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Biotech Industry Replies |
HenryTo
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Joined: 06 Aug 2004
Posts: 11723
Location: Los Angeles, California
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 Posted: Mon Feb 13, 2012 3:51 pm Post subject: |
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Morningstar on the recent FDA guidelines on biosimilars.
| Quote: | | The Food and Drug Administration released draft guidelines for the abbreviated app roval pathway for biosimilars, or nearly equivalent versions of branded biotech drugs. Overall, the proposed guidelines, which will be finalized after a 60-day comment period, matched our expectations. The guidelines confirm our belief that the significant challenges of developing biosimilars support economic moats of biotech and big pharma companies, as well as the few generic manufacturers capable of entering the market. We don't plan to change our moat ratings or fair value estimates for the biotech and drug manufacturers under our coverage since our expectations for the developing biosimilars market have already been incorporated into our forecasts. Next to existing biosimilars guidelines at the European Medicines Agency, the FDA's guidance is comparatively vague, but the agency's approach provides for a flexible and interactive approval process for these complex drugs. While these guidelines create an abbreviated approval pathway that simplifies and reduces the req uirements to achieve biosimilar drug approval, this pathway offers scant resemblance to the abbreviated pathway for conventional generic drugs. As opposed to relatively simple synthesis for most small-molecule drugs, biologics, which are manufactured from living cells, require large development costs and complex manufacturing processes. Similarly, biosimilar manufacturers face significantly higher development, manufacturing, and regulatory hurdles than experienced with conventional generics. The FDA's guidelines suggest biosimilars will be approved through a "stepwise approach" where manufacturers consult with the agency throughout the biosimilar development process. The FDA will handle applications on a case-by-case basis, setting up predetermined "milestones" unique to each manufacturer's analytical and manufacturing capabilities. The FDA will use a "totality of the evidence" framework for approving biosimilars utilizing a basket of comparative analytical, animal, and clinical studies to ensure safety, purity, and potency requirements have been met. A manufacturer's ability to demonstrate sameness through robust analytical characterization early in the application process will then determine the size and scope of animal or human clinical trials required. The agency will allow for nonclinically meaningful differences between a biosimilar and its branded counterpart, as long as effectiveness and safety have not been compromised. However, for biosimilars to achieve the interchangeability status with the referenced biosimilar, extensive studies are likely. Although the FDA's guidelines offer some additional clarity regarding formation of the U.S. biosimilars market, we expect the complexity and financial requirements for launching biosimilars will keep industry competition minimized. The large costs associated with biosimilar development, stringent regulatory approval criteria, and unique marketing requirements to hospitals and clinics should slow market share losses while upholding pricing power and profitability for biotech companies, such as Amgen AMGN and Roche RHHBY, helping to reinforce their economic moats. Meanwhile, we expect Teva TEVA, Novartis NVS, Merck MRK, Pfizer PFE, Watson WPI (through its partnership with Amgen), Baxter BAX (through its partnership with Momenta), and Hospira HSP (through its partnership with Celltrion) will be the main competitors in the U.S. biosimilars market, bolstering economic moats for these firms. |
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HenryTo
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Location: Los Angeles, California
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rffrydr
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Joined: 30 Oct 2005
Posts: 16929
Location: Sunny California
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| Posted: Tue Jul 21, 2009 7:44 am Post subject: |
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[img]http://stockcharts.com/c-sc/sc?s=$BTK&p=W&yr=2&mn=9&dy=0&i=p72266628457&r=5986[/img]
_________________
Today is the Tomorrow you worried about Yesterday! |
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HenryTo
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Joined: 06 Aug 2004
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Location: Los Angeles, California
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| Posted: Tue Jul 14, 2009 12:20 am Post subject: |
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This piece of legislation will pave the way for the inevitable bull market in biotech stocks starting sometime in the next few years:
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US Senate panel backs 12-year biotech drug shelter
Mon Jul 13, 2009 11:57pm EDT
* Decision seen as victory for biotech drugmakers
* White House, AARP back seven-year limit
* Generic drugmakers decry decision as blow to consumers (Adds biotech industry group comment, paragraphs 10-11)
By Lisa Richwine
WASHINGTON, July 13 (Reuters) - Biotechnology medicines would be protected from cheaper rivals for 12 years under a plan that cleared a U.S. Senate committee on Monday.
The 16-7 vote in the Senate health committee was a victory for major biotech drugmakers such as Amgen Inc (AMGN.O) and Roche Holding AG (ROG.VX). Manufacturers of brand-name biotech drugs have been pushing for a period of 12 to 14 years before generic copies of their medicines can win approval.
Generic drugmakers have backed proposals limiting the exclusivity period to five or seven years.
The Senate plan could change when the healthcare bill goes to the floor for a vote. Senators also will need to work out an agreement with the House, where the issue is still being debated.
A key lawmaker, House Energy and Commerce Committee Chairman Henry Waxman, backs up to five years of protection.
Biotech medicines, or biologics, are made from living things and are more complicated to produce than traditional, chemical-based drugs. They can cost tens of thousands of dollars per year.
The drugs treat conditions ranging from anemia and rheumatoid arthritis to cancer. Examples include Roche's Herceptin and Avastin cancer treatments, and Amgen's Epogen and Aranesp anemia therapies.
Lawmakers working on an overhaul of the U.S. healthcare system are crafting plans to create a legal path for approval of cheaper copies of biotech medicines. The exclusivity period for the brand-name versions has been a key sticking point.
Brand-name companies say they need an adequate period without competition to encourage companies to develop new medicines.
"A minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of competition," said Jim Greenwood, president of the Biotechnology Industry Organization, which represents brand-name biotech drugmakers.
The Senate panel's vote "marks a significant defeat for those who would shortchange future breakthroughs and the hope for cures for some of the most devastating diseases by providing an abbreviated period of data exclusivity," Greenwood said.
The committee rejected a shorter period of seven years, the time the White House says strikes an appropriate balance between promoting innovation and providing competition. Seniors lobbying group AARP also backed seven years.
"This unprecedented action strikes a huge blow to consumers at a time when many Americans are struggling to pay for the medicines they need," Kathleen Jaeger, president of the Generic Pharmaceutical Association, said of the Senate panel's action.
Companies aiming to sell copies of biologics include generic drugmakers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O). |
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HenryTo
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Posts: 11723
Location: Los Angeles, California
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| Posted: Fri Feb 06, 2009 12:48 pm Post subject: |
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A huge breakthrough (although we have note that the Europeans already approved the drug in 2006). The era of personalized medicine will come later. For now, it is all about utilizing drugs that are chemically syntheised, resulting in more effective treatments with less side effects, etc.
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FDA OKs 1st drug from genetically altered animals
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer Ricardo Alonso-zaldivar, Associated Press Writer – 1 hr 28 mins ago
WASHINGTON – The Food and Drug Administration made history Friday as it approved the first drug made with materials from genetically engineered animals, clearing the way for a new class of medical therapies.
GTC Biotherapeutics said regulators cleared its drug ATryn, which is manufactured using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner.
The drug's approval may be the first step toward new kinds of medications made not from chemicals, but from living organisms altered by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.
The FDA cleared the drug to treat patients with a rare hereditary disorder that causes a deficiency of the protein, putting them at higher risk of deadly blood clots. The injectable treatment will be marketed in the U.S. by Deerfield, Ill.-based Ovation Pharmaceuticals
About 1 in 5,000 people don't produce enough antithrombin protein, according to Framingham, Mass.-based based GTC. As a result, their blood is more likely to stick together, occasionally causing clots that can travel to the lungs or brain, causing death. Pregnant women with the disorder are at higher risk of miscarriage or stillbirth, because of blood clots in the placenta.
Patients with hereditary anithrombin deficiency are currently prescribed conventional blood thinners, like Plavix from Bristol-Myers Squibb and Sanofi-Aventis. That will not change with the new approval. ATryn is only approved for use when patients are undergoing surgery or having a baby, times when the risk of dangerous clots is particularly high. Those patients would receive the drug by intravenous infusion for a limited time before and after their procedures.
To make the drug, scientists at GTC put DNA for the human antithrombin protein into single cell embryos of goats. Goat embryos with the gene were then inserted into the wombs of surrogate mothers who gave birth to baby goats that produce the protein-charged milk.
Genetically engineered animals are not clones but rather animals that have had their DNA changed to produce a desirable characteristic.
Amid growing questions about the technology, the FDA last month issued guidelines for how it will regulate products made from genetically altered animals.
FDA said it will not allow any such products to be sold without first submitting them to scrutiny by independent advisers at a public meeting. The agency's panel of blood product experts recently concluded ATryn was safe and effective.
But consumer groups said the FDA's long-awaited policy will not require all genetically engineered foods to be labeled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment, particularly if some escape and begin to mate with animals in nature.
The drug received European approval in 2006.
Shares of GTC Therapeutics rose 5 cents, or 5.5 percent, to 87 cents in midday trading. |
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HenryTo
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Joined: 06 Aug 2004
Posts: 11723
Location: Los Angeles, California
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| Posted: Sat Jan 17, 2009 1:04 am Post subject: |
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| Quote: | What's the Difference?
> Biotech: Employs living microbes (often E. coli or yeast) to churn out complex "large molecule" drugs that are similar to compounds that occur naturally in the human body.
> Traditional pharma: With chemical-synthesis methods, produces "small molecule" drugs from plants or other materials. The drugs don't resemble substances found in the human body. |
Article discusses Wyeth's transition from a traditional pharma company into a global biotech firm:
http://www.fastcompany.com/magazine/132/grand-experiment.html?page=0%2C0 |
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HenryTo
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Posts: 11723
Location: Los Angeles, California
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HenryTo
Site Admin
Joined: 06 Aug 2004
Posts: 11723
Location: Los Angeles, California
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| Posted: Sun Nov 23, 2008 1:03 am Post subject: |
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An update:
http://www.bloomberg.com/apps/news?pid=20601109&sid=a55.vWF5YPhA&refer=home
| Quote: | The global economic crisis has cut funding for biotechnology companies to the lowest level in a decade, triggering bankruptcies and threatening development of drugs based on biomedical breakthroughs.
In the past month, at least five biotechnology businesses have sought bankruptcy protection, according to company news releases, and others may be heading toward a similar fate. Those at highest risk have experimental compounds moving into costly human research. Peptimmune Inc., a 6-year-old closely held firm, says it’s struggling to pay for clinical trials of its promising multiple sclerosis drug.
The amount raised this year by biotechnology companies fell by $9.7 billion through September, or 54 percent, compared with the same period in 2007, according to Burrill & Co., a life sciences investment bank in San Francisco. That may mean work on dozens of potential treatments will stall or die as companies fire workers and shelve early research projects, industry executives and investors said. |
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