Monthly Archives: March 2012

Pharmaceutical Industry Near Collapse Because It Is Stupid and Incredibly Bad at Its Business

Plug the world’s tiniest violin into the world’s largest amplifier: the pharmaceutical industry is in a state of “panic,” the New York Times reported yesterday, because…because…well, because it is hopelessly idiotic. No, really, that is why. For instance:
This year alone, because of patent expirations, the drug industry will lose control over more than 10 megamedicines whose combined annual sales have neared $50 billion.

This is a sobering reversal for an industry that just a few years ago was the world’s most profitable business sector but is now under pressure to reinvent itself and shed its dependence on blockbuster drugs.
By “reinvent itself,” the Times means “do what it was supposed to be doing all along.” This $50 billion crisis is not caused by the government unexpectedly seizing the drug formulas and giving them out for free. It is caused by the drug companies’ patents reaching their long-anticipated expiration dates.

Patents last for 20 years. Things can be a little draggy at the start, OK, but let’s be very nice to the drug companies and call it a decade. So this sudden terrible problem has been obvious and on schedule for at least 10 years.

It honestly is that simple and that stupid. The pharmaceutical industry turned all its energy toward wringing as much money as possible out of the drugs it already had, and quit making any sort of plans that would lead to having a new (and, you know: medically useful) batch of drugs under patent in the future, when the patents on the old batch expired.

Now the pharmaceutical companies are laying off tens of thousands of workers because they are worried about their financial future, because although they are officially in the business of producing and selling drugs, they stopped producing drugs. Essentially, a global industry with more than half a trillion dollars in annual revenue is acting like a college sophomore who spent all semester holed up in his dorm room smoking pot, only to suddenly realize it’s exam week and he isn’t sure what classes he was even supposed to have gone to:
Still, the industry faces intense pressure from generic competition and has tried every tactic to ward it off, including extended-release versions of the same medicine and new pills that combine two ingredients. But 75 percent of all prescriptions in the United States are now low-price, low-profit generic drugs.
Every tactic, that is, except inventing new drugs. What have the drug companies been working on, instead?
The industry has also been unsettled by the scores of fraud, bribery and kickback cases involving conduct that federal investigators contend have added billions to the nation’s drug bill….

In 2009, Pfizer paid the largest criminal fine in the nation’s history as part of a $2.3 billion settlement over marketing drugs for unapproved uses. Some analysts say larger fraud and foreign bribery cases will come. The drug companies are responding with extra-careful sales training and vows to restrain marketing zeal. But the change in corporate culture could cost them: internal documents show some of the companies have profited spectacularly from seeking federal approval of a new drug for a limited use, then marketing it far more widely off label.

Other changes….include growing restrictions on gifts, fees and trips to influence doctors to use their products; curbs on the ghost writing of medical journal articles and a push for more disclosure of negative study results. As the golden age of blockbuster drugs fades, so are some of the marketing excesses of the past two decades — the tactics that helped bring in immense profits.
“Immense profits” doesn’t quite describe it. What the drug companies were doing, in that “golden age,” was looting their 2012 revenues for the sake of 2002 revenues. When Bernard Madoff did that, people called it something else.

New CO2-based drug processing method ‘may revolutionise industry’

A new method for manufacturing drugs using highly pressurised carbon dioxide could be set to revolutionise the pharmaceutical sector.

Pressurised carbon dioxide kept at room temperature has successfully been used to create crystals in the compound processing phase of drug production by a team of scientists at the University of Missouri.

The researchers were led by Department of Chemistry professor Jerry Atwood, who believes this new method may eventually be used as an alternative to the complex and often expensive methods currently utilised in drug production.

Commenting on the findings, which are published in the Journal of the American Chemical Society, Professor Atwood noted: “I believe this could have huge implications for the pharmaceutical industry.

“In addition to streamlining processes, pressurising gas could circumvent some of the more difficult techniques used on an industrial scale, leading to better pharmaceuticals, more effective treatments and ultimately a lower price.”

Last month, a report by PricewaterhouseCoopers indicated that the UK pharmaceutical industry needs to undergo major reform to cope with modern demands.

Typical Guttridge equipment used in the pharmaceutical industry includes; Feeders – metering screw feeders – weighing systems

Drug bill is not the answer

The innovative pharmaceutical community shares the conviction that more must be done to combat disease and expand access to life saving drugs in least developed countries. However, patents are not the problem and gutting intellectual property rights as proposed in Bill C-393 is not the answer.

Former U.S. president Bill Clinton has said, “My experience has been that almost no one in the world will die this year because of the cost or the lack of availability of AIDS medicine.” Instead, the main barriers include poverty, hunger, and access to basic health care and infrastructure. Clinton should know. His Foundation’s Health Access Initiative has helped more than two million people get access the medicines needed for treatment, which represents nearly half of the people living with HIV and on treatment in developing countries.

Our industry in Canada and globally works with the Clinton Foundation and participates in more than 200 partnerships in Africa and the developing world. These partnerships not only supply drugs at low cost or no cost, but also address the root causes of disease and death in the least developed countries.

So far, these initiatives have provided health interventions for 1.75 billion people. In addition, the global innovative pharmaceutical industry invested $365 million in research and development in 2008 to combat the diseases of the developing world.

Bill C-393 not only proposes to remove the safeguards included in Canada’s Access to Medicines Regime, it also sends the wrong signal about whether Canada supports research to discover new treatments to prevent and treat diseases throughout the world.

Parliamentarians want to do the right thing. So does our industry in Canada and around the world. But we need to work together on initiatives that will actually make a difference.

Hospitals face drug shortage

Like their counterparts across the country, doctors at mid-valley hospitals are finding it harder to get some of the important drugs they need to treat their patients.

Some of the toughest to come by include those used for cancer treatment, non-oral antibiotics, some pain medications, the anticoagulant heparin, and drugs used for emergency treatments such as epinephrine.

“We are working diligently every day to ensure that we provide care to our patients and that it isn’t interrupted by drug shortages,” said Penny Reher, director of pharmacy for Samaritan Health Services.

Drugs have become more difficult to obtain for more than a year, Reher said, citing manufacturing and quality control problems that have impacted deliveries.

“Most of the shortages involve injectable products used in hospitals,” she said. “Everything that is happening on the national scene that is causing shortages is being experienced here.”

According to the U.S. Food and Drug Administration, there were a record 178 shortages in 2010, up from 157 in 2009. Federal health officials indicate about 60 of those are medically necessary drugs.

Since most shortages involve injectable drugs, outpatient and retail pharmacies aren’t experiencing the same level of problem that hospitals are having.

The shortages range from manufacturers having difficulties getting the drugs out due to toxins in medicines to incorrectly filling out safety paperwork, according to the FDA. Issues such as these have become more prominent since the federal government increased its enforcement of quality standards.

Reher said that according to the drug wholesaler for Samaritan, called McKesson, consolidation of the generic drug industry has added to the problem.

“Absolutely doctors are concerned about this but they also are very supportive and have worked with us to find solutions for the problems,” Reher said.

She said medical staff and pharmacists have been consulting regularly about medications they commonly prescribe and alternative therapies or even new plans of care that may help patients.

There is currently legislation before the federal government that would direct the FDA to address shortages by requiring manufacturers to notify the FDA about problems or when a drug product will be discontinued. It would also require the FDA to maintain an online list of drugs facing shortages.

“I believe all of us need to advocate for a solution to this problem,” Reher said.

Qualitest Receives FDA Approval for Emoquette™

Qualitest Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Emoquette™ (Desogestrel and Ethinyl Estradiol Tablets. 0.15mg/0.03mg, generic Ortho-Cept®) for the prevention of pregnancy in women who elect to use oral contraceptives for the prevention of pregnancy.

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, the business combination between Endo and Qualitest, Endo’s and Qualitest’s financial position, results of operations, market position, product development and business strategy, as well as estimates of Endo’s future total revenues, future expenses, future net income and future earnings per share. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may” “intend,” “guidance” or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors could affect the business combination of the companies, future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in this press release. These factors include, but are not limited to: the risk that the operations of Endo and Qualitest will not be integrated successfully; Endo’s ability to successfully develop, commercialize and market new products; timing and results of pre-clinical or clinical trials on new products; Endo’s and Qualitest’s ability to obtain regulatory approval of any of their respective pipeline products; competition for the business of Endo’s and Qualitest’s branded and generic products, and in connection with its acquisition of rights to intellectual property assets; market acceptance of our future products; government regulation of the pharmaceutical industry; Endo’s dependence on a small number of products; Endo’s dependence on outside manufacturers for the manufacture of a majority of its products; Endo’s dependence on third parties to supply raw materials and to provide services for certain core aspects of its business; new regulatory action or lawsuits relating to Endo’s or Qualitest’s use of narcotics in many of its core products; Endo’s and Qualitest’s exposure to product liability claims, market withdrawals and product recalls and the possibility that Endo may not be able to adequately insure itself; the successful efforts of manufacturers of branded pharmaceuticals to use litigation and legislative and regulatory efforts to limit the use of generics and certain other products; Endo’s ability to successfully implement its acquisition and in-licensing strategy; regulatory or other limits on the availability of controlled substances that constitute the active ingredients of some of its products and products in development; the availability of third-party reimbursement for our products; the outcome of any pending or future litigation or claims by third parties or the government, and the performance of indemnitors with respect to claims for which we have been indemnified; our dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion of its total revenues; a determination by a regulatory agency that Endo is engaging or has engaged in inappropriate sales or marketing activities, including promoting the “off-label” use of its products, the risk that demand for and acceptance of our products or services may be reduced; the risk of changes in governmental regulations; the impact of economic conditions; the impact of competition and pricing and other risks and uncertainties, including those detailed from time to time in Endo’s periodic reports filed with the Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion under the caption “RISK FACTORS” in our periodic and current reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Risks Associated with Veterinary Compounding Pharmacy Choices (AAEP 2010)

More than 12,000 compounding pharmacies operate in the United States, and each year compounded product sales reach $300 million–25% of that is spent in the animal pharmaceutical industry alone. The Food & Drug Administration (FDA) has developed regulations to provide assurances for safety and efficacy of drugs and devices, to ensure food supply safety, and to regulate food chain supplies and animal foods; so how do these apply to compounding? At the 2010 American Association of Equine Practitioners (AAEP) Convention, held Dec. 4-8 in Baltimore, Md., Scott Stanley, PhD, professor of Equine Analytical Chemistry at the University of California, Davis, discussed FDA’s ongoing attempts to ensure safety of drugs produced by compounding pharmacies (that provide individualized medications ordered by prescribers which are unavailable through normal means).

He described a study conducted by the FDA in which scientists analyzed 29 samples from 12 compounders. Stanley noted that 10 of the samples failed to meet the FDA standard for quality testing (which for potency is ±10% of the labeled concentration), yielding a 34% failure rate as compared to the typical 2% failure rate seen among the entire pharmaceutical industry in general. More than half of the failed samples contained less than 70% of the labeled potency.

Equine practitioners must evaluate the integrity of compounding pharmacies as well as the quality and consistency of drugs produced. Stanley remarked than many practitioners express concerns about efficacy of products that different compounding pharmacies compound, noting that just because a pharmacy prepares a product doesn’t mean that it’s efficacious–what an owner might perceive as a legitimate, reliable source of medication might not always be. In addition, veterinarians must consider the quality (potency, purity, and stability) and consistency of drugs as well as their liabilities for using that particular product.

Stanley explained that the FDA does not permit compounding, but rather uses “enforcement discretion,” meaning that if a product cannot be obtained to control a life-threatening disease process or to control suffering, then use of a compounded product is permitted.

The Animal Medicinal Drug Use Clarification Act (AMDUCA) allows manufacturing, preparation, propagation, processing, and compounding of drugs as long as a product is not already commercially available. In addition, there must be a valid veterinarian-client-patient relationship to dispense these drugs. Three categories of drugs are available for use:
FDA-approved “pioneer” drugs: These are studied through clinical trials that show efficacy, safety, and quality; it often costs $30 million to get a drug through the FDA-approval process;
Generic drugs: These are subjected to an abbreviated process for verifying efficacy–companies must demonstrate that generics are the biologic and/or chemical equivalent of a drug and must meet label claims for that product; and
Compounded drugs.

Compounding a drug is a form of adulteration, according to Stanley, since it is any manipulation of a drug formulation to produce a dosing form different from label requirements. He said that pharmacies should not provide drugs that are commercially available or those slightly altered by flavoring or by small changes in drug strength.

There is little external oversight; compounding pharmacies are mostly self-regulated. A compounded product cannot be called a generic equivalent and cannot be substituted for an available FDA-approved product. A compounder may reformulate an approved animal or human drug to change its delivery, as for example turning powder into paste, or if a formerly FDA-approved drug is no longer available. In addition, only a 72-hour supply should be kept on-hand at the pharmacy for dispensing. In every compounding case there must be a valid veterinarian-client-patient relationship. Label instructions include specific details on how it is to be used.

Before choosing a compounding pharmacy, Stanley recommends researching information about the pharmacy, asking if it is accredited by the Pharmacy Compounding Accreditation Board (PAB), if the pharmacist has obtained appropriate training, and if the pharmacy has liability insurance. He also recommends finding out if the product you’re seeking is prepared using pharmaceutical or chemical (bulk) grade materials and where these were obtained.

He noted red flags that are causes for concern, such as an overly long expiration date–by law the longest expiration date on a compounded product can only be six months. Other red flags include statements of sterility, marketing materials presenting the product as cheaper than an available FDA-approved product, or AVMA or pharmaceutical complaints that have been filed. Clients should be concerned about websites that advertise compounded drugs, particularly when medications are available without necessary prescriptions.

Stanley described omeprazole as an example of compounding issues that arise. Two FDA-approved products (Gastrogard and Ulcergard) with demonstrated efficacy and stability are available. Any compounded formulation with omeprazole is currently considered pirated since Merial still owns the use patent. The pH of omeprazole is very sensitive–pH less than 7.8 results in rapid deterioration. Compounded pirated omeprazole products showed low pH values as well as dosing inconsistencies–only one of six products met FDA potency requirements upon arrival at the test lab. Similar findings occurred with non-steroidal anti-inflammatory medications: Levels were only 68% of label-claimed potency in injectable flunixin meglumine (Banamine) and 72% potency in powdered phenylbutazone (Bute).

FDA regulations on medical devices are stringent–a medical device is defined as an external device that does not result in a chemical reaction within or on the body. There are several products FDA-approved as medical devices but used as drugs for intra-articular therapies; therefore, Stanley remarked that any injectable medical “device” is considered a drug. Should a practitioner choose to use a device as a pharmaceutical, he or she should be aware that these products have not been evaluated to determine their suitability for that usage by any regulatory agency.

Stanley also stressed that a client cannot consent to substandard care (per legal standards for medical malpractice). Clients might not understand that just because a product is formulated and prepared for resale doesn’t mean it is therapeutic to achieve desired results. Stanley also emphasized the importance of client education, including counseling the client regarding potential adverse reactions and possible efficacy failure.

He summed up the possibilities of what can go wrong in compounding:
Inadequate oversight of quality assurance and control, resulting in formulation error or drug used in an improper application;
Inadequate storage– If the potency is low (deteriorated) then the drug might not work (therapeutic failure). If the drug degrades into a toxic intermediate, the patient can become sick or die from it;
Lack of product testing;
Lack of recall procedures (if a product were to test as unsafe, sufficient structure might not exist to be able to recall the products, as there would be with an FDA-approved product);
Inadequate processing facilities regarding cleanliness (resulting in a potentially contaminated product).Improper operation and maintenance of equipment; and
Oversight by FDA and state pharmacy boards can be difficult/limited due to economic cutbacks.

Analyst upgrades Simcere Pharmaceutical Group to ‘outperform’ from ‘perform’

Simcere Pharmaceutical Group is poised to gain from a Chinese pharmaceutical market that may surpass Germany to become the world’s third largest this year, according to an Oppenheimer analyst.

Katherine Lu said in a research note Friday that the Chinese company’s focus on proprietary drugs, first-to-market generics and over-the-counter drugs has set up Simcere to benefit from China’s increased medicine use driven by health care reform. She also said the drugmaker’s net margin improvement will be a strong driver for profit growth in the next few years.

Lu upgraded the company to “outperform” from “perform” and established a 12- to 18-month price target of $15.50.

“We like (Simcere) as an attractive turnaround story, well positioned to benefit from China’s growing domestic pharmaceutical market,” the analyst said.

Decade in Review: Pharmaceutical Sector Leads Health Care M&A

According to Deal Search Online, an Irving Levin Associates M&A database, there has been a total of 1,431 pharmaceutical M&A deals, totaling $632.3 billion dollars committed to the industry during the ten-year period ended December 31, 2010. Pharma was the single most active sector of the health care industry in the decade’s health care M&A market, accounting for roughly 40 percent of all dollars spent during the decade. The high cash flow pharmaceutical companies possessed also helped drive M&A activity in the biotechnology sector. With high cash flow, big pharma also drove much of the M&A activity in the biotech sector.

The five largest pharmaceutical M&A transactions reported in 2010 are listed below.

1. Teva Pharmaceutical Industries acquired Ratiopharm for $4.97 billion

2. Biovail Corp. acquired Valeant Pharmaceuticals International for $3.86 billion

3. Abbott Laboratories acquired Piramal Healthcare Limited for $3.72 billion

4. Pfizer, Inc. acquired King Pharmaceuticals, Inc. for $3.6 billion

5. Eisai Company Inc. acquired the rights to market Lorcaserin for $1.37 billion

In the most recent year, 2010, over $38.7 billion was committed to pharmaceutical M&A, a 74 percent decrease from 2009’s decade high total of $147.2 billion. There were 127 mergers and acquisitions announced last year, a 9.3 percent decrease from 2009’s 140 deals. This marked the second lowest total in deals per year over the last decade; in 2001 just 87 pharmaceutical M&A transactions were reported. However, the data is somewhat misleading. We note that 2009’s decade-high in dollars committed was in large part due to two first quarter mega deals, which combined for $109.1 billion. Pfizer, Inc. acquired Wyeth, Inc. for $68 billion and Merck & Co., Inc. acquired Schering-Plough Corp for $41.1 billion. Therefore the drop off since last year in terms of the number of deals or dollars committed was not as significant as one might assume by simply glancing at the data.

Fuan Pharmaceutical To Issue 33.40M Shares In IPO

March 4 – Chongqing Fuan Pharmaceutical Group (300194) plans to offer 33.4 million shares in its initial public offering (IPO) on ChiNext Board, reports p5w.net, citing a company filing. Post-IPO total equity will not exceed 133.4 million shares.

The source noted that 6.63 million shares will be issued off-line, accounting for 19.85 percent of total issuance.

Fuan Pharmaceutical researches, produces and sells antibiotic raw materials.

Proceeds will go to the production of antibiotics raw materials, antibiotics preparation and product research, together costing roughly 408 million yuan.

Remaining proceeds will be used to supplement operating cash flows.