The new laboratory has added an additional 1,200 sq m to the existing facility and will be adjacent to SGS’s existing global center of excellence for cell banks and viral vaccine biosafety.

The facility now totals 2,400 sq m, employs 65 staff and plans to increase the number of scientific and quality personnel at the site. Clients will benefit from a fully comprehensive range of validated biosafety methods to support cell bank and viral vaccine manufacturing and lot release of drug product, as well as new technologies for pathogen detection, including next-generation nucleic acid sequencing and new cell based viral detection systems. The new laboratory will also increase the capacity of all existing biosafety services and enhanced real-time polymerase chain reaction (PCR) platforms, to support viral safety and genetic stability assessment of cell banks for vaccines, gene and cell therapies.

Additionally, in accordance with the requirements of the US and European Pharmacopeia, SGS will undertake the development and validation of new cell-based viral detection systems at the site.

The study will be the largest ever undertaken by CSL, and will enroll more than 17,000 patients from approximately 1,000 sites around the world to evaluate whether the drug can reduce cardiovascular events in high-risk patients during the critical 90 day period following a heart attack. The decision to proceed follows positive results from Phase 1 and 2 trials and was announced today during CSL’s annual R&D Investor Briefing in Sydney.

Cardiovascular disease (CVD) is the leading cause of death globally.1 Every year in Australia, an estimated 54,0002 people are hospitalised as a result of a heart attack. Nearly one in five survivors of acute myocardial infarction (MI), or heart attack, will experience a recurrent cardiovascular event (non-fatal MI, stroke, cardiovascular death) within one year of the initial event.3,4 The majority of these recurrent events happen within the first 90 days and are associated with a high rate of morbidity and mortality.4,5,6 In addition, recurrent events are associated with increased economic and healthcare burden.

“Despite recent advances in cardiovascular care, we still have an unacceptable rate of early recurrent cardiovascular events occurring in high-risk patients following an acute MI,” said C. Michael Gibson, M.D., Ph.D., Professor of Medicine at Harvard Medical School and co-lead investigator of the Phase 3 study, known as AEGIS-II. “We are optimistic that CSL112 will offer a novel, rapid approach to reduce these events during the 90-day period when heart attack survivors are most vulnerable.”

“Current treatments available to reduce the high risk of recurrent heart events are limited, and innovative, more effective alternatives are needed in order to ensure higher survival rates for this population of patients,” said Professor Steve Nicholls, South Australia’s SAHMRI Heart Foundation Heart Health Theme Leader and member of the AEGIS –II Phase 3 Executive Committee.

Early recurrent cardiovascular events are commonly caused by the rupture or erosion of cholesterol-rich plaque in the arteries. CSL112 may offer a new approach through the rapid enhancement of cholesterol efflux capacity, a process by which cholesterol is removed from plaque and transported to the liver for elimination from the body.
“The decision to proceed to Phase 3 of the clinical program for CSL112 reflects our promise to patients and deep commitment to innovation, along with our heritage of delivering plasma-derived therapies,” said Professor Andrew Cuthbertson, Chief Scientific Officer for CSL Limited.

“We believe CSL112 has the potential to change the current treatment paradigm for heart attack survivors and improve global health outcomes for the millions of people at risk for early recurrent cardiovascular events.”
CSL112 has been developed by CSL’s global Research and Development team, including scientists in Australia working in collaboration with global sites and partners. The Phase 3 trial, known as ‘AEGIS-II’ (ApoA-I Event reducinG in Ischemic Syndromes II), is expected to take around four years to complete, with patient enrollment beginning in early 2018.

Media Contact
Jemimah Pentland,
Head of Communications
CSL Limited
Phone +61 412 635 483

ABOUT CARDIOVASCULAR DISEASE & RECURRENT EVENTS
An estimated 17.7 million people died from cardiovascular diseases in 2015, which accounted for 31 percent of all global deaths.1 Of these deaths, an estimated 7.4 million were due to coronary heart disease.1 The most common cause of coronary heart disease is the build-up of fatty deposits (atherosclerosis) within the inner walls of the arteries that supply blood to the heart. A well-known clinical manifestation of coronary heart disease is acute myocardial infarction (MI).7 Patients who suffer an MI may also have atherosclerosis in other vascular beds, which can further increase the risk of recurrent events. In the US alone, a heart attack occurs roughly every 40 seconds.3 Despite optimal care, approximately one in five patients will experience a recurrent cardiovascular event in the year following an acute MI, with approximately 60-70 percent of recurrent events occurring in the first 90 days following the initial event.4,5

ABOUT CSL112
CSL112, Apolipoprotein A-I (Human), is a novel formulation of plasma-derived apoA-I, the primary functional component of HDL. It is reconstituted to form HDL particles suitable for intravenous infusion. Studies have shown that infusion of CSL112 rapidly enhances cholesterol efflux capacity8. CSL112 may offer a new approach for rapidly stabilizing atherosclerotic plaque lesions and is being developed for reduction in the risk of early cardiovascular events in acute myocardial infarction patients.

ABOUT THE AEGIS CLINICAL STUDY PROGRAM
AEGIS-II is a Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of CSL112 on reducing the risk of MACE (Major Adverse Cardiac Event), defined as cardiovascular death, myocardial infarction, and stroke in acute coronary syndrome (ACS) patients who are receiving evidence-based medical therapy, diagnosed with either ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

In the new production hall, employees will make core injection-molded components for pharmaceutical containers, port systems – which enable infusions to be administered as gently as possible, for example during chemotherapy – and medical disposables. The latter include such products as feeding tubes and giving sets, which are routinely used in hospitals to administer infusion therapies, clinical nutrition and intravenous drugs. The extension will enable Fresenius Kabi to produce components it previously had to purchase from suppliers.

At approximately 1,000 square meters (10,700 square feet), the new hall doubles the amount of space available for production activities at the plant in Mihla, a town in the eastern German state of Thuringia. The project also includes an expansion of the plant’s warehouse to hold as many as 2,000 pallets – a more than six-fold increase.

Dr. Christian Hauer, President Medical Devices Division of Fresenius Kabi, said: “Products from Fresenius Kabi are used in the care of chronically and critically ill patients, which makes the highest standards of quality and reliability essential. Our employees in Mihla have been doing outstanding work for many years. I’m delighted that with this extension, we are making our Mihla production location ready for the future.”

Mayor Laemmerhirt praised Fresenius Kabi for its commitment to his community: “I am very happy that Fresenius Kabi, as a globally active company, is investing here in Mihla. This can also be seen as a positive sign for our region and its economic development.”

Martin Kunze
Director External Communications
T: +49 (0) 6172 608-2115
martin.kunze@fresenius.com

The investment expands GSK’s previously announced effort to generate genetic sequencing data from UK Biobank, the world’s most comprehensive health resource. GSK’s new commitment will support the sequencing of data from all 500,000 volunteer participants, beyond the first 50,000 subset announced by the company earlier in 2017.

The funding will also strengthen GSK’s ‘Open Targets’ collaboration with the European Bioinformatics Institute, the Wellcome Trust Sanger Institute, Biogen and Takeda, which was established in 2014 in Cambridge, UK, which makes genetic and biological data openly available to help researchers identify and prioritise new targets for developing future medicines.

Patrick Vallance, President, R&D, GSK, said: “This new investment by GSK, along with money from other public and private organisations, is building on the UK’s already world-leading status in the field of genomics and bioinformatics. Genetic evidence has revolutionised scientific discovery and drug development in recent years by providing clear links between genes and disease. Currently, an estimated 90% of potential medicines entering clinical trials fail to demonstrate the necessary efficacy and safety, and never reach patients. Many of these failures are due to an incomplete understanding of the link between the biological target of a drug and human disease. By contrast, medicines developed with human genetic evidence have had substantially higher success rates and patient care has benefited.”

Phil Thomson, President, Global Affairs, GSK, said: “The UK has a world class life sciences sector, but that will only continue to thrive through a strong partnership of Government, industry and academia. This Sector Deal contains a number of very practical commitments to strengthen the UK’s life science base and make it more attractive to international investment in areas such as clinical trials and high-tech research. Ultimately, this should provide benefits to the economy and create jobs. We look forward to seeing further initiatives result from this strategy for the sector.”

GSK is one of the largest private R&D investors in the UK, where it spends over a £1billion a year and which is home to one of its two global research centres, based in Stevenage, Hertfordshire. The company focuses 80% of its pharmaceutical research spending across Respiratory, HIV/ Infectious Diseases, Oncology and Immuno-Inflammation research.

GSK – a science-led global healthcare company with a special purpose: to help people to do more, feel better, live longer.

Issued: London UK
The ZOE-HSCT study succeeded in its primary objective by demonstrating an efficacy of 68.17% [95%CI: 55.56 – 77.53] against shingles in subjects above 18 years of age after receiving an autologous haematopoietic stem cell transplant. In subjects aged 50 and above, the efficacy was similar, 67.34% [95% CI: 52.60 – 77.89]. The vaccine reduced overall complications linked to shingles episodes by 77.76% [95% CI: 19.05% – 95.93%]. Vaccine efficacy for the prevention of post-herpetic neuralgia, a form of chronic nerve pain and the most common complication associated with shingles, was 89.27% [95% CI: 22.54–99.76]. No safety issues related to the vaccine were detected during the study.

“The immune systems of these stem cell transplant recipients is substantially weakened compared to the general older adult populations studied in other Shingrix efficacy trials,” Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK said. “This puts them at much higher risk for viral diseases like shingles and, at the same time, makes developing an effective vaccine to help protect them more challenging.”

“Today’s results, demonstrating the vaccine’s ability to help prevent shingles and its complications with just two doses, may provide a much-needed benefit to these patients considering the high incidence and burden of disease they face,” he said.

Shingrix is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.

GSK is evaluating these results together with those of other Phase III studies in immune-compromised patient populations. All these data will be shared and discussed with regulatory as well as public health agencies with the objective of best informing health care providers on the use of Shingrix in those patients with greatest medical need.

Shingrix is now approved in Canada and US for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan.

About the ZOE-HSCT Study
ZOE-HSCT was a Phase III clinical study to evaluate the efficacy, safety and immunogenicity of a two-dose course of Shingrix for prevention of shingles (herpes zoster) when given to adults 18 years and above with the first dose administered 50-70 days after they had undergone autologous haematopoietic stem cell transplant (auHSCT). Study participants were randomized 1:1 to receive either Shingrix or placebo.

The study started in July 2012 and enrolled 1846 subjects in 28 countries worldwide spanning the North and South America, Europe, Africa, Asia and Oceania.

The safety profile of the vaccine was found to be clinically acceptable in this study. Overall, the proportion of severe adverse events (SAEs), fatal SAEs, potential immune-mediated diseases (pIMDs) and relapses (of the underlying disease) was similar between groups. Observations regarding reactogenicity were in line with the observations in previous studies.

This is the first time that Shingrix efficacy has been evaluated in immune-compromised patients such as those who have received auHSCT and who are at higher risk of developing shingles and its complications. These data complement the available efficacy results from ZOE-50 and ZOE-70 generated in adults aged 50 years and older.

Previously the only available shingles vaccine was live attenuated and therefore contra-indicated for those with weakened immunity. Developing an effective vaccine for these patients was an area of unmet medical need.

About auHSCT
Hematopoietic stem cells consistently replicate and ensure the production of new blood cells. They are located in the red bone marrow which is contained in the core of most bones.

Hematopoietic stem cell transplantation (HSCT) in adults is most commonly performed as part of the treatment for blood cancer. It requires the extraction of haematopoietic stem cells, usually collected from the bone marrow or blood, to be thereafter transfused into the patients’ bloodstream where they induce normal blood cell production. The transplant is called ‘autologous’ when the patient’s own cells are used.

In preparation for the transplant, the patients are treated with high-dose chemotherapy, with or without radiotherapy, with the intention of eradicating the patient’s malignant cell population at the cost of partial or complete bone marrow ablation (destruction of patient’s bone marrow’s ability to grow new blood cells).

For this reason, since the recipient’s cellular immune system is usually destroyed by the radiation or chemotherapy before transplantation, HSCT recipients are at high risk from viral infections like shingles, and its complications.[i]

Over 11,000 people in the US undergo auHSCT each year.[ii]

About Shingles
Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox.[iii] Nearly all adults have the VZV dormant in their nervous system, which can reactivate with advancing age[iv] or when a person is immune compromised due to certain diseases (such as cancer or HIV) or is receiving immune-suppressive treatments (such as chemotherapy).

Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks. The pain associated with shingles is often described as burning, shooting or stabbing.[v] [vi]Even once the rash is gone, a person can experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years. PHN is the most common complication of shingles, occurring in 10 to 18 percent of all shingles cases.[vii]

There are an estimated one million cases of shingles in the United States each year.[viii] More than 99 percent of those over 50 years old are infected with VZV, and one in three Americans will develop shingles in their lifetime.

About Shingrix
Shingrix is a non-live, recombinant adjuvanted subunit vaccine approved in the United States and Canada to help prevent shingles (herpes zoster) in people aged 50 years or older. Shingrix is not contraindicated in immune-compromised people in this age population.

It combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age as well as weakened immunity due to disease or immune-suppressive treatments.[ix]

In April 2015, WuXi Biologics announced a $150 million plan to build a state-of-the-art biologics manufacturing facility in Wuxi city. In September 2016, the first phase of construction was completed with two 1,000 L disposable bioreactors for perfusion processes, making it the largest perfusion biologics manufacturing facility using disposable bioreactors in Asia. Just 15 months later, a cGMP campaign has been started in the second phase of the cGMP facility, now equipped with additional fourteen 2,000 L disposable bioreactors for fed-batch cell culture.

The new facility quintuples the existing manufacturing capability of WuXi Biologics. This facility will support the robust biologics commercial manufacturing pipeline coming from its global partners and further strengthens WuXi Biologics’ position as a global premier biologics manufacturer. In addition, the newly added capacity will address the urgent needs of Chinese companies as biologics contract manufacturing for Chinese companies is recently being piloted by the China Food and Drug Administration (CFDA).

The new 500,000 sq. ft. manufacturing facility will complement WuXi Biologics’ existing biologics manufacturing capabilities. In 2012, WuXi Biologics completed its first state-of-the-art biologics drug substance and drug product manufacturing facilities in Wuxi city. This facility was the first in China that met cGMP standards of the United States, the European Union, and China. In 2014, the facility received the Honorable Mention Award “Facility-of-the-Year” by International Society for Pharmaceutical Engineering (ISPE), a first for China. In August 2017, the U.S. FDA completed the Pre-License Inspection (PLI) at this cGMP manufacturing facility where TaiMed Biologics’ ibalizumab, for the treatment of multi-drug resistant HIV, was manufactured. This inspection makes WuXi Biologics the first Chinese company to receive a U.S. FDA PLI or cGMP inspection for biopharmaceuticals.

“We are very pleased that it only took us a little more than two years from our own innovative concept of using single-use bioreactors for commercial manufacturing facilities to actual completion of a global standard state-of-the-art facility in Wuxi city. This new facility design with a lower capital expenditure and shorter facility timeline compared to that of traditional biologics commercial manufacturing facilities, represents a novel design for facility-of-the-future, which has been emulated by several companies globally,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. “The new site in Wuxi delivers to our customers additional capacity, greater flexibility and higher efficiency.”

Dr. Ge Li, Chairman of WuXi Biologics commented, “We are very pleased with the new facility. We will continue to enhance WuXi Biologics’ capabilities and capacities in integrated biologics discovery, development and manufacturing to accelerate biologics development for our global partners and ultimately benefit patients worldwide.”

About WuXi Biologics
WuXi Biologics, a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information on WuXi Biologics, please visit www.wuxibiologics.com

“The ImThera device is highly aligned with our existing Neuromodulation business, and we are extremely excited about the opportunity to optimize the technology and fold it into our universal platform. In the near term, we will focus on expanding ImThera’s current commercial presence in the European market, while advancing enrollment in a U.S. Food and Drug Administration (FDA) pivotal trial,” said Damien McDonald, LivaNova’s Chief Executive Officer. “The OSA market is large and growing, with many unmet needs. With our strong commercial capabilities and robust manufacturing, we look forward to bringing this innovative technology to the large patient population that has been unsuccessful with other treatments, allowing them to improve their quality of life.”

Patients with OSA can experience impaired daytime functionality, along with severe comorbidities such as heart failure and stroke. ImThera’s implantable device received CE Mark in 2012 and is indicated for patients with moderate to severe OSA who are unable or unwilling to use continuous positive airway pressure (“CPAP”) therapy. For these patients, the device is designed to reduce or eliminate sleep apnea, as demonstrated through clinical studies and its initial commercial use in Europe. Enrollment in a pivotal study is currently under way with the FDA to obtain premarket approval for the OSA implant.

“Adding ImThera and its obstructive sleep apnea device to our portfolio will strengthen our position as a leader in the field of neuromodulation,” said Jason Richey, LivaNova’s President of North America and General Manager of the Neuromodulation business.

LivaNova has been an investor in ImThera since 2011 and has agreed to pay up to approximately $225 million to acquire the remaining outstanding interests of ImThera. Up-front costs are approximately $78 million with the balance paid on a schedule driven by regulatory and sales milestones. The deal is projected to be near-term accretive and is expected to close in early 2018 (subject to approvals and other customary closing conditions).

“ImThera Medical shares LivaNova’s mission to help patients live longer, better lives. We are proud of the accomplishments we have made in developing an effective CPAP alternative for individuals suffering from OSA. This acquisition will benefit healthcare providers, shareholders and most of all, the patients who are at the heart of everything we do,” said Marcelo Lima, ImThera’s Founder, President and Chief Executive Officer. “This is the culmination of several years of hard work by our team of dedicated professionals. We welcome the opportunity to become part of the LivaNova family and look forward to the continued evolution of our product.”

Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

“Targeted therapy success stories in paediatric oncology are uncommon, and larotrectinib has invigorated the pediatric oncology community,” said Brian Turpin, D.O., the presenting SCOUT principal investigator and assistant professor in the division of oncology at Cincinnati Children’s Hospital. “Larotrectinib’s near universal response rate and compelling durability of response in pediatric patients with TRK fusion cancers is likely to be practice changing. Furthermore, the first-ever TRK inhibitor response in a TRK fusion glioblastoma patient highlights the potential for larotrectinib in TRK fusion central nervous system tumors.”

“These data confirm that larotrectinib – a highly differentiated compound – can deliver consistent and durable responses in TRK fusion patients across age groups and multiple tumor types,” said Robert LaCaze, executive vice president and head of the oncology strategic business unit at Bayer. We hope these data continue to support future milestones that will ultimately improve outcomes and change the course of cancer care for TRK fusion patients and their families.”

As of the July 17, 2017 data cut-off date, 24 paediatric patients were enrolled, including 17 patients with TRK fusion cancers. TRK fusion patients carried primary diagnoses of infantile fibrosarcoma, thyroid cancer, and various soft tissue sarcomas. The Overall Response Rate (ORR = PR + CR, Partial Response + Complete Response) in the TRK fusion patients was 93 per cent as assessed by both the investigators and an independent review committee. Among the 17 patients with TRK fusion cancers, 94% either remain on drug or received surgery with curative intent; four patients have been followed greater than one year and 12 have been followed greater than six months. The larotrectinib adverse event profile is consistent with data previously presented publicly. The most common treatment-related adverse events at the dose given in the Phase II, included increased liver function tests, neutropenia and nausea, all largely grade 1.

Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients across a wide range of cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

In an analysis of 55 adult and pediatric patients with TRK fusion cancers that were evaluable according to RECIST, larotrectinib demonstrated a 75 percent independently-reviewed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. Larotrectinib received Orphan Drug Designation (ODD) in the US for the treatment of solid tumors harboring NTRK-fusion proteins and in Europe for soft tissue sarcoma. Additionally, the FDA granted breakthrough therapy designation to larotrectinib for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.

In November 2017, Bayer and Loxo Oncology entered into an exclusive global collaboration on the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology will jointly develop the two products, larotrectinib and LOXO-195, and Bayer will lead ex-U.S. regulatory activities as well as worldwide commercial activities. In the US Bayer and Loxo Oncology will co-promote the products. Loxo Oncology will remain responsible for the filing in the US.

TRK fusions are chromosomal abnormalities that occur when one of the NTRK genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another, unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in uncontrolled TRK signaling that can lead to cancer. TRK fusions occur rarely but broadly in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. TRK fusions can be identified through various diagnostic tests, including targeted next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH).

Bayer and Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Connecticut, US, announced updated clinical data from the larotrectinib (LOXO-101) paediatric phase I SCOUT trial (NCT02637687). These data were presented at the American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer Research in Atlanta, US.

Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

“Targeted therapy success stories in paediatric oncology are uncommon, and larotrectinib has invigorated the pediatric oncology community,” said Brian Turpin, D.O., the presenting SCOUT principal investigator and assistant professor in the division of oncology at Cincinnati Children’s Hospital. “Larotrectinib’s near universal response rate and compelling durability of response in pediatric patients with TRK fusion cancers is likely to be practice changing. Furthermore, the first-ever TRK inhibitor response in a TRK fusion glioblastoma patient highlights the potential for larotrectinib in TRK fusion central nervous system tumors.”

“These data confirm that larotrectinib – a highly differentiated compound – can deliver consistent and durable responses in TRK fusion patients across age groups and multiple tumor types,” said Robert LaCaze, executive vice president and head of the oncology strategic business unit at Bayer. We hope these data continue to support future milestones that will ultimately improve outcomes and change the course of cancer care for TRK fusion patients and their families.”

As of the July 17, 2017 data cut-off date, 24 paediatric patients were enrolled, including 17 patients with TRK fusion cancers. TRK fusion patients carried primary diagnoses of infantile fibrosarcoma, thyroid cancer, and various soft tissue sarcomas. The Overall Response Rate (ORR = PR + CR, Partial)

“This acquisition, coming within two months of the acquisition of the Hyderabad, India-based pharma company YM Drugs and Chemicals by PMC Group International, puts the latter in a solid position to serve all the regulated pharma markets around the world with cost-effective offerings of proprietary drugs, drug intermediates, and custom drug research & manufacturing services for a wide range of disease categories,” said Dr. Raj Chakrabarti, Executive Vice President of PMC Group International.

About PMC
PMC Group is a growth oriented, diversified, global chemicals and plastics company dedicated to innovative solutions to everyday needs in a broad range of end markets including plastics, consumer products, electronics, paint, packaging, personal care, food, automotive and pharmaceuticals. The Company was built on a sustainable model of growth through innovation while promoting social good. PMC operates from a global manufacturing, innovation and marketing platform with facilities in the Americas, Europe and Asia. More information about PMC and its activities around the world can be found at www.pmc-group.com

Contacts
PMC Group International Inc.
Patti Griggs,
856-533-1870

The approval of OZEMPIC® is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, OZEMPIC® showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.1 As a secondary endpoint in the trials, treatment with OZEMPIC® resulted in reductions in body weight. The most common adverse reactions reported in ≥5% of patients treated with OZEMPIC® are: nausea, vomiting, diarrhea, abdominal pain and constipation.1

“The OZEMPIC® approval builds on Novo Nordisk’s commitment to offering healthcare professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “We are grateful to the many adults with type 2 diabetes who participated in the studies, as well as the clinical trial investigators. Thanks to their collective contributions, Novo Nordisk is able to bring once-weekly OZEMPIC® to the type 2 diabetes community.”

OZEMPIC® is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the OZEMPIC® pre-filled pen.1

The global Phase 3a clinical trial program for OZEMPIC® comprised eight clinical trials involving more than 8,000 adults with type 2 diabetes, including a two-year cardiovascular outcomes trial that evaluated safety in adults with type 2 diabetes at high risk of cardiovascular events.1

“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, and past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers healthcare professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”

Novo Nordisk expects to launch OZEMPIC® in the U.S. in Q1 2018, with a goal of ensuring broad insurance coverage and patient access to the product. OZEMPIC® will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce co-pays for eligible commercially-insured patients. Additionally, as part of the access strategy, Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions.

Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

What is OZEMPIC®?
OZEMPIC® (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

OZEMPIC® is not recommended as the first choice of medicine for treating diabetes.
It is not known if OZEMPIC® can be used in people who have had pancreatitis.
OZEMPIC® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if OZEMPIC® is safe and effective for use in children under 18 years of age.

Important Safety Information
Do not share your OZEMPIC® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What is the most important information I should know about OZEMPIC®?
OZEMPIC® may cause serious side effects, including:
Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, OZEMPIC® and medicines that work like OZEMPIC® caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use OZEMPIC® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use OZEMPIC® if:
you or any of your family have ever had MTC or if you have MEN 2.
you are allergic to semaglutide or any of the ingredients in OZEMPIC®.

Before using OZEMPIC®, tell your health care provider if you have any other medical conditions, including if you:

have or have had problems with your pancreas or kidneys.
have a history of diabetic retinopathy.
are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if OZEMPIC® will harm your unborn baby or passes into your breast milk. You should stop using OZEMPIC® 2 months before you plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use OZEMPIC®?
OZEMPIC® is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject OZEMPIC® into a muscle (intramuscularly) or vein (intravenously).
Do not mix insulin and OZEMPIC® together in the same injection.
Change (rotate) your injection site with each injection. Do not use the same site for each injection.
Talk to your healthcare provider about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.

What are the possible side effects of OZEMPIC®?
OZEMPIC® may cause serious side effects, including:
inflammation of your pancreas (pancreatitis). Stop using OZEMPIC® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

changes in vision. Tell your healthcare provider if you have changes in vision during treatment with OZEMPIC®.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use OZEMPIC® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.

kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
serious allergic reactions. Stop using OZEMPIC® and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.

The most common side effects of OZEMPIC® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.

About OZEMPIC® (semaglutide)
OZEMPIC® (semaglutide) injection 0.5 mg or 1 mg was approved by the FDA in December 2017, and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 OZEMPIC® is an analog of native human glucagon-like peptide-1 (GLP-1) and, through its high albumin binding resulting in a long half-life of approximately one week, OZEMPIC® is suitable for once-weekly dosing.1 OZEMPIC®, administered once-weekly, stimulates insulin and lowers glucagon secretion in a glucose-dependent manner.1

About Type 2 Diabetes
Type 2 diabetes is a serious condition that affects more than 28 million people in the United States (9.4 percent of the population).2 The diagnosis is most common in adults and occurs when the body no longer produces enough of the blood sugar-regulating hormone, insulin, or is no longer able to use the insulin the body produces properly. Additionally, people with type 2 diabetes are two to four times more likely to have cardiovascular disease than those without diabetes.3 Type 2 diabetes is a life-long condition once diagnosed, but can be managed through a combination of lifestyle modifications like eating healthy, physical activity and oral and/or injectable medications as prescribed by a physician.4

About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States.