Global Briefs: Teva, Aurobindo, Pfizer, BI & ShionogiBy
A roundup of news from Teva/Aurobindo, Pfizer, BI/ Trutino Biosciences, BI/CarthroniX, and Shionogi.
*Teva, Aurobindo Settle Patent Litigation
*Pfizer Acquires ReViral Therapies for $525 M
*BI Agrees to Option for Acquiring Trutino Biosciences
*BI in Pact for Small-Molecule Canine Oncology Drug
*Shionogi Partners To Provide Global Access to Antibiotic
Teva, Aurobindo Settle Patent Litigation
Teva Pharmaceutical Industries, through its US affiliates, Teva Branded Pharmaceutical Products R&D, and Auspex Pharmaceuticals, has reached an agreement with Aurobindo, a Hyderabad, India-based pharmaceutical manufacturing company, to resolve patent litigation over Aurobindo’s abbreviated new drug application for a generic version of Teva’s Austedo (deutetrabenazine), a drug for treating chorea (involuntary movements) associated with Huntington’s disease and tardive dyskinesia, an involuntary neurological movement disorder. Austedo posted 2021 revenues of $802 million.
Teva and Aurobindo have been involved in patent-infringement litigation in which Teva asserted a number of patents against Aurobindo that cover Teva’s Austedo. Under the settlement agreement, the litigation between the parties in a federal district court (the US District Court for the District of New Jersey) will be ended, and Aurobindo will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.
Pfizer Acquires ReViral Therapies for $525 M
Pfizer has acquired ReViral, a Stevenage, Hertfordshire, UK-based-clinical-stage bio/pharmaceutical company focused on antiviral therapeutics for respiratory syncytial virus (RSV), for $525 million.
ReViral’s lead asset is sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell. The drug has been granted fast-track designation by the US Food and Drug Administration. It is in Phase II development in adults and infants. A second program for sisunatovir is focused on the inhibition of RSV replication targeting the viral N protein. The lead candidate in that program is in Phase I development.
Under the agreement, Pfizer acquired ReViral for a total consideration of up to $525 million, including upfront and development milestones. If successful, Pfizer says it believes annual revenue for these programs has the potential to reach or exceed $1.5 billion.
BI Agrees to Option for Acquiring Trutino Biosciences
Boehringer Ingelheim (BI) has signed an option to acquire Trutino Biosciences, a San Diego, California-based preclinical stage bio/pharmaceutical focused on cytokine therapies to treat immuno-oncology and autoimmune diseases.
Under the agreement, BI reserves the right to purchase all shares of Trutino once specified program milestones have been achieved within a given time frame. Until that time, Trutino will continue to operate as an independent company.
The transaction consideration consists of an option fee, the issuance of a convertible note, and fixed purchase price terms to acquire Trutino once pre-defined milestones are achieved. The option fee and principal amount of the convertible note funded by BI at the signing of the option will collectively fully finance Trutino through its next major development milestones.
The companies had formed a multi-target strategic partnership on conditionally masked cytokines in 2020.
Source: Boehringer Ingelheim
BI in Pact for Small-Molecule Canine Oncology Drug
Boehringer Ingelheim (BI), and CarthroniX, a Lancaster, California-based bio/pharmaceutical company focused on developing small molecule-based therapies for degenerative and aging-related diseases, have entered into a research collaboration to pursue small-molecule therapeutics in canine oncology.
Under the agreement, BI will test a select group of small molecules provided by CarthroniX with the goal of determining their impact on canine cancers.
Source: Boehringer Ingelheim
Shionogi Partners To Provide Global Access to Antibiotic
Shionogi & Co., an Osaka, Japan-headquartered bio/pharmaceutical company, and the Global Antibiotic Research and Development Partnership (GARDP), a Geneva, Switzerland-based not-for-profit R&D organization, have executed a license and technology transfer agreement with the Clinton Health Access Initiative (CHAI), a Boston, Massachusetts-based global health organization, to increase access to antibiotics globally.
The agreements will provide access to cefiderocol, an antibiotic for treating Gram-negative bacterial infections, which may be resistant to other antibiotic treatments. Cefiderocol was recently added to the World Health Organization (WHO) Model List of Essential Medicines and targets a number of Gram-negative WHO priority pathogens. It was approved by the European Medicines Agency in 2020 and, separately, by the US Food and Drug Administration in 2019.
Under the agreement, GARDP will manufacture and commercialize cefiderocol through sub-licensees in a large range of countries that have delayed access or have no access to newer antibiotics. The license territory includes all low-income countries, most lower middle- and upper middle-income countries, and select high-income countries to provide access to 135 countries in total, accounting for almost 70% of countries globally. The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programs that ensure appropriate use.
Source: Shionogi & Co.