Taiho Oncology Announces Agreement with Otsuka to Commercialize Astex Pharmaceuticals’ Drug Candidates

PRINCETON, N.J., June 7, 2019 – Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will commercialize these compounds in Canada.

The two candidates are in late-stage clinical development by Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka. Taiho Oncology is also part of the Otsuka group of companies.

“This commercialization agreement is highly significant for Taiho Oncology as it allows us to build on the long-term strategy of expanding our presence in North America,” said Taiho Oncology, Inc. Chief Executive Officer Timothy Whitten. “These investigational therapies have the potential to provide physicians and patients with much-needed treatment options for a range of hematologic malignancies. We look forward to working with Astex as we bring these compounds to market.”

On June 6, 2019, Astex Pharmaceuticals and Otsuka announced top-line results from the Phase III ASCERTAIN study evaluating ASTX727 vs. decitabine IV in adults with intermediate and high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). The trial met its primary endpoint of decitabine area-under-the-curve (AUC) equivalence of total 5-day dosing between orally administered ASTX727 and IV decitabine. The full data will be presented at an upcoming scientific meeting.

Astex has current studies with guadecitabine (SGI-110) in relapsed and refractory acute myeloid leukemia (R/R AML) and relapsed and refractory myelodysplastic syndromes (R/R MDS) and CMML.

About Taiho Oncology, Inc. (U.S.)
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. and an indirect subsidiary of Otsuka Holdings Co., Ltd., has established a world-class clinical development organization that works urgently to develop innovative cancer treatments and has built a commercial business in the U.S.

Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping us to define the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.

For more information about Taiho Oncology, please visit: https://www.taihooncology.com.

For more information about Taiho Pharmaceutical Co., Ltd., please visit:

https://www.taiho.co.jp/en/.

About Astex Pharmaceuticals, and Otsuka Pharmaceutical
Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has multiple partnered products in development under collaborations with leading pharmaceutical companies. Astex became a wholly owned subsidiary of Otsuka in 2013.

Otsuka Pharmaceutical Co., Ltd., based in Tokyo, Japan, is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, visit: http://www.astx.com.

For more information about Otsuka Pharmaceutical, visit: http://www.otsuka.com/en/.

###

Contacts for U.S. Media

On behalf of Taiho Oncology:
Craig Heit
GCI Health
Taihooncology@gcihealth.com
646-946-6690

At Astex:
Martin Buckland
Chief Corporate Officer
Astex Pharmaceuticals, Inc.
info@astx.com
925-560-2857

PL-PM-US-0007 06/2019

British Company Behind Groundbreaking Breast Cancer Treatment

Astex welcomes positive, new data showing breast cancer drug, Kisqali® (ribociclib), cuts risk of death by up to a third when given with hormone therapy

Cambridge, UK, 7 June 2019. A new set of statistically significant overall survival (OS) data unveiled at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract# LBA1008), and published in The New England Journal of Medicine, are being heralded as a major breakthrough forpre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancerpremenopausal women with advanced breast cancer.

Kisqali was discovered and developed by the Novartis Institutes for Biomedical Research (NIBR) under a research collaboration entered into with Astex in 2005.  Kisqali is a CDK4/6 inhibitor that slows the progression of cancer by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly.

Successful results from the phase III MONALEESA-7 clinical trial resulted in Kisqali receiving marketing approval in the US and EU in 2018 in combination with an endocrine-based therapy for pre- and perimenopausal women with (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.

The UK’s National Institute for Health and Care Excellence (NICE) recommended Kisqali as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer in November 2017. Advanced breast cancer in premenopausal women is the leading cause of cancer death in women 20-59 years old [1],[2].

Kisqali is the only CDK4/6 inhibitor to show superior overall survival in a clinical trial (alt. “v. placebo”) in advanced breast cancer (HR=0.712; p=0.00973)[3]. In its announcement at ASCO, Novartis noted that the new data from its MONALEESA-7 trial showed that after a median of 42 months follow-up, survival rate for women was 70.2% for women who received Kisqali combination therapy compared to 46.0% for women who received endocrine therapy alone. The breakthrough data has been widely reported in the world’s press.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “It’s fantastic to see such a significant advance in cancer treatment. Ultimately as life science entrepreneurs, our goal is to improve lives through the discovery of new therapies. Kisqali was the first new cancer drug discovered and developed from our collaboration with Novartis to reach marketing approval and was a milestone for the company in 2017.  These new data are a real milestone for patients.”
The paper,Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer, was a published in The New England Journal of Medicinetoday and is available online.

See the discovery journey for Kisqali, here: https://astx.com/research-development/partnered-products-and-programs/kisqali-ribociclib-cdk46-inhibitor-oncology/

-ENDS-

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.  Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
For more information about Astex Pharmaceuticals, please visit http://www.astx.com
For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

References

[1] Benz CC. Impact of aging on the biology of breast cancer. Crit Rev Oncol Hematol. 2008;66:65-74.
[2] World Health Organization. Top cancer per country, estimated age-standardized mortality rates (World) in 2018, females, all ages. 2018. Available at http://gco.iarc.fr/today/home. Accessed May 2019
[3] Hurvitz S, Seock-Ah I, Yen-Shen L et al. Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results. Presented at the 2019 ASCO Meeting, June 1, 2019, Abstract# LBA 1008.

CONTACT:

At the Company:
Jeremy Carmichael
VP Corporate Development
Head of Business Development
Tel: +44(0)1223 226289
Email: jeremy.carmichael@astx.com

For Media Enquiries:
Sue Charles / Ashley Tapp
Instinctif Partners
Tel: +44 (0)20 7866 7863
Email: astex@instinctif.com

 

Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASCERTAIN study of the novel oral cedazuridine and decitabine fixed-dose combination (ASTX727) in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML)

  • Cedazuridine and decitabine, administered orally as a fixed-dose combination (ASTX727), met the primary endpoint of decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and IV decitabine in the phase 3 ASCERTAIN study in MDS and CMML patients
  • The study confirmed that the safety profile and clinical activity of the cedazuridine and decitabine fixed-dose combination was similar to that observed in the phase 1/2 study and similar to the expected clinical profile of decitabine IV
  • Astex plans to file a New Drug Application (NDA) with the US FDA by the end of 2019
  • Astex is continuing to develop cedazuridine and decitabine fixed-dose combination in additional patient populations including those with acute myeloid leukemia (AML) and low-risk MDS

Pleasanton, CA and Tokyo, Japan, June 6th, 2019. Astex Pharmaceuticals, Inc. a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., announce top-line results from the ASCERTAIN phase 3 study evaluating cedazuridine and decitabine fixed-dose combination (ASTX727) vs decitabine IV in adults with intermediate and high-risk MDS or CMML.

The study met its primary endpoint of decitabine exposure equivalence of 5-day dosing between orally administered ASTX727 and IV decitabine as per the protocol analysis plan. Safety and clinical activity were similar to that observed in a previous phase 1/2 study. The full data will be presented at an upcoming scientific meeting.

Astex plans to file an NDA with the US FDA by the end of 2019.

“We are delighted with the outcome of the ASCERTAIN trial, and the demonstration that the fixed dose combination of cedazuridine with decitabine enables successful oral delivery of decitabine, alleviating the significant burden of five days of monthly IV infusions for patients who may continue to benefit from the drug for several months or even years,” said Mohammad Azab, Astex Pharmaceuticals’ president and chief medical officer. “Subject to regulatory review and approvals, ASTX727 could bring a new treatment option to patients with these deadly diseases. We are extremely grateful to all the patients, caregivers, partner research and manufacturing organizations, as well as the healthcare professionals who contributed to this effort.”

About Cedazuridine and Decitabine Fixed-Dose Combination (ASTX727)

ASTX727 is a novel, orally administered fixed dose combination of cedazuridine, an inhibitor of cytidine deaminase, with the anti-cancer DNA hypomethylating agent, decitabine.1  By inhibiting cytidine deaminase in the gut and the liver, ASTX727 allows for oral delivery of the approved DNA hypomethylating agent, decitabine at exposures which are equivalent to the approved intravenous form of decitabine administered over 5 days.

ASTX727 has been evaluated in a phase 1/2 pharmacokinetics-guided dose escalation and dose confirmation study in patients with MDS and CMML to define appropriate doses of the individual components of ASTX727 (cedazuridine and decitabine) so that decitabine exposure after oral administration of ASTX727 is similar to exposure after IV decitabine at the approved daily dose of a 1-hour infusion at 20 mg/m2 (see https://www.clinicaltrials.gov NCT02103478). This study demonstrated that ASTX727 allowed decitabine to be delivered orally at a dose that emulates parenteral pharmacokinetics, as measured by 5-day area-under-the-curve (AUC).3 The drug’s safety profile was similar to that of IV decitabine. Of particular note was the low level of gastrointestinal adverse events.3

The concept of using cedazuridine to block the action of cytidine deaminase is also being evaluated in a low dose formulation of cedazuridine and decitabine for the treatment of lower risk MDS (see https://www.clinicaltrials.gov NCT03502668). ASTX727 may also have potential in all-oral combination regimes for the treatment of a range of different tumor types.

Astex is also expanding the evaluation of cedazuridine – decitabine combinations through a program of investigator-sponsored trials.

ASTX727 is an investigational compound and is not currently approved in any country.

About the ASCERTAIN Study

The ASCERTAIN study was designed to demonstrate that the cedazuridine and decitabine fixed-dose combination (ASTX727) could deliver orally a pharmacokinetically equivalent exposure of decitabine compared to IV decitabine in adults with previously untreated or treated MDS, including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and CMML), and subjects with MDS International Prognostic Scoring System (IPSS) int-1, int-2, or high-risk MDS. (see https://www.clinicaltrials.gov NCT03306264). The study was designed as a randomized, open-label cross-over study in which patients were randomized in a 1:1 ratio to receive ASTX727 daily x 5 in the first 28-day cycle followed by IV decitabine daily x 5 in the second 28-day cycle, or the converse order. Following completion of the first two cycles, patients continued to receive treatment with ASTX727 in 28-day cycles until disease progression, unacceptable toxicity, or the subject decided to discontinue treatment or withdrew from the study. The primary endpoint of the study was total 5-day AUC exposures of decitabine after treatment with ASTX727 versus IV decitabine as measured across the first two cycles. Secondary endpoints included safety assessments, pharmacodynamic measurements, secondary PK parameters, clinical responses, red blood cell transfusion independence, leukemia-free survival, and overall survival. The study was conducted in 138 patients at 46 sites in the US and Canada.

About Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and associated with cytopenias affecting one or more of the three lineages. US incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.4,5 The prevalence has been estimated to be from 60,000 to 170,000 in the US.6 MDS may evolve into acute myeloid leukemia (AML) in one-third of patients.7 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML. CMML is a clonal hematopoietic malignancy characterized by accumulation of abnormal monocytes in the bone marrow and in blood. The incidence of CMML in the US is approximately 1,100 new cases per year,8 and CMML may transform into AML in 15% to 30% of patients.9 The hypomethylating agents decitabine and azacitidine are effective treatment modalities for hematologic cancers and are FDA-approved for the treatment of higher risk MDS and CMML. These agents are administered by IV infusion, or by large-volume subcutaneous injections.

About Astex Pharmaceuticals, and Otsuka Pharmaceutical

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has multiple partnered products in development under collaborations with leading pharmaceutical companies. In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit: http://www.astx.com

For more information about Otsuka Pharmaceutical, please visit: http://www.otsuka.com/en/

Contact Details

Martin Buckland
Chief Corporate Officer
Astex Pharmaceuticals, Inc.
4420 Rosewood Drive, Suite 200
Pleasanton 94588, CA, USA
Tel: +1-925-560-2857
Email: info@astx.com

 

References

  1. Oganesian A, Redkar S, Taverna P, Choy G, Joshi-Hangal R, Azab M. Preclinical data in cynomolgus (cyn) monkeys of ASTX727, a novel oral hypomethylating agent (HMA) composed of low-dose oral decitabine combined with a novel cytidine deaminase inhibitor (CDAi) E7727 [ASH Abstract]. Blood 2013;122(21): Abstract 2526.
  2. Ferraris D, Duvall B, Delahanty G, Mistry B, Alt, J, Rojas C, et al. Design, synthesis, and pharmacological evaluation of fluorinated tetrahydrouridine derivatives as inhibitors of cytidine deaminase. J Med Chem 2014; 57:2582-2588.
  3. Savona MR, Odenike O, Amrein PC, Steensma DP, DeZern AE, Michaelis LC, et al. An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study. Lancet Haematol [Internet]. 2019;6(4):e194-e203.
  4. Garcia-Manero G. Myelodysplastic syndromes: 2015 update on diagnosis, risk-stratification and management. Am J Hematol 2015; 90(9) 831-841.
  5. Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: Incidence and survival in the United States. Cancer 2007;109(8):1536–1542.
  6. Cogle C. Incidence and burden of the myelodysplastic syndromes. Curr Hematol Malig Rep 2015; 10(3): 272-281.
  7. Shukron O, Vainstein V, Kündgen A, Germing U, Agur Z. Analyzing transformation of myelodysplastic syndrome to secondary acute myeloid leukemia using a large patient database. Am J Hematol 2012;87:853–860.
  8. What are the key statistics about chronic myelomonocytic leukemia? American Cancer Society Web site. https://www.cancer.org/cancer/chronic-myelomonocytic-leukemia/about/key-statistics.html. Accessed 08 April 2019.
  9. About chronic myelomonocytic leukemia (CMML). Cancer Research UK Web site. https://www.cancerresearchuk.org/about-cancer/other-conditions/chronic-myelomonocytic-leukaemia-cmml/about. Accessed 08 April 2019.

 

Astex Pharmaceuticals Celebrates as Second New Cancer Drug Receives US Marketing Approval

Astex Pharmaceuticals Celebrates as Second New Cancer Drug Receives US Marketing Approval
  • Further Milestone from Janssen on NDA Approval by the US FDA of BALVERSA™ (erdafitinib) for the Treatment of Urothelial Cancer

Cambridge, UK, 12 April 2019. Astex Pharmaceuticals (Astex), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it has received a milestone payment from Janssen Pharmaceutica N.V. (Janssen). This follows the United States Food and Drug Administration’s (FDA) accelerated review and approval of a Janssen New Drug Application (NDA) for BALVERSA™ (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

BALVERSA™ (erdafitinib) is a once-daily, oral pan-FGFR inhibitor that was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and licence agreement to identify novel, small molecule inhibitors of FGFR kinase, including for the treatment of cancer. Under the ongoing collaboration, Janssen is responsible for the clinical development and commercialisation of all products, including erdafitinib. Astex is eligible to receive further milestone payments on additional regulatory filings and approvals in the US and Europe and for additional indications, as well as tiered double-digit royalty payments on annual sales of erdafitinib.

BALVERSA™ (erdafitinib) received Breakthrough Therapy Designation from the FDA for the treatment of patients with metastatic urothelial cancer in March 2018 and Janssen announced submission of an NDA seeking its approval to the US FDA in September 2018. Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.

Before entering into its exclusive worldwide collaboration and licence agreement with Janssen, Astex performed pioneering work on FGFR with the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre, Northern Institute for Cancer Research, Newcastle University, UK, underlining the quality of UK science and strengths in academic-biotech collaboration.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “‘We are delighted with the approval of BALVERSA™ and congratulate our valued colleagues at Janssen for their determination and excellent work in the discovery and development of this new medicine. We also congratulate our academic collaborators at Newcastle University for their contribution to our pioneering early collaboration on FGFR that aided in its discovery. Astex continues to strive to discover new medicines for cancer patients and is very proud that BALVERSA™ is the second of our Pharma-partnered products to have been approved in the last two years.’

-ENDS

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit http://www.astx.com

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

BALVERSA is a trademark of Janssen Biotech, Inc.

Contact

At the Company:
Jeremy Carmichael
VP Corporate Development
Head of Business Development

Tel: +44(0)1223 226289
Email: jeremy.carmichael@astx.com

For Media Enquiries:
Sue Charles / Ashley Tapp
Instinctif Partners

Tel: +44 (0)20 7866 7863
Email: astex@instinctif.com

Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASTRAL-1 study of guadecitabine (SGI-110) in treatment-naïve AML patients ineligible to receive intense induction chemotherapy

Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASTRAL-1 study of guadecitabine (SGI-110) in treatment-naïve AML patients ineligible to receive intense induction chemotherapy

  • Guadecitabine did not meet the co-primary endpoints of complete response (CR) rate or overall survival (OS) in the ASTRAL-1 study
  • Astex continues to focus on completing the phase 3 ASTRAL-2 and ASTRAL-3 studies evaluating the efficacy and safety of guadecitabine in relapsed and refractory acute myeloid leukemia (R/R AML) and relapsed and refractory myelodysplastic syndromes (R/R MDS) and chronic myelomonocytic leukemia (CMML)

Pleasanton, CA and Tokyo, Japan, July 30th, 2018. Astex Pharmaceuticals, a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., announce top-line results from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine (SGI-110) in adults with previously untreated AML who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete response (CR) rate (p>0.04), and overall survival (OS) (p>0.01) as per the protocol analysis plan, compared with the control arm of physician’s choice of azacitidine, decitabine, or low dose cytarabine. Evaluation of the study’s secondary endpoints and safety data is ongoing. The full data will be presented at an upcoming scientific meeting.

The company continues to focus on completing the ongoing global phase 3 ASTRAL-2 and ASTRAL-3 studies evaluating guadecitabine in the treatment of relapsed and refractory AML and relapsed and refractory MDS and CMML.

“We are disappointed in the outcome of the ASTRAL-1 study,” said Mohammad Azab, Astex’s president and chief medical officer. “The study used very strict criteria of ineligibility to receive intensive chemotherapy based on age (over 75 years) or poor performance status (ECOG PS of 2 or 3) or comorbidities, which made it a difficult population to show superior benefit of guadecitabine.” Dr. Azab also added, “ASTRAL-1 is the largest global prospective study ever conducted in this specific patient population with low intensity therapy, with 815 patients randomized, of whom about 90% were treated with hypomethylating agents or HMAs (guadecitabine, azacitidine, or decitabine). The large body of clinical and genetic data will still provide the medical community with very valuable insights into the role of several prognostic clinical and genetic markers that may influence outcome with HMA treatment. We are extremely grateful to all the patients, physicians and other healthcare professionals, and partner research and manufacturing organizations who contributed to this global effort. We are now looking forward to the completion of the ASTRAL-2 and ASTRAL-3 studies currently actively recruiting in two different indications.”

About Guadecitabine (formerly SGI-110)

Guadecitabine is a next-generation DNA hypomethylating agent.1,2 Guadecitabine was rationally designed to be resistant to degradation by cytidine deaminase, prolonging the exposure of tumor cells to the active metabolite, decitabine, thus ensuring greater uptake of decitabine into the DNA of rapidly dividing cancer cells.3 Guadecitabine, through the action of decitabine, inhibits DNA methyl transferase (DNMT), with the potential to reverse aberrant DNA methylation, an epigenetic change characteristic of many cancer cells that results in silencing of critical genes. This action may restore the expression of silenced tumor suppressor genes and tumor-associated antigens.4 Through this re-expression of silenced genes, guadecitabine may have the potential to sensitize tumor cells to other anticancer agents,5,6,7 including immunotherapeutics,8 as well as re-sensitizing cancer cells previously resistant to chemotherapeutics.7

Guadecitabine is currently being studied in two additional phase 3 studies:

  • ASTRAL-2: A randomized, open-label study in leukemia patients with relapsed or refractory acute myeloid leukemia (AML) following intensive chemotherapy. See www.clinicaltrials.gov NCT02920008.
  • ASTRAL-3: A randomized, open-label study in myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) after failure of treatment with azacitidine, decitabine, or both. See www.clinicaltrials.gov NCT02907359.

In addition, guadecitabine is being evaluated in over twenty investigator and company-sponsored trials in other hematological malignancies and in solid tumors, both as a single agent, and in combination with chemotherapy or immunotherapy.

Guadecitabine was designed to be administered subcutaneously as a low-volume, stable formulation.

About the ASTRAL-1 Study

The ASTRAL-1 study evaluated the efficacy and safety of guadecitabine (formerly SGI-110) in adults with previously untreated AML who are not eligible for intensive induction chemotherapy (see www.clinicaltrials.gov NCT02348489). The study is the largest global prospective study ever conducted in this specific patient population, with 815 patients randomized from 163 investigator sites in 24 countries worldwide. The study compared guadecitabine, delivered subcutaneously (SC) 60mg/m2/day for 5 days, with physicians’ choice of azacitidine IV or SC 75 mg/m2/day for 7 days, decitabine IV 20 mg/m2/day for 5 days, or low dose cytarabine SC 20 mg bid for 10 days, all administered in 28-day cycles. In addition to the co-primary endpoints of OS and CR, the study evaluated multiple secondary endpoints including progression-free survival; composite CR or CRc (CR + CRi + CRp); overnight stays in hospital; red cell / platelet transfusions; QOL (EQ-5D-5L); duration of response and safety.

About Acute Myeloid Leukemia

AML is the most common form of acute leukemia in adults.9 There were an estimated 21,380 new cases of AML diagnosed in the US in 2017,10 and an estimate of 10,590 patients were projected to have died from AML in the US in 2017.11 Although 60 to 80 percent of AML patients less than 60 years of age may achieve a complete response (CR) with standard intensive induction chemotherapy,12 the outlook for patients 60 years of age or more is significantly worse, with response rates less than 50 percent, cure rates following transplant remaining at less than 10 percent and a median survival of less than one year.12,13,14 These figures have not significantly improved during the last three decades. These patients have few therapeutic options available.15,16 Effective, less toxic therapies are needed for the treatment of AML, particularly for elderly patients where comorbidities and other consequences of aging may often render them ineligible to receive intensive induction chemotherapy, thus denying them a potentially curative transplant.14

About Astex Pharmaceuticals and Otsuka Pharmaceutical

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has multiple partnered products being developed under collaborations with leading pharmaceutical companies. In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit http://www.astx.com

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.com/en/

Contact Details
Martin Buckland
Chief Corporate Officer
Astex Pharmaceuticals, Inc.
4420 Rosewood Drive, Suite 200
Pleasanton 94588, CA, USA
Tel: +1-925-560-2857
Email: Info@astx.com

 

References

  1. Kantarjian HM, Roboz GJ, Kropf PL, et al. Guadecitabine (SGI-110) in treatment-naive patients with acute myeloid leukaemia: phase 2 results from a multicentre, randomised, phase 1/2 trial. Lancet Oncol 2017; 18(10): 1317-26.
  2. Roboz GJ, Kantarjian HM, Yee KWL, et al. Dose, schedule, safety, and efficacy of guadecitabine in relapsed or refractory acute myeloid leukemia. Cancer 2018; 124(2): 325-34.
  3. Issa JJ, Roboz G, Rizzieri D, et al. Safety and tolerability of guadecitabine (SGI-110) in patients with myelodysplastic syndrome and acute myeloid leukaemia: a multicentre, randomised, dose-escalation phase 1 study. Lancet Oncol 2015; 16(9): 1099-110.
  4. Griffiths EA, Choy G, Redkar S, Taverna P, Azab M, Karpf AR. SGI-110: DNA Methyltransferase Inhibitor Oncolytic. Drugs Future 2013; 38(8): 535-43.
  5. Kuang Y, El-Khoueiry A, Taverna P, Ljungman M, Neamati N. Guadecitabine (SGI-110) priming sensitizes hepatocellular carcinoma cells to oxaliplatin. Mol Oncol 2015; 9(9): 1799-814.
  6. Srivastava P, Paluch BE, Matsuzaki J, et al. Immunomodulatory action of SGI-110, a hypomethylating agent, in acute myeloid leukemia cells and xenografts. Leuk Res 2014; 38(11): 1332-41.
  7. Fang F, Munck J, Tang J, et al. The novel, small-molecule DNA methylation inhibitor SGI-110 as an ovarian cancer chemosensitizer. Clin Cancer Res 2014; 20(24): 6504-16.
  8. Lindblad KE, Goswami M, Hourigan CS, Oetjen KA. Immunological effects of hypomethylating agents. Expert Review of Hematology 2017; 10(8): 745-52.
  9. De Kouchkovsky I, Abdul-Hay M. ‘Acute myeloid leukemia: a comprehensive review and 2016 update’. Blood Cancer J. 2016; 6(7):e441.
  10. Society AC. Key Statistics for Acute Myeloid Leukemia 2018 [Available from: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html.
  11. SEER. Cancer Stat Facts: Leukemia – Acute Myeloid Leukemia (AML) 2018 [Available from: https://seer.cancer.gov/statfacts/html/amyl.html.
  12. Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017; 129(4):424-47.
  13. Burnett A, Wetzler M, Lowenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011; 29(5):487-94.
  14. Dombret H, Gardin C. An update of current treatments for adult acute myeloid leukemia. Blood. 2016; 127(1):53-61.
  15. Medeiros BC, Satram-Hoang S, Hurst D, Hoang KQ, Momin F, Reyes C. Big data analysis of treatment patterns and outcomes among elderly acute myeloid leukemia patients in the United States. Ann Hematol. 2015; 94(7):1127-38.
  16. Wang R, Zeidan AM, Halene S, Xu X, Davidoff AJ, Huntington SF, et al. Health Care Use by Older Adults With Acute Myeloid Leukemia at the End of Life. J Clin Oncol. 2017; 35(30):3417-24.

Astex’s Harren Jhoti Made Fellow of the Royal Society

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that Harren Jhoti Ph.D., co-founder of Astex and President and CEO of Astex Pharmaceuticals (UK) has been elected a Fellow of the Royal Society in recognition of his outstanding contribution to drug discovery research and science in general.

Election to the Fellowship of the Royal Society is the highest accolade in UK science and recognises individuals for their scientific excellence and substantial contributions to research endeavours. At Astex Dr. Jhoti pioneered the development of fragment-based drug discovery, an approach now widely used in pharmaceutical and academic drug discovery centres worldwide.

Astex is one of the UK’s leading biotech companies, employing some 130 staff at its research headquarters in Cambridge UK and over 200 worldwide, and has been highly successful in translating research into new medicines. Notably this includes Kisqali®, a drug co-discovered by Astex under a partnership with Novartis that received marketing approval in the USA and in Europe as a treatment for metastatic breast cancer in 2017.

Dr. Jhoti commented, “I’m delighted and humbled to have been made a Fellow of the Royal Society.  I would like to thank all my scientific colleagues, past and present, who have supported me in my research career. This Fellowship is also a reflection of the excellence of science at Astex created by its many highly talented researchers.”

-ENDS-

Notes to Editors

About Astex Pharmaceuticals

Harren Jhoti co-founded Astex in 1999 and was Chief Scientific Officer until November 2007 when he was appointed Chief Executive Officer.  He was elected a Fellow of the Royal Society in 2018, the Royal Society of Biology in 2017, the Royal Society of Chemistry in 2016, and of the Academy of Medical Sciences in 2015.  In January 2018 he was honoured with a Lifetime Achievement Award from the UK BioIndustry Association (BIA).  He received the Prous Institute-Overton and Meyer Award for New Technologies in Drug Discovery from the European Federation for Medicinal Chemistry in 2012 and was also named by the Royal Society of Chemistry as “Chemistry World Entrepreneur of the Year” for 2007.

He has published widely including in leading journals such as Nature and Science, and has also been featured in TIME magazine after being named by the World Economic Forum a Technology Pioneer in 2005.  He has served on the board of the BIA, the UK BioIndustry Association and currently consults for life science venture capital firms. Before founding Astex in 1999, he was head of Structural Biology and Bioinformatics at GlaxoWellcome in the United Kingdom (1991-1999). Prior to Glaxo, Dr. Jhoti was a post-doctoral scientist at Oxford University. He received a B.Sc. (Hons) in Biochemistry in 1985 and a Ph.D. in Protein Crystallography from the University of London in 1989.

More information on the Royal Society can be found here: https://royalsociety.org/

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan; a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit http://www.astx.com

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

At the Company

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: jeremy.carmichael@astx.com

 

Astex Continues to Deliver in Oncology as Erdafitinib, a Potential New Treatment for Metastatic Urothelial Cancer, Receives US FDA Breakthrough Therapy Designation

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that its pharmaceutical collaborator, Janssen Pharmaceutica N.V. (Janssen), has been granted Breakthrough Therapy Designation by the US FDA for erdafitinib in the treatment of metastatic urothelial cancer.

Erdafitinib was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and licence agreement to identify novel, small molecule inhibitors of Fibroblast Growth Factor Receptor (FGFR) kinase, including for the treatment of cancer.  Janssen is responsible for the clinical development and commercialisation of all products arising from this collaboration.

The FGFR inhibitor programme between Astex and Janssen underlines the UK strengths in academic-biotech collaboration as it originated from pioneering work on FGFR between Astex and the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre, Northern Institute for Cancer Research, Newcastle University, UK.

Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.  Breakthrough Therapy Designation allows for the expedited development and regulatory review of erdafitinib as a potential new treatment option for patients with metastatic disease.  It was granted based on positive data from a multicenter, open-label Phase 2 clinical trial.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “This is a great endorsement of our scientific approach and our team.  Astex is committed to the fight against cancer and so is delighted that erdafitinib has been granted Breakthrough Therapy Designation by the US FDA.  Congratulations to our valued collaborators at Janssen for their excellent work in advancing erdafitinib to this exciting stage in its development.”

-ENDS-

Notes to Editors

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.  Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit http://www.astx.com

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

At the Company

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: jeremy.carmichael@astx.com

Harren Jhoti Receives Lifetime Achievement Award from the UK BioIndustry Association

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that Harren Jhoti Ph.D., co-founder of Astex and President and CEO of Astex Pharmaceuticals (UK) has been honoured with a Lifetime Achievement Award from the UK BioIndustry Association (BIA).

The Award was presented to Dr. Jhoti by BIA Chair, Dr. Jane Osbourn, at the BIA Gala Dinner, the BIA’s annual flagship event, which was held last night at The Brewery, in central London.

The BIA Lifetime Achievement Award, the highest accolade awarded by the BIA, recognises outstanding contribution to the life sciences sector in the UK.  The award is made in recognition of Dr. Jhoti’s scientific contributions to the UK life science sector, his entrepreneurial approach and his commitment to scaling and supporting UK biotech.

Dr. Jhoti has steered Astex to become one of the UK’s most successful biotech companies. Employing some 130 staff at its research headquarters in Cambridge UK and over 200 worldwide, including at its clinical development and regulatory headquarters in Pleasanton, California, USA, Astex is today an independent wholly-owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan, with a focus on cancer and diseases of the central nervous system.

The Company has applied its leading fragment-based discovery platform and other technologies to the development of an internal pipeline of proprietary novel therapies and several partnered products are being developed under collaborations with leading pharmaceutical companies.  2017 was a pivotal year for the company with Kisqali® (ribociclib, formerly known as LEE011), a drug co-discovered under a partnership with Novartis receiving marketing approval in the USA and Europe as a treatment for advanced (metastatic) breast cancer.

On receiving the Award last night Dr. Jhoti commented, “As scientists we always hope that our discoveries will make a difference and as entrepreneurs we strive to build sustainable companies to translate those discoveries into significant new medicines for patients.  At Astex we have been lucky enough to achieve both of these goals due largely to our highly talented team.  These achievements have been made possible  by playing an active part in the life sciences community in Cambridge and the UK, and I’m delighted and humbled to have received this award from the BIA.

Jane Osbourn, BIA Chairman, said: “Harren’s contribution to the UK biotech sector recognises his combination of scientific and leadership skills, as well as his passion and determination to succeed. He has risen to the challenges of driving innovation, developing productive partnerships, raising investment capital and motivating a team.  He makes an active contribution to initiatives in the UK biotech sector and provides a role-model for today’s entrepreneurs.”

-ENDS-

Notes to Editors

Harren Jhoti co-founded Astex in 1999 and was Chief Scientific Officer until November 2007 when he was appointed Chief Executive Officer.  He also served as President and member of the Board of Directors of Astex Pharmaceuticals Inc., following the merger of Astex with SuperGen Inc., (subsequently renamed Astex Pharmaceuticals Inc.) in July 2011.

Dr. Jhoti was elected a Fellow of Royal Society of Biology in 2017, a Fellow of the Royal Society of Chemistry in 2016, and of the Academy of Medical Sciences in 2015.  He was awarded the Prous Institute-Overton and Meyer Award for New Technologies in Drug Discovery by the European Federation for Medicinal Chemistry in 2012 and was also named by the Royal Society of Chemistry as “Chemistry World Entrepreneur of the Year” for 2007.

He has published widely including in leading journals such as Nature and Science and has also been featured in TIME magazine having been named by the World Economic Forum a Technology Pioneer in 2005.  He has served on the board of the BIA, the UK BioIndustry Association and currently consults for life science venture capital firms.  Before founding Astex in 1999, he was head of Structural Biology and Bioinformatics at GlaxoWellcome in the United Kingdom (1991-1999).  Prior to Glaxo, Dr. Jhoti was a post-doctoral scientist at Oxford University.  He received a B.Sc. (Hons) in Biochemistry in 1985 and a Ph.D. in Protein Crystallography from the University of London in 1989.

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan; a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit http://www.astx.com

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

At the Company

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: jeremy.carmichael@astx.com

Otsuka Signs Statement of Support for Women’s Empowerment Principles

January 19, 2018

Otsuka Signs Statement of Support for Women’s Empowerment Principles

Astex Pharmaceuticals (“Astex”), an indirect subsidiary of Otsuka Holdings Co., Ltd., announces that the latter has signed the CEO Statement of Support for the Women’s Empowerment Principles (WEPs), a set of Principles focusing on corporate action to promote gender equality and women’s empowerment in the workplace, marketplace and community. The WEPs are the result of collaboration between the United Nations Global Compact (UNGC) 1 and the United Nations Entity for Gender Equality and the Empowerment of Women (UN Women).2

Under the corporate philosophy of “Otsuka-people creating new products for better health worldwide,” the Otsuka group of companies is a total health care group active on the global stage. Convinced that maximizing the talents of a diverse group of individuals becomes the driving force for growth, Otsuka promotes diversity across the group companies, including proactively encouraging the participation and advancement of women in the workplace. The signing of the CEO Statement of Support for the WEPs is an opportunity to reinforce efforts to ensure gender equality and women’s empowerment.

Women’s Empowerment Principles (WEPs)
The Women’s Empowerment Principles are a set of voluntary principles offering guidance for corporate practices to promote equality and women’s empowerment, launched in 2010 as the result of collaboration between the UNGC and UN Women. By signing the CEO Statement of Support for the WEPs, a company demonstrates its dedication to contributing to workplace, marketplace and community environments that encourage advancement and empowerment of women. The seven Women’s Empowerment Principles are listed below.3
                                                     
1. Establish high-level corporate leadership for gender equality
2. Treat all women and men fairly at work – respect and support human rights and nondiscrimination
3. Ensure the health, safety and well-being of all women and men workers
4. Promote education, training and professional development for women
5. Implement enterprise development, supply chain and marketing practices that empower women
6. Promote equality through community initiatives and advocacy
7. Measure and publicly report on progress to achieve gender equality

About Otsuka Holdings Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company for the Otsuka group of companies, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of approximately USD 10.2 billion in the fiscal year ended December 31, 2016.
The Otsuka group of companies conducts research, development, manufacturing and marketing of innovative products that are uniquely positioned to provide advanced therapy, improve quality of life and support a healthy lifestyle. Additional information can be obtained at https://www.otsuka.com/en/

About Astex Pharmaceuticals
Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a member of the Otsuka Group, based in Japan. Otsuka is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit http://www.astx.com
For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.com/en/

References:
1. The UNGC is a voluntary initiative encouraging participation in a worldwide, principle-based framework, aiming to promote sustainability through creative leadership and responsible corporate citizenship. Otsuka Holdings became a signatory to the UNGC in 2016.
2. UN Women is a United Nations entity working for the empowerment of women. It was established in 2010 through the merger of the Division for the Advancement of Women (DAW), the International Research and Training Institute for the Advancement of Women (INSTRAW), the Office of the Special Adviser on Gender Issues and Advancement of Women (OSAGI), and the United Nations Development Fund for Women (UNIFEM).
3. Women’s Empowerment Principles: http://www.weprinciples.org/

Astex Pharmaceuticals Celebrates as Cancer Drug Receives Marketing Approval in Europe

Further Milestone Payment Under Novartis Collaboration as Kisqali® (ribociclib) Receives Approval in Europe as a First-Line Treatment for HR+/HER2- locally Advanced or Metastatic Breast Cancer with an Aromatase Inhibitor
– Kisqali was discovered as part of a strategic research collaboration under which Astex and Novartis Institutes for BioMedical Research (NIBR) scientists jointly developed and optimised the chemical structure of Kisqali, which was then progressed through clinical trials by Novartis
-Marketing approval in Europe follows US marketing approval announced in March 2017

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that its long-standing pharmaceutical collaborator, Novartis, has received marketing approval in Europe for Kisqali® (ribociclib) plus an aromatase inhibitor as a first-line treatment in post-menopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.

Astex is eligible to receive a milestone payment in respect of the European marketing approval, as well as royalty payments on annual sales of Kisqali, under the drug discovery alliance entered into between Astex and Novartis in 2005.

Approval by the European Commission follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use (CHMP). The positive CHMP opinion was based on superior efficacy and demonstrated safety of Kisqali plus letrozole versus letrozole alone in the pivotal Phase III MONALEESA-2 clinical trial of first-line ribociclib plus letrozole in hormone receptor-positive HER2-negative advanced breast cancer which showed that Kisqali plus letrozole reduced the risk of progression or death by over 44% over letrozole alone at interim analysis. In a subsequent analysis of the trial data, after nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months and 16.0 months for letrozole alone.1 The European approval allows for oncologists to prescribe Kisqali with letrozole, anastrozole or with exemestane and to use their discretion to select the treatment choice they believe is best for each individual patient.

Harren Jhoti, President and CEO of Astex, UK, said, “We are delighted that Novartis has received European approval of Kisqali arising from our productive collaboration with the opportunity to bring a new treatment option to many more women in Europe with advanced breast cancer.”

Astex received a milestone payment following the FDA approval of Kisqali in March 2017 and has received a first royalty payment from Novartis based on sales of Kisqali in the US, and is eligible to receive a milestone payment on approval of an additional regulatory filing in Japan.

-ENDS-

Notes to Editors

Kisqali® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drug that helps slow the progression of cancer by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly. Kisqali is a registered trademark of Novartis AG.

About Astex Pharmaceuticals
Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a member of the Otsuka Group, based in Japan. Otsuka is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit http://www.astx.com
For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.com/en/

References
1 Hortobagyi G, Stemmer S, Burris H, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole in hormone receptor-positive HER2-negative advanced breast cancer. Presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), June 4, 2017, Chicago, Illinois (abstract #1038).

At the Company
Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: jeremy.carmichael@astx.com