India’s Lupin Says Ready To Present Mandideep Plan To U.S. FDA; Push On Novel Drug Delivery, Biosimilars And Indian Market To Propel Revenue Growth

MUMBAI - Indian drug maker Lupin hopes to clear up issues with U.S. regulators on its Mandideep-based manufacturing unit, which has been issued warning letters by the U.S. FDA. The FDA had charged the facility deviated from current good manufacturing practices in the production of oral and injectable cephalosporins in November 2008.

Lupin Group President Nilesh Gupta told PharmAsia News that the company has worked on all the important issues pointed out by the FDA and expects to hammer out a solution soon.

"We will first put up a correction plan with FDA officials this month and follow up with a meeting. We had fixed eight of the 15 issues raised by the FDA much earlier, and are now in a position to present our complete case," Gupta noted.

Among the issues raised by the FDA, and still pending, are the failure to maintain production control or distribution records associated with a batch and the needed saefguards to prevent contamination in defined critical areas (Also see "U.S. FDA Issues Warning Letter To Lupin Citing Manufacturing Deficiencies; Warns Products Will Not Be Approved Until Corrective Action" - Scrip, 31 May, 2009.).

FDA inspections have prompted Lupin to initiate a company-wide quality overhaul. "We are setting our own internal benchmarks and are committed to take our company beyond the rest of the pack in quality control specifications," Nilesh Gupta said, and added that international consultants are helping Lupin in the exercise.

If there is a delay in getting things sorted out on the Mandideep plant, Gupta said, the company will develop a back-up plan to source cephalosporins from other Indian manufacturing companies.

In contrast to its peers in India including Ranbaxy and Dr. Reddy's, Lupin entered the U.S. generic drugs market as late as in 2003, but has managed to become the ninth largest player in that extremely competitive business environment. Suprax is a flagship anti-infective brand of Lupin that is helping the company quickly grow its revenues in the U.S.

Suprax is one of the key products coming out of the Mandideep unit and combined with the other big brand - Aero Chambers - it recorded sales of $74 million in the U.S. last year. Lupin's sales grew in the range of 35 percent to nearly $800 million in the last financial year. Lupin has forecast a growth of at least 20 percent to 25 percent for the next three years.

A report put out by India's Karvy Stock Broking May 18 said, "Lupin's per product revenues are the highest amongst Indian peers in the U.S. market."

As part of Lupin's aggression in the U.S. market, in 2008 the company filed 28 abbreviated new drug applications while posting a 74 percent rise in sales during the last year. It is estimated the company has more than 50 new product approvals.

Lupin is among the world's largest producers of anti-hypertensive drugs like lisinopril and is an established player in the entire range of anti-TB drugs like rifampicin, isoniazid, ethambutol and pyrazinamide.

In order to expand its revenue flows beyond generic drugs, Nilesh Gupta said that the company is undertaking a major restructuring of its drug research programs. Lupin is stressing the launch of differentiated products through novel drug delivery technologies that range from oral contraceptives to mini-tabs to laser drill technology and patch delivery.

Lupin has settled many of its patent disputes against brands of multinational drug companies; the latest in that series was anti-depression brand Effexor XR (venlafaxine) of Wyeth.

Now, Lupin has decided to make a new beginning with its novel drug discovery program and will work on compounds that have a strong potential to reach the market. "With our inherent strengths, collaborative research is an area we are exploring very seriously," Gupta noted.

"Our new research setup will house no less than 300 scientists and will absorb money for three years, but from the fourth year we expect revenues to kick in," Gupta explained, while adding that the company has filed for approval of 15 to 20 difficult-to-make ophthalmic products in the U.S. Gupta hinted that asthma drugs and delivery devices presents a sizeable exports opportunity too.

"Novel drug delivery products are tricky," said Gupta. "Only one out of ten products makes it to the last, but that could present sizeable revenues for the company," he said. "We are in continuous talks with multinational companies which want to extend the life of their products and want to in-license our products," Nilesh Gupta told PharmAsia News.

After lying low for many years, Lupin expanded swiftly into markets like the Phillipines, Japan, Australia, Germany and South Africa, mainly through acquisition of small to medium-size local units (Also see "World's Largest TB Drug Maker Lupin Acquires German Generic Company Hormosan To Extend Reach Into Europe" - Scrip, 31 Jul, 2008.). The company's strategy to spread out into emerging generic markets has been followed with optimism by market and investment analysts at Karvy and First Global.

Besides, India has been a big unexplored market for Lupin. With an expanded therapy base that ranges from anti-TB drugs to cardiovascular drugs to inhalation devices for asthma patients, Lupin has grown its revenues by more than 20 percent, catapulting itself to fifth place in the highly fragmented Indian formulations market.

Biosimilars is one more big area of potential expansion for Lupin. The company has acquired a small unit at Pune in India and has started work on identifying six products initially. "We will start with less regulated markets and then see how the pathways open up in the highly regulated markets," Nilesh Gupta said.

- Vikas Dandekar ([email protected])