Akorn, Inc. Announces FDA Approval For Hydromorphone Hydrochloride Injection 10mg/ml In 1ml, 5ml And 50ml Doses

Akorn, Inc. Announces FDA Approval For Hydromorphone Hydrochloride Injection 10mg/ml In 1ml, 5ml And 50ml Doses
Akorn, Inc. (NASDAQ: AKRX) a niche generic pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of Dilaudid-HP® 10mg/ml Injection. The company intends to begin shipping the product next month. In addition, the Company has commenced the manufacturing of Vancomycin …

Read more on Medical News Today

Current Trends in Monoclonal Antibody Development and Manufacturing

Product Description

Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade.

Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Current Trends in Monoclonal Antibody Development and Manufacturing

Buy Or Sell Biotechnology

The tidal wave of changes driven by initiatives from the Obama administration and Congress is causing investors to abandon well thought out strategies. On Thursday, February 26, 2009, the Obama administration released more details of their 2010 budget proposal calling for access to cheaper generic versions of biotechnology drugs as a way to pay for an overhaul of healthcare. Investors reacted to the news by aggressively selling the biotechnology sector, with the S&P SPDR Biotechnology ETF (XBI) falling $5.07 from $51.35 to $46.28 in two days. Is this a sign of further weakness in the sector, or is it a buying opportunity for the biotechnology firms and the generic firms?

Budget Statements and Intentions

President Obama’s 2010 budget seeks to accelerate the development of lower cost generic versions of biotechnology drugs by establishing a new regulatory pathway at the Food and Drug Administration. To speed development of generic drugs, the administration’s budget requests $20 million in 2013 to create this pathway for FDA approval of generic versions of biologic drugs, which are made from living organisms. This plan, which must be passed by Congress, has key Democratic support. The budget document estimates that $9.2 billion over 10 years could be saved, helping to pay for expanded insurance coverage and improved care.

Henry Waxman, House Energy and Commerce Committee Chairman, said legislation to allow FDA approval of generic biologics “is one of my highest priorities this year.” Biologic drugs are more difficult to reproduce than traditional pharmaceuticals. Biologic drugs can cost patients tens of thousands of dollars a year.

Obama’s budget seems to back a period “consistent with the principles in the Hatch-Waxman law” for chemical-based drugs. That law provides five years of exclusivity for new medicines, and three years for new formulations of existing drugs, according to Kathleen Jaeger, president of the Generic Pharmaceutical Association, a trade group. There are mentions in the budget proposal that the exclusive period should be seven years.

The biotechnology industry has been pushing for 14 years of exclusivity, indicating that is the time they need to help them recover the investment necessary to develop, test and produce the medicine. According to Jim Greenwood, president of the Biotechnology Industry Organization, the projected savings in Obama’s plan appear to be based on Congressional Budget Office calculations that were related to a Senate bill with 12 years of exclusivity.

Another part of Obama’s plan prohibits biotech firms from “evergreening” drugs to protect them from competition for extended periods. Ever-greening adjusts the dosage or formulation to extend the patent protection. In addition, they are seeking to prevent drug companies from blocking generic drugs with anti-competitive agreements to keep the cheaper generics off the market.

Getting such legislation passed by the House will be relatively easy. However, the Senate will be more difficult, as the Democrats do not have sufficient votes to override a filibuster. Most likely, there will be some sort of compromise that will preserve much of the exclusivity sought by the biotechnology companies in return for not fighting other initiatives such as ever-greening and blocking generic firms from developing their version of the drugs as the patent expires. Moreover, the request to fund the pathway is 2013, four years away.

According to Mark McCellan, a former Food and Drug Administration commissioner, now with the Brookings Institution, the proposal sets an important starting point; however, there will be proposals for longer exclusivity leading to a negotiated settlement in Congress.

Implications for Generic Drug Manufacturers

According to the Congressional Budget Office, letting generic drug companies manufacture their own versions of medicines produced by biotechnology companies like Genentech Inc. and Amgen Inc. could save $25 billion in the first decade they’re on the market. Moreover, the legal pathway opens up the market to generic firms such as Teva Pharmaceuticals Ltd (TEVA), Watson Pharmaceuticals (WPI) and Mylan Inc. (MYL). Generic versions of biologics would be prohibited for periods “consistent with” current limits. This will create additional opportunities for generic drug manufacturers to expand their market.

Manufacturing biologics, which are living proteins, is more difficult and costs more than molecular based drugs. It also requires new manufacturing facilities to be constructed, leading to additional investment by any generic drug manufacturers that wish to produce their own biologics. Instead of building their own facilities, these firms might acquire one or more firms that already have approved biologics manufacturing capability. In any case, the generic drug companies must invest substantial amount of money to be able to manufacture biologics properly.

Should the pathway to FDA approval for generic biologics be passed and begin operation on or after 2013, it will create new opportunities for the generic drug companies. However, this opportunity is four years away, so a lot can happen in the mean time. Investing in generic drug stocks, hoping that they will benefit from the move to generic biologics is a risky venture. The smarter play is to wait to see what happens in the Congress and the market before making a commitment. This does not mean the generic drug companies are not a good investment for other reasons.

Implications for Biotech Sector

The proposal to provide a pathway to the FDA for approval of generic versions of biologics will have a big impact on biotech companies like Amgen, Genentech and Gilead Sciences, as well as traditional drug makers like Merck that have said they want to get into biotech.

According to most analysts, the production of approved biologics is years away. First, the pathway is four years away, at least. Second, the generic firms must request approval to manufacture the drug, showing they know how to handle a living protein, which requires careful handling and a large investment. As a result, the threat from generic biologics is years away.

In addition, the pathway proposal will go through the legislative process where it is likely to face some compromise. Many of the biotech firms are located in democratic districts, so the passage of a law that meets everything the generic firms want is not a sure thing.

On Friday February 27, 2009 Deutsche Bank’s biotech sector analyst, Mark Schoenebaum sent out a message to his clients titled:  “Mean 2010 Biotech PE Is Now Under 15x !!” The implication is the biotech sector is still a good place to invest and we should not panic. Rather, the sell off represents an opportunity to buy shares at a discount.

James Thomas co-founder of venture firm Thomas, McNerney & Partners believes that the drug industry should gain from health care reform even if there are pressures to lower prices. Drug prices have very high gross margins. Growth for biotech companies is driven more by the number of units sold then by price. Expanding health coverage will boost sales, offsetting price reductions.

The Bottom Line

The recent sell off in the biotechnology sector is an opportunity to buy into the sector rather than a signal to sell. First, the competitive impact of generic biologics is years away. Second, Congress must pass legislation to give the FDA the faster process for generic firms to produce biologic drugs. Like most legislation, there will be a compromise that is different from what was proposed. Of course, there can be no guarantee that the results will be a positive for biotechnology firms.

Third, the sell off is bringing down the share prices on all the biotechnology firms to historically low levels. The good firms are growing revenues at 30% or more, while their PE ratios are falling to 15. The threat from the pathway to the FDA is four years away. In addition, many biotechnology firms based in the U.S. receive half of their revenue from foreign sources, not subject to the U.S. generic pathway threat. For example, Gilead’s foreign sales are 42% of antiviral sales, growing at 45%. The company’s U.S. sales are 58% of antiviral sales, growing at 30%. Moreover generic drug companies will offer significant investing opportunities as they increase their sales.

The risk to the biotechnology industry is now higher. With higher risk comes the possibility of higher rewards. Look to buy on dips in the price of quality companies in the sector as well as the sector’s ETFs. Use proven risk management techniques to lower the down side risk. Capture profits by selling half of the position on any run up in the share price and protecting the rest from any loss.

 

Engineered Food and the Fda

To get bioengineered medicines, grains, vegetables, and animals on the market for human consumption, U.S. biotech companies must pass their products through the Food and Drug Administration (FDA).

Recently, the FDA has been in the news because its Prescription Drug User Fee Act of 1992, which forces drug companies to pay in to expedite drug approval, came up for renewal. That same year, the FDA rejected mandatory labeling of genetically modified organism (GMO) products. How might the FDA affect the future of bioengineered food?

The User Fee Act has, in Harvard professor Jerry Avorn’s opinion, “pretty much transformed the FDA. The sense now is we report to the industry; they pay our salaries; we had better be quick on these approvals.”

Some biotech products will zoom through the FDA because they are advances in medical treatment, and, of course, we all want the sick to get the best new therapies. The problem is that the FDA is underfunded, so most resources are dedicated to medical advances. Thus, according to David Kessler of the FDA, “other parts of the agency—post-market surveillance, food safety, the field resources—those areas of the agency suffer.”

In addition, the FDA is essentially rubber-stamping the tests performed by each company that has developed a product, and since they’re bogged down in analysis of drug tests, they hardly ever follow up on the market to see if bioengineered products are having a negative impact on consumers. One publicized mishap in 2000 resulted in traces of StarLink Bt10 corn, meant only for industrial purposes, cross-pollinating with conventional corn and winding up in taco shells. We know the FDA isn’t catching problems like this one–and that, as yet, consuming products deemed marginally unsafe won’t cause an epidemic—but eventually the biotech industry may get consumer backlash for causing a serious problem that could have been avoided if the budget were expanded.

I should probably note that the U.S. Department of Agriculture (USDA) oversaw the restrictions on this brand of corn, and the Department of Health and Human Services, of which the FDA is a part, only posts notices for products consumed by humans—so there’s a further complication for biologically engineered products. They may be subject to these two departments as well as the Environmental Protection Agency, and this structural weakness probably doesn’t make for excellent communication.

One could argue that GMO labeling is only a minor issue in the U.S. and that the average citizen isn’t too concerned about the provenance of his or her food. There are at least two problems with this attitude. The first is that U.S. exports will be increasingly suspect to foreign markets, particularly the EU, which require labeling and stringent testing. The second is that any misstep, such as a genetically engineered product that results in widespread sickness, will create distrust of the FDA and bioengineering in general.

Europe’s vigorous standards regarding approval, track-back, and isolation for GMO crops may be driving North America out of the market. Agricultural specialists like Dan McGuire are questioning if GMO crops are really to their economic advantage.

“I can’t recall any foreign or domestic corn customer ever requesting that U.S. farmers start planting and supplying genetically engineered corn. So the introduction of GMOs was not a response to importers or consumers requesting such a change. Indeed, it’s a direct result of biotech companies introducing those products into the domestic and foreign market without market research on consumer acceptance. Indeed, the first I heard about GMOs was from European importers,” said McGuire.

Leaders in the biotechnology industry need to be activists for their products—labeling their products will bring them one step closer to informing the public and leading us into discussions of benefits like cheaper crop production and less pesticide runoff.

The Handbook of Microbiological Media for the Examination of Food

Product Description
Responding to an estimated 14 million cases of food-borne disease that occur every year in the United States alone, the Food and Drug Administration and US Department of Agriculture have begun implementing new regulations and guidance for the microbial testing of foods. Similarly, Europe and other regions are implementing stricter oversight, as foodborne pathogens that cause deadly diseases such as e. coli 0157:H7 have raised the stakes everywhere. Food safety scientists have acted on this growing public health risk by developing improved media for the cultivation of bacteria, fungi, and viruses, much of it geared toward specific rapid detection.

Reflecting the development of these new media and the latest FDA recommendations, the second edition of the Handbook of Microbiological Media for the Examination of Foodprovides an essential resource for anyone involved with the monitoring of both food production and post-production quality control.

Organized alphabetically by medium, the expanded edition of this highly respected handbookincludes –

·         Descriptions of nearly 1,400 media including those recommended by the FDA, as well as media used elsewhere in the world

·         Concise and lucid instructions for the preparation and uses of each of the media

·         Cross-referenced indexing that allows the media to be found by name or specific microorganism of interest

·         Descriptions of expected results as they apply to microorganisms of importance for the examination of foods

·         Common synonyms for the various media and listings of compositions, so that alternate media an be effectively employed when needed

Compiled by Ronald M. Atlas, a world-renowned researcher and author known for his pioneering work in pathogen detection, the Handbook of Microbiological Media for the Examination of Food, Second Edition, provides microbiologists with an essential tool for safeguarding public health.

The Handbook of Microbiological Media for the Examination of Food

« Previous Page