Watson Transactions	3 Months Ended
Mar. 31, 2012
WATSON TRANSACTIONS [Abstract]
Mergers, Acquisitions and Dispositions Disclosures [Text Block]	WATSON TRANSACTIONS: On July 2, 2010, the Company sold to Watson Pharmaceuticals, Inc. (“Watson”), (i) substantially all of its assets primarily relating to the research, development, regulatory approval, manufacture, distribution, marketing, sale and promotion of pharmaceutical products containing progesterone as an active ingredient, including progesterone vaginal gel 8% and progesterone vaginal gel 4% (collectively, the “Progesterone Products”), including certain intellectual property, promotional materials, contracts, product data and regulatory approvals and regulatory filings (the “Purchased Assets”), and (ii) 11,200,000 shares (the “Shares”) of the Company's common stock (“Common Stock”). The Company retained certain assets and rights relating to its progesterone business, including all rights necessary to perform its obligations under its agreement with Merck Serono S.A. (“Merck Serono”). These transactions are referred to collectively as the “Watson Transactions.” Watson paid the Company $47 million in cash, forgave $15 million in debt, and assumed certain liabilities associated with the Purchased Assets. The Watson Transactions allow for certain milestone payments that can be earned by the successful completion of clinical development milestones in the Company's Phase III study designed to evaluate the ability of progesterone vaginal gel 8% to reduce the risk of preterm birth in women with premature cervical shortening (the “PREGNANT study”), regulatory filings, receipt of regulatory approvals and product launches. Watson will also make royalty payments to the Company of 10 to 20 percent of annual net sales of certain Progesterone Products provided, however, that royalty rates would be reduced by 50% in a particular country if a generic entry by a third party occurs in such country and certain other circumstances are fulfilled. In addition, if Watson commercializes a product through a third party outside of the U.S., in lieu of royalties, the Company will be entitled to 20% of gross profits associated with such commercialization. If Watson or its affiliates effects a generic entry with respect to a Progesterone Product in a particular country in the circumstances permitted by the Purchase and Collaboration Agreement, dated as of March 3, 2010, between the Company and Watson (the “Purchase Agreement”), in lieu of royalties payable in respect of net sales for such generic product, the Company will be entitled to 20% of the gross profits associated with the commercialization of such generic product in such country. The Company and Watson are collaborating with respect to the development of Progesterone Products. In connection therewith, the parties established a joint development committee to oversee and supervise all development activities. The Company was responsible for completing the PREGNANT study and will be responsible for such other activities as determined by the joint development committee. The Company was responsible for the costs of the preparation, filing and approval process of the new drug application (“NDA”) in the preterm birth indication with the Food and Drug Administration (“FDA”) up to a maximum of $7.0 million incurred after January 1, 2010. All other development costs incurred in connection with the development collaboration will be paid by Watson. As of March 31, 2012, the Company has spent $10.6 million in costs related to the PREGNANT study and related NDA. Watson has reimbursed the Company for $3.2 million of these costs and has been invoiced for $0.4 million equal to the research and development (“R&D”) expense reimbursement recognized in the first quarter of 2012. The $3.6 million in reimbursable costs were credited to R&D expense. On February 10, 2012, the Company transferred to Watson NDA 22-139 (as defined below) pursuant to the second closing Watson Transactions. The parties also entered into various ancillary agreements in connection with the Purchase Agreement, including an Investor's Rights Agreement (pursuant to which Watson designated a member of the Company's board of directors for the period set forth therein, Watson obtained certain registration rights pertaining to the Shares, and Watson agreed to certain transfer restrictions pertaining to the Shares)and a Supply Agreement (pursuant to which the Company will supply Progesterone Products to Watson for sale in the U.S. at a price equal to 110% of cost of goods sold, and a License Agreement relating to the grant of certain intellectual property licenses). As part of the Purchase Agreement, the Company agreed not to manufacture, develop or commercialize products containing progesterone or any other products for the preterm birth indication, subject to certain exceptions, from July 2, 2010, (the date of the closing of the Watson Transactions) until the second anniversary of the date on which the Company and Watson terminate their relationship with respect to the joint development of Progesterone Products. The joint development collaboration is terminable by either party on or after July 2, 2015. Upon the closing of the Watson Transactions on July 2, 2010, the Company allocated the $47 million initial proceeds plus the $15 million in forgiven debt plus accrued interest to the fair value of the Shares and the elimination of the remaining book value of the progesterone vaginal gel intangible assets in the amount of $16.2 million. The excess was recorded as deferred revenue and was amortized over the remaining R&D period for the PREGNANT study including the Company's submission to, and the FDA's filing of the related NDA. The Company recognized revenue from the amortization of these deferred revenues of $8,393,926 for the three months ended March 31, 2011. The Company completed the amortization of these deferred revenues as of June 2011. In April 2011, the Company announced positive results from the PREGNANT study, a pivotal Phase III clinical trial of progesterone vaginal gel 8% conducted in collaboration with the National Institutes of Health (“NIH”) to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy. We filed an NDA (NDA 22-139), for this indication with the FDA in April 2011. The NDA was reviewed by the FDA's Advisory Committee for Reproductive Health Drugs in January 2012. While Committee members generally agreed that progesterone vaginal gel 8% is safe, the Committee stated that more information is needed to support approval. On February 24, 2012, Watson received a Complete Response Letter (“CRL”) from the FDA indicating that the NDA review cycle is complete and the application is not ready for approval in its present form. The CRL stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at ≤ 32 ⁶/₇ weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Watson has requested an End-of-Review meeting with the FDA to discuss the issues outlined in the CRL and to determine if a viable path forward can be established for this application.

WATSON TRANSACTIONS:

On July 2, 2010, the Company sold to Watson Pharmaceuticals, Inc. (“Watson”), (i) substantially all of its assets primarily relating to the research, development, regulatory approval, manufacture, distribution, marketing, sale and promotion of pharmaceutical products containing progesterone as an active ingredient, including progesterone vaginal gel 8% and progesterone vaginal gel 4% (collectively, the “Progesterone Products”), including certain intellectual property, promotional materials, contracts, product data and regulatory approvals and regulatory filings (the “Purchased Assets”), and (ii) 11,200,000 shares (the “Shares”) of the Company's common stock (“Common Stock”). The Company retained certain assets and rights relating to its progesterone business, including all rights necessary to perform its obligations under its agreement with Merck Serono S.A. (“Merck Serono”). These transactions are referred to collectively as the “Watson Transactions.”

Watson paid the Company $47 million in cash, forgave $15 million in debt, and assumed certain liabilities associated with the Purchased Assets. The Watson Transactions allow for certain milestone payments that can be earned by the successful completion of clinical development milestones in the Company's Phase III study designed to evaluate the ability of progesterone vaginal gel 8% to reduce the risk of preterm birth in women with premature cervical shortening (the “PREGNANT study”), regulatory filings, receipt of regulatory approvals and product launches. Watson will also make royalty payments to the Company of 10 to 20 percent of annual net sales of certain Progesterone Products provided, however, that royalty rates would be reduced by 50% in a particular country if a generic entry by a third party occurs in such country and certain other circumstances are fulfilled. In addition, if Watson commercializes a product through a third party outside of the U.S., in lieu of royalties, the Company will be entitled to 20% of gross profits associated with such commercialization. If Watson or its affiliates effects a generic entry with respect to a Progesterone Product in a particular country in the circumstances permitted by the Purchase and Collaboration Agreement, dated as of March 3, 2010, between the Company and Watson (the “Purchase Agreement”), in lieu of royalties payable in respect of net sales for such generic product, the Company will be entitled to 20% of the gross profits associated with the commercialization of such generic product in such country. The Company and Watson are collaborating with respect to the development of Progesterone Products. In connection therewith, the parties established a joint development committee to oversee and supervise all development activities. The Company was responsible for completing the PREGNANT study and will be responsible for such other activities as determined by the joint development committee. The Company was responsible for the costs of the preparation, filing and approval process of the new drug application (“NDA”) in the preterm birth indication with the Food and Drug Administration (“FDA”) up to a maximum of $7.0 million incurred after January 1, 2010. All other development costs incurred in connection with the development collaboration will be paid by Watson. As of March 31, 2012, the Company has spent $10.6 million in costs related to the PREGNANT study and related NDA. Watson has reimbursed the Company for $3.2 million of these costs and has been invoiced for $0.4 million equal to the research and development (“R&D”) expense reimbursement recognized in the first quarter of 2012. The $3.6 million in reimbursable costs were credited to R&D expense. On February 10, 2012, the Company transferred to Watson NDA 22-139 (as defined below) pursuant to the second closing Watson Transactions.

The parties also entered into various ancillary agreements in connection with the Purchase Agreement, including an Investor's Rights Agreement (pursuant to which Watson designated a member of the Company's board of directors for the period set forth therein, Watson obtained certain registration rights pertaining to the Shares, and Watson agreed to certain transfer restrictions pertaining to the Shares)and a Supply Agreement (pursuant to which the Company will supply Progesterone Products to Watson for sale in the U.S. at a price equal to 110% of cost of goods sold, and a License Agreement relating to the grant of certain intellectual property licenses).

As part of the Purchase Agreement, the Company agreed not to manufacture, develop or commercialize products containing progesterone or any other products for the preterm birth indication, subject to certain exceptions, from July 2, 2010, (the date of the closing of the Watson Transactions) until the second anniversary of the date on which the Company and Watson terminate their relationship with respect to the joint development of Progesterone Products. The joint development collaboration is terminable by either party on or after July 2, 2015.

Upon the closing of the Watson Transactions on July 2, 2010, the Company allocated the $47 million initial proceeds plus the $15 million in forgiven debt plus accrued interest to the fair value of the Shares and the elimination of the remaining book value of the progesterone vaginal gel intangible assets in the amount of $16.2 million. The excess was recorded as deferred revenue and was amortized over the remaining R&D period for the PREGNANT study including the Company's submission to, and the FDA's filing of the related NDA. The Company recognized revenue from the amortization of these deferred revenues of $8,393,926 for the three months ended March 31, 2011. The Company completed the amortization of these deferred revenues as of June 2011.

In April 2011, the Company announced positive results from the PREGNANT study, a pivotal Phase III clinical trial of progesterone vaginal gel 8% conducted in collaboration with the National Institutes of Health (“NIH”) to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy. We filed an NDA (NDA 22-139), for this indication with the FDA in April 2011. The NDA was reviewed by the FDA's Advisory Committee for Reproductive Health Drugs in January 2012. While Committee members generally agreed that progesterone vaginal gel 8% is safe, the Committee stated that more information is needed to support approval. On February 24, 2012, Watson received a Complete Response Letter (“CRL”) from the FDA indicating that the NDA review cycle is complete and the application is not ready for approval in its present form. The CRL stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at ≤ 32 ⁶/₇ weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Watson has requested an End-of-Review meeting with the FDA to discuss the issues outlined in the CRL and to determine if a viable path forward can be established for this application.