10/3/2012

Actinium Announces Multi-Million Financing

Actinium Pharmaceuticals, Inc. recently announced it has engaged Laidlaw & Company (UK) Ltd. and launched a new round of fundraising that will culminate in a going public transaction.

The Company intends to raise up to $20 million in new funds to be used for further clinical development of Actimab-A and Iomab-B, Actinium’s clinical-stage drug candidates for treatment of hematologic malignancies, and continued preclinical development of additional drug candidates in solid cancer indications as well as for general working purposes.

“With this capital raise, we will be able to progress our pipeline further in terms of generating proof-of-concept results for our Actimab-A program in elderly acute myeloid leukemia and advance our Iomab-B program into a registration trial to enable a bone marrow transplant in patients otherwise ineligible for this curative procedure,” said Jack Talley, Actinium’s CEO.

Laidlaw & Company (UK) Ltd., founded in 1878, is a full-service investment banking and brokerage firm offering personalized investment advice and skillful execution to private and public institutions, as well as high net worth individual investors.

Under the proposed terms of the offering, accredited investors will receive units consisting of company’s common stock and warrants. This offering will culminate in the company becoming a publicly traded entity on a US stock exchange targeted for later this year.

Actinium Pharmaceuticals, Inc. is a NY-based biopharmaceutical company that develops innovative alpha particle immunotherapeutics based on its proprietary platform for the therapeutic utilization of alpha particle emitting actinium-225 and bismuth-213 radiopharmaceuticals in association with monoclonal antibodies. For more information, visit www.actiniumpharmaceuticals.com.

Clinipace Worldwide Buys Paragon Biomedical; Plans New Hires

Clinipace Worldwide and Paragon Biomedical, Inc. recently announced a definitive merger agreement under which Clinipace Worldwide has acquired all outstanding shares of the privately held, Irvine, CA-based company and its subsidiaries. The merger will significantly expand Clinipace Worldwide’s therapeutic expertise, site management capabilities, and clinical operations. In addition, the company extends its global footprint with the addition of offices in Irvine, High Wycombe, UK, and Trivandrum, India.

“Paragon is an ideal partner to achieve our common long-term goals to drive innovation in clinical research through a technology-amplified service platform. Bringing our two companies together provides the foundation for a more compelling service offering, supported by a substantial body of work spanning 20 years, a great reputation for quality, a differentiated technology-enabled clinical operations platform, a strong site management organization, and an experienced management team,” said Jeff Williams, CEO, Clinipace Worldwide. “We offer a formidable and globally integrated array of clinical development services along with strategic product development, regulatory, and GxP/CMC/QA consultancy.”

Bringing these organizations together strengthens Clinipace Worldwide’s already strong oncology franchise with additional therapeutic expertise in the areas of cardiovascular, immunology, infectious diseases, central nervous system, respiratory, dermatology, and medical device clinical research services. Clinipace Worldwide also greatly expands its global footprint with a total of 12 offices in 8 countries.

Paragon clients gain access to Clinipace’s proprietary technology (TEMPO eClinical platform); and a comprehensive and integrated clinical operations, data management, biostatistics, and regulatory consultancy in North and South America, as well as Europe. Together, Clinipace Worldwide will double in size to more than 430 global employees. The combined company has managed over 1,200 clinical research, strategic product development, regulatory, and GxP/CMC/QA projects for venture-backed, mid-tier, and strategic pharmaceutical, biotechnology, and medical device firms.

“With complementary strengths, we’re thrilled to be combining forces with Clinipace Worldwide to create one globally integrated company,” said Gena Reed, Founder and CEO of Paragon Biomedical. “Moreover, the company cultures and senior leadership teams blend well, creating a corporate marriage that is ideal for our employees and customers.”

Ms. Reed will remain with the combined company in a strategic advisory capacity and will join the Clinipace Board of Directors. Mark Harvill, previously President and Chief Operating Officer for Paragon, will assume the COO role at Clinipace Worldwide, where he will be responsible for all global service and delivery-related teams. Chris Porter, formerly Clinipace’s COO, will transition to President and General Counsel, where he will continue to lead corporate and global business development efforts. Carol Abel, Paragon CFO and VP, Administration, will assume the role of Integration Advisor. Jeff Williams will continue to serve as CEO.

There are no layoffs or office closings planned; and the new combined organization will continue to hire throughout the year. “It is rare to bring two equally sized companies together without reductions, but these two companies fit together very well and we are pleased to preserve and add jobs” added Mr. Williams. “Additionally, our combined contract backlog has increased nearly four-fold compared to a year ago and provides a great platform for our continued growth and innovation.”

As a global full-service digital contract research organization (dCRO), Clinipace has pioneered an innovative technology-amplified CRO service model to serve the unique needs of venture-backed, mid-tier, and strategic pharmaceutical, biotechnology, and medical device firms. For more information, visit www.clinipace.com.

Covidien’s Mallinckrodt to Acquire Company for $100 Million

Mallinckrodt, the Pharmaceuticals business of Covidien, recently announced a definitive agreement to acquire CNS Therapeutics, Inc. Mallinckrodt will acquire all of the outstanding capital stock of CNS Therapeutics, based in St. Paul, MN, for approximately $100 million. The transaction, subject to customary closing conditions, is expected to be completed during the fourth calendar quarter of 2012. CNS currently has one marketed product and a diverse pipeline of pain and spasticity products in development.

“This acquisition supports our strategy of leveraging our therapeutic expertise and our core capabilities in manufacturing, regulatory, and commercialization to serve patients,” said Mark Trudeau, President, Pharmaceuticals. “CNS Therapeutics’ marketed product line complements our branded portfolio. Their central nervous system and pain management products in development complement our pipeline and address an important need for patients.”

Mallinckrodt is the largest US supplier of opioid pain medications and among the top 10 generic pharmaceuticals manufacturers in the US, based on prescriptions. Covidien announced last December that the company planned to spin off Mallinckrodt into a stand-alone company, a process that is expected to be completed in mid-2013. Assuming a fourth calendar quarter 2012 closing, Covidien does not expect this transaction to have a material impact on its fiscal 2013 sales or earnings per share. Once the transaction has been completed, Covidien will report the CNS Therapeutics business in the Specialty Pharmaceuticals product line within the Pharmaceuticals segment.

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes, and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies.

Mallinckrodt, the pharmaceuticals business of Covidien, is a vertically integrated leader in providing products used in diagnostic procedures and in the treatment of pain and related conditions. The company is the largest US supplier, by prescription, of opioid pain medications and a leading manufacturer of active pharmaceutical ingredients. It is also the largest US supplier of the medical isotope technetium-99m and an industry leader in radiopharmaceuticals and contrast media and delivery systems. For more information, visit www.mallinckrodt.com.

Theorem Clinical Research Expands Service Area Worldwide

To help bring life-saving drugs to market around the world, Theorem Clinical Research Inc. offers Theorem Strategic Sourcing Solutions to provide staffing and outsourcing services to the pharmaceutical and biotech industries in more than 30 countries, with a special focus in Asia-Pacific and Latin America, but with the ability to deploy staff to any country where presence is required.

“It is fundamentally important to us that we are able to offer a full range of staffing solutions to meet the needs of clinical research professionals worldwide,” said Theorem CEO John Potthoff. “That includes being able to provide qualified staff, help reduce overhead costs, and increase productivity.”

Theorem outsourcing managers are clinical research professionals who have experience in clinical trial administration, bioanalysis, data management, medical writing, drug safety, and other research areas. Theorem’s dedicated recruitment teams find qualified English-speaking scientists who are the right fit for each project, and back them up with the support of the global Theorem Clinical Research network.

Theorem’s 90% retention rate is a reflection of the achievements of its sourcing talent, compared to the 20% turnover rate throughout the rest of the industry. Theorem assigns a dedicated, regionally based manager, with in-depth knowledge of local employment laws and recruiting, to each client. Through openness, trust, and collaboration, these managers establish client requirements and expectations and provide feedback on staff performance as well as support future resource planning

Theorem Strategic Sourcing Solutions business unit consistently delivers quality service with the ability to identify, screen, interview, and onboard staff across a broad spectrum of functional areas. Theorem Clinical Research Inc. is a leading mid-size provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base composed of some of the world’s leading pharmaceutical, biotech, and medical device companies. A world leader in the most complex medical device and drug-device combination trials in addition to a notable capability in pharmaceuticals and biologics, Theorem has deep expertise in a broad range of therapeutic areas and in all phases of development. Some of the industry’s top scientists and most advanced clinical analytics capabilities help ensure smooth-running, successful trials. For more information, visit www.theoremclinical.com.

Hovione Expands Offering to Solve Bioavailability & Other Delivery Challenges

Hovione recently announced the expansion of its solutions to solve issues of poor bioavailability, patient acceptability, and the enabling of optimal delivery for non-oral routes of administration. Building on the experience of more than 100 projects and successful commercialization of spray dried dispersions, Hovione’s toolkit of solutions now includes crystal design, particle size reduction to the micro or nano-scale, and amorphous solid dispersions. These services are offered from bench to commercial scale and are complemented with formulation development and clinical manufacture to Phase II.

“We are very pleased to offer our customers these technologies. In response to customers’ needs, Hovione is investing in new technologies, many of them capable of handling highly potent compounds. These will help drive compounds with development challenges from early clinical to market,” said Guy Villax, Chief Executive.

Colin Minchom PhD, who has been leading Hovione’s Particle Design business since March, stated, “More than the technologies, the quality of Hovione’s scientists, engineers, and their experience in the application of 21st Century methodologies, such as QbD, PAT, and process modelling are outstanding.”

Hovione will be presenting its new offering in detail during the AAPS Annual Meeting and Exposition at McCormick Place in Chicago. Hovione scientists and staff will be available to support your queries at booth 3936 from October 15-17. The company will also be exhibiting at Booth 3D39 at CPhI in Feria de Madrid, Spain (October 9-11). For those interested in the offering but are not able to attend either event, please visit www.hovione.com/pd or contact particledesign@hovione.com.

Hovione is a global company with over 50 years of experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design, formulation development, and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Kinexum & Pennington Biomedical Announce Collaboration

Kinexum and Pennington Biomedical Research Center recently announced plans to establish an integrated approach for emerging companies and early stage therapies to achieve high-value regulatory and early phase human clinical trials. The approach will focus on acceleration and efficiency for translational research of scientific discoveries and therapeutic development to achieve important regulatory requirements, proof-of-concept, and first-in-human studies. The collaboration will bring together unparalleled experience and capabilities in diabetes, obesity, and chronic metabolic diseases to address critical milestones essential to bringing innovative products to market faster and more cost effectively.

Kinexum has been advising global regulatory and development strategy and providing management support for emerging companies in diabetes, obesity, and metabolic syndrome for over a decade.

“We have seen increasing challenges for innovative products and early stage companies to cost effectively meet the complex requirements that are critical to success in meeting regulatory, preclinical, clinical, and manufacturing milestones,” said Dr. Alexander Fleming, Founder and CEO of Kinexum. “The integrated approach with Pennington Biomedical’s Phase I Research Unit fits our mission to advance innovative therapies quickly and cost effectively, mitigate risk, and accelerate commercialization of new healthcare products.”

The Pennington Biomedical Research Center has a 25 year history of leading clinical research in nutrition, obesity and metabolism. Pennington Biomedical’s fully integrated Phase I Research Unit, as part of its comprehensive Clinical Research program, involving both outpatient and inpatient services, has recently expanded capacity and includes state-of-the-art technology, proven expertise, and specialized metabolic assessment capabilities. Pennington Biomedical is located in Baton Rouge, LA, in the heart of one of the nation’s highest prevalence regions for diabetes, obesity, and chronic metabolic disease.

“This collaboration between Kinexum and Pennington Biomedical leverages the unique strengths and capabilities of both partners, and combines the expertise in regulatory and development strategies with a sophisticated and comprehensive research infrastructure. Collectively, this partnership will result in research efficiencies, enhanced translational research, and more rapid development of products that may prove beneficial for improving human health,” says Dr. Cefalu, Associate Executive Director of Clinical Research.

With a global diabetes epidemic, huge healthcare costs, and very lean industry product pipelines, the importance of innovation has never been greater. Kinexum and Pennington Biomedical offer joint expertise to advance innovative products to first-in-human, proof-of-concept as well as Phase II clinical trials. A full range of strategy, management, and trial execution capabilities are available to meet the regulatory and technical challenges necessary for advancing therapeutic development through important milestones that mitigate risk and attract interest and value recognition from industry partners and investors.

Kinexum specializes in translational regulatory and development strategy for the global healthcare industry. Kinexum professionals bring decades of experience from the FDA and industry spanning regulatory, preclinical, clinical, and manufacturing solutions. Kinexum has helped more than 200 companies based in Europe, Asia, and North and South America over the past decade to achieve successful commercial-value milestones. For more information, visit www.kinexum.com.