PHILADELPHIA, Sept. 3 /PRNewswire-FirstCall/ -- Lannett Company, Inc. announces that it has signed an agreement with Unichem Laboratories Ltd. (Unichem) of India for the exclusive supply of one or more generic drug products.
Under the terms of the agreement, Unichem will develop its formulation for the finished dosage drug product using its internally-manufactured active pharmaceutical ingredient (API). Unichem and Lannett will share the cost of bioequivalence studies for the generic finished dosage drug product. Lannett will assist Unichem in preparing and submitting an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) for marketing approval in the U.S. Once approved, Lannett has the contractual right to market and distribute the product exclusively in the U.S. The profits earned on sales of the drug will then be shared by Unichem and Lannett. Since Lannett and Unichem have no control over the FDA review process, they are unable to anticipate whether or when they will be able to begin commercially shipping the product.
A Lannett Company spokesman said, "We are very excited about the opportunity to work with Unichem on this project. Unichem produces their own API, so we believe that there may be a competitive advantage over other finished dosage manufacturers that must purchase their API from other companies. Unichem has several other commercial and R&D product offerings. We believe that our companies will continue to work on other R&D product candidates, thereby increasing the volume of products which we will distribute in the future. With a talented scientific staff and a high quality operation, Unichem has an excellent future in the U.S. pharmaceutical industry. We believe that we can assist them with our strong customer relationships."
Unichem Laboratories Ltd. is a pharmaceutical company headquartered in Mumbai, India. Its stock is traded publicly on the stock exchange in India. Unichem produces high quality APIs and finished dosage products for several markets around the world, including the United Kingdom, Europe, South Africa, Switzerland and Australia.
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Lannett's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Lannett's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Lannett's Annual Report on Form 10KSB for its fiscal year ended June 30, 2003 and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Lannett Company's common stock trades on the American Stock Exchange under the symbol "LCI." For more information, please call Investor Relations at 215/333-9000.
Lannett Company, Inc.