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Bristol-Myers Squibb Announces Submission of Biologics License Application to the U.S. Food and Drug Administration (FDA) for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

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Bristol-Myers Squibb Announces Submission of Biologics License Application to the U.S. Food and Drug Administration (FDA) for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

Dec 18, 2019: Bristol-Myers Squibb Company announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel) and its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising independently formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with the relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies.

This submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including the diffuse large B-cell lymphoma (DLBCL).

Recently, BMS presented data from this pivotal study at the American Society of Hematology annual meeting. Liso-cel is an investigational compound that is not approved for use in any of the country.

Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL that accounts for three out of every five cases.

Around one-third of patients with DLBCL relapse after receiving first-line treatment, and approx 10% have refractory disease.

In the past, median life expectancy for patients who relapse or are refractory to the current standard of care treatments is approximately six months.

Combining these approaches is a solution of delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-submission-biologics-license-ap

FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for the treatment of locally Advanced or Metastatic Urothelial Cancer

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FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for the treatment of locally Advanced or Metastatic Urothelial Cancer

Dec 18, 2019: Seattle Genetics and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV ™ for the treatment of adult patients with locally advanced or metastatic urothelial cancer for the patients who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or also in a locally advanced or metastatic setting.

PADCEV (approved under the FDA’s Accelerated Approval Program ) is the first FDA approved treatment in the U.S. for these patients.

It is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein situated on the surface of cells and highly expressed in bladder cancer. 

The FDA’s Accelerated Approval Program allows approval of a medicine that is based on a surrogate endpoint if the medicine fills an unmet medical need for the serious condition.

A global, randomized phase 3 confirmatory clinical trial (EV-301) is in progress and is also intended to support global registrations. https://www.oaoa.com/news/business/article_770940b8-3c8e-5154-9d92-40e44354226b.html

astellas.com/en/news/15511

Novartis provides update on (fevipiprant) LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma

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Novartis provides update on (fevipiprant) LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma

Dec 16, 2019: Novartis announced topline results from its pivotal global Phase III LUSTER-1and LUSTER-2 studies examing the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant (QAW039).

The pooled analyses of the LUSTER trials did not meet the clinically relevant entrance for reduction in the rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of  doses (150mg / 450 mg).

The studies included patients who had incorrectly controlled moderate-to-severe asthma (GINA Steps 4 and 5) despite receiving inhaled mid-to-high dose corticosteroids (ICS) and at least one additional controller. The entirety of these results do not support further development of fevipiprant in asthma. Fevipiprant, in general well tolerated, with treatment-emergent adverse events normally balanced across groups and comparable to placebo.

Company continues to invest into respiratory medicines with in-market products Xolair® (severe allergic asthma [SAA] and chronic spontaneous urticaria [CSU]), Ultibro® Breezhaler® (COPD), Phase III investigational products QVM149 (moderate-to-severe asthma), and QMF149 (moderate-to-severe asthma), as well as active research programs covering asthma, COPD and other areas of the high unmet need, such as idiopathic pulmonary fibrosis and sarcoidosis. https://www.novartis.com/news/media-releases/novartis-provides-update-luster-phase-iii-studies-patients-uncontrolled-gina-45-asthma

Roche concludes getting hold of Spark Therapeutics, Inc. to reinforce presence in gene therapy

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Roche concludes getting hold of Spark Therapeutics, Inc. to reinforce presence in gene therapy

Dec 17, 2019: Roche and Spark Therapeutics, Inc. announced the completion of the acquisition following the receipt of regulatory approval from all the government authorities required by the merger agreement.

Roche and Spark together will be able to appreciably improve the lives of patients through innovative gene therapies. 

This acquisition supports our long-lasting commitment in order to bring transformational therapies and innovative approaches to people around the world with serious diseases.

Spark Therapeutics, based in Philadelphia, Pennsylvania, is a fully incorporated, commercial company that is committed to discovering, developing and delivering gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases, also Spark Therapeutics will continue to operate as an independent company within the Roche Group. https://www.roche.com/media/releases/med-cor-2019-12-17b.htm

Enzalutamide Approved by FDA for metastatic castration-sensitive prostate cancer (mCSPC) Treatment

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Enzalutamide Approved by FDA for metastatic castration-sensitive prostate cancer (mCSPC) Treatment

Dec 17, 2019: Pfizer Inc. and Astellas Pharma Inc.recieves the FDA approved (first and only oral treatment) supplemental new drug application for enzalutamide (Xtandi) to treat men with metastatic castration-sensitive prostate cancer (mCSPC).

FDA approved enzalutamide with three distinct types of advanced prostate cancer: non-metastatic and metastatic castration-resistant prostate cancer (CRPC), and mCSPC.

The agency based its approval on results from the randomized phase III ARCHES trial which is designed to evaluate enzalutamide plus androgen deprivation therapy (ADT), compared with the placebo and ADT, in 1,150 men with mCSPC.

Across sites in the US, Canada, Europe, South America, and the Asia-Pacific region, patients were randomized to receive 160 mg of enzalutamide daily or placebo and continued on a luteinizing hormone-releasing hormone agonist or antagonist or had a history of bilateral orchiectomy. https://www.cancernetwork.com/news/fda-approves-enzalutamide-mcspc-treatment

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

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Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

Dec 17, 2019: AstraZeneca and MSD announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for the patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy.

The NDA submission was based on the positive results from the Phase III POLO trial that results in a statistically significant and clinically meaningful improvement in progression-free survival and reduced the risk of disease progression or death by 47% based on a risk ratio of 0.53. 

Lynparza almost doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a average of 7.4 months vs. 3.8 months on placebo.

The advantage of maintenance with Lynparza was seen over and over across a range of clinically meaningful endpoints. From six months onwards, more than double the  patients treated with Lynparza showed no disease progression vs. those on placebo.

In patients with assessable disease at baseline, 23% responded to Lynparza vs.12% on placebo and had a median duration of the treatment in excess of two years (24.9 months) vs 3.7 months on placebo. https://www.astrazeneca.com/media-centre/press-releases/2019/lynparza-recommended-by-fda-advisory-committee-for-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer.html

Takeda collaborates with MiTest Health to Launch Innovative Disease Risk Prediction Tool to Redefine Crohn’s Disease Management

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Takeda collaborates with MiTest Health to Launch Innovative Disease Risk Prediction Tool to Redefine Crohn’s Disease Management

Dec 14, 2019: Takeda and MiTest Health LLC a pioneering health technology company, announced an exclusive partnership to optimize MiTest’s personalized risk and outcome prediction tool for the widespread use in patients with Crohn’s disease (CD).

The validated tool can help predict a patient’s individual potential risk for CD-related complications based on the clinical, serologic and genetic variables and create a visual report to support informed and shared decision-making with their healthcare providers.

Overwhelming complications from CD – such as fistulas, abscesses, strictures, and intestinal obstruction are common, so far the course of CD is highly variable and difficult to predict.

These validated predictive tool was developed by MiTest in 2014 and validated via analysis of a well-characterized cohort of adult patients with CD and predictive modelling and has been used on a limited basis in clinical settings to date.

Takeda will also provide support in scaling up and operationalizing the tool to be more broadly support providers and patients. https://www.takeda.com/en-us/newsroom/news-releases/2019/takeda-partners-with-mitest-health-to-launch-innovative-disease-risk-prediction-tool/

Horizon Therapeutics first FDA-approved medicine Teprotumumab for the Treatment of Thyroid Eye Disease (TED)

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Horizon Therapeutics first FDA-approved medicine Teprotumumab for the Treatment of Thyroid Eye Disease (TED)

Dec. 16, 2019: Horizon Therapeutics announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted collectively about the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), compensate the potential risks for the treatment of Thyroid Eye Disease (TED).

Thyroid Eye Disease is a rare, serious, progressive and vision-threatening autoimmune disease that is related with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement that can appreciably impact patient’s quality of life.

“TED can affect patients both physically and emotionally, limiting their ability in order to perform everyday activities like driving, working, reading, sleeping and participating in social activities”.

At present FDA is evaluating a Biologics License Application (BLA) for teprotumumab for the treatment of TED. https://ir.horizontherapeutics.com/news-releases/news-release-details/fda-advisory-committee-votes-unanimously-support-use

U.S. FDA Approved Avadel’s Nouress™ (AV001), a Cysteine Hydrochloride Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

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U.S. FDA Approved Avadel’s Nouress™ (AV001), a Cysteine Hydrochloride Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

Dec. 16, 2019: Avadel Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition (TPN).

Additionally, Avadel announced that the United States Patent and Trademark Office (USPTO) recently issued the United States Patent No. 10,493,051 covering cysteine solutions that includes the approved Nouress product (listed in the Orange Book for Nouress) and is set to expire in March of 2039.

This validates our strategy for developing innovative medicines for the patients. Nouress is the fourth FDA approved product in the sterile injectable hospital business. https://fda.einnews.com/pr_news/504993767/avadel-pharmaceuticals-receives-u-s-fda-approval-for-nouress-av001-a-cysteine-hydrochloride-injection-for-treating-neonate-patients-requiring

FDA approved Salarius’s Seclidemstat by Fast Track Designation for Lead Drug Candidate, in Relapsed or Refractory Ewing Sarcoma

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FDA approved Salarius’s Seclidemstat by Fast Track Designation for Lead Drug Candidate, in Relapsed or Refractory Ewing Sarcoma

Dec. 16, 2019: Salarius Pharmaceuticals announced that its lead investigational drug candidate, Seclidemstat(a potent reversible LSD1 inhibitor), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Ewing sarcoma for the patients who have relapsed or are refractory to standard-of-care therapy.

Ewing sarcoma is a rare and deadly bone cancer that most often strikes children and young adults, for which there are no targeted therapies approved, Seclidemstat has demonstrated a potential to address this significant unmet need. https://fda.einnews.com/pr_news/504993934/salarius-pharmaceuticals-receives-fda-fast-track-designation-for-lead-drug-candidate-seclidemstat-in-relapsed-or-refractory-ewing-sarcoma

AstraZeneca completed an Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia

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AstraZeneca completed an Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia

Dec 16, 2019: AstraZeneca has completed an agreement with Cheplapharm Arzneimittel GmbH (Cheplapharm) to deprive its commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia.

As per the terms of agreement, AstraZeneca has received a payment of $178m from Cheplapharm,may also receive future sales-contingent payments of up to $61m.

Future payment will be reported in AstraZeneca’s financial statements within the Other Operating Income & Expense in the fourth quarter of 2019.

In the year to 31 December 2018, the cumulative profit before tax referable to Seroquel and Seroquel XR in the relevant territories was $86m.

The deliberation was paid in cash and the profits will be used for general corporate purposes. Seroquel and Seroquel XR are atypical anti-psychotic medicines with antidepressant properties used for the treatment of schizophrenia and bipolar disorder. 

Seroquel XR is also approved in some markets for the major depressive disorder and generalised anxiety disorder.
https://www.astrazeneca.com/media-centre/press-releases/2019/agreement-with-cheplapharm-for-rights-to-seroquel-and-seroquel-xr-in-europe-and-russia-completed-16122019.html

Soligenix initiates phase 1C, double-blind, placebo-controlled, phase 1C trial of RiVax, a lyophilized ricin toxin A-chain subunit vaccine with alum-adjuvant

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Soligenix initiates phase 1C, double-blind, placebo-controlled, phase 1C trial of RiVax, a lyophilized ricin toxin A-chain subunit vaccine with alum-adjuvant

Dec 14, 2019 : Soligenix announced that it has opened the study titled “A phase 1C, double-blind, placebo-controlled, randomised study to evaluate the safety of RiVax, a Lyophilized Ricin Toxin A-Chain subunit vaccine with the Alum-Adjuvant, in healthy, normal adults.” initial safety results from the trial are expected in the second quarter of 2020 with longer-term safety and immunogenicity results from all the way through the 6-month follow-up period expected in the fourth quarter of 2020.

RiVax is the company’s vaccine candidate for the prevention of the death following exposure to a lethal dose of ricin toxin using a unique antigen that is totally devoid of the toxic activity of ricin.

The RiVax antigen has confirmed safety in two previous phase 1 clinical studies. When formulated by using Soligenix’s proprietary heat stabilization technology (ThermoVax), RiVax has demonstrated considerably enhanced thermostability and up to 100% protection in non-human primates (NHPs) in preclinical aerosol challenge models.

RiVax contains a genetically distorted version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule.

A phase 1A clinical trial was conducted with the formulation of RiVax that did not contain an adjuvant. This trial exposed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.

The adjuvant-free formulation of RiVax induced toxin neutralizing antibodies that lasted up to 127 days after third vaccination in the several individuals. http://www.pharmabiz.com/NewsDetails.aspx?aid=119946&sid=2

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