AstraZeneca in Cancer Deal with Daiichi Sankyo
AstraZeneca announced that it has acquired joint development and commercialization rights to a promising cancer candidate from Japanese drug maker Daiichi Sankyo.
Trastuzumab deruxtecan, also known as DS-8201, is being developed in HER2-expressing cancers including five pivotal late-stage studies for HER2-expressing breast and gastric cancers and mid-stage studies for HER2-expressing advanced colorectal cancer and metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC. The first regulatory application for trastuzumab deruxtecan is expected to be filed in the second half of 2019 for advanced or refractory breast cancer.
DS-8201 received the FDA’s Breakthrough Therapy status for HER2-positive metastatic breast cancer in patients who have been previously treated with Roche’s RHHBY breast cancer medicines Herceptin (trastuzumab) and Perjeta(pertuzumab) and witnessed disease progression after trastuzumab emtansine.
AstraZeneca CEO Pascal Soriot says the drug “could become a transformative new medicine” for some breast and gastric cancers.
AstraZeneca is aggressively working on strengthening its oncology product portfolio and has several candidates in its pipeline.
“Over the last four years oncology has been focused on pipeline revitalization … We feel that we have re-emerged and now our sights shift towards true leadership in the oncology space,” said Dave Fredrickson, AstraZeneca’s head of oncology.
The collaboration requires no shareholder or regulatory approval.
Amazon’s Alexa Can Now Handle Patient Information
Amazon announced a new Alexa upgrade that offers some HIPAA-compliant skills that will provide new opportunities for drug makers that want to utilize the voice-activated artificial-intelligence assistant.
Six healthcare partners have already launched, including Express Scripts and Livongo. With Express Scripts, members can check the status of a home delivery prescription and can request Alexa notifications when their prescription orders are shipped.
“With our new Express Scripts skill, we are trying to make it easier for people to make better informed health care decisions. In particular, we believe voice technology, like Alexa, can make it easy for people stay on the right path by tracking the status of their mail order prescription, helping us further solve the costly and unhealthy problem of medication non-adherence.” said Mark Bini, Vice President of Innovation and Member Experience, Express Scripts.
With Livongo, a leading consumer digital health company that creates new and different experiences for people with chronic conditions, members can query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.
In discussing reasons she expects users to embrace voice technologies, Livongo’s president Jenny Schneider said: “Some of those people might have difficulty reading, or they just have busy lives and it’s just an easy option”. The company estimates that approximately 20,000 of its customers already have an Alexa device in their home.
Companies that want to utilize Alexa must be able to follow various HIPAA requirements, like the Privacy Rule, Breach Notification Rule, and Security Rule. Of these, the Security Rule can be the most difficult for companies to follow. The Security Rule covers topics such as encryption and having proper controls related to who can access which types of information.
Sanofi to Offer Patient Insulin Subscriptions
Sanofi announced that it had unveiled a program that provides a subscription-type service to its patients, supplying insulin products for a flat monthly rate.
Starting in June, the Insulin Valyou Savings Program will deliver up to 10 boxes of insulin pens and 10 mL vials per month for $99 per month.
“It is unacceptable to Sanofi that some people living with diabetes are struggling to pay for their insulin, so we have moved to act creatively and aggressively to help address affordability and access needs,” said Michelle Carnahan, the head of North America primary care at Sanofi.
While some commercially insured patients with a high deductible can benefit from the program, its target population is uninsured patients who do not qualify for traditional patient assistance programs like co-pay and free-medicine initiatives. Under current regulations, it cannot offer the plan to patients insured under the government’s Medicare or Medicaid programs or similar federal and state health programs.
FDA Approves Janssen’s Balversa
The FDA granted accelerated approval to Janssen’s Balversa for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy. This is the first targeted therapy approved for metastatic bladder cancer.
The efficacy of Balversa was studied in a clinical trial that included 87 patients with locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, that had progressed following treatment with chemotherapy. The overall response rate in these patients was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. The response lasted for an average of approximately five-and-a-half months. About a quarter of patients in the study were previously treated with anti PD-L1/PD-1 therapy, which is a standard treatment for patients with locally advanced or metastatic bladder cancer. Responses to Balversa were seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.
“We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. Today’s approval represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs.”
Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.
Teva Halts Alternative Use Testing of Migraine Drug
Teva Pharmaceutical stated it would stop developing its migraine drug Ajovy, known generically as fremanezumab, for treating cluster headaches after the company found the treatment was unlikely to meet the main goal of a late-stage trial.
Fremanezumab is part of a new class of antibody drugs developed to block a protein associated with pain called calcitonin gene-related peptide (CGRP). Last September, the FDA approved fremanezumab for migraines in both monthly and once-every-three months dosing. The company launched the drug soon after.
The drug’s first failure in cluster headache happened last June. At that time, Teva announced it would stop testing fremanezumab as a treatment for chronic cluster headaches, which last for weeks or months and do not have a remission period of longer than one month.
The failure announced was for episodic cluster headaches that consist of one to four short headaches per day lasting 15 to 20 minutes. Teva stated that an interim analysis of a Phase 3 study found that Ajovy was unlikely to reduce the average number of headache attacks over a four-week treatment period, the main goal of the study.
Cluster headaches are rare and painful, occurring in clusters or cyclical patterns and are frequently confused with migraines.
“We’d like to thank the patients and investigators for their immense contributions to this study. Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology,” said Tushar Shah, M.D., Senior Vice President, and Head of Global Specialty Clinical Development at Teva.
Pfizer’s Pipeline Making Progress
Pfizer reported its financial results for first-quarter 2019, including reporting that Xeljanz sales have experienced recent growth reflecting continued strong volume growth in the rheumatoid arthritis indication and from the launches of the psoriatic arthritis and ulcerative colitis indications.
Additionally, in July, Xtandi added an additional indication in nonmetastatic, castration-resistant prostate cancer (CRPC). It was previously approved for metastatic castration-resistant prostate cancer.
Pfizer said its business development priorities are now focused on enhancing its pipeline of drugs in development. Pfizer had several recent drug approvals in the U.S., including approval of its biosimilar version of injected breast and gastric cancer drug Herceptin and approval of Ibrance for men. The company expects U.S. approvals this year for biosimilar medicines for cancer and rheumatoid arthritis, plus approval of tafamadis for a rare, tough-to-diagnose heart disorder with no current treatment.
“Our pipeline continues to deliver differentiated therapies that have the potential to improve the standard of care for patients across multiple therapeutic areas. In the first four months of 2019, we have received five regulatory approvals and presented Phase 3 data for Xtandi in metastatic hormone-sensitive prostate cancer as well as Phase 2 immunogenicity data in adults for our 20-valent pneumococcal vaccine candidate,” said CEO Albert Bourla. “I believe our pipeline today represents an unprecedented opportunity to deliver a life-changing impact for millions of patients while enhancing value for all of our stakeholders,” he added.
AbbVie Settles Humira Patent Litigation
Abbvie announced that it had settled its Delaware patent infringement suit against Boehringer Ingelheim regarding their proposed biosimilar version of AbbVie’s rheumatoid arthritis drug, Humira.
Under the terms of the resolution, AbbVie will grant Boehringer Ingelheim a non-exclusive license to its Humira-related intellectual property in the United States beginning on July 1, 2023 in exchange for royalties on net sales of the biosimilar product named Cyltezo.
“This is an important settlement as it resolves all Humira-related patent litigation in the U.S and provides access for another biosimilar manufacturer seeking to enter the U.S.,” said Laura Schumacher, Vice Chairman, External Affairs and Chief Legal Officer at AbbVie. “As an innovation-driven biopharmaceutical company, we will continue to develop novel cures for the toughest health challenges and rely on a robust patent system to protect that investment in innovation.”
“We are proud of the role we play in raising public awareness of biosimilars and being able to stimulate competition to bring more affordable treatment options to U.S. patients,” said Sheila Denton, Senior Vice President and U.S. General Counsel, Legal & Government Affairs/Public Policy at Boehringer Ingelheim. “This resolution provides clarity regarding the availability of Cyltezo and allows us to focus on serving patients who need to manage their chronic disease.”
Johnson & Johnson’s Invokana Receives FDA Priority Review of sNDA
Johnson & Johnson announced that the FDA granted them Priority Review for their supplemental New Drug Application (sNDA) for Invokana in reducing the risk of end-stage kidney disease, the doubling of serum creatinine, and renal or cardiovascular death in adults with type 2 diabetes and chronic kidney disease. If approved for this new indication, Invokana will be the first and only diabetes medicine to treat chronic kidney disease in patients with type 2 diabetes.
The FDA granted the drug a Priority Review based on an outcomes trial showing Invokana, combined with standard-of-care treatment, topped the standard of care alone at fending off kidney disease progression. The drug also cut the risk of cardiovascular death and heart failure-related hospitalizations by 31%.
“Millions of people with type 2 diabetes will develop chronic kidney disease,i,ii which leads to a high risk of progressing to kidney failure and developing CV disease.iii We are pleased the FDA recognizes the urgency to deliver a novel treatment that can reduce the risk of kidney failure and prevent life-threatening cardiovascular events in people with type 2 diabetes and chronic kidney disease,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “This Priority Review designation brings us one step closer to addressing this major unmet need and providing a new standard of care to those living with this serious condition.”
The FDA grants Priority Review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. This designation shortens the review period to six months compared to ten months for Standard Review.
Bristol-Myers Squibb to Sell Otezla for Celgene Merger
Bristol-Myers Squibb (BMS) announced plans to divest itself of the psoriasis drug Otezla as part of its planned acquisition of Celgene, in order to address what they called “concerns” raised by the U.S. Federal Trade Commission (FTC) regarding the deal.
“Bristol-Myers Squibb is committed to working with regulatory authorities around the world on the proposed combination with Celgene. The company is focused on realizing the promise of the transaction, and is continuing to work to complete the transaction on a timely basis,” the company said in a securities filing.
The divestiture is subject to further review by the FTC and requires BMS to enter a consent decree with the commission. BMS acknowledged that its purchase of Celgene would take longer to close than initially anticipated – “at the end of 2019 or the beginning of 2020,” rather than during the third quarter as predicted when the deal was announced in January.
Additionally, BMS is currently developing its own autoimmune disease drug candidate, BMS-986165, for indications that include psoriasis.
“The company is continuing to develop its promising immunology pipeline asset, tyrosine kinase 2 (TYK2) inhibitor, in several autoimmune diseases, including psoriasis,” BMS stated. “Bristol-Myers Squibb looks forward to advancing its leadership in core areas of focus, including immunology, and delivering highly innovative medicines that bring meaningful benefits to patients as a combined company.”
Novartis Completes Acquisition of Xiidra
Novartis announced that it has completed its acquisition of dry eye drug Xiidra 5% from Takeda.
Xiidra (lifitegrast ophthalmic solution) is the first and only prescription treatment approved by the FDA for both signs and symptoms of dry eye disease, with a mechanism of action that targets inflammation.
“This deal delivers on our ongoing commitment to reimagine medicine for patients suffering from a variety of eye diseases, while also laying critical groundwork for future, potential front-of-the-eye pipeline products we have in development.” Said Marie-France Tschudin, President, Novartis Pharmaceuticals.
“The completion of this transaction marks an important step in executing Takeda’s strategy, which is focused on optimizing our portfolio around the key business areas that are core to our long-term growth and creating the most value for our patients and shareholders,” said Christophe Weber, President and Chief Executive Officer of Takeda. “We are making solid progress on our commitment to simplify our portfolio and meet our deleveraging targets, while continuing to deliver highly-innovative medicines and transformative care to patients around the world and enhance long-term shareholder value. We are proud of the benefits Xiidra has created for patients as part of Takeda, and confident that Novartis will be a strong steward of this innovative therapeutic.”
GSK’s Dovato Meets Primary Study Endpoints
GlaxoSmithKline’s HIV subsidiary, ViiV Healthcare announced that the late-stage study evaluating it newly approved, single-tablet two-drug combination of dolutegravir and lamivudine HIV regimen, Dovato, met the primary endpoint.
The phase III TANGO study assessed the antiviral efficacy and safety of switching to Dovato in HIV-1 infected patients, who are virally suppressed and stable on a three-drug tenofovir alafenamide fumarate (TAF)-based regimen.
The 48-week data from the study showed that Dovato was non-inferior in maintaining viral suppression in such patients compared with the TAF regimen, thereby achieving the study’s primary goal. The study also confirmed that no patients met virologic withdrawal criteria or developed any treatment resistance with Dovato.
“When we developed the TANGO study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression. These Week 48 data clearly indicate that they can – individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to a 2-drug regimen of dolutegravir plus lamivudine.” said Kimberly Smith, head of global research & medical strategy at ViiV Healthcare.
Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science later this month.
FDA Updates Website
The FDA recently launched a revamped FDA.gov website, designed to be more user-friendly and easily viewable on any device. They provided the following goals for the improved website:
- Remodeled webpages that can be viewed on any internet-ready device
- Easier access to popular content
- Updated navigation based on data and audience behavior
- Easier to find FDA content in search results
- Better consistency of FDA content across web and social channels
The updated FDA.gov’s design will provide more visuals and interactive content and has a modern look-and-feel.
Nearly 5 million people visit the FDA’s public website each month, the agency said in an announcement. “It serves as the face of the agency and a critical vehicle for meeting FDA’s mission, as it’s home to agency policy and perspectives and information about recalls, safety alerts and important regulatory actions,” the agency said. “Ensuring that this content is easy to find is a top priority.”