Global Pharma Briefs: News from Merck & Co., Sanofi, Bausch Health
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A roundup of news from Egypt (Bausch Health), Japan (Daiichi Sankyo, Sanofi), UK (AstraZeneca), and the US (Merck & Co., Sandoz, Zydus, Alembic, and Apotex).

Egypt

Bausch Health To Sell Amoun Pharmaceuticals for $740 M
Bausch Health Companies (formerly Valeant Pharmaceuticals) has agreed to sell all of its equity interests in Amoun Pharmaceutical, an Egyptian-based pharmaceutical company, to ADQ, an Abu-Dhabi-based holding company, for total gross consideration of approximately $740 million.

Amoun manufactures, markets, and distributes branded generics of human and animal health products.

The transaction is expected to close in the first half of 2021, subject to customary closing conditions, including receipt of applicable regulatory approvals and the approval of the financial regulatory authority in Egypt of the mandatory tender offer to be launched by ADQ for all of the issued share capital of Amoun.

Source: Bausch Health and ADQ


Japan

Daiichi Sankyo End Sale of Vaccine Due to Mfg Issue
Daiichi Sankyo has terminated its marketing alliance agreement with Sanofi for the Squarekids tetravalent combination vaccine for the prevention of diphtheria, pertussis, tetanus, and polio after discontinuing the sale of the product due to manufacturing issues. Daiichi Sankyo will also end joint development efforts for VN-0105, its pentavalent combination vaccine.

Daiichi Sankyo decided to suspend the production of Squarekids and its supply to the market due to a problem in the manufacture of pertussis vaccines. Although the company says it has looked into ways to address the problem with a view to resuming the manufacture and supply of the product, it has decided to discontinue production by terminating its agreement with Sanofi and discontinued distribution effective March 31, 2021. In addition, Daiichi Sankyo will also end joint development efforts for VN-0105.

Daiichi Sankyo will incur a loss of JPY 15 billion ($137 million) as it compensates Sanofi for the loss sustained from the termination of the two agreements. Daiichi Sankyo will continue working with Sanofi through the manufacture and supply of other pharmaceutical products, including vaccines.

Source: Daiichi Sankyo


UK

UK Prime Minister Visits New AstraZeneca Facilities
UK Prime Minister Boris Johnson visited AstraZeneca’s Macclesfield, UK global manufacturing and development campus following a £380-million ($522-million) investment that AstraZeneca made last year (2020) in a new drug-manufacturing facility and global medicines packaging center.

The investment was made in March 2020, and the visit was rescheduled due to COVID-19 restrictions. The Macclesfield campus employs more than 3,000 people and is a global center from where AstraZeneca exports more than 50 medicines to 130 countries.

The investment in a manufacturing and packing facility provides capacity for AstraZeneca’s oncology medicine, Zoladex (goserelin acetate). Only produced in Macclesfield using a sterile production process, the drug had 2020 product sales of $888 million..

Source: AstraZeneca


US

Merck & Co., Alkermes in Clinical Trial, Supply Pact for Keytruda Combo
Merck & Co. and Alkermes have entered into a clinical trial collaboration and supply agreement for a planned Phase III study to evaluate nemvaleukin alfa, Alkermes’ investigational immunotherapy, in combination with Merck’s Keytruda (pembrolizumab), an immuno-oncology drug, in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer.

Under the agreement, Alkermes is responsible for conducting the Phase III study, which is planned to begin in the second half of 2021.

Source: Alkermes


Zydus Issues Recall of Four Lots of Antiviral Drug in US
Zydus Pharmaceuticals USA, the US subsidiary of Zydus Cadila, an Ahmedabad, India-based pharmaceutical company, is voluntarily recalling four lots of acyclovir sodium injection, 50- mg/mL, 10-mL and 20-mL vials, to the hospital and user level after receiving several complaints of crystallization in vials.

Acyclovir sodium injection is indicated for treating various forms of herpes and varicella-zoster (shingles) infections in immunocompromised patients. The product is packaged in single-dose glass vials and was distributed nationwide in the US to Cardinal Health, AmerisourceBergen Drug Corporation, and Morris & Dickson Company.

Source: US Food and Drug Administration


Alembic Recalls One Lot of Blood Pressure Drug for Labelling
Alembic Pharmaceuticals, Inc., a subsidiary of Alembic Pharmaceuticals Ltd., a Gujarat, India-based generics pharmaceutical company, is voluntarily recalling one lot of telmisartan tablets, USP, 20 mg, packaged in 30-count bottles, to the consumer level due to a labelling issue.

The product received a market complaint that stated that one bottle labeled as 30-count telmisartan tablets, USP, 20 mg, incorrectly contained 30 tablets of telmisartan tablets, USP, 40 mg.

The product is used for the treatment of hypertension and is packaged in a bottle of 30 tablets. The affected lot of telmisartan tablets, USP, 20 mg expires in March 2022.

Source: US Food and Drug Administration


Apotex Issues Recall of Three Lots of ADHD Medicine
Apotex is voluntarily recalling three lots of guanfacine extended-release tablets (2 mg) to the consumer level due to trace amounts of quetiapine fumarate, a psychotropic drug for treating mental health and mood disorders.

Guanfacine is indicated treating attention deficit hyperactivity disorder (ADHD) and can be used with other stimulant medications. Quetiapine is indicated for treating schizophrenia and other serious mental disorders such as bipolar disorder manic episodes, bipolar disorder, and depressive episodes.

Administration of guanfacine extended-release tablets containing trace amounts of quetiapine fumarate to a patient can result in the possibility of hypersensitivity reaction and may potentially have additive effects in lowering blood pressure, sleepiness/sedation, and dizziness. Pediatric patients, pregnant patients and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product. To date (as reported on March 31, 2021), Apotex has not received any reports of adverse events related to this recall.

Source: US Food and Drug Administration


ANI Pharmaceuticals Acquires Select Products from Sandoz
ANI Pharmaceuticals, a Baudette, Minnesota-headquartered pharmaceutical company and provider of CDMO services, has acquired the new drug applications (NDAs) and abbreviated new drug application (ANDA) for select branded products from Sandoz, the generics and biosimilars arm of Novartis.

ANI has acquired NDAs for: (1) Oxistat (oxiconazole) lotion, a treatment for dermal infections; (2) Veregen (sinecatechins) ointment, a treatment for external genital and perianal warts; and (3) Pandel (hydrocortisone) cream, a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANI also acquired the ANDA for ApexiCon E (diflorasone diacetate) cream, a topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Collectively, these products generated net revenues of $13.2 million in 2020. Pandel will be transitioned later upon receiving the requisite approvals (as reported on April 6, 2021).

In conjunction with the acquisition, ANI and Sandoz have entered into a multi-year manufacturing and supply agreement for Oxistat, Pandel, and ApexiCon E. ANI intends to transfer the manufacture and packaging of these three products to its own manufacturing sites in the future.

Source: ANI Pharmaceuticals

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