Lupin buys Gavis Pharmaceuticals and gains first US facility

By Gareth Macdonald contact

- Last updated on GMT

Lupin's US manufacturing facility in Somerset, New Jersey (source Google)
Lupin's US manufacturing facility in Somerset, New Jersey (source Google)

Related tags: Food and drug administration

Lupin acquired drug formulation developer Gavis Pharmaceuticals this week in a deal that gives it its first manufacturing site in the US.

The facility in New Jersey is operated by Gavis’ subsidiary, Novel Laboratories.

It is equipped to manufacture and store schedule II to V drugs and undertake solvent-based production processes. According to Gavis the site has passed three US Food and Drug Administration (FDA) inspections.

BMI Research said in a note to investors that: "Gavis' US-based R&D organisation would complement Lupin's Coral Spring, FL, inhalation R&D centre​."

In addition to the manufacturing plant, the takeover gives Lupin a combined portfolio of 120 US-approved generic drugs and 185 pending ANDA applications, including 45 first-to-file (FTF) products offering 180 day market exclusivity.

Caveats

The takeover was approved by the US Federal Trade Commission (FTC) last month​ on the condition Gavis sold assets for two generic products - doxycycline monohydrate and mesalamine ER – to rival G&W.

Gavis was also required to transfer manufacturing technology for doxycycline and to produce it on G&W’s behalf for a two-year interim period.

Similarly, Gavis must make mesalamine for G&W and give the firm access to knowledgeable production staff to allow the firm to seek FDA approval for the product.

Completion of the $850m (€744m) deal follows days after Lupin confirmed it plans to build a generic drug manufacturing facility in Tottori​, Japan to try and capture a greater share of the country’s growing non-branded drug market.

Business dynamics

Completion of the Gavis takeover also comes a few weeks after Lupin published financial results that illustrated the growing importance finished drug products to its business.

Total revenue the third quarter of FY16 increased 11.9% to INR35.6bn ($54 0 .5m) with the contribution from formulations – finished drug products – growing 7.4% year on year to INR30.82bn.

Lupin’s active pharmaceutical ingredient (API) business – which is founded on key products like cephalosporin antibiotics and cardiovascular and anti-TB drug actives - generated revenue of INR2.76bn, which is just 0.1% higher than in fiscal 2015.

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