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Hi-Tech Pharmacal Co.

AMITYVILLE, N.Y -- In an industry where consolidation and mergers are the order of the day, Hi-Tech Pharmacal is different: self-reliant, focused on its customers and committed to bringing a continuing stream of new products to market. The company's highly regarded research and development program never stands still--and the results show.

* September 2007--Hi-Tech Pharmacal received approval for ciclopirox topical solution 8%. Hi-Tech's ciclopirox topical solution is the generic equivalent of Dermik Laboratories' nail fungus treatment Penlac Topical Solution 8%.

* January 2008--Hi-Tech Pharmacal was granted final approval for fluticasone propionate nasal spray, 50 mcg. Hi-Tech's fluticasone propionate nasal spray is the AB-rated generic equivalent of GlaxoSmithKline PLC's Flonase, which is used in the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis.

* February 2008--Hi-Tech Pharmacal received approval for hydrocodone bitartrate and homatropine methylbromide syrup, the generic equivalent of Endo Pharmaceuticals' hycodan. Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough.

* March 2008--Hi-Tech Pharmacal was granted final approval for ofloxacin otic solution 0.3%. Hi-Tech's ofloxacin otic solution is the generic equivalent of Daiichi's toxin otic solution 0.3%, indicated for the treatment of bacterial infections of the ear.

* April 2008--Hi-Tech Pharmacal was granted tentative approval for dorzolamide hydrochloride with timolol maleate ophthalmic solution. Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic equivalent of Merck & Co.'s Cosopt and is indicated for the treatment of glaucoma.

* May 2008--Hi-Tech Pharmacal announced that it entered into a distribution and supply agreement with a subsidiary of Warner Chilcott Ltd. to market the authorized generic version of Warner Chilcott's Dovonex Scalp Solution (calcipotriene solution 0.005%). It is indicated for the topical treatment of psoriasis of the scalp.

Hi-Tech currently has 12 products awaiting approval at the Food and Drug Administration that together target brand and generic sales of more than $500 million. In addition, the company has 20 products in active development targeting brand sales of over $2 billion, including sterile ophthalmic products, oral solutions and suspensions, and solid dosage forms.

"We're committed to finding ways to deliver value at Hi-Tech," says David Seltzer, the company's president and chief executive officer. "We're driven by the same core values we established when the company was founded in 1981: focus, innovation, confidence and trust."

In an industry that faces continual challenges, Seltzer exhibits the confidence that comes with success. "We remain very optimistic about our future," he says. "We see tremendous opportunity ahead of us, as our generic pipeline is more robust than ever. We are continuing to invest in our future, and we have every confidence that it will lead to future sales growth and higher profitability."

Seltzer continues: "The acquisition of Midlothian Laboratories in December 2007 has expanded our product line and broadened our dosage form offerings, bringing us into new therapeutic categories and adding to the company's growing pipeline of products as well as experienced management.

Generics are only part of the story at Hi-Tech. The company acquired the rights in the United States and Canada to the Choice DM brand name from Novartis AG. Hi-Tech will market a line of Choice DM nutritional supplements and beverages, which are formulated to meet the dietary needs of diabetes patients, through its O-ToC division, Health Care Products.

These new products and lines will join an already impressive portfolio, including acyclovir oral suspension, albuterol sulfate inhalation solutions, albuterol sulfate syrup, lactulose solution, prednisolone syrup, promethazine syrup, promethazine DM syrup, promethazine with codeine syrup, sulfamethoxazole/trimethoprim pediatric suspension, valproic acid syrup and a complete line of poly-vitamin and trivitamin pediatric drops.

"They say that the generic business is driven by new products. That's one way to look at it. Here's another way: Every new product is another opportunity to make strong partnerships even stronger," says Ed Berrios, vice president of sales and marketing. "In a nutshell, that's how we approach it. We're a business partner first and foremost. We're very proud of the relationships we've built with our partners in pharmacy. We believe those partnerships have been an integral part of our success, and we're committed to providing even greater value in the future."

The value of these partnerships has been exemplified by Hi-Tech's ability to execute a license and supply agreement that brought to market a generic for Carnitor solution and tablets. "Pursuing arrangements that expand our portfolio of key and niche products adds another level of value for our customers," Berlios says. In addition, Hi-Tech acquired the U.S. rights to Tanafed DMX, as well as to Zostrix and Zostrix HP, two successful topical analgesic products that will be marketed by the company's Health Care Products division.

These acquisitions, along with a continuing stream of new generic approvals, enhance Hi-Tech's ability to bring a broad range of opportunities to its pharmacy partners.


369 Bayview Ave.

Amityville, N.Y. 11701

Key contacts:

DAVID SELTZER, resident & Chief Executive Officer

ED BERRIOS, Vice President of Sales & Marketing

Phone: (631) 789-8228

Fax: (631) 789-8429
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Title Annotation:RX/GENERIC DRUGS--Profiles; Hi-Tech Pharmacal Company Inc.
Publication:Chain Drug Review
Article Type:Company overview
Date:Sep 29, 2008
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