Antibody Engineering Poster: Development and Characterization of CEP-37248: Potent IL-12/23 antagonism via novel mode of receptor inhibition

Leading up to the Antibody Engineering Event, we'll be sharing the posters that will be featured in the Exhibit Hall.  Antibody Engineering & Therapeutics will take place December 8-12, 2013 in Huntington Beach, California.  For more information the program, download the agenda.  If you'd like to join us, as a reader of this blog, when you register to join us and mention code XD13172BLOGJP, you'll save 20% off the standard rate!

Featured Poster:  Development and Characterization of CEP-37248: Potent IL-12/23 antagonism via novel mode of receptor inhibition

Featured Presenter: Adam Clarke, Teva Pharmaceuticals

About the Poster: Antibodies against the p40 subunit of IL-12 and IL-23 have proven efficacious for the treatment of psoriasis, which is considered a largely IL-23-driven disease. However, in Crohn’s Disease, considered to have a major IL-12-driven component in addition to the role of IL-23, clinical efficacy has been less compelling. There is scope for more effective therapy through the development of therapeutics that more completely inhibit both IL-12 and IL-23. This presentation covers the development of CEP-37248, an anti–IL12/23 p40 monoclonal antibody that strongly antagonizes both IL-12 and IL-23. CEP-37248 was humanized and affinity matured to bind with high affinity to IL-12 and IL-23. The site on IL-12p40 to which CEP-37248 binds has been determined by X-ray crystallography and protein mutagenesis. When CEP-37248 binds to IL-12p40 it inhibits the IL-12 and IL-23 receptor-ligand complex in a novel manner, resulting in potent antagonist activity - when tested in IL-12- based cell activity assays CEP-37248 is orders of magnitude more potent then an existing anti-IL-12/23 antibody. This superior potency is also demonstrated in in vivo models. We conclude that CEP-37248 has the potential to be a more effective treatment for IL-12/23-driven autoimmune disease, warranting investigation in the clinic.

Do you have new research to share with your industry colleagues? Your poster can be featured in the Antibody Engineering Exhibit hall as well! Find out how here.  The deadline for poster submissions is November 1.

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Last Chance to Register for IIR's 14th Annual Business of Biosimilars

Finally, it's almost here! IIR's 14th Annual Business of Biosimilars takes place next week, October 15-17 in Boston. Just a final reminder that your last chance to register online is next Monday, October 14th. Join us at the Hyatt Regency in Boston to hear directly from AstraZeneca, Pfizer, Amgen, Teva and more!

Have you seen our latest agenda that includes one of our most exciting and exclusive opportunities - Understanding the Nuts and Bolts of Biosimilar Regulatory Strategy Workshop where you will experience intensive training to improve your Biosimilar regulatory strategy.

To learn more, download our full agenda.

As a member of the Business of Biosimilars LinkedIn Group, you’ll receive 15% off when you use code XP1886BLOG to register. Have any questions about the event? Feel free to contact Kate Devery at kdevery@iirusa.com or visit the webpage.

We hope to see you next week!

Cheers,
The Business of Biosimilars Team

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Ranbaxy announces plans for future biosimilars

Yesterday, Ranbaxy Laboratories announced it's plans to have three biosimilars on the market in India by 2015. The drugs will mainly be used to treat cancer. Their goal is to become serious competitors of Sandoz and Teva, and plan to do that by gaining biosimilars experience with approval of their biosimilars in India then expanding to the United States and Europe. They currently have one approved biosimilar on the market - a copy of Neupogen, an Amgen drug.Find out more at Reuters.

At the Business of Biosimilars and Generic Drugs this September 10-12 in Boston, Volker Schellenberger, CSO, AMUNIX will be on hand to present "Improve and Approve: Boost the Safety and Convenience of Biobetters, and Navigate the New Regulatory Environment." In this discussion, Schellenberger will look at the current pathway to biosimilar approval, which will be required for the drugs to enter the market. For more information on this year's program, download the agenda. If you'd like to join us in Boston, register today and mention code XP1786BLOG to save 10% off the standard rate.

Do you think that gaining biosimilars knowledge in India before moving into the US Market will benefit companies like Ranbaxy? Why or why not?

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DDP 2010: Annual Wall Street Address: Retrospective View Over the Past Twelve Months

Annual WALL ST ADDRESS: Retrospective View Over the Past Twelve Months: Analyze the Economy’s Affects on Pharma and Drug Delivery and Prepare with an Outlook for the Future

David Steinberg, Managing Director, Equity Research, Specialty Pharmaceuticals and Drug Delivery
Deutsche Bank


The last two years has been interesting and stressful. Things are improving, but it is not clear or not if we are out of the recession. The year is looking up. As for healthcare, in 2008, pricing environment was reasonable and robust, international Rx growth was accelerating. In those stocks, smaller and risky companies weren’t doing well.

Why were healthcare stocks failing to perform?
-Investors were in trouble.
-Credit markets effectively shut down
-Equity financing was virtually non-existent
-There was a torrent of mutual funds and hedge fund redemption
-Smaller companies bore the brunt of the carnage

In 2008 there were 0 IPOs, in 2009, there were only two. Many companies no longer had to accept financing. Over 180 companies had less than one year’s cash. Now we were looking at a situation where hundreds of companies might go bankrupt.

Rabid Consolidation is a key theme in Pharma sector. There is an unprecedented amount of activity. There were 27 mergers in 2009, 4 were drug delivery companies.

Why?
-The bigger the company is the more likely they’re not going to have a great product pipeline.
-It’s a great exit strategy for private companies.
-Purchases of closely held companies to provide liquidity to a concentrated shareholder base

Who are the buyers? Usually we see branded specialty companies, generic companies, big Pharma, and private equity.

Who are the sellers?
-Profitable companies that have competitive/sustainability/critical mass issues
-Developmental state companies with attractive late-state pipelines that require major funding to market new products/receive FDA approval for both
-Special situations – attractive product partnership economics
-The “sweet spot” – profitable companies with market values between $750 mil and $5 billion

Stock Performance –
Acusphere, Aradigm, Neopharm, Middlebrook, and many others have had very poor stock performance over the past five years.

Optimized business model (CR model, etc) – stock performance has been very high. Shire, Kos, Adams Respiratory and New River Pharma have done very well.

Live cycle extension products –
-Generic drug companies helped change the rules of the game
-Managed care has caught on the life cycle extension game

How do you outsmart generics? David advised to start with the product idea and work backwards. Also look at what your company’s product strategy is, in addition to creating an opportunity for settlement. They key is to stay ahead of generics.

Unapproved drugs? Changing FDA regulations There are numerous unapproved drugs on the market if a company does clinical trials on it FDA grants exclusivity to the company

Abbott Tricor example great life cycle strategy
Adams Mucinex example Adams pursued NDA on guaifennesin-CR FDA granted exclusivity
Naispan Kos examples Abbott acquired Kos for $3.7B in November 2006
Vyvanse New River example a single enantiomer product of adderal a long lifecycle replacement for short duration $1B ADHD Drug

Some of the key recent launched:
Vyvance – Shire
Intuniv-Shire
Lialda-Shire
Zenpep-Eurand

Favorite Specialty Pharma stocks in 2010
Large cap- Teva Pharma (Teva), Shire Shire (SHPGY)
Mid cap – Bivail (BVF)
Small Cap: MAP Pharma (MAPP), Eurand (EURX)

Modest but prolonged recession? Look at these factors for 2010:
-Financial
-Investor base
-Regulatory side
-Political side

In 2009, things were very dismal. Now, if a company is looking to borrow money, it is available. The healthcare plan still will be a great influence on how these things work. At the current moment, the stock market could go either way. Companies with strong management teams who are willing to take risks and borrow money, devise some business plans and come up with the right product, they’ll survive and be rewarded with acquisitions and high stock prices among other things.

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