Tekni-Plex adds new, tight tolerance, silicone tubing extrusion line to China manufacturing facility

Tekni-Plex has installed an additional silicone tubing extrusion line in its Suzhou, China manufacturing facility that will increase capacity and enable the addition of smaller sizes.

The new tubing capability range features an inside diameter of 0.2-25 mm (0.0079-0.984 inches), with wall thicknesses ranging from 0.10-3.0 mm (0.0039-0.118 inches), and tolerances as low as +/- 0.03 mm (0.001 inch). This newly expanded range of Natvar single-lumen silicone tubing is intended to better serve a range of medical pump applications, including peristaltic and patient-controlled analgesia (PCA) pumps.

Silicone tubing can withstand a wide range of temperatures and chemicals while maintaining strength and flexibility. Additionally, it does not support microbiological growth, making it ideal for medical and pharmaceutical pump applications.  For peristaltic pumps, tubing size and tolerance is critical.  The wall thickness of the tube must precisely match the gap between the pump roller and housing. Slight differences or irregularities in wall thickness can significantly reduce the life of a pump. Tekni-Plex’s silicone tubing offers tolerances as low as +/- 0.03 mm (0.001 inches).

“The ability to supply tight tolerances in silicone tubing from our China facility will be of interest to pump manufacturers who assemble their medical devices in the region and have had challenges sourcing quality tubing,” explains Bob Donohue, general manager, Natvar, a Tekni-Plex business. “Further, our manufacturing capability in China is backed by Tekni-Plex’s global technology base.” The Suzhou facility opened in 2017, backed by a $15 million investment to support the growing needs of the Asia-Pacific pharmaceutical and medical device markets, as well as to provide a secondary supply source for other regions.

Almac Group engages with Science Exchange to promote US small molecule analytical services

Almac Sciences, a member of the Almac Group, engages a collaboration with Science Exchange, the world’s leading R&D Services Management company. The partnership will offer online access to Almac’s integrated services from development through commercial scale production of active pharmaceutical ingredients to clients worldwide.

Almac Sciences has profiled its service offerings on the Science Exchange website, including the recently announced full suite of analytical services now offered from its European and North American facilities. Employing 150 highly skilled analysts working in GMP / GLP environments, Almac is positioned as the partner of choice with significant experience in the analysis of both small and large molecules and a range of product types including peptides, biologics, conjugates, potents and controlled substances.

Science Exchange was founded in 2011 with the mission of democratising access to the world’s scientific expertise in order to move the research world forward at a faster pace.  Science Exchange’s secure online solution to manage R&D services makes it easy for researchers to access the world’s leading scientific service providers and most innovative technologies.

“Science Exchange gives Almac Sciences another avenue where potential clients can find us in a quick and efficient manner,” says Denis Geffroy, VP Business Development, Almac Sciences. “This unique platform will enable us to provide added value across the clinical development lifecycle and help drive our clients to R&D success.”

Elizabeth Iorns, Ph.D., CEO and Co-Founder of Science Exchange, commented, “We are delighted that Almac has chosen to profile its offerings on our marketplace, where researchers from across the globe can readily access details on Almac’s vast range of services. Clients can use our platform to order services directly from Almac under a single, pre-established contract, enabling them to save time and money.”

Boehringer Ingelheim (Canada) Ltd. and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials

Boehringer Ingelheim (Canada) Ltd. and IBM Canada had announced at the Healthcare Information and Management Systems Society (HIMSS) conference in Orlando, Florida, their plans to explore the use of blockchain technology in clinical trials.

This collaboration underscores Boehringer Ingelheim’s commitment to healthcare innovation and marks the first time that blockchain technology will be explored in a clinical trial setting in Canada.

Based on the findings of regulatory authorities, processes to ensure the quality of clinical trials are frequently inadequate, and clinical trial records are often erroneous or incomplete, which may put patient safety and interpretability of trials at risk.

Significant opportunity exists to improve the quality of clinical trial processes and record keeping. Boehringer Ingelheim (Canada) Ltd. and IBM Canada aim to test whether blockchain technology in clinical trials provides a decentralized framework that enables data integrity, provenance, transparency, and patient empowerment as well as automation of processes, ultimately improving trial quality and patient safety at reduced cost.

“Our guiding philosophy is to bring value to patients and the healthcare system through innovation,” said Dr. Uli Brödl, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd. “The clinical trial ecosystem is highly complex as it involves different stakeholders, resulting in limited trust, transparency and process inefficiencies without true patient empowerment. Patients are at the heart of everything we do, so we are looking into novel solutions to improve patient safety and empowerment.”

IBM Canada brings core blockchain technologies to this collaboration which provides patient consent, secure health data exchange and patient engagement. IBM’s technology helps provide trust and transparency around the complex trial process.

“IBM is excited to collaborate with Boehringer Ingelheim to explore how blockchain technology could help improve the quality of clinical trials,” said Claude Guay, General Manager, IBM Services, IBM Canada. “We’ve been using blockchain in other industries, and we are now investigating how we can use this technology to give Canadian patients the same level of security and trust when it comes to their personal health information.” By collaborating with leaders in other sectors to devise solutions that benefit patients and our healthcare system, Boehringer Ingelheim (Canada) Ltd. continues to spearhead innovation and pave the way for future cross-stakeholder collaborations and partnerships.

Roche enters into definitive merger agreement to acquire Spark Therapeutics

Roche and Spark Therapeutics, Inc. had announced that they have entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics.

Spark Therapeutics, based in Philadelphia, Pennsylvania, is a fully integrated, commercial company committed to discovering, developing and delivering gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases.

Spark Therapeutics’ lead clinical asset is SPK-8011, a novel gene therapy for the treatment of haemophilia A, which is expected to start Phase 3 in 2019. Spark Therapeutics also has SPK-8016 in a phase 1/2 trial aimed at addressing the haemophilia A inhibitor population. Additionally, Spark Therapeutics was the first company to receive FDA approval for a gene therapy for a genetic disease in 2017. LUXTURNA® (voretigene neparvovec-rzyl), a one-time gene therapy product indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy is currently marketed in the US by Spark Therapeutics. The European Commission granted marketing authorisation for LUXTURNA in 2018.

Spark Therapeutics’ additional clinical assets include: SPK-9001, an investigational gene therapy for the potential treatment of haemophilia B in Phase 3 and SPK-7001 for choroideremia in Phase 1/2. The company is also developing SPK-3006 for Pompe disease and SPK-1001 for CLN2 disease (a form of Batten disease) which are expected to be ready for clinical development in 2019, as well as additional preclinical programmes for Huntington’s disease and Stargardt disease.

Commenting on the transaction, Severin Schwan, CEO of Roche, said, “Spark Therapeutics’ proven expertise in the entire gene therapy value chain may offer important new opportunities for the treatment of serious diseases. In particular, Spark Therapeutics’ haemophilia A programme could become a new therapeutic option for people living with this disease. We are also excited to continue the investments in Spark Therapeutics’ broad product portfolio and commitment to Philadelphia as a center of excellence.” Spark Therapeutics’ will continue its operations in Philadelphia as an independent company within the Roche Group.

“As the only biotechnology company that has successfully commercialised a gene therapy for a genetic disease in the US, we have built unmatched competencies in the discovery, development and delivery of genetic medicines. But the needs of patients and families living with genetic diseases are immediate and their needs vast,” said Jeffrey D. Marrazzo, CEO of Spark Therapeutics. “With its worldwide reach and extensive resources, Roche will help us accelerate the development of more gene therapies for more patients for more diseases and further expedite our vision of a world where no life is limited by genetic disease.”

Abbott and Novo Nordisk enter partnership to provide integrated digital solution to people with diabetes using insulin

Abbott and Novo Nordisk had announced a non-exclusive partnership that will integrate insulin dose data from Novo Nordisk pre-filled and durable connected pens directly into the digital health tools compatible with the FreeStyle Libre system (FreeStyle LibreLink[2] mobile app and LibreView[3]cloud-based system). The partnership reflects both companies’ commitment to make diabetes management easier by connecting key technologies such as continuous glucose monitoring (CGM) and connected insulin pens.

Integrating these two products will enable healthcare professionals, caregivers and people with diabetes to view glucose and insulin data together to help them make more informed treatment decisions and to have a more meaningful and productive conversation about health outcomes.

Lack of reliable information is a cause of huge frustration for many people with diabetes and their doctors,” said Anders Dyhr Toft, corporate vice president, Commercial Innovation, Novo Nordisk. “Together with partners like Abbott, our connected pens will give healthcare professionals a better understanding of a patient’s individual diabetes management and can help people with diabetes feel more confident in their treatment.”

It is our aim at Abbott to continuously provide life-changing technology to people living with diabetes,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “Diabetes is a time-intensive condition to manage. People with diabetes must make a variety of decisions every single day about their glucose monitoring, nutrition, insulin and medication intake. By enabling insulin dosing data from Novo Nordisk’s connected pens to be shared with our digital health tools, we’ll be able to help further eliminate those daily hassles for people, so they have more time to live a fuller, healthier life.

Abbott and Novo Nordisk are working hard to bring these integrated solutions to patients as soon as possible.

Almac Group Flows into Continuous Technology

Almac Sciences, a member of the Almac Group, has expanded its technology capabilities within its Active Pharmaceutical Ingredients (API) services & chemical development portfolio with the implementation of continuous flow expertise at its global headquarters in Craigavon, UK, with further plans to introduce flow capacity within Arran Chemical Company (Athlone, Ireland).

Continuous flow manufacture is an innovative technology platform which is gaining momentum within the pharmaceutical industry with the FDA supporting the adoption for the manufacture of APIs. It offers significant improvements in relation to product quality, process safety, reduction in plant footprint and provides the ability to perform chemistry that is difficult or impossible to do in batch mode.

Almac Sciences has a 4-year strategy to develop Flow Assisted Synthesis Technology (FAST) focusing on four key areas; (1) high pressure hydrogenations, (2) high energy chemistry, (3) oxidation and (4) photo-redox LED mediated chemistries. To support this, Almac Sciences has been awarded a Knowledge Transfer Partnership from Innovate UK for the development of novel routes to chiral amines using flow technology. In addition, Arran Chemical Company, in partnership with Queen’s University, Belfast, has been successful in securing a Horizon 2020 funded programme to support 4 PhD studentships for the next 4 years (beginning in 2019) in line with the FAST strategy.

Almac will develop highly flexible, robust, efficient flow technology platforms for continuous manufacture for the benefit of its clients who seek high quality and best-in-class pharmaceutical synthesis.

Prof. Tom Moody, VP Technology Development & Commercialisation, Almac & Arran Chemical Company commented, “The introduction of continuous flow technology further enhances Almac Sciences’ capabilities within API development and manufacture. Flow technology is highly flexible, robust, economic and regarded as the most exciting and innovative growth technology for the preparation of APIs. We are delighted to now offer this within our portfolio and will strive to continue providing world-class solutions to advance human health globally.”

Merck and Tencent Announce Collaboration on Intelligent Digital Healthcare Services in China

Merck, a leading science and technology company, signed a strategic collaboration agreement today with Tencent, a leading provider of Internet value added services. The collaboration will primarily focus on increasing public disease awareness and providing more accessible healthcare services via digital platforms in China, by leveraging the company’s scientific leadership and expertise combined with Tencent’s leading technology in the fields of internet and artificial intelligence.

“In this collaboration with Tencent, we will jointly explore the innovative combination of patient-centric healthcare management and digital platforms, which brings us one step closer to reaching our mission of transforming the lives of 40 million patients in China by 2025,” said Rogier Janssens, Managing Director and General Manager of Merck’s Biopharma Business in China. “The Healthcare Business of Merck in China is committed to developing a multi-dimensional intelligent medical ecosystem together with more cross-industry partners for the benefit of patients.”

“Tencent launched a major strategic upgrade in 2018. While we continue to stay committed to Consumer-Based Internet, we are also actively embracing Industrial Internet[i], with the healthcare field being an important focus.” Zhang Meng, Vice President of Tencent Medical said, “We want to build on advanced internet platforms and artificial intelligence, big data, and cloud computing capabilities, and work with partners to make healthcare in China more convenient and efficient for all patients.”

With the agreement, Merck and Tencent will create intelligent digital healthcare services, thereby increasing public knowledge of diseases and improving patients’ understanding of disease symptoms and effective treatment options. The collaboration will also provide patients with more convenient and smarter medical services, helping to better manage chronic diseases.

The focus areas will include all treatment areas of Merck’s Healthcare business in China: in allergies, Merck and Tencent will explore digital services that increase the awareness of allergy symptoms and encourage adherence to treatment plans; in the area of infertility, the collaboration will work to enhance awareness of disease and treatment options and help patients who are in need of fertility resources to shorten the process of medical treatment. The two companies will also focus on diabetes, thyroid disorders and cardiovascular diseases, as well as oncology such as metastatic colorectal cancer (mCRC).

In the future, Merck and Tencent will continue to extend the scope of collaboration to other areas such as exploring the use of innovative medical service models based on “A.I. doctors” to provide more comprehensive disease awareness education and treatment services for mCRC and other diseases.

Leveraging the collaboration with Tencent at the beginning of 2019, Merck is driving digitalization, an integral part of Merck’s strategy in China. With big data insights, new platforms and partnerships, Merck will adopt a more integrated approach to contribute to the key goals of the national “Healthy China 2030” blueprint and to safeguard the health of all Chinese citizens.

Endo to Acquire Somerset Therapeutics and Business of Affiliate Wintac Limited

Endo International plc has announced that it has reached definitive agreements to acquire Somerset Therapeutics, LLC, a New Jersey based specialty pharmaceutical company that develops and markets sterile injectable and ophthalmic drugs for the U.S. marketplace, and the business of its India based affiliate Wintac Limited, which operates as Somerset Therapeutics’ contract developer and manufacturer. Endo is paying approximately $190 million in total for Somerset Therapeutics and Wintac’s business. Together, the acquisitions will secure for Endo’s Par Sterile injectable business Somerset Therapeutics’ commercial and pipeline products as well as Wintac’s manufacturing capabilities for those products.

Focusing on the fast-growing U.S. sterile injectable drugs market, Somerset Therapeutics’ portfolio includes 8 commercial products as well as a pipeline of more than 40 products, over 25 of which have been submitted for approval to the U.S. Food and Drug Administration (FDA). With this acquisition, Endo significantly increases the number of filed injectable applications. Wintac, located in Bangalore, India, operates an FDA-inspected sterile manufacturing facility with proven
sterile injectable and ophthalmic R&D capabilities.

“We believe Somerset Therapeutics is an ideal strategic fit for Endo as it expands our portfolio of sterile injectable and ophthalmic products,” said Paul Campanelli, President and CEO of Endo. “Additionally, Wintac’s strong sterile R&D and high-quality manufacturing capabilities have contributed greatly to Somerset Therapeutics’ steady revenue growth. We see significant opportunities to leverage our existing sales and marketing capabilities as we seek to maximize the value of the current and expected future Somerset Therapeutics’ products. We look forward to working with our new colleagues to provide essential medicines thatbenefit patients.”

“Par has deep experience in the growing U.S. sterile injectable drugs market. They are well-suited to move Somerset Therapeutics and Wintac’s business to the next stage of development and growth,” said Dr. Veerappan Subramanian, Chairman and CEO of Somerset Therapeutics. “I want to personally thank our team for their contributions in building a highly attractive organization. We are excited to become a part of Endo and Par, a company we have successfully collaborated with in the past.”

Upon closing, Somerset Therapeutics will become a wholly-owned subsidiary of Par Pharmaceutical, Inc. and the Wintac business will become part of Par Formulations Private Limited. The transaction is subject to requisite regulatory approvals in the U.S. and India and customary closing conditions and is expected to
be completed by the end of 2018.