Almac Sciences, part of Almac Group (Booth 2600), has made several appointments.

Denis Geffroy has been named vice president Business Development, with global responsibility. Mr. Geffroy was most recently senior business manager Europe and had been leading Almac Sciences’ rapidd™ early stage development offering.

He joined Almac Sciences in 2004 and has notably developed the European business by adding numerous major pharmaceutical clients to the Almac Sciences portfolio. His new remit includes lab synthesis, PRD chemistry, GMP manufacturing, analytical services, peptide synthesis, radio-labelling, solid state chemistry and biocatalysis. He previously held technology and commercial roles with Chiroscience/ChiroTech and ICI/Synetix Chiral Technologies.

Dr. Charles Shields is joining Almac Sciences as vice president Peptides Operations. Dr. Shields was formerly U.S.-based vice president Global Business Development for Avecia’s oligonucleotides (DNA medicines) business. Prior to 2003 he held a series of senior positions with Avecia, including New Products Development Manager with its Ink Jet Printing Materials business.

Helen McKeever has been named as preclinical program manager, responsible for implementation of rappid™ early stage development programmes. A biochemist with more than 20 years’ CRO experience, Ms. McKeever was most recently senior project manager with Covance.

Almac Sciences president and managing director Stephen Barr remarked, “These appointments bring high levels of proven customer service leadership and delivery in key areas of Sciences’ business, and further increase our emphasis on added value services.”

Quay Pharma (Booth 2412) is investing nearly $4 million to move to a new purpose-designed factory and headquarters, allowing the company to greatly increase its development and clinical trial manufacturing capacities. The move is expected to create around 52 jobs in the next three years.

The new facility in North Wales, UK, is close to Quay Pharma’s existing premises in the Wirral, and brings together the company’s entire range of services — currently housed in two separate facilities — under one roof.The 40,400-sq.-ft. building, which is four times the size of its existing premises, will feature a variety of state-of-the-art equipment that will enable the company to meet increasing demand for its specialist capabilities, including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging.

In particular, the expanded operation will provide the opportunity for the further development of Quay Pharma’s expertise in oral dosage form design and development, especially for new chemical entities that exhibit poor solubility and bio-availability, according to the company.

“Our extensive knowledge and experience can play a crucial role in the critical early stages of drug development and in recent years we have seen increasing demand for our services,” said Quay Pharma’s chief executive, Mike Rubinstein. “By creating this new advanced facility to our specific requirements, we will be able to offer an enhanced level of support to our clients.”

The move is planned for January 2010, and will be phased to ensure work on existing client projects is maintained throughout. The new facility is being part funded by a grant from the Welsh Authority Government.

Avantium (Booth 2061) and Avant-garde Materials Simulations (AMS) have entered into a collaboration for the further development and commercialization of Crystal Structure Prediction (CSP) with AMS’ GRACE software. Pharmaceutical companies can use CSP to predict the crystal structures of their drug compounds. CSP provides an essential approach to significantly reduce the risk of missing a more stable crystal form.

AMS will further develop the software to accelerate the calculations and broaden the range of compounds for which it can be used. AMS will also perform the predictions for third parties. Avantium will develop efficient experimental strategies to physically generate the predicted crystal forms and commercialize Crystal Structure Prediction as a stand-alone service or in combination with experimental programs.

CSP, as developed by AMS, is a breakthrough approach, showing for the first time that the reliable prediction of crystal forms is feasible. AMS in collaboration with the Institute of Pharmaceutical Innovation at the University of Bradford were the first participants ever to score a 4 out of 4 success rate at the 2007 CSP Blind Test.

“The scope of applicability and the accuracy of CSP will continue to improve rapidly,” said Marcus Neumann, managing director of AMS. “The next key challenge is to actually produce predicted but not yet observed forms by rational experiment design. With Avantium Pharma we have found the ideal partner to write the next chapter of the story.”

“The CSP technology is a great extension of our service portfolio,” remarked Guus Scheefhals, chief operating officer of Avantium Pharma. “The predictions will prevent overlooking the most stable crystal form, which will strengthen the IP position of our clients and will help to reduce the risk of crystal form inter-conversions in drug development.”

GlaxoSmithKline and Nabi Biopharmaceuticals entered an exclusive worldwide option and licensing agreement for nicotine conjugate candidate vaccine NicVAX, an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.

Nabi will receive $40 million upfront and GSK will have an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-gen nicotine vaccines using Nabi's intellectual property. Nabi is eligible to receive more than $500 million in option fees and regulatory, development and sales milestones. Nabi will also receive royalties on global sales of NicVAX and next-gen nicotine vaccines, should GSK exercise its option.

NicVAX is currently in Phase III trials. Nabi will be responsible for the Phase III development costs. Upon successful completion of the Phase III studies, GSK can exercise its option to take over further development and commercialization.

"If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent, a habit that is well documented to be very hard to stop permanently," said Jean Stephenne, president of GSK Biologicals. "This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio."

"We are very pleased with this deal and proud it is with GSK, one of the world's leading vaccine companies, to further develop and commercialize NicVAX," said Dr. Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. "We look forward to addressing one of the largest unmet medical needs of our time with what we believe will be an effective tool to help people quit smoking and remain smoke-fee for the rest of their lives."

The transaction, subject to approval and customary closing conditions, is expected to close in 1Q10.

Sciele Pharma, Inc., a U.S.-based group of Shionogi & Co., Ltd., has entered an agreement to acquire and Addrenex Pharmaceuticals, a private, specialty pharmaceutical company, for approximately $29 million in cash.

Addrenex specializes in developing drugs that regulate the adrenergic system. Sciele previously licensed three products from Addrenex: Clonicel for attention deficit hyperactivity disorder (ADHD), Jenloga XR for hypertension, and ADX-415 for the treatment of vasomotor systems and hypertension. The NDA for Clonicel was filed with the FDA in October 2009.

With the acquisition, Sciele will gain two additional mid-stage development products and access to a large library of compounds in various therapeutic areas, including pain management, cardiovascular, and dermatology.

Patrick Fourteau, president and chief executive officer of Sciele Pharma, said, “We are pleased to announce the acquisition of Addrenex, a company we established a partnership with more than two years ago. Addrenex has an exciting development platform and several compounds that have the potential to further expand and diversify our product portfolio.”

Moise Khayrallah, Ph.D., chief executive officer of Addrenex, said, “Sciele Pharma has been a valuable partner and catalyst for the success of Addrenex. The partnership has enabled our team to expand the development pipeline and now gives Sciele access to a large portfolio of products that offer tremendous promise for patients and their families.”

Robert A. Stewart has joined Watson Pharmaceuticals in the newly created position of senior vice president, Global Operations, effective immediately. Mr. Stewart will be responsible for global manufacturing, supply chain, quality and technical operations. He joins the company from Abbott Laboratories, where he most recently served as divisional vice president, Global Supply Chain.

Also, Thomas R. Russillo has been named executive vice president, Global Generics and will head the company's newly formed Global Generics commercial function. Mr. Russillo will have overall responsibility for generic sales and marketing for the U.S. and Canada, as well for all international markets once the acquisition of Arrow Group is complete. Previously, he served as executive vice president and president of Watson’s Generics Division since 2006. Both Mr. Stewart and Mr. Russillo report to Paul Bisaro, president and chief executive officer of Watson.

"As we prepare to maximize our global footprint following the acquisition of the Arrow Group, we are refining our management structure in ways that will enhance our ability to aggressively capitalize on expanded opportunities," said Mr. Bisaro. "Bob brings more than 20 years of experience in global pharmaceutical supply chain management. By centralizing all quality and supply chain functions under his leadership, we can ensure that we more effectively continue to pursue additional cost and operational efficiencies under our Global Supply Chain Initiative and Operational Excellence programs. In addition, Bob's extensive international experience will help us maximize the increased international capabilities we gain following the closing of the Arrow acquisition."

Mr. Bisaro continued, "By creating this Global Generics commercial structure, we will look to Tom to develop the strategies that will strengthen and grow Watson's and Arrow's current product portfolios and market positions around the world. He will also have responsibility for ensuring that our commercial needs are appropriately aligned with new product R&D and that Watson efficiently expands its generics position with key product introductions across the 20 countries in which we will operate, including established, expanding and emerging markets."

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