Global Pharma Briefs: News from AstraZeneca, Pfizer, Merck & Co., Gilead
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A roundup of news from China (AstraZeneca, Junshi Biosciences), the UK (Pfizer, GSK, CPI), and the US (Gilead Sciences, Merck & Co., AstraZeneca, AbbVie, Mitokinin).

China

AstraZeneca, Junshi Biosciences in Pact for Cancer Drug in China
AstraZeneca and Junshi Biosciences, a Shanghai-based biopharmaceutical company, have entered into an agreement where Junshi will grant AstraZeneca exclusive promotion rights in mainland China for Junshi’s toripalimab, a PD-1 inhibitor for treating various cancers, for urothelial carcinoma indications and all indications in non-core areas.

Junshi Biosciences will continue to be responsible for the promotion of other indications approved and to be approved excluding urothelial carcinoma indications in core areas. Junshi Biosciences and AstraZeneca will continue to explore overseas business collaboration, including for emerging markets and actively explore the possibility of expanding for future collaborations.

Source: Junshi Biosciences


UK

Pfizer Partners in Medicines Mfg Center for Solid-Dosage Continuous Mfg
Pfizer has entered into an agreement with the Center for Process Innovation (CPI) as the newest partner of CPI’s Medicines Manufacturing Innovation Center collaboration.

The Medicines Manufacturing Innovation Center is a collaboration between CPI, the University of Strathclyde in Glasgow, Scotland, and founding industry partners, GlaxoSmithKline and AstraZeneca. The program is partly funded by Innovate UK, the UK government’s innovation agency, through the Industrial Strategy Challenge Fund and Scottish Enterprise, a government economic development organization, via the Scottish government.

The new partnership with Pfizer will focus on “Grand Challenge 1”, which aims to develop a continuous direct compression (CDC) platform for oral solid dosage medicines. The CDC platform will feature a digital twin and data predictor model to allow for the modeling of processes in a digital space.

Pfizer will be providing data, skill, and knowledge of continuous mixing technology. Pfizer’s contributions to “Grand Challenge 1” will aim to minimize costs and reduce risk by providing technical expertise for further development of the digital twin and data predictor model for the CDC platform.

Source: Center for Process Innovation


GSK To Supply Rotavirus Vaccine on Humanitarian Basis
GlaxoSmithKline (GSK) has agreed to supply its rotavirus vaccine, Rotarix, to children living in humanitarian crises through the Humanitarian Mechanism, developed by Médecins Sans Frontières (MSF), Save the Children, UNICEF, and the World Health Organization (WHO).

The Humanitarian Mechanism was founded in 2017 through a partnership of UN and civil society organizations–MSF, Save the Children, UNICEF and WHO–to enhance access to vaccines in emergencies by civil society organizations in countries that are not otherwise eligible for support from Gavi, a global public health partnership.

GSK has committed to supply Rotarix at its lowest global price for the tube presentation, already supplied to UNICEF for use in Gavi-supported immunization programs.

The agreement builds on GSK’s existing commitment to the Humanitarian Mechanism for its pneumococcal conjugate vaccine (PCV), Synflorix, at the lowest global price for its four-dose vial presentation, also supplied to UNICEF for use in Gavi programs. GSK has been providing Synflorix through in this way since 2017.

Source: GlaxoSmithKline and the World Health Organization


US

Gilead Sciences Completes Acquisition of MYR GmbH in $1.75-Bn Deal
Gilead Sciences has completed its acquisition of MYR GmbH, a Bad Homburg, Germany-based biopharmaceutical company focused on developing and commercializing therapeutics for treating chronic hepatitis delta virus (HDV), in a EUR 1.45-billion ($1.75-billion) deal ($1.39 billion upfront and up to $364 million in milestone payments). The acquisition was first announced late last year (December 2020).

MYR’s lead product is Hepcludex (bulevirtide) for treating HDV. It was conditionally approved by the European Medicines Agency for treating HDV in adults with compensated liver disease in July 2020.

As a result of the completion of the merger, MYR has become a wholly owned subsidiary of Gilead.

Source: Gilead Sciences


Merck & Co. Withdraws Small Cell Lung Cancer Indication for Keytruda in US
Merck & Co. is voluntarily withdrawing in the US an indication for Keytruda (pembrolizumab) for metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The withdrawal of this indication was done in consultation with the US Food and Drug Administration (FDA), and Merck is working to complete this process over the coming weeks (as reported on March 1, 2021). This decision does not affect other indications for Keytruda, Merck’s anti-PD-1 therapy, which is approved for multiple cancer indications.

This accelerated approval for Keytruda for the SCLC indication was granted in June 2019 based on tumor response rate and durability of response data. Continued approval for this indication was contingent upon completion of the post-marketing requirement establishing superiority of Keytruda as determined by overall survival. In January 2020, the confirmatory Phase III trial for this indication met one of its dual primary endpoints of progression-free survival but did not reach statistical significance for the other primary endpoint of overall survival.

Source: Merck & Co.


AstraZeneca Gains Favorable Ruling in Symbicort Patent Litigation
A US federal district court has ruled in favor of AstraZeneca over Mylan (now Viatris) and Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, in patent litigation for AstraZeneca’s Symbicort (budesonide/formoterol), a drug for treating asthma and chronic obstructive pulmonary disease (COPD). Symbicort is one of AstraZeneca’s top-selling drugs with 2020 sales of $2.7 billion.

The US District Court for the Northern District of West Virginia ruled that Mylan’s and Kindeva’s asserted claims in three of AstraZeneca’s patents protecting Symbicort in the US are not invalid.

In October 2018, AstraZeneca initiated litigation against Mylan and subsequently against 3M Company asserting infringement of various US patents covering Symbicort. In July 2020, Kindeva was added as a defendant in the action. 3M was voluntarily dismissed from the case.

In September 2020, Mylan and Kindeva stipulated to patent infringement to the extent that the asserted patent claims were found to be valid and enforceable, but reserved the right to seek a vacatur of the stipulation if the US Court of Appeals for the Federal Circuit reverses or modifies the District Court’s claim construction. At trial, Mylan and Kindeva contended that each asserted patent claim is invalid under US patent laws.

Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid that treats underlying inflammation, and formoterol, a long-acting beta2-agonist bronchodilator with a fast onset of action, in a single inhaler. Symbicort was launched in 2000 and is approved in approximately 120 countries to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pressurized metered-dose inhaler (pMDI). In the US, Symbicort is only approved for use in a pMDI. In January 2020, AstraZeneca entered an agreement with Prasco, a Cincinnati, Ohio-based generic-drug company, to distribute an authorized-generic version of Symbicort in the US.

Source: AstraZeneca


AbbVie To Acquire Exclusive Right to Acquire Biopharm Company Mitokinin
AbbVie has agreed to purchase an exclusive right to acquire Mitokinin, a biopharmaceutical company developing PINK1-targeted therapeutics for neurodegenerative diseases, following completion of investigational new drug (IND)-enabling studies on Mitokinin’s lead PINK1 compound.

Mitokinin’s PINK1 compounds selectively increase the activity of PINK1, a master regulator of mitochondrial quality control that is genetically linked to Parkinson’s disease, according to information from Mitokinin.

Under the agreement, Mitokinin will receive an upfront payment and will continue developing its PINK1 activator program through completion of IND-enabling studies for Mitokinin’s lead compound. No financial details were disclosed.

Source: Mitokinin

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