latest on diquafosol

[Rebecca Petris]

Not exactly a content-rich press release, but at least it's not no news.

Press release

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) met with the U.S. Food and Drug Administration (FDA) on March 22, 2006 regarding the approvable letter received from the FDA on December 1, 2005 for diquafosol tetrasodium ophthalmic solution. The meeting with the FDA involved a broad discussion of Inspire's dry eye clinical program for diquafosol.

Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, "Based upon this meeting, we intend to provide the FDA with additional information to facilitate ongoing discussions related to diquafosol. We have discussed these plans with our partner, Allergan, Inc., and appreciate Allergan's support throughout this process. We expect to provide the information to the FDA and continue our discussions with them over the next several months."

[neil0502]

Thanks, Rebecca.

From the little I've seen [1], I'm not waiting for this one with bated breath.

Clinical trials look only so-so which, to me, means: what are the side effects, since that seems as likely as not to be the only effect I'll see. I'll definitely be following subsequent trials and their results, though.

[1] http://www.inspirepharm.com/diquafosolclinical.html

[Flick]

(oops, just saw that Rebecca hit this in her Journal Roundup)

Inspire continues talks with FDA on diquafosol

DURHAM, N.C. — Inspire Pharmaceuticals Inc. met with the Food and Drug Administration in September 2006 to continue ongoing discussions over its diquafosol tetrasodium ophthalmic solution for dry eye syndrome, the company announced.

The efficacy of diquafosol was called into question when the drug failed to meet efficacy endpoints in a phase 3 trial conducted in February 2005. Based on the recent meeting, Inspire plans to provide the FDA with additional information regarding the drug and company officials expect to meet with the agency after it reviews that information.

"We believe our discussions with the FDA have been constructive but the overall program remains challenging and the outcome is uncertain," Christy L. Shaffer, PhD, president and CEO of Inspire, said in the release.

[kdc66]

Latest on Inspire

This is from Inspire's 4th qtr 2006 press release on Feb 27, 2007. They didn't provide much information about Prolacria/diquafosol except to say another study will be required:

Ophthalmology Research & Development
Met with the FDA in early 2007 to continue ongoing discussions related to Inspire's dry eye clinical program for Prolacria(TM) (the proposed U.S. trade name for diquafosol tetrasodium ophthalmic solution 2%). Based on this meeting, Inspire has begun a process to validate that staining scores in the central region of the cornea are a clinically relevant endpoint for a clinical trial in dry eye patients. If Inspire is able to validate this endpoint and come to agreement with the FDA, the Company expects to request a Special Protocol Assessment and initiate an additional clinical trial.

[kdc66]

Inspire article

Inspire to give dry-eye drug another try

Losses rose 75 percent for Shaffer's company in 2006.


Sabine Vollmer, Staff Writer
DURHAM - Inspire Pharmaceuticals won't drop its dry-eye drops. Not yet.
The Durham drug development company reported Tuesday that it might conduct another late-stage test, its fifth, to get regulatory approval for its Prolacria dry-eye treatment. Over three years, the experimental therapy has repeatedly come up short of winning the endorsement of the Food and Drug Administration.

The announcement, made by Inspire chief executive Christy Shaffer during the company's earnings report, dominated the conversation during a conference call with analysts. Some, including Angela Larson of Susquehanna Financial Group, said that many investors would prefer that Inspire abandon Prolacria and focus on making other drugs in its pipeline market-ready.

Inspire's stock has doubled in value since August as it secured promising medicines from other companies and revamped its drug-development lineup. One, a treatment for pink eye, has a chance of coming to market this year. Two others could follow in the next two to three years and make the company profitable.

However, the increase in research and development activity contributed to a doubling of Inspire's losses in the fourth quarter.

Inspire reported a $15.5 million loss for the three months that ended Dec. 31, up from $7.1 million a year ago. Analysts expected a quarterly loss of $15.5 million to $21.2 million, according to Thomson Financial.

For the full year, losses rose 75 percent to $42.1 million.

Operating expenses for the fourth quarter were $25 million, up 52 percent. The increase was partly because of an $11.9 million payment for the rights to bring to market an allergy drug developed by a Spanish company. For the full year, operating expenses were $83.7 million, up 70 percent from 2005.

Fourth-quarter revenue rose 62 percent to $8.5 million. For the full year, revenue rose 59 percent to $37 million.

Larson said a 6 percent decline in Inspire's shares Tuesday had more to do with the sell-off on Wall Street than anything in the company's financial report.

Inspire shares closed at $6.95 Tuesday, down 48 cents.