7/11/2012
RoundTable Healthcare Acquires DPT Laboratories
RoundTable Healthcare Partners, an operating-oriented private equity firm focused exclusively on the healthcare industry, recently announced that its portfolio company, Renaissance Acquisition Holdings, LLC has acquired DPT Laboratories Inc. DPT is a leading pharmaceutical contract development and manufacturing organization with facilities in San Antonio, TX, and Lakewood, NJ. As part of the transaction, the current shareholders of DPT will maintain a meaningful equity stake in the combined business.
“Renaissance is excited by the opportunity to further invest in the continued growth and success of DPT,” said Pierre Fréchette, President and CEO of Renaissance. “We are committed to supporting DPT’s leading market position in semi-solid contract manufacturing and development as well as their emerging business in sterile manufacturing and specialty products.”
“RoundTable and Renaissance are ideal partners for DPT,” said John Feik, President and COO of DPT’s parent company, DFB Pharmaceuticals, Inc. “RoundTable’s track record of building strong, successful businesses combined with their unique capabilities in this industry truly differentiates them.”
Paul Dorman, Chairman and CEO of DFB, added, “RoundTable’s depth of experience gave us confidence to work exclusively with them to execute on the strategic plan that will drive accelerated growth at DPT.”
The existing DPT management team will continue to run day-to-day operations at DPT while assuming additional responsibilities within Renaissance.
“Renaissance’s acquisition of DPT is an important milestone in RoundTable’s strategy to build new pharmaceutical platforms,” stated Lester B. Knight, Chairman of Renaissance and Founding Partner and Co-Chairman of RoundTable. “We continue to be enthusiastic about the opportunities in this important market and look forward to partnering with the DPT management team to build on their success and accelerate the growth of their business.”
To finance the acquisition of DPT and further growth opportunities, RoundTable facilitated the successful completion of new senior credit facilities and a private placement of senior subordinated notes. The senior credit facilities were led by GE Commercial Finance Healthcare Financial Services as Administrative Agent and Co-Lead Arranger, and included PNC Bank National Association as Co-Lead Arranger and Syndication Agent. DPT’s senior subordinated notes were acquired by RoundTable Capital Partners II (Capital Fund II), RoundTable’s second captive subordinated debt fund. Capital Fund II is a dedicated subordinated debt fund that makes fixed rate subordinated debt investments alongside the equity investments of RoundTable’s equity funds. The current shareholders of DPT also acquired a portion of the senior subordinated notes.
RoundTable Healthcare Partners,
Renaissance Acquisition Holdings,
Encap Announces Significant Capital Expenditure Program
Encap Drug Delivery recently announced a $2-million capital expenditure program to support its growing CMO activities. Following the earlier expansion in 2008 when the company completed a $3-million investment involving an expansion of the Oakbank Park Way facility to provide two additional clean room suites, including a High Potency facility and further expansion of its development laboratories, Encap is now providing new investment for additional high-volume manufacturing equipment.
During the last 24 months, Encap has experienced a 20% increase in sales of its Pharmaceutical Development Services (PDS) and commercial manufacturing (CMO) activities and is forecasting a similar rate of growth in 2012/14. To complement the growth plans, Encap has committed a further $2 million of capital expenditure, buying the latest product mixing and capsule filling equipment, including a highly flexible Esco Labor (EL200) mixer and a high-speed Bosch filling machine (GKF2500L) and weight checker (KKE2500). Delivery of the new equipment will start this August and will be completed by February 2013.
“Encap has seen tremendous growth in its PDS business in the past 2 years with the initiation of more than 30 new pharma client projects,” said Encap’s Chief Executive Officer, Dr. Stephen Brown. “We have also recently completed the launch of three new commercial pharmaceutical products in EU and
Encap Drug Delivery is the world’s largest contract development and manufacturing organization (CDMO) totally dedicated to liquid and semi-solid (hot melt) filled capsules. The company was established in 1989 and is a global provider of oral drug delivery and pharmaceutical development services. The company provides clients with fully integrated analytical and formulation development services, clinical trial manufacturing, and high-volume commercial manufacturing. For more information, visit www.encapdrugdelivery.com.
Quotient Clinical & Capsugel Announce Collaboration
Quotient Clinical and Capsugel recently announced a collaboration to enable the rapid development and clinical assessment of lipid-based formulations. Together, the companies will use their technology and expertise to address the drug delivery challenges of poorly soluble molecules with limited oral bioavailability.
The collaboration integrates Quotient’s RapidFACT real time clinical manufacture and testing service with Capsugel’s lipid-based formulation expertise and manufacturing capability. With up to 70% of the industry’s development pipeline consisting of molecules with poor solubility, the collaboration will fast track the effective clinical evaluation of lipid-based drug delivery systems in man, whilst optimizing the drug product for downstream development. As part of the collaboration, Quotient will utilize Capsugel’s CFS Liquid Capsule Filling and Sealing technology at its facility in Nottingham and will be able to access the formulation expertise in Capsugel’s Development Centre in
“The collaboration with Capsugel will help our customers address prevalent drug delivery challenges for poorly soluble compounds in a more effective way. It will further empower our RapidFACT service by ensuring that selected drug products can be rapidly scaled up and transitioned into downstream development, further reducing timelines to critical development milestones,” said Mark Egerton, Managing Director of Quotient Clinical.
“Our expertise with poorly soluble drugs includes a proprietary predictive modeling technology based on an extensive database of lipid formulations that allows us to find the best formulas quickly,” added Keith Hutchison, Senior Vice President of R&D at Capsugel. “We also have a deep knowledge of capsules and our Licaps liquid filling and sealing technology helps to speed up the development process. These are perfect complements to Quotient’s ability to accelerate the generation of human clinical data, and we look forward to offering the new service to our global customers.”
Quotient Clinical, part of Quotient Bioresearch, has over 20 years of experience delivering high-quality data to provide innovative early drug development solutions to pharmaceutical and biotechnology clients worldwide, including 17 of the top 20 pharmaceutical companies. For more information or to discuss your specific needs, contact clinical@quotientbioresearch.com or visit www.quotientbioresearch.com/clinical.
Capsugel is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, liquid-filled, and vegetarian capsules, to innovative R&D equipment, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production. Capsugel also specializes in the formulation, development, clinical, and commercial supply of liquid filled hard and soft shell capsules to the healthcare industry. For more information about Capsugel, visit www.capsugel.com.
BASF Sells Marine Biopolymers Business
BASF SE and the Norwegian company Seagarden ASA recently announced they have signed a contract to transfer the Chitosan marine biopolymers business. Chitosan marine biopolymers are used in personal care products and as pharmaceutical ingredients. The transaction is expected to be formally completed by August 2012.
The divestment of the Chitosan business from former Cognis results from the portfolio optimization following the acquisition of Cognis by BASF in 2010. The Chitosan business, including the production site in
BASF Care Chemicals division offers a broad range of ingredients for hygiene, personal care, home care, industrial & institutional cleaning, and technical applications. It is the global leading supplier for the cosmetics industry as well as the detergents and cleaners industry and supports its customers with innovative and sustainable products, solutions, and concepts.
Seagarden ASA is a Norwegian Public Company with around 80 shareholders. The company is registered in
GlobeImmune Files for $69-Million IPO
GlobeImmune, Inc. recently announced it has publicly filed a registration statement with the US SEC relating to a proposed initial public offering of shares of its common stock. GlobeImmune previously submitted its registration statement to the SEC on a confidential basis under the Jumpstart Our Business Startups Act. The number of shares to be offered and the price range for the offering have not been determined. The company has filed an application for its common stock to be listed on the NASDAQ Global Market under the symbol GBIM.
Wells Fargo Securities, LLC, and Piper Jaffray & Co. will act as joint book-running managers for the offering. JMP Securities, LLC, will act as co-manager. A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The offering will be made only by means of a prospectus.
GlobeImmune is a biopharmaceutical company focused on developing therapeutic products for cancer and infectious diseases based on its proprietary Tarmogen platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines, which stimulate predominately antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture.
In May 2009, the company entered into a collaboration agreement with Celgene Corporation focused on the discovery, development, and commercialization of product candidates for the treatment of cancer. In October 2011, the company entered into a worldwide, strategic collaboration with Gilead Sciences, Inc., to develop Tarmogens for the treatment of chronic hepatitis B infection. For more information, visit www.globeimmune.com.
Starpharma Reports Rapid Advancement of Delivery Program
Starpharma Holdings Ltd recently provided an update on the developments within its substantial drug delivery program. Starpharma’s program to enhance the blockbuster cancer drug docetaxel is advancing rapidly and plans are underway for clinical trials to commence in 2013.
Starpharma has also demonstrated its dendrimer technology’s applicability to hormones such as insulin, and antibodies, further diversifying drug delivery product potential into these high-growth segments of the market. In addition, Starpharma continues to expand its partnered delivery programs with major pharmaceutical companies’ proprietary drugs.
The strong preclinical data produced by Starpharma’s docetaxel formulation supports the advancement toward clinical trials. As part of this preparation, Starpharma is currently scaling-up its dendrimer-docetaxel synthesis to support both further development studies and clinical trials.
Earlier this year, Starpharma reported its docetaxel-dendrimer formulation had showed a substantial increase in efficacy in a breast cancer model compared to treatment with docetaxel alone. In that study, 60% of animals treated with the dendrimer-docetaxel formulation had no evidence of tumours at 94 days into the study, whereas by that timepoint all of the Taxotere (docetaxel) treated mice showed significant tumor regrowth or recurrence. Following these extremely positive findings, the company commenced additional efficacy studies to explore the activity of Starpharma’s dendrimer formulation in various cancer types and at different dose levels. These studies are ongoing and continue to progress well.
The company has recently demonstrated that the plasma half-life of its dendrimer-docetaxel formulation is 60 times longer (30 hours for the dendrimer formulation compared to 30 minutes for Taxotere). This observation supports the potential for less-frequent dosing and is in line with Starpharma’s target product profile for the dendrimer-improved formulation. Therefore Starpharma’s dendrimer-docetaxel formulation has already demonstrated at least three important advantages over conventional docetaxel (1) improved efficacy – demonstrated in breast cancer model-, (2) longer plasma half-life, and (3) solubilization and removal of toxic excipients (ie, detergent) from the formulation
Whilst Starpharma’s primary internal drug delivery program focuses on docetaxel, the technology is also valuable more broadly as it can be applied to a wide variety of drugs (including proteins, antibodies, hormones) in addition to being particularly valuable in cancer treatments. The company has successfully formulated its dendrimers with several chemotherapeutic drugs, including platinum compounds gemcitabine, paclitaxel (Taxol), methotrexate, and doxorubicin. Starpharma’s rapid advancement of its drug delivery program has been facilitated by running parallel internal and big pharma-partnered development projects.
With many leading drugs either off-patent or nearing the end of patent lifetimes, Starpharma’s technology offers a significant opportunity to develop a range of new and improved formulations, which can be the basis for new patents. This potentially rich source of new products is very attractive to companies seeking to expand and manage the life-cycle of their portfolios. This strategy is also attractive as it carries lower development risk than developing completely new products.
“Based on recent successes of our anti-cancer drug delivery projects and positive developments with partners, Starpharma is investigating additional opportunities to broaden its program and target high-value, market-leading drugs. The evidence supports a high likelihood of Starpharma being able to enhance their properties, or widen their areas of application though the use of dendrimers,” said Starpharma Chief Executive Officer Dr. Jackie Fairley. “Other priority targets – apart from docetaxel – include the major chemotherapeutics including a class of widely used, but highly toxic platinum anticancer drugs, which include carboplatin and oxaliplatin. We have also successfully formulated the leading oncology drug gemcitabine with our dendrimers. In addition, Starpharma has recently demonstrated the ability of dendrimers to conjugate to certain therapeutic antibodies, thus opening up the possibility of entering the very exciting field of antibody”“drug conjugates.”
Antibodies belong to a class of drug called biologics, which include some of the most targeted and effective drugs on the market today, such as Roche’s highly publicized Herceptin for the treatment of breast cancer. The area of biologics is a major growth area for modern medicine, and the commercial potential for a technology that enhances antibody activity and functionality is theoretically enormous.
“We are in a period of rapid progress with advancement in multiple areas within our drug delivery program, and we continue to make good progress toward clinically validating this technology,” added Dr Fairley.
The potential applications for Starpharma’s dendrimers go beyond drugs to include hormones such as insulin and testosterone. Starpharma’s chemistry team has recently applied its dendrimer delivery technology to create an improved formulation of testosterone. This highly water-soluble dendrimer form of testosterone would potentially permit the use of much narrower, therefore less painful, needles and may also offer other delivery benefits, such as extended duration of activity.
“Whilst the $1.5-billion global testosterone replacement market is dominated by transdermal products, injectable products do not suffer from concerns with secondary exposure and are therefore still important in certain settings and geographies. This example together with antibodies and cancer drugs illustrate the extraordinary versatility of Starpharma’s platform technology,” said Dr Fairley. “Perhaps the best way of illustrating the potential of our drug delivery program is by considering its potential application to the world’s best-selling pharmaceutical products. We recently reviewed the chemistry of the top 200 pharmaceuticals worldwide and found that more than 50% would be amenable to dendrimer conjugation. This exciting result underlines the potential value and breadth of our technology.” Dr Fairley concluded. For more information, visit www.starpharma.com.
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