Sanofi and Lonza Enter into a Strategic Partnership to Establish a Large-Scale Biologics Production Facility

Sano

Sanofi and Lonza have announced that they have entered into a strategic partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The strategic partnership in the form of a joint venture combines the strong biologics development pipeline of Sanofi with the expertise of Lonza to design, construct, start-up and operate a state-of-the-art large-scale mammalian cell culture facility. The initial investment will be around CHF 290 million (€ 270 million), to be split equally between each company.

The initial phase of the facility will commence construction in 2017, pending necessary regulatory approvals, and is expected to be fully operational by 2020. Lonza has previously built and licensed three similar facilities in the U.S. and Singapore.

“In addition to the investments we are making in building our own internal production capabilities, the joint venture between Sanofi and Lonza emphasizes our commitment to provide access for patients to high quality therapeutic monoclonal antibodies,” said Philippe Luscan, Executive Vice President, Global Industrial Affairs, Sanofi. “Approximately sixty percent of our pipeline is made up of biologics, including monoclonal antibodies, dedicated to key disease areas such as cardiovascular, immunology and inflammation, neurology and oncology. Lonza is a highly experienced partner in this field and the capabilities which this joint venture will create are critical to meeting our patients’ needs for these important therapies.”

“By entering into this long-term strategic relationship we have developed a tailor-made business model that best fits both Sanofi’s and Lonza’s requirements. It provides to Sanofi dedicated capacity, which allows for a clear win-win situation for all participants,” said Marc Funk, COO Pharma & Biotech, Lonza. “As part of our strategic roadmap, we will develop further innovative business models based on the requirements of our customers. We intend to address these long-term market needs by establishing a state-of-the-art strategic biologics manufacturing platform. The strategic partnership with Sanofi represents the first module in this undertaking; and we are convinced that with this future-oriented approach, we can serve additional customers.”

The partnership provides both Sanofi and Lonza with substantial flexibility in an innovative setup:

  • Each party will share the available capacity in line with their equity shareholding in the joint venture
  • Sanofi will have additional access to bio-manufacturing capacity to support increasing demands for their portfolio of biologic therapeutic products, should they require it
  • Lonza will be free to market their share of capacity, if not required by Sanofi, and will also market unused Sanofi capacity, where available.
  • Lonza will construct the facility and will support the joint venture in its operation of the facility.

The strategic partnership enables Sanofi to react quickly to fluctuations in demand in a short timeframe, reinforcing their capability to launch high-quality, next generation biologic medicines and ensure consistent access for patients. It also provides Lonza with needed capacities to respond to growing manufacturing demands for large-scale mammalian cell culture based therapeutic proteins, therefore allowing Lonza to better serve its customers. By adding flexibility in this way, this model will help to optimize biologics production capacity across the whole industry.

Spider web of cancer proteins reveals new drug possibilities

Senior author Haian Fu, PhD

Scientists at Winship Cancer Institute of Emory University have mapped a vast spider web of interactions between proteins in lung cancer cells, as part of an effort to reach what was considered “undruggable.”

This approach revealed new ways to target cells carrying mutations in cancer-causing genes. As an example, researchers showed sensitivity to an FDA-approved drug, palbociclib, for a gene that is commonly mutated in lung cancer cells, which is now being tested in a clinical study.

 

Senior author Haian Fu, PhD

Many genes that drive the growth of cancer cells don’t have any drugs available against them. For “tumor suppressor” genes, researchers are often not sure how to go after them. When the tumor suppressors are gone, cells often become more deranged, but there’s no bullseye left to target. Exploiting the cancer cells’ derangement remains a daunting challenge, says senior author Haian Fu, PhD.

“Our approach is to place tumor suppressors in the context of a network of cancer-associated proteins and link tumor suppressors to drugs through a known drug target protein” Fu says. “In this way, changes in a tumor suppressor may be linked with the response of the target to the connected drug.”

The study is part of a push by the National Cancer Institute’s Cancer Target Discovery and Development (CTD2) network to translate genomics data into therapeutic strategies, he says. Emory is a member of the NCI CTD2 network.

Fu holds the Winship Partner in Research endowed chair and is leader of Winship’s Discovery and Developmental Therapeutics Program, director of the Emory Chemical Biology Discovery Center and professor of pharmacology and hematology and medical oncology. Co-corresponding author Fadlo Khuri, MD, maintains his professor appointment at Winship Cancer Institute and is now president of the American University of Beirut in Lebanon.

Cancer researchers have been searching for ways to target mutations in the gene STK11/LKB1, found in 15 to 25 percent of non-small cell lung cancers. The tumor suppressor STK11/LKB11 encodes an enzyme that is thought to regulate cell migration and metabolism.

One of the Winship team’s newly identified interactions — a “thread” in the spider web — suggested that palbociclib, recently approved against metastatic breast cancer, may work against cells carrying mutations in LKB1, through LKB1’s connection to CDK4, the target of palbociclib.

That prediction was supported by genomic data analysis and cell culture experiments: lung cancer cells with LKB1 defects showed a tendency of increased sensitivity to palbociclib. Now a study led by Taofeek Owonikoko, MD, at Winship is using LKB1 status as a biomarker for interpreting the effect of palbociclib.

How OncoPPI works

If cells are complex machines, then a number of ways exist for figuring out how the machines’ parts, dominated by proteins, fit together. Some of them involve multiple washing steps to remove nonspecific partners after breaking cells apart, but FRET (Förster resonance energy transfer) does not. If two fluorescent molecules with colors that are near on the spectrum are close enough (less than 10 nanometers), that proximity can be detected by FRET.

Fu and his colleagues established a large-scale platform for tagging proteins with two different fluorescent molecules, introducing them into cancer cells, and then detecting interactions between the proteins. They call this network of cancer-associated proteins “OncoPPI.”

Emory 2

Starting witha set of 83 lung cancer-related proteins, the team detected more than 260 interactions that were not known previously. They tested the interactions several times, in different orientations, and in other lung cancer cell lines with selected interactions to establish reliability. More than 80 percent of the interactions the researchers detected could be confirmed by another method (GST pulldown).

As an additional example to illustrate the utility of a protein interaction web, the team focused on the prominent oncoprotein Myc, which was also considered “undruggable.” But the researchers could connect Myc indirectly through NSD3 to another protein called Brd4, against which inhibitors have been developed. Brd4 inhibitors are being currently tested in clinical trials. This finding revealed a new pathway Brd4-NSD3-Myc as potential targets for therapeutic intervention, Fu says.

The OncoPPI research was supported by the National Cancer Institute Cancer Target Discovery and Development network, lung cancer program project and Winship Cancer Institute and the Georgia Research Alliance, and the Emory University Research Committee. The clinical study of palbociclib is sponsored by Pfizer.

MilliporeSigma Opens Production Facility Exclusively for Meglumine in Spain

MilliporeSigma

MilliporeSigma opens a facility in Mollet des Vallès, Spain dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media.

The facility, validated by the FDA, is the only location in Europe that manufacturesmeglumine, an amino sugar derived from glucose. The facility in Spain is solely dedicated to the production of meglumine, thereby ensuring continuity of supply to customers as well as meeting increasing demand for the excipient. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility. Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as APIs. “Our new facility was optimized around the manufacturing process to achieve greater efficiencies and meets the most stringent quality standards for manufacturing meglumine,” said Andrew Bulpin, Head of Process Solutions Strategic Marketing & Innovation, MilliporeSigma. “The result is a high level of confidence in quality and security of supply for our customers.”

Lilly enhances its existing pain management portfolio for migraine with CoLucid Pharmaceuticals acquisition

Lilly

Lilly and CoLucid Pharmaceuticals Announce Agreement for Lilly To Acquire CoLucid

$960 million deal will enhance Lilly’s existing pain management portfolio for migraine; adds potential near-term launch to its late-stage pipeline

Eli Lilly and Company and CoLucid Pharmaceuticals, have announced an agreement for Lilly to acquire CoLucid for approximately $960 million. This transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.

More than 36 million people suffer from migraine in the United States alone. Lasmiditan, if approved, would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies.

Lasmiditan is an important addition to Lilly’s emerging pain management pipeline, which includes galcanezumab, a potential medicine in Phase 3 clinical development for the prevention of migraine and cluster headache. In addition, tanezumab is being studied, in collaboration with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain.

“Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine,” said David A. Ricks, Lilly’s president and chief executive officer. “This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine.”

Lasmiditan was originally discovered at Lilly and was out-licensed to CoLucid in 2005. Over the past 12 years, CoLucid has taken important steps to decrease the risk related to development and commercialization of lasmiditan as evident by the first positive Phase 3 trial. At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly. Lilly has since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain.

“We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization,” said Thomas P. Mathers, CoLucid’s chief executive officer. “We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients.”

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 and is developing lasmiditan oral tablets for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.

www.lilly.com/newsroom/social-channels

Pulmonary & nasal drug delivery experts to attend RDD Europe 2017

RDD Europe 2017

Register now to attend the RDD Europe 2017 Scientific Conference to be held April 25-28, 2017, in Antibes, France.

The Respiratory Drug Delivery (RDD®) Europe 2017 scientific conference will welcome pulmonary and nasal drug delivery experts from around the world to Antibes, France, April 25-28, 2017. The joint organizers
of this event, RDD Online® and Aptar Pharma invite you to register at www.rddonline.
com/rddeurope2017.

Bringing the Respiratory World Together
Respiratory Drug Delivery Europe is a major conference bringing together experts from around the world to exchange emerging scientific knowledge and providing a dynamic forum for business networking. Approximately 450 delegates from 29 countries attended the 2015 edition in Antibes, France. RDD Europe attracts high level academic, industrial and regulatory scientists and clinicians. It is a must attend conference for companies involved in the research, development, testing and marketing of medicines, devices and services associated with
pulmonary or nasal products.

A premium, interactive three-day conference
This year, the conference will start with a plenary lecture entitled “Patient Focused Device Design: Addressing Inhaler Technique”, hosted by Federico Lavorini, M.D. PhD, Department of Experimental and Respiratory Medicine, Careggi University Hospital, Florence, Italy.

Subsequent sessions will focus on:
– Progress in Inhaled Drug Development
– Can Connected Devices Improve Respiratory Outcomes?
– Changing Regulations in Europe
– Achieving Deposition Equivalence
– Novel Approaches to Characterize Aerosol Dynamics
– Designing Inhalation Products in a Quality by Design Era

As part of the conference, RDD Europe 2017 will underline innovative research contributions in both podium and scientific poster sessions. Scientific posters will highlight recent nasal and pulmonary pharmaceutical research. Five of the best posters will be showcased during ‘Posters on the Podium,’ a fast-paced interactive session in
the main auditorium. All accepted graduate student poster abstracts are automatically eligible for the VCU RDD Peter R. Byron Graduate Student Award.

RDD Europe 2017 will also host 12 workshops led by device experts and service providers. Participants can self-select and attend interactive technical Workshops highlighting innovative technologies, products and services. Valuable networking opportunities RDD Europe 2017 offers numerous networking opportunities including the Technology
Exhibition. Exhibitors display innovative technologies and services throughout the conference in our signature table-top format. Device and equipment designers, and service providers, and consultants can interact and share their input.

A networking cocktail reception will take place on the evening of April 25 and a Gala Dinner sponsored by Aptar Pharma will be hosted on Thursday, April 27.

For many years, RDD Europe events have reached capacity, so early registration is strongly recommended. The early bird rate will be available until January 16, 2017.

Further information about RDD Europe 2017, including the detailed program and registration details, is available now here

Aptar Pharma nears completion of elastomer component capacity in North America

Aptar

Aptar Pharma, a leading provider of drug delivery systems, is nearing completion on its expansion at its Congers, NY state-of-theart manufacturing site. The new space will enable the company to better serve North American pharmaceutical customers, as injectable elastomeric component manufacturing will be completed in the United States for the first time by Aptar. Final construction is planned by the end of the first quarter of 2017 so that Aptar Pharma can anticipate shipping validation batches to customers in the second quarter of next year. The expansion is part of a stepped program to increase Aptar Pharma’s footprint in the United States, according to Bas Van Buijtenen, President of the Injectables Division of Aptar Pharma.

“This investment is continuing our commitment to growing and accelerating our footprint in North America. More significantly, the technology we are introducing will increase our ability to provide world-class manufacturing capabilities to our customers locally. This will provide premium products, shorter lead-times and more responsive service for the US elastomeric components markets,” Van Buijtenen said. The added space will house state-of the-art clean rooms and integrated best-in-class vision equipment, according to Van Buijtenen. “Vision equipment will be used to perform 100% of the automatic inspection of all parts during the finishing process to ensure PremiumVisionTM product quality,” he said. “The increased facility space also enables the company to conduct all of our finishing operations in the United States, including Aptar Pharma’s recently launched Premium Coat TM coated stoppers.”

The expansion was necessary to meet the continued growth of Aptar Pharma’s US injectables business and is part of Aptar’s multiyear investment program supporting the global growth of its injectables business. “We are bringing all of our knowledge and the value-adding parts of our process closer to the customer,” he added. “We want our customers to know us better. To understand what we can do for them on an entirely different level.” Van Buijtenen also commented, “We are a global player with a strong position in North America. Our integration into AptarGroup gives us access to the latest technologies, exceptional people and great financial stability. Our US business has been growing very rapidly, and this investment in capacity will support and accelerate our growth into the future.” he said.

INTERPHEX March 21-23, 2017 Javits Center, New York, NY

Interphex

Find all of the Solutions you need to Cost Effectively Develop and Manufacture Product.

INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the product development life cycle. It brings 11,000+ global industry professionals together with 600+ suppliers through our no cost technical conference, exhibits, and networking events.

www.INTERPHEX.com

IBM and Pfizer to Accelerate Immuno-oncology Research with Watson for Drug Discovery

pzifer

Partnership combines IBM Watson’s cognitive computing capabilities with Pfizer’s scientific knowledge to help scientists generate meaningful insights

A collaboration that will utilize IBM Watson for Drug Discovery to help accelerate Pfizer’s research in immuno-oncology, an approach to cancer treatment that uses the body’s immune system to help fight cancer. Pfizer is one of the first organizations worldwide to deploy Watson for Drug Discovery, and the first to customize the cloud-based cognitive tool – tapping in to Watson’s machine learning, natural language processing, and other cognitive reasoning technologies to support the identification of new drug targets, combination therapies for study, and patient selection strategies in immuno-oncology.

Immunotherapies, which modify a patient’s immune system to recognize and target cancer cells using a combination of vaccines, immunomodulators, and small/large molecules, are reshaping the field of oncology. Oncology researchers at Pfizer will use Watson for Drug Discovery to analyze massive volumes of disparate data sources, including licensed and publicly available data as well as Pfizer’s proprietary data. With this new tool, Pfizer researchers will analyze and test hypotheses to generate evidence-based insights for real-time interaction. The customized technology can also support efficient safety assessments.

Cancer is one of the leading causes of death worldwide, and is arguably one of the most complex diseases known to mankind.1 Many researchers believe that the future of immuno-oncology lies in combinations tailored to unique tumor characteristics, which could transform the cancer treatment paradigm and enable more oncology patients to be treated.

“Pfizer remains committed to staying at the forefront of immuno-oncology research,” said Mikael Dolsten, President, Pfizer Worldwide Research & Development. “With the incredible volume of data and literature available in this complex field, we believe that tapping into advanced technologies can help our scientific experts more rapidly identify novel combinations of immune-modulating agents. We are hopeful that by leveraging Watson’s cognitive capabilities in our drug discovery efforts, we will be able to bring promising new immuno-oncology therapeutics to patients more quickly.”

Laurie Olson, Executive Vice President, Strategy, Portfolio and Commercial Operations, Pfizer, said, “At Pfizer, we are entering a new frontier in data innovation in which we are investing in a range of new technologies and digital solutions to help us dynamically mine both internal and external data sources to find new connections in science, as well as help us better understand how diseases progress and how they could potentially be treated. Applying the power of cognitive computing to an area that is a core part of our DNA – discovering new medicines – is helping Pfizer to learn how we can most efficiently discover those immuno-oncology therapies that have the best chance of successful outcomes for patients.”

The newly launched Watson for Drug Discovery is a cloud-based offering that aims to help life sciences researchers discover new drug targets and alternative drug indications. The average researcher reads between 200 and 300 articles in a given year2, while Watson for Drug Discovery has ingested 25 million Medline abstracts, more than 1 million full-text medical journal articles, 4 million patents and is regularly updated.  Watson for Drug Discovery can be augmented with an organization’s private data such as lab reports and can help researchers look across disparate data sets to surface relationships and reveal hidden patterns through dynamic visualizations.

“We believe that the next great medical innovations will emerge as researchers and scientists find new patterns in existing bodies of knowledge. In order to do this, they need access to R&D tools that can help them efficiently navigate the opportunities and challenges presented by the explosion of data globally,” said Lauren O’Donnell, Vice President of Life Sciences, IBM Watson Health. “IBM is honored to collaborate with Pfizer, and put Watson for Drug Discovery to work to support efforts in bringing life-saving immunotherapies to doctors and patients worldwide.”

Takeda and Lightstone Ventures launch Cerevance

takeda

Takeda and Lightstone Ventures launched Cerevance, a neuroscience company focused on discovering and developing novel therapeutics for neurological and psychiatric disorders. The company will use a new technology, created in the Howard Hughes Medical Institute laboratory of Nathaniel Heintz, Ph.D. at the Rockefeller University.

Takeda will jumpstart the new company by providing a 25-person neuroscience research team from its Cambridge, United Kingdom site, including industry veteran Mark Carlton, Ph.D., fully equipped laboratory space, and licenses to a portfolio of preclinical and clinical stage drug programs. Cerevance is funded with $36 million that includes a $21.5 million Series A financing investment from Takeda and Lightstone Ventures, with each joining Cerevance’s Board of Directors.

“Seven of the ten leading causes of disability in the world are central nervous system disorders,” said Brad Margus, Cerevance Chief Executive Officer. “With a well capitalized, proven team and promising drug programs already underway, we hope to rapidly advance a pipeline of therapeutics into the clinic in parallel with scaling up a truly novel approach to brain diseases based on our new technology.”

“We are thrilled to assemble some of our best scientists, programs and discovery resources in a highly focused endeavor as part of our increased emphasis on leveraging external innovation,” said Andrew Plump, M.D., Ph.D., Chief Medical and Scientific Officer of Takeda. “When we announced the closure of our research site in Cambridge, UK, our goal was to find an innovative externalization home for our most promising CNS programs and scientists in an entrepreneurial setting. Cerevance is a great example of our new R&D strategy.”

“Lightstone is excited to lead the Series A in Cerevance and believes the combination of Nat Heintz’s expertise and platform technology, the proven and impassioned management team, and Takeda’s strong support represent a compelling early-stage investment opportunity,” said Jason Lettmann, Partner at Lightstone Ventures. “Cerevance is in a unique position to bring a breakthrough technology to the development of treatments for central nervous system diseases that affect millions of people worldwide.”

This is not the first time that Takeda, Heintz and Margus have joined forces. In 2009, Takeda invested in and later collaborated with CNS drug discovery start-up Envoy Therapeutics which included Heintz and Margus as founders and which also licensed a technology from the Rockefeller University. Takeda ultimately acquired Envoy in 2012.

Cerevance will have sites in both Massachusetts and the United Kingdom, surrounded by vibrant academic research ecosystems that support biotechnology and pharmaceutical companies.

Novartis acquires Selexys Pharmaceuticals Corporation

novartis

Novartis acquires Selexys Pharmaceuticals Corporation and SelG1 antibody for reduction of pain crises in sickle cell disease (SCD)

Novartis has acquired Selexys Pharmaceuticals Corporation, a company specializing in development of therapeutics in certain hematologic and inflammatory disorders. Novartis exercised its right to acquire Selexys following receipt of results of the SUSTAIN study, a Phase II trial evaluating the use of SelG1, an anti-P-selectin antibody, in the reduction of vaso-occlusive pain crises in patients with sickle cell disease (SCD). Results from the study will be presented during the Plenary Scientific Session at the 58thAmerican Society of Hematology (ASH) Annual Meeting on December 4, 2016, in San Diego, California.

“Sickle cell disease affects millions of people around the world and there are limited therapies available for treatment of vaso-occlusive pain crises, a very common complication of the disease,” said Bruno Strigini, CEO of Novartis Oncology. “With this acquisition, Novartis is able to leverage its leadership in hematology research to advance development of a potential new treatment option for patients living with this debilitating condition.”

Novartis obtained the exclusive right to acquire Selexys and SelG1 in 2012. Prior to the acquisition, Selexys Pharmaceutical Corporation was a privately held biopharmaceutical company headquartered in Oklahoma City, Oklahoma. Terms of the deal could total up to $665 million in upfront, acquisition and milestone payments.