Pantarhei Bioscience sells estrogen therapy to Uteron Pharma

ZEIST, The Netherlands—Specialty pharmaceutical companyPantarhei Bioscience, which specializes in developing therapies for women'shealth and endocrine cancer, has announced the sale of the human fetal estrogenEstetrol (E4) for oral contraception.

The transaction follows Pantarhei Bioscience B.V.'s Jan. 21sale of its 30 percent share stake in Estetra S.A. to Uteron Pharma S.A.Estetra is a joint venture formed by the two companies in late 2009 with thesole focus of developing E4 for oral and emergency contraception. Last year,the joint venture completed clinical Phase II development of Estelle, an oralcontraceptive that contains E4. Per the terms of the companies' contract,Uteron Pharma acquired Pantarhei Bioscience's Estetra shareholding via cash,shares in Uteron Pharma and future cash payments tied to milestones.

"Selling our Estetra shares to Uteron Pharma strengthens thefinancial position of Pantarhei Bioscience and will enable us to reward ourprivate shareholders and proceed with new projects. We are also delighted thatActavis will now complete the Phase III clinical development of Estelle," Prof.Herjan Coelingh Bennink, M.D., Ph.D., founder and CEO of Pantarhei Bioscience,said in a press release regarding the deal. "Pantarhei started the developmentof the unique human fetal estrogen Estetrol in 2001 and established that thisnatural estrogen has a body-friendly profile with anticipated important safetyadvantages over existing estrogens. Indeed, personally I am very pleased thatmost likely, this natural estrogen rediscovered by Pantarhei will come to themarket and be available in the not-too-distant future for women choosing oralcontraception."

E4, as noted by Pantarhei Bioscience, "is produced solelyand in large quantities by the fetal liver during human pregnancy only." Amongits unique characteristics is the presence of an additional alpha-hydroxy groupin the molecule, which "extends, in comparison with other estrogens, the humanelimination half-life from 10 minutes to 28 hours." In testing Estetrol,preliminary results from clinical proof-of-concept work (for a 28-day treatmentperiod) showed that the product inhibits ovulation, does not increase E2 anddoes not cause a significant increase in sex hormone-binding globulin.

Among other indications, the product is undergoingdevelopment for as a potential hormone replacement therapy and for theindication of osteoporosis. It is also being developed as an add-back estrogentreatment in order to counter the side effects of endocrine treatment in womenwith breast cancer or endometriosis.

In related news, on Jan. 23, Watson Pharmaceuticals Inc.(which was recently re-branded as Actavis) acquired all of Uteron Pharma'soutstanding shares for $150 million upfront, with the potential for up to $155million in future milestone payments. The transaction is expected to beminimally dilutive to non-GAAP earnings this year and next year, and beaccretive in 2015.

"This is a strategic acquisition of a solid pipeline,sound development expertise and sufficient manufacturing capacity to generatevalue for shareholders within the next two years, and provide the potential ofmultiple global product introductions through the latter half of thedecade," Fred Wilkinson, president of Watson Global Brands andBiosimilars, said in a press release. "We have structured the financials of theacquisition to reflect the immediate value of the late-stage pipeline, withapproximately $45 million in near-term milestones and appropriately balancingthe development risks and investments required to commercialize these assets,when compared to the longer-term opportunities."

SOURCE: Pantarhei Bioscience press release