure and backbone and side-chain modifications that provide unique, beneficial properties not found in natural peptides. The result is a highly specific and stable molecule with improved cell permeability and the potential for greatly increased bioavailability.

Cyclomimetics result from the company’s proprietary Extreme Diversity platform. The platform is unique in that it combines in vitro display technology, a completely defined translation system, and a wide variety of non-natural amino acids. Unlike certain other display technologies, in vitro display does not require the use of a bacterial or yeast host, and it can produce libraries of 10 to 100 trillion members. Further, the technology has the potential to address protein-protein interactions and other previously undruggable targets.

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