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.

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 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


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.


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


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 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 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.

Survey Reveals Most People Don’t Know Heart Disease Is the No. 1 Killer of People with Type 2 Diabetes


Boehringer Ingelheim and Lilly launch For Your SweetHeart™, an educational campaign to help bridge knowledge gap and encourage people with type 2 diabetes to know their cardiovascular risk

Physician and host of The Doctors, Dr. Travis Stork, joins the campaign to urge people with type 2 diabetes and their loved ones to take action by taking the Heart You Quiz

A new national survey of more than 1,500 adults, including 501 who have type 2 diabetes, finds that three out of four Americans and two out of every three people with type 2 diabetes don’t know that heart disease is the number one health-related killer of people with type 2 diabetes. The survey also finds more than half (52 percent) of adults with type 2 diabetes do not understand that they are at an increased risk for heart disease and related life-threatening events, such as heart attack, stroke or even death. To address this critical information gap, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) are launching For Your SweetHeart™: Where diabetes and heart disease meet. The For Your SweetHeart campaign aims to raise awareness of the link between type 2 diabetes and heart disease and to encourage people with type 2 diabetes to know their risk and speak to their healthcare provider, for the sake of their health and the people they cherish the most.

Reaching Millions of Hearts Across the USA

Cardiovascular disease (which includes heart disease and other problems with the heart and blood vessels like heart attacks and strokes) causes approximately two-thirds of deaths in people with type 2 diabetes, making it the number one cause of death. But the good news is, the sooner people understand their risk, the sooner they can talk to their healthcare provider to learn more about the link between type 2 diabetes and potentially life-threatening heart attacks, strokes or even death.

To help raise awareness of this critical issue, Boehringer Ingelheim and Lilly have teamed up with board-certified emergency medicine physician and host of the Emmy award-winning show The Doctors, Dr. Travis Stork, to encourage the millions of people with type 2 diabetes and their “sweethearts” to better understand the connection between diabetes and heart disease.

“In the emergency room, I regularly see people with type 2 diabetes experiencing life-threatening events like heart attacks or strokes,” said Stork. “Few know they are more likely to experience these kinds of complications simply because they have diabetes. I’ve joined the For Your SweetHeart campaign because awareness of heart disease risk is critical for people with type 2 diabetes and their loved ones, and taking action today may help save lives.”

For Stork, it’s also a personal issue that hits close to home. “My grandfather had type 2 diabetes, and from him, I learned a lot about the importance of managing the disease before I ever became a doctor. I urge everyone with type 2 diabetes to visit ForYourSweetHeart.com, take and share the Heart You Quiz to learn about their risk for heart disease, then talk to their healthcare provider.”

People with diabetes have an increased risk of heart disease for a number of reasons, including high blood pressure, abnormal blood lipids and obesity. Uncontrolled diabetes damages blood vessels, making them more prone to injury from high blood pressure and from plaque build-up and inflammation in the arteries. Boehringer Ingelheim and Lilly surveyed 1,505 people on their understanding of the link between type 2 diabetes and heart disease. The survey was comprised of a nationally representative sample including: 1,004 adults 18 years and older in the U.S. and 501 adults 18 years and older in the U.S. who have type 2 diabetes. The survey found:

If people with type 2 diabetes knew they were at increased risk of heart disease, 99 percent responded that they would be likely do something about it. More than 80 percent said they would change their diet/eating habits, exercise and speak with their healthcare provider to decrease their risk of heart disease

Less than 35 percent of people overall and only 41 percent of people with type 2 diabetes surveyed were aware that those with type 2 diabetes are at increased risk for heart attack

“The truth is cardiovascular disease is the leading cause of death among people with diabetes, but there is hope. The earlier people with diabetes understand this risk, the sooner they become engaged and take action to help reduce their chances of heart attacks, strokes or even death,” said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. “We’re excited to launch For Your SweetHeart to encourage people with type 2 diabetes to assess their risk through the Heart You Quiz and to speak with their healthcare provider about the link between diabetes and heart disease. The most important thing people can do is know everything they can about their health and encourage their loved ones to do the same.”

“People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes,” said Mike Mason, vice president, U.S., Lilly Diabetes. “Educating the public about this important health crisis is just another component of our responsibility and commitment to delivering the best care for people with type 2 diabetes. We hope this initiative will encourage people to take action, not only for themselves, but also for their sweethearts.”

About For Your SweetHeart: Where diabetes and heart disease meet

For Your SweetHeart is a U.S. initiative to raise awareness of the link between type 2 diabetes and heart disease and to encourage people with type 2 diabetes to know their heart disease risk and speak to their healthcare provider, for the sake of their health and the people they cherish the most. Learn more about the For Your SweetHeart initiative and take and share the Heart You Quiz at ForYourSweetHeart.com.

The For Your SweetHeart survey was conducted online, between Oct. 24 and Nov. 1, 2016, among a nationally representative sample of n=1,505 respondents, including: n=1,004 adults 18 years and older in the U.S. (including n=364 type 2 diabetes “sweethearts,” or those who know someone with diabetes) and n=501 adults 18 years and older in the U.S. who have type 2 diabetes.

For Your SweetHeart was developed and sponsored by Boehringer Ingelheim and Eli Lilly and Company. Elements of the campaign, including the For Your SweetHeart survey and Heart You Quiz, were reviewed and validated by a steering committee of leading cardiologists and endocrinologists.

Participating medical experts:

Karol E. Watson, M.D., Ph.D., FACC, professor of medicine/cardiology, co-director, UCLA Program in Preventive Cardiology, director, UCLA Barbara Streisand Women’s Heart Health Program

Ty J. Gluckman, M.D., FACC, FAHA, medical director, Clinical Transformation, Providence Heart and Vascular Institute, Portland, Oregon

Matthew Budoff, M.D., professor of medicine, UCLA, Endowed Chair of Preventive Cardiology, program director, Division of Cardiology, Los Angeles Biomedical Research Institute

Leigh Perreault, M.D., associate professor of medicine, Division of Endocrinology, Metabolism and Diabetes, Affiliate Center for Global Health, University of Colorado Anschutz Medical Campus, associate professor of epidemiology, Colorado School of Public Health

Anne Peters, M.D., director, USC Clinical Diabetes Program, professor, Keck School of Medicine of USC

About Diabetes and Cardiovascular Disease

Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28 percent of Americans with diabetes—totaling eight million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. Approximately 50 percent of deaths in people with type 2 diabetes worldwide and approximately two-thirds of deaths in people with type 2 diabetes in the U.S. are caused by cardiovascular disease. In the U.S., health care costs for managing cardiovascular conditions in patients with diabetes totaled more than $23 billion in 2012.

Having diabetes can shorten a person’s lifespan by as much as six years compared with someone without diabetes.* And having both diabetes and a history of heart attack or stroke can shorten a person’s lifespan by as much as 12 years compared with someone without these conditions.**

* Based on having a history of diabetes at age 60.

** Based on having a history of diabetes and heart attack or stroke at age 60.

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

Sanofi & Verily Life Sciences, unit of Google, are launching Onduo, a diabete management platform

sanofi & google

Sanofi and Verily Life Sciences LLC, (formerly Google Life Sciences), an Alphabet company, today announced the launch of Onduo, a joint venture created through Sanofi and Verily’s diabetes-focused collaboration. The joint venture is based in Kendall Square in Cambridge. Onduo’s mission is to help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine, and professional care to enable simple and intelligent disease management.

Under the leadership of Onduo’s newly appointed Chief Executive Officer, Joshua Riff, M.D., M.B.A., the company will leverage Verily’s experience in miniaturized electronics, analytics, and consumer software development, and Sanofi’s clinical expertise and experience in bringing innovative treatments to people living with diabetes. Dr. Riff joins Onduo from Optum, the health services company of UnitedHealth Group, where he was senior vice president of prevention and wellbeing.

My experience as a physician and in leading consumer health initiatives has shown me the daily burden of living with diabetes,” said Dr. Riff, CEO, Onduo. “From monitoring food intake to testing glucose levels to actively seeking medical care, the challenges both on the physical and mental well-being of a person living with diabetes are incredibly difficult. We want to develop solutions that allow people living with diabetes to focus on the things they love and enjoy in life by providing tools to make dealing with their diabetes less burdensome.
Initially, Onduo will focus on the type 2 diabetes community, specifically on developing solutions that could help people make better decisions about their day to day health, ranging from improved medication management to improved habits and goals. Over time, the company plans to expand its focus to include the type 1 diabetes community, and eventually to people at risk of developing diabetes with the goal of helping them better prevent the onset of the disease.

The integration of multiple interventions, such as data-driven patient support and devices in addition to treatment, can help improve outcomes, which is important from the perspective of patients, healthcare professionals and the overall healthcare system,” said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. “The new company Sanofi and Verily invested in will adopt a more service-centric approach and support doctors in their efforts to treat their patients more effectively. In addition to developing innovative therapies for diabetes which will remain a key focus for Sanofi, we see these solutions which combine innovative therapies and services as the future for diabetes care. We believe this will help societies cope with the burden of this epidemic.

Joining Forces with Experts and Advocates
Onduo is taking a multi-stakeholder approach to diabetes management by involving the diabetes community, clinicians, payers and healthcare professionals in the product development process. Sutter Health of Northern California and Allegheny Health Network of western Pennsylvania are among the first healthcare networks to collaborate with Verily and Onduo to test the Onduo platform with healthcare professionals and people with type 2 diabetes in a clinical care setting. Sutter Health’s not-for-profit network of physicians, hospitals, outpatient surgery and specialty centers and other healthcare services, including home health and hospice, medical research and education/training, cares for more than 3 million patients. . Allegheny Health Network is an academic healthcare system consisting of eight hospitals, outpatient surgery centers, health and wellness pavilions, a research institute and more than 1,100 employed physicians. Premier Medical Associates, part of Allegheny Health Network, is the largest multi-specialty physician practice in the Greater Pittsburgh area.

This is an innovative collaboration that spans the healthcare continuum and benefits from deep and cross-functional expertise, giving us unique potential to create tools and solutions that could have a positive clinical effect,” said Jessica Mega, M.D., M.P.H., chief medical officer of Verily. “Our goal is to connect the dots for health care providers on the ‘moments of truth’ that happen outside of the clinical setting, and to help people manage diabetes on a daily basis. Our collaborations with health networks like Sutter Health and Allegheny Health will help bring that vision to life.

Additionally, Onduo is discussing with patient advocacy groups like Taking Control of Your Diabetes (TCOYD) to provide input on future product designs.

With Onduo, Sanofi and Verily are bringing forward a platform that is novel and critical in diabetes management,” said, Steven V. Edelman, M.D., Founder and Director, TCOYD. “Onduo is a company focused on the improvement of health outcomes through the marriage of technology and medicine. Its information-based solutions align well with TCOYD’s mission to empower people with diabetes and their loved ones to effectively and easily take control of diabetes. We welcome and support Onduo’s efforts and look forward to their progress.”

Joshua Riff, M.D., M.B.A. Named CEO
Dr. Riff is an emergency medicine physician by training. He was most recently the senior vice president of prevention and well-being at Optum, the service arm of United Healthcare. Prior to that, Dr. Riff served as medical director at Target, where he ran the health plan for Target team members and provided medical oversight to their clinics and pharmacies. He completed his M.D. and M.B.A. at Tufts University in conjunction with Brandeis University in Boston, Mass. After medical school he completed his residency in Emergency Medicine at Johns Hopkins Hospital.

About Diabetes
Diabetes is a chronic disease characterized by elevated blood sugar due to inefficient or deficient insulin production. In 2014 it was estimated that globally, 422 million people suffer from the disease.1 Diabetes can be classified in two major subsets, type 1 and type 2. Type 1 diabetes is an autoimmune disease that occurs when the pancreas stops making insulin and therefore must be regulated via daily administration of insulin. Type 2 diabetes is a metabolic disorder in which a person’s body produces insulin, but is not able to regulate it efficiently. Over time, the disease can result in serious or life threatening complications, including damage to the heart, eyes, kidneys and nerves.2 Research suggests that the recommended self-care regimen for people with type 2 diabetes on oral medications requires at least two hours daily.3 It has been estimated that the global economic burden of diabetes is U.S. $827 billion.


What’s next for CMOs?


CMOs are finding ways to survive and thrive in a rapidly changing landscape

Why is the CMO industry in such flux, and why does the rate of change seem to be accelerating?

There are a great many factors, but the most prominent is cost. Pharmaceutical companies worldwide are under enormous pressure to contain costs, and in response have reduced their internal manufacturing, R&D and marketing functions. New efficiencies in communications, development, production, and distribution have allowed smaller, more nimble CMOs to step into the areas that larger companies are now outsourcing.

For years, CMOs quietly went about their business, delivering APIs and excipients, providing supplies for clinical trials and augmenting in-house capabilities to meet demand as production was ramped up to meet launch demands or increasing sales. They flew under the radar, quietly servicing their more vertically-integrated customers.

And then it all changed. Introductions of blockbuster drugs, which had driven so much of the growth of Big Pharma, slowed to a virtual halt. Important new drugs were—and are—being brought to market constantly, but compared to the products introduced during the 1990s and 2000s, don’t offer the potential sales volume of their category-creating predecessors.

The great fragmentation is underway

In an effort to cut costs, many pharmaceutical companies have returned to their core competencies such as R&D and marketing, while outsourcing many other resource-intensive functions. While this has led to leaner, more focused organizations, it has also created a new set of realities: CMOs now have to be brought into the product development process far earlier than previously, working protocols have to be established to insure efficient use of resources and personnel, and communications systems have to be enhanced to assure clear communications throughout the development process, especially at critical touch points and handoffs. CMOs have adapted to this new reality and ramped up equipment and services to meet the demand. Many have merged with other companies to bring greater capabilities and cost-savings in-house, or to provide profitable niche services, such as small production runs for clinical trials.

At the same time, biopharmaceuticals and biosimilars, with their challenging development, manufacturing and distribution profiles, have continued to experience tremendous growth. Sales of biologics now top $200 billion, while sales of biosimilars have increased to $20 billion, a figure that is expected to more than double by 2020. The increasing applicability of large-molecule agents to a variety of disease states and conditions has further served to boost demand and stretch capacities. CMOs are meeting these challenges with technologies that address key issues such as targeted delivery, abuse-deterrent formulations, and new administration modalities.

As the trend toward outsourcing has continued, pharmaceutical companies have come to expect greater and greater involvement and capabilities from their CMOs. CMOs have had to look beyond their traditional roles and to consider expanding into areas that just a few years ago would have been considered beyond their core competencies. If the past is any indication, the wider the range of capabilities and the more expertise the CMOs can bring to the table, the more likely it is that large pharmaceutical manufacturers will have the confidence to establish long-term strategic relationships with them.

This is not to say that smaller biopharmaceutical companies have been sidelined. They have been playing important roles in the research and development of new drugs and have helped to keep open the pipeline of new products under development. Many have developed unique niche capabilities that their clients value but can’t perform economically in house and must therefore outsource.

Opportuities abound

The downsizing and consolidations of the larger pharmaceutical companies have created opportunities for forward-looking CMOs, which have been expanding into plants that the larger companies have vacated. The French CMO Fareva is expanding their existing plants in France and has been investing in new facilities in the United States and Latin America as well. With many of its plants in France reaching the saturation point, expansion has become increasingly necessary. “We are facing pressing demand for some forms and types of product that we produce at the plants concerned,” explains Bernard Fraisse, chairman of the family-owned business. The company, which has experienced rapid growth, largely from new acquisitions, is now “prioritizing organic growth,” according to Fraisse.

Like Fareva, other CMOs are taking advantage of consolidation to buy up facilities and equipment to meet the burgeoning demand. The trend shows no sign of abating thus far. For CMOs that can provide the service, capabilities and capacity that major manufacturers need, the future seems bright indeed.

Allergan strengthens its Medical Dermatology Pipeline with Vitae Pharmaceutical acquisition


Allergan acquires Vitae Pharmaceuticals a clinical stage biotech company. They have entered into a definitive agreement under which Allergan will acquire Vitae for $21.00 per share, in cash, for a total transaction value of approximately $639 million. The Boards of Directors of both companies have unanimously approved the transaction.

The acquisition will strengthen Allergan’s dermatology product pipeline, with the addition of VTP-43742, a Phase 2 first-in-class, orally active RORγt (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis and other autoimmune disorders.

In preclinical studies, VTP-43742 has been observed to inhibit RORγt activity, is highly selective versus other ROR isotypes and may provide a treatment that could be administered as a once-daily oral dose.

The acquisition also adds VTP-38543, a topical LXRβ (Liver X Receptor beta) selective agonist for the potential treatment of atopic dermatitis.

VTP-38543 is currently in a Phase 2a proof-of-concept clinical trial assessing the safety, tolerability and efficacy in patients with mild to moderate atopic dermatitis.

“The acquisition of Vitae is a strategic investment for Allergan that adds strength and depth to our innovative medical dermatology franchise,” said Brent Saunders, CEO and President of Allergan.  “Vitae has pioneered the discovery and development of highly differentiated first-in-class compounds in atopic dermatitis, psoriasis and autoimmune diseases, areas of medicine where innovation is needed for patients.”

“Both the VTP-43742 and VTP-38543 programs offer the potential for highly differentiated mechanisms of action for the treatment of dermatologic conditions where patients are underserved by currently approved treatments,” said David Nicholson, Chief Research & Development Officer, Allergan. “In addition, Vitae’s novel Contour drug discovery platform and its team, which have been instrumental in the discovery of novel ‘difficult to drug’ compounds, will be highly complementary to Allergan’s existing R&D discovery efforts in key therapeutic areas.”

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Vitae common stock for $21.00 per share. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Vitae common stock. The merger agreement contemplates that Allergan will acquire any shares of Vitae that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pending approvals, Allergan anticipates closing the transaction by the end of 2016