The Big Red Biotech Blog

EMA Still Not Supporting Biosimilar Interchangeability

Many health experts insist that biosimilars will not truly hit their upside potential until they achieve interchangeability status with the innovator product they are intended to mimic. The post below from the BioProcess Blog indicates that the EMA is still not supporting interchangeability as is contemplates its new guidelines for biosimilars.

EMA Still Not Supporting Biosimilar Interchangeability.

In the post, the EMA is lauded for updating its thinking and proposed guidelines on biosimilars from its 2005 regulations -- particularly its recognition of the importance of defining reliable PK/PD markers for biosimilarity in non-clnical studies, plus the possibility of using non-inferiority as an end-point for clinical trials. 

Non-inferiority should allos for faster, smaller and less expensive clnical trials, but will also likely make it harder to establish interchangeability. The current guidelines and proposed revisions do not address what it will take to establish interchangeability accordign to blog authors. The conclude that neither the EMA nor the FDA will likely establish a menaingful path to interchangeability in the forseeable future.  Thus, biosimilars will not achieve their peak market penetration and ultimate sales potential that could be predicted with interchangeability.

 

 

 

Posted by Bruce Lehr Oct 31st 2011.

The 2011 Biotech Graveyard

 

 

 

 

Fierce Biotech published its 3rd annual recount of the Biotech Graveyard.  In 2011, we lost another 8 companies to the vaguaries of drug discovery and financing in the biotech world. The companies who met their demise are as follows:

• Advanced Life Sciences
• Altair Therapeutics
• Ambrilla Biopharma
• ARYx Therapeutics
• Peptimmune
• Phoenomix Corporation
• Tolerx
• Transdel

Many of these were effectively one-trick ponies whose drugs failed to show efficacy in the clinic.  In many cases, the companies also lost the backing of a big pharma partner to continue paying the bills required to bring a therapy fully to market. Of course, the capital markets don't offer an alternative source of funding to companies of this ilk at this juncture.  Result?  Liquidation of assets if any.

Posted by Bruce Lehr Oct 31st 2011.

New Hope for Neglected Diseases

Here's an interesting post from the PharmTech Talk blog, speaking about a new UN initiative called WIPO Re:Search.  Is a forum for public and private organizations to share IP to help develop new drugs and vaccines to treat neglected tropical diseases, malaria and tuberculosis.  Sharing occurs through a public access database.

The National Institutes of Health as well as pharma companies like AstraZeneca, Eisai, GSK, Novartis, Pfizer and Sanofi have agreed to work with the group.

PharmTech Talk » New Hope for Neglected Diseases.

WIPO Re:Search members agree to license IP to researchers royalty-free in many, but not all, cases.  Royalty-free licenses are really extended to the very poorest countries of the developing world and not to all countires where these diseases are prevalent. 

For example, Chagas disease affects 21 countries in the America's but only Haiti (a non-endemic site) actually gets royalty-free status. In looking at the Chagas example (transmitted by black flies), it would seem the goals of WIPO Re:Search are laudable but there still seems to be room to get the bugs out in implementation.

Posted by Bruce Lehr Oct 31st 2011

 

Pfizer Scales Back Unit Sell Off

Pfizer says it is now considering selling its animal health and nutrition businesses -- which together account for about $5.5 B of its combined $68 B corporate sales. This is a more modest approach than what Ian Read had spoken about earlier in the year.  Earlier, he had suggested that Pfizer might sell everything other than its innovative drug business in order to get back to its core offering. 

Now Pfizer says it will hang on to its established products division ($10 B in revenues) that contains its generic drug portfolio. Pfizer will also keep its consumer healthcare business ($2.7 B).  Both of these units had been previously mentioned as potential sales candidates.

In the meantime, JP Morgan has been enlisted to sell off the animal health buiness, and Centerview and Morgan Stanley will be entrusted to deal with the nutrition business. The deals might take as much as 24 months to pull off according to company spokesmen.  Eli Lilly has been mentioned as a possible taker for animal health, and Nestle or Danone might be fits for the nutrition group. See the FT.com story.

 

 

Posted by Bruce Lehr Oct 24th 2011

Big Pharma Courting Biosimilars After All

Despite protests to the contrary, many Big Pharma (and some Big Biotechs) are pursuing biosimilars as a means to generate additional revenue -- particularly in the emerging markets.  Many had disavowed ever pursuing these markets -- symbolically likening them to ugly frogs of the drug world --  but have changed their tune as times toughened and pipelines dried up.

The IN VIVO Blog: So We're Courting Biosimilars After All -- For Market Access.

But now, the following companies (and the list is not exhaustive) have made it clear that biosimilars are important to their future commercial strategies.  The list includes: Amgen, Biogen Idec, Pfizer, Merck, Boehringer Ingelheim, and Eli Lilly to name just a few.  That is in addition to some of the traditional big players in generics field like Sandoz, Teva and Hospira.

The biosimilars field is likely to get crowded and be very competitive.  There is no reason to doubt that the leaders that emerge will be very familiar names that we all know from the innovator pharma space plus a few big genercis houses.  Both groups will begin to look much more like one another as portfolios expand and blend innovator and biosimilar (& generics) products within.

All will be courting those formerly spurned frogs in an attempts to find handsome comercial princes.

Posted by Bruce Lehr Oct 24th 2011.

Merck plans $250m Singapore manufacturing expansion

Expanding markets in Asia continue to spur investment in facilities and R&d in the region.  The latest example comes from Merck's announcment that it will spend $250 M in Singapore to expand its biotech operations, add new technology to support product launches, and collaborate with more local universities to develop its workforce.

Merck plans $250m Singapore manufacturing expansion.

The Singapore Economic Development Board (SEDB) is backing Merck's expansion as part of its goal to draw more biomanufacturing to the country.  Previously, the SEDB has been successful in getting Lonza to invest in facilities in Singapore (one of which was later purchased by Roche).

"We are encouraged that this will pave the way for Singapore to continue to enhance our capabilities as an integrated global pharmaceutical site in Asia", said Beth Swan Gin, managing director of SEDB.

Posted by Bruce Lehr Oct 24th 2011.

Amgen Rethinks R&D Like Big Pharma Brethren

The news is out that Amgen is rethinking its R&D structure.  A statement by the company says it is evaluating ways to "improve focus and re-allocate resources to key pipeline assets and activities."  Meaning? It is likely going to cut R&D jobs at its Seattle, South San Francisco and Cambridge, MA sites.  The formal plan will likely be unveiled at its Q3 earnings call on October 24th.  

The Disconnect Continues: Amgen Rethinks R&D // Pharmalot.

This appears to be just th elatest evolution of the company from its biotech roots to becoming more and more like a Big Pharma player.  Analysts note that Amgen spent nearly 19% ($2.9 B) of its $15.1 B in revenues last year on R&D.  They and investors feel their is room for Amgen to spend less and pass some of the cash down to investors.  We'll see how that plays.  About 4 years ago the company eliminated more than 2000 jobs but here we are again in 2011. See Xconomy and Fierce Biotech.

 

Posted by Bruce Lehr Oct 13th 2011.

Bayer Latest Company to Move on Russia

Bayer is the latest member of Big Pharma to move to Russia -- receiving $860 M in economic development aid to support domestic development and production of therapeutics.  Bayer will partner with the locally owned Yunona Holdings.

Russian officials have indicated unhappiness with the fact that the country has to import 80% of its therapeutics. And as a result they're giving preferential treatment to the companies that do more development and manufacturing work inside Russia.  The country also has been attracting a number of biotechs avid to tap into the lower-cost clinical studies that can be pulled off there. 

This is just the latest example of Big Pharma investing in emerging markets to spur top line growth in an effort to replace revenues lost through patent attrition.  In the case of Russia, government policy has been very forceful in demonstrating that you NEED to have a local presence if you want to play in their Market.

Posted by Bruce Lehr Oct 12th 2011.

FDA Positive Approval Record on Orphan Drug Reviews

A new study by the National Organization for Rare Disorders (NORD) shows that the FDA demonstrated flexibility in reviewing and approving 90 orphan drugs in a 135 drug cohort between 1983 and 2010.

“This review of FDA actions concludes that two of every three orphan drugs approved show FDA’s historic flexibility in its review of effectiveness data on orphan drug therapies,” Frank Sasinowski, the NORD chairman.

FDA Reviews, Orphan Drugs And Misconceptions // Pharmalot.

The study also notes that the FDA can demonstrate its flexibility in a number of ways, most notably by regulators' willingness to accept a far more limited set of clinical trial data for an orphan drug, including instances where a single trial was enough to warrant an approval. In 58 cases regulators were willing to customize the approval process to the therapy.

He adds that the FDA should memorialize its approach to provide greater certainty. “It would be helpful for such flexibility and importance to be recognized in a formal FDA policy, and for FDA officials to incorporate and recognize that flexibility in a systematic way in their evaluations of each new therapy in development and under FDA review for Americans with any rare disease,” he says.

Interestingly, orphan drugs already seem to have greater odds of winning FDA approval according to a 2010 study by the Tufts Center for the Study of Drug Development.  Sponsors engaged in clinical development between 2000 and 2009 funded through orphan grants reported that 22 percent of their programs led to approvals, compared to a clinical approval success rate of 16 percent among other drug developers.

Further, orphan drugs have faster development time lines, lower R&D expenses, and a higher likelihood of clinical and regulatory success. Once on the market, they tend to have less competition, lower marketing costs and a longer life-cycle with less risk of generic erosion. Orphan drug products are also generally more innovative than non-orphan drugs as evidenced by a high number of new molecular entities.

The study seems to show their are plenty of reasons for drug companies to now pursue more orphan indications.  In fact, several major players -- among them GSK, Pfizer, Merck and Novartis -- have announced orphan programs at least partially based on historic successes realized by comapnies like Genzyme and Shire. See Fierce Biotech.

Posted by Bruce Lehr Oct 12th 2011.  

India - No Cap on Foreign Drug Company Investment

India's policy makers had been contemplating putting a cap of 49% on foreign drug maker's ability to buy Indian drug companies, but decided not to go that route.  The policy discussion had been kicked off by the fact foreign companies had increased their share in India's drug market from 15% to more than 25% in the past three years.  It was feared that foreign drug makers would not have an interest in supplying affordable medicines to India's poorer citizens.

India Will Not Cap Foreign Investment In Pharma // Pharmalot.

However, a different compromise has been struck.  Foreign Investment instead of being capped will be closely scrutinized by India's Foreign Investment Promotion Board which will itself be overseen by the Competition Commission (anyway see any hints of previous British rule in this bureacracy?).  It seems terribly bureacratic to me, but all the key players seem happy from global multinationals like Pfizer to the domestic trade group Indian Pharmaceutical Alliance.

So who am I to criticize?

 

 

 

 

Posted by Bruce Lehr Oct 11th 2011.

Glaxo R&D Goes Hollywood

It's been 3 years since Glaxo reorganized its R&D department into 38 teams or drug performance units (DPUs) in an effort to boost R&D producitivity. In addition to the 38 DPUs the company also has 50 more external partnerships that primarily are responsible for drug discovery.

Glaxo R&D Chief Offers A Progess Report // Pharmalot.

In adopting this model, GSK follows four key principles: focus on the best science, re-personalize R&D, externalize R&D and focus on ROI.  In doing this, GSK has reduced its R&D bugdet from $5 B to about $4.4 B, shifted its internal discovery efforts from 60% down to 38% and boosted its internal development efforts to 62% up from 40%.  It is now targeting an ROI on R&D of 14%. 

Now, GSK is at the beginning of a new 3 year cycle and its time to evaluate the success of the DPUs to see if they get an extension or not.  In the meantime, GSK's R&D Chief, Moncef Slaoui, says he's learned from Hollywood -- rely less on your own studio for hits.  See Fierce Biotech.

Posted by Bruce Lehr Oct 11th 2011.

iBio produces Rituximab in plants

iBio successfully expanded the use of its technology to biosimilar mAbs by producing rituximab in non-transgenic green plants, thereby expanding its use beyond production of viral antigens for vaccines.

"The production of functional rituximab in plants suggests that many if not all mAbs can be produced using the iBioLaunch system," says Terence Ryan, senior vice president. 

iBio says that the rituximab produced in plants underwent a number of preclinical tests to evaluate efficacy.  The plant-derived treatment showed similar target cell cytotoxicity and antigen recognition to rituximab produced in mammalian cells.  No word if the products were compared under similar guidelines used by the EMEA to judge a biosimilar versus the approved reference product -- or not.

Rituximab success paves way for plant produced mAbs.

That's it.  Run get your gardening gloves and shovel.  Order some mulch and fertilizer.  Cell culture is DEAD!  Or perhaps word of its death is greatly exaggerated.

 

 

Posted by Bruce Lehr Oct 10th 2011.

Sanofi Bets on Vaccines in India

According to Chris Viehbacher, CEO Sanofi, India is the place to be for Sanofi to capture 40% of its sales from emerging markets by 2015 -- as compared to only 29% now. Thus, Sanofi acquired Shantha Biotech for 550 M euros in 2009, and plans to invest another 220 M euros in a new Hyderabad vaccine facility.  The facility -- touted to be Asia's largest -- is slated to open its doors by March 2012.

Sanofi is targeting vaccines as one of its 6 key initiatives to help replace the 1/3 of its sales and 50% of its profits that it will be losing through patent expirations.  One of the other key initiatives is to grow fast in the emerging markets. So building a new vaccine plant in India couples growth plans between vaccines and emerging markets.  See European Biotechnology News.

 

 

 

 

Posted by Bruce Lehr Oct 10th 2011.

FDA Pledges to Speed Up New Drug Regulatory Process

You've heard it. The FDA is slowing down the introduction of new drugs through an overly cumbersome regulatory process -- or so charge the critics. 

In a most recent example, the New Venture Capital Association cited a new survey that indicated that 39% of its members had decreased investment in the life sciences.  Another 39% of VC groups plan to do so over the next few years which could result in a decrease of more than $500 M in venture capital aimed at biotech.    The decrease they say is due to the unpredictability of the FDA regulatory approval process -- that results in delays and cost increases to the introduction of new drugs and lessens the ROI that can be achieved by VC groups. One third of the VCs surveyed say they will increase their investments in Europe, with 44% planning to spread their wings in Asia and only 13% planning to get more ambitious in North America. 

In response, the FDA pledges to speed up the process -- particularly for new drugs targeted at serious unmet needs.  Thes drugs will receive an "expedited drug development path".  The new path will be overseen by a new deputy commissioner who will govern the regulatory process for biologics and cell based medicines. Personalized medicines will receive top priority under the new plan.

"The Obama Administration is committed to encouraging the entrepreneurs and businesses that are hmodernizing and strengthening our health care system," said HHS Secretary Kathleen Sebelius.

 

 

 

 

Posted by Bruce Lehr Oct 8th 2011.

Contract Research Organizations Are Hot Hot Hot!

Two private equity firms paid $3.9 billion in cash for Pharmaceutical Product Development -- a CRO.  Why?  A recent RW Baird survey of 388 drugmakers and biotechs sheds some light on the matter. Namely, prices at CROs rose by 42% in Qtr2 (up from 33% in Qtr1).  This coupled with an expected increase of 3.6 to 8 percent in R&D budgets among drugmakers and biotechs makes the area look attractive.

Why Contract Research Organizations Are Hot // Pharmalot.

CRO clients report that their R&D budgets for outsourcing will go up on average by 9% again projecting good growth potential for the sector. CROs in fact have seen their share of market projects rise from 35% to 38% in 2011. The folks at RW Baird project over the very long term this might rise as high as 60 to 80 percent.

Further, "The vast majority of internal pharma staff surveyed believe that they are spending the same, or more, per unit of outsourced work today than in the recent past," writes RW Baird analyst, Eric Coldwell.

Thus the influx of private investors to a perceived market opportunity with the added bonus of NOT having to report quarterly earnings as seen in the public sector.

 

Posted by Bruce Lehr Oct 4th 2011