|Applicable indicator||Not applicable|
Wockhardt is a biopharmaceutical company, selected for having a pipeline that targets priority pathogens. It was evaluated in the area of Research & Development only, although it has a number of antimicrobials on the market. Although its performance in the Benchmark is lower compared to other biopharmaceutical companies in scope, all five of its R&D projects target priority pathogens. Wockhardt does not engage in public-private partnerships; however, it conducts R&D in-house and/or with private-sector partners to develop its antibiotic candidates. The company reports no information on access or stewardship provisions for its five antibiotic candidates in late-stage development. Wockhardt was not evaluated in the Appropriate Access & Stewardship area. However, it engages in patient and community educational programmes in India and also coordinates an AMR surveillance programme to monitor resistance trends in India.
Sales & operations
Wockhardt is an Indian-based biopharmaceutical company with a focus on R&D. Besides pharmaceutical research, the company’s research programme includes areas such as genomics, biotechnology and novel drug delivery systems. Wockhardt is currently developing a new drug discovery programme focussing on unmet needs in bacterial infections (both gram-negative and gram-positive). The company is also involved in the development of diagnostics for antibiotic susceptibility testing (AST) relevant to its novel antibacterial drugs under development. Wockhardt sells antimicrobial medicines in the USA, the UK, Ireland, Puerto Rico, Russia, Norway, India and Vietnam. The latter two are considered low- or middle-income countries.* Its vaccines are sold exclusively in India. In the fiscal year 2016, Wockhardt sold 142 million Standard Units (SUs) of antimicrobial medicines and 1.1 million SUs of vaccines.
Wockhardt markets at least 25 antimicrobial medicines, 19 of which are listed on the WHO EML (Section 6). Twenty-one of the company’s antimicrobial medicines are antibiotics, with 15 listed on the WHO EML (Section 6), including one in the EML’s Reserve group (colistin, Wockstin®). The remainder (four) of the company’s portfolio consists of two antifungals, the antimalarial quinine and the antiviral aciclovir, all listed on the WHO EML (Section 6). The company’s vaccines target hepatitis A (Biovac A®) and chickenpox (Biovac V®).
Plan ahead for access and stewardship during R&D.
Wockhardt is developing five antibiotic candidates in late-stage clinical development. Wockhardt can ensure access and stewardship provisions are in place for these candidates, for example, through partnerships.
A. Research & Development
5 projects, 5 target priority pathogens
A.2.1-2.2 Five broad-spectrum antibiotics targeting priority pathogens.
Biopharmaceutical companies in scope were selected based on their pipelines that target priority bacteria. Wockhardt has five antibiotics that target priority pathogens, one of which is a combination of two existing agents. All five medicines are in Phase III clinical stage development. The company’s pipeline includes a new ß-lactam enhancer (zidebactam), developed in combination with ß-lactam cefepime for the treatment of multidrug-resistant gram-negative bacterial infections. In 2017, the FDA agreed to an abridged Phase III clinical trial for this antibiotic. The other four medicines in the company’s pipeline are: one macrolide (nafithromycin); two broad-spectrum antibiotic fluoroquinolones (alalevonadifloxacin and levonadifloxacin), which are being developed specifically for gram-positive bacterial infections (including MRSA infections and community-acquired bacterial pneumonia); and a new high-dose combination of cefepime/tazobactam, which is active against multidrug-resistant Enterobacteriaceae, including ESBL-, KPC- and OXA-181-expressing strains.
A.3 No public-private partnerships reported.
Wockhardt conducts R&D in-house and/or with private-sector partners. It does not participate in public-private partnerships, or in partnerships with non-profit organisations, for antimicrobial R&D.
A.4 No information on access or stewardship provisions.
Wockhardt reports no information on access or stewardship provisions for its five antibiotic candidates in late-stage development. It has signed the Davos Declaration, which includes a general commitment to ensuring access to antimicrobial medicines and vaccines, and to support the appropriate and responsible use of these products.
Pipeline targeting priority pathogens
B. Manufacturing & Production
Wockhardt is a biopharmaceutical company that did not meet the criteria for evaluation in this Research Area. It does, however, have products on the market.
C. Appropriate Access & Stewardship
Wockhardt is a biopharmaceutical company that did not meet the criteria for evaluation in this Research Area. It does, however, have products on the market, and notable practices relevant to this area are mentioned.
C.4 No apparent involvement in AMR-related education for HCPs.
Wockhardt was not eligible for this indicator, and does not provide any information in AMRrelated education for HCPs. Notably, however, the company engages in patient education with its Mobile 1000 programme in India through the Wockhardt Foundation. This programme includes Water, Sanitation and Hygiene (WASH) education and other health promotion activities.
C.7 Only biopharmaceutical company to run a surveillance programme.
Wockhardt was not eligible for this indicator. Notably, however, the company coordinates a surveillance programme in India, which works with hospitals and laboratories to monitor resistance trends. This programme is completely funded by Wockhardt.
Animal Health & Diagnostics
Activities in this area are not scored by the Benchmark. This information is provided given the importance of animal health and diagnostics on the topic of AMR.
Wockhardt is involved in the development of diagnostics for antibiotic susceptibility testing (AST) relevant to its novel antibacterial drugs under development.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
† EML Section 6: Anti-Infective Medicines
§ Revenue from operations; FYE 31 March 2017