The commercialisation of varlitinib in China is expected to begin approximately one year earlier than previously anticipated following recent discussions with the CFDA regarding its planned clinical development strategy for varlitinib in biliary tract cancer.
SINGAPORE, Jan. 08, 2018 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Pte Ltd (ASLAN, 6497.TT), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced that commercialisation of varlitinib in China, if approved, is expected to begin approximately one year earlier than previously anticipated following recent discussions with the Chinese Food and Drug Administration (CFDA) regarding its planned clinical development strategy for varlitinib in biliary tract cancer.
Dr. Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals said: “Recent regulatory changes mean that the development of innovative drugs addressing areas of high unmet need in China, such as biliary tract cancer, can potentially be accelerated. This may allow us to bring important new therapies to patients with few treatment options sooner. Following our recent agreement to acquire the full global rights to develop and commercialise varlitinib, we are now starting to build our organisation in China to prepare for the anticipated launch of varlitinib.”
ASLAN initiated a pivotal, single-arm, multicentre clinical trial of varlitinib plus capecitabine in China in patients with advanced or metastatic biliary tract cancer who have progressed on at least one line of prior chemotherapy in 2017. Professor Shukui Qin, Chair of the Chinese Society of Clinical Oncology and Deputy Director of the Nanjing 81 Hospital, is the lead investigator for the trial.
The trial will assess the safety and efficacy of varlitinib in combination with capecitabine in a total of 68 patients and is now actively enrolling patients. The primary endpoint will be objective response rate. ASLAN expects to report topline data from this trial in late 2018 and, if the primary endpoint is met, subsequently submit its first regulatory filing for approval for second-line biliary tract cancer to the CFDA, ahead of previous timelines that anticipated longer clinical development.
ASLAN is working closely with its manufacturing partner in China and in 2017 established the manufacturing process of varlitinib to cGMP standards. A commercial supply chain is expected to be validated in China in 2018 and 2019 to support a potential regulatory filing and, if approved, subsequent commercial supply.
Annually, there are approximately 200,000 new cases of biliary tract cancer in Asia, of which up to 145,000 are in China, and approximately 12,600 new cases in the United States, where biliary tract cancer is considered to be an orphan disease. There are currently no approved treatments in China or the United States.
About varlitinib (ASLAN001)
Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2, HER3 and HER4. These receptors can be mutated or overexpressed in many tumors, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumor growth. Varlitinib is currently being studied in gastric, biliary tract, breast and colorectal cancers. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (ASLAN, 6497.TT) is a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets. ASLAN targets diseases that are both highly prevalent in Asia and orphan indications in the United States and Europe. Led by a senior management team with extensive experience in global and regional development and commercialization, ASLAN is headquartered in Singapore and has offices in Taiwan and China. ASLAN’s portfolio is comprised of four product candidates which target validated growth pathways applied to new patient segments, novel immune checkpoints and novel cancer metabolic pathways. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. For additional information please visit www.aslanpharma.com.
Cautionary statement
All materials and information set out herein are for reference only and whilst we make every effort to ensure accuracy and completeness, we cannot guarantee this. We make no recommendation as to the competence or suitability of persons or entities referenced herein (if any). Nothing herein constitutes an invitation or offer to invest in or deal in the securities of ASLAN. Anyone considering investment in ASLAN should refer to the information officially published the Taiwan Stock Exchange Market Observation System (MOPS). This press release contains forward-looking statements including, but not limited to, the commercialisation of varlitinib. Statements including words such as “plan,” “anticipate,” or “expect” and statements in the future tense are forward-looking statements. All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on such forward-looking statements, which are inherently unreliable, and you should not rely on them. Any such forward-looking statement will have been based on ASLAN’s expectations, assumptions, estimates and projections about future events on the date(s) made. Actual outcomes are subject to numerous risks and uncertainties, many of which relate to factors beyond ASLAN’s control, that could cause them to differ materially from those expressed in a forward-looking statement. ASLAN has no obligation to update or otherwise revise any forward-looking statements to reflect the occurrence of unanticipated events or for any other reason.
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