China's Innovative Pharma Industry: What the Latest Set of 5-year Plans means for this sector

It is China month here at Bioassociate, and in our previous post on China we covered some of the new initiatives filed in the latest set of 5-year plans aimed at making China a competitor in the originator pharma space.

One such initiative has been the direction of foreign investment towards niches which the government has deemed "innovative". Needless to mention, pharma and biotech are high priority on the list of said niches.

Another issue which the government has prioritized (for very obvious reasons) is the intellectual property protection situation in the country. Historically, China has been one of the most notorious violators in the IP space, but perhaps all of that is about to change over the next decade.

Direction of Foreign Investment

The Chinese government has specified rules on the direction of foreign investment in order to nurture certain priority sectors and to restrict investment in others. China’s foreign investment policy is outlined in the Regulations for Guiding the Direction of Foreign Investment, which essentially classifies foreign investment into one of four classes: encouraged projects, permitted projects, restricted projects and prohibited projects.

As of 2009, investment in innovative pharma falls under the category of encouraged projects, specifically the production of raw pharmaceuticals which are under patent, those which are granted administrative protection in China, and products which use new technologies. Investment in generic APIs and traditional Chinese medicines is currently restricted, in order to direct investment towards the innovative sector.

In a step to improve investment opportunities for its innovative industries, the Chinese government launched ChiNext on the Shenzhen Stock Exchange—China’s “NASDAQ”—in 2009, paying particular attention to innovative enterprises and supporting venture entities. ChiNext is expected to play a crucial role in innovation by providing an important exit alternative for many start-ups over the coming years. The independent exchange caters to the high-growth, high-tech sector, and the majority of its 354 listed companies are SMEs with a combined market value of roughly US$ 118 billion. Currently, 24 companies are listed in the Pharmaceutical Industry on the ChiNext, 9 of which were listed in the last year (see table 1).

Table 1. 24 Pharmaceutical companies listed on the ChiNext (as of Oct. 2012)

1. Ticker	Company Name	Listing Date	Market Cap. (CNY bn.)
   300006	CHONGQING LUMMY	30/10/2009	3.37
   300009	ANHUI ANKE BIOTECHNOLOGY	30/10/2009	2.37
   300016	BEILU PHARMA	30/10/2009	2.05
   300026	CHASE SUN PHARM.	30/10/2009	7.55
   300039	SHANGHAI KAIBAO	08/01/2010	6.50
   300049	INNER MONGOLIA FREE MEDICAL TECH.	20/01/2010	1.59
   300086	HAINAN HONZ	26/05/2010	2.65
   300110	QINGDAO HUAREN PHARM.	25/08/2010	3.09
   300119	TIANJIN RINGPU BIOTECH.	17/09/2010	3.28
   300122	CHONGQING ZHIFEI-BIOLOGICAL PROD.	28/09/2010	12.6
   300138	CHENGUANG BIOTECH	05/11/2010	1.67
   300142	WALVAX BIOTECH	12/11/2010	6.73
   300147	XIANGXUE PHARM.	15/12/2010	3.55
   300158	SHANXI ZHENDONG PHARM	07/01/2011	2.74
   300181	ZHEJIANG JOLLY PHARM	22/02/2011	2.02
   300194	CHONGQING FUAN PHARM	22/03/2011	2.66
   300199	HYBIO PHARM	07/04/2011	3.10
   300204	STAIDSON BIOPHARM	15/04/2011	6.24
   300239	BAOTOU DONGBAO BIOTECH	06/07/2011	1.80
   300254	SHANGXI C&Y PHARMACEUTICAL	19/08/2011	1.16
   300255	HEBEI CHANGSHAN BIOCHEM.	19/08/2011	2.17
   300267	HUNAN ER-KANG PHARM	27/09/2011	4.33
   300289	BEIJING LEADMAN BIOCHEM	16/02/2012	3.52

Note: There is substantial discrepancy between Market Cap values contained in the ChiNext company index found on the official Shenzhen Stock Exchange website, and values found on leading financial data websites. The official ChiNext company index can be found here: http://www.szse.cn/main/en/marketdata/sinformation/index.shtml?CATALOGID=1693&TABKEY=tab4

Intellectual Property Protection

Historically, China has had a skeptical approach towards IP protection, as it was viewed as a hindrance to the country’s imitation- and manufacturing-driven economy. Before 1992, patent protection was virtually non-existent, and between 1992 and 2008 pharmaceutical patents could essentially be violated on a “me-too” basis, where minor structural differences from existing drugs would suffice for marketing approval. In 2008 China became the newest entrant to the intellectual property arena, having finally adopted comprehensive patent protection regulations. Since then, the protection system strengthened significantly, albeit not sufficiently, and, despite the new initiatives, the IP protection arena remains in need of improvement. Current regulations still exclude IP protection of medical treatments, which encompass drug delivery, medical devices and personalized medicine.

Along with remaining regulatory concerns and loopholes, IP implementation is a pressing issue, particularly due to lack of adequate enforcement procedures in place, and due to insufficient numbers of enforcement authorities throughout the country whose pharmaceutical industry is highly geographically fragmented. In 2009, US businesses lost a colossal US$ 48 billion in sales, royalties and licensing fees due to patent infringement by Chinese manufacturers.

In a recent move to act on this issue, the Supreme People’s Court of China (SPC) has set up two judicial IP protection bodies to act on behalf of the innovative pharmaceutical industry. The government is additionally making an effort to engage with industry representatives and foreign authorities in order to progress necessary amendments in the IP system. A positive increase in numbers of IPR cases in recent years showcases the government’s efforts, and, because the government is able to draw on established legal environments, it is a matter of time before a sufficiently operational IP protection system is in place.

China’s strengthening IP protection regulations will certainly be an addition to the plethora of factors which will serve to buttress the innovative pharma industry over the next decade

Source found here

Big Pharma in India

To read an interesting blog post on Big Pharma in India click here

Counterfeit Prescription Drugs: How to Protect Yourself

by Rhona Finkel on December 5, 2012

The World Health Organization defines a counterfeit medicine as one "which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging."
Counterfeit medicines are defined broadly throughout the world by the World Health Organization. On April 1-3, 1992, experts from the world over met in Geneva for the first international meeting which gathered together member states and other organizations, such as INTERPOL, World Customs Organization (at the time known as Customs Cooperation Council), International Narcotics Control Board, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP) in response to a World Health Assembly resolution (WHA41.16)."
The number of counterfeit drugs continues to grow. According to SafeMedicines.org, counterfeit drugs have killed an estimated 700,000 people from malaria and tuberculosis alone.
Up to a third of all anti-malarials are suspect, and around 10% of all essential drugs in emerging markets fail basic quality tests.
No country is safe. India is the world’s largest manufacturer of generic drugs, but it’s estimated that from 12-25% of their supply might be contaminated with substandard or counterfeit medicines. The WHO reports that many of those medicines find their way to Africa, where some nations may have up to 40% of their drug supply contaminated.

Which drugs are most commonly counterfeited?

Here in the U.S., certain drugs are more likely to be counterfeit.
Cardiovascular Medications
Cardiovascular drugs are for a serious need, one which many Americans turn to foreign drug-makers for. But, points out Haiken, the danger isn't that the Americans won't get the medications--rather it's that they will get a dangerous counterfeit instead.
Antibiotics
Of course a counterfeit version might very well not heal you--but it could also make you sicker, as fake meds can be tainted with heavy metals or some other dangerous ingredients.
Cancer Drugs
Fake cancer drugs have been found in both Israel and China--and just February of this year in the U.S. In fact it's possible that doctors' offices and clinics might have bought counterfeit Avastin, containing no real drug, but rather acetone and water.
ED Medications
The Pharmaceutical Security Institute reports that 37% of all fake medicines seized are ED drugs. ED drugs are offered for sale via thousands of fake online pharmacies without prescription requirements. Writes Ms. Haiken, "The real danger of buying these drugs from a non-VIPPS approved pharmacy is that there is a very good chance they will not just be counterfeit, but poison."
Treatments for Chronic Ailments Like HIV, Diabetes & Alzheimer’s
Because chronic ailments respond slowly to treatment. it's hard to know if the drugs are really fake.
Psychiatric Medications
A Google search for Xanax, Ativan, Adderrall, or Ambien reveals hundreds of websites offering these powerful drugs without a prescription.
It is a dangerous world out there, and one where you have to keep your senses about you, since the matter can very easily be the difference between life and death.

Common Sources of Counterfeit Drugs

India and China are most commonly the source of counterfeit drugs. Havocscope, which keeps track of counterfeit medicines worldwide, found that genitourinary medicines, anti-infective drugs, and central nervous system drugs are the most frequently counterfeited kinds of medications. Just this August, according to Scientific American, "$182,000 worth of fake medicines for diabetes, high blood pressure, and cancer were seized in China."
Dr Sneh Khemka, Bupa International's medical director, notes that so many of the world's counterfeit medicines come from Asia, particularly China, that it is a dangerous area when you're searching for medical purity. Khemka writes that across the country between 50-85% of some drugs are fake and kill up to 300,000 people per year, which is the equivalent of wiping out the entire population of Iceland every year.
Don't think you're safe if you buy your drugs in any other country, however.
According to the CBS news, the FDA found in April 2012 that a counterfeit version of Roche’s Altuzan (bevacizumab), an injectable cancer medication, contained no active ingredient.
In an article entitled “Fake pharmaceuticals: Bad medicine,” in October 13, 2012's, issue of Economist, the authors determined that Pfizer found 20 counterfeit versions of their drugs in 81 countries in January 2009, and by July 2012, Pfizer reported finding 60 of their counterfeit drugs in 106 countries.
Create.org in a whitepaper on health and safety risks of counterfeits asserts that up to 40 million U.S. prescriptions are filled each year with counterfeits.
"Pharmaceutical counterfeiting is a low-risk, high-profit criminal enterprise that attracts entrepreneurs and organized criminals," says John P. Clark, vice president and chief security officer for the drug company Pfizer. "What was once seen as a problem limited to lifestyle medicines is now recognized as a threat from which no therapeutic area is immune."
In September/October, Computer World reported, an Interpol operation involving 100 countries seized $10.5 million worth of counterfeit drugs. Nearly 18,000 websites selling fake drugs were shut down during the operation, and 3.7 million doses of counterfeit drugs were seized.
Despite the way counterfeit drugs have encroached upon the U.S., CBS news points out that most of the ingredients in fake American medicines still come from other countries, including China and India, which are known to have weak regulatory systems. The FDA only inspects about 12% of overseas facilities a year.

How to know Whether Your Prescription Drugs are Counterfeit

The World Health Organization estimates that over half the drugs sold online via websites that hide their physical address are counterfeit. Writes the WHO:
"Criminal organizations manufacture these counterfeits, not in quality-controlled laboratories, but in hidden rooms with unsanitary conditions. And instead of patented ingredients, these meds can contain a haphazard mix of chemicals and fillers like highway paint, floor wax and boric acid — ingredients and doses that can actually harm you and your family."
It is a serious problem, one which the Department of Justice recognizes poses great danger, and the government recognizes that they need help--our help.
Attorney General Eric Holder launched a massive public education campaign, calling for help from all corners, from the TV, the radio, the newspapers, and blogs."
Because the government can't stop the onslaught alone, in his public campaign, Holder has asked that all Americans be proactive when buying their medications.
He strongly encouraged online-prescription-buyers to follow these tips to avoid counterfeit and possibly harmful products, and these are his warnings verbatim:

1. Don’t buy drugs from sites that sell prescription drugs without a prescription from your own physician.
2. Consult the National Association of Boards of Pharmacy, which maintains a list of accredited online pharmacies" [to be sure that the pharmacy from which you're buying the medication is valid].
3. If using an online pharmacy, make sure it has a legitimate brick-and-mortar street address, as well as a pharmacist on duty and available.
4. Discard the medication if it is of a different size or color, or if it has a different or odd-looking brand insignia from the medication you are used to taking.
5. Discard the medication if it dissolves differently or badly or has a strange or bitter taste that you are not accustomed to.
6. If you suspect a website is selling counterfeit meds, report it here.
7. And for more info on buying medicine on the Internet, go to fda.gov/ForConsumers/ConsumerUpdates or nabp.net/programs/consumer-protection/buying-medicine-online/counterfeit-drugs/.

By following these simple tips suggested by the FDA, you can help ensure that the medication your family buys online is what it claims to be."
A new technology may aid in tracking down counterfeit medications. This September, the Food and and Drug Administration unveiled the Counterfeit Detection Device #3 or CD3.
Battery-operated, the machine can emit up to 10 different wavelengths of ultraviolet and infrared light and can be used on capsules, tablets, powders, and packaging like inks, papers and covert markings. It's also capable of detecting products that have been tampered with, re-labeled, or re-glued. It has already analyzed nearly 100 counterfeit products, finding counterfeits masquerading as Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singular, Plavix, and Wellbutrin.

Protecting Yourself

Huffington Post has a few ideas. Know that Pfizer has partnered with the National Association of Boards of Pharmacy® (NABP) and several other organizations on a YouTube channel, SpotFakeMeds, that allows consumers to hear firsthand from anti-counterfeiting experts about what to look out for and how to buy online safely.
Despite the threats posed by counterfeit medicines, it is possible to safely purchase legitimate, FDA-approved prescription medicines online if you keep your eyes open. For example, one way to purchase your meds if you have a valid prescription is to ensure that you are buying from a legitimate site. All legitimate sites receive VIPPS® (Verified Internet Pharmacy Practice Sites) accreditation from NABP, which indicates one can find there FDA-approved medications for purchase. A list of VIPPS-accredited pharmacies can be found on the NABP website, www.AWARERx.org.
Dr. Sneh Khemka, publishing on Bupa International, runs through some clues to a counterfeit pill:

• Spot the difference. Is the lettering on the packaging hazy and printed flat (rather than raised), or is the expiry date missing?
• Read carefully. Are the labeling and patient information in a language you understand? If there are misspelled words, contact the manufacturers – it can be a telltale sign.
• Use your senses. Is the medicine the same size, shape, texture, colour and taste as your previous prescription?
• Feel for consistency. When you handle the drug does it fall apart easily? If so, it could signal a fake.
• Do a price check. Does the cost of the drug seem very cheap in comparison with your official provider? If it’s much lower, it could be a scam.

Now, let's say you're buying the medicine online--what should you keep a close eye out for?

• Prescriptions. Make sure the website you buy from requires a prescription and has a pharmacist you can contact for questions.
• Licensing. Only buy from certified online pharmacies. Search the website for a declaration of authenticity or certification and double- check this with your country’s official drug regulatory agency. For example, pharmacies in the UK that are registered with the Royal Pharmaceutical Society of Great Britain can display a logo on their website.
• Security. Don’t supply any credit card numbers unless you are sure the website has policies in place to protect your information and has a secure online payment system.
• Promises. Statements such as ‘no risk’ and ‘money-back guarantees’ can be key giveaways of a counterfeit website.

In short, if the way you're getting your medicine seems just too good to be true--then it very likely is, and the dangers of buying your medicine that way are manifold. It is in your own greatest interest to make sure that the drugs you are buying are indeed what they advertise themselves to be--and are not chemicals that create even more problems than they claim to address


Source: Counterfeit Prescription Drugs: How to Protect Yourself - Drugsdb.com http://www.drugsdb.com/blog/counterfeit-prescription-drugs.html#ixzz2GXn3Z6VG

Did off-label promotion just become legal?

To read a blog on this issue, click here

K-V Pharmaceutical Receives Court Approval of Hologic Settlement

Clears Path Forward for K-V's Pursuit of Chapter 11 Reorganization Plan

ST. LOUIS, Dec. 28, 2012 /PRNewswire/ -- K-V Pharmaceutical Company ("K-V" or "the Company") today announced that the U. S. Bankruptcy Court for the Southern District of New York, the Honorable Judge Allan L. Gropper presiding, approved the Company's settlement agreement with Hologic, Inc. ("Hologic Settlement"), and authorized the Company to enter into an $85 million debtor-in-possession ("DIP") financing to, among other things, fund the settlement.

"The resolution of the Hologic litigation is a major milestone in our restructuring. Now that it is resolved, K-V can focus on completing all other necessary steps for confirmation of a plan of reorganization and timely emergence from Chapter 11," said K-V President and CEO Greg Divis. "We are committed to our core women's health care business and continue to work closely with our customers to advance the care of the patients we serve."

Southwest Veterinary Symposium SEPTEMBER 26–29, 2013 Henry B. Gonzalez Convention Center | San Antonio, Texas

For more information click here

18th Annual North Carolina Veterinary Conference! November 1–3, 2013 at the Raleigh Convention Center!

More information will be posted at the site located here as it becomes available

CA court rules pet owners can sue for more than market value

A California appeals court recently sided with pet owners in two cases where the owners were attempting to sue for damages beyond the animals’ market value. The decision sets another precedent in the legal system’s efforts to legally and monetarily define a pet’s value. The Second District Court of Appeals wrote in its opinion filed Oct. 23: “We hold that a pet owner is not limited to the market value of the pet and may recover the reasonable and necessary costs incurred for the treatment and care of the pet attributable to the injury.” Instead of tackling the subject of sentimental value, which has been a thorny issues for courts in other states, the appeals court based its decision on the actual costs paid by owners to treat their pets following an injury. Case summaries In the first case considered by the Second District Court of Appeals, a woman took her dog to have a small liver lobe removed. According to the court documents, the veterinarian allegedly “nicked and cut” the dog’s intestine during surgery, causing internal bleeding. The veterinarian also reportedly left a piece of surgical gauze inside of the dog. The woman spent $4,836.16 on the initial surgery, and then paid an emergency hospital $37,766.06 to stop the resulting internal bleeding and remove the gauze. She filed her lawsuit after the veterinarian reportedly offered to refund the $4,836.16 but refused her requests for money related to the emergency hospital fees. The second case involved a dog that escaped into a yard next door and began barking at the neighbor’s dog. The neighbor shot the dog in the leg and claimed it was self-defense even though the dogs were still separated by a gate. Veterinarians were  eventually forced to amputate the leg, and the dog’s owner sued the neighbor for $20,789.81 in veterinary bills. In those two cases, trial courts ruled that the owners could only sue for market value, which prompted them to bring their cases to appeals court. Ruling details The ruling from the appeals court reversed the previous decisions and allowed the owners to sue for more than market value â?? as long as the amount is based on “reasonable and necessary” costs related to the animal’s treatment. In the court’s written opinion, the judge explained that a previous case â?? Kimes, supra, 195 Cal.App.4th 1556 â?? heavily influenced the court’s ruling. In the Kimes case, the owner of an adopted stray cat sued his neighbors after they allegedly shot the pet with a pellet gun and left it paralyzed. The owner’s lawsuit asked for $6,000 for the emergency surgery as well as $30,000 for costs incurred while caring for the cat. According to the appeals court, the opinion in the Kimes case stated: “In this case, plaintiff is not plucking a number out of the air for the sentimental value of damaged property; he seeks to present evidence of costs incurred for [the cat‘s] care and treatment by virtue of the shooting — a ‘rational way’ of demonstrating a measure of damages apart from the cat‘s market value.” The Second District Court of Appeals further explained its position by referring to animals using the terms “sentient beings” and “distinct and specially protected form of property,” which are terms that many courts have historically refrained from using. The article was provided by the American Animal Hospital Association. The court stated: “In California, the Legislature has recognized since 1872 that animals are special, sentient beings, because unlike other forms of property, animals feel pain, suffer and die. Civil Code section 3340 provides that â?? [f]or wrongful injuries to animals being subjects of property, committed willfully or by gross negligence, in disregard of humanity, exemplary damages may be given. Laws criminalizing animal abuse underscore the Legislature‘s view that animals are a distinct and specially protected form of property.” Source found here

2013 OVMA 98th Annual Convention & Expo Sunday, January 27, 2013 - Tuesday, January 29, 2013

Oklahoma Veterinary Medical Association 98th Annual Convention  will be held in Tulsa, Oklahoma, Sunday, January 27, 2013 - Tuesday, January 29, 2013, with a wide list of topics and speakers.  For more information, click here

2013 Midwest Veterinary Conference Features Compounding Topics

February 21-24, 2013 at the Greater Columbus Convention Center, Columbus, Ohio Topic Ohio Pharmacy Laws; Compounding Topics Mr. Kyle Parker For more information click here