Astex Pharmaceuticals, Inc. (ASTX) today announced that Janssen-Cilag International NV, who holds marketing and development rights for DACOGEN™ in all markets except the North America, was notified that the CHMP (Committee for Medical Products for Human Use) of the EMA (European Medicines Agency) granted a positive opinion recommending approval of DACOGEN™ for injection in the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary AML (acute myeloid leukemia), according to the World Health Organization classification who are not candidates for standard induction chemotherapy.
Janssen anticipates receiving the regulatory decision from the Commission in the end of the third quarter of 2012.
James S.J. Manuso, PhD, Chairman and CEO of Astex Pharmaceuticals, commented:
We are pleased to learn that the CHMP’s review of data from the DACO-016 trial has resulted in a positive recommendation for DACOGEN™ in this indication. We look forward to the EMA’s decision later this year with the hope that clinicians and patients in Europe may soon have access to this treatment option.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favorable benefit-to-risk balance for DACOGEN™ and therefore recommends the granting of the marketing authorization.
Drug development expenses shouldn’t prevail over $10 million, thus $23 million into ASTX revenues pool adds $0.247 to the EPS. Even with the conservative PE ratio of 10 (versus industry’s PE of 15) the current stock price ought to increase of $2.47 per share.
Conclusion: with DACOGEN™ approval in EU and its marketing potentials the ASTX share price should be at least $4/share
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