Global Pharma Briefs: News from Asia, Europe and the US
A roundup of news from China (Boehringer Ingelheim), Europe (J&J), and the US (Lupin, Merck & Co., Sandoz, Civica Rx, and Mylan).
China
Boehringer Ingelheim Launches External Innovation Hub in China
Boehringer Ingelheim (BI) is launching an External Innovation Hub in Shanghai, China to co-locate the activities of three BI organizations—Research Beyond Borders (RBB), Business Development & Licensing (BD&L), and the Boehringer Ingelheim Venture Fund (BIV)—to facilitate external collaboration and investment in the life sciences in China.
RBB is a global research division, which examines emerging science and technologies. The BD&L team as well as the BIVF further advance scientific approaches into business ideas. The BD&L function forms project partnerships with entrepreneurs and scientists. The BIVF operates as a separate legal entity and spins out companies out of academic labs with seed financing and additional investment.
BI has established collaborations with academic institutions and companies in China, including strategic partnerships with Tsinghua University and Peking University, both in Beijing. The company says additional collaborations are underway with several research institutes under the Chinese Academy of Sciences in Beijing and other scientific organizations., BI has also formed four partnerships in Korea, Singapore and India over the past 12 months (as reported on July 2, 2020).
Source: Boehringer Ingelheim
Europe
J&J Wins EU Approval for Ebola Vaccine
The European Commission has approved the marketing authorization of Johnson & Johnson’s (J&J) Janssen Ebola vaccine regimen for the prevention of Ebola virus disease caused by the Zaire ebolavirus species.
The vaccine uses the company’s proprietary viral vector technology, AdVac, which is the same technology being applied to the company’s development of a COVID-19 vaccine and is the basis of the company’s investigational HIV, respiratory syncytial virus (RSV), and Zika vaccine candidates. Janssen’s AdVac vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.
Two marketing authorization applications were submitted to the European Medicines Agency for the vaccines composing a two-dose regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). The regimen includes Ad26.ZEBOV as the first dose, based on Janssen’s AdVac viral vector technology, and MVA-BN-Filo as the second dose, based on Bavarian Nordic’s MVA-BN technology, administered approximately eight weeks later.
Janssen says it is also collaborating with the World Health Organization on vaccine pre-qualification to help accelerate registration of the Ebola vaccine regimen in African countries. Discussions with the US Food and Drug Administration have taken place to define the required data set for filing US licensure.
Source: Johnson & Johnson
US
Lupin Issues Voluntary Recall of Diabetes Drug Metformin
Lupin Pharmaceuticals, the US subsidiary of Lupin, a Mumbai, India-based pharmaceutical company, is voluntarily recalling in the US all batches of the Type II diabetes drug, metformin hydrochloride extended-release (USP 500-mg and 1000-mg tablets), to the consumer level.
The company says that certain tested batches were above the acceptable daily intake limit for N-nitrosodimethylamine (NDMA), a potential carcinogen.
To date (as reported on July 8, 2020), Lupin says it has not received any reports of adverse events related to this recall.
Last month (June 2020), five companies—Teva Pharmaceuticals USA, Lupin, Apotex, Anmeal Pharmaceuticals and Marksans Pharma—issued voluntary recalls in the US for select lots of metformin extended-release formulations due to detection of the NDMA impurity.
The FDA’s investigation into nitrosamine impurities in metformin is part of ongoing investigations and company recalls due to nitrosamine impurities in other active pharmaceutical ingredients (APIs). In 2018, the FDA and the European Medicines Agency initiated investigations of nitrosamine impurities in certain “sartan”-containing APIs, used in anti-hypertensive and cardiovascular drugs, such as valsartan, candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations into prescription and over-the-counter forms of ranitidine, a H2 (histamine-2) blocker used to decrease the amount of acid created by the stomach.
In late 2019, the FDA announced it had become aware of NDMA in some metformin products in other countries and began investigating whether the metformin in the US supply was at risk as part of its ongoing investigation into nitrosamine impurities across medication types.
Source: US Food and Drug Administration
Merck & Co, Eisai Issued Complete Response Letter for Keytruda Combo
Merck & Co. and Eisai have been issued a Complete Response Letter (CRL) by the US Food and Drug Administration (FDA) regarding their applications seeking accelerated approval of Keytruda (pembrolizumab), Merck’s anti-programmed death (PD)-1 antibody for treating cancer, plus Eisai’s Lenvima (lenvatinib mesylate), a multiple receptor tyrosine kinase inhibitor, for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
The CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease.
Both companies say they plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination. Merck and Eisai are continuing to evaluate the Keytruda plus Lenvima combination across 13 different tumor types
The CRL does not impact the current approved indications for Keytruda or for Lenvima.
Source: Merck & Co. and Eisai
Sandoz, Civica Rx Enter Five-Year Pact to Reduce Generics Shortages
Sandoz, the generics and biosimilars arm of Novartis, has entered into a five-year agreement with Civica Rx, a non-profit company providing drugs in shortage, under which Sandoz will supply six injectable generic medicines for use at Civica’s 1,200 US member hospitals.
Civica Rx is a non-profit company focused on providing generic medicines to its hospital members, which to date include more than 50 health systems, representing 1,200 hospitals and more than 30% of licensed US hospital beds.
These injectable medicines include antibiotics, acid reducers, blood thinners, blood-pressure regulators, and medicines required in the operating room. Initial supply is expected to begin shipping to Civica Rx later in 2020.
Source: Sandoz
Mylan Initiates Recall of One Lot of Antibacterial Daptomycin
Mylan’s US-based Mylan Institutional business is conducting a voluntary nationwide recall in the US to the consumer level of one lot of daptomycin for injection, 500-mg/vial due to the presence of particulate matter found in a single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility.
To date (as reported on July 7, 2020), Mylan says it has not received any reports of adverse events related to this recall. This batch was distributed nationwide in the US to wholesalers and retail pharmacies between April 2020 and May 2020.
Daptomycin is an injectable antibacterial indicated for the treatment of complicated skin and skin structure infections and Staphylococcus aureus bloodstream infections (bacteremia) in adult patients.
Source: Mylan and the US Food and Drug Administration
