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Friday, January 31, 2020

Celgene withdraws enasidenib application in Europe

Bristol-Myers Squibb (NYSE:BMY) unit Celgene (NASDAQ:CELG) has withdrawn its marketing application in Europe for Idhifa (enasidenib) for the treatment of adults with acute myeloid leukemia (AML).
The company took action after determining that it could not fully address EMA objections. Specifically, the agency concluded that the data supporting the application were insufficient to prove efficacy.
https://seekingalpha.com/news/3536875-celgene-withdraws-enasidenib-application-in-europe

European advisory group backs expanded use of J&J’s Rezolsta

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending an expanded label for Johnson & Johnson (NYSE:JNJ) unit Janssen-Cilag International NV’s HIV med Rezolsta (darunavir/cobicistat) to now include adolescents as young as 12 years old (previously 18 years old) weighing at least 40 kg.
A final decision from the European Commission usually takes ~60 days.
https://seekingalpha.com/news/3536851-european-advisory-group-backs-expanded-use-of-j-and-js-rezolsta

European advisory group backs Pfizer’s crisaborole for atopic dermatitis

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Pfizer’s (NYSE:PFE) Staquis (crisaborole) for the treatment of adults and pediatric patients at least two years old with mild or moderate atopic dermatitis with no more than 40% of body surface area affected.
A final decision from the European Commission usually takes ~60 days.
https://seekingalpha.com/news/3536796-european-advisory-group-backs-pfizers-crisaborole-for-atopic-dermatitis

Bayer Gets EU Panel Recommendation for Prostate Cancer Treatment

Bayer AG said Friday that the European Union’s Committee for Medicinal Products for Human Use has given a positive opinion on its darolutamide medicine as a new treatment for men with a particular type of prostate cancer.
The compound–jointly developed with ORION Corp. (271560.SE)–is recommended for men with non-metastatic castration-resistant prostate cancer who have a high risk of developing metastatic disease, the pharmaceutical firm said.
In most cases a recommendation leads to marketing approval. Bayer said that it expects a decision to be made in the coming months.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-Gets-EU-Medicines-Agency-Recommendation-for-Prostate-Cancer-Treatment-29920247/

EMA Recommends Novo Nordisk Diabetes Drug for Marketing Approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use said Friday that it is recommending Rybelus, a drug developed by Novo Nordisk A/S (NOVO-B.KO), as a treatment for type 2 diabetes.
The committee said this was the first oral glucagon-like peptide, or GLP-1, treatment to be recommended for this indication. This recently-developed class of drugs is a non-insulin medicine for type 2 diabetes which helps regulate insulin levels and has been shown to help achieve weight loss.
“We believe [Rybelus] has the potential to set a new standard for the treatment of type 2 diabetes in the EU,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk.
In most cases a recommendation by the CHMP leads to European marketing approval. Novo Nordisk said it expects to receive marketing authorization in the second quarter. The drug is already approved in the U.S.

https://www.marketscreener.com/NOVO-NORDISK-AS-1412980/news/Novo-Nordisk-EMA-Recommends-Novo-Nordisk-Diabetes-Drug-for-Marketing-Approval-29920377/

Astellas Pharma keeps profit forecast as prostate cancer drug sales rise

Japan’s Astellas Pharma Inc reiterated its full-year operating profit forecast on Friday, as a jump in sales of its prostate cancer drug Xtandi countered overseas acquisition costs.

The company said it expects an operating profit of 263 billion yen ($2.4 billion) for the year ending March 31, higher than analysts’ average expectation of 256 billion yen, according to IBES data from Refinitiv. Astellas reported an annual operating profit of 244 billion yen last year.
Shares in the company closed 2.4% higher in Tokyo compared with a 1% rise in the broader market.
Sales of Xtandi rose 18% to 298 billion yen in the third quarter ended Dec. 31.
However, core operating profit for the quarter was 3.3% lower, hurt partly by a 2.5% drop in revenue from Prograf, used to prevent rejection of organ transplants.
The company also said it will book a one-off charge of about $100 million in the fourth quarter related to its purchase of U.S.-based biotech Audentes Therapeutics Inc.
Astellas, the country’s second-biggest drugmaker by sales, has ramped up overseas acquisitions to broaden its drug pipeline.
The company said in December it would pay up to $665 billion for Xyphos Biosciences Inc to expand its immuno-oncology business. Earlier that month, Astellas said it would purchase Audentes in a deal worth $2.65 billion to expand into genetic medicines.
Both Xyphos and Audentes are based in San Francisco, a hub for biotech companies that are fetching huge premiums for global pharma firms eager to bolster their drug pipelines.
Among other major Japanese pharma companies reporting earnings, Daiichi Sankyo Co, Japan’s fourth-largest drug company by sales, raised its full-year operating profit forecast, citing lower taxes. It expects to earn 135 billion yen in the year ending March 31 versus 125 billion predicted in October.
Eisai Co, the partner of Biogen Inc on Alzheimer’s disease drug candidate aducanumab, maintained its full-year operating profit forecast at 110 billion yen, a 16% increase from last year, driven by sales of its cancer drug Lenvima.
Daiichi Sankyo shares rose 1.6% while Eisai gained 2.2%.

https://www.marketscreener.com/ASTELLAS-PHARMA-INC-6491262/news/Astellas-Pharma-keeps-profit-forecast-as-prostate-cancer-drug-sales-rise-29918320/

AbbVie Venclyxto Gets Positive Opinion from Euro panel

AbbVie said Friday the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for Venclyxto venetoclax in combination with obinutuzumab for the treatment of patients with chronic lymphocytic leukemia who were previously untreated.
The company said the European Commission is expected to deliver its final decision in the first half of 2020.
AbbVie said if Venclyxto is approved by the EC, the venetoclax and obinutuzumab combination would be the first chemotherapy-free option for treatment-naive patients with chronic lymphocytic leukemia where dosing can be completed in one year.
The CHMP positive opinion is based on results from the Phase 3 CLL14 clinical trial, which evaluated the efficacy and safety of Venclyxto in combination with obinutuzumab compared with chlorambucil in combination with obinutuzumab. The primary endpoint was progression-free survival as assessed by an investigator.
Venclyxto is being developed by AbbVie and Roche (RHHBY). It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

https://www.marketscreener.com/ABBVIE-INC-12136589/news/AbbVie-Venclyxto-Gets-CHMP-Positive-Opinion-29920345/