Sandoz preps early ’19 launch for EpiPen alternative Symjepi at 16% discount

Only days after Teva launched its generic to Mylan’s EpiPen, Novartis’ Sandoz has released launch plans for its own epinephrine injector product. Sandoz’s Symjepi won FDA approval in September, and on Thursday the company said it will launch in early 2019 at a slight discount to options from Mylan and Teva.

While Teva opted not to release its medication with a list-price discount compared with Mylan’s authorized generic, Sandoz is going with a 16% discount.

Sandoz’s two-pack will hit the market with a list price of $250, while Teva and Mylan injectors cost $300 for a two-pack.

Sandoz is “well underway to ensure appropriate supply of this life-saving medicine for healthcare professionals and patients in need of a new treatment option,” according to a Thursday release.

Adamis Pharmaceuticals developed Symjepi and licensed U.S. rights to the epinephrine injector to Sandoz in July. The product won FDA approval in September.

Thursday’s news follows Teva’s generic EpiPen launch late last month. That drugmaker suffered two years of regulatory delays and finally won approval in August.

Earlier in the EpiPen saga, Mylan faced criticism for routine price hikes that took branded EpiPen’s price to more than $600 for a two-pack. Amid the controversy, the company said it would release an authorized generic, which now costs $300 for a two-pack.

Due to new competition and new scrutiny on its big-selling injector, EpiPen sales fell $655 million last year, Mylan disclosed.

https://www.fiercepharma.com/pharma/sandoz-preps-early-2019-launch-for-epipen-alternative-symjepi-at-16-discount

FDA OKs Genentech Combo With Chemo for Lung Cancer

– Approval based on survival benefit of Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), in people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations compared to Avastin plus chemotherapy –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq^®(atezolizumab), in combination with Avastin^® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

“This Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Today’s approval supports our combination approach for Tecentriq in lung cancer and our vision to develop medicines that improve outcomes for patients with this complex disease.”

This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer compared to Avastin and chemotherapy (median overall survival [OS] = 19.2 versus 14.7 months; hazard ratio [HR] = 0.78; 95 percent CI: 0.64-0.96; p=0.016) in the intention-to-treat wild-type (ITT-WT) population. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

Genentech is working with the FDA on postmarketing commitments (PMCs) to better understand and characterize the potential effects of Tecentriq-related anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) across all of our studies. An analysis of ADAs in the IMpower150 study showed no impact on the efficacy of Tecentriq.

Tecentriq is also approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK genetic alterations.

https://www.marketscreener.com/ROCHE-HOLDING-LTD-9364975/news/Roche-FDA-Approves-Genentech-rsquo-s-Tecentriq-in-Combination-With-Avastin-and-Chemotherapy-for-th-27718762/

Celgene, bluebird Complete Enrollment of Car T Cell Therapy Myeloma Study

Celgene Corporation(Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) announced the completion of enrollment for the KarMMa pivotal study of bb2121, the companies’ lead investigational anti-BCMA CAR T cell therapy candidate for patients with relapsed and refractory multiple myeloma. bb2121 is being developed as part of a Co-Development, Co-Promote and Profit Share Agreement between Celgene and bluebird bio (see also Celgene Corporation).

“We continue to be excited about bb2121 as a potential first-in-class BCMA-targeted therapy for patients with multiple myeloma,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “We would like to thank everyone who enabled this achievement, especially the patients and caregivers, and we congratulate the physicians and others involved in the KarMMa study, including our dedicated partners at bluebird bio. We look forward to seeing the data from this study and are progressing our broader bb2121 development program as we advance closer toward delivering this important new option to appropriate patients in need.”

“We are committed to developing new treatment options to improve the care of patients with multiple myeloma, and completing enrollment of the KarMMa study moves us closer to this goal,” said David Davidson, M.D., chief medical officer, bluebird bio. “As we advance our clinical studies of bb2121 in earlier lines of therapy in collaboration with our partners at Celgene, we remain very grateful to the patients, families and healthcare providers who have made this program possible.”

KarMMa is a pivotal, open-label, single-arm, multi-center phase 2 study evaluating the efficacy and safety of bb2121 in patients with relapsed and refractory multiple myeloma. In November 2017, bb2121 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration and PRIority Medicines (PRIME) eligibility by the European Medicines Agency. The BTD designation and PRIME eligibility were based on preliminary clinical data from the phase 1 CRB-401 study.

The FDA action date for the bb2121 NDA is anticipated in 2020. bb2121 is currently an investigational therapy; safety and efficacy have not yet been established. bb2121 has not been approved for use by any health authority.

https://www.marketscreener.com/CELGENE-CORPORATION-8736/news/Celgene-Corporation-and-bluebird-bio-Complete-Enrollment-of-Pivotal-KarMMa-Study-of-anti-BCMA-Car-27717633/

Akorn falls following appeals court hearing in Fresenius fight

Shares of Akorn (AKRX) are down 20% following an appeals court hearing in Delaware on Wednesday regarding Fresenius (FSNUY) being allowed to terminate the companies’ merger agreement. In the appeals hearing, Akorn argued that a trial judge improperly rewrote state law and used “guesswork” in permitting Fresenius to walk away, according to a recount of events provided by Bloomberg. “Akorn seems to be facing an uphill battle because it’s not just one finding they need to overcome, but there seems to be several independent basis for lower court findings,” MDC Financial Research’s Michael Cohen told Bloomberg in a phone interview. Separately, RBC analyst Randall Stanicky stated that the arguments at the appeal were largely “recycled” from the trial, but that Akorn appeared to face the “higher burden” of questioning, Bloomberg added. In afternoon trading the day after the hearing, Akorn shares have slid $1.30, or 20%, to $5.18. On October 1, Delaware Chancery Court Judge Travis Laster ruled that Fresenius had proper grounds for canceling its $34 per share buyout of the generic drugmaker.
https://thefly.com/landingPageNews.php?id=2833229

Novartis says BYL719 plus fulvestrant ‘consistently’ improved PFS in trial

Novartis (NVS) announced additional analysis from the global Phase III SOLAR-1 trial investigating the alpha-specific PI3K inhibitor BYL719 in combination with fulvestrant in men and postmenopausal women with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer. In SOLAR-1, the addition of BYL719 to fulvestrant nearly doubled median progression-free survival in patients with PIK3CA mutated HR+/HER2- advanced breast cancer who progressed on or after an aromatase inhibitor compared to fulvestrant alone. In this analysis, BYL719 plus fulvestrant also showed consistent clinically meaningful treatment benefit after progression on an AI or after receiving up to one additional line of therapy for advanced breast cancer. These data will be presented today during an oral presentation at the 2018 San Antonio Breast Cancer Symposium. BYL719 in combination with fulvestrant consistently improved median PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer who progressed within 12 months of AI treatment or received up to one additional line of therapy for advanced breast cancer. Mutation status of participants in SOLAR-1 was identified by a clinical trial assay developed by Qiagen (QGEN). A significant PFS benefit was observed for BYL719 plus fulvestrant in patients with a PIK3CA mutation regardless of whether the mutation was identified by a tumor tissue test or ctDNA test, suggesting the potential viability of using liquid biopsies to identify PIK3CA mutation status. Novartis has entered into agreements with both Qiagen and Foundation Medicine to develop flexible companion diagnostic solutions for BYL719 that utilize both tumor tissue and plasma sample types.

https://thefly.com/landingPageNews.php?id=2833127

Qiagen, Novartis collaborate to develop companion diagnostic

QIAGEN (QGEN) announced that a clinical development program is underway with Novartis (NVS) to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer. The Novartis drug candidate is in late-stage development, and QIAGEN expects to provide its companion diagnostic to clinical laboratory partners who will then be ready to offer immediate access to the test upon potential regulatory approvals of BYL719 and QIAGEN’s test. Novartis has completed a Phase III clinical trial, testing BYL719 in combination with fulvestrant for patients with PIK3CA mutated HR+/HER2- advanced breast cancer. QIAGEN’s companion diagnostic for PIK3CA mutations will provide a complete Sample to Insight workflow, from DNA extraction to detection of the clinically relevant mutations and final reporting. The test will be clinically validated for analysis of both FFPE tissue and liquid biopsy samples using plasma. The companion diagnostic will run on the Rotor-Gene Q MDx cycler, which is part of the modular QIAsymphony family of automation solutions, established in numerous pathology laboratories worldwide.

https://thefly.com/landingPageNews.php?id=2833141

Puma Presents Phase 2 Breast Cancer Results at San Antonio Conference

Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that results from an ongoing Phase II clinical trial of Puma’s drug neratinib are being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas. The presentation entitled, “Neratinib + fulvestrant for HER2-mutant, HR-positive, metastatic breast cancer: Updated results from the phase 2 SUMMIT trial,” are being presented at a Spotlight Session by Lillian M. Smyth, M.D., Breast Medicine Service and Early Drug Development Service, Memorial Sloan Kettering Cancer Center, an investigator of the trial.

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX^® (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission for the extended adjuvant treatment of hormone receptor-positive HER2-positive early stage breast cancer in September 2018.

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 or HER3 mutations. In the HER2-mutant, HR-positive breast cancer cohort, 47 patients received 240 mg of neratinib daily in combination with fulvestrant at the labeled dose. In this cohort, 43 patients (92%) had HER2-non-amplified disease, and patients had received a median of 3 prior lines of therapy in the metastatic setting (range 0-11 prior regimens) before entering the trial. All patients had been previously treated with an endocrine agent prior to entering the study, including 25 patients (53%) who had received prior fulvestrant. Further, 20 patients (43%) received prior cyclin-dependent kinase 4/6 (CDK4/6)-inhibitor therapy.

https://www.biospace.com/article/releases/puma-biotechnology-presents-results-from-the-phase-ii-summit-trial-of-neratinib-for-erbb2-her2-mutant-her2-non-amplified-metastatic-breast-cancer-at-the-2018-san-antonio-breast-cancer-symposium/