FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio(TM) (abemaciclib) as Initial Treatment of Advanced Breast Cancer
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for its New Drug Application (NDA) for Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. The NDA was based upon the positive interim results from MONARCH 3, a study of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The results were presented at the European Society for Medical Oncology (ESMO) 2017 Congress, and recently published in the Journal of Clinical Oncology."On the heels of our recent FDA approval of Verzenio, we are pleased with this important step forward in the agency's consideration to expand the use of Verzenio in metastatic breast cancer," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "We look forward to ongoing collaboration with the FDA to advance this important treatment across the spectrum of care for patients living with advanced or metastatic breast cancer."Priority Review aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment. With Priority Review of a new drug, the FDA's goal is to take action within eight months of receiving an application, compared with the standard review timeframe of 12 months.1In the third quarter of 2017, Lilly completed EU and Japan regulatory submissions for abemaciclib.
CAMBRIDGE, England & CAMBRIDGE, Mass.--(EON: Enhanced Online News)--Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, today announced that it has been recognised by Biotech and Money, a community of senior life science decision makers, as the Private Life Science Growth Company of the Year. In addition, the company received the award of Best Platform Technology at the World ADC Awards. Presented during the World ADC Conference, the award acknowledges the best linker or payload platform technology and is selected for the system’s novelty and originality as well as scientific and commercial validation of the platform.“We are honoured to be recognised by Biotech and Money and the World ADC Conference for our progress in pioneering our innovative new class of therapies for cancer and other diseases of high unmet need” “We are honoured to be recognised by Biotech and Money and the World ADC Conference for our progress in pioneering our innovative new class of therapies for cancer and other diseases of high unmet need,” said Kevin Lee, Ph.D., Bicycle’s Chief Executive Officer. “Our team is working with urgency to advance our deep and robust pipeline of Bicycles, including our lead molecule BT1718, which will enter clinical development in partnership with Cancer Research UK in the near future. These awards are a testament to our efforts, and to the great potential for Bicycles to transform the treatment paradigm for patients with cancer and other hard to treat diseases.”Bicycles are a brand new class of chemically synthesised molecules designed to rapidly and selectively penetrate tumours while minimising exposure to healthy tissue. They are cleared quickly by the kidneys; avoiding liver toxicity often associated with other drug classes. Bicycles can be used as stand-alone therapeutic entities, as tandem or multimeric Bicycles to modulate more than one target, or chemically coupled to deliver a variety of payloads.In addition to these two awards, Bicycle’s scientific founder, Sir Gregory Winter, received an award for individual input to the drug conjugate field in 2016 at the World ADC awards. Bicycle has also been named a finalist in three categories for the 2017 Scrip Awards, which will be announced on November 29.“I am delighted to be recognized by the World ADC conference for my contributions to Bicycle Therapeutics,” said Sir Gregory Winter, one of Bicycle’s scientific founders. “Using low molecular weight, bicyclic peptides for the targeted delivery of toxic payloads is an exciting application of this technology and I look forward to seeing the clinical data.”About Bicycle TherapeuticsBicycle Therapeutics is developing a new class of medicines to treat oncology and other important diseases based on its proprietary bicyclic peptide (Bicycle®) product platform. Bicycles® exhibit the affinity and exquisite target specificity usually associated with antibodies. Their small size enables rapid and deep tissue penetration, allowing tissues and tumours to be targeted from within. Their peptidic nature provides a “tuneable” pharmacokinetic half-life and a renal route of clearance, thus avoiding the liver and gastrointestinal tract toxicity often seen with other drug modalities. Bicycle Therapeutics is rapidly advancing towards the clinic with its lead programs using Bicycle Drug Conjugates® to selectively deliver toxins to tumours. Bicycle Therapeutics is collaborating in oncology and other areas to realise the full potential of the technology. Bicycle Therapeutics’ unique intellectual property is based on the work initiated at the MRC Laboratory of Molecular Biology in Cambridge, U.K., by the scientific founders of the company, Sir Gregory Winter and Professor Christian Heinis. Bicycle Therapeutics is headquartered in Cambridge, U.K., with a U.S. subsidiary in Cambridge, Massachusetts. For more information, visit www.bicycletherapeutics.com.
InDex Pharmaceuticals Gets New Patent in the US
InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod will be issued by the United States Patent and Trademark Office (USPTO). The patent provides additional protection for treating chronic active ulcerative colitis in patients that are not responding or are intolerant to anti-inflammatory therapy, wherein cobitolimod is not administered in combination with corticosteroid or glucocorticosteroid. The continuation patent, entitled Method for prevention of colectomy (patent number 9795627), will provide an exclusivity period until November 2032, with the possibility of up to 5 years term extension after market approval. “This new patent constitutes a valuable complement to our existing portfolio of granted patents for cobitolimod in the US,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “The patent covers the use of cobitolimod for treatment of ulcerative colitis in patients with or without a history of steroid use when cobitolimod is not administered in combination with steroids, and it is not limited to certain dosing regimens of cobitolimod.” The USPTO has notified the company that the patent will be issued on October 24, 2017. Corresponding patent applications have been or will be filed in Europe, Japan and Canada and will be diligently prosecuted to grant. For more information: Peter Zerhouni, CEO Phone: +46 8 508 847 35 E-mail: firstname.lastname@example.org
Merck KGaA, Darmstadt, Germany, Opens New Life Science Center for Scientific Collaboration
• Massachusetts Gov. Charlie Baker and company executive board members cut the ribbon on new Life Science Center in Burlington, Massachusetts, USA • Company convenes scientific symposium with leaders in Genome Editing, eCommerce and Big Data • New Life Science Center includes an M Lab™ Collaboration Center and region’s first BioReliance® Biodevelopment CenterDarmstadt, Germany, October 11, 2017 – Merck KGaA, Darmstadt, Germany, a leading science and technology company, today officially opened its new Life Science Center in Burlington, Massachusetts. The new center serves as a regional hub for scientific advancement and customer collaboration.
Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio(TM) (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer
PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that its Phase 3 JUNIPER study evaluating Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). However, an analysis of the secondary study endpoints of both progression-free survival (PFS) and overall response rate (ORR) showed evidence of monotherapy activity in the abemaciclib arm. In addition, the control arm showed a higher overall survival rate than expected based on historical data in this setting. Lilly will submit the data for presentation at a medical meeting in 2018."While the outcome is unfortunate for patients with KRAS-mutated, advanced lung cancer, we remain encouraged by the antitumor activity observed with abemaciclib in this form of lung cancer where few clinical advances have been achieved," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology.Dr. Garraway added, "As we analyze secondary endpoints and explore specific patient subgroups in order to better evaluate the prospects for abemaciclib in NSCLC, we will continue to work with the oncology community to inform potential future treatment avenues for patients with KRAS-mutated advanced lung cancer. Moreover, we have several studies ongoing of rational combinations that include abemaciclib in non-small cell lung cancer and other malignancies. We look forward to seeing the results of these studies."JUNIPER, a global Phase 3, interventional, open-label study was designed to evaluate the efficacy and safety of abemaciclib versus erlotinib in patients with stage IV NSCLC with a detectable KRAS mutation, who have progressed after platinum-based chemotherapy and who may have received one additional systemic therapy. A total of 453 patients were randomized to receive 200 mg of abemaciclib orally twice a day on a continuous dosing schedule, every 12 hours or 150 mg of erlotinib administered at its approved dose and schedule until disease progression, death or unacceptable toxicity. The primary endpoint of the study was OS, with key secondary endpoints of safety, ORR, and PFS. The adverse events were generally consistent with previous studies of abemaciclib, with the most common adverse events being diarrhea, fatigue, decreased appetite, and nausea.
Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids
Potential First-in-Class, Oral Treatment for a Condition Affecting an Estimated 26 Million U.S. Women(1) If Approved, First Oral Therapy to Demonstrate Efficacy and Safety for Uterine Fibroids in Two U.S. Pivotal Studies DUBLIN , Oct. 10, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the New Drug Application (NDA) for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids. Allergan plc logo "Women with symptomatic uterine fibroids may suffer from physical and emotional distress2,3 without realizing their symptoms are caused by a treatable medical condition," said David Nicholson , Ph.D., Chief Research and Development Officer, Allergan . "Even when diagnosed, women in the U.S. are faced with limited treatment options. We are eager to continue working with the FDA on the potential approval of the first, once-daily oral treatment for abnormal uterine bleeding in women with uterine fibroids." "Uterine fibroids have a serious impact on public health, and I am hopeful ulipristal acetate will offer millions of women a new, non-surgical treatment option that will help them manage their uterine fibroids," said Millie A. Behera M. D ., FACOG, Reproductive Endocrinology and Fertility Medical Director, Bloom Reproductive Institute . "It is welcome news for physicians to learn about the possibility of an oral treatment option, and that's exactly what U.S. physicians can look forward to if the investigational drug ulipristal acetate is approved for abnormal uterine bleeding in women with uterine fibroids." Allergan expects the ulipristal acetate Prescription Drug User Fee Act (PDUFA) action date to occur in the first half of 2018. About Uterine Fibroids According to an analysis published by the Agency for Healthcare Research and Quality (AHRQ), an agency within the United States Department of Health and Human Services , in the United States an estimated 26 million women between the ages of 15 and 50 years old have uterine fibroids,1 and at least half of these women have symptoms that may impact the routine activities of their daily lives. Common symptoms include heavy menstrual bleeding, long menstrual cycles, irregular menstrual cycles, anemia, pelvic pain, pelvic pressure and urinary symptoms.2 These symptoms can be associated with iron deficiency, fatigue, pain, social embarrassment, interference with daily and social activities as well as lost productivity in the work place.2,3 Currently, surgery is a common treatment option for symptomatic uterine fibroids. In fact, uterine fibroids are responsible for over 350,000 hospitalizations and are the leading cause of hysterectomies, accounting for more than one-third of all hysterectomies annually in the U.S.4 The economic burden of uterine fibroids is also large, costing the economy up to billion each year.4 About Ulipristal Acetate Ulipristal acetate, an investigational drug in the U.S. for the medical treatment of abnormal uterine bleeding in women with uterine fibroids, is a selective progesterone receptor modulator (SPRM), which acts directly on the progesterone receptors in three target tissues: the endometrium (uterine lining), uterine fibroids, and the pituitary gland. In the U.S, the safety and efficacy of ulipristal acetate has been evaluated in two North American Phase 3 studies (Venus I and VENUS II) of more than 500 adult women of reproductive age. Ulipristal acetate is protected by a patent that expires in 2029. In addition to the Venus I and II trials, the efficacy of ulipristal acetate has been demonstrated in a series of four, multi-center, Phase 3, European trials involving more than 1,000 women with uterine fibroids. In Europe, ulipristal acetate is marketed under the trade name Esmya® by Gedeon Richter . In Canada, ulipristal acetate is available under the trade name FibristalTM and marketed by Allergan . Esmya® and FibristalTM are currently approved for the pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. To date, approximately 500,000 women have been treated with ulipristal acetate for fibroids in over 70 countries worldwide.5 About Allergan Women's Healthcare Allergan is a leader in women's healthcare that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women's healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women's Healthcare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women. About Allergan plc Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland , is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs currently in development. Allergan's success is powered by our more than 18,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. For more information, visit Allergan's website at www.Allergan.com.
ASTRAZENECA PLC ANNOUNCES TAGRISSO GRANTED BREAKTHROUGH THERAPY DESIGNATION BY US FDA
TAGRISSO GRANTED BREAKTHROUGH THERAPY DESIGNATION BY US FDA FOR THE 1ST-LINE TREATMENT OF PATIENTS WITH EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG CANCERAstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The Breakthrough Therapy Designation acknowledges not only Tagrisso's potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease. The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis." The FDA granted the BTD based on data from the Phase III FLAURA trial of Tagrisso versus standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy in previously-untreated patients with locally-advanced or metastatic EGFR mutation-positive NSCLC. In the trial, median progression-free survival was nearly double at 18.9 months for Tagrisso compared with 10.2 months for current 1st-line EGFR TKIs (erlotinib or gefitinib). Improvements were seen in all pre-specified subgroups, including patients with and without brain metastases. Tagrisso was well tolerated with a safety profile consistent with previous experience. On 28 September 2017, the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the 1st-line treatment of patients with locally-advanced or metastatic EGFR mutation-positive NSCLC. The use of Tagrisso for the 1st-line treatment of patients with locally-advanced or metastatic EGFR mutation-positive NSCLC is not yet FDA approved. However, Tagrisso is currently approved in more than 50 countries, including the US, EU, Japan and China, as 2nd-line treatment for patients with advanced NSCLC who progress following treatment with an EGFR TKI due to the EGFR T790M resistance mutation. This is the sixth BTD that AstraZeneca has received from the FDA for an oncology medicine since 2014. BTD is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need. About NSCLC Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths, more than breast, prostate and colorectal cancers combined. Approximately 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC. These patients are particularly sensitive to treatment with currently-available EGFR TKIs, which block the cell-signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to EGFR TKI treatment leading to disease progression. Approximately half of patients develop resistance to approved EGFR TKIs such as gefitinib and erlotinib due to the resistance mutation, EGFR T790M. Tagrisso also targets this secondary mutation that leads to disease progression. There is also a need for medicines with improved CNS efficacy, since approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis. About Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system (CNS) metastases. Tagrisso 40mg and 80mg once-daily oral tablets have been approved in more than 50 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being investigated in the adjuvant setting and in combination with other treatments. About FLAURA The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg once daily vs standard-of-care EGFR TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. The trial was a double-blinded, randomised study, with 556 patients across 30 countries. The primary endpoint of the trial was progression-free survival (PFS), and secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety, and measures of health-related quality of life (HRQoL).
Medtronic Endurant(TM) II/IIs Stent Graft System Receives FDA Approval to Treat Short Neck Anatomies When Used with Heli-FX(TM) EndoAnchor(TM) System
New Indication Expands Treatment Options for AAA Patients with Hostile Neck AnatomyDUBLIN - October 9, 2017 - Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60° infra-renal angulation when used in combination with the Heli-FX(TM) EndoAnchor(TM) system. The expanded indication enables the Endurant II/IIs stent graft to be used in conjunction with the Heli-FX EndoAnchor system to treat a wider range of patients with short, hostile aortic neck anatomies, independent of renal stenting.Until now, some patients with short infra-renal necks (<10mm) were considered ineligible for endovascular aneurysm repair (EVAR), leaving them with limited treatment options. Up to 30 to 40 percent of patients with AAA disease are considered unsuitable candidates for conventional EVAR.1 According to estimates from physicians across Europe and the United States, more than one-third of these patients have AAA proximal neck anatomies <= 10mm.2"Due to the complex and hostile proximal aortic neck anatomy, this patient population remains a challenge to treat," said William Jordan, Jr., M.D., professor of surgery and chief, Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine and co-principal investigator of the ANCHOR registry. "With minimal time added to the procedure, EndoAnchor fixation has been proven to enhance outcomes and durability, establishing a new treatment approach that addresses this critical patient need."The FDA approval is supported by a short neck cohort of the ANCHOR registry, a global multi-center, multi-arm, prospective, post-market registry evaluating the real-world applicability of the Heli-FX EndoAnchor system. Led by co-principal investigators Dr. Jordan and Jean-Paul de Vries, M.D., chief of Vascular Surgery at St. Antonious Hospital in Nieuwegein, the Netherlands, outcomes from a sub-analysis of 70 patients with proximal AAA neck lengths <10mm down to 4mm who were treated with Endurant and Heli-FX demonstrated a technical success rate of 88.6 percent, based on delivery and deployment of the stent graft and each EndoAnchor implant used, and a 97.1 percent procedural success rate (investigator-assessed), with a rate of 1.9 percent proximal type Ia endoleaks at one year. Additionally, there was only one type Ia endoleak that resulted in a secondary procedure through one year.At one year there were no AAA expansions or instances of main body migration and through one year, no instances of AAA ruptures. There was minimal EndoAnchor implant time added to the overall procedure, with an average of 17 minutes."The acquisition of Aptus Endosystems in 2015 demonstrated our deep-rooted commitment to investing in solutions that treat complex aortic disease, and this new indication expansion for the Endurant II/IIs stent graft system is a significant milestone that underscores our promise to improve patient outcomes in partnership with the clinician community," said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "With the use of the Heli-FX Endoanchor system, physicians can now provide durable seal and fixation with a proven stent graft technology to expand care to patients with hostile neck anatomies."About the Endurant(TM) II/IIs Stent Graft System The Endurant II/IIs stent graft system is based on the leading Medtronic Endurant stent graft system, which is selected for nearly one of every two endovascular AAA repairs globally resulting in nearly 300,000 successful implants. The original Endurant system received the CE (Conformité Européenne) Mark in June 2008 and approval from the FDA in December 2010. The Endurant II/IIs stent system is approved in the U.S. for neck lengths >=10 mm and <=60° infra-renal angulation. With the new indication expansion, Endurant with Heli-FX EndoAnchor system has been approved by the FDA for use in patients with shorter neck lengths (less than 10mm down to 4mm).Additionally, in December 2016, Medtronic received CE Mark for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients using a ChEVAR procedure.About the Heli-FX and Heli-FX(TM) Thoracic EndoAnchor Systems The Medtronic Heli-FX and Heli-FX Thoracic EndoAnchor systems feature an endovascular-deployed anchor designed to attach a variety of aortic endografts to the native vessel wall. This off-the-shelf, customized solution minimizes the need for complicated procedures for the select subset of patients who would benefit from supplementary fixation including patients with challenging anatomies, risk factors for a secondary intervention, existing seal complications, as well as in situations where a physician may intraoperatively determine the need for additional security.The Heli-FX system is cleared by the FDA for distribution in the U.S. and has been granted CE Mark for distribution in the European Union. Both products are also commercialized in other countries worldwide. The Heli-FX EndoAnchor system can be used with a wide variety of commercially available stent grafts, including the Medtronic Endurant and Valiant(TM) stent graft systems.In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.