9/19/2012

PharmaTelevision Spotlights Aptalis’ Year in Review

FDA approvals, revenue gain, and organic business growth are just a few of the topics that John Fraher, President, Aptalis Pharma, addresses during an on-air interview with Fintan Walton, CEO, PharmaVentures and PharmaTelevision. The interview, conducted during BIO 2012 in Boston, reflects Mr. Fraher’s commentary regarding the integration of companies post Axcan Intermediate Holdings’ acquisition of Eurand N.V. in 2011. The interview is available via on-demand at PharmaTelevision and will also be available to the public at the Aptalis Pharmaceutical Technologies website www.AptalisPharmaTech.com. Mr. Fraher serves a key role in setting strategic direction for Aptalis with specific oversight of the company’s Pharmaceutical Technologies and Global Supply Chain business unit.

Approximately 1 year ago PharmaTelevison conducted its first interview with Mr. Fraher just a few months after Axcan completed its acquisition of Eurand N.V. During the months following the acquisition, the companies completed their integration while realizing several major milestones, including FDA approvals, the in-licensing of a number of products, and a closing-year revenue of $470 million – a significant increase on the prior year. During his BIO 2012 interview with PharmaTelevision, Mr. Fraher discusses these milestones and the company’s strategic direction moving forward. Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders. Aptalis, formed from the recent combination of Axcan Pharma and Eurand, has manufacturing and commercial operations in the United States, the European Union, and Canada, and its products include ZENPEP, CANASA, CARAFATE, PYLERA, LACTEOL, DELURSAN, PANZYTRAT, and SALOFALK. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms, including bioavailability enhancement of poorly soluble drugs, custom-release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.

Aptalis Pharmaceutical Technologies, formerly known as Eurand Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODTs, and other dosage forms. Together, these technology platforms combined with licensing, manufacturing, and R&D capabilities enable Aptalis Pharmaceutical Technologies to produce customized drug formulation solutions for partners across a range of dosage forms and therapies with high patient acceptability. Aptalis Pharmaceutical Technologies will continue to develop and manufacture products for its partners, as well as support the drug development process for the Aptalis Pharma pipeline and portfolio of products.

Catalent & CTC Bio to Help Korean Pharma Enter New Markets

Catalent Pharma Solutions and CTC Bio have entered into a collaboration to provide optimal solutions to South Korean pharmaceutical companies seeking to commercialize solid oral dose and controlled-release products in the US and Europe.

Under the agreement, Catalent and CTC Bio will align their expertise and experience in innovative drug delivery technologies to enable South Korean pharmaceutical companies access to global markets for their products and formulations.

Combining CTC Bio’s leading position in the region with Catalent’s expertise in controlled-release formulations, manufacturing network, and broad experience in global product launches will provide South Korean companies with unparalleled access to international markets.

“South Korea is a highly innovative region, developing new products and effective pharmaceutical formulations,” said Dr. HR Jeon, Chief Science Officer of CTC Bio. “This collaboration with Catalent provides South Korean pharmaceutical customers with better access to the leading provider of innovative controlled-release drug delivery technologies and supply capabilities. Catalent’s breadth of services and reputation for successful new product launches in international markets makes them an ideal partner for us and our clients/partners in South Korea.”

“CTC Bio is a leading regional provider of innovative drug products and formulation services, and its capabilities perfectly complement those of Catalent,” added Ian Muir, President of Catalent’s Modified Release Technologies business. “In collaboration with CTC Bio, Catalent can now provide South Korean pharmaceutical customers with seamless scale-up and transfer within Catalent’s controlled-release capabilities at our Winchester, KY, and Somerset, NJ, facilities in the US and at Schorndorf, Germany, in Europe. These are leading commercial facilities for oral solids and controlled-release dosage forms, ensuring that commercial manufacture for global supply is carried within the target markets and meets all international standards of quality and reliability.”

Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. For more information, visit www.catalent.com.

Ei Gains Exclusive World-Wide License

Metro Charlotte-based Ei has signed agreements with European-based professors and technologists for the exclusive worldwide license of a novel class of sphingolipids. Sphingolipids are found in the extracellular spaces of the stratum corneum, where they play a critical role in strengthening the barrier function of the skin, promoting moisture retention and increasing elasticity of the skin.

The specific technology consists of a novel lamellar lipid topically delivered through a custom formulation system. In preliminary clinical studies, the technology has demonstrated significantly better barrier function with substantial improvement in moisture retention when compared to commercially available sphingolipid compounds. As part of this exclusive licensing arrangement, Ei has been granted options on several related technologies in various stages of development.

“As A Pharmaceutical SolutionWorks, this investment in intellectual property demonstrates Ei’s mission to offer our customers value beyond typical development and manufacturing capability,” said Michael Kane, CEO, Ei. “Our customers have asked for – and we are responding with – unique, efficacious, and highly protected ways to innovate for their customers and enhance the value of their brands.”

Ei provides product development, analytical and clinical services to develop solutions for Rx pharmaceutical, OTC, therapeutic skin care, topical (semi-solid and liquid), and animal health products.

“We are pleased to have been able to partner Ei with a unique group of specialists to develop this important advancement in skincare,” added David Yurkerwich, Vice President at Charles River Associates, the consulting firm that helped to broker the licensing agreement. “The group was attracted to Ei’s topical expertise and valuable network of strategic partners to commercialize the assets.”

Ei’s research and development team takes an integrated approach to product development and management. This strategic approach creates high-technology solutions for their customers and allows Ei to utilize its full network of resources and assets for successful product creation. Ei prides itself on not just the cutting-edge science and state-of-the-art manufacturing expertise of its people, but the protection and strengthening of each individual customer’s brand. This European license illustrates Ei’s continued commitment to seeking out intellectual property opportunities for their customers.

Based in metro Charlotte, North Carolina, Ei, A Pharmaceutical SolutionWorks, develops and manufactures topical liquid, semi-solid, and loose powder lines for Rx, OTC, therapeutic skin care, and animal health products for a wide range of brands. The company operates 180,000-sq-ft of state-of-the-art manufacturing facilities. Ei offers topical drug product expertise and turn-key project management, including formula development, package sourcing, testing, method development, validation, ICH stability programs, bulk manufacturing, filling, and regulatory filing assistance. Ei represents over 50 customers with a strong concentration of multi-national, top-tier pharmaceutical, and therapeutic skin care companies and other Fortune 100 companies. Ei is privately held and was founded in 1983. For more information, visit www.eisolutionworks.com

Xcelience Opens New Development Facility

Xcelience LLC recently announced the grand opening of a new 24,000-sq-ft facility, located south of the Tampa airport at 4901 Grace Street. The building will be dedicated to primary and secondary packaging, labeling, distribution, and warehouse services.

Xcelience serves national and international clients in the biotech and pharmaceutical industries, offering cGMP services from preformulation and formulation through clinical manufacturing and clinical supplies for Phase I-III clinical trials. This is the company’s second facility in the Tampa Bay area, and it will be audited and approved for domestic as well as European clinical trials. The expansion also promises to open the door to more highly skilled jobs for the Tampa Bay Area.

“At Xcelience, we work on several dozens of molecules, each of which has the potential to radically improve people’s lives,” said Derek Hennecke, CEO and President. “We love being in Tampa because through USF, UF, and Tampa’s growing biotech community, we have access to scientists at the height of their fields. We don’t have to go far to find people who thrive on the challenge of working with different molecules, upholding rigorous FDA standards while also demonstrating the agility to meet client parameters for speed, cost, and efficiency.”

Xcelience has doubled its staff throughout the past 3 years and will soon be celebrating the hiring of the company’s 100th employee. The new plant will enable Xcelience to double its headcount again throughout the next 3 years.

“Tampa’s been called one of the best places to do business. Our health sciences cluster is creating the jobs of the future,” said Tampa Mayor Bob Buckhorn. “I am proud Xcelience calls Tampa home, and congratulate them on the opening of their second facility here.”

“Xcelience has been a wonderful addition to our business community, and we’re pleased to join them in celebrating the opening of their new facility,” said Rick Homans, President and CEO of the Tampa Hillsborough Economic Development Corporation. “Their continued growth and expansion is a testament to the quality of our workforce, and their presence is a significant asset as we work to expand our life sciences industry.”

Guests for the ceremony in addition to staff, clients, and corporate partners include Honorable Jack Latvala, Florida Senate, Tampa Mayor Bob Buckhorn, Honorable Al Higginbotham, Hillsborough County Board of County Commissioners, Honorable Dana Young, Florida House of Representatives, Julie Fitzpatrick from the office of Congresswoman Kathy Castor, and supporting members from the Tampa Hillsborough Economic Development Corporation and the Tampa Bay Partnership.

Xcelience wishes to thank the Florida institutions that have offered continued economic stimulation and sustained capital investment to Xcelience and other Florida companies like it. In particular: The Tampa Hillsborough Economic Development Corporation – officially designated by Enterprise Florida as Hillsborough County’s primary business recruitment economic development team; and The Tampa Bay Partnership – a CEO-led regional economic development organization with a mission to work with its partners to market the region nationally and internationally, to conduct regional research, and to coordinate efforts to influence business and government issues that impact economic growth and development.

Xcelience LLC is a premier provider of formulation development and clinical supplies solutions with a solid reputation for accelerating early phase clinical development. The company’s outstanding quality record, drug development expertise, disciplined project management, and willingness to customize enables delivery of real advantages to pharmaceutical innovators focused on small-molecule development. Partnering with a specialist for early development can accelerate development timelines and streamline the supply chain. Since 1997, Xcelience has been reliably expediting drug development and reducing compound risk. Company scientists have specialized experience in overcoming challenging physical and chemical properties while achieving improved solubility and compound bioavailability. For more information, visit www.xcelience.com.

Life Technologies to Partner With Bristol-Myers Squibb

Life Technologies Corporation recently announced the company has entered into a Master Development Agreement with Bristol-Myers Squibb Company for current and future companion diagnostics projects. The current agreement constitutes the second collaboration between the two companies and represents another step in Life Technologies’ strategy to develop its diagnostic business through internal development, partnerships, and select acquisitions. The agreement covers an initial project for oncology and provides for a long-term partnership across a potentially broad range of Life instrument platforms and a wide range of therapeutic areas.

“The pharmaceutical industry is increasingly turning its focus to discovering and delivering targeted, personalized medications,” said Ronnie Andrews, President of Medical Sciences at Life Technologies. “As more and more targeted drugs come onto the market in the next decade, there will be a growing need for diagnostics that can help predict which patients will benefit from which drugs. For oncology alone, hundreds of agents are currently in clinical trials, and we see strong market opportunity in the robust expansion this will mean for the companion diagnostics space.”

Life Technologies possesses a breadth of platforms that can be leveraged in the development of new diagnostics. These platforms span both genetic and proteomic analysis, including next-generation sequencing, Sanger sequencing, qPCR, flow cytometry, and immuno-histochemistry. In addition, the company recently announced that its Ion Torrent Personal Genome Machine (PGM) would be developed for proteomics capabilities.

“Life is uniquely positioned to provide pharma a flexible, cost-effective means to manage the evolution of the companion diagnostic assay through the drug development process,” said Mr. Andrews.

Life Technologies Corporation is a global biotechnology company with customers in more than 160 countries using its innovative solutions to solve some of today’s most difficult scientific challenges. Quality and innovation are accessible to every lab with its reliable and easy-to-use solutions spanning the biological spectrum with more than 50,000 products for agricultural biotechnology, translational research, molecular medicine and diagnostics, stem cell-based therapies, forensics, food safety, and animal health. Its systems, reagents, and consumables represent some of the most cited brands in scientific research, including: Ion Torrent, Applied Biosystems, Invitrogen, GIBCO, Ambion, Molecular Probes, Novex, and TaqMan. For more information, visit www.lifetechnologies.com.

Synergy Files IND for GI Diseases

Synergy Pharmaceuticals, Inc. recently announced that an Investigational New Drug (IND) application was submitted on September 7, 2012, for clinical evaluation of SP-333 to treat inflammatory bowel disease (IBD). SP-333 is a second-generation guanylate cyclase-C (GC-C) agonist with the potential to treat GI disorders and diseases.

“SP-333, to our knowledge, represents the most potent and stable uroguanylin analog ever developed,” said Dr. Gary S. Jacob, President and CEO of Synergy Pharmaceuticals. “The submission of the IND on SP-333 is a major milestone for the company, as it broadens our clinical portfolio of GC-C agonists for treatment of GI disorders and diseases.”

“The science behind SP-333 marks a new approach to the treatment of GI inflammatory diseases,” said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals. “We are excited with SP-333’s impressive anti-inflammatory activity. In studies with experimental models of colitis in mice, SP-333 at an oral dose as low as 0.05 mg/kg body weight demonstrated superior anti-inflammatory activity compared to 5-aminosalicylic acid (5-ASA) given at a dose of 100 mg/kg.”

SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone that is normally produced in the body’s intestinal tract. Deficiency of uroguanylin is likely to be one of the primary reasons associated with formation of polyps as well as debilitating and difficult-to-treat GI inflammatory disorders, such as ulcerative colitis and Crohn’s disease. Orally administered SP-333 binds to and activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the GI mucosa, resulting in stimulation of cyclic GMP in target tissues. SP-333 has been found to be highly stable against proteolysis in simulated intestinal fluid for up to 24 hours. Its enhanced stability makes this peptide an extremely potent GC-C agonist in animal studies in mice and monkeys, promoting bowel movement in monkeys, and ameliorating GI inflammation in mice, respectively.

Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy’s lead proprietary drug candidate plecanatide is a synthetic analog of the human gastrointestinal hormone uroguanylin, and functions by activating the guanylate cyclase C receptor on epithelial cells of the GI tract. Synergy completed a Phase I study of plecanatide in healthy volunteers and a Phase IIa clinical trial in CIC patients. In October, 2011, Synergy initiated dosing of patients in a major Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation.

Plecanatide is also being developed to treat constipation-predominant irritable bowel syndrome, with the first trial in IBS-C patients planned for the second half of 2012. Synergy’s second GC-C agonist SP-333 is currently in preclinical development to treat inflammatory bowel diseases. For more information, visit www.synergypharma.com.

Plecanatide is a member of a new class of essentially non-systemic drugs, referred to as guanylate cyclase C (GC-C) agonists, which are currently in development to treat CIC and IBS-C. Plecanatide is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered plecanatide binds to and activates GC-C receptors expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator (CFTR), and leading to augmented flow of chloride and water into the lumen of the gut.

Activation of the GC-C receptor pathway is believed to facilitate bowel movement as well as producing other beneficial physiological responses, including improvement in abdominal pain and inflammation. In animal models, oral administration of plecanatide promotes intestinal secretion and also ameliorates GI inflammation.