Global Pharma Briefs: News from Europe and the US

By Miranda Greenberg -

July 23, 2020

A roundup of news from Switzerland (BI, Numab Therapeutics) and the US (Bayer, Elanco, Mylan, Merck & Co, Dewpoint Therapeutics, and Nephron Pharmaceuticals).

Switzerland

BI, Numab Therapeutics in Pact for Antibody Therapies for Cancer, Retinal Disease
Boehringer Ingelheim (BI) and Numab Therapeutics, an oncology-focused biopharmaceutical company based in Wädenswil, Switzerland, have entered into a research collaboration and worldwide licensing agreement for two projects to develop antibody therapeutics to treat gastrointestinal cancers and geographic atrophy, a retinal disease that occurs in patients with age-related macular degeneration.

Under the alliance, the companies will work together to discover one multi-specific antibody drug candidate in each area. From Numab, BI will receive exclusive global license to develop and commercialize the resulting candidates in exchange for upfront and milestone payments, as well as tiered royalties on net sales of all products resulting from the alliance. No financial terms were disclosed.

Source: Boehringer Ingelheim and Numab Therapeutics


US

Bayer Withdraws Pending Motion for $1.25-Bn Class-Action Roundup Settlement
Bayer has decided to withdraw a pending motion for preliminary approval of a class-action settlement over its glyphosate-based herbicide, Roundup. Bayer gained the product as part of its $63-billion acquisition of Monsanto, an agrochemical and seed company, in 2018.

Last month (June 2020), Bayer agreed to pay between $10.1 billion and $10.9 billion to resolve current and future product-liability litigation in the US over Roundup, which included a payment up to $1.25 billion to support a separate class agreement to address potential future litigation.

Bayer says the withdrawal will enable it to more comprehensively address the questions recently raised by a federal district court judge, Federal District Court Judge Vince Chhabria of the Northern District of California, who presides over the federal Roundup litigation.

“Bayer remains strongly committed to a resolution that simultaneously addresses both the current litigation on reasonable terms and a viable solution to manage and resolve potential future litigation,” said Bayer in July 9, 2020 statement. “Mass tort settlement agreements like this are complex and may require some adjustments along the way, but the company continues to believe that a settlement on appropriate terms is in the best interest of Bayer and all of its stakeholders.”

Source: Bayer


FTC OKs Elanco’s $7.6-Bn Acquisitions of Bayer Animal Health
Elanco Animal Health has received approval from the US Federal Trade Commission (FTC) for its $7.6-billion acquisition of Bayer Animal Health, a division of Bayer. The FTC decision represents the final antitrust clearance needed to complete the transaction, which is on track to close for closing at the beginning of August.

Elanco is the former animal-health business of Eli Lilly and Company, which was spun out as a stand-alone company in 2019.

Elanco continues to expect necessary worldwide divestitures to be in the previously announced range of $120 million to $140 million of annual revenue to help advance regulatory reviews. In addition to FTC approval, Elanco has received antitrust clearance for the transaction from the European Commission as well as in Australia, Brazil, Canada, China, Colombia, New Zealand, South Africa, Turkey, Ukraine, and Vietnam.

Source: Elanco Animal Health


Mylan, Fujifilm Get FDA Approval of Humira Biosimilar, Hulio
Mylan and Fujifilm Kyowa Kirin Biologics, a biosimilars joint venture of Fujifilm and Kyowa Kirin, have received US Food and Drug Administration (FDA) approval for Hulio (adalimumab-fkjp), a biosimilar to AbbVie's Humira (adalimumab). Humira had 2019 global sales of approximately $19.2 billion.

Hulio was approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations.

In accordance with its patent-license agreement with AbbVie, Mylan will be able to launch Hulio in the US during July 2023.

Mylan and Fujifilm Kyowa Kirin Biologics entered into a partnership in 2018 for the commercialization of Hulio in Europe, and Mylan has commercialized the product in several countries. In 2019, Mylan and Fujifilm Kyowa Kirin Biologics expanded their partnership globally. Recently, Hulio received regulatory approval in Japan.

Source: Mylan and Fujifilm Kyowa Kirin Biologics


Merck & Co, Dewpoint Therapeutics in Pact for HIV Drug Development
Merck & Co., and Dewpoint Therapeutics, a Boston-based drug-discovery company have formed an exclusive collaboration agreement, in a deal worth up to $305 million, to evaluate drug mechanisms based on biomolecular condensates for developing treatments for HIV.

Biomolecular condensates are droplet-like structures that form dynamically within cells when diverse “communities” of proteins, RNAs, and other biomolecules come together through a process called phase separation, according to information from Dewpoint Therapeutics. Biomolecular condensates play a role in a range of normal biological functions and disease processes, including viral infection. The developed mechanism will use Dewpoint’s proprietary platform for condensate-based drug discovery. Dewpoint’s high-throughput condensate platform provides the ability to understand the interactions of biomolecular communities and find drugs that intervene.

Under the agreement, Dewpoint will receive up to $305 million in upfront and milestone payments as well as royalties on sales of any approved product resulting from the collaboration.

Source: Dewpoint Therapeutics


Nephron Pharmaceuticals To Invest $215 M for Expansion in South Carolina
Nephron Pharmaceuticals, a West Columbia, South Carolina-based company developing generic inhalation and suspension products, plans to invest $215 million to expand in Lexington County, South Carolina by adding 380 new full-time jobs by 2024 and adding new office, warehouse and vaccine-production space.

These projects will be additions to an initial $313-million investment that brought the company headquarters and production facility to South Carolina.

The company also operates a 503B outsourcing facility division that produces prefilled sterile syringes and intravenous bags for hospitals across the US.

Source: Nephron Pharmaceuticals