IBM & the Institute of Bioengineering & Nanotechnology Find Breakthrough Treatment

Researchers from IBM and the Institute of Bioengineering and Nanotechnology recently discovered a nanomedicine breakthrough in which new types of polymers were shown to physically detect and destroy antibiotic-resistant bacteria and infectious diseases like Methicillin-resistant Staphylococcus aureus, known as MRSA.

Discovered by applying principles used in semiconductor manufacturing, these nanostructures are physically attracted to infected cells like a magnet, allowing them to selectively eradicate difficult-to-treat bacteria without destroying healthy cells around them. These agents also prevent the bacteria from developing drug resistance by actually breaking through the bacterial cell wall and membrane, a fundamentally different mode of attack compared to traditional antibiotics.

MRSA is just one type of dangerous bacteria that is commonly found on the skin and easily contracted in places like gyms, schools, and hospitals, where people are in close contact. In 2005, MRSA was responsible for nearly 95,000 serious infections and associated with almost 19,000 hospital stay-related deaths in the US.

The challenge with infections like MRSA is two-fold. First, drug resistance occurs because microorganisms are able to evolve to effectively resist antibiotics because current treatments leave their cell wall and membrane largely undamaged. Additionally, the high doses of antibiotics needed to kill such an infection indiscriminately destroy healthy red blood cells in addition to contaminated ones.

“The number of bacteria in the palm of a hand outnumbers the entire human population,” said Dr. James Hedrick, Advanced Organic Materials Scientist, IBM Research – Almaden. “With this discovery, we’ve been able to leverage decades of materials development traditionally used for semiconductor technologies to create an entirely new drug delivery mechanism that could make them more specific and effective.”

If commercially manufactured, these biodegradable nanostructures could be injected directly into the body or applied topically to the skin, treating skin infections through consumer products like deodorant, soap, hand sanitizer, table wipes, and preservatives, as well as be used to help heal wounds, tuberculosis, and lung infections.

“Using our novel nanostructures, we can offer a viable therapeutic solution for the treatment of MRSA and other infectious diseases. This exciting discovery effectively integrates our capabilities in biomedical sciences and materials research to address key issues in conventional drug delivery,” said Dr. Yiyan Yang, Group Leader, Institute of Bioengineering and Nanotechnology, Singapore.

The human body’s immune system is designed to protect us from harmful substances, both inside and out, but for a variety of reasons, many of today’s conventional antibiotics are either rejected by the body or have a limited success rate in treating drug-resistant bacteria. The antimicrobial agents developed by IBM Research and the Institute of Bioengineering and Nanotechnology are specifically designed to target an infected area to allow for a systemic delivery of the drug.

Once these polymers come into contact with water in or on the body, they self-assemble into a new polymer structure that is designed to target bacteria membranes based on electrostatic interaction and break through their cell membranes and walls. The physical nature of this action prevents bacteria from developing resistance to these nanoparticles.

The electric charge naturally found in cells is important because the new polymer structures are attracted only to the infected areas while preserving the healthy red blood cells the body needs to transport oxygen throughout the body and combat bacteria.

Unlike most antimicrobial materials, these are biodegradable, which enhances their potential application because they are naturally eliminated from the body (rather than remaining behind and accumulating in organs).

The antimicrobial polymers created by IBM Research and the Institute of Bioengineering and Nanotechnology and were tested against clinical microbial samples by the State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, First Affiliated Hospital, College of Medicine and Zhejiang University in China. The full research paper was recently published in the peer-reviewed journal Nature Chemistry.

Researchers from IBM are already applying principles from nanotechnology to create potential medical innovations like the DNA Transistor and 3-D MRI. Most recently, they have been working on a one-step point-of-care-diagnostic test based on an innovative silicon chip that requires less sample volume, can be significantly faster, portable, easy to use, and can test for many diseases. Dubbed Lab on a Chip, the results are so quick and accurate that a small sample of a patient’s blood could be tested immediately following a heart attack to enable the doctor to quickly take a course of action to help the patient survive.

Merck Serono & Newron to Broaden Collaboration on New Therapies

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, recently announced that Merck KGaA has entered into an agreement that broadens the scope of the collaboration with Newron Pharmaceuticals S.p.A., Milan, Italy. The two companies are already collaborating on the development of safinamide in Parkinson’s disease.

Under the terms of the agreement, Newron will receive a development license for two Merck clinical-stage compounds, pruvanserin and sarizotan. Merck will retain buy-back options for each compound upon completion of proof-of-concept trials. Should these options be exercised by Merck, Newron will have a co-development option. No further financial terms are disclosed.

Pruvanserin and sarizotan are highly selective compounds for specific serotonin or dopamine receptors and modulate the activity of these neurotransmitters in the brain. Both compounds exhibit pharmacological properties and have clinical data that support further evaluation and development. Newron will assess the potential of these compounds in additional preclinical experiments prior to initiating proof-of-concept studies in CNS diseases.

“We are very pleased to continue building our relationship with Newron,” said Dr. Bernhard Kirschbaum, Executive Vice President for Global Research and Development at Merck Serono. “We believe this expanded collaboration will leverage Newron’s strong expertise in the early stage development of compounds targeting CNS indications.”

“This agreement is an excellent opportunity for Newron to expand its development pipeline with innovative compounds within Newron’s field of expertise, added Dr. Ravi Anand, Newron’s Chief Medical Officer.

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on novel therapies for diseases of the CNS and pain. Phase III trials of safinamide are currently ongoing for the treatment of Parkinson’s disease. As per the agreement signed with Newron in 2006, Merck Serono, has exclusive worldwide rights to develop, manufacture, and commercialize the compound in Parkinson’s disease, Alzheimer’s disease, and other therapeutic applications. Newron is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases.

Antares Pharma Announces NDA Accepted for Filing

Antares Pharma, Inc. recently announced the NDA for Anturol Gel in patients with overactive bladder (OAB) was accepted for filing for review by the US FDA. Anturol is an oxybutynin gel incorporating Antares’ ATD Gel technology. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011, 10 months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.

“The FDA’s acceptance of the NDA filing is an important milestone in the review process to secure approval from the FDA for commercial distribution of Anturol. We look forward to working with the FDA in their ongoing review of Anturol,” said Kaushik J. Dave RPh, PhD, MBA, Senior VP Product Development of Antares Pharma.

The Anturol NDA submission is supported by data from a Phase III randomized, double-blind, placebo-controlled clinical trial involving 600 patients with OAB. In the 12-week study, patients treated with Anturol 56 mg daily or 84 mg daily experienced a significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day. Anturol was well tolerated in the study with no reported serious treatment-related adverse events. Anticholinergic side effects, such as dry mouth and constipation, were low, and no increase in CNS side effects was seen compared to placebo. The study was conducted under a Special Protocol Assessment (SPA) by the FDA.

“The FDA’s acceptance for filing of the NDA for Anturol, Antares Pharma’s first NDA, is another notable achievement for the company resulting from the dedicated efforts of the entire Antares team. This is an important accomplishment in the continued execution of our product-focused strategy,” said Paul K. Wotton, PhD, President and CEO.

Anturol is an oxybutynin gel based on the ATD Gel technology platform, which is a clear, odorless, hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The company’s subcutaneous and intramuscular injection technology platforms include Vibex disposable pressure-assisted auto-injectors, Valeo/Vision reusable needle-free injectors, and disposable multi-use pen injectors.

Aptar Pharma Registers Contract Test Laboratories With US FDA

Aptar Pharma’s French manufacturing sites in Le Vaudreuil and Val-de-Reuil have been registered as Contract Test Laboratories for extractables testing with the US FDA. A number of pharmaceutical and biotechnology companies working with Aptar Pharma drug delivery devices have expressed a requirement to use Aptar Pharma extractables testing for batch release of their drug products. They can now benefit from this advantageous Aptar Pharma service.

Through decades of experience working closely with its pharmaceutical and biotechnology customers in a spirit of continuous improvement, Aptar Pharma understands their evolving needs. As a world-leading supplier of innovative non-invasive drug delivery devices, Aptar Pharma has developed a variety of analytical capabilities, of which extractables data is critical for customers. Now that Aptar Pharma analytical laboratories have been registered with the FDA, customers can reduce their own testing burden, further enhancing the value of their partnership with Aptar Pharma.

Pharmaceutical and biotechnology drug manufacturers are responsible for identifying and quantifying extractables and leachables and for evaluating any associated potential toxicity. Drug delivery device components are typically made of materials, such as polymers and elastomers. The measurement of extractables from materials that are in contact with drug product is growing in importance due to increased regulatory scrutiny from organizations, such as the FDA. Regulators are concerned about the interaction of the drug delivery device components with drug products. Extractables assessment of plastic and elastomeric components forms an integral part of the submission for approval, as well as for the routine controls used to release batches of the drug product.

Aptar Pharma manufacturing sites in France have been inspected by the FDA with an excellent outcome. The Aptar Pharma sites at Le Vaudreuil and Val-de-Reuil have been inspected twice by the FDA in recent years. These inspections were very satisfactory, with no observations being made (also known as the FDA 483 Inspectional Observations notice). With this FDA registration, Aptar Pharma French sites, which are already ISO-15378 certified and which operate with a robust and mature cGMP-compliant quality system, will further improve service and commitment to support their drug manufacturer customers.

Comprehensive Clinical Development Finalizes Acquisition

Comprehensive Clinical Development, formerly operating as Comprehensive NeuroScience, Inc., a strategic clinical research organization delivering high-quality clinical development services from early proof-of-concept through commercialization, recently announced the acquisition of Charles River Clinical Services Northwest, Inc., including its 250-bed, 77,000-sq-ft, Phase I-IIa facility located in Tacoma, Washington.

The newly combined companies offer over 160 years of collective industry experience and provide an end-to-end turn-key clinical development solution, from inception of clinical testing through proof-of-concept trials. The increased capacity and capabilities deliver numerous benefits to support clients’ complete drug development programs, including geographic diversification allowing clients a more proximal location to conduct studies and increase service offerings from coast to coast, established experience in conducting radiolabeled studies; streamlined optimization and extensive expertise in biologics studies; access to leading physicians in numerous specialties including oncology, expansive patient populations, and unique nuclear pharmacy capabilities, allowing for highly differentiated studies;s pecialized pharmacy services optimized for compounding, including radiolabeled compounds; and extensive access to populations for targeting treatments for patients with hepatitis C.

“We are thrilled to have the team from Charles River Clinical Services joining the Comprehensive network,” said Comprehensive Clinical Development CEO Jack McGovern. “We are uniquely aligned with similar cultures, industry experience, and business philosophies. What is just as exciting is how complementary the businesses are in terms of customer mix, service offerings, geographic location, and subject populations.”

“Joining Comprehensive Clinical Development is a very positive development for our future in the clinical trials industry,” added Charles River Clinical Services General Manager Colleen Hoke. “Leveraging best practices and the expertise of each firm will provide clear benefits to our clients. The similar cultures and aligned goals of the organizations will facilitate a smooth integration of operations.”

Pfizer Selling Capsugel to KKR for $2.38 Billion, Could Set Stage For Other Divestitures

Pfizer and Kohlberg Kravis Roberts & Co L.P. recently announced they have entered into an agreement whereby an affiliate of KKR will acquire Pfizer’s Capsugel business for $2.375 billion in cash. Capsugel, a world leader in hard capsules and an innovator in drug delivery systems, generated approximately $750 million in revenue and manufactured more than 180 billion hard capsules in 2010.

“The transaction is an endorsement of Capsugel’s consistent success to date and its potential for future growth with KKR, a firm with deep industry expertise and a long history of partnering with market-leading businesses to take them to the next level,” said Guido Driesen, President and General Manager of Capsugel. “Capsugel’s employees and I are excited to work with KKR and eager to enhance the value of our business in partnership with our customers.”

Over the past 34 years, KKR has invested in more than 185 transactions with a total value of more than $435 billion. KKR’s current private equity portfolio includes over 60 portfolio companies with over $210 billion of annual revenues and more than 900,000 employees.

“Capsugel has an excellent portfolio and outstanding reputation for providing high-quality, innovative drug delivery solutions,” said Henry R. Kravis and George R. Roberts, Co-Founders, Co-Chairmen and Co-CEOs of KKR. “We look forward to working with Capsugel’s talented employees and investing in this business. We share Capsugel’s enthusiasm for its future potential to grow, develop, and continue to deliver an unmatched quality of products.”

Pfizer expects to make additional repurchases of its common stock on the open market during 2011 as a result of this transaction, assuming completion this year. Pfizer’s repurchases of its common stock funded by Capsugel sale proceeds would be in addition to the previously announced anticipated repurchase of approximately $5 billion of shares planned for 2011. Pfizer will also continue to look to identify and invest in other opportunities to maximize its value, including business development.

Capsugel is a world-leading provider of hard capsules and an innovator in drug delivery systems for the pharmaceutical, OTC, and health and nutrition industries. Capsugel offers a comprehensive array of products and services, from hard gelatin, vegetarian, and liquid-filled capsules, to innovative R&D equipment and liquid formulations as part of its Licaps Drug Delivery System.

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