Elan & PPD Announce Global Business Relationship in Drug Development

Elan, plc and PPD, Inc. recently announced they have formed a global business collaboration focused on the advancement, progression, and execution of Elan’s development portfolio. The primary objective of this relationship is to deploy both companies’ skills and expertise in a flexible, integrated manner to drive the execution of Elan’s clinical programs in a parallel and expedited basis and on a global scale.

Under this business agreement, PPD will act as Elan’s primary service provider for all development functions and activities. Elan will retain ownership of its assets and accountability for decision-making with regard to strategy and progression of the individual molecules as well as the overall portfolio. This business construct will enable Elan to leverage the significant and high-quality capabilities of PPD across project and data management, biostatistics, regulatory, clinical and medical monitoring, quality assurance, pharmacovigilance, and other areas. Elan and PPD intend to work closely to build upon this initial relationship and continuously explore opportunities to leverage both companies’ respective competencies and maximize the full opportunity of moving Elan’s science into clinical development and advancing toward patients.

“Establishing this strategic collaboration with PPD will enable Elan to accelerate the progression of our science into the clinical development setting in a rapid and global fashion,” said Eliseo Salinas, Chief Medical Officer, Executive Vice President and Head of Development for Elan. “The ability to fluidly access additional expertise and execution capability on a global scale will complement our internal talent and may enable us to move multiple programs forward in a parallel manner.”

“PPD will act as a strategic collaborator and deliver capabilities, resources, and expertise that will enable us to advance our business on a global scale while capturing efficiencies and flexibility from a business and operational point of view,” added Elan’s Executive Vice President and Head of Alliance Management, Doug Love.

“PPD and Elan have established an innovative relationship structure that enables Elan to continue to invest in and advance its world-leading work in biology and its broad application in neuroscience while leveraging PPD’s expertise and execution capabilities across key program areas on a global scale. This relationship brings together the strongest resources of both companies, and we are pleased to have created this unique and strategic business arrangement with Elan,” commented David Grange, Chief Executive Officer of PPD. Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. PPD is a leading global contract research organization providing drug discovery, development, and life-cycle management services.

Ethypharm Sells its Subsidiary in India

The pharmaceutical company Ethypharm recently announced it has sold all of its operations in India to Athena Pharm. Ethypharm leaves India in order to refocus its activities on Europe, the United States, China, and Japan; different markets where Ethypharm’s know-how and its competence in the development and registration sectors are renowned.

“The sale of our Indian subsidiary is part of the Ethypharm’s strategy to continue its growth by focusing our resources on our most profitable markets” said Hugues Lecat, Chairman and CEO of the Management Board of Ethypharm.

Present in India since 1997, Ethypharm employed 80 people in production, formulation, development, and marketing. Athena Pharm will respect all contracts and previous technical and commercial commitments of Ethypharm former Indian subsidiary and continue to provide best-in-class and seamless service to its clients.

Ethypharm is one of the leading pharmaceutical companies dedicated to the development of innovative medicines. Its patented technologies offer multiple benefits for patients by improving efficacy, administration, compliance, and reducing side-effects. The company provides its clients with solutions for the life-cycle management of their drugs and has one of the broadest portfolios of technologies to become the worldwide privileged partner of pharmaceutical companies. Ethypharm offers customized solutions for the development of the medicines of the future.

Athena Pharm is the purchaser of the former subsidiary of Ethypharm in India. Athena Pharm, with its EU level factory near Mumbai and state-of-the-art R&D center, will focus on innovative and value-added products for Pharmemerging markets and will continue to engage in fee-for-development model for specialty pharma, multinational, and other established companies.

ICIG to Acquire Pharmaceutical Intermediates Business From Genzyme

International Chemical Investors Group (ICIG) recently announced it has entered into a purchase agreement under which an affiliate of ICIG will acquire the pharmaceutical intermediates business from Genzyme Corporation. Under the terms of the agreement, ICIG will purchase substantially all of the pharmaceutical intermediates business, excluding the drug delivery technologies portion of the business.

ICIG has agreed to offer employment to the unit’s approximately 120 employees upon closing, and plans to maintain operations at its primary location, a manufacturing facility in Liestal, Switzerland. The acquired pharmaceutical intermediates business will be renamed Corden Pharma Switzerland LLC and will operate as part of ICIG’s pharmaceutical business within the Corden Pharma platform. The companies’ goal is to close the transaction during the first quarter of 2011. Financial terms are not disclosed.

As part of the agreement, ICIG will enter into a 5-year supply contract to provide Genzyme with materials needed for the production of eliglustat tartrate, an investigational treatment for Gaucher disease Type 1 that is currently in Phase III clinical trials. ICIG will also supply materials needed for the manufacture of other treatments in earlier stages of development, including neo-GAA, currently in preclinical development as a potential next-generation Pompe disease therapy.

Genzyme Pharmaceuticals develops and manufactures chemically synthesized pharmaceutical materials and technologies for the global pharmaceutical industry and focuses on lipids, peptides, carbohydrates, oligonucleotides, and custom small molecules.

ICIG is a privately owned industrial holding company focusing on mid-sized chemicals and pharmaceutical businesses. Since inception in 2004, ICIG has acquired 15 businesses, all of which have origins in major global chemical or pharmaceutical corporations and are independently managed. ICIG companies currently employ more than 3,000 people and operate 15 manufacturing facilities in Europe and the United States. Corden Pharma group companies offer contract development and contract manufacturing for advanced pharmaceutical intermediates, APIs, and drug product formulations with more than 1,500 individuals supporting their customers with specialized technologies in all international markets.

Infinity Initiates Phase II Portion of Pancreatic Cancer Trial

Infinity Pharmaceuticals, Inc. recently announced the initiation of the randomized Phase II portion of the trial of IPI-926 in combination with gemcitabine (also known as Gemzar) in patients with previously untreated, metastatic, pancreatic cancer. The Phase II portion of the trial is a double-blind study that will compare treatment with IPI-926 in combination with gemcitabine to treatment with placebo and gemcitabine. The primary endpoint is overall survival. The trial is expected to enroll approximately 120 patients worldwide. Pancreatic cancer, a difficult-to-treat disease with limited therapeutic options, is the fourth leading cause of cancer death in the US and has a 5-year survival rate of only 6%.

IPI-926 is a novel, oral molecule that inhibits Smoothened, a key component of the Hedgehog pathway. Inhibition of the Hedgehog pathway represents a fundamentally new approach for addressing a broad range of cancers, including pancreatic cancer. Inhibiting Smoothened with IPI-926 is believed to deplete the dense, fibrous stroma surrounding pancreatic tumors, leading to increased vascularity and facilitating the delivery of chemotherapy to the tumor.

“IPI-926 may represent a novel method for treating pancreatic cancer by altering the tumor microenvironment and improving the delivery of chemotherapy to the tumor,” said Charles Fuchs, MD, MPH, Director, Gastrointestinal Cancer Center at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “Pancreatic cancer is a very aggressive disease with limited treatment options. The start of this Phase II trial marks an important step in exploring the potential of IPI-926 in this area of cancer research.”

“Unfortunately, survival has not improved substantially for patients with pancreatic cancer in over 40 years due in large part to the lack of effective treatment options for patients,” added Julie Fleshman, President and CEO of the Pancreatic Cancer Action Network. “The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. Clinical trials evaluating potential new treatments for pancreatic cancer, like this study with IPI-926, will hopefully lead to advances with the potential to improve survival for patients.”

The Phase Ib/II clinical trial evaluates the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated, metastatic pancreatic cancer. The Phase II portion of the trial is an international, multi-center, randomized, double-blind, study designed to compare treatment with IPI-926 in combination with gemcitabine to treatment with placebo and gemcitabine in approximately 120 patients. The primary endpoint of the Phase II portion of the trial is overall survival. Secondary endpoints include progression free survival, time to progression, and overall response rate.

The Phase Ib portion of the study evaluated once-daily oral administration of IPI-926 at escalating doses in combination with weekly intravenous administration of the standard dose of gemcitabine and established 160 mg as the dose of IPI-926 that will be used in the Phase II portion of the ongoing trial. Infinity expects to present data from the Phase Ib portion of the trial later this year.

“In less than 2 years, we have translated a breakthrough preclinical finding of IPI-926 in pancreatic cancer into a randomized, controlled clinical trial, underscoring our commitment to patients fighting this devastating disease,” said Julian Adams, PhD, President of Research and Development at Infinity. “Beyond pancreatic cancer, preclinical data suggest that inhibition of the Hedgehog pathway has application across a broad range of difficult-to-treat cancers, and we are planning to begin additional studies with IPI-926 in 2011.”

Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs in the inhibition of the Hedgehog pathway, the Hsp90 chaperone system, fatty acid amide hydrolase, and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development.

Studies Show Triolex for Parkinson’s Disease Crosses the BBB in Mice

Harbor BioSciences, Inc., which is investigating the use the company’s proprietary compound Triolex as a treatment for Parkinson’s disease (PD) with funding from The Michael J. Fox Foundation (MJFF), recently announced positive results in initial preclinical studies. These studies in orally treated mice demonstrate that Triolex crosses the blood-brain barrier in significant quantities.

Harbor BioSciences designed these studies to determine if Triolex, an anti-inflammatory, small-molecule compound believed to reduce inflammation in the brain, was capable of crossing the blood-brain barrier. The results described here show that more than 50% of levels of Triolex measured in plasma were found in mouse brains after oral administration. These positive findings support rodent efficacy studies, which are expected to be completed before the end of this year.

The terms of the collaboration call for MJFF to fund up to approximately $150,000 toward preclinical development of Triolex in rodents. If these studies are successful, additional funding may be awarded by MJFF to continue the clinical development of Triolex for the treatment of PD.

“Anti-inflammatory approaches to PD are of increasing interest to Parkinson’s researchers, but even the most effective potential treatment must cross the blood-brain barrier in order to be translated into practical treatments for PD patients,” said Todd Sherer, PhD, Chief Program Officer, The Michael J. Fox Foundation. “We are encouraged by the initial data showing that Triolex may accomplish both of these goals, and look forward to partnering with Harbor BioSciences to continue vetting this novel compound in the hope of speeding its path to the clinic.”

Harbor BioSciences believes Triolex may decrease chronic inflammation in the brain, thereby protecting neurons whose loss would otherwise lead to the damage associated with PD. This belief is based on several factors: the company’s previously reported data regarding the anti-inflammatory effects of Triolex in human clinical studies; attenuation of neuroinflammation in rodent models; and the extensive literature describing the benefits of related natural compounds in both humans and animal PD models. To date, Triolex has been well tolerated when administered to more than 180 people with type 2 diabetes and healthy volunteers.

“It is a privilege to be collaborating with MJFF to assess the potential benefits of Triolex in patients suffering from PD,” commented James M. Frincke, Harbor BioSciences’ Chief Executive Officer. “If Triolex demonstrates an effect on regulating key inflammatory cytokines in PD patients similar to that observed in animal models and in type 2 diabetes patients, it should provide an entirely new approach to the treatment of this debilitating disease. We are also hopeful that if Triolex is able to reduce neuro-inflammation and protect neurons in PD, it may also be useful in other inflammation-driven neurodegenerative disorders, such as Alzheimer’s disease and multiple sclerosis.”

Harbor BioSciences is a development-stage company with two product candidates that recently completed Phase I/IIa clinical trials: Apoptone (HE3235) in patients with late-stage prostate cancer, and Triolex (HE3286) in obese type 2 diabetes mellitus patients. Apoptone and Triolex represent two of the lead candidates from Harbor BioSciences’ small molecule platform based on metabolites or synthetic analogs of endogenous human steroids.

Quintiles Supports Samsung’s Entry Into Biopharmaceutical Market

Samsung Electronics Co., Ltd., the world’s largest electronics company, and its affiliated companies (Samsung) recently announced they have entered into a strategic partnership with Quintiles, the world’s leading pharmaceutical services company, to support Samsung’s entry into the biopharmaceuticals market.

Under an agreement signed last week, Quintiles will make a minority 10% investment of approximately $30 million to start a new joint venture company with Samsung in the first half of 2011 to provide biopharmaceutical contract manufacturing services in South Korea. Samsung will own the remaining 90% of the joint venture company in the following proportions: Samsung Electronics Co., Ltd., 40%; Samsung Everland, Inc., 40%, and Samsung C&T Corporation, 10%.

The strategic partnership will support Samsung’s entry into the biopharmaceutical market and reinforces Quintiles’ role as an ally to help companies succeed in the New Health landscape.

“We are very pleased that Samsung has selected Quintiles as its ally to enter the biopharmaceuticals business through the manufacture of biosimilars,” said Anand Tharmaratnam, Senior Vice President and Head of Asia Markets for Quintiles. “South Korea is an important part of our growth strategy in Asia. This strategic partnership illustrates how Quintiles can use its resources and expertise across the clinical, commercial, consulting, and capital spectrum to help companies achieve their strategic goals. We’re also very pleased to drive innovation and advance the role of South Korea in the global biopharmaceutical industry.”

“This partnership with Samsung demonstrates how at Quintiles we leverage not only our intellectual and human capital but also how we can invest to advance mutual interests and accomplish shared goals,” added Paul Casey, Vice President and Head of Asia Corporate Development for Quintiles. “It shows we are committed to developing non-traditional alliances in order to help our customers navigate risks and seize opportunities in the complex industry landscape and ultimately help patients.”

The joint venture company represents Samsung’s first step into the biopharmaceutical business. Samsung also plans to commercialize biosimilars by 2016, and expand into innovative biologics in the future. Plans call for the joint venture company to construct a biopharmaceutical manufacturing plant in the Incheon Free Economic Zone in Songdo, Incheon, South Korea. Groundbreaking is expected in the first half of 2011 and full-scale operation is expected to commence in April 2013. The plant will be fully equipped with cutting-edge technologies and an 8,000-gallon (30,000 liters) mammalian cell culture bioreactor capacity capable of producing 1,300 pounds (600 kilograms) of biopharmaceutical products. The products are expected to be sold mostly on international markets.

Quintiles is the only fully integrated bio pharmaceutical services company offering clinical, commercial, consulting, and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety, and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant.