1/17/2012
NantWorks to Invest $85.5 Million, Creating New Jobs & Drugs
California-based NantWorks, LLC, recently announced plans to locate a new pharmaceutical manufacturing plant in
“With the strength of our life sciences industry and a first-class work force, it’s no surprise that innovative companies from high-tax, business-hostile states continue to choose
Dr. Patrick Soon-Shiong, Chairman and CEO of NantWorks, has previously developed two pharmaceutical companies addressing the unmet needs of critically ill patients. His injectable drug company APP was the nation’s only safe source of heparin during a supply crisis in 2008, and his biopharmaceutical company Abraxis Bioscience developed the world’s first protein nanoparticle cancer drug for breast cancer. Dr. Soon-Shiong sold these companies in 2008 and 2010, raising several billion dollars to pursue his vision of personalized medicine.
“As a country, we need to develop and enhance our capabilities to manufacture injectable and next-generation drugs in
The Indiana Economic Development Corporation offered NantWorks, LLC up to $2 billion in conditional tax credits and up to $100,000 in training grants based on the company’s job creation plans. These tax credits are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives.
“NantWorks’ proposed acquisition and subsequent redevelopment of the former Pfizer property exceeds our greatest expectations for the property,” said Mike Ciolli, President of the Vigo County Board of Commissioners. “We couldn’t be more thrilled.”
NantWorks, LLC is a company founded and led by Dr. Patrick Soon-Shiong. Its core mission is to converge a wide range of technologies to transform scientific research and healthcare. It is building an integrated evidence-based, genomically informed, personalized approach to the delivery of care and the development of next-generation diagnostics and therapeutics.
Xenon Pharmaceuticals Signs $646 Million Pain Pact With Roche
Xenon Pharmaceuticals, Inc. recently announced a strategic alliance with Genentech, a member of the Roche Group, to discover and develop compounds and companion diagnostics for the potential treatment of pain.
“We are delighted to be collaborating with Genentech,” said Simon Pimstone, President and CEO of Xenon. “Genentech is among the world’s leading biotech companies and an ideal strategic partner for Xenon as we share a common emphasis on using human genetics for drug development. Further, this collaboration allows Xenon to both deepen and broaden our pipeline of novel medicines in development.”
Xenon and Genentech will collaborate on the discovery of new therapeutic approaches for treating pain. Under the terms of the agreement, Genentech has an exclusive license to compounds and a non-exclusive license to diagnostics from Xenon for development and commercialization of products. Xenon will receive an undisclosed up-front payment, research funding, and is eligible to receive research, development, and commercialization milestone payments, totaling up to $646 million for multiple products and indications. In addition, Xenon will receive royalties on sales of products resulting from the collaboration.
“This new alliance, which represents our sixth partnership with a major pharmaceutical company to date, once again highlights the keen interest in Xenon’s unique genetics approach and in our translational R&D capabilities,” said Michael Hayden, CSO of Xenon.
Xenon is a privately owned, clinical genetics-based drug discovery and development company engaged in developing small molecule therapies based on the genetic causes of select metabolic, neurological, and cardiovascular diseases.
Ventana Medical Systems & Cell Signaling Technology to Collaborate With Pfizer on Companion Diagnostic
Ventana Medical Systems, Inc., a member of the Roche Group, recently announced it has entered into a collaboration agreement with Pfizer Inc. and license agreement with Cell Signaling Technology to develop the first fully automated and standardized immunohistochemistry (IHC) companion diagnostic test for ALK gene rearrangements. Ventana will develop the test, which is intended to identify non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma receptor tyrosinekinase (ALK) gene rearrangements who may benefit from Pfizer’s XALKORI (crizotinib), approved in the US in August of 2011. The test will measure the associated protein product when an ALK gene rearrangement is present. This news comes on the heels of two separate companion diagnostic strategic collaborative agreements Ventana recently announced with Aeterna Zentaris GmbH and with Syndax Pharmaceuticals, Inc.
Under the terms of the agreements with Pfizer Inc. and CST, the VENTANA ALK IHC diagnostic test will be based on CST’s D5F3 antibody and VENTANA OptiView DAB detection, for performance on VENTANA automated platforms.
“At Ventana, our mission is to improve the lives of all patients afflicted with cancer,” said Mara G. Aspinall, President of Ventana Medical Systems, Inc. “We believe this collaboration will provide enormous benefit to patients suffering from NSCLC through biomarker identification. Our early development data suggests that the combination of CST’s D5F3 antibody and VENTANA OptiView detection generates a highly sensitive assay that detects cases with very low expression of the ALK protein in lung tissue, which means that XALKORI may be an appropriate treatment for those patients.”
NSCLC is the world’s number one cause of cancer-related death, the most common form being adenocarcinoma. The determination of the presence of ALK gene rearrangements helps physicians select more specific therapies for NSCLC patients, including XALKORI. The benefits of IHC testing include laboratory workflow automation, speed, and cost effectiveness. The broad availability of IHC testing on VENTANA instruments will also benefit physicians and patients worldwide.
“In line with our vision for Personalized Healthcare, this agreement will help further our quest to be the companion diagnostics Partner of Choice to pharma companies worldwide,” added Mr. Aspinall.
“We are delighted to collaborate with Ventana to develop an additional testing option to identify NSCLC patients with ALK gene rearrangements. Working with regulatory authorities, our goal is to help those patients and their physicians determine the treatment options available to them,” said Garry Nicholson, President and General Manager, Pfizer Oncology. “Pfizer believes that each cancer patient’s tumor is genetically unique, and that biomarker testing helps to identify those patients who may benefit from therapy.”
“CST is very excited to enter into this agreement with Ventana for the development of next-generation diagnostic products that intend to fulfill the promise of personalized cancer medicine,” said Michael J. Comb, PhD, CST President and CEO. “CST and one of its partners own dominant rights to the intellectual property directed to the detection of EML4-ALK translocations. As a leader in the development and manufacture of high-performance antibody products, we are thrilled that the strategic R&D and intellectual property investments we’ve made in the area of EML4-ALK translocation detection are being applied to significant unmet needs in the diagnosis and treatment of cancer patients.”
As new biomarker and diagnostic tests become increasingly available, they provide valuable information about potential recipients for these novel agents. Matching specific drugs to specific cancer types, or fitting the treatment to the patients, is at the heart of Roche’s scientific vision for Personalized Healthcare. It is the company’s highest priority now and in the future.
Inhibitex to be Acquired by Bristol-Myers Squibb for $2.5 Billion
Bristol-Myers Squibb Company and Inhibitex, Inc. recently announced the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire Inhibitex for $26 per share in cash pursuant to a cash tender offer and second-step merger. The transaction, with an aggregate purchase price of approximately $2.5 billion, has been approved by the boards of directors of both companies. The board of directors of Inhibitex has agreed to recommend that Inhibitex’s shareholders tender their shares in the tender offer. In addition, shareholders with beneficial ownership of approximately 17% of Inhibitex’s common stock, have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the tender offer.
Inhibitex is a clinical-stage biopharmaceutical company dedicated to the development of innovative products that can treat or prevent serious infections, whose primary focus is on the development of nucleotide/nucleoside analogs for the treatment of hepatitis C virus (HCV). Its lead HCV asset is INX-189, an oral nucleotide polymerase (NS5B) inhibitor in Phase II development that has exhibited potent antiviral activity, a high barrier to resistance and pan-genotypic coverage. Nucleotides/nucleosides are emerging as an important class of antivirals that may play a critical role as the backbone of future direct-acting antiviral-only combination approaches to HCV treatment.
“The acquisition of Inhibitex builds on Bristol-Myers Squibb’s long history of discovering, developing, and delivering innovative new medicines in virology and enriches our portfolio of investigational medicines for hepatitis C,” said Lamberto Andreotti, CEO, Bristol-Myers Squibb. “There is significant unmet medical need in hepatitis C. This acquisition represents an important investment in the long-term growth of the company.”
“This transaction puts INX-189 and the company’s other infectious disease assets in the hands of an organization that can more optimally develop them and which believes as strongly as we do in INX-189’s potential in the treatment of chronic HCV,” said Russell Plumb, President and CEO of Inhibitex. “Bristol-Myers Squibb’s expertise in antiviral drug development, and its existing complementary portfolio, will ensure the potential of INX-189 is realized as part of future oral combination therapies for millions of patients in need around the world.”
Sigma-Aldrich to Acquire BioReliance Corporation for $350 Million
BioReliance, a leading provider of global biopharmaceutical testing services, recently announced it has agreed to be acquired by Sigma-Aldrich Corporation. Avista Capital Partners, the majority owner of BioReliance Holdings, Inc., agreed to sell the company for $350 million in cash. The acquisition is subject to customary closing conditions, including regulatory clearance, and is expected to close in the first quarter of 2012.
BioReliance provides critical services that include biologics testing, specialized toxicology, and animal health testing to pharmaceutical, biopharmaceutical, diagnostics, and other life science clients worldwide. BioReliance’s service offering helps facilitate drug development, manufacturing, and commercialization activities. The company’s ability to develop and execute global testing protocols in compliance with various regulatory standards enables BioReliance’s clients to register products with regulatory agencies worldwide.
Sigma-Aldrich is a leading life science and high technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease, and as key components in pharmaceutical and other high-technology manufacturing.
“The acquisition of BioReliance by Sigma-Aldrich creates one of the broadest product and service offerings for the development and manufacture of biological drugs,” said BioReliance’s President and CEO Charles Harwood. “In addition, BioReliance’s Specialized Toxicology and Animal Health Services segments are complementary to other Sigma-Aldrich product and technology areas.”
Avista Capital Partners acquired BioReliance in 2007. With regard to the acquisition of BioReliance by Sigma-Aldrich, Avista Partner and President David Burgstahler added, “BioReliance is a world-class organization led by an outstanding team of seasoned life sciences professionals that has demonstrated success through impressive growth, scientific innovation, and exceptional customer service. Avista is committed to work with Sigma-Aldrich to ensure the successful transition of BioReliance and believes that the addition of BioReliance’s capabilities and service portfolio will allow Sigma-Aldrich to significantly enhance value to its clients and stakeholders.”
Brabender Pharma & Particle Sciences to Expand Extrusion Capabilities
Particle Sciences Inc. (PSI), a leading pharmaceutical CRO, is adding a Brabender Mini-Compounder 12-mm twin screw extruder, plus an ATR Torque Rheometer with single screw extruder for co-extrusion applications, to its development and production lines. This is Particle Sciences’ fourth extruder dedicated to drug/polymer combinations.
“The demand for cGMP extrusion is increasing,” said Mark Mitchnick, Particle Sciences’ CEO. “Needs range from hot melt extrusion for solid oral dosage forms to drug eluting devices. Particle Sciences is the leading CRO in this area having invested heavily in equipment, high potency compound handling infrastructure, and proprietary modeling software. With injection molding, tube extrusion, coextrusion, and the leading analytic support facility, we are working very hard to make sure our clients’ projects move as quickly as possible. In 2011 we successfully brought such products into the clinic and already have several scheduled for cGMP manufacturing in 2012. While there are several fine extruders on the market, Brabender Pharma has focused their 12 mm on the pharmaceutical development space. Its ease of cleaning, full cGMP compliance, and extensive data capture capabilities make it a valuable addition to rapid product development efforts.”
“Particle Sciences is an innovative leader in pharmaceutical extrusion, and we are very pleased to be working with them,” Kevin Van Allen, Brabender Pharma’s V.P. of Sales & Marketing. “With the placement of the Mini-Compounder at Particle Sciences, Brabender Pharma clients will now have a
Brabender Pharma USA, Inc. is an innovative company specializing in the manufacturing of twin-screw extruders for HME applications. The effort has been to concentrate on top quality equipment to produce small batch sizes up to production scale processes. The 12-mm Min-Compounder is ideally suited to this undertaking, while other models offer options to achieve production capacity.
Particle Sciences is an integrated provider of drug development services, focusing on BCS II/III/IV molecules, biologics, and highly potent compounds through a variety of technologies, including emulsions, gels, micro and nano-particulates, drug/device combination products, solid solutions and others. Through a full range of formulation, analytic, and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic.
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