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Inspire Announces Dry Eye Program Update
Jan 4 2007, 6:30 AM EST
BIOWIRE
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today an update in its dry eye program.
Inspire provided additional information to the U.S. Food and Drug Administration (FDA) in November 2006 related to Prolacria(TM) (the proposed U.S. trade name for diquafosol tetrasodium ophthalmic solution 2%). Inspire has been granted a meeting with the FDA to continue discussions regarding Inspire's dry eye clinical program and expects to provide an update on this program by the end of February 2007.
ProlacriaTM (diquafosol tetrasodium) Treatment of dry eye disease
Overview. Diquafosol is a dinucleotide that we discovered, which functions as an agonist at the P2Y2receptor and is being developed for the treatment of dry eye disease. Prolacria, the proposed U.S. tradename for diquafosol tetrasodium ophthalmic solution 0.05%, stimulates the release of three components of natural tears - mucin, lipids and fluid. To date, we have completed four Phase 3 clinical trials of Prolacria for the treatment of dry eye disease. In total, we have conducted placebo-controlled clinical trials of Prolacria in more than 2,000 subjects.
We are developing Prolacria as an eye drop for dry eye disease. If approved, Prolacria could be the second FDA approved pharmacologically active agent to treat dry eye disease and the first one with this mechanism of action. Since Prolacria and Restasis have different mechanisms of action, we consider them complementary products and, if Prolacriais approved by the FDA, we believe there is commercial opportunity for both of these products.
Development Status. In June 2003, we filed a New Drug Application, or NDA, with the FDA for Prolacria for the treatment of dry eye disease. In response to that NDA, we were granted a "Priority Review" designation and subsequently, received an approvable letter in December 2003. In June 2005, we submitted an amendment to our NDA for Prolacria and received a second approvable letter in December 2005. On March 22, 2006, we met with the FDA regarding the second approvable letter. The meeting with the FDA involved a broad discussion of our dry eye clinical program for Prolacria. We have provided some initial information to the FDA and more information may be required in order to facilitate ongoing discussions related to Prolacria. In addition, our partner, Santen Pharmaceutical Co., Ltd., or Santen, is currently developing diquafosol in Japan. Our development, license and supply agreement with Santen allows Santen to develop diquafosol for the therapeutic treatment of ocular surface diseases, such as dry eye disease, in Japan and nine other Asian countries and provides for certain milestones to be earned by us upon completion of or achievement of development milestones by Santen. In March 2006, Santen completed its Phase 2 clinical trial testing of diquafosol in Japan which entitled us to receive a milestone payment of $1.25 million. Depending on whether all milestones are achieved, we could receive up to an additional $3.0 million, as well as royalties on net sales of licensed products, if the product candidate is approved for commercialization.
Pursuant to our agreement with Allergan, Allergan is responsible for obtaining regulatory approval of diquafosol in Europe. We are working with Allergan to determine a European regulatory filing strategy for diquafosol for the treatment of dry eye disease.
Depending on the outcome of discussions with the FDA regarding the future of the dry eye disease program, estimated subsequent costs necessary to amend our NDA submission for Prolacria and resubmit the application for commercial approval in the United States are projected to be in the range of $1 million to $8 million, depending on whether additional Phase 3 testing is required for approval. This range includes costs for regulatory and consulting activities and for potentially completing an additional Phase 3 clinical trial, salaries for development personnel, and other unallocated development costs, but excludes the cost of pre-launch inventory which is Allergan's responsibility. Currently, we have not initiated an additional Phase 3 clinical trial for Prolacria and we do not anticipate initiating an additional Phase 3 clinical trial until our discussions with the FDA are complete. Costs of other clinical trials for Prolacria are excluded from this projection. If we are required to do more than one Phase 3 clinical trial, our costs will likely be higher than the projected range. The projected costs associated with Prolacria are difficult to determine due to the ongoing interaction with the FDA and the uncertainty of future regulatory requirements and actual costs could be materially different from our estimate. For a more detailed discussion of the risks associated with the development of Prolacria and our other development programs, including factors that could result in a delay of a program and increased costs associated with such a delay, please see the Risk Factors described elsewhere in this report.
Collaborative Agreement. Under the joint license, development and marketing agreement with Allergan, we have continued our efforts to develop and commercialize Prolacria. Under this agreement, we have received up-front and milestone payments of $11 million and may receive up to an additional $28 million in milestone payments assuming the successful completion of all remaining milestones under this agreement. We will also receive co-promotion revenue from Allergan on net sales, if any, of Prolacria worldwide, excluding most larger Asian markets. In the third quarter of 2003, we exercised our right under the Allergan agreement to co-promote Prolacria with Allergan in the United States and expect to begin promoting this product if and when we receive FDA approval and the product is launched.
Jan 4 2007, 6:30 AM EST
BIOWIRE
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today an update in its dry eye program.
Inspire provided additional information to the U.S. Food and Drug Administration (FDA) in November 2006 related to Prolacria(TM) (the proposed U.S. trade name for diquafosol tetrasodium ophthalmic solution 2%). Inspire has been granted a meeting with the FDA to continue discussions regarding Inspire's dry eye clinical program and expects to provide an update on this program by the end of February 2007.
ProlacriaTM (diquafosol tetrasodium) Treatment of dry eye disease
Overview. Diquafosol is a dinucleotide that we discovered, which functions as an agonist at the P2Y2receptor and is being developed for the treatment of dry eye disease. Prolacria, the proposed U.S. tradename for diquafosol tetrasodium ophthalmic solution 0.05%, stimulates the release of three components of natural tears - mucin, lipids and fluid. To date, we have completed four Phase 3 clinical trials of Prolacria for the treatment of dry eye disease. In total, we have conducted placebo-controlled clinical trials of Prolacria in more than 2,000 subjects.
We are developing Prolacria as an eye drop for dry eye disease. If approved, Prolacria could be the second FDA approved pharmacologically active agent to treat dry eye disease and the first one with this mechanism of action. Since Prolacria and Restasis have different mechanisms of action, we consider them complementary products and, if Prolacriais approved by the FDA, we believe there is commercial opportunity for both of these products.
Development Status. In June 2003, we filed a New Drug Application, or NDA, with the FDA for Prolacria for the treatment of dry eye disease. In response to that NDA, we were granted a "Priority Review" designation and subsequently, received an approvable letter in December 2003. In June 2005, we submitted an amendment to our NDA for Prolacria and received a second approvable letter in December 2005. On March 22, 2006, we met with the FDA regarding the second approvable letter. The meeting with the FDA involved a broad discussion of our dry eye clinical program for Prolacria. We have provided some initial information to the FDA and more information may be required in order to facilitate ongoing discussions related to Prolacria. In addition, our partner, Santen Pharmaceutical Co., Ltd., or Santen, is currently developing diquafosol in Japan. Our development, license and supply agreement with Santen allows Santen to develop diquafosol for the therapeutic treatment of ocular surface diseases, such as dry eye disease, in Japan and nine other Asian countries and provides for certain milestones to be earned by us upon completion of or achievement of development milestones by Santen. In March 2006, Santen completed its Phase 2 clinical trial testing of diquafosol in Japan which entitled us to receive a milestone payment of $1.25 million. Depending on whether all milestones are achieved, we could receive up to an additional $3.0 million, as well as royalties on net sales of licensed products, if the product candidate is approved for commercialization.
Pursuant to our agreement with Allergan, Allergan is responsible for obtaining regulatory approval of diquafosol in Europe. We are working with Allergan to determine a European regulatory filing strategy for diquafosol for the treatment of dry eye disease.
Depending on the outcome of discussions with the FDA regarding the future of the dry eye disease program, estimated subsequent costs necessary to amend our NDA submission for Prolacria and resubmit the application for commercial approval in the United States are projected to be in the range of $1 million to $8 million, depending on whether additional Phase 3 testing is required for approval. This range includes costs for regulatory and consulting activities and for potentially completing an additional Phase 3 clinical trial, salaries for development personnel, and other unallocated development costs, but excludes the cost of pre-launch inventory which is Allergan's responsibility. Currently, we have not initiated an additional Phase 3 clinical trial for Prolacria and we do not anticipate initiating an additional Phase 3 clinical trial until our discussions with the FDA are complete. Costs of other clinical trials for Prolacria are excluded from this projection. If we are required to do more than one Phase 3 clinical trial, our costs will likely be higher than the projected range. The projected costs associated with Prolacria are difficult to determine due to the ongoing interaction with the FDA and the uncertainty of future regulatory requirements and actual costs could be materially different from our estimate. For a more detailed discussion of the risks associated with the development of Prolacria and our other development programs, including factors that could result in a delay of a program and increased costs associated with such a delay, please see the Risk Factors described elsewhere in this report.
Collaborative Agreement. Under the joint license, development and marketing agreement with Allergan, we have continued our efforts to develop and commercialize Prolacria. Under this agreement, we have received up-front and milestone payments of $11 million and may receive up to an additional $28 million in milestone payments assuming the successful completion of all remaining milestones under this agreement. We will also receive co-promotion revenue from Allergan on net sales, if any, of Prolacria worldwide, excluding most larger Asian markets. In the third quarter of 2003, we exercised our right under the Allergan agreement to co-promote Prolacria with Allergan in the United States and expect to begin promoting this product if and when we receive FDA approval and the product is launched.
... but then "there is commercial opportunity for both of these products". I'm relieved 
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