Global Pharma Briefs: News from Asia, Europe, and the US

By Miranda Greenberg -

August 20, 2020

A roundup of news from Denmark (Novo Nordisk), Germany (Evotec, Novo Nordisk), Japan (Takeda), and the US (Lupin, Sun Pharma, Alnylam, Teva, and others).

Denmark

Novo Nordisk To Invest $135 M in Danish Production Facilities
Novo Nordisk plans to invest DKK 850 million ($135 million) in expanding its production facilities in Kalundborg, Denmark, which currently manufacture a range of products for diabetes treatment.

This new investment brings Novo Nordisk’s total investments in the Kalundborg site to more than DKK 2 billion ($319 million) in 2020. The new investment will be used to rebuild and expand an existing production facility to create additional capacity for manufacturing diabetes-treatment products.

In February (February 2020), Novo Nordisk announced an investment of DKK 800 million ($117 million) for upgrading and expanding facilities at the production site in Kalundborg. In May (May 2020), the company announced a further investment of DKK 150 million ($24 million) in a new tablet-packaging production line, followed in June (June 2020) with an investment of DKK 225 million ($36 million). The new investment of DKK 850 million ($135 million) will expand the company’s capacity for manufacturing future diabetes products.

The Kalundborg site covers a total area of 1.2 million square meters and employs more than 3,000 people.

Source: Novo Nordisk


Germany

Evotec Resolute Therapeutics Partner in Antibiotic Project
Evotec, a Hamburg, Germany-based drug-discovery and development company, has entered into a new partnership with Resolute Therapeutics, a Winston Salem, North Carolina-based biopharmaceutical company  to develop a broad-spectrum antibiotic against drug-resistant bacteria.

The partnership will received funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership led by Boston University for funding and supporting the development of therapeutics, vaccines, and rapid diagnostics to address the most serious drug-resistant bacteria.

Under the agreement, Evotec will in-license a research program from Resolute currently in optimization and continue the preclinical development on the company’s proprietary drug discovery and development platforms. The goal of the partnership is to develop a broad-spectrum antibiotic with both Gram-positive and Gram-negative coverage for several indications, including complicated urinary tract, intra-abdominal infections, and hospital-acquired pneumonia.

Evotec will receive an award from CARB-X of up to $2.91 million over the next two years (as reported on August 11, 2020) plus an additional $5.53 million over the three following years if certain project milestones are met, which will cover a substantial part of Evotec’s expenses. Resolute will receive an undisclosed upfront payment from Evotec as well as success-based milestone payments while Evotec retains the right to take over the project at a pre-agreed value inflection point and subsequently continue the development with other potential clinical and marketing partners.

Source: Evotec


Novo Nordisk, Evotec in Drug-Development Pact
Novo Nordisk and Evotec, a Hamburg, Germany-based drug-discovery and development company, have entered into a strategic collaboration for the discovery and development of innovative therapeutics to treat chronic kidney disease.

Under the agreement, Evotec and Novo Nordisk will share responsibilities during drug discovery and preclinical development. Novo Nordisk will be responsible for the clinical development and commercialization of the products. Evotec will receive an undisclosed upfront payment, research funding and milestone potential of more than EUR 150 million ($179 million) per product as well as tiered royalties on net sales.

Source: Evotec


Japan

Takeda Begins Shift to New Personnel System in Japan
Takeda reports that it has begun to shift to a new personnel system, which includes support for the early retirement and transfer of employees, which it calls the "Career Program."

The Career Program is for eligible employees from the company’s domestic business departments (Japan Pharma Business Unit, Japan Oncology Division) who have been employed for three years or longer (including re-employed employees after retirement). The target age is 30 years or older. The application period for the program is September 28, 2020 to October 16, 2020 with a retirement date of November 30, 2020. The program will provide a retirement allowance and re-employment support.

Takeda says it is considering various systems such as the introduction of a global grading system, remuneration system, and pension system, as well as examining opportunities to expand the range of careers in the program without leaving Takeda. It is also discussing the introduction of an early-development system for developing executives as part of its Japan-based personnel system.

The new personnel system is aligned with the company’s new organizational focus on five major business areas (digestive system diseases, rare diseases, plasma-fractionation products, oncology, and neuroscience) and follows Takeda’s $62-billion acquisition of Shire in January 2019. At the time of the deal closure, Takeda said it expected to achieve recurring pre-tax synergies of at least $1.4 billion annually. The company also has made and is pursuing divestment of non-core assets.

Source: Takeda (in Japanese)


US

Blackstone, Alnylam Close $150 M in R&D Funding for RNAi Drugs
Blackstone, a private investment firm, and Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based biopharmaceutical company focused on RNA interference (RNAi) therapeutics, have announced the closing of the $150-million R&D funding component of the companies’ previously announced $2-billion strategic financing collaboration to accelerate the advancement of RNAi therapeutics.

Under the agreement, Alnylam will receive up to $150 million from Blackstone Life Sciences for the development of Alnylam’s cardiometabolic disease programs, vutrisiran and ALN-AGT. The investment includes up to $70 million to support an ongoing Phase III study of vutrisiran in ATTR amyloidosis patients with cardiomyopathy and up to $80 million to support Phase II and Phase III development of ALN-AGT, in development for the treatment of hypertension.

In April 2020, Blackstone and Alnylam entered into a broad $2-billion strategic financing collaboration. The deal included an R&D funding component and was further anchored by Blackstone’s purchase of 50% of the royalties owed to Alnylam on global sales of inclisiran, an investigational RNAi therapeutic for treating hypercholesterolemia (high cholesterol) currently under review by the US Food and Drug Administration and other regulatory authorities.

Source: Blackstone and Alnylam Pharmaceuticals


Lupin Issues Voluntary Recall of Blood Pressure Drug Lisinopril
Lupin Pharmaceuticals, a Mumbai, India-based pharmaceutical company, has issued a Class II recall in the US of 11,688 bottles of lisinopril tablets, a high-blood pressure drug, due to the presence of foreign tablets/capsules. The recall was noted in the US Food and Drug Administration’s Weekly Enforcement Report of August 5, 2020.

The US-based arm of Lupin is issuing a Class II recall of 11,688 bottles of lisinopril tablets, (prescription, 10 mg, packaged in a 1,000-count bottle) due to the presence of lisinopril 20-mg tablets found in lisinopril 10-mg 1,000-count bottles. A Class II recall is initiated in a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Also, in June (2020), Lupin issued a Class II recall of 4,224 bottles of lisinopril tablets, (prescription, 5 mg, packaged in a 1,000-count bottle) in the US due to product mix-up in which lisinopril 10-mg tablets were found in lisinopril 5-mg 1,000-count bottle, according to the FDA's Weekly Enforcement Report of June 17, 2020. 

Source: US Food and Drug Administration


Sun Pharma Issues Voluntary Recall of Anti-Zeizure Drug Clonazepam
Sun Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, has issued a Class III recall in the US of 3,516 bottles of clonazepam, an anti-seizure drug, due to cross contamination with other products. The recall was noted in the US Food and Drug Administration’s Weekly Enforcement Report of August 5, 2020.

The US-based arm of Sun Pharmaceuticals is issuing a Class III recall of 3,516 bottles of clonazepam orally disintegrating tablets, (prescription, 0.125 mg, packaged in a 60-count bottle) in the US due to cross contamination with other products based on out-of-specification results discovered during routine stability testing of an unknown impurity later identified as clozapine, a schizophrenia drug. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Source: US Food and Drug Administration


Teva, Alvotech Enter Pact to Collaborate in the US Biosimilar Market
Teva Pharmaceutical Industries and Alvotech, a developer of monoclonal antibody biosimilars, have entered into an exclusive strategic partnership for the commercialization in the US of five biosimilar product candidates.

Under the agreement, Alvotech will be responsible for the development, registration, and supply of the biosimilars while Teva will exclusively commercialize the products in the US. The agreement includes an upfront payment, with subsequent milestone payments over the next several years. Teva and Alvotech will share profit from the commercialization of the biosimilars. Other financial terms and product details were not disclosed.

Source: Teva Pharmaceutical Industries and Alvotech


Lupin in Distribution Pact with ForDoz Pharma for Injectable Assets
Lupin Limited’s US based wholly owned subsidiary, Lupin Inc., has entered into an agreement with ForDoz Pharma Corp, an East Windsor, New Jersey-based specialty pharmaceutical company, for the exclusive rights to market and distribute two complex injectable assets in advanced stages of development in the US and its territories.

The two assets are in the oncology and anti-infective therapeutic areas and will be manufactured in ForDoz’s US-based manufacturing site. ForDoz will be responsible for development and obtaining the necessary regulatory approvals. Lupin will use its existing commercial infrastructure for marketing and distribution of the two assets.

Source: Lupin


Novilytic Gets $1.4-M US Gov't Grant for Antibody Purity Testing 
Novilytic, a West Lafayette, Indiana-based company that secures drugs and medical devices, has been awarded a $1.4 million Phase II Small Business Innovation Research (SBIR) contract by the National Institute of General Medical Sciences, one of the National Institutes of Health.

The $1.4-million Phase II contract will allow Novilytic to continue the research, development, and commercialization of its new Proteometer, an instrument designed to test antibody purity in process.

The company, which is also launching a seed-round funding opportunity, will be opening new laboratories and hiring additional scientists in the coming months (as reported on July 16, 2020). Through the support of the Purdue Research Foundation, a private, nonprofit foundation from Purdue University and Purdue Foundry, an entrepreneurship and commercialization hub, Novilytic says it will continue to grow in the West Lafayette area.

Source: Novilytic