Osphena® – How a Small Early-Phase CRO can help bring a Drug to Market

Turku, Finland: – Scientists at Hormos Medical and Clinical Research Services Turku (CRST) have published four academic articles about early-phase clinical development of the headline-making drug Osphena® (ospemifene).

Osphena® made news around the world as ‘the pink Viagra’ when it was approved by the U.S. Food & Drug Administration (FDA) in February 2013 for use by postmenopausal women experiencing pain during sex. Approval followed nine Phase 1 clinical trials, including various drug interaction trials as well as food effect studies, conducted by CRST in collaboration with Hormos Medical.

“We are extremely happy that this long work has borne fruit,” said Mika Scheinin, Professor of Pharmacology at the University of Turku, Finland, and Director of CRST. Prof. Scheinin is co-author of the articles, along with Dr. Risto Lammintausta, CEO of Hormos Medical during the development of Osphena®.

“Osphena® was a really interesting drug development project for us as we were able to put together our knowledge and resources when planning these studies with Hormos,” said Prof. Scheinin.”

Textbook Collaboration
“It was a truly joint project in which a small drug discovery company and small clinical CRO were able to collaborate seamlessly to bring a ground-breaking drug to market with a challenging clinical trial programme,” he added.

Prof. Scheinin said many valuable lessons learned during the trials had now been recorded in the articles to serve as medical case studies.

“We are really looking forward to undertaking similar collaborations in the future. This experience demonstrates that even if the CRO is small, the quality of its team and experience can make a big difference,” said Prof. Scheinin.

Dr. Lammintausta, now CEO of ForendoPharma, added: “The clinical PK information of Osphena® was mainly built up with the expert team of CRST and summarized to the satisfaction of the FDA.”

“The CRST team worked in a highly professional manner all the way from the CTAs to delivery of the study reports. We hope to replicate this success with our next program,” said Dr. Lammintausta.

About CRST
CRST is a Clinical Research Organisation that provides a wide array of clinical, preclinical and bio-analytical research services for drug developers. CRST specialises in the early phases of clinical drug development, in particular in the facilitation of proof-of-concept by scientifically demanding studies.

CRST offers a committed team who are professionals in clinical trials. Its team comprises clinical researchers, laboratory technicians, study nurses and other research personnel who will work alongside you to achieve your goals in study planning, reporting and conduct.

The company’s aptitude in technologies and expertise has been built on networking with academic and private partners in Finland. Through networking, CRST has enhanced its knowledge enabling it to provide services covering all areas of clinical drug research. This allows them to provide cutting-edge solutions established on the most up-to-date scientific information.

The work carried out at CRST is in accordance with Good Clinical Practice guidelines as well as the European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulations in regard to clinical studies.

References:
1: Koskimies P, Turunen J, Lammintausta R, Scheinin M. Single-dose and steady-state pharmacokinetics of ospemifene, a selective estrogen receptor modulator, in postmenopausal women. Int J ClinPharmacolTher. 2013 Sep 30. [Epub ahead of print] PubMed PMID: 24075094. Available online at: http://www.ncbi.nlm.nih.gov/pubmed/24075094

2: Koskimies P, Katila K, Lammintausta R, Aaltonen AM, Vuorinen J, Saarni O, Scheinin M. Oral bioavailability of ospemifene improves with food intake. Int J ClinPharmacolTher. 2013 Oct;51(10):787-94. doi: 10.5414/CP201873. PubMed PMID: 24040848. Available online at: http://www.ncbi.nlm.nih.gov/pubmed/?term=24040848

3: Turpeinen M, Uusitalo J, Lehtinen T, Kailajärvi M, Pelkonen O, Vuorinen J, Tapanainen P, Stjernschantz C, Lammintausta R, Scheinin M. Effects of ospemifene on drug metabolism mediated by cytochrome P450 enzymes in humans in vitro and in vivo. Int J Mol Sci. 2013 Jul 5;14(7):14064-75. doi: 10.3390/ijms140714064. PubMed PMID: 23880855; PubMed Central PMCID: PMC3742231. Available online at: http://www.ncbi.nlm.nih.gov/pubmed/?term=PMC3742231

4: Lehtinen T, Tolonen A, Turpeinen M, Uusitalo J, Vuorinen J, Lammintausta R, Pelkonen O, Scheinin M. Effects of cytochrome P450 inhibitors and inducers on the metabolism and pharmacokinetics of ospemifene. Biopharm Drug Dispos. 2013 Oct;34(7):387-95. doi: 10.1002/bdd.1853. Epub 2013 Aug 15. PubMed PMID: 23852652. Available online at: http:/www.ncbi.nlm.nih.gov/pubmed/?term=23852652

Contact:
Clinical Research Services Turku CRST
Professor Mika Scheinin, M.D. Ph.D,
Tel: +358 2 333 7502
Email: [email protected]

For more information about how a small early-phase CRO can help bring a drug to market, please contact Clinical Research Services Turku CRST directly.