среда, 4 июня 2014 г.

Who's The Best In Drug Research? 22 Companies Ranked


Billionaire hedge fund manager Bill Ackman is fundamentally wrong in the arguments that he is making in his efforts to force Botox-maker Allergan to sell itself to Valeant Pharmceuticals. Merck and Novartis, both regarded as paragons of R&D, are actually laggards. And Pfizer and AstraZeneca, far from sad sacks driven into each others arms by an inability to develop new drugs, are actually average.

Those are some of the surprising conclusions reached in a new ranking of the top 22 firms by R&D productivity created by Sector & Sovereign Health and its lead analyst, Richard Evans, a former Roche executive and longtime Wall Street analyst. The ranking is included below.
Drug Companies Ranked By R&D Performance  
        
Rank CompanyEconomic Returns to R&D Spending*Patents / $1M R&D spend*Average Relative Quality of Innovation*Average Rank (by share of innovation) in Target Research AreasInternal Bias Index
1 Bristol-Myers Squibb1.5%0.221.21.923
2 Celgene32.3%0.231.58.498
3 Vertex-125.4%0.812.44.253
4 Gilead20.8%0.161.16.4185
5 Allergan8.0%0.461.48.196
5 Roche7.7%0.090.92.024
7 Amgen9.4%0.091.15.358
8 Johnson & Johnson8.2%0.071.04.834
9 Novo Nordisk17.5%0.111.710.8439
9 AbbVie11.1%0.121.09.454
9 Pfizer-3.2%0.110.92.524
12 AstraZeneca3.9%0.101.07.143
12 Biogen Idec9.1%0.131.113.1155
12 Shire18.6%0.111.415.4338
15 Sanofi1.5%0.090.94.228
16 Merck3.0%0.080.95.435
17 GlaxoSmithKline1.0%0.091.06.036
18 Novartis8.4%0.050.75.337
19 Regeneron8.3%0.160.713.7638
20 Bayer-2.1%0.070.910.382
21 Eli Lilly4.5%0.050.811.7131
22 Alexion12.8%0.030.421.48,012
  Sources: Bloomberg; AcclaimIP; SSR Health Hidden Pipeline Analysis and assumptions. *Rolling 5-year average. 
       
The goal of the report, available for purchase at HiddenPipeline.com, is to start to provide metrics that companies can use to measure how well they are doing when it comes to inventing new drugs — and to get better. T0o often, Evans says, pharmaceutical executives instead use the industry’s low success rates as an argument that success is right around the corner. “A gambler that has lost everything he owned, just because he now has a strong hand doesn’t make him a good gambler,” Evans says.
“This is a very rigorous report,” says Elliott Sigal, the former head of research and development at Bristol-Myers Squibb, the top-ranked company. “Nobody would argue: the general trend is that by many measures R&D productivity of the group is going down. Those of us trying to compete and do well in this space see a lot of value for being in the upper quartile. You used to do well if you were in the average.”
The business of inventing, testing, and marketing new medicines is in a protracted crisis. The number of new drugs invented per billion dollars of research money spent has been halved every nine years going back decades, like a perverse reversal of the exponential improvement of microchips that keeps Silicon Valley constantly hopped up on its own grandeur.
But when it comes to fixing the R&D difficulties of any particular company, there is a huge problem: the business of inventing and testing drugs is so full of random chance that it is hard to measure how well a company is doing. Merck might launch no drugs one year and six the next because of luck, not because it got infinitely better in that short time. So how do you tell if a particular company is doing better or worse than average? How do you measure R&D productivity so that you can get better?

This is the problem Evans is trying to tackle in his ranking, which he detailed in a 128-page report that he shared with me, and that I have shared with several experts in drug company R&D. Based on discussions with them, I think Evans’ work provides a valuable new lens through which to view drug company research labs, although there’s a lot more work to do before we know how bankable his conclusions are.
Evans ranks firms based on five metrics:
  1. The economic returns of each company’s R&D spending — essentially, how does income now compare to R&D investment a decade ago?
  2. The number of patents filed by companies for every $1 million they spend on R&D; only patents before drugs hit the middle stages of trials count, because after that some companies file extra patents with an eye toward defending marketed products later.
  3. How often a company’s patents are cited by other patents or publications.
  4. A “leadership” index: is the company is leading or lagging in terms of the number of patents it files in particular diseases or types of chemist. Is it #1 or #11?
  5. And a ranking of internal bias: basically, how good is a company at avoiding “not-invented here syndrome.
“It’s a really good, solid, and thought-provoking piece of work,” writes Jack Scannell, a noted researcher on pharma R&D productivity, in an email. “I wish I had written it or something like it.” But Scannell notes that, except for the financial metrics, the new data have not been back-tested. “If such an analysis showed that measures did not present subsequent economic returns (or stock returns), then the measures would appear to be demonstrably useless and there would have been no point in writing a big report about them.”
Evans ignores one of the most common measures of research productivity, and one of my favorites: the number of new drugs, called new molecular entities or new biologic entities, approved by the Food and Drug Administration in a given year. Evans says these can be “grossly misleading” because they reflect “the sporadic nature of research.”
Bernard Munos, of the InnoThink Center for Research in Biomedical Innovation, worries that Evans may actually be understating the degree that R&D is a money-losing proposition for drug firms. One reason is that Evans doesn’t separate out R&D in pharma from that in other businesses, like medical devices or over-the-counter products, nor does he try to filter improvements in earnings from introducing new medicines from those that come from cutting costs or increasing drug prices. “The top 12 pharma companies spend $70 billion on R&D, but what comes from their pipelines doesn’t generate $70 billion or more in sales,” Munos writes. However, Evans’ data do indicate that R&D prospects have continued to worsen, even as many executives argue they have turned a corner.
Bristol-Myers Squibb tops Evans’ ranking, as it does the rankings that I’ve published using Munos’ data and R&D figures. Celgene and Gilead are ranked #2 and #4, which is, again not a surprise: they’re the two most successful biotechnology companies of the past couple decades. Worth noting: Evans includes R&D costs from companies that are acquired, so Gilead gets credit for the hepatitis C drug, Sovaldi, which it bought, but which is having the most successful drug launch ever.
Vertex Pharmaceuticals of Cambridge, Mass., does surprisingly well. Evans points to it as a rare example of a company focusing in on a core competency — in this case, the science of understanding how drugs bind to receptors, and compares Vertex to the amazing numbers that were posted by Genentech when it was a standalone company.
One big surprise is the performance of #5-ranked Allergan, which is currently the subject of a hostile bid by Valeant Pharmaceuticals and its billionaire CEO Michael Pearson with some help from Ackman. Valeant’s model has been to buy companies that are wasting money on unproductive R&D and to cut costs to make them more profitable and return money to shareholders. If Allergan’s R&D is actually productive, this effort becomes value-destroying. “It’s absolutely counter to Valeant’s argument, no doubt,” says Evans.

Evans admits that for companies that have only launched one product, like Alexion or Regeneron, the analysis may not be valid. Munos also argues that AbbVie shines only because of its marketing of one new drug, Humira, not because of its ability to introduce new products, and that Lilly is dinged because of its losses in the U.S. insulin market, despite a better record of introducing new drugs.
Twenty years ago, Merck was viewed as the best drug research firm on the planet, a lot like Genentech. Novartis has recently achieved a similar reputation. But Evans says both are actually inefficient, because they follow a model of paying a lot of internal researchers, many of them in fields in which the company is not a leader, to work on a huge number of products. Over the course of its history, Evans says, Merck’s success has not been because it has had better ideas, but because it spends even more money when it finds one, like the cholesterol-lowering statin drugs.
“The reason they are so innovative is because they’ve taken a four-cylinder engine and put nitro in it,” he says. A more efficient model is the one adopted by Bristol under Sigal, which focused on bringing in products from the outside (Bristol’s breakthrough cancer drugs came from the purchase of Medarex) and using capital efficiently.
Evans has more work to do if he wants to make this ranking definitive; there are just too many ways to measure research productivity and they all give slightly different answers. But it’s a valuable contribution as we try to figure out the shape of the problem facing drug research and look for solutions.

https://tinyurl.com/26s96tew

воскресенье, 27 апреля 2014 г.

How to Make Friends When Working Abroad



Going abroad for an extended period of time can be frightening. You’re confronted with your own cultural differences on a daily basis, everything and everyone will likely seem alien, and you may begin to harbor ill feelings to your new country. My second month living in Thailand led to a lot of evening time on my computer. The result? I am now unnecessarily up to date on all pop culture. Someday, I promised myself, this Grandpa will rule all trivia. Because I’m fairly quiet, it was a difficult leap into a new country whose language I didn’t know and making friends while I worked there wasn’t even the first thing that crossed my mind.

But the best way to get over this period of cultural adjustment is to stop hiding in that cozy and well stocked apartment of yours and make friends. But how, you may ask. How can friends be found in a world where you can’t even speak the language?
Make the Most of Your Workplace 

There are a number of ways to go about it. First, try and branch out through your workplace. Unless you have some sort of contagious disease, you’ll likely be able to meet some friendly people through your job. You should realise that social inclusion and kindness transcends language and loneliness can be temporarily alleviated simply by another person’s daily smile. Ultimately though, deeper connections will require learning the language. So learn bit by bit and immerse yourself in the local people. At some point, your new local friends will expect you to know the language well enough that you can make basic conversation.
Connect With Other Foreigners

In my case, I don’t have a workplace other than a few coffee shops I daily bless with the noise of my typing fingers. If you’re living in a new place and doing business online, try and initially fight your loneliness by connecting with other foreigners. There’s likely a good deal of people doing exactly what you’re doing, and you may find some backpackers that you can hang out with as well. Though these meetings can be fleeting connections, as most foreigners you meet will be short time tourists, they’re still great ways to connect as you’ll have someone you can relate to. And the fleeting aspect of it can be a boon too. I recently poured a beer on a backpacker’s head and never had to face any social consequences.
Find Like-minded People

You can also try and find people with similar interests. Great places to find groups of like-minded people include Meet Up and Couchsurfing. Both will allow you to make friends among fellow foreigners and travelers, as well as some local people.
 
Take Advantage of the Melting Pot

However, after a few months into your work, the majority of your friends really shouldn’t be fellow foreigners. If that’s the case, then you’re insulating yourself and it will make homesickness all the worse. If you don’t branch out to make friends among the local people, you’ll begin to treat your new culture with suspicion and you’ll inevitably begin to harbor some prejudice. Your goal in a new country should ideally be to broaden your horizons and assimilate different cultural opinions. Eventually your eyes will have been dipped in your new culture for long enough that you’ll be bicultural.
Become a Habitué

A really great way to create a local group of friends is to become a regular at some restaurant or coffee shop. You’ll grow closer with the employees and owners. Make sure to be kind and respectful, avoid making a mess, learn names, and greet them warmly each time. Practice your language skills whenever you see them. You can make great and dependable friends that way, and you’ll form a reliable group of people who are happy to see you each time you come by. You should be able to swing some free food out of it too. Everyone’s got to eat.
Start new Social Hobbies 

You should also try and develop some social hobbies. Evening walks, fishing, writing, and other similar activities are all well and good, but the fact of the matter is that they don’t tend to involve other people. Try and develop a hobby that brings you into contact with a group. For instance, you can take dance classes, you can learn a martial art, you can join an adult sports league, or you can go on pub crawls. Volunteering is also a great way to immerse yourself in a community. You can even turn a typically solitary activity social. You can go to life drawing sessions through Meetup and turn your drawing habit into a way to make friends.

Really, the most important thing about making friends when working abroad is to just get out and about. Everyone knows Spongebob Seasons 2 and 3 are the greatest gifts to man in the history of the world, but re-watching it every night while screaming ‘My Leg’ probably won’t make you friends. Simple things like walking around downtown on typically social nights will bring you closer to making a group of friends that can help you grow as a person.
Posted by 
Adam Mohamed

вторник, 8 апреля 2014 г.

Ukraine Imposes 20% VAT on Import of Drugs and Medical Devices and 7% VAT on Supplies of Domestic Products



[April 04th, 2014] Ukraine Imposes 20% VAT on Import of Drugs and Medical Devices and 7% VAT on Supplies of Domestic Products, Arguably in Violation of GATT

On March 27, 2014, as part of the tax legislative package to prevent financial disaster, [1] Verkhovna Rada, the parliament of Ukraine, revoked VAT exemption for import of drugs and listed medical devices manufactured outside of Ukraine. As a result, import of drugs and medical devices shall be subject to 20% VAT in Ukraine from April 1, 2014. Any subsequent sale of imported drugs and medical devices, which used to be exempt from VAT, shall be subject to VAT at the rate of 7%..

Likewise, any sale of drugs and medical devices manufactured in Ukraine, which used to be exempt from VAT, shall be subject to VAT at the rate of 7% from April 1, 2014.

We do not exclude that 20% VAT on import of drugs and medical devices might have been an oversight, while the intention could have been to impose 7% VAT both to sales of drugs and medical devices and their import to Ukraine. However, for the time being 20% VAT rate applies to imports under the Tax Code as amended.

A. PRICE REGULATIONS

This tax measure will result in increase of prices of imported drugs and medical devices, because 7% VAT on their resale in Ukraine would eventually be borne by consumers.

As prices of drugs and medical devices are regulated in Ukraine, international pharmaceutical companies operating in Ukraine should consider the following possible repercussions of 20% import VAT / 7% supplies VAT for their operations:
  1. Because drugs and medical devices used to be exempt from VAT in Ukraine, domestic and foreign manufacturers were not entitled to recover any input VAT incurred in Ukraine, including material amounts of input VAT incurred in respect of marketing and promotion of their product in Ukraine. From April 1, 2014 domestic manufacturers shall be entitled to recover or refund their input VAT because they would be engaged in VAT-able sales (supplies) of drugs and medical devices (at 7% rate). Foreign manufacturers, to be capable of competing with domestic producers on the same footing, might need to reconsider their distribution channels so that their Ukrainian subsidiaries or branches (commercial offices) are capable of crediting (recovering) input VAT on marketing, promotion and other expenses in Ukraine. Presently, many foreign pharmaceutical companies recover marketing and promotion expenses incurred by their Ukrainian subsidiaries through services charges, subject to VAT in Ukraine, or by other means, which do not permit recovering input VAT.
  2. Because prices of domestic and imported drugs and medical devices (both on wholesale and retail levels) or for state or municipal procurement purchases are regulated in Ukraine, introduction of 20% VAT on imports and 7% VAT on supplies of drugs and medical devices from April 1, 2014 would most probably require reconsideration of the existing pricing arrangements with wholesale dealers in Ukraine.
  3. Moreover, existing state or municipal procurement contracts do not account for 7% VAT, which would result in material losses of revenues. Foreign manufacturers and their dealers should, therefore, examine whether they could demand increase of the procurement prices.
  4. 20% VAT on import of drugs and medical devices (exceeding 7% VAT on their resale in Ukraine) may put many importers in a VAT refund position. Because VAT is refunded in Ukraine with great delays and subject to many issues, 20% import VAT will have negative cash flow consequences for importers and may require additional financing.
  5. VAT on import of drugs and medical devices may result in increasing attention of the customs authorities to customs valuation of imports, especially if drugs and medical devices are imported by subsidiaries of foreign manufacturers, which may give grounds to the tax authorities to question customs value of the products imported in related-parties transaction and declared under the first method (contract price). It is common for the customs authorities to question customs values in related-parties transactions based on different customs values of same products imported directly by wholesale dealers.

B. GATT

20% VAT on import of drugs and medical devices, arguably, discriminates foreign manufacturers of such products in violation of Ukraine’s obligations under the GATT 1994. Under Paragraph 2 of Article III of the GATT 1994, Ukraine undertook that:
“the products [drugs and medical devices] of territory of any contracting party imported into the territory of any other contracting party [Ukraine] shall not be subject, directly or indirectly, to internal taxes or other internal charges of any kind [20% import VAT] in excess of those applied, directly or indirectly, to like domestic products [7% VAT on domestic supplies]”. (Clarification in brackets by us)
The government apparently favors domestic production by levying 20% VAT on “import” of drugs and medical devices manufactured outside of Ukraine, while supplies of drugs and medical devices manufactured in Ukraine are subject to 7% rate.

If 20% VAT rate on import of drugs and medical devices is retained in Ukraine, foreign manufacturers may consider the following actions to protect their interests:
  1. To approach individually or collectively through business associations (e.g., EBA, ACC) the government of Ukraine to communicate discriminatory nature of 20% import VAT in violation of Paragraph 2 of Article III of the GATT 1994 and to request the government to extend 7% VAT to import of drugs and medical devices; and/or
  2. To approach their respective authorities responsible for international trade and WTO relations (e.g. the EU Commission in the EU and the US Trade Representative in the USA) to communicate this issue and the apparent breach by Ukraine of its obligations under Paragraph 2 of Article III of the GATT 1994 and to request official consultations to be held with Ukraine to revoke this tax measure (20% import VAT) or to extend 7% VAT to import of drugs and medical devices to Ukraine.
We will keep you updated on further developments.

If you have any questions, please do not hesitate to contact MarchenkoDanevych Law Firm:

Oleh Marchenko, Partner
oleh.marchenko@marchenkodanevych.com

Leonid Cherniavskyi, Associate
leonid.cherniavskyi@marchenkodanevych.com

[1] Law of Ukraine “On Prevention of Financial Disaster and Establishment of Pre-Conditions for Economic Growth” dated March 27, 2014 (“Law”), which enters into effect on April 1, 2014.

вторник, 1 апреля 2014 г.

ТОП-10 фармкомпаний по объему продаж в 2013 г.


К концу I квартала 2014 г. большинство крупных фармкомпаний уже опубликовали отчёты за IV квартал и подвели итоги 2013 г. Их показатели не вызвали большого удивления аналитиков, которые внимательно следили за развитием фармацевтического рынка.  
Показатели двух крупнейших мировых фармкомпаний Pfizer и Merck&Co. несколько снизились на фоне реорганизаций и патентных вопросов, а AbbVie, выделенная Abbott в самостоятельный бизнес в начале 2013 г., вообще не попала в десятку сильнейших (табл.). Вместо нее на десятой строчке расположилась Eli Lilly. В свою очередь, немного поднялся в рейтинге Bayer HealthCare.
После патентных потрясений 2012 г. прошедший год, по мнению аналитиков, стал переходным. Финансовые показатели выросли  у Johnson&Johnson, Novartis, Roche, GlaxoSmithKline, Eli Lilly и Bayer. Выручка от фармацевтического бизнеса вкупе с показателями потребительского направления позволили Bayer увеличить общий объем продаж на 7,6% в долларовом выражении.  Продажи Johnson&Johnson увеличились на 6,7% также, в основном, за счет фармподразделения. Показатели других компаний практически остались на уровне 2012 г. или показали рост менее 3%.
Последствия патентного обвала стали причиной снижения показателей продаж компаний Pfizer, Sanofi, Merck&Co. и AstraZeneca. Так, объем продаж Merck&Co. сократился на 6,8% на фоне потери патентной защиты на препарат Singulair. Объем продаж Pfizer, который еще не отошел от последствий окончания срока действия патентов на Lipitor в 2011 г., снизился на 6%. При этом, аналоги Lipitor на 9% подорвали объем продаж препарата Crestor компании AstraZeneca, общий показатель которой за 2013 г. сократился на 8%.
Продажи Sanofi упали на 5,7% на фоне целого ряда отрицательных факторов, в т.ч. окончания патентной защиты на препарат Plavix.
Таблица. ТОП-10 фармкомпаний по объему продаж в 2013 г.
Компания
Объем продаж, млрд долл.


2013 г.
2012 г.
1.
Johnson&Johnson
71,3
67,2
2.
Novartis
57,9
56,7
3.
Roche
52,3
47,8
4.
Pfizer
51,6
59,0
5.
Sanofi
45,1
47,8
6.
GlaxoSmithKline
44,1
39,9
7.
Merck&Co.
44,0
47,3
8.
Bayer HealthCare
26,0
24,3
9.
AstraZeneca
25,7
28,0
10.
Eli Lilly
23,1
22,6

Crimean Dispute Poses Risk To Indian Generic Drug Companies

 

BMI View : The fallout from the Crimean dispute on global financial markets is set to impact Indian drugmakers. The rouble and the hryvnia have tumbled against the rupee, wiping out some of the cost advantages that Indian companies enjoy against competitors. With prices fixed on a considerable proportion of medicines on the market in Russia , the impact of these currency movements will be felt on the profit line for many Indian generic drugmakers.
The crisis in Ukraine involving Russia and the subsequent annexation of the Crimea has had considerable macroeconomic consequences; the Russian rouble experienced a considerable sell-off in the previous two months as capital flows reversed and investors sought safer assets in developed countries. Similarly, Russian companies and citizens traded roubles for dollars to hedge against further devaluation amidst a climate of heightened volatility on the currency and capital markets.
While the impact has not immediately filtered through to multinational companies with local subsidiaries in the country, the implications of the events in Crimea will be undoubtedly be felt at the end of quarter when cash is repatriated from Russian subsidiaries to their country of residence. As a result, investors in Indian pharmaceutical equities have sold off positions, with the benchmark BSE Healthcare Index down by 5.9% over the two week period between February 28 and March 18, although some of this decline was attributable to bearish sentiment following FDA warnings prior to the events.
Rouble And Hryvnia Sell Off To Hurt Indian Companies
INR-RUB and INR-UAH Spot Rates
The rouble has tumbled 22% against the Indian rupee since August 2013; similarly the Ukrainian hryvnia has fallen almost 35% against the Indian rupee. Indian companies have invested into building local manufacturing capacity through joint ventures or on greenfield developments, but these sites are years from completion; currently, the vast majority of Indian medicines sold on the Russian market are imported first. Furthermore, the Russian government mandates fixed prices on its Vital and Essential Drugs List (VED) with recourse for price changes once a year to account for inflation; despite India's position as a low cost manufacturing base, Indian exports to Russia will effectively be discounted in real terms, with negative connotations for profit margins of medicines.
Similarly, pharmaceutical manufacturer associations such as the Federation of Indian Chambers Of Commerce And Industry (FICCI) are concerned about the situation in the Ukrainian economy; almost 30% of Indian trade with the Eastern European country was in pharmaceuticals. With the prospects of Ukraine defaulting and the potential onset of hyperinflation, Indian companies are worried about the landed cost of their goods and whether import demand will dry up in the Ukrainian market.
Owing to the historic ties between Russia and India, Indian companies have aggressively targeted the country and neighbouring CIS markets in Ukraine, Uzbekistan and Kazakhstan to supply generic drugs from a low cost manufacturing base in India. Of all the Indian generic firms, Dr Reddy's Laboratories has the highest exposure to Russia and the CIS markets, with almost INR16.9bn (US$277mn) in sales generated from the region alone; in 2013, this represented almost 14.5% of total global revenues for the company. As a result, we now believe that Dr Reddy's first quarter results will potentially surprise to the downside, and hold a bearish view on the equity.
These developments are on top of sanctions handed down by regulatory agencies in Europe and the US to some of the larger Indian generic players such as Ranbaxy Laboratories and Sun Pharmaceutical Industries over quality control issues and sub-standard manufacturing practices at their Indian sites. The cumulative impact of these developments has fostered negative sentiment around Indian generic pharmaceutical stocks, and we expect that over the coming quarters, there will be further downside risk to their share price.
Medium Term Outlook For Russian Market
Imports of pharmaceuticals will continue to remain elevated in the short term, underpinned by growth in real household consumption spending, but as the provision of healthcare shifts from consumer and onto the state over the medium term, we expect that reliance on imports within the Russian pharmaceutical market will decline as more and more drugmakers invest in local capacity in anticipation of further narrowing of procurement rules and a push from the state to reduce the country's dependence on imported goods.
We previously expected pharmaceutical sales to reach US$50.48bn by 2022, but we now expect sales to fall significantly short of that figure; our forecasts now expect sales of US$42.76bn. The compound annual growth rate (CAGR) in US dollar terms has been revised down considerably in the medium term; whereas previously we expected a five year CAGR of 9.4% in US dollar terms, we now forecast the market to deliver a five-year CAGR of 6.6% to US$33.38bn in 2018.
The Russian pharmaceutical market posted sales of RUB766bn (US$24.30bn) in 2013, growing 11.0% year over year in rouble terms and 9.3% in US dollar terms. Over the next five years, we expect the market to achieve a compound annual growth rate of 9.1% in local currency terms and 6.2% in US dollar terms to a value of RUB1.19trn (US$32.86bn) in 2018.
Shifting Macroeconomic Fundamentals Impact Long Term Outlook
Russian Pharmaceutical Sales, US$bn
- See more at: http://www.businessmonitor.com/news-and-views/crimean-dispute-poses-risk-to-indian-generic-drug-companies#sthash.VCDuLi2E.dpuf