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Thursday, December 6, 2018

Big pharma’s off-patent drugs lose out in China’s new price-cutting scheme


In a Battle of Waterloo-style defeat, off-patent drugs from big pharma firms lost major markets in China as the government adopted a novel procurement scheme to slash generic drug costs. But after steep price cuts, local firms aren’t considered winners, either.
Among the 31 drugs China’s newly formed health insurance watchdog listed for procurement in a pilot program, multinational pharmas participated in bidding to supply almost all of them, but landed only two contracts, according to multiple local reports of preliminary tender results.
The drugs all have generic versions available in China and include prominent brands such as Pfizer’s Lipitor, AstraZeneca’s Crestor, Sanofi’s Plavix, Gilead’s antiviral Viread (marketed by GSK in China), Novartis’ Gleevec and Lilly’s Alimta, among others. In the end, only AstraZeneca’s EGFR inhibitor Iressa and Bristol-Myers Squibb’s heart drug Monopril won their fights against local copycats.
Just how important is the procurement?
The Chinese government is testing a bulk purchase scheme for 11 major cities, including Beijing and Shanghai. On average, these cities make up about 30% of China’s total drug sales, local media reported. Each city calculated its annual demand at public hospitals—where most prescriptions in China are filled—for each drug and allocated around 30% to 50% share of that purchasing to a bidding pool, down from the previously rumored 60% to 70%, according to a tally by brokerage firm China Galaxy Securities as cited by local publication Healthcare Executive.
The winner takes all: The successful bidder on a particular drug walks away with the entire guaranteed purchase amount from all 11 cities.
Pocketing that kind of huge market should be a huge win for drugmakers. Why, then, did the MSCI China Health Care Index fall 8.4% Thursday, its largest decline since 2009, according to Bloomberg? As with any government-led drug purchases in China, huge price cuts are expected. Not to mention this is the first time drug procurement bids carried purchase amount promises with them.

The fight on this initial round was brutal to say the least. According to local reports, for drugs with three or more bidders, the lowest tender price was automatically chosen. Chia-tai Tianqing Pharma, for instance, cut its price by 90% to win a contract for hepatitis B treatment entecavir, as a generic to BMS’ Baraclude. Shares in the Chinese company’s parent firm, Sino Biopharmaceutical, plummeted 14% in Hong Kong Thursday.
While the official results have yet to be announced, the size of the price cuts appear to have gone beyond market expectations, and the example put a chilling effect on biopharma companies that didn’t even make the cut this time. Fosun Pharma saw its shares tumble 8.6% at the news. Even Chinese CRO giant WuXi AppTec dropped more than 6%. One of the few exceptions was Zhejiang Huahai Pharmaceutical, whose carcinogen-tainted valsartan API triggered a global recall recently. After it reportedly won the most tenders—six in total—its stock climbed 3%.
For all biopharma companies, foreign or domestic alike, winning such bulk purchase bids represent a dilemma. On the one hand, it means a sizeable secured market and savings on marketing efforts; but on the other, lowering prices significantly could put profits at risk.
The new procurement scheme comes at a time when China is pushing for wider adoption of generic drugs to drive down overall health spending and make room to adopt new innovative drugs in its national drug reimbursement system.
It could mean a bumpy road ahead for Big Pharma companies, which have enjoyed fast growth in China, thanks in part to some legacy drugs. For a long time, foreign pharma’s original drugs were considered better in China and were not placed in direct competition with local copycats. But those days are gone as the Chinese government inches forward with a campaign to evaluate the bioequivalence between domestically-made generics and their originators.

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.

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.

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.

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.

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.