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TOPIC: Good article to keep the hope alive

Good article to keep the hope alive 10 Jun 2013 11:28 #538

  • joeycav11
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Some talk of Japenese partnering also...
Jun 10, 2013 (ACCESSWIRE via COMTEX) -- Shinzo Abe assuming the role of Prime Minister of Japan last December has provided a boon for Japanese biotechnology stocks, with half of the top 10 movers on JASDAQ in 2013 coming from that sector. Helping fuel biotechs has been a commitment from the Japanese government to provide 110 billion yen ($1.17 billion) in cash for the regenerative medicine industry over the next decade. Japan's own version of quantitative easing now includes 7 trillion yen ($68 billion) in debt buying, bringing buyers into speculative plays like biotechnology stocks as well. Further, Abe's Cabinet in May adopted bills focused on promoting regenerative medicine technologies as the nation looks to establish itself as a world leader in the space.

Abe's vow to reform the Pharmaceutical Affairs Law to encourage biotech R&D, including stem cells, will be monitored closely by investors as the Health Ministry is expected to submit an amendment for the law to Parliament on June 27.

Once regarded as a nation lagging in biotechnology, there is a major effort to reverse this by changing regulations to expedite new drug development and putting its pricing system under review that could lead to far greater compensation for drug developers than current standards.

Ira Wolf, Japan representative of the Pharmaceutical Research and Manufacturers of America, told The Economist in February, "For foreign [drug] companies, it's the best market in the world right now."

Japan's initiatives dovetail nicely with efforts in the United States to support the development of new therapies that can potential deliver a vast improvement over existing therapies. Last July, the "Food and Drug Administration Safety and Innovation Act" went into effect, adding a "breakthrough therapy" designation as a high-priority complement to other FDA programs meant to hasten the pace of development for new therapies that address areas of great unmet medical need. So far, 13 new "breakthrough therapy" designation have come from the FDA.

The FDA is apparently making good on its promise to shepherd drug candidates along more expeditiously. Peter Lebowitz, Global Oncology Therapeutic Area Head and Johnson & Johnson's /quotes/zigman/230812/quotes/nls/jnj JNJ +0.85% Janssen, told the Wall Street Journal this week that they have been able to get very quick meetings with the FDA regarding their cancer drug candidate ibrutinib in development with Pharmacyclics /quotes/zigman/53242/quotes/nls/pcyc PCYC +0.40% that has been ruled a breakthrough therapy for three different indications. Lebowitz said that he expects the designation to have a "big impact" on the pace of advancing ibrutinib.

Shares of Pharmacyclics, a company with no FDA approved drugs and a $6 billion market capitalization, climbed from about $70 to $96 in about three weeks after receiving their first FDA breakthrough designations in February.

Investors are not ignoring the potential future revenue that can come relatively quickly through initiatives by regulatory agencies to accelerate the development of treatments that can address serious and life threatening conditions. In fact, they appear to be staring firmly at the potential, particularly in Japan, where many biotechs are delivering robust gains in 2013, including companies like Japan Tissue Engineering Co., which has risen about 900 percent since receiving approval for insurance reimbursement from Japan's Health Ministry.

Leaders in the Japanese drug business have been expanding quickly to stay competitive. For example, Takeda Pharmaceuticals has made seven acquisitions in the past two years, including spending $14 billion to buy Switzerland-based Nycomed.

It is foreseeable that many U.S.-listed companies can greatly benefit from the recent changes in Japan and potentially even more from reformation of the Pharmaceutical Affairs Law. Changes in Japanese laws will likely support acceleration in acquisition and partnering activities between Japanese and U.S. companies. Such activity would meet the needs of companies on both sides of the ocean, with the Japanese firms leapfrogging ahead in the development process, and the U.S. firm benefiting by potentially shaving years off time to commercialization and establishing the ability to rapidly penetrate a significant market.

Abe seems to have a particular affinity for regenerative medicine, including technologies such as induced pluripotent stem cells, which could increase interest that is brewing around Cellular Dynamics International Inc., a Wisconsin-based stem cell firm that has recently filed a registration statement aiming to raise about $57 million in an initial public offering to begin trading on the Nasdaq exchange under the ticker ICEL. Cellular Dynamics has pioneered a technique to create induced pluripotent stem cells from blood samples. Branded "iCell," the technology is used for evaluating genetic variations to understand diseases and for pre-clinical drug research, toxicity testing and more. The company also has other products on the market employing induced pluripotent stem cells in the cell banking business and research applications.

On the front of making strides for an indication that has been challenging, StemCells, Inc. /quotes/zigman/5728491/quotes/nls/stem STEM -0.55% may receive a warm embrace in Japan with its advancements in spinal cord injury. StemCells is currently in the midst of a Phase 1/2 clinical trial in Zurich, Switzerland evaluating the safety and preliminary efficacy of its HuCNS-SC product candidate (purified human neural stem cells) as a new therapy for chronic spinal cord damage.

The company is only four patients into the trial (scheduled for 12 patients total) that is addressing some of the most serious spinal cord injuries with three of the first four patients classified as AIS A with no neurological function below the level of injury. Two of the first three patients showed improvement in sensory function one year after transplantation of the HuCNS-SC cells, a promising sign for the therapy. Optimistic news was delivered this week as Health Canada authorized StemCells to expand its clinical trial into Canada, which should lend to enrollment and data collection as the trials advance.

Other leaders in the regenerative medicine sector could see an impact as well, especially those that are well positioned to address the biggest areas of unmet medical need in Japan. One such company could be Athersys, Inc. /quotes/zigman/107852/quotes/nls/athx ATHX 0.00% , which has an ongoing Phase 2 clinical trial in treating ischemic stroke, which represents a leading cause of death and disability in Japan, and also a multi-billion dollar market opportunity.

The Athersys pipeline is built around MultiStem, an allogeneic stem cell product that is currently being evaluated in several clinical trials, including Inflammatory Bowel Disease (IBD), heart disease, stroke and other indications. The Phase 2 trial of MultiStem for ulcerative colitis, the most common form of Inflammatory Bowel Disease, is being conducted through a partnership with Pfizer, Inc. /quotes/zigman/238207/quotes/nls/pfe PFE +0.46% , which entered into a partnership with Athersys in late 2009 specifically for IBD, but has no other rights. Per the agreement with Pfizer, Athersys is entitled to milestone payments of up to $105 million upon successful achievement of development, regulatory and commercialization milestones, as well as royalties or profit sharing on approved drugs. This relationship might also provide an eventual gateway to Japan, as Pfizer operates four main sites through its Pfizer Japan segment. Additionally, Pfizer has a long-standing relationship with Takeda in Japan. Alternatively, Athersys might elect to partner with another Japanese company around a potential blockbuster indication like stroke, or perhaps other indications it is pursuing.

Learn more and sign up to follow Athersys here:
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Good article to keep the hope alive 10 Jun 2013 12:40 #539

  • rothco619
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(Investors are not ignoring the potential future revenue that can come relatively quickly through initiatives by regulatory agencies to accelerate the development of treatments that can address serious and life threatening conditions. )

Well they sure as hell have been ignoring cytori as we continue to drift to area near our 52 week low with no financing in sight. :bang:
Continues to be frustrating and difficult to remain positive with no positive news coming. seems now all is resting on Barda, which is a dangerous place to be with all eggs in one basket :puke:

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Good article to keep the hope alive 10 Jun 2013 13:32 #541

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Abe's vow to reform the Pharmaceutical Affairs Law to encourage biotech R&D, including stem cells, will be monitored closely by investors as the Health Ministry is expected to submit an amendment for the law to Parliament on June 27

.

If that means the law could get through in this legislation period (ending June) than that is excellent news.
Certainly in view of what Hedrick said-

What you may not know is over the last couple of years, we've been actively involved in terms of our regulatory group and clinical group in shaping these emerging regulations. So we've been on the ground floor as these have been coming through the system.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Good article to keep the hope alive 10 Jun 2013 15:20 #542

  • fatboy
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Well Fas,
All of us (shorts excluded) need some good news. With its aging population demographic and high individual wealth component I think concentrating on the Japanese market is a good strategy. I hope it pans out.

S&P Analyst Research Notes and other Company News
May 10, 2013
Cytori Therapeutics, Inc. reported unaudited consolidated earnings results for the
first quarter ended March 31, 2013. For the quarter, the company reported
product revenues of $1.4 million against $1.5 million a year ago. Operating loss
was $6.7 million against $8.4 million a year ago. Net loss was $7.7 million, or $0.11
per basic and diluted share, for the first quarter of 2013 compared to $9.3 million,
or $0.16 per basic and diluted share, in the first quarter of 2012. Net cash used in
operating activities was $9.3 million against $7.7 million a year ago. Purchases of
property and equipment were $0.08 million against $0.03 million a year ago.
Combining product and government contract revenues in the first quarter of 2013
were $1.9 million, compared to $1.4 million in the first quarter of 2012. Government
contract revenues were $0.5 million in the first quarter of 2013 related mostly
entirely to work performed under the BARDA contract, but which there were no
comparable revenues recognized in the first quarter of 2012. Gross margins are
expected to increase substantially in the second half of 2013 as increased second
half revenues are realized. The company expects a more significant growth in the
second half of the year. The company is guiding to revenue of $15 million in 2013,
which is comprised of approximately $12 million in product revenue and $3 million
from services provided under the BARDA contract. Product revenue will be
weighted towards the second half of 2013 and will come from a combination of
sources. The growth in product sales in 2013 will come predominantly as a result
of the Japan Class 1 clearance received September last year, recent addition of
new geographic territories in Europe, the expansion of its solution CE Mark for
additional indications including tissue ischemia and intravascular delivery of
Cytori cell therapy derived from the Celution System. The company continues to
anticipate that the majority of 2013 product sales will come from Japan, which is
consistent with historical trends.

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