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DelMar Pharma Partners with Wuzhou Pharma on Cancer Drug
ChinaBio: To start off, what is the business strategy behind DelMar Pharma?
Jeffrey Bacha: We looked at what we would consider proven cancer medicines, their mechanisms and unmet medical needs, trying to find a match. Much of the DelMar team comes from ChemGenex, another company where we followed a similar plan. At ChemGenex, we had what was essentially an old drug sitting by the side of the road and we showed that it was an effective treatment for drug-resistant chronic myeloid leukemia (CML).
ChinaBio: For DelMar, the drug you found was VAL-083. How did you discover this molecule?
Jeffrey Bacha: Dennis Brown [CSO and Co-founder of DelMar] initiated the process that surfaced the drug. He asked the question, “What does a good cancer drug look like?” And he identified the drug from the NCI database. Historically, it had shown activity against a number of different cancers. Importantly, it is based on a mechanism that is different from other agents currently being used to treat glioblastoma multiforme (GBM), the most aggressive form of brain cancer. Last month, we announced encouraging interim results from a US Phase I trial of the drug in patients with GBM.
ChinaBio: Now let’s move on to the partnering aspect of this story. How did you find Wuzhou Pharmaceutical Company?
Jeffrey Bacha: It was fairly serendipitous. Our team has done some research into manufacturers in China, where we have some experience, because we were looking for sources to procure API that we would use for samples to conduct clinical trials. We learned that someone was already making not just API, but a finished drug that might be acceptable for FDA. It was Wuzhou. Their drug was approved by China’s FDA for CML and lung cancer, and Wuzhou produced the drug in a sophisticated manufacturing operation.
ChinaBio: How did you approach them?
Jeffrey Bacha: We told them that we wanted to buy a couple of vials of the drug, a drug that they weren’t selling much of. But we also explained that we wanted a supplier relationship, because we intended to use the drug for clinical trials in the West. We took a trip over there fairly early and explained what we thought might happen. We made it clear that if we were successful in creating upside for the drug by developing it for other indications, the developments would have an effect in China.
ChinaBio: What did Wuzhou think of their drug?
Jeffrey Bacha: To them, it was sort of a pseudo-generic. The period of exclusivity had expired, but there was still a high barrier of entry for manufacturing the drug, because it is not a simple drug to produce.
Overall, Wuzhou had not done much to promote it. In fact, the drug had never been launched in the large metropolitan areas of Beijing and Shanghai, potentially its two most lucrative markets. We talked to doctors there, and showed them data we developed. The doctors were surprised because they had never heard of it.
ChinaBio: What happened next?
Jeffrey Bacha: We developed a process for making the drug using HPLC (high-pressure liquid chromatography) to purify the samples following FDA guidelines. We now own IP on the drug. Meanwhile, China raised its GMP standards, bringing them in line with FDA and EMA rules, so we were able to help Wuzhou comply with the new requirements.
We also put our heads together Wuzhou about expanding the market for VAL-083 in China. Because the drug is already approved there, we will focus initially on existing indications [CML and lung cancer]. Over a number of years, we want to show that the drug, which Wuzhou calls DAG for Injection, is particularly useful in cases that are refractory to tyrosine kinase inhibitors (TKIs).
In a recent Nature Biology, it was shown that East Asians often have a sub-type of CML and lung cancer that is resistant to TKI drugs. Our research shows that VAL-083 is effective against this sub-type. We will want the right marketing partner in China to take advantage of these sales.
That is, by developing a non-clinical data set, we were able to position the drug differently. We have developed new IP around formulations and new uses, a re-profiling sort of approach.
ChinaBio: How did you structure your deal with Wuzhou?
Jeffrey Bacha: They will be our global supplier for the drug. We will have rights to VAL-083 around the globe, and we will initially develop it as a treatment for GBM and TKI-resistant cancers, particularly acute myeloid leukemia and NSCLC. The agreement includes the rights to sell the product in China for those indications.
ChinaBio: Why do you think the partnership has been successful?
Jeffrey Bacha: I think we had a lot of mutual benefits in the mix. It was a win-win, as the Chinese like to say. We really had an opportunity with a partner where there was a mutual need.
Beyond that, given that we were all people with experience, it’s a slow simmer for a while, a lot of time building trust, learning what people’s needs are, often spending time around a dinner table. But then it suddenly comes to a boil and things begin to move quickly. That creates a partnership with a strong relationship that lasts for many years to come.
ChinaBio: Where are you now with VAL-083?
Jeffrey Bacha: We have essentially global rights to the drug. We have global patents outside of China. We are moving to have rights for GBM and other indications. In China, we have a partner in Wuzhou, and we are helping them with data and clinical data to expand the revenues in China.
ChinaBio: Do you have advice for people who want to enter a partnership in China?
Jeffrey Bacha: It’s a long process. Patience is key. Language can be a problem. It’s a high melting point at which things begin to move quickly. Most of the issues will be settled before the meeting takes place in a board room. Once you get there, the meeting itself is largely a formality because all the major issues have been worked out.
ChinaBio: Thanks, Jeff, for your time and insights.
See our other articles on DelMar Pharma.