Nerlynx is a kinase inhibitor indicated as a single agent for the extended adjuvant treatment of adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy. It is also indicated in combination with capecitabine for the treatment of adults with advanced or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2 based regimens in the metastatic setting.

The approval for the use of Nerlynx dose escalation was based on data from the multicenter, open-label, multi-cohort phase 2 CONTROL trial (ClinicalTrials.gov Identifier: NCT02400476) that included adults with early stage HER2-positive breast cancer. Patients received either Nerlynx 240mg daily for up to 1 year, along with loperamide prophylaxis with additional anti-diarrheal treatment as needed, or Nerlynx dose escalation with loperamide as needed. In the dose escalation cohort, patients received Nerlynx 120mg daily for week 1, then 160mg daily for week 2, then 240mg daily for week 3 and thereafter.

Findings showed that dose escalation therapy was associated with improved management and prevention of grade 3 diarrhea, including a 60% reduction in the percentage of patients with grade 3 diarrhea (40% vs 13%), a 50% reduction in median cumulative days of grade 3 diarrhea (5 days vs 2.5 days), and an approximately 80% reduction in discontinuation rates (17% vs 3%), when compared with data from the phase 3 ExteNET trial (ClinicalTrials.gov Identifier: NCT00878709), which did not include dose escalation or antidiarrheal prophylaxis.

“We believe that utilizing dose escalation has the potential to improve the overall tolerability of Nerlynx and increase the average length of therapy, with the end result benefiting more patients battling breast cancer,” said Alan H. Auerbach, Chief Executive Officer and President of Puma.

Nerlynx will also be made available in a new 133-count bottle containing a 4-week supply of 40mg tablets for use in dose escalation.

Key Features

-Multi layer foil laminate provides resistance to tear, puncture and abrasion

-Offers superior gas and moisture barrier

-Nylon-based mid-ply layer with uncoated Tyvek® allows for gas exchange

-Suitable for use with desiccants or humectant sachets

-Chevron or corner peel options available

-Devices sterilized by radiation and ETO

Customer benefits

-Simplified packaging format provides quick and simple access to the device

-High quality peel that is specifically tailored to give exceptional clean and controlled seal/peel open performance

-Dessicant sachets seperated from the device in second non-peelable chamber to elimiante risk of containation and aid aesptic presentation

End consumer benefits

-Single dual chamber pouch replaces a double-pouch system

-Simplified packaging solution reduces the risk of device damage

-Improved shelf life for sensitive devices

-Simplified inventory management

Noble and Aptar Pharma are pleased to announce the launch of AdhereIT™ – a connected, intuitive and user-friendly onboarding solution for the growing number of patients with chronic conditions who use autoinjectors to administer their medications at home. AdhereIT™ is the first fully interchangeable, connected add-on solution that can work across a multitude of autoinjector platforms. This launch is an important advancement for Noble, an Aptar Pharma company, whose mission is to foster healthy outcomes for patients who self-administer their therapies, partnering with pharma and biotech companies to provide robust training devices and onboarding programs.

Adherence to prescribed biologics is a significant challenge. A recent report in the Journal of the American Academy of Dermatology reported that 45% of studied patients suffering from psoriasis discontinue their treatments. The reasons include insufficient training or time with an instructor, lack of confidence during the self-injection process, and feelings of high anxiety and lack of control. COVID-19 has contributed to the increase utilization of telemedicine and remote healthcare, which has even further complicated this challenge by reducing healthcare professional (HCP) training opportunities with patients.

AdhereIT™ is part of the digital ecosystem that enables patients to gain control and confidence over their at-home drug delivery while easing the anxiety associated with self-injecting. AdhereIT™ integrates with the existing software applications developed by the Digital Healthcare team at Aptar Pharma by pairing a patient’s autoinjector via Bluetooth technology to their mobile phone. The device – available in two design options to accommodate dexterity for a one-handed or two-handed injection process – precisely detects an injection event and provides real-time visual, audio and haptic feedback about whether the injection was performed correctly. The AdhereIT™ onboarding platform also allows HCPs to monitor their patients’ therapeutic performance via a smart analytical dashboard, providing valuable patient-specific adherence behavior information.

“We are excited to welcome Noble’s AdhereIT™ connected onboarding platform into the suite of Aptar Pharma’s Digital Healthcare solutions. This innovative technology further enhances our ability to improve patients’ lives by creating a seamless integration of injectable products into our disease management offerings,” said Adam Shain, Director of Business Development for Digital Healthcare, Aptar Pharma.

Noble developed AdhereIT™ in partnership with Aptar Pharma, who has made significant investments in digital healthcare over the past three years to actively develop a portfolio of disease management platforms and connected device solutions across dermal, pulmonary, nasal, ophthalmic and injectable routes of administration.

“Connected medical devices represent the future of healthcare for patients, pharmaceutical companies, health insurers and HCPs, playing a vital role in the remote tracking and treatment of chronic illnesses, and delivering a range of benefits that include improved drug management, enriched patient experiences and enhanced patient outcomes,” said Tim McLeroy, Noble’s Executive Director of Marketing & Patient Services. “The connectivity of digital technology solutions like AdhereIT™ also create market differentiation and enable value-based contracting for biopharmaceutical companies and medical device manufacturers to survive in a competitive and challenging marketplace.”

From the beginning of 2021 ADMV will again be run as a separate sub-brand within FlexLink. This serves the sustainable diversification in the product range and a clear positioning of the solution offer. It is also intended to strengthen customer relationships and simplify communication in the market. In the future, ADMV will act as an expert brand with a focus on beginning-of-line and in-line applications.
Extensive industry knowledge and high modularity
The ADMV team, based in Crémieu near Lyon in France, designs and manufactures feeding machines such as bulk material feeders and step conveyors, handling and assembly machines as well as collaborative robot applications. The machines ensure gentle product handling, avoid efficiency losses due to congestion and enable seamless speed changes. A high degree of modularity and flexibility enables line modifications for quick adaptation to production changes and thus shortens the time to market.