BenzaClin, Duac what now?

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desertrat

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I work at Medicis but was wondering what this will do to the BPO/clind market. Assume it is now approved. May even affect Ziana.

Drug Details
Drug Name(s) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (Generic Drug)
FDA Application No. (ANDA) 065443
Active Ingredient(s) BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Company DOW PHARM SCIENCES
Original Approval or Tentative Approval Date August 11, 2009
 






desertrat said:
I work at Medicis but was wondering what this will do to the BPO/clind market. Assume it is now approved. May even affect Ziana.

Drug Details
Drug Name(s) CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (Generic Drug)
FDA Application No. (ANDA) 065443
Active Ingredient(s) BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Company DOW PHARM SCIENCES
Original Approval or Tentative Approval Date August 11, 2009
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Just another parasitic company that always claimed to have the best R&D minds in the derm world and when they go out on their own to market products the only thing they can do is steal the work of two of the best derm companies ever. Dow is a pathetic excuse for a company. Hope all the derms understand how offensive it is to see this new entrant steal the technology of another company. Do not prescribe it.
 






HaHa, Stiefel, Dermik

You have got to be kidding, Stiefel and Dermik the leading companies. They are totally pathetic at developing new products; name one new product that they have brought to market in the last 5 years. Dow has gotten 5 products approved: Metrogel 1%, Clobex Spray, Desonate, Ziana and Acanya. Oh sorry that's only about 400 million in annual sales. High time that Stiefel and Dermik got the rug pulled out from under them for the cash cow BPO/clind combo. The docs will have no choice but to write scrips for the generic, the managed care formularies will mandate it.
 






Re: HaHa, Stiefel, Dermik

dermdog said:
You have got to be kidding, Stiefel and Dermik the leading companies. They are totally pathetic at developing new products; name one new product that they have brought to market in the last 5 years. Dow has gotten 5 products approved: Metrogel 1%, Clobex Spray, Desonate, Ziana and Acanya. Oh sorry that's only about 400 million in annual sales. High time that Stiefel and Dermik got the rug pulled out from under them for the cash cow BPO/clind combo. The docs will have no choice but to write scrips for the generic, the managed care formularies will mandate it.
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http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Generics
 


















Re: HaHa, Stiefel, Dermik

dermdog said:
You have got to be kidding, Stiefel and Dermik the leading companies. They are totally pathetic at developing new products; name one new product that they have brought to market in the last 5 years. Dow has gotten 5 products approved: Metrogel 1%, Clobex Spray, Desonate, Ziana and Acanya. Oh sorry that's only about 400 million in annual sales. High time that Stiefel and Dermik got the rug pulled out from under them for the cash cow BPO/clind combo. The docs will have no choice but to write scrips for the generic, the managed care formularies will mandate it.
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True Dat!
 






You're proud about Ziana, Desonate, and Acanya (The Third Me Too Drug in the BPO/Clinda Class) Get Bent and Get A Clue--No new molecular discovery has come out of Derm. since Differin--and I don't work for Galderma. Stop touting your company as doing something great--your higher ups are in this gig for selling out, no for R&D.
 






LATWTTB

So what is any different from what Connetics, Collagenex, and now Stiefel have done and Dow? They were all clever, timely and hard working; end result, they sold their companies and made some some nice dough. You are right, there hasn't been any innovative new chemical entities developed in derm since Elidel and Protopic (not Differin, sheesh). Detecting some jealousy here. By the way if you think that developing line extensions or me-too products is so easy then why isn't Connetic's Velac approved yet? Dow blew right past the nimrod incompetents at Connetics; the nimrods made millions via the Stiefel acquisition.
 






Re: HaHa, Stiefel, Dermik

dermdog said:
You have got to be kidding, Stiefel and Dermik the leading companies. They are totally pathetic at developing new products; name one new product that they have brought to market in the last 5 years. Dow has gotten 5 products approved: Metrogel 1%, Clobex Spray, Desonate, Ziana and Acanya. Oh sorry that's only about 400 million in annual sales. High time that Stiefel and Dermik got the rug pulled out from under them for the cash cow BPO/clind combo. The docs will have no choice but to write scrips for the generic, the managed care formularies will mandate it.
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Will Stiefel package Duac with a useless bottle of soap to confound generic prescriptions?
 






Re: HaHa, Stiefel, Dermik

dermdog said:
You have got to be kidding, Stiefel and Dermik the leading companies. They are totally pathetic at developing new products; name one new product that they have brought to market in the last 5 years. Dow has gotten 5 products approved: Metrogel 1%, Clobex Spray, Desonate, Ziana and Acanya. Oh sorry that's only about 400 million in annual sales. High time that Stiefel and Dermik got the rug pulled out from under them for the cash cow BPO/clind combo. The docs will have no choice but to write scrips for the generic, the managed care formularies will mandate it.
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Hahaha! You are so pathetically stupid!! Every single one of those products was an ANDA! Generic! Easy to get approved. Not a new chemical. You stole the technology from the companies and scientist that actually know what they are doing. That's right. You stole it. You did nothing to deserve the right to market any of these drugs. You are the parasitic like companies that make real scientific companies have to raise prices so much to anticipate your sucking of our hind tit! You literally and figuratively suck!
 






Way off base

OK time to lecture the dumb sales guy. Metrogel 1%, Desonate, Clobex spray, Ziana and Acanya were all original NDAs. Large phase 3 trials, Pk studies, phase 2 studies and nonclinical studies were required. The generic was an ANDA but required a big clinical study. Go to the FDA website, drugs@fda, and check. If the SBA is available you can read (big assumption) all about the complex work that was done. If you think it was easy, you are dumber than Miss South Carolina. Now get off your pathetic rear end and try to sell something; the BenzaClin and Duac gravy train just got derailed. Managed care knows all about the kit game (Duac CS kit with cleanser, now there is innovation), it isn't going to work.
 






Re: Way off base

Turk said:
OK time to lecture the dumb sales guy. Metrogel 1%, Desonate, Clobex spray, Ziana and Acanya were all original NDAs. Large phase 3 trials, Pk studies, phase 2 studies and nonclinical studies were required. The generic was an ANDA but required a big clinical study. Go to the FDA website, drugs@fda, and check. If the SBA is available you can read (big assumption) all about the complex work that was done. If you think it was easy, you are dumber than Miss South Carolina. Now get off your pathetic rear end and try to sell something; the BenzaClin and Duac gravy train just got derailed. Managed care knows all about the kit game (Duac CS kit with cleanser, now there is innovation), it isn't going to work.
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Dumb sales guy? Why would you think that? That post is correct. You didn't take it the right way. Those molecules were of course at some point NDA's. The point was that the products Dow has come out with are ALL ANDA's. No matter what you say, the work involved in an ANDA is nothing compared to a NDA! The FDA publishes what has to be done and how to do it! Dow does not do discovery work like Dermik, Stiefel, Galderma and others. And if they do, you will have to prove it by showing me a commercial NCE. Dumb sales guy? You, my friend, are an asshole.
 






Dumber than a

sack of hammers. Go check the FDA website as was suggested. All of the Dow products were NDAs with more stringent requirements (even more studies than the original reference products like Duac, Benzaclin, Clobex lotion for example) than the originals. Again the newly approved generic was an ANDA. Duac was approved after Benzaclin, so where is the originality there? Ziana is a new combination, the first and only approved (realize it is not a great product) tretinoin/clind acne product. Thank god you are in sales, you don't have the smarts to actually develop a drug and get it approved. You clearly don't understand the process and the FDA requirements.
 












We don't need

no stinking pumps. Good point but do you think the third party payors or managed care really care? The amount of savings to the bottom line for the payors is significant; long time coming for a generic for BenzaClin/Duac. Hey kid here is your bpo/clind, in a jar, good luck; at least you are not subject to the death committee.
 






Re: Dumber than a

Dermatious said:
sack of hammers. Go check the FDA website as was suggested. All of the Dow products were NDAs with more stringent requirements (even more studies than the original reference products like Duac, Benzaclin, Clobex lotion for example) than the originals. Again the newly approved generic was an ANDA. Duac was approved after Benzaclin, so where is the originality there? Ziana is a new combination, the first and only approved (realize it is not a great product) tretinoin/clind acne product. Thank god you are in sales, you don't have the smarts to actually develop a drug and get it approved. You clearly don't understand the process and the FDA requirements.
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Like the last guy/girl said, You are an asshole!
 












Anonymous said:
You're proud about Ziana, Desonate, and Acanya (The Third Me Too Drug in the BPO/Clinda Class) Get Bent and Get A Clue--No new molecular discovery has come out of Derm. since Differin--and I don't work for Galderma. Stop touting your company as doing something great--your higher ups are in this gig for selling out, no for R&D.
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You're incorrect. Tazorac was launched after Differin and this year Allergan launched the first new topical in 10 years. Aczone. NOT a me too.
 






Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International. The preparation is the first generic version of Sanofi Aventis' BenzaClin(R) to be approved by the U.S. Food and Drug Administration (FDA).

On Aug. 11, Dow received FDA approval for its Abbreviated New Drug Application (ANDA) for Clindamycin 1% and Benzoyl Peroxide 5% Gel, a prescription-strength topical antibiotic used to treat acne. According to IMS Health, BenzaClin had total U.S. sales of approximately $221 million for the 12 months ending June 30.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; operates a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.
 






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