Generic drug manufacturers Lupin and Gavis Pharmaceuticals have agreed to sell the rights and assets for two generic drugs, in order to address regulatory concerns over their merger.
The US Federal Trade Commission (FTC) has asked the companies to divest the products as it is concerned that the proposed $850m acquisition would reduce competition in the market.
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FTC said: "Without a divestiture, the merger would have combined two of only four companies that currently market generic doxycycline monohydrate capsules in two dosage strengths, used to treat bacterial infections, likely resulting in higher prices."
The companies have decided to sell generic drugs for treating bacterial infections and ulcerative colitis to G&W Laboratories.
Lupin would transfer all of Gavis’ rights and assets related to generic doxycycline monohydrate capsules to G&W Laboratories within ten days after the acquisition is consummated, so that G&W can begin selling the product immediately.
The transfer includes Gavis’ manufacturing technology, which Lupin will help G&W set up at the latter’s facilities. In the interim, Lupin will supply G&W with the finished product for two years.
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By GlobalDataLupin is also required to transfer all confidential business data related to both divested products, and provide access to knowledgeable employees, so that G&W can obtain all necessary FDA approvals in a timely manner.
Meanwhile, Gavis will divest its rights and assets related to generic mesalamine capsules to G&W before the acquisition takes place.
If the deal goes ahead, Lupin will expand its presence in the US generic market, in addition to its portfolio in dermatology, controlled substance products and other niche generics.
Based in New Jersey, Gavis is involved in formulation development, manufacturing, packaging, sales, marketing, and distribution of pharmaceuticals products.
Currently, the firm has 66 ANDA filings pending approval with the US FDA, as well as pipeline of around 65 niche dosage forms. The company has also filed 25 Para IVs and eight FTFs products.
