When Baxalta Incorporated spun out of Baxter on July 1, it already qualified as “big pharma.” With USD 6 billion in annual revenues, 16,000 employees, operations in 100 countries and USD 600 million invested in R&D, it focuses its assets tightly on the patient experience and expects its partners to do the same.
Even before leaving Baxter, its philosophy differed from that of its parent. “Our culture, risk profile and investors, for example, are different from the medical devices division of Baxter,” said John Orloff, MD, EVP, Global Head of R&D, and CSO.
Baxalta is entrepreneurial, accepting enhanced risk as a price of innovation. “Therefore, we spun off the bioscience division with an eye to growing the business we’ve already established in hematology and immunology, capitalizing on their synergies with oncology to create another growth pillar.”
John Orloff, MD, EVP, Global Head of R&D, and CSO, Baxalta
Capitalizing on Cambridge
That culture was one of the key reasons it located its Global Innovation and R&D Center in Cambridge, Massachusetts. The 200-employee Baxalta Global Innovation and R&D Center is focused primarily on R&D. As its staff increases to an anticipated 500 by year’s end, the center also will include business development, the corporate strategy and commercial operations group and the business units for oncology and biosimilars development.
“The Cambridge life sciences community is one of the richest in the world. It has more than 130 biotech companies as well as several leading academic institutions,” he continued. That concentration of life sciences companies, institutions and support functions creates an ecosystem of people who understand and accept the risks that are inherent in this industry. As Orloff said, “Culture plays a big role in calculated risk-taking. Not being afraid to fail is important, and that mindset is not present in a lot of big pharma—or even other—business models.
“We’re still building out our capabilities on the regulatory front,” Orloff said. “We’re actively engaged with BIO and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Particularly in policy development, it’s beneficial to partner with others with similar views.”
The richness of the Boston life sciences ecosystem supports the development of cross-functional teams as well as partnerships. “We’re a niche company, focused on orphan drugs and unmet medical needs,” Orloff said. From our Cambridge location, “we can meet face-to-face with like-minded companies across the street or around the corner.”
For example, Baxalta partners with nearby Merrimack Pharmaceuticals, Inc. to develop irinotecan liposome injections to treat patients with metastatic adenocarcinoma. Baxalta’s biosimilars projects were developed with input from Momenta Pharmaceuticals “just down the street.”
Baxalta also works closely with its service providers. Quintiles, which functions as an extension of Baxalta’s own development arm, is a good example. This seamless integration enables the two entities to work together as one, planning access to resources and innovations to increase the probabilities of success.
The result shortened timelines. As one example, for BAX 855 (a PEGylated form of Baxter’s rFVIII product ADVATE™), the time between protocol approval to acceptance of the first patient into clinical trials was 30 percent faster that average. At the end of the trial, the time between the last patient’s exit from the trial to delivery of the database log was halved to 21 days.
Aggressive in-licensing and acquisitions
“We’re looking to bring in new molecules through partnering,” Orloff said. Baxalta plans to launch 20 products within the next five years, adding approximately USD 2.5 billion to annual revenue. Much of this growth will occur through acquisitions and in-licensing.
A dozen acquisitions and strategic partnerships already have been signed. “Our most recent acquisition was SuppreMol, a German company with a platform for autoimmune and allergic diseases,” he said. And, in May this year, Baxalta announced its intention to acquire Sigma-Tau’s oncology platform, which includes Oncaspar® and calaspargase pegol. Both compounds target acute lymphocytic leukemia (ALL).
Baxalta already has a strong portfolio in hematology (particularly hemophilia), immunology and plasma technologies. Its pipeline boasts more than 40 programs, including biologics and gene therapies. Of these, 13 are in Phase III development, while four products in Baxalta’s three focus areas are undergoing regulatory review. Of those, the oncology products are expected to be commercialized first, he suggested. The biosimilars business unit also has products in various stages of development.
For in-licensing and acquisitions, Orloff said the company is interested in further strengthening its immunology, hematology and plasma platforms and expanding its work in oncology.
The company is looking broadly at assets for potential acquisition, from discovery to Phase III. The objective, he told partneringNEWS, is to develop a balanced portfolio in Baxalta’s key therapeutic areas and to balance risk across its platform.
Innovative partnering models
Identifying attractive compounds is only one part of the growth strategy, however. The other part is to develop innovative, flexible business models.
Optioning innovations, he said, is one alternative to in-licensing agreements. Baxalta uses it mainly for preclinical and discovery-stage projects. For example, Baxalta Ventures, the company’s investment arm, just announced an incubator agreement with Velocity Pharmaceutical Development and the Mayo Clinic to discover and develop antibody and protein-based therapeutics biologic assets in immunology, oncology and hematology.
“We provide financing and manufacturing. Velocity provides target identification, early stage candidate selections, study protocol design and project management for preclinical and clinical development. The Mayo Clinic provides in-kind support for Phase I studies,” Orloff explained.
The company formed by this collaboration, Vitesse Biologics, LLC, will scan the life sciences ecosystem for promising development candidates. Then, he added, “we’ll have exclusive rights to option these assets into our pipeline for global commercialization.”
Building a purpose-driven culture
Throughout discover and development, working with all the stakeholders is a key element in Baxalta’s philosophy. “That takes a concerted effort,” Orloff said.
When envisioning the target profile of an entity, for example, “we get input from payers, healthcare providers and patient advocates, actively engaging with them to determine what patients believe would improve their quality of life. Then we incorporate those insights into our development plans in addition to the FDA and EMA endpoints for product registration.” The goal, he said, is to improve standard of care and ensure access.
As Baxalta develops a purpose-driven culture, it aims to ignite innovative sparks among its partners as well as its employees, so they are empowered to contribute new ideas that create meaningful, sustained value for all stakeholders.
“We’re rolling out a governance model for cross-functional collaboration to foster an environment that lives up to the spark,” Orloff said. That model stresses that Baxalta is a patient-centric company. “Everyone from discovery research through sales and marketing should understand that our primary mission is to make a positive impact for patients with orphan diseases or unmet needs. That drives everything we do.”
Imbuing collaborative partners with that same drive doesn’t occur by osmosis. It takes training and time to graft our patient-centric culture—our expected behaviors—into our partners’ cultures. Baxalta, he said, is committed to ensuring that graft takes.
BioPharm America™ 2015 will meet in Boston in September to offer unequaled partnering opportunities in the Boston/Cambridge life science ecosystem.
No related posts.