Mumbai: In a serious setback to the research prospects of India’s second largest drug maker Ranbaxy Laboratories Ltd, its project collaborator and sponsor, Medicines for Malaria Venture or MMV, a World Health Organization (WHO) agency, has decided to end a much-touted joint anti-malarial drug research project.
Said a top MMV official, who can’t be named because he is not authorized to talk to the media: “We have decided to stop funding the project after review of preliminary data and other portfolio priorities.”
MMV is a Geneva-based international agency that aims to develop new drugs for malaria. The mosquito-borne malaria parasite, along with tuberculosis, is the biggest killer of humans worldwide.
Despite the apparent setback, Ranbaxy vows to continue with the project on its own.
Ranbaxy has been working on this anti-malaria research project since 2003 in collaboration with the WHO body to develop a synthetic version of a well-known Chinese malaria herbal drug, Artemisinin, known for its efficacy.
The anti-malarial drug candidate, RBx 11160, has been projected as a promising molecule to treat uncomplicated malaria. For Ranbaxy, it was the leading project in its new-drug discovery research. MMV, which has financed the bulk of the anti-malarial project cost, is estimated to have spent between $13 million and $15 million (Rs52-60 crore) on the research project; Ranbaxy’s expenditure on it could not be immediately ascertained.
Earlier this month, Ranbaxy said it was targeting a launch of the drug within four years.
“Hopefully, if everything continues to be successful, by 2011, we shall have a new chemical entity (NCE, a pharmaceuticals industry reference to new drug molecules) in the market and will probably be India’s first NCE out globally,” managing director Malvinder Mohan Singh is quoted as telling the Press Trust of India in Beijing on 5 September.
On Thursday, Ranbaxy stuck by Singh’s comments. “Ranbaxy's potential anti-malarial molecule, Arterolane, has concluded its Phase II clinical trials and we are conducting Phase II trials for the combination product. The molecule is progressing well and if all goes per plan, we will be introducing the drug by 2011 which could probably be the first Indian NCE drug,” a spokesperson for the Gurgaon-based firm said in an email response. Calls and messages to company executives seeking more details proved unsuccessful.
Even if Ranbaxy successfully develops the malaria drug and receives regulatory approvals, it could have problems selling it in large numbers, one industry expert said. Since malaria is a disease most prevalent in poor countries, almost 90% of the anti-malarial drugs are procured through tenders, explained K.K. Jain, a health-care expert associated with several WHO projects in India and other countries. “Since only WHO pre-qualified drugs are procured (by such buyers), products that are not identified by MMV would not pass through,” Jain said. Malarone, a drug developed by drug giant GlaxoSmithKline Plc. and another drug, Ablaquine, developed by the Central Drug Research Institute of India, or CDRI, and licensed to Nicholas Piramal India Ltd, still have not made an entry in the $800 million anti-malarial market.
The same MMV official said the drug co-developed with Ranbaxy had undergone two so-called pharmacokinetic studies, which are used to determine how the human body reacts to a new drug, on volunteers and patients in Thailand last year. “A Phase II study (which indicates the appropriate dosage of a drug) was also initiated the same year in adult patients in Africa, India and Thailand to identify the best dose or future studies of the drug in combination therapy, followed by three other advanced studies internationally,” the official added.
The MMV-Ranbaxy collaboration developed the Arterolane anti-malarial drug for single drug therapy as well as a combination with other known anti-malarial drugs. “Both these forms had been tested in patients and the data from the combination therapy studies was presented at The American Society of Tropical Medicine and Hygiene conference in Atlanta in November 2006 as well,” the MMV official said, adding “The (Ranbaxy co-developed drug’s) results were not very satisfactory compared to other drug candidates available in the agency’s other collaborative projects.”
A senior Ranbaxy executive, who didn’t want to be named, confirmed the MMV decision. “We have received a communication from MMV in this regard and the company’s decision is now to go on its own,” the executive said.
MMV has collaborated with at least half a dozen projects as part of its initiative to identify and sponsor promising research works towards developing a new class of anti-malarial compounds centred mainly around synthetic peroxides of Artemisinin, the Chinese herbal drug. The initiative kicked off in the wake of shortage of Artemisinin-based drugs, which in turn was triggered by a major shift of anti-malarial therapy worldwide away from the conventional chloroquine-based treatment. This followed a WHO recommendation based on the increased resistance of malaria parasites to conventional treatments. Also, Artemisinin costs at least 10 times as much as chloroquine.
WHO statistics put the number of malaria cases worldwide at about 300 million—about 5% of the world population—annually, and estimates deaths from the disease at 1.5-2 million a year, mostly in developing countries.
A stock analyst tracking Ranbaxy said the MMV decision would dent the drug maker’s research efforts. “It may not have immediate financial implication on Ranbaxy, but is certainly a setback to its research pipeline as the anti-malaria drug was one of the key projects in its new drug research portfolio,” said Kirit Gogri, a pharma analyst with ASK Raymond James Securities India Pvt. Ltd.
Ranbaxy has about 10 drug research programmes under way, targeting infectious diseases, metabolic disorders, inflammatory and respiratory problems, and cancer.
The same Ranbaxy executive said the company was not aiming at the tenders floated by governments and NGOs fighting malaria. “By commercializing RBx11160, we are targeting the non-tender business, such as travel market and markets in the developed as well as (niches in) developing countries,” said the executive, while conceding that such a market was relatively tiny.
Two Artemisinin-based drug molecules developed by CDRI and licensed to Mumbai-based Ipca Laboratories Ltd, meanwhile, have been pre-qualified by WHO. MMV has also identified another drug candidate developed by the Chandigarh’s Unimark Pharmaceuticals Ltd.