Aptar Pharma and Propeller Health Partner to Develop Digital Medicine Platform Across Therapeutic Areas

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Aptar Pharma, a leading provider of innovative drug delivery systems, and Propeller Health, a leading digital therapeutics company, announced plans to collaborate on the launch of a comprehensive platform to develop digital medicines for multiple therapeutic areas and diseases.

The digital medicine platform, spanning inhaled, injectable, nasal and dermal medicine delivery forms, will combine software and experiences with connected drug delivery devices to more effectively treat diseases and improve clinical outcomes for patients.

Aptar Pharma and Propeller will work together with pharmaceutical and healthcare partners to accelerate the development, manufacturing and commercialization of digital medicines for leading marketed and pipeline brands. Digital medicines can help to personalize treatments, monitor patients in real-time, detect day-to-day changes in disease condition and increase patient adherence. Key objectives are to improve patient outcomes and help contribute to lower healthcare costs.

The collaboration brings together Aptar Pharma’s decades of expertise in device development, packaging innovation and quality manufacturing with Propeller’s platform and leading experience in digital therapeutics design and implementation.

The two companies initially partnered in 2016 to develop the world’s first fully-integrated
connected metered dose inhaler (cMDI).

Salim Haffar, President of Aptar Pharma, commented, “Aptar Pharma has been providingbinnovative drug delivery systems for nearly 50 years, helping billions of patients around the world. Today, we are excited to broaden our offerings as we continue this journey towards improved patient care and clinical outcomes by growing our partnership with Propeller Health, the leader in their field of digital therapeutics.”

“Propeller draws on nearly a decade of experience pioneering digital respiratory medicines and putting them to work in healthcare organizations around the world,” said David Van Sickle, cofounder and CEO of Propeller. “We’re excited to expand our relationship with Aptar and apply our expertise to new diseases. Our end-to-end infrastructure enables fast, flexible and secure development and commercialization of digital medicines.”

Propeller and Aptar Pharma will co-market the platform, with Propeller managing the digital services and Aptar Pharma managing the device development, manufacturing and supply chain.

In addition to expanding the partnership, Aptar Pharma has made a strategic equity investment of $10 million in Propeller Health during their latest funding round.

Tekni-Films introduces SBC 240 performance-oriented super-barrier coated thermoformable film for pharma blister packs

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A new super barrier-coated (SBC) thermoformable film for pharmaceutical blister packs is being launched by Tekni-Films, a Tekni-Plex business.

Tekni-Films SBC 240 is being positioned as a performance and improved-cost alternative for 4- and 6-mil PCTFE and cold formed foil in thermoformable blister applications. The triplex structure is ideal for applications such as pharmaceuticals, nutraceuticals, probiotics and other related products.

In addition to its desirable clear properties, SBC 240 doesn’t require stiffening ribs, which can be used to improve the ability of PCTFE to lie flat, nor the oversized blister wells created by cold forming. This means that pharmaceutical companies can use a smaller blister card to contain the same number of tablets or capsules, or increase the count on a same-sized card. The end result is material cost savings all the way through the packaging process, including cartons and cases, as well as improved production efficiencies.

SBC 240 offers ultra-high moisture and oxygen barrier properties to protect products susceptible to degradation. It also has a wider processing window than PCTFE—as much as 20 degrees Fahrenheit—which helps meet specific production speed preferences.

SBC 240 is created by applying a “next generation” high-barrier variant of polyvinylidene chloride (PVdC) coating to a film structure made from layers of polyethylene. Multiple layers can be applied to create different coating thickness weights.  As coating weight increases, so do the barrier attributes.

This latest grade is just one more example of Tekni-Film’s robust SBC thermoformable film capabilities. The company also offers 120-, 150-, 180- and 210-gram coating thicknesses, as well as other custom solutions.

Almac Group Receives Recognition at The Irish Laboratory Awards with Laboratory Supplier of the Year Award

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Almac Group, the global contract development and manufacturing organisation has announced it has won the Laboratory Supplier of the Year Award during this year’s Irish Laboratory Awards, presented by Business River. This award recognises BioClin Research Laboratories’, a Member of the Almac Group, commitment to delivering the highest quality analytical services to its customers and clients.

The Irish Laboratory Awards spotlight excellence and achievement in the laboratory environment, covering management, innovation, collaboration, personnel development and laboratory equipment supply. The winners were revealed at a ceremony on 19th April at Ballsbridge Hotel in Dublin. An independent panel of recognised and expert judges, representing Ireland’s scientific sector, determined the 2018 winners.

Judges awarded this based on the excellence demonstrated as a service provider, delivering “best in class” solutions to the pharmaceutical industry. Five additional companies were finalists for each category, as part of over a hundred nominees competing for twenty-two individual category awards.

Stephen Barr, President & Managing Director, Almac Sciences, commented: “I’m proud of our employees who work daily to provide unparalleled service to our customers and clients throughout the world. This award serves to highlight our team’s dedication and commitment to quality, and also showcases our diverse ability to deliver pharmaceutical, bio science and laboratory supplier services to the industry.”

Launched in 2013, The Irish Laboratory Awards has established itself as the premier event in Ireland for benchmarking those that demonstrate excellence, best practice and innovation in Ireland’s laboratories. These awards are an opportunity to showcase a company’s extensive knowledge, enthusiasm and expertise in the industry.

CPhI & P-MEC China 2018 | Your pharmaceutical trade & networking platform

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CPhI and P-MEC China – at SNIEC, Shanghai from June 20 to June 22, is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new partners of getting the latest market insights, this is your one-stop-shop platform for reaching out to the entire Chinese pharmaceutical industry.
This year over 45,000 pharma professionals will attend the 18th edition of Asia’s Premier Pharmaceutical event. 3,000+ exhibitors from over 150 countries will be showcasing their latest products, developments and innovations. The ideal place to source, learn, and match with the right parties!

Alongside the event, the 2nd edition of China Pharma Week will be held from 19 – 23 June. During this week you can enjoy numerous opportunities to connect, network, and interact with both Chinese and international attendees, elevating your event experience to a higher level.
Did you know? This year CPhI will host the 8th edition of the Buyers Sourcing Service. This matchmaking service connects international buyers with local suppliers. Establish relationships with local suppliers, and provide them with a better understanding of the international market. Apply now and submit a request; CPhI will match you with the right party for a face-to-face meeting onsite.
Attend CPhI & P-MEC China to do cost effective business in 1 location!

The event is just under 2 months away, and now is the ideal time to register to attend. Don’t get caught out by visa applications and travel arrangements: register now !


CPHI

Endo to Acquire Somerset Therapeutics and Business of Affiliate Wintac Limited

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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.

Immuno-oncology researchers seek to build smart drug combos

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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.”