Acquisition Includes Chatham’s Gene Therapy Technology for
DEERFIELD, Ill. and CHAPEL HILL, NC, April 2, 2014 - Baxter International Inc. (NYSE:BAX) and Chatham Therapeutics, LLC, today announced that Baxter has agreed to acquire all of Chatham's outstanding membership interests. As a result of the transaction, Baxter will acquire Chatham's developmental gene therapy programs directed toward the development and commercialization of treatments for hemophilia.
In May 2012, Baxter and Chatham entered into a collaboration to evaluate Chatham's Biological Nano Particle (BNP™) platform – an advanced recombinant adeno-associated virus (rAAV)-based gene therapy technology – as a potential treatment for hemophilia B, known as BAX 335, which is currently in a Phase I/II study. As a result of this acquisition, Baxter obtains broad access to Chatham's gene therapy platform, including the previously partnered hemophilia B (FIX) program, a preclinical hemophilia A (FVIII) program, and the potential future application to additional hemophilia treatments.
"Chatham's gene therapy platform technology offers the potential to redefine treatment of both hemophilia A and B," said Ludwig Hantson, Ph.D., president of Baxter BioScience. "This technology will be highly complementary to our expanding pipeline of bleeding disorder treatments as we continue our pursuit of a bleed-free world."
Under the terms of the agreement, Baxter will make an initial payment of $70 million to acquire all of the outstanding membership interests of Chatham. Baxter may make additional payments in the future based on specified development, regulatory and commercial milestones.
"Given Baxter's long-standing commitment to innovative product development in hemophilia, we are confident that this transaction provides the best opportunity for the advancement of our BNPTM gene therapy platform technology for the benefit of hemophilia patients worldwide. The integration of Chatham's next-generation technology and expertise, along with Baxter's global marketing and distribution presence, is a combination we anticipate will support efficient delivery of a potential new class of therapeutics to the hemophilia market," said Jade Samulski, Co-Founder of Chatham and Vice President of Asklepios BioPharmaceutical, Inc.
Baxter will continue the ongoing Phase I/II open-label clinical trial to assess the safety and optimal dosing schedule of BAX 335, an investigational FIX gene therapy treatment for hemophilia B. The BNPTM technology provides a mechanism for the patient's own liver to begin producing FIX following a single dose of the genetically engineered treatment. The design of the vector allows for more targeted delivery of the FIX therapeutic "cargo" into the natural site of FIX synthesis. This may permit effective therapy with low quantities of the vector.
The Phase I/II clinical trial is proceeding as expected and aims to enroll up to 16 hemophilia B patients.
Following the acquisition, Chatham will maintain its licensing and development relationship with Asklepios BioPharmaceutical, Inc. (AskBio) on the development of novel hemophilia therapeutic gene therapy candidates using the Biological Nano Particle (BNP™) platform. AskBio is involved with the development of its proprietary BNPTM gene-delivery platform technology for therapeutics targeting diseases in the heart, CNS, muscle, ocular and liver tissues.
About Baxter in Hemophilia
Baxter has more than 60 years' experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work focuses on optimizing hemophilia care and improving the lives of people worldwide living with bleeding disorders.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
About Chatham Therapeutics, LLC
Chatham Therapeutics, LLC (Chatham) is a privately held clinical development-stage biotechnology company engaged in the development of novel, gene therapy-mediated treatments for hemophilia. The company is currently engaged in gene therapy-based therapeutic programs for both hemophilia A and B. For additional information on AskBio, visit AskBio's Web site at http://www.askbio.com.
This release includes forward-looking statements concerning an agreement entered into by the company to acquire certain developmental gene therapy programs for hemophilia through the acquisition of Chatham Therapeutics, LLC, including expectations regarding upfront and other future payments, on-going clinical trials and Baxter's R&D pipeline. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; clinical trial results; changes in laws and regulations; product quality or patient safety issues; and other risks identified in Baxter's most recent filings on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.