Amgen Invests $200 Million in Monoclonal Antibodies

Amgen recently announced plans to build a new manufacturing facility in the Tuas Biomedical Park area of Singapore. Over the next several years, Amgen anticipates investing approximately $200 million to build an innovative new facility, which will initially focus on expanding Amgen’s manufacturing capability for monoclonal antibodies. The facility will be capable of manufacturing both clinical and commercial products.

“Amgen is pleased to be planning for a new world-class facility in Singapore as part of our global expansion strategy. Singapore is an ideal location to further our manufacturing efforts based on its rich talent pool and friendly business environment,” said Madhu Balachandran, Executive Vice President of Operations at Amgen.

Construction is expected to begin in the next few months, and the site will be staffed with both new recruits and experienced staff. Amgen is currently partnering with local universities to recruit for a number of positions in Manufacturing and Quality.

As one of the industry’s original innovators, Amgen has extensive knowledge and first-hand expertise in clinical and commercial manufacturing of biotechnology-based medicines as well as a track record of safely and reliably delivering medicines to patients who need them. Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. To learn more about its pioneering science and its vital medicines, visit www.amgen.com or follow them on www.twitter.com/amgen.

Xceleron & Crystal Pharmatech Announce Strategic Development Partnership

Xceleron recently announced a partnership that will offer drug developers early bioavailability data that will lead to optimized solid-state forms and formulations. The partnership with Crystal Pharmatech will enable sponsors to make faster decisions in the early stages of development.

Contemporary small molecules represent a challenge in translational development due to their physic-chemical properties and the low predictivity of traditional nonclinical biological models. Too frequently, drug efficacy suffers because of poor pharmacokinetic properties.

The partnership between Xceleron and Crystal Pharmatech provides a solution. They combine the accelerator mass spectrometry (AMS) technology with the expertise to cost-effectively remove pharmacokinetic uncertainty by providing better early clinical and solid state information. This enables their customers to make better decisions sooner about a candidate’s later-stage readiness.

“At Xceleron, we believe that technology can get life-changing drugs to people who need them, sooner and at a lower cost. This partnership will help our clients do that by efficiently and cost-effectively answering critical questions earlier,” said Dr. Michael Butler, CEO of Xceleron.

“Having robust bioavailability and pharmacokinetic data at the outset provides a strong foundation for determining the best solid form and formulation,” added Dr. Alex Chen, CEO of Crystal Pharmatech. “Each company brings significant expertise to the discussion of novel clinical outcomes.”

Xceleron provides bioanalytical AMS services for accelerated early drug development. The company pioneered human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I, and Phase II/III clinical trials. It has been providing drug development services for more than 10 years and has conducted more GLP and GCP studies than any other analytical service provider of its type. For more information, visit www.xceleron.com.

MonoSol Rx Enters Licensing Agreement With Vestiq Pharmaceuticals

MonoSol Rx recently announced it has licensed Zuplenz (ondansetron) to Vestiq Pharmaceuticals, a specialty pharmaceutical company focused on innovative therapeutic remedies within the supportive care markets.

Zuplenz is an oral soluble film (OSF) for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting. The licensing agreement comprised an undisclosed up-front payment from Vestiq, as well as double-digit royalty payments from sales of Zuplenz. Vestiq relaunched Zuplenz in the United States in the fourth quarter of 2012. The approval of Zuplenz by the US FDA makes it the first oral soluble lingual film product approved by the FDA as a prescription medication, based on MonoSol Rx’s proprietary PharmFilm technology.

“We are excited that Zuplenz is once again available to meet the needs of patients,” said A. Mark Schobel, President and CEO of MonoSol Rx. “We have found the right partner in Vestiq Pharmaceuticals and are excited about their ability to positively impact the supportive care market. We know that this oral film delivery of the drug ondansetron fulfills a significant unmet need, as we have fielded a continuous stream of inquiries from doctors and nurses regarding the availability of Zuplenz. Providers are now able to ensure their patients receive the best care possible by utilizing our innovative drug delivery technology to eliminate swallowing issues and discomfort associated with chemotherapy, radiotherapy, and surgery. Today’s announcement reinforces MonoSol Rx’s position as a leader in the film space, and our continued dedication to patients in need.”

“We are pleased to be working with MonoSol Rx to relaunch Zuplenz into the US market,” added Martin Baum, Chairman and CEO of Vestiq Pharmaceuticals. “The oral film delivery technology is a major breakthrough for ease of use and compliance for supportive care patients, who consistently have difficulty swallowing. We intend to build on the initial acceptance of Zuplenz by the oncologists, general surgeon, and oncology nurse communities, who are now able to provide their patients with an alternative product for nausea and vomiting.”

Zuplenz is a unique formulation of ondansetron developed using MonoSol Rx’s proprietary PharmFilm technology, and co-developed with partner APR Applied Pharma Research s.a. of Switzerland. It is based on a novel and proprietary oral drug delivery technology platform and consists of a polymeric OSF containing ondansetron. Once placed in the mouth, it dissolves in a few seconds and is swallowed with saliva without the need for water.

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm technology to develop products that address the unmet needs of patients. PharmFilm is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The company’s leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm technology, and two FDA approvals. For more information, visit www.monosolrx.com.

Vestiq is a specialty pharmaceutical company focused on innovative therapeutic remedies within the supportive care markets. Vestiq is committed to becoming the market leader in providing pharmaceutical products and technologies to the supportive care market. The company’s portfolio is supported by strong intellectual property, a pipeline of other supportive care prescription products, and a committed commercialization team of industry experts. For more information, visit www.Vestiqpharma.com.

Domain Therapeutics Grants Prexton Therapeutics Exclusive License & Development Option

Domain Therapeutics S.A. recently announced that Domain Therapeutics granted Prexton Therapeutics an exclusive option to license and develop metabotropic glutamate receptor 4 (mGluR4) Positive Allosteric Modulator (PAM) drugs targeting Parkinson’s disease.

The chemical series was previously developed through a licensing and collaboration agreement signed between Domain and Merck Serono, a division of Merck in January 2011. This agreement between Domain Therapeutics and Prexton Therapeutics – a spin-off company of Merck Serono formed around its R&D portfolio in the field of Parkinson’s disease – follows a strategic decision from Merck Serono to focus its research efforts on certain diseases, such as multiple sclerosis, cancer, and immune-mediated diseases.

Under the terms of the agreement signed between Domain and Prexton, Prexton will benefit from an exclusive license option to progress the mGluR4 PAM drug candidates into clinical development.

“We are pleased to sign this agreement with former seasoned scientists of Merck Serono, who had been involved in this mGluR4 PAM project within Merck Serono,” said Pascal Neuville, Chief Executive Officer, Domain Therapeutics. “We are very confident that this newly founded company with a unique focus on mGluRs for neurodegenerative diseases will be the best partner to drive the project to an Investigational New Drug (IND) stage and then ensure its clinical development.”

“I had the opportunity to follow Domain’s mGluR4 PAM compounds, and I am very glad that we can benefit from the collaborative work led by Domain and Merck Serono,” added François Conquet, Chief Executive Officer, Prexton Therapeutics. “This license option agreement clearly strengthens Prexton’s franchise in the business of mGluR drugs.”

Domain Therapeutics is a biopharmaceutical company located in Strasbourg, France, dedicated to the discovery and early development of small molecules targeting G-Protein Coupled Receptors (GPCRs), one of the most important classes of drug targets. Domain Therapeutics discovers GPCR drugs by exploiting its innovative and differentiated approach. The company’s pipeline is composed of new chemical entities, ranging from hits to optimized leads for significant CNS and metabolic disorders. For more information, visit www.domaintherapeutics.com.

Prexton Therapeutics has the mission to develop innovative drugs to improve the quality of life of people who suffer from Parkinson’s disease and other brain disorders. Recently founded in Geneva, Switzerland, Prexton Therapeutics is developing novel mGluR4 PAM series. Considerable efforts are going into creating chemical diversity of drug-like molecules with properties suitable for brain diseases, such as blood-brain barrier penetration or an ADME/PK profile optimized to achieve target coverage. For more information, visit www.prextontherapeutics.com.

The Quadruple Helix in the Human Genome Could Lead to New Cancer Drugs

The discovery of a quadruple helix in human cells could be a key to fighting cancer, according to the Cambridge researchers who made the findings. They come almost exactly 60 years after James Watson and Francis Crick burst in to the pub next to their Cambridge lab excitedly proclaiming that they had found the secret of life in the double helix structure of DNA.

Quadruple helixes intertwine four rather than two strands of DNA, and had been created in the lab by curious researchers, but it was generally thought that they didn’t exist in nature. But now these quadruple helixes – or G-quadruplexes – have been found in cancer cells, according to a study published in Nature Chemistry. The quadruple helix might be unique to human cancer cells – and the discovery means that cancer drugs to target these unusual DNA structures could be developed.

“We are seeing links between trapping the quadruplexes with molecules and the ability to stop cells dividing, which is hugely exciting,” said Professor Shankar Balasubramanian from the University of Cambridge’s Department of Chemistry and Cambridge Research Institute.

The research, which has been funded by Cancer Research UK, shows clear links between concentrations of four-stranded quadruplexes and the process of DNA replication, which is pivotal to cell division and production.

In 1953, Cambridge scientists James Watson and Francis Crick suggested what is now accepted as the first correct double-helix model of DNA structure in the journal Nature.

Their double-helix, molecular model of DNA was then based on a single X-ray diffraction image taken by Rosalind Franklin and Raymond Gosling in May 1952.

Cancers are usually driven by genes called oncogenes that have mutated to increase DNA replication – causing cell proliferation to spiral out of control, and leading to tumor growth.

The increased DNA replication rate in oncogenes leads to an intensity in the quadruplex structures. This means that potentially damaging cellular activity can be targeted with synthetic molecules or other forms of treatments.

“This research further highlights the potential for exploiting these unusual DNA structures to beat cancer – the next part of this pipeline is to figure out how to target them in tumor cells,” said Dr Julie Sharp, Senior Science Information Manager at Cancer Research UK.

Mr. Balasubramanian told the BBC, “I’m hoping now that the pharmaceutical companies will bring this on to their radar and we can perhaps take a more serious look at whether quadruplexes are indeed therapeutically viable targets. The quadruple helix DNA structure may well be the key to new ways of selectively inhibiting the proliferation of cancer cells. The confirmation of its existence in human cells is a real landmark.”

Imaxio Acquires Orphan Drug From D&A Pharma

Imaxio recently announced the acquisition of Trolovol (D-penicillamine), a drug for human usage indicated for an orphan disease affecting around 1,200 patients in France. This product previously belonged to D&A Pharma and the transaction was facilitated by CMC Consulting. The financial terms of the deal have not been disclosed.

This purchase will allow Imaxio to generate almost EUR 500,000 of additional revenue in 2013, representing an increase of 20% in its turnover compared to 2012. This revenue will be re-invested in research and development activities relating to its proprietary technology for reengineering antigens, known as IMX313. This technology is used to significantly increase immunogenicity and thus the efficacy of vaccines in which it is used.

This acquisition also fits in with Imaxio’s strategy of consolidating its pharmaceutical range. The company currently distributes Spirolept, a human vaccine indicated for preventing a professional infectious disease, which became part of Imaxio’s portfolio in 2009 following the acquisition of the company Axcell Biotechnologies. In 2012, sales of Spirolept totalled almost EUR 2 million and generated a turnover of EUR 2.5 million.

“We are delighted to have finalized this transaction, which is a perfect fit for our external growth strategy,” said Alexandre Le Vert, Managing Director of Imaxio. “With the revenue generated by the sales of Trolovol, Imaxio will have the additional means necessary to advance in the clinical field, in particular with regard to its highly promising IMX313 technology for vaccines. Over the next 3 years, there are plans for Phase I/IIa clinical trials in indications for tuberculosis, influenza and staphylococcus aureus infections.”

In the medium term, Imaxio plans to acquire further new products and to license its IMX313 immunogenic technology for new indications in human and animal healthcare.

Imaxio SA is a biopharmaceutical company specialized in the areas of vaccines and genomics. Using IMX313, its antigen re-engineering technology, Imaxio is developing, both individually and with its partners, recombinant vaccines with improved effectiveness for applications in both human and animal health. In France, Imaxio already markets Spirolept, a human vaccine indicated for preventing a professional infectious disease and Trolovol, an orphan drug indicated for a congenital metabolic disease. For more information, visit www.imaxio.com.

D&A Pharma is a French pharmaceutical company specialized in the development of innovative and patented treatments of addictions. The company has three key products under development. Its alcohol dependence treatment product (currently in Phase IIb/III trial) is a solid form of a liquid product which has been marketed for more than 15 years in Italy. For more information, visit www.da-pharma.fr.