Category Archives: Press Releases

$55M contract modification awarded to BioCryst

A $55 million contract modification has been awarded to BioCryst Pharmaceuticals Inc. by the U.S. Department of Health & Human Services, according to a press release, to fund the completion of Phase 3 development of its intravenous flu drug peramivir.
The total award from HHS is brought to $234.8 million due to this contract modification, providing funding during completion of Phase 3 development and for peramivir the filing of a new drug application in the U.S. Through the end of 2013 it also extends the contract term by 24 months.

A Big Win for Small Particles: A SPECTROstar Nano Awarded to the University of Helsinki for Nanoparticle Research

BMG LABTECH is proud to announce that the fourth SPECTROstar Nano will be going to Finland to aid in developing a discovery platform for pharmaceutical nanoparticles at the University of Helsinki. Dr Marco Casteleijn says “The discovery platform for pharmaceutical nanoparticles relies on an unconventional combination of modern methods. It will open important new horizons and it is expected to fundamentally renew the field of drug delivery.”

“Specific experiments could benefit greatly by the use of the SPECTROstar Nano due to its fast reading times, robotic interface mode, low volume measurements, plate reading capabilities, shaking and incubating capabilities, and full spectrum readout. In addition, gas vent for atmospheric control could be useful for other applications in the future, in case of automated growth and control of mammalian cell lines. In addition, model drug concentrations such as calcein, small lipophilic molecules (e.g. rhodamine B), siRNA and pDNA can be evaluated by the SPECTROstar Nano during the formulation process” explained by Dr Marco Casteleijn.

BMG LABTECH will be awarding the last of five SPECTROstar Nanos on 30 July 2011. Just submit a short two to four page proposal explaining how your lab would benefit from this new and innovative absorbance microplate, cuvette and low-volume reader before the final deadline, 15 July 2011. If you would like to be the final winner, tell BMG LABTECH how you propose to use the SPECTROstar Nano in a unique fashion or propose to use one of the instrument’s many unique features such as: full UV/Vis spectrum per well, gas vent for atmospheric control, 1536-well plate reading capability, incubation and shaking, reference corrections to improve data, cuvette and plate kinetics, BMG LATECH’s low volume LVis Plate, or robotic interface mode.

Anton Paar Puts MKT 50 Millikelvin Thermometer on the Road to Success

Since the 1960s Anton Paar has been active in the field of temperature measurement. Continuous improvements based on longstanding experience have lead to the development of the highly precise MKT 50 millikelvin thermometer. This ‘lightweight’ portable thermometer stands out for its high measuring accuracy of 0.001°C (1mK). It can be operated from the mains or from a battery and has Ethernet and RS-232 interfaces for remote control. MKT 50 has a measuring range of -260°C to +960°C (13.15K to 1233.15K) and is traceable to national standards. It is therefore ideal for use as a reference thermometer for the most accurate temperature measurements, comparison calibrations and fixed-point calibrations for industry, laboratories and research.

MKT 50 is a robust and versatile digital thermometer. It is in use around the world at well-known official calibration institutes such as DAkkS (Deutsche Akkreditierungsstelle, formerly DKD, Germany), PTB Physikalisch-technische Bundesanstalt (Germany), ÖKD Österreichischer Kalibrierdienst (Austria), UKAS United Kingdom Accreditation Service and NIST National Institute of Standards and Technology (USA). MKT 50′s excellent accuracy and long-term stability have been confirmed in evaluations by the CMI Czech Metrological Institute, SMU Slovak Institute of Metrology and PTB.

Aravo Offers FCPA Webinar for Pharmaceutical and Life Sciences Firms

Aravo Solutions Inc. announced that it has joined with Richards Kibbe & Orbe to deliver a must-see webinar for Pharmaceutical and Life Sciences companies addressing the Federal Corrupt Practices Act (FCPA). The webinar, designed for in-house and retained counsel, compliance officers, and executives who manage third party intermediaries, will explore the key elements of successful FCPA programs, discuss real-world examples, and demonstrate how technology can automate critical compliance processes and documentation.

“In fact, companies having no knowledge of corrupt payments can be prosecuted if they were aware of potential warning signs and consciously failed to conduct due diligence and implement controls” said Robert.

The FCPA and the business and legal risks of potential corruption have become top of mind for Pharmaceutical and Life Sciences companies around the world. In the U.S., the Department of Justice, FBI, and the Securities and Exchange Commission have begun a rigorous anti-corruption campaign, and the prosecution of non-compliant global businesses under the FCPA is on the rise. With the passage of similar legislation in the UK and other markets, anti-bribery compliance is now a global concern.

Robert Shecterle, VP-Marketing, Aravo says FCPA requirements apply to not only a company’s employees but also to its agents, contractors, investors and suppliers. “While relationships between suppliers and other business entities are generally opaque and difficult to track, many companies have discovered the hard way that “willful blindness” only increases their culpability in the eyes of Federal regulators.”

The webinar will explore the FCPA’s two key provisions: the anti-bribery provision and internal records and process standards. The anti-bribery provision prohibits companies from giving money, gifts, or anything of value to obtain or retain business. The internal records and process standards require companies keep accurate records and maintain clear, accurate, and adequate controls with employees and trading partners to protect against improper payments or influence.

William Barry, of Richards Kibbe & Orbe, LLP says “lack of evidence to verify proper, compliant management of these trading relationships is the first line of defense when regulators come calling. In fact, companies having no knowledge of corrupt payments can be prosecuted if they were aware of potential warning signs and consciously failed to conduct due diligence and implement controls.”

Astex Pharmaceuticals to Present a Novel Targeted Approach to the Treatment of HCV at the AASLD Meeting

Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), a pharmaceutical company dedicated to the discovery, development and commercialization of novel therapeutics, announced that it will present data on its novel, first-in-class direct acting antiviral agents (DAA) against Hepatitis C Virus (HCV) at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 4-8, 2011.

The following presentations are scheduled for Saturday, November 5, 2011 at 2:00 pm PT during poster session R06: HCV Therapy: Preclinical and Early Clinical Development.

  • Abstract #371: Cell based replicon validation of novel HCV NS3 allosteric inhibitors result in a new therapeutic approach
  • Abstract #352: Discovery of a novel allosteric binding site on the full length HCV NS3/4a enzyme by fragment-based X-ray screening

Astex Pharmaceuticals has used its proprietary fragment-based drug discovery approach, Pyramid™, to target a previously unknown allosteric binding site on the full length HCV NS3 protease – helicase complex. Agents acting at this site have a novel mode of action and a different resistance profile compared to NS3 protease inhibitors. The NS3 protein is essential for viral replication and represents a validated HCV therapeutic target. These data represent a new approach to development of targeted agents to treat HCV infection. As part of its presentations, Astex Pharmaceuticals scientists will present on the discovery of the allosteric site using their Pyramid approach and on initial work aimed at validating the anti-viral activity of these first-in-class fragment-derived allosteric inhibitors.

Astex Pharmaceuticals is currently selecting a clinical candidate with a view to filing an IND in 2012. This research program, which has been supported with £2 million of funding from the Wellcome Trust Seeding Drug Discovery initiative, is wholly owned by Astex Pharmaceuticals.

About Astex Pharmaceuticals

Astex Pharmaceuticals is dedicated to the discovery, development, and commercialization of novel therapeutics with a focus on cancer. The Company is developing a proprietary pipeline of novel cancer therapies, will selectively in-license assets possessing a strategic fit with an attractive cost – value ratio, and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals, formerly SuperGen, developed Dacogen® (decitabine) for Injection and receives significant royalties on global sales.

For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com.

Cumberland Pharmaceuticals Receives FDA Approval for New Formulation of Acetadote

Cumberland Pharmaceuticals Inc. has made it known that it has obtained consent for a new formulation of Acetadote® (acetylcysteine) Injection from the U.S. Food and Drug Administration (FDA), the product of the company used to treat poisoning with acetaminophen. The new formulation that is privately owned, which has no Ethylene diamine tetracetic acid or any other chelating and stabilization agents and is preservatives free, will substitute the product that is currently marketed. U.S. launch activities are immediately being commenced by Cumberland for this next generation Acetadote product and the previously approved formulation will no longer be manufactured.

Endress+Hauser and Finesse Solutions Form Strategic Partnership

Process automation specialist Endress+Hauser has acquired a stake in Finesse Solutions, a US company that develops, produces and distributes sensors, hardware and software for bioprocess engineering.

Endress+Hauser intends to strengthen its position in the area of biotechnology through this cooperation. “Biotechnological procedures will play an increasingly important role in the future, not only in the life sciences industry but also in other industries such as the chemical industry to manufacture products in a more environmentally friendly and economical fashion,” emphasizes Klaus Endress, CEO of the Endress+Hauser Group. “Our partnership with Finesse offers us the possibility of gaining experience in this area without neglecting our core business.”

Combined offers for customers

Finesse Solutions will profit from leveraging the know-how of the new strategic relationship to extend its product portfolio and to enhance its global sales and service capabilities. The two companies intend to cooperate closely in relation to products, markets and customers, and to complement each other; for example, in the provision of global after-market services to bioprocess end users. “Endress+Hauser and Finesse Solutions have many common customers who can profit from this cooperation,” stated Finesse CEO Barbara A Paldus.

The previous majority shareholder, Skymoon Ventures, will hold an equal stake to Endress+Hauser. The company’s staff of about 50 will maintain their ownership in the company. Endress+Hauser will elect two representatives to the board of directors, which Barbara A Paldus will continue to chair.

 

For $375 Million, Gilead Sciences to Acquire Calistoga Pharmaceuticals

Calistoga Pharmaceuticals, Inc. and Gilead Sciences, Inc. have announced recently the signing of a final agreement related to which Gilead will acquire Calistoga for $375 million. Calistoga Pharmaceuticals is a biotechnology company that is privately-held and focused on the development of medicines to treat inflammatory diseases and cancer. If certain milestones are achieved Calistoga could earn up to an additional $225 million. Subject to satisfaction of certain closing conditions, and plans to finance the acquisition through available cash on hand, Gilead anticipates that the deal will close in the second quarter of 2011.

Fujifilm Diosynth Biotechnologies and ContraFect Corporation Collaborate for Novel Anti-Staph Biologic

Fujifilm Diosynth Biotechnologies and ContraFect Corporation have announced that they have signed a contract to support the process development and cGMP manufacture of CF-301, ContraFect’s Staphylococcal-specific bacteriophage lysin. CF-301 is ContraFect’s lead compound and displays potent activity against all forms of Staph infections, including methicillin-resistant (MRSA) and vancomycin-resistant strains (VISA/VRSA).

The initial part of the programme will utilise Fujifilm Diosynth Biotechnologies’ pAVEway™ advanced protein expression technology to establish a high productivity process. The pAVEway™ technology is a platform based on a unique set of protein expression plasmids that can incorporate a range of vectors developed by Fujifilm Diosynth Biotechnologies using DNA looping to tightly control protein production at high and reproducible expression levels. The programme will be executed at Fujifilm Diosynth Biotechnologies’ site in Billingham, UK.

Founded in 2008 by Dr Robert Nowinski, who serves today as the company’s chief executive officer and chairman of the board, ContraFect is a biotechnology company pioneering the use of lysins to treat life-threatening infectious diseases. “CF-301 is a protein that differs from antibiotics and is effective against all current and potential drug-resistant Staph infections,” remarked Dr Nowinski. “ContraFect has now completed its laboratory research on CF-301 and has moved to pre-clinical development with an eye towards its IND submission in Q2 2012 and our first in man clinical trials later that year.”

Fujifilm Diosynth Biotechnologies brings to the development of CF-301 over 25 years of biopharmaceutical contract development and manufacturing experience with over 150 projects, including commercial manufacturing of four licensed products. “We are delighted to be selected by ContraFect for development of CF-301,” said Steve Bagshaw, managing director of Fujifilm Diosynth Biotechnologies’ UK business. “By combining the application of our pAVEway™ expression technology with our extensive knowledge and experience, we are well positioned to have a long and successful partnership between our companies. This partnership with ContraFect is very much in line with our goal to be a solutions provider to our clients.”

“ContraFect Corporation is very pleased to work with Fujifilm Diosynth Biotechnologies to bring CF-301 through clinical development and to the market,” said Dan Couto, ContraFect’s vice president of product development. “Fujifilm Diosynth Biotechnologies’ vast experience with microbial production and large-scale integration mitigates many typical risks in CMC biologics development, thus assuring material supply to our patients for this unmet medical need.”

Gilson Launches New LC/MS Purification System

Gilson is pleased to announce the expansion of its range of HPLC purification systems with the launch of a new Gilson LC/MS system. This system provides researchers with the ability to use the specificity of mass spectrometry to increase the efficiency of their purification processes.The addition of a mass spectrometer allows mass targeted purification, and thus reduces the number of collected fractions to be processed, while providing information on the mass of purified compounds.

Gilson has developed the first easy-to-use, practical mass-based purification system. The LC/MS Purification System from Gilson features a world class performing MS detector combined with Gilson’s industry-leading preparative HPLC system to produce a truly unique and usable mass targeted purification system.

The Flexar SQ 300 mass spectrometer is a single quadrupole detector with a wide mass range (50-3000 amu) and a fast scanning speed (10,000 amu / sec), making it suitable for a large number of chemical compounds and fast enough for the precise fraction collection associated with all Gilson preparative HPLC systems.

The large range dynamic splitter allows the implementation of this new MS detection to the entire range of Gilson purification systems from analytical, semi-preparative and preparative up to 200ml/min.