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India’s Biggest Drugmaker Plans to Start Developing Its Own Medicines

India’s Biggest Drugmaker Plans to Start Developing Its Own Medicines

You’d be hard-pressed to find someone who’s lost more during the recent upheaval in the generic drug business than Dilip Shanghvi: He forfeited $17 billion to be precise, plus the title of India’s richest man.

After a four-year decline that erased 65% from the value of Sun Pharmaceutical Industries Ltd., the drugmaker he founded, Shanghvi is preparing to bounce back. He’s doing it by borrowing a page from Big Pharma’s playbook: investing in higher-margin patented medicines rather than relying solely on copying drugs.

That won’t be easy, especially when the multinationals that dominate the pharmaceutical business have already seen the payoffs from their massive research and development spending become more uncertain. Those giants are increasingly turning to acquisitions to fill out their pipelines, and that’s where Shanghvi also sees an opening. Aided by an ability to move quickly because of Sun Pharma’s relatively small size—it had only about $4 billion in sales in 2018, compared with Pfizer Inc.’s $53.6 billion—and streamlined decision-making, Shanghvi thinks the company can eventually pick up enough early-stage innovations and key personnel to generate half its revenue from patented medicines. “It does require some additional skills beyond what a typical generic has,” Shanghvi says, but those skills aren’t impossible to acquire.

Revenue at the world’s biggest generic drugmakers has been hit as the Trump administration approves generic rivals at a record pace to increase competition. At the same time, the industry is under fire in a set of sweeping price-fixing lawsuits filed by U.S. states that allege companies inflated prices on drugs.

Generics makers, including Mylan NV and Teva Pharmaceutical Industries Ltd., are following a path similar to Sun’s. But Mylan’s investments in patented products have contributed to a drag on its profitability, and the Pennsylvania-based company is now conducting a strategic review of its entire business, as it has no obvious successor on the horizon for its blockbuster patented medical device, the EpiPen. Meanwhile, sales of Teva’s lone success in innovative drugs, the multiple sclerosis treatment Copaxone, are dropping faster than expected. The two branded medicines the Israel-based company had been counting on to replace Copaxone’s billions of dollars in annual revenue produced only about $100 million in combined sales last quarter.

Shanghvi says he and Sun have a better chance of success. For one, he’s proved adept at dealmaking. Shanghvi recognized the opportunity in generic dermatology products at an early stage, acquiring a controlling stake in distressed Israeli drugmaker Taro Pharmaceutical Industries in 2010 and using price increases on its portfolio to help improve Sun’s profitability. Sun today is India’s largest drugmaker, thanks in part to the 2015 acquisition of a troubled local competitor, Ranbaxy Laboratories.

Shanghvi says the inspiration for his strategy is British drugmaker Shire Plc, which largely eschewed research and development in favor of a “search and development” model: acquiring and licensing products created by others. Shire was bought for $62 billion earlier this year by Japan’s Takeda Pharmaceutical Co. to bolster its own dwindling product pipeline.

Because he controls 55% of Sun’s shares, Shanghvi says, the company can pursue opportunities more nimbly than rivals weighed down by corporate bureaucracy. “The advantage is that I have end-to-end understanding of all aspects of the business,” he says. “It’s easier for me to take decisions involving risk, because I am able to assess risk from multiple dimensions. In a big company they will need 8 or 10 people who have to look at it.”

Investors are more skeptical. Sun’s shares have fallen 6.8% over the past year, while India’s benchmark stock index has climbed 14%. The industry price-fixing case is likely to add to the pressure. More than a dozen top generic-drug makers, including Sun, have been sued in U.S. federal courts by more than 40 states, which accused them of inflating prices of at least 100 different drugs. “We believe the allegations made in these lawsuits are without merit, and we will continue to vigorously defend against them,” a Sun spokesman says.

Many analysts are also doubtful about the company’s plans to move beyond generics. “It’s a different ballgame altogether,” says Surajit Pal, an analyst with Prabhudas Lilladher Pvt. in Mumbai, who has a reduce rating on Sun. “I don’t have any data on any company, be it Indian or non-Indian generic majors, who have made an impact out of launching or selling new drugs.”

Shanghvi estimates that Sun has invested about $1 billion in its patented-drug program so far. He says growth in the Indian generics business, a push into China, and new generic products in the U.S. will generate cash that can be plowed into reinventing the company. “The performance of many large multinational Big Pharma companies has been mixed,” says Shanghvi, whose personal fortune now stands at about $7.8 billion, making him India’s eighth-wealthiest person, according to the Bloomberg Billionaires Index. “I think one can learn from that.”

BOTTOM LINE – Sun Pharmaceuticals founder Dilip Shanghvi saw his wealth fall by $17 billion as prices for generic drugs dropped. So now he’s turning to patented drugs.

24 May, 2019

https://www.bloomberg.com/

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May 27, 2019 / Pharma News