Abbott To Acquire Cephea Valve Technologies, Inc.

Abbott has announced that it has exercised its option to purchase Cephea Valve Technologies, Inc., a privately held medical device company developing a less-invasive heart valve replacement technology for people with mitral valve disease.

Cephea’s technology is being developed to provide an option for people whose diseased mitral valves need to be replaced. The artificial valve is designed to be delivered through a vein in the leg, forgoing the need for open-heart surgery. Replacement of the diseased mitral valve restores normal blood flow through the heart.

“The acquisition of Cephea builds on Abbott’s strong position in structural heart therapies and is consistent with our strategy to develop comprehensive treatments for people with mitral valve disease,” said Michael Dale, vice president of Abbott’s structural heart business. “Cephea’s novel approach to replace the mitral valve adds to our other catheter-based technologies and is being developed to provide an additional option for patients who suffer from this difficult-to-treat disease.”

Mitral valve disease is the most common heart valve problem, affecting more than 4 million people in the U.S. alone. It comes in two forms: regurgitation, a condition where blood leaks backward into the heart, or, less commonly, stenosis, a narrowing of the valve. The condition puts people at risk for health complications such as irregular heartbeats, high blood pressure, blood clots or heart failure.

Abbott has led the development of minimally invasive solutions for mitral valve disease since 2009 when it acquired Evalve, Inc., with its MitraClip technology. MitraClip, the first-of-its-kind product to repair leaky heart valves, launched in Europe in 2008 and the U.S. in 2013 and remains the only mitral valve repair device of its kind on the market.

In 2015, Abbott expanded its portfolio by acquiring Tendyne Holdings, Inc. and securing an option to acquire Cephea Valve Technologies, companies that are both developing minimally invasive devices intended to fully replace the mitral valve in the heart. Minimally invasive mitral valve procedures are expected to become a multi-billion-dollar market in the coming years. In addition, Abbott acquired St. Jude Medical in 2017, adding to the company’s expertise and offerings to treat structural heart disease.

Sun Pharma acquires Pola Pharma in Japan, to help in building global dermatology business

Sun Pharmaceutical Industries Ltd. Has announced that Sun Pharma has entered into a definitive agreement to acquire Pola Pharma Inc. (“Pola Pharma”), a Japanese pharmaceutical company engaged in research and development, manufacture, sale and distribution of branded and generic products in Japan. The portfolio of Pola Pharma primarily comprises dermatology products.

Pola Pharma, part of POLA ORBIS Group, has two manufacturing facilities in Saitama with capabilities to manufacture topical products and injectables. It also has R&D capabilities to develop new technologies and formulations.

Kirti Ganorkar, Executive Vice President, Sun Pharma said, “This acquisition is in line with our strategy to strengthen our global dermatology presence. Pola Pharma is a leading dermatology company and it will help us to launch our speciality and generic dermatology products in the Japanese market in future.

We also get access to local manufacturing capability enabling us to serve the Japanese pharmaceutical market more effectively.” Junichi Nakamichi, Country Head of Japan, Sun Pharma said, “By combining Sun Pharma’s global strengths with Pola Pharma’s local expertise, we will have a great opportunity to further strengthen our presence in Japan, especially in the area of dermatology.”

Roche subsidiary Genentech acquires Jecure Therapeutics

Jecure Therapeutics Inc., a biotechnology company with novel drug discovery programs targeting serious inflammatory diseases, today announced a definitive agreement by which it will be acquired by Genentech, a member of the Roche Group. With this acquisition, Genentech will obtain full rights to Jecure’s entire preclinical portfolio of NLRP3 inhibitors.

Genentech has an extensive history of translating pioneering science into transformative medicines,” said Jeffrey A. Stafford, Ph.D., president and CEO of Jecure. “The acquisition of Jecure provides a unique opportunity to bring novel NLRP3 inhibitors to patients.

“We’ve had a long-standing interest in targeting inflammatory pathways that may play a role in a number of serious diseases,” said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. “We’re excited to combine Jecure’s portfolio with our discovery and development capabilities, as well as our expertise in NLRP3 biology, to potentially help people with inflammatory diseases.”

Jecure began operations in 2015 with a seed financing from founding investor Versant Ventures. The company raised $20 million in a Series A round from Versant in 2017 to continue to develop and advance its portfolio of NLRP3 inhibitors.

Amgen Invests £50 Million ($66 Million) In Oxford Nanopore Technologies

Amgen and Oxford Nanopore had announced Amgen’s equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology.

Oxford Nanopore has developed and brought to market a proprietary sequencing technology that uses many nanopores (nano-scale holes made by proteins contained within a synthetic membrane) in combination with electronics to perform direct, real-time sequencing of DNA and RNA. The technology ranges in scale from pocket-sized to very high throughput benchtop devices and can sequence very long fragments of DNA or RNA, which has a number of benefits in genomic analysis.

The investment in Oxford Nanopore aligns with Amgen’s strategic focus on using human genetics to deliver new medicines to patients. Amgen subsidiary deCODE Genetics, a world leader in human genetics, uses Oxford Nanopore’s sequencing technologies to conduct genome research, including the identification and validation of new targets.

“The study of human genetics continues to uncover insights into the diseases we face as a society,” said Kári Stefánsson, founder of deCODE Genetics. “Oxford Nanopore’s long-read sequencing capability creates a window into parts of the genome that have been out of reach, as well as giving us a much better handle on structural variants that confer risk of a wide variety of diseases. We have used Oxford Nanopore technology to sequence several hundred human genomes and continue to see the promise of this emerging technology.”

“As a biotechnology pioneer, Amgen has demonstrated what can be achieved for society through innovation and a deep understanding of genetics,” said Gordon Sanghera, chief executive officer of Oxford Nanopore. “We are delighted to welcome them as a shareholder.”

Nanopore technology is uniquely scalable. MinIONTM, the only pocket-sized sequencer, can be used to sequence in any location. In addition, Oxford Nanopore has developed benchtop, on-demand, high-throughput devices such as PromethIONTM designed for very large projects or large numbers of samples.

AstraZeneca strengthens and expands oncology development and commercialisation collaboration with Innate Pharma

AstraZeneca, and its global biologics research and development arm MedImmune, announced a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly. The extended collaboration will enrich AstraZeneca’s immuno-oncology (IO) portfolio with pre-clinical and clinical potential new medicines.
AstraZeneca will obtain full oncology rights to the first-in-class humanised anti-NKG2A antibody, monalizumab, expanding its partnership with Innate from the initial collaboration announced in 2015. AstraZeneca also gains option rights to IPH5201, an antibody targeting CD39, as well as four preclinical molecules from Innate’s pipeline. Innate is licensing the US and EU commercial rights to recently FDA-approved Lumoxiti (moxetumomab pasudotox) for hairy cell leukaemia (HCL).

Pascal Soriot, Chief Executive Officer, said: “Our expanded collaboration with Innate Pharma enables us to further strengthen our leadership in immuno-oncology, and to explore the potential of next-generation immuno-oncology pathways, together with the world-class scientific team of Innate. Today’s agreement also secures the long-term commercialisation of the recently FDA approved rare disease medicine, Lumoxiti, through dedicated focus and investment by Innate Pharma.”

Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, said: “Today is a defining moment for Innate Pharma as we transition to become a fully-integrated oncology-focused biotech. Lumoxiti is a major therapeutic innovation for patients who suffer from relapsed/refractory hairy cell leukaemia, and we are proud to be in a position to address a significant unmet medical need. Our commercial team will be focused on rare cancers and generate more value as our own haemato-oncology proprietary pipeline develops.”

Novo Nordisk announces plans to transform its approach to Research & Development

Novo Nordisk has announced plans to restructure its Research & Development (R&D) organisation to accelerate the expansion and diversification of its pipeline across serious chronic diseases. To enable increased investment in transformational biological and technological innovation within both core and new therapy areas, approximately 400 employees will be laid off from R&D roles in Denmark and China.

To support its strategic ambitions, Novo Nordisk will establish four Transformational Research Units in 2018 to pursue novel treatment modalities and platform technologies. The biotech-like units, based in Denmark, the US and the UK, will operate as satellites of Novo Nordisk’s central R&D function and will drive innovation in priority fields such as translational cardio-metabolic research and stem cell research.

Furthermore, to drive a faster and more efficient path towards lead molecule selection and development, Novo Nordisk will significantly increase its investment in automation and digital capabilities including machine learning and artificial intelligence (AI). The integration of laboratory infrastructure and IT systems will also be prioritised to increase the efficiency of the R&D organisation.

“Delivering on our ambition of achieving even higher levels of innovation across a broader and more diverse range of chronic diseases requires that we have the optimal future skill base and allocate resources to our priority areas,” said Mads Krogsgaard Thomsen, chief science officer, Novo Nordisk. “Unfortunately, this implies that a number of valued colleagues will lose their jobs in order to ensure that we have sufficient new research capabilities needed to support our long-term growth ambitions.”

The restructuring and re-allocation of resources supports Novo Nordisk’s ambition to transform the way it works within R&D in order to identify and develop truly innovative drug candidates. This will be facilitated by the identification and pursuit of new therapeutic approaches based on external collaborations – a priority that Novo Nordisk will accelerate via the establishment of a new Business Development unit in Cambridge, MA, US.

Allergan to Acquire Bonti Adding New Neurotoxin Programs to Medical Aesthetics Pipeline

Allergan has announced it has agreed to acquire Bonti, Inc., a privately held clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin programs for aesthetic and therapeutic applications.

Following completion of the acquisition, Allergan will obtain global rights to Bonti’s pipeline consisting of two botulinum neurotoxin serotype E (BoNT/E) programs currently in Phase 2 development, EB-001A (aesthetic) and EB-001T (therapeutic). The active ingredient in both programs, EB-001, is a novel botulinum neurotoxin serotype E (BoNT/E) with a unique clinical profile, characterized by a rapid onset of action within 24 hours and a 2 to 4-week duration of effect. Bonti recently announced topline results of the first clinical study of EB-001 in glabellar frown lines. The study confirmed both the safety and efficacy of the differentiated profile.

In the U.S. there are currently approximately 65 million consumers who are considering facial injectable treatments, including some who may be interested in being treated with a faster acting shorter-duration product.

“The acquisition of Bonti is a strategic investment for the future of our Medical Aesthetics business and has the potential to enhance our best-in-class Medical Aesthetics pipeline,” said Brent Saunders, Chairman and CEO of Allergan. “With the Medical Aesthetics market vastly expanding, a fast-acting neurotoxin with a 2 to 4-week duration will be an attractive option for consumers, particularly those who are considering a Medical Aesthetics treatment for the first time.”

“We’re excited about the development and commercial prospects for our novel programs within Allergan’s leading Medical Aesthetics portfolio,” commented Fauad Hasan, CEO and co-founder at Bonti. “The promise of benefitting more consumers worldwide with our novel neurotoxin programs plus Allergan’s stature and resources in this market will help realize our team’s and investors’ aims. We could not envision a more compelling acquirer or better strategic fit.”

Allergan will acquire Bonti for an upfront payment of $195M and additional potential commercial milestone payments, subject to certain adjustments and other customary closing conditions.

Efficient Track & Trace solutions for Acino Pharma

Pioneer in Track & Trace

It must be possible to precisely identify and trace prescription-only medicines worldwide along the entire value and supply chain. Machine-readable codes on the packaging ensure unique product assignment for this purpose and form the basis for counterfeit-proof drugs in pharmacies. Depending on the country, the labelling requirement for Track & Trace also includes higher-level logistics units or trade levels. Track & Trace and the technology needed for it found its way to Acino several years ago. The key area apart from serialisation was having the necessary flexibility in the line – the aim being to have as much room for development as possible for the line staff. Having a presence in global markets with its own products and filling the orders of international customers are basic requirements. So it was recently necessary to find solutions that significantly simplified handling for the logistics units where throughput was higher and at the same time made it possible for the operating staff to run the lines in 24/5 operation with a manageable amount of training and a minimal amount of servicing.

TQS offers unlimited drug safety thanks to serialisation and aggregation

Having installed the WIPOTEC-OCS solutions, Acino can offer its customers both serialisation and also aggregation at several levels of logistics units. This simplifies the logistics processes because importers can capture the content of deliveries much faster. Along the supply chains of serialised drugs, aggregation makes it easier for wholesalers, repackagers or pharmacy chains to find out the contents of a box or pallet from the barcode. Aggregation also simplifies goods receipt, repackaging and shipping processes, not to mention considerably simplifying reporting and verification of products along the supply chain. Using aggregation, there is no need to physically open and check what is inside the pre-packaged shipping units. All the necessary data can be obtained in seconds by scanning the barcode, resulting in significant savings of time and resources. Bartlomiej Sedek is convinced that, “If aggregation becomes mandatory in countries in the future, we would not need to change any of our existing lines because of it.”

Semi-automatic aggregation is among the standard solutions which Acino offers its customers. Two more lines will shortly be added in Aesch. One of them will provide fully automated aggregation which will be implemented by pester pac automation GmbH with WIPOTEC-OCS. “Unlike others, WIPOTEC-OCS has come up with lots of new ideas in machine construction and on top of that also has the better team,” Sedek says, summing up the reasons for his decision.

ConfigureFast for the easiest handling

The overall aim in Aesch was to give the operating staff on the line more responsibility, establishing a maximum operating level. ConfigureFast, the operating concept of the TQS machines, meets these requirements very well: it is used to control the transport system, coding unit, camera, checkweigher and labeller from a single software package. For the operator, this means convenient set-up and short changeover times on product change during which there is no longer any need for the usual lengthy changes to several different user interfaces. This consistency covers all levels of aggregation. ConfigureFast will enable the line staff to convert the production lines much more easily and quickly – saving Acino a lot of time. Acino’s target is 800 layouts, combined with the claim of implementing the best packaging standards in the northwest of Switzerland. And this is the sign of special quality, easy to read and easy to see: Swiss made.

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Immuno-oncology researchers seek to build smart drug combos

Novartis has launched a comprehensive research program to help find the right combinations of therapies for the right patients

Immunotherapies for cancer have been life-changing for patients who respond to them. Yet, overall, only about 20% of patients respond to these drugs. To expand the reach of these medicines, approximately 1 100 clinical trials have been launched by companies and research institutions over the past few years to test them in a range of combinations.

This is a huge number of clinical trials – each taking up the time and resources of physicians, hospitals, scientists and patients. Companies have taken a shotgun approach, simultaneously launching trials of a wide range of combination therapies, says Glenn Dranoff, Global Head of Immuno-oncology at the Novartis Institutes for BioMedical Research (NIBR). And it’s not sustainable. There are too many drugs and too many possible combinations, and perhaps most importantly, there isn’t enough knowledge about how immunotherapies work in cancer.

So researchers at Novartis have launched a comprehensive research program designed to systematically inform the selection of smart combination therapies. Through the program, the team has generated preliminary evidence that two experimental immunotherapies, LAG525 and spartalizumab (also called PDR001), show early clinical activity in some cancers, though more clinical investigation is required.

“Combinations will be important going forward,” says Catherine Sabatos-Peyton, an immunologist at NIBR. “How do we smartly combine our drugs for patients? Answering this question is the goal of our program.”

The research enlists the help of every patient who enrolls in an immunotherapy clinical trial run by NIBR – an effort that might engage hundreds of patients. Researchers examine tissue from these patients and look for signals that will help them identify differences between those who respond to a given therapy and those who don’t. The scientists are taking a wide-eyed approach in an effort to ensure that no signal will be missed. By going beyond the current assumptions about how cancer therapies work, Novartis aims to move toward a scientifically guided rationale for choosing smart combinations of cancer therapies.

“What is important now is discovery,” says Dranoff. “We’re taking an unbiased view of what’s happening in our patients and bringing the best discovery tools available to understand why some people respond to immunotherapies and some do not.”

Study of combos

Novartis launched a clinical trial of the compounds LAG525 and spartalizumab in patients with solid tumors a few years ago. The thinking was that these compounds might work together because they both lift brakes on immune cells called T-cells. Preclinical experiments in animal models of cancer suggested that these two therapies could potentially lead to greater anti-tumor effects.

T-cells normally attack foreign or diseased cells. But sometimes receptors appear on the surface of the T-cells and act as brakes to keep them from going haywire. “These brakes dampen the immune system before it damages healthy tissue,” says Sabatos-Peyton.

Tumors have learned to protect themselves from the immune system’s cancer-fighting power by sending out signals that increase this built-in braking action.

So-called checkpoint inhibitors like LAG525 and spartalizumab aim to remove the brakes. For instance, spartalizumab targets PD-1, the most well-known checkpoint receptor. The majority of the approved immunotherapies for cancer so far target PD-1 or its binding partner PD-L1. LAG525 targets LAG-3, which most often appears on the surface of a T-cell alongside PD-1, almost like an emergency brake.

Researchers suspect that the presence of LAG-3 could undermine the effects of anti-PD-1 therapy, potentially explaining cases where patients don’t respond to PD-1 inhibitors or relapse after taking them. “This is why combination therapy has the potential to be potent,” says Sabatos-Peyton. “The compounds might release the brakes on two sides.”

Early clinical data from this small trial showed responses in some patients with triple-negative breast cancer. But Sabatos-Peyton’s team wanted to go beyond their original thinking and learn more. The human immune system is incredibly complex, and they suspected that LAG-3’s role might not be limited to braking alongside PD-1.

So they connected their trial with the larger research program at NIBR to understand more about how these immunotherapies work in patients. Deep study of patient samples from this trial suggests that the two agents together might potentially stimulate an immune response in certain tumors in multiple ways. Tissue from the patients who responded to the combination therapy showed enhanced immune activation – specifically an increase in specialized forms of T-cells after therapy. These preliminary findings, which are helping the team identify patients who might benefit from the combination, were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2018, in Chicago, Illinois, in the US.

We’re taking an unbiased view of what’s happening in our patients and bringing the best discovery tools available to understand why some people respond to immunotherapies and some do not.

Glenn Dranoff, NIBR Global Head of Immuno-oncology
The team is continuing this research effort to better understand how the combination influences the immune system. “This research is critical for our understanding of the mechanisms of the agents we’re already investigating and also for discovery of what we need to be doing that we aren’t,” says Sabatos-Peyton.

Systematic study

This comprehensive research program encompasses studies of all the therapies Novartis is developing for cancer, including immunotherapies and therapies that target molecular pathways in tumors, called targeted therapies. “What we learn will help us to rank and prioritize the combinations and help us design the next generation of medicines,” says Peter Hammerman, Global Head of Oncology Translational Research at NIBR.

The researchers take in clinical samples from patients enrolled in NIBR trials. They study human tissue in addition to using animal models because the mouse immune system does not always work the same as the human immune system. The tissue, taken before and after treatment, includes not just tumor cells but also surrounding cells so that immune cells and signals can be studied.

Hammerman’s team sends the samples to NIBR’s next-generation diagnostics team for analysis. The diagnostics include RNA sequencing (RNAseq), which reveals which genes have been turned up or down by the cancer or in response to a drug.

RNAseq is employed across the industry, typically using tools that focus on analyzing a limited set of genes. But NIBR researchers have developed technology that enables researchers to examine gene expression across the entire genome for large numbers of samples. Using this approach, no change in gene expression levels should be missed. Unbiased RNAseq enabled Sabatos-Peyton’s team to make their early observations of enhanced immune activity with combination immunotherapy using LAG525 and spartalizumab.

The scale of the challenge of selecting smart combinations might best be appreciated by considering that Novartis currently has over a dozen immunotherapies in its pipeline. Those experimental medicines are supported by about a hundred immunologists who are working on understanding them and discovering more. Hammerman’s team is also learning that targeted therapies might also influence immune cell behaviors, so they could be viable partners for immunotherapies.

“There’s a long way to go,” says Hammerman. “If we’re successful, our work will lead to combinations of compounds that add to the efficacy of immunotherapy broadly across patients. And we will have used a scientific approach to get there.”