Allergan strengthens its Medical Dermatology Pipeline with Vitae Pharmaceutical acquisition

allergan

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

Clariant Desiccant Canisters with Red Labels Help Enhance Packaging Safety

clariant
  • Red labels help differentiate desiccant from drug product
  • ‘Do Not Eat’ appears in multiple languages
  • Only FDA- and EU-compliant materials are used

Muttenz, 2016 – Clariant, a world leader in specialty chemicals, through its Healthcare Packaging business unit, is introducing desiccant canisters with bright red labeling to better differentiate them from drug products. Displaying an easy-to-understand pictogram and the words “Do Not Eat” in multiple languages, the colored labels offer a further option to support packaging safety.

Drop-in style desiccants, such as canisters and packets, are the most widely used method of controlling moisture in nutraceutical and pharmaceutical bottle packaging applications.

“All desiccant canisters are marked with warnings to help avoid accidental ingestion,” explains Philippe Depois, Head of Sales, Clariant Healthcare Packaging. “However, depending on the color of the drug there may not be a sharp contrast.  The distinctive and vibrant color of the red canister label can help patients more easily recognize the desiccant.”

The new labels are made using FDA- and EU-compliant materials and include an outer varnish coating, so ink is not in direct contact with the drug.  The canister labels can also be customized for specific color-differentiation or with a customer’s specific branding.

Designed for high speed insertion, Clariant’s full line of rigid canisters has become the solution of choice when controlled atmosphere packaging is required to control moisture, oxygen, odor and other volatiles. The active packaging platform is customizable with various sorbent materials including silica gel and molecular sieve.

Clariant has the capacity to produce over 1 billion desiccant canisters per year at its plant in Belen, NM, USA. Construction has begun on a new plant in Cuddalore, India, which will also produce labelled desiccant canisters, supporting customers’ Business Continuity Planning (BCP).

“The safety of the patients using our customers’ products is paramount to our mission,” said Philippe Depois.  “By color-differentiating the canisters, we are adding another layer of safety to protect our customers and consumers.”

Visit Clariant’s Booth

Union Plastic presents its new innovative mircrotabs dispenser UP’PHARM

union plastic

The company Union Plastic, specialized in the manufacturing of medical device and pharmaceutical primary packaging, has created a new dispensing device with an innovative design. The new product has a lot of advantage:

  • Easy to use and Praticable
  • Adaptable to dosage form
  • Dispensing one by one to 5 by 5
  • Food and/or pharmacopoeia grade materials
  • Suitable for standard tube
  • Customisation possible

About UNION PLASTIC

Global Expert for Healthcare Industries.
Since 1955, UNION PLASTIC design and manufactures innovative healthcare industryspecific
plastic solutions. Its expertise and know-how are recognized worldwide:
– Pharmaceutical
– Veterinary
– Medical
– Diagnostic

UNION PLASTIC belongs to OMERIN group since 2015.
CEO: Xavier OMERIN
Union Plastic Managing Director: Frédéric GOUNON
OMERIN group in figures:
• 900 people
• 9 production units
• € 165M in consolidated turnover (Forecast 2016)
• Export: 45%
An international Group to support your project

Visit Union Plastic’booth

Packaging attracts attention

metsa

“Technically, cartonboard packaging is often referred to as the ‘secondary’ package,” Christophe Baudry, Commercial Director, Beautycare and Healthcare at Metsä Board, explains, “as it contains the bottle or other dispenser. But isn’t it in fact the primary packaging in terms of its importance? The consumer’s first impression resides here.”

The appearance of packaging in drug stores has grown in importance. It is no longer considered only a functional entity, but rather an asset to attract attention when selling over-the-counter. Supplements and vitamins have been around forever, and now – with the help of eye-catching packaging – their sales are steadily growing as the average consumer becomes more interested in them.

Then there is the rise of a new genre of product altogether – “cosmeceuticals”. The name, of course, refers to the combination of cosmetics and pharmaceuticals. These new cosmetic products tend to contain biologically active ingredients purporting to have medical or drug-like benefits.

Another completely new product category sold in drugstores, “nutraceuticals”, combines food and pharmaceuticals. Attractive packaging with the capacity to stand out naturally becomes key to communicating the benefits of these new ranges. This is what makes Metsä Board’s paperboards, made from fresh fibres, the perfect choice in these segments.

Visit Metsa’Booth

Discover Nemera: patient focused drug delivery devices

nemera

Nemera, a world leader in design, development and manufacturing of drug delivery solutions, invites you to hear from our experts presenting 2 innovative subjects at next CPhI WorldWide in Barcelona!


INNOPACK SHOWCASE – October 4th at 2 pm:

“Tailoring an auto-injector to the targeted patient and the formulation: SAFELIA®

Isabelle Delcroix, Strategy Director

http://www.cphi.com/europe/agenda/speakers/isabelle-delcroix

Discover how to ease the self-injection experience for the patients and to ensure the best delivery of the formulation.

PHARMA INSIGHT BRIEFINGS – October 5th at 1:30 pm

“Quality by Design – The integration of the Quality by Design in the development of drug delivery devices”

Dimitri Grasswill, Innovation Director, and Philippe Pitard, Quality Director

https://ubmemeaensoprod.s3.amazonaws.com/CPHI_EUROPE/nemera_1539.pdf

Our experts will detail a concrete and pragmatic way to integrate the Quality by Design into the device development process, based on risk management and regulatory compliance.

Visit Nemera at stand 2M38 (Hall 2) during CPhI Worldwide, October 4-6

Visit Nemera’booth on My PharmaPlace

Merck’s Consumer Health business presents new purpose to help prepare society for 100 healthy years

merck

Merck, revealed the new purpose “Prepare society for a new era of humans living 100 healthy years” for its Consumer Health business. The purpose will be brought to life through the movement “WE100®” aimed at raising awareness of healthy living, all the way from children’s age to 100 years. The WE100 movement with its motto “Young for old. Old for young.” will also coordinate concrete actions to help prepare society for humans living 100 healthy years.

The new purpose of the Consumer Health business of Merck has been presented along with the WE100 movement by Uta Kemmerich-Keil, President and CEO of the Consumer Health Business, who commented “Our main objective is to change perceptions of society and take concrete action to articulate the next steps on our journey toward 100 healthy years. This initiative is equally aimed at the younger population, which needs to be educated now about the right approach to healthy ageing.” Kemmerich-Keil added “We decided to launch a new purpose and WE100 as a neutral movement so that everybody sharing the goal of preparing society to live 100 healthy years could join,” Kemmerich-Keil concluded.

The WE100 movement was also recently presented at Cannes Creativity Festival by Atilla Cansun, Chief Marketing Officer of the Consumer Health business of Merck, who explained “We believe age does not influence how much one has to offer. Our first step will be to eliminate the barriers preventing the older generation to be fully involved and integrated in society. We want to set the bar high and we welcome anyone sharing our goal to prepare society for humans living 100 healthy years to join us as the WE100 movement develops.”

As life expectancy continues to increase dramatically across the world since 1945, surveys shows that society is not yet prepared for the prospect of humans living 100 years. Omnibus Daily for Merck group Ageing Survey among 2344 participants

According to the World Health Organization (WHO), the world’s population over 60 years will nearly double from 12% to 22% by 2050.

As a first step of the WE100 movement, the Consumer Health business of Merck conducted a survey on ageing and the perception of ageing across society, which showed that 80% of interviewees think that society needs to dramatically change its perception and attitude towards ageing. The survey also showed that 95% of interviewees believe governments are not taking a proactive role in findings solutions to trigger greater involvement in the society after retirement. In addition, 80% of those interviewed think they have lower chances to find jobs at age 50+ versus younger generations. Finally, when asked whether children are prepared to live 100 healthy years, 93% of survey respondents say current education is falling short of providing the necessary information to prepare children early on to live a long healthy life.

As part of the WE100 movement pilots, activities in schools are planned in 2017 to help children prepare for healthy ageing. Finally, as of October 2016, WE100 will start working on establishing partnerships with public and private organizations around the theme of living 100 healthy years to involve relevant stakeholders in the movement.

European Pharmaceutical Market Access, Pricing & Reimbursement Conference

SMI

Conference: 10th October to 11th October 2016
Workshops: 12th October 2016
Holiday Inn Kensington Forum, London, United Kingdom

SMi Group’s 22nd annual European Pharmaceutical Market Access, Pricing and Reimbursement conference returns to London from 10-11 October 2016. The conference is one of the most established in the world, focusing on the changes in pricing and reimbursement and market access.

Key topics include:
• Updates on AMNOG and its implication on pricing and reimbursement
• How biosimilars are affecting your pricing strategy
• Capture on emerging markets’ regulatory framework to adapt your market access and P&R models
• Orphan drugs using recent examples to highlight the impact on pricing
• Cancer drug funding and budget cuts in the UK
• Innovative solutions beyond the pill
• Japanese and Turkish regional updates

2016 SPEAKERS INCLUDE:

• Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon
• Ulf Staginnus, Head Market Access Oncology, Region Europe, Baxalta
• Gordon Spencer, Regional Market Access Lead – EU & Canada, Shire International GmbH
• Alexander Natz, Secretary General, EUCOPE
• David Watson, Director of Pricing and PPRS, Association of the British Pharmaceutical Industry
• Panos Kefalas, Head of Health Economics and Market Access, Cell & Gene Therapy Catapult
• Ken Walsh, Senior Principal, Global Payer Strategy Consulting, Evidera

The conference will feature two exclusive post-conference workshops:

A: HTA and reimbursement decisions for innovative medicines
Workshop Leader: Patrick Mollon, Former Director Global Health Economics & Outcomes Research, Novartis; HEOR Director, PMHE2020

B: Managing the global to local challenge
Workshop Leader: Janice Haigh, Practice Leader, Quintiles

For more information please visit: www.pharmaceuticalpricing.co.uk

To register: contact Fateja Begum on +44 (0)20 7827 6184 or email: fbegum@smi-online.co.uk

GSK and Google invest £540 M in bioelectronic medicines

gsk

GSK and Verily to establish Galvani Bioelectronics – a new company dedicated to the development of bioelectronic medicines

GSK has announced an agreement with Verily Life Sciences LLC (formerly Google Life Sciences), an Alphabet company, to form Galvani Bioelectronics to enable the research, development and commercialisation of bioelectronic medicines. GSK will hold a 55% equity interest in the new jointly owned company and Verily will hold 45%.

Galvani Bioelectronics will be headquartered in the UK, with the parent companies contributing existing intellectual property rights and an investment of up to £540 million over seven years, subject to successful completion of various discovery and development milestones.

Bioelectronic medicine is a relatively new scientific field that aims to tackle a wide range of chronic diseases using miniaturised, implantable devices that can modify electrical signals that pass along nerves in the body, including irregular or altered impulses that occur in many illnesses. GSK has been active in this field since 2012 and believes certain chronic conditions such as arthritis, diabetes and asthma could potentially be treated using these devices.

The agreement to establish Galvani Bioelectronics represents an important next step in GSK’s bioelectronics research. The new company will bring together GSK’s world class drug discovery and development expertise and deep understanding of disease biology with Verily’s world leading technical expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications. Initial work will centre on establishing clinical proofs of principle in inflammatory, metabolic and endocrine disorders, including type 2 diabetes, where substantial evidence already exists in animal models; and developing associated miniaturised, precision devices.

Moncef Slaoui, GSK’s Chairman of Global Vaccines, who was instrumental in establishing GSK’s investments in the field of bioelectronics, will chair the board of the new company. He said:

“Many of the processes of the human body are controlled by electrical signals firing between the nervous system and the body’s organs, which may become distorted in many chronic diseases. Bioelectronic medicine’s vision is to employ the latest advances in biology and technology to interpret this electrical conversation and to correct the irregular patterns found in disease states, using miniaturised devices attached to individual nerves. If successful, this approach offers the potential for a new therapeutic modality alongside traditional medicines and vaccines.

“This agreement with Verily to establish Galvani Bioelectronics signals a crucial step forward in GSK’s bioelectronics journey, bringing together health and tech to realise a shared vision of miniaturised, precision electrical therapies. Together, we can rapidly accelerate the pace of progress in this exciting field, to develop innovative medicines that truly speak the electrical language of the body.”

Brian Otis, Verily’s Chief Technology Officer, said: “This is an ambitious collaboration allowing GSK and Verily to combine forces and have a huge impact on an emerging field.  Bioelectronic medicine is a new area of therapeutic exploration, and we know that success will require the confluence of deep disease biology expertise and new highly miniaturised technologies.

“This partnership provides an opportunity to further Verily’s mission by deploying our focused expertise in low power, miniaturised therapeutics and our data analytics engine to potentially address many disease areas with greater precision with the goal of improving outcomes.”

Galvani Bioelectronics will be headquartered within GSK’s global R&D centre at Stevenage in the UK, with a second research hub at Verily’s facilities in South San Francisco. It will initially employ around 30 expert scientists, engineers and clinicians, and will fund and integrate a broad range of collaborations with both parent companies, academia and other R&D companies. GSK and Verily believe this collaborative way of working will rapidly accelerate the development of bioelectronic medicines.

Kris Famm, GSK’s Vice President of Bioelectronics R&D, has been appointed President of the new company. Famm has pioneered work in both large and small molecule drug discovery and worked for a decade developing and delivering R&D strategy with a recurring focus on emerging technologies. He has co-designed and led GSK’s exploration of bioelectronics.  A seven-member board, chaired by Moncef Slaoui, will also be appointed and will include Andrew Conrad, CEO of Verily. The new company will be fully consolidated in GSK’s financial statements.

This agreement is subject to customary closing conditions (including requisite antitrust approvals) and is expected to close before the end of 2016.

 

Roche launches next generation blood glucose monitoring system

roche

Roche launches innovative Accu-Chek® Guide blood glucose monitoring system, which makes every step of testing easy

  • To simplify everyday diabetes routines, the Accu-Chek® Guide system offers a new spill-resistant SmartPack vial and a unique strip design with a large easy-edge dosing area
  • Wireless connectivity to the Accu-Chek® Connect mobile app and the cloud-based diabetes management system enables easy handling of important diabetes data and remote monitoring
  • The Accu-Chek® Guide system’s advanced accuracy enables reliable diabetes management

Roche has announced the launch of the Accu-Chek® Guide, the next-generation blood glucose monitoring system. This new system is designed to make everyday blood glucose (BG) monitoring easier with features such as the spill-resistant SmartPack test strip vial, which helps users to remove just one strip at a time and avoid spillage or contamination. The Accu-Chek® Guide system also provides for advanced accuracy, which enables reliable diabetes management. “As the global leader in diabetes management we are dedicated to supporting people with diabetes, in thinking less about their daily therapy routines. We are very excited to introduce this innovative system, that simplifies blood glucose monitoring and improves the testing experience,” said Roland Diggelmann, CEO Roche Diagnostics. First markets to launch the new system are Denmark, Switzerland and Australia. Morecountries will follow subsequently starting in early 2017.

The Accu-Chek® Guide system enables on-board pattern detection that helps to increase awareness of too high or too low glucose readings as well as Bluetooth Low Energy connectivity to the Accu-Chek® Connect diabetes management solution via a mobile app. This cloud-based solution guarantees a secure online data exchange and automatic data logging. People with diabetes, caregivers, and healthcare providers can share diabetes information virtually anywhere for timely advice and remote monitoring. Such telemedicine solutions can help people with diabetes and their caregivers manage diabetes more efficiently and give them peace of mind and a feeling of relief. Hence, 97% of 197 participants in a recently published study from France and the US agreed that the system was very easy to use and offers a better testing experience1.

The Accu-Chek® Guide system not only fulfills current accuracy standards2 but delivers even tighter 10/10 accuracy for more reliable results3. Consistently accurate measurements are essential for reliable BG monitoring and deriving the correct therapy decisions4,5. Large deviations of the measured BG values from the true glucose levels can result in higher HbA1c levels, glycemic excursions and markedly increased rates of hypoglycemic events, as a recently published retrospective study revealed6. In addition, studies have demonstrated that only about half of the BG meters evaluated meet the minimum accuracy requirements as defined by the ISO 15197:2013/EN ISO 15197:2015 standard.