PharmAsiaSummit: Emerging Markets Are Growth, Growth, Growth, But Where's The Beef?

Windhover's PharmAsiaSummit is October 25-26 in San Francisco. For a more information and a complete PharmAsiaSummit agenda, visit our website or email Josh Berlin to learn more. We hope to see you in San Francisco. What follows is an advertisement for the meeting.

A recent forecast by IMS Health demonstrates much of what we've been hearing in emerging markets over the last several years. The market research firm forecasts 15-17% growth next year in the 17 countries designated as "pharmerging" markets, which includes the usual suspects (the BRIC countries), as well as fast followers ranging from Turkey to Indonesia to Mexico.

To be sure it's off a smaller base, but the base is growing, and next year IMS predicts revenue will reach $170-$180 billion. In other words, it isn't peanuts.

In 2011, pharmerging markets will equal roughly half the size of the US market ($320-$330 billion), which will grow at a comparatively paltry 3-5%, IMS says.

China, of course, is the Big Kahuna, with a pharma market set to reach $50 billion next year, making it the third largest. With a growth rate of 25-27% - fueled by demographics (a rapidly aging population and urbanization, for instance) and a massive government push to extend basic health insurance to China's 1.3 billion population - it is no wonder that IMS recently raised China to its own tier as part of its analysis, essentially separating the C from the BRI.

Although much of the growth will come from local manufacturers selling branded generics, there is plenty of growth to go around. Pfizer, for instance, is the largest foreign pharma in China, yet it's captured only 2% of the market, Morgan Stanley notes in a recent report. In India, Abbott is the top dog following its acquisition of Piramal earlier this year, yet it commands only 6% of India's famously fragmented market.

It's no wonder that pharmas from Pfizer to Abbott to Merck to AstraZeneca have jumped into the branded generics space, looking to sell off-patent medications in emerging markets and in some cases partnering with Indian generic companies to expand their offerings.

The editors of our sister publication, PharmAsia News, which has boots on the ground in China, India and elsewhere in Asia, like to talk about the excitement they hear from sources and friends in the industry - excitement about growth opportunities, new models for R&D, commercial strategy, China healthcare reform and so forth.

But one thing we often find missing in the discussion is specifics. What, specifically, are the right commercial strategies for China, or India or Korea? What, specifically, should biopharma companies do to take advantage of China health care reform? What, specifically, are the opportunities for partnerships or outsourcing in China? What specifically, should you do to protect intellectual property in India?

Who should you talk to? What case studies are relevant? Where should you place your bets?

Specifics are hard to come by via channels we use in the West - the media for instance or trusted websites. In Asia, most important lessons are discussed offline, and things change so quickly in markets like China and India that what worked last year might not work today.

In short, you need a strong, local network to understand the rapidly changing market.

That's the idea behind our PharmAsia Summit. We've decided to bring some of our Asia network to San Francisco this month to talk about specifics - what works, what doesn't, and what you need to know to succeed. If you're based in the U.S., it's a great chance to meet face-to-face with Asia pharma leaders.

We won't have all the answers - no one does. And what works today might not work tomorrow. But what you'll have is a forum where industry leaders - from Biogen Idec's Gunther Winkler to Merck's Ramesh Subrahmanian to Onyx's Tony Coles - will discuss Asia case studies on dealmaking, commercial strategy, outsourcing, regulatory risks, IP protection, and pricing and reimbursement.

We'll have leading Asia investors like OrbiMed's Jonathan Wang, top China analysts like Piper Jaffray's Hongbo Lu, commercial gurus like MSD's Sanjiv Navangul - a key figure behind Merck's groundbreaking strategy for Januvia in India - and IMS Health Asia VP Jan Willem Eleveld, who will provide the latest Asia data and trends.

And as policies are changing so quickly in Asia, we also have a few regulators making the trip, including Shanghai FDA's Yi Chengdong, Korea FDA's Hong Soon Wook, and U.S. FDA country directors from China and India, Chris Hickey and Bruce Ross.

FDA and Drug Safety: It Keeps Getting Worse

How bad is the drug safety climate? Just ask GlaxoSmithKline.

Sure, last Monday was a rough day—nothing like having two FDA officials tell an advisory committee that one of your biggest products ought to be pulled—but we’re not talking about Avandia today.

No, today we are talking about the product formerly known as Trexima, a fixed-dose combination of the GSK’s migraine drug sumatriptan (Imitrex) and the nonsteroidal anti-inflammatory drug naproxen. GSK is developing the combo in partnership with Pozen. On July 31, the Food & Drug Administration issued a second “approvable” letter for Trexima, saying that it is still not convinced the combination is safe enough for marketing. (FDA has already told the companies that it will not approve the Trexima brand name, but the firms are still using it until they settle on a new one.)

In particular, Pozen says, FDA is concerned about a positive genotoxicity test. The agency apparently wants the company to conduct a relatively simple human study to provide reassurance that it is a false signal. This comes after FDA previously declined to approve Trexima because of concerns about the cardiovascular safety profile of the combination.

Keep in mind that this pill combines two ingredients that have been used together countless times in the 15 years that Imitrex has been on the market. If there really is a safety problem here, FDA probably should be doing more than just sending an “approvable” letter to Pozen.

To be fair, Imitrex has well known cardiovascular risks, and naproxen’s cardiovascular safety profile became an issue in the context of the cox-2 inhibitor safety brouhaha. So you can understand why FDA asked for more data. Now, Pozen says, the agency is satisfied on that front (thanks in part to GSK’s willingness to do a post-marketing study on the blood pressure effects of the combo). But the drug is still on hold.

Welcome to the world of new drug reviews in 2007. Trexima is just the latest indication that this may be the worst time ever to try to get a new drug through FDA.

There should be good news soon. Congress is on the verge of enacting historic drug safety legislation—at least, Congress says it will after August vacation. The bill will put new burdens on manufacturers to be sure, but it will also allow Congress to declare the drug safety problem to be fixed. That may lead to increased confidence in FDA as a regulator—and maybe increased confidence within FDA itself to allow the agency to approve drugs even if they do have a safety signal.

SHAMELESS SELF-PROMOTION ALERT: The RPM Report and Ropes & Gray will host a webinar on Aug. 14 to discuss the impact of the pending FDA bill. Two experts from Ropes & Gray’s legal practice will dissect the key provisions of the legislation, and the editors of The RPM Report will tease out the business implications of the law. Registration information is available here.

Drug Safety...or Food Safety...or Tobacco Safety...or Pet Food Safety...or Dietary Supplement Safety?

So which is most important to you? Well, if you're in charge of FDA, they all are. That came through loud and clear during a health care reporters breakfast with commissioner Andrew von Eschenbach organized by the folks at Health Affairs.

But fortunately for us here at the IN VIVO Blog, we only have to worry about drugs and biologics. With Congress taking off for their August recess, it looks like the Prescription Drug User Fee Act reauthorization as part of the much grander FDARA drug bill will have to wait until September to get passed.

So wait, doesn't that mean droves of FDA employees will be out of a job come September 1st because there will be no money to pay them (FDA gets half of its drug review budget from user fees)? Not so much. Von Eschenbach said the agency has already dipped into "carry-over" funds to ensure the agency will run smoothly while they wait for lawmakers to act. He expects/hopes the bill will pass in the first few days when the House and Senate come back from recess. Von Eschenbach emphasized he was working very closely with specific players in Congress to make sure that happens. The "carry-over" money, which seems to have magically appeared, is enough to last a couple of months before FDA would have to send out lay-off notices.

The RPM Report will be hosting a webinar on August 14 in partnership with the law firm Ropes & Gray to explain the commercial impact of the new drug safety rules for pharma and biotech companies. This will be the first in a series of audioconferences on the pending drug safety reforms.

The RPM Report has fancy new e-digs

Our colleagues from The RPM Report (and fellow bloggers here at The IN VIVO Blog) have a beautiful new web site over at http://therpmreport.com/, which we wholeheartedly encourage you to visit for the best analysis of biopharma regulation/policy/market access on these here internets.