New FDA Approved Med For Oral Candida

April 20, 2010

FDA approves BioAlliance Pharma's Oravig for OPC

17. April 2010 00:10

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â€œWith OravigÂ®, BioAlliance has developed an innovative local treatment for

oral candida infection. We are very proud to now bring OravigÂ® to health care

providers and patients in the USâ€

BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), a company dedicated to

the treatment and supportive care of cancer and AIDS patients, announces today

the approval by the US FDA (Food and Drug Administration) of OravigÂ®

(miconazole LauriadÂ®, known as LoramycÂ® in Europe) for the treatment of

Oropharyngeal Candidiasis (OPC) in adults.

OravigÂ® is licensed to Strativa Pharmaceuticals, the proprietary products

division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. and

will be launched in the course of this second semester. The license agreement

signed in July 2007 contemplates a $20 million milestone payment upon FDA

approval, additional sales milestones and royalties on sales of the product.

" This is a major achievement and the first time for a French biotech company to

gain a US approval. BioAlliance expertise in development and registration at the

international level is here properly recognized and rewarded. Following our

commercial partnership agreement with Therabel Group for Europe (LoramycÂ® and

SetofilmÂ®), we are very confident in Strativa's commercialization ability to

ensure OravigÂ® success in the US " , said Dominique Costantini, President and CEO

of BioAlliance Pharma.

" With OravigÂ®, BioAlliance has developed an innovative local treatment for oral

candida infection. We are very proud to now bring OravigÂ® to health care

providers and patients in the US " , added Mac Phee, Strativa President.

The NDA submission was based on the European file and on data from a large Phase

III study (577 patients, 28 sites in the United States, Canada, and South

Africa) comparing OravigÂ® (miconazole LauriadÂ®) to MycelexÂ® Troche

(clotrimazole, the reference product in the USA) in the complete resolution of

signs and symptoms of OPC.

April 21, 2010

Thanks Joe,

Sorry for not writing back the last few times. Have really been under the

weather even literally as the recent explosion of pollen and mold has kept me

more exhausted than ever and restricted to indoors. I've been really forgetful

and even before the pollen issue have been real weak.

I've started to work with a doc in western md, who is familiar with Shoemaker,

Zeim and has his own protocols which are interesting. If it seems to pan out I

will share it with you. Like the above mentioned docs he does alot of testing.

We are just starting out.

The day at the game looked great. Boy do I miss that. The last time I saw the

Mets play was ... well Willy Mays hit a home run! We were always closer to

Yankee Stadium and for some reason free tickets came my way to see the Yanks

over the years more often. Last one at the Yanks was shortly before I moved

away-- Don Mattingly was still playing! I miss it all. Have loads of Shea and

Yankee Stadium memories. You do have a good son.

God Bless,Sam

From: Joe Salowitz <josephsalowitz@...>

Subject: [] New FDA Approved Med For Oral Candida

" " < >

Date: Tuesday, April 20, 2010, 9:43 AM

FDA approves BioAlliance Pharma's Oravig for OPC

17. April 2010 00:10

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