Global Pharma Briefs: News from Novartis, BMS, AstraZeneca

By Miranda Greenberg -

November 5, 2020

A roundup of news from Japan (Lilly, Daiichi Sankyo, Novartis), the UK (AstraZeneca, GSK), and the US (BMS, Novartis, Vedere Bio, Nostrum Laboratories).

Japan

Novartis Gets OK for CAR-T Cell Therapy Mfg Site in Japan
Novartis has received approval from Japan’s Ministry of Health, Labor and Welfare to allow the Foundation for Biomedical Research and Innovation (FBRI), a coordinating body for technology and industry in Kobe, Japan, to manufacture and supply Novartis’ Kymriah (tisagenlecleucel), a chimeric antigen receptor (CAR) T cell (CAR-T) therapy for treating B-cell acute lymphoblastic leukemia.

Novartis has seven CAR-T manufacturing facilities globally. Commercial manufacturing for Kymriah now takes place at five sites globally, including at Novartis’ facility in Morris Plains, New Jersey, where the US Food and Drug Administration recently approved a further increase in manufacturing capacity.

Overall, Novartis conducts CAR-T commercial and clinical trial manufacturing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France, and Morris Plains, New Jersey and through contract manufacturing sites at the Fraunhofer-Institut for Cell Therapy and Immunology (Fraunhofer-Institut für Zelltherapie und Immunologie) in Leipzig, Germany, and now at the FBRI in Kobe, Japan. Manufacturing production at Cell Therapies Pty in Australia and Cellular Biomedicine Group in China is forthcoming.

Source: Novartis


Lilly, Daiichi Sankyo in Pact for Migraine Drug in Japan
Eli Lilly Japan, headquartered in Kobe-shi, Hyogo, Japan, and Daiichi Sankyo have concluded an agreement for a commercialization collaboration in Japan for Lilly’s galcanezumab, a treatment for migraines.

Galcanezumab was approved for the prevention of migraine in September 2018 in the US and is approved in 20 countries globally. Eli Lilly Japan has submitted a new drug application for the drug in Japan. Under the agreement, Eli Lilly Japan will hold a marketing authorization for galcanezumab, and Daiichi Sankyo will take charge of its distribution and sales after marketing approval.

Source: Daiichi Sankyo


UK

AstraZeneca Divests Hypertensive Drugs to Cheplapharm in $400-M Deal
AstraZeneca has agreed to sell the commercial rights of its anti-hypertension drugs, Atacand (candesartan cilexetil) and Atacand Plus (a fixed-dose combination of candesartan cilexetil and hydrochlorothiazide), to Cheplapharm Arzneimittel GmbH, a Greifswald, Germany-based supplier of branded products, in a deal worth up to $400 million.

Under the deal, Cheplapharm will pay AstraZeneca a total of $400 million in non-contingent consideration anticipated during the fourth quarter of 2020. Of the $400 million consideration, $250 million will be payable on completion of the closing of the deal, and the remainder in the first half of 2021. In 2019, Atacand and Atacand Plus generated sales of $148 million and profit before tax of $89 million in the countries covered by the agreement. The agreement covers a total of more than 70 countries. Cheplapharm previously acquired the rights to Atacand in Europe.

AstraZeneca will continue to manufacture and supply Atacand and Atacand Plus and will continue to commercialize the medicine during a three-year transition period.

Source: AstraZeneca


GSK Sets Environmental Sustainability Goals by 2030
GlaxoSmithKline (GSK) has announced new environmental sustainability goals in both climate and nature with an aim to have a net zero impact on climate and a net positive impact on nature by 2030.

Over the next decade, GSK says it will invest in measures to reduce its environmental impact, in restoration programs to balance the remaining environmental impact that the company cannot reduce, and to put back into nature more than it takes out.

The company has set new targets across its different businesses, including: 100% renewable electricity usage and good water stewardship at all GSK sites; 100% of materials sustainably sourced and deforestation free; and transitioning to 100% usage of electric vehicles by GSK sales representatives globally.

The new goals apply to GSK’s Biopharma business and portfolio. The company’s Consumer Healthcare business will also contribute toward these goals through delivery of its own targets while it is still part of GSK. In late 2018, GSK and Pfizer reached an agreement to combine their consumer health businesses into a new joint venture, with GSK holding a majority controlling equity interest of 68% and Pfizer an equity interest of 32%. Post separation, the new Consumer Health company will have new targets to reflect GSK’s environmental goals.

Source: GlaxoSmithKline


US

BMS Moves Forward on Closing $13.1-Bn Acquisition of MyoKardia
Bristol-Myers Squibb (BMS) took a step forward in closing its $13.1-billion acquisition of MyoKardia, a Brisbane, California-based clinical-stage biopharmaceutical company focused on cardiovascular diseases, with the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. BMS had agreed to acquire MyoKardia early last month (October 2020).

Expiration of the waiting period satisfies one of the conditions necessary for the consummation of the transaction. Unless the tender offer is extended, the offer and withdrawal rights will expire at midnight on November 16, 2020.

MyoKardia’s lead drug candidate is mavacamten, in Phase III development, for treating obstructive hypertrophic cardiomyopathy (HCM), a chronic heart disease. A new drug application for mavacamten for treating symptomatic obstructive HCM is expected to be submitted to the US Food and Drug Administration in the first quarter of 2021.

Source: Bristol-Myers Squibb


Novartis Acquires Gene-Therapy Company Vedere Bio in $280-M Deal
Novartis has acquired Vedere Bio, a Cambridge, Massachusetts-based gene-therapy company, in a $280-million deal ($150 million upfront and up to $130 million in milestone payments).

The acquisition includes Vedere Bio’s lead preclinical intravitreally injected adeno-associated viruses gene-therapy programs focused on pan-genotypic vision restoration in patients with photoreceptor-based vision loss.

The acquisition, however, does not include certain earlier-stage vision restoration and vision preservation assets using the company’s ocular gene-therapy toolbox. These assets were spun out into a newly formed entity, Vedere Bio II, which will operate as a wholly independent entity from Novartis.

Source: Vedere Bio


Nostrum Issues Voluntary Recall of Metformin ER Tablets
Nostrum Laboratories, a Kansas City, Missouri-based manufacturer, marketer, and distributor of pharmaceutical products, is voluntarily recalling two lots of metformin hydrochloride extended-release (ER) tablets (USP 750 mg) to the consumer level in the US due to exceeding acceptable daily intake limit levels of a nitrosamine impurity, N-Nitrosodimethylamine (NDMA), a probable human carcinogen. Metformin ER is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes.

The recall is the latest in a series of recalls for NDMA impurities in metformin-ER products and of NDMA impurities in other products. In June (June 2020), five companies—Teva Pharmaceuticals USA, Lupin, Apotex, Anmeal Pharmaceuticals and Marksans Pharma—voluntarily recalled in the US select lots of metformin ER formulations due to elevated levels of NDMA. In late September (September 2020), Sun Pharma recalled one lot in the US of Riomet ER (metformin hydrochloride for ER oral suspension), 500 mg per 5 mL, to the consumer level. Late last month (October 2020), Marksans made an additional recall of 76 lots of metformin hydrochloride ER tablets (USP 500 mg and 750 mg) to the consumer level.

These recalls are part of an ongoing investigation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) into nitrosamine impurities in certain active pharmaceutical ingredients (APIs) with metformin extended-release products being the latest product of inquiry. In 2018, the FDA and the EMA initiated investigations of nitrosamine impurities in certain “sartan”-containing APIs, used in anti-hypertensive and cardiovascular drugs, such as valsartan candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations into prescription and over-the-counter forms of ranitidine, a H2 (histamine-2) blocker used to decrease the amount of acid created by the stomach.

Source: US Food and Drug Administration