For the vast majority of the 40 years it has been in existence, Glenmark Pharmaceuticals has been focused on generics. But that changed in 2001 when CEO Glenn Saldanha decided to transition the company from an Indian generics business into an unlikely innovator. The company now has a pipeline of several new chemical and biological entities in various stages of preclinical and clinical development. It has also experienced significant growth, both in the U.S. and India. In fact, earlier this year it was named India’s third fastest growing company by BW Businessworld.
PM360 spoke to Kurt Stoeckli, who joined Glenmark in the midst of this transition as President and Chief Scientific Officer. He explains why he decided to make the switch from big pharma to help with Glenmark’s growth, the secret behind the company’s success, and what to expect from the company in the future.
PM360: Glenmark has been transitioning from a generics company to doing more innovative R&D. What is the thought process behind your company’s new R&D strategy and what’s been leading to your success?
Kurt Stoeckli: It is exactly as you described. Back in 2001, our Chairman and Managing Director, Glenn Saldanha, recognized that, in the long term, generics would face challenges to maintain the same pace and growth rate the category has historically delivered. His vision was to start an innovation business that would grow organically, funded by the revenues from our generics business. And, that vision propelled us to where we are today.
Among our largest undertaking during this time, Glenmark initiated a significant project in Switzerland aimed at developing antibodies concentrated on three therapeutic areas: Oncology, respiratory, and dermatology. And those are the three areas you will find in all three pillars of the company: Generics, specialty, and innovation. What is different is we are researching and developing very novel types of modalities to treat unmet medical needs.
Our most advanced project is in Phase II for an autoimmune, dermatological disease called atopic dermatitis. Then, in oncology, we have a number of projects aimed at superiority compared to current standard-of-care therapies based on immuno-oncology principles. That’s the story that excites me and why I decided to move away from big pharma, because at Glenmark I have the opportunity to help shape these clinical development programs based on my experience.
Do you feel that you’re able to do more here than you could at a big pharma company? What are the differences between working at big pharma and Glenmark?
What is very different at Glenmark, even unique, is our decision making. It’s very fast and nimble. That is extremely different from big pharma where there are many layers of management and committees. Here, Glenn assembled a leadership team with experience in big pharma and innovation medicine which allows for very rapid decision-making. We don’t necessarily take higher risks, but we have an efficient way of moving forward.
Is there a reason the company choose to focus specifically on oncology, respiratory, and dermatology?
We were already present, active, and successful in dermatology for generics. We also have specialty products in respiratory that are in late development (Phase II and III). Our considerable expertise and experience in those markets makes it easier to ensure cross-pollination between our three pillars (generics, specialty, and innovation) happens. We are simply moving up the value chain.
That is one reason, and the other is we are cognizant that opportunities for collaboration and cooperation of talent and resources must be fully maximized to develop the scientific capabilities necessary for innovative drug discovery. Glenmark strategically selected our core therapeutic areas based on where we can make a difference. And, our antibody platform gives us the highest probability of success in the three areas I mentioned.
What are some of the innovative products your company is working on in those three therapeutic areas?
In oncology, we are in Phase I on a project called GBR1302, which is for metastatic breast cancer and certain gastrointestinal cancers. In preclinical studies, GBR 1302 demonstrated potential superiority compared to current standard-of-care. If successful, we will expand development into other metastatic tumors.
Our second asset, GBR1342, recently received Investigational New Drug application acceptance by the FDA. In preclinical testing, the compound demonstrated superiority compared to current standard-of-care today in multiple myeloma. Our third oncology asset. GBR1372, is being investigated for colorectal cancer.
In addition, our autoimmune/dermatology candidate, GBR830, is a biologic in Phase II and we expect to share significant data later this year. We also have a biosimilar in development as a potential treatment for respiratory diseases. We are not focused on biosimilars as a company, but this asset aligns with our core therapeutic areas.
Your company also recently announced that GSP301, which is a nasal spray, reached Phase III. What can you tell me about that?
That comes from our specialty business, which is a separate pillar from our innovation and generics business. Under this pillar, we are developing new drug-device combinations that provide advantages and convenience to the patient. GSP301, a combination of established drugs on the market, is designed to improve adherence and compliance for patients. We are seeking approval for the components to be used as a combination within the spray.
One of the other keys of the company’s success has been the focus on India, the U.S., and emerging markets. How does your strategy differ for each of those markets since the regulatory environment is different in each one?
The U.S. is one of our leading markets today, along with India and select countries in emerging markets such as Russia and Brazil. In each of these markets the regulatory environment for generics is unique, but the most significant differences are seen in the regulation of innovative medicines.
For innovative medicines, our focus is on the U.S. and Europe. To deliver on this focus, our clinical studies and manufacturing strategy are U.S.- and EU-centric. Meanwhile, the generics are mainly developed from our R&D centers in India because the local talent and infrastructure can support all of the necessary end-to-end development and production.
Is there anything else you attribute to your company’s recent success?
Yes, I would like to mention the way we are managing this transition into an unexpected innovator is unique, it is something I have not seen before in other companies. And one of the reasons is Glenn invested in a team that brings talent and experience from diverse areas. For instance, there was clearly an intention by Glenn to build out the innovation business by making strategic investments where the talent already resides, such as Switzerland for our biologics capabilities.
He has brought new people on board from across the industry, including big pharma, people who have already worked on similar early- and late-stage clinical development projects. Not only do these people bring their own experience, but they also help attract new talent, which is a key factor for Glenmark to grow the innovation space in the same way we did with generics. Finally, the way we are partnering with big pharma and mid-sized companies is different. Instead of relying on out- or in-licensing deals, a typical growth pathway in generics, our aim is strategic partnerships based on a co-development or co-commercialization strategy. Our multi-pronged approach to growing our generics business as a means of fueling our innovation ensures Glenmark maintains a thoughtful and controlled evolution.