Drug program eyes multinational tie-up
MANILA, Philippines — A P30-million government research eyes the sale of an “immunoliposome” cancer drug delivery license to multinational Janssen Pharmaceuticals Inc. (JPI) which may open up a big and entirely new drug innovation industry for Philippines.
Funded by the Philippine Council for Health Research and Development (PCHRD), the cancer research program by state-funded National Institute of Molecular Biology (NIMB) and two other institutes have started talks with Janssen.
“I cannot preempt Janssen, (but) we have communicated with them our intention. I expect to have more definite words from them,” said Dr. Jay Enrico Lazaro, in an interview, during a presentation of “AMOR 2: Pharmacokinetics and Pharmacodynamics of hCC49 Immunoliposomes in Nude Mice.”
This project is part of a Department of Science and Technology-led interagency High Impact Technology Solutions (HITS) for which PCHRD also seeks financing for sustained implementation.
“We don’t keep our limited investments for health research secret because we’re aware that that’s how we can raise funding,” said Dr. Jaime C. Montoya, PCHRD executive director. He explains that a single drug really takes $1 billion to produce from basic research to clinical trial, and technology packaging and marketing.
Filipino drug researchers are optimistic of the country’s potential licensing of this cancer drug delivery system as it aligns with the global trend on “biologics” which is overtaking research on new drug substances. Biologics are medicinal products created through biological processes and can consist of sugars, proteins, or nucleic acids or their combination or of cells and tissues and other living organisms.
Lazaro said NIMB’s work together with the institutes of Chemistry and Biology – University of the Philippines – is very similar to what Japan is working on. Being still a pioneering work, this offers Philippines huge economic potential.
Being a state-of-the-art drug system where the drug destroys cancer cells exclusively, it offers a high price of P50,000 per 20 milligram (mg) once marketed. And yet it pays for cancer patients to take such drugs since it avoids omits a breast cancer treatment situation that normally involves one-third chemotherapy and two-thirds treating its side effects.
“We don’t have a pharmaceutical industry to speak of. Nobody works on biologics for commercial use. We’re at a terrible disadvantage when it comes to our risk. But what I’m counting on is the novelty of our product. It’s difficult to copy this antibody,” said Lazaro.
NIMB’s intention is to sell the license or partner with Janssen or other firms at the drug research’s initial stage. Here, it can flow back its initial capital for further research investments.
The first product is a license on the linker which “links” the antibody and the liposome which contains the cancer drug that should be delivered to the cancer cell. Immunoliposomes combine antibody-mediated tumor recognition with liposomal delivery, according to “Seminars in Oncology.”
“This linker, the phospholipid, has IP (intellectual property) issues (which we cannot disclose because we’re patenting it),” Lazaro said.
The second product for patenting and sale is the antibody.
“The antibody that we’re using, we engineered it. It’s not yet patented. We just have to do a few experiments on the material, and then we can proceed to patenting it,” he said.
Janssen is the target market for these products since it owns a drug-carrying liposome branded Caelyx priced P44,000 per 20 mg in the market. Caelyx is administered intravenously to breast cancer patients. NIMB plans later to go into drug research for other cancer types such as liver.
Lazaro said the Philippines actually stands to gain immensely more if it advances this drug research program up to at least the clinical early phase stage, unlike the pre-clinical stage at present.
“If I sell it at the preclinical stage, they will buy license at a cheap price, but if I sell it at clinical Phase 1 stage, the license will be much much more expensive,” he said.
The P30 million may already be enough to sell the license at pre clinical stage, but it may cost P300 to P700 million to bring it to clinical Phase 1.
Biologics. has been the ‘way to go’ in cancer drug as it has been known that “one effective means of targeting tumors would be via conjugation (or linking) of antitumor antibodies or portions of antibodies to liposomes.”
This drug system is also known as “monoclonal antibody” therapy which uses monoclonal antibodies to stick to target cancer cells. This way, the patient’s immune system is stirred to attack cancer cells. This treatment is very specific to the cancer cell since researchers are able to identify cell surface receptors of tumors such as ib breast cancer cell.
MAB, as of 2006, generated sales of $20.6 billion, and research on it attracted 200 companies and billions of dollars in research.
In the mAB process, “you have here a cancer drug , and you enclose the drug inside a nano capsule called a liposome. On the surface of the liposome you attach antibody that are very specific to certain antigens located on cancer cells. I’m talking about breast cancer, said Lazaro.
“The cancer cell contains Tag 72, and we are fortunate enough to know the gene for this Tag 72 and genetically engineered it. When you produce that antibody, you will attach it to the surface of my liposome, and this antibody will make this liposome stick to the cancer cells.
“Why? Because the cancers are contained in Tag 72, and my liposome contains the antibody. So it’s going to stick to the cancer cell, it will be internalized, inside the cancer cell this is where the liposome is going to break open, release the content in the cell.”
