India

Indian pharma gains on U.S. turmoil

Tracy Staton — Thu, 14 Aug 2008 10:43:10 -0400

U.S. pharma's troubles--coupled with a falling rupee--are boosting Indian drugmakers' fortunes. Analysts say that Big Pharma's cost-cutting wave, which has washed lots of outsourcing work toward the subcontinent, is a big plus for the Indian drugs business. Meanwhile, turmoil in the U.S. markets have weakened the rupee, which in turn has made Indian drugs less expensive in the States.

That can only be good for India's pharma companies, which rely heavily on U.S. sales for growth. And because U.S. drugmakers and financial firms aren't expected to recover quickly, analysts look to Indian drugmakers for strong revenue and earnings growth in the near term, the Wall Street Journal reports.

Two things could hold India's drug makers back, though. The rupee could appreciate, hitting companies that have been expanding their exports on the falling currency. And long term, Indian pharma needs to make the leap to branded drugmaking in a big way, rather than remaining primarily generics makers.

- read the WSJ article

India mulls monopoly purchasing

Tracy Staton — Mon, 28 Jul 2008 10:05:00 -0400

Barack Obama may have spooked drugmakers with his proposal to have Medicare buy meds in bulk, but that proposal pales beside a plan India is now considering. The Indian government may take over all patented-drug purchases--not only for public healthcare but also for private providers. That means that the government would be the country's sole supplier.

Monopoly purchasing, of course, would allow the government to do some tough negotiating on price. Supporters say it would offer patients better access to new treatments, which remain out of reach financially for most of India's enormous population. They also say that drugmakers would benefit too: They'd have huge bulk contracts--with assured cash flow--and they'd save money on marketing, because they wouldn't have to promote their products to retailers, hospitals, and pharmacies. But critics say the government could end up limiting patients' access by choosing, say, one cholesterol-lowering drug out of the array of many.

Such an arrangement would be a game-changer for the many drugmakers who've been eyeing the Indian market for a big chunk of their future growth. We'll see if the plan proceeds past the proposal phase.

- see the story in PharmaTimes

India lets pharma fight compulsory licenses

Tracy Staton — Mon, 07 Jul 2008 10:14:03 -0400

India's patent office has decided that drugmakers should be able to have their say before the country grants compulsory licenses, which allow domestic generics makers to export copies of patented medicines to countries that don't have the ability to make the drugs needed to combat a public health crisis. Report

M&A menu: India's top 10 drugmakers

Tracy Staton — Thu, 19 Jun 2008 10:20:49 -0400

SPOTLIGHT: India's top 10 drugmakers
As soon as Ranbaxy's founding Singh family agreed to sell out to Japan's Daiichi Sankyo, the Indian press started speculating about which pharma firm might be next on the buyout list. Well, we can't pretend any knowledge of upcoming M&As, but we can point you to a ranking of subcontinental drugmakers--by revenue--for your own speculative pleasure. Changes are the next target would be among this top 10. Report

Indians ask Ranbaxy CEO who's next

Tracy Staton — Mon, 16 Jun 2008 09:01:45 -0400

In the investment world, the proposed Daiichi Sankyo-Ranbaxy Laboratories merger is just another big deal. But in India, it's taken on symbolic significance. The family-controlled company surrendering to the market, the domestic success story and conferrer of bragging rights selling out to outsiders, the company poised to make its own global mark settling for a spot underneath a multinational umbrella--is it a harbinger of things to come? Will more Indian drugmakers soon fall to M&A fever? For Malvinder Singh, Ranbaxy CEO and grandson of its founder, the questions have been incredulous.

"Have you actually sold your shareholding?" his friends have been asking. Yes, Singh says. And why? Because he and his family concluded that the company could do more as part of a multinational than it could on its own. From Daiichi, Ranbaxy will get expertise at developing new drugs; from Ranbaxy, Daiichi will get generics and low-cost manufacturing and an emerging-market foothold. "I was convinced that the business model in the global pharmaceuticals industry was going to change and that there will be a coming together of 'big pharma' and generics," Singh explains.

Hence the frenzied speculation about which Indian drugmaker is next. If Big Pharma and generics will be joining forces, then India's generics makers are logical takeover targets. And why wouldn't other domestic drugmakers sell out, now that they've seen what Ranbaxy will bring? "A huge positive for Ranbaxy but a negative for Indian pharma," one analyst sniffed.

And speaking of speculation, Singh told the Financial Times that talk of Pfizer quashing the Daiichi deal with a hostile bid of its own is "very speculative." He's not been in talks with the U.S. drugmaker, he says.

- see the BusinessWeek article on copycat deals
- check out the Singh interview in the FT

Bureaucracy slows FDA offices in China

Tracy Staton — Tue, 27 May 2008 09:17:28 -0400

Easy to announce you're opening offices in China. Not so easy to actually do it--especially when you're wrestling with Chinese red tape. That's what the FDA is discovering as it struggles to establish a presence in Beijing, Shanghai, and Guangzhou. Apparently, China's health ministry is expressing support for the new offices, which will employ 13 people. But the foreign ministry has yet to give the required stamp of approval. And once the office itself gets the OK, then the FDA workers will all need visas--yet another round of red tape.

Next on the FDA's list of overseas locations: India, according to HHS Secretary Michael Leavitt. After that, its Central America. Good thing the Senate approved $275 million in additional funding for the agency last week.

- see the Wall Street Journal story

Big Pharma changes rules in emerging markets

Tracy Staton — Wed, 21 May 2008 11:04:31 -0400

If that well-meaning advice-giver in The Graduate were speaking to pharma today, he might well say, "Two Words: Emerging Markets." That phrase is getting more and more traction these days, as drugmakers wake up to the fact that the coming growth areas on the globe aren't found in North America or Europe. And as the importance of countries such as India, China, and Brazil grows more evident to Big Pharma, so is the fact that the strategies that work in the super-industrialized world won't serve in countries where the middle class is just now growing by leaps and bounds.

We all know that the pharma majors are moving into R&D in places like India and China, and that more and more are outsourcing their manufacturing to emerging countries. But to sell products there, on the ground, they're trying things that they'd never do elsewhere. "Differential pricing," for one thing, which takes into account per-capita income in setting prices; soon, there might even be different prices for middle class Indians, for instance, and the subcontinental poor. Standard arguments against it--that these cheaper meds will get resold on the black market, for instance--are falling by the wayside. What else might Big Pharma do to gain a major foothold? We'll have to watch and see.

- see the story in The Economist

Wyeth pounces on Sandoz's copycat Protonix

Tracy Staton — Wed, 21 May 2008 10:46:11 -0400

Wyeth is going toe-to-toe with Novartis. The Protonix maker--and its partner, Nycomed--filed suit against Novartis' generics arm, saying its copycat drug violates the heartburn med's U.S. patent. Sandoz, you'll recall, filed last month for FDA approval of an injectable form of the drug.

It's just the latest twist in the rapidly lengthening story of copycat Protonix. Last year, Teva Pharmaceuticals launched its version, but stopped shipping to sit down with Wyeth at the negotiating table. No settlement of the companies' patent fight has yet been reached, but in the meantime, Wyeth teamed up with Prasco Laboratories to sell an authorized generic. Soon after, a division of India's Sun Pharmaceuticals released its own version.

Wyeth's sales--both branded and generic--dropped by 66 percent during the first quarter--a painful loss, considering the fact that Protonix once was the drugmaker's biggest seller. It's still defending its Protonix patent, though, and plans to ask for lost profits and damages from both Teva and Sun when the patent case goes to trial.

- see the Wall Street Journal story

SPOTLIGHT: U.S. 'a complete mess,' Indian CEO says

Mon, 12 May 2008 06:59:52 -0400

Dr. Reddy's vice chair and CEO G.V. Prasad predicts increasing difficulty obtaining financing and declining market caps industry-wide as the U.S. economy slows. But, he says, India and China will grow as traditional pharma markets brake. "The U.S. is in a complete mess," Prasad told the Indian pub DNA Money in a Q&A interview. Report

Could Clarinex be vulnerable to generics?

Wed, 30 Apr 2008 06:59:55 -0400

Consider this scenario from Fred Hassan's nightmares: The $800 million Clarinex, ostensibly under patent till 2020, falls early victim to generic competition. Early, as in next year. In court documents filed April 16, the Indian generics maker Orchid Chemicals alleges that Clarinex RediTabs was never covered by Schering-Plough's '274 patent. If that's so, then Orchid could launch its version of RediTabs almost immediately, the documents state. And so, apparently, could other copycat drugmakers circling the allergy med.

Schering disagrees with Orchid, of course. And though Orchid has some smart lawyers on the case, so does Schering-Plough. We'll have to wait and see what the court decides.

- check out the Pharmalot story
- see the item at Shearlings Got Plowed

ALSO: Drugmakers are lobbying Congress to change a particular patent rule that allows protection to be canceled if the patent holder misrepresented or concealed info in its application. Generics makers, however, say the penalty is necessary, because without it, branded drugmakers could "cheat and get away with it," making it more difficult for cheaper generic meds to make it to market. Report