Branding Pharmaceutical Drugs in China
Did you know according to the Chinese Association for Pharmaceutical Equipment group that the Chinese pharmaceutical industry has been growing at an average annual rate of 16.72% over the last few decades?
And that growth isn’t going to slow down anytime soon.
China stands at the cusp of a modern society with an increasingly affluent and growing population. And it’s this growing population that is demanding better services and quality of life – but how will this impact the pharmaceutical industry in China – particularly in regards to branded pharmaceutical drugs?
Not just in the pharmaceutical industry, but for all industries across the board, China has become the must win market. An aging population, increasingly affluent younger population, and the rise of diseases in China all create an emerging need for drugs, which is why The IMS Institute has predicted that by 2016 China will overtake Japan as the second largest pharmaceutical market in the world. So it’s no wonder why billions of dollars a year are being invested in the country.
Many foreign players such as AstraZeneca, Pfizer, Bayer and GSKhave already established themselves firmly in the market and are expanding their services regularly within the country. But with the entry of foreign players in the industry, the competition amongst these players will continue to increase. China has more than 5,000 pharma companies, and in 2010 was the leading country filing pharmaceutical trademarks – even beating out the United States, one of the most mature pharmaceutical markets by nearly 10,000 trademarks filed. Even though China is the global leader filing pharmaceutical trademarks, the majority of the drugs manufactured in China are generic. But as China’s consumer mindset continues to mature and grow, so will the branded pharmaceutical sector.
Why the continued growth?
Specifically for pharmaceuticals, powerful product brand names are important tools to offset competitive pressure from generics and to build customer loyalty. Though heavily regulated by state legislations, in China’s case the SFDA, brand naming for pharmaceutical products is unique, and can greatly affect marketing decisions.
In highly competitive environments, a strong brand will rise above the clutter and demand attention. With a strong brand, you secure a unique position of credibility in the consumer mind, have more influence on your market and motivate customers to purchase from you.
From a marketing perspective, brand naming for a pharmaceutical product may take into consideration aspects such as the chemical/biological nature of its active ingredient, composition/formulation, therapeutic indication, associated medical condition, benefit and adherence to the corporate identity.
From a communication point of view, pharmaceutical branding specialists must decide whether to focus on the functionality or the end-user benefits. It is also from the same angle that pharmaceutical naming is usually considered of great complexity, as most of the time, both audiences should be targeted.
Chinese regulations on pharmaceutical drug naming frown upon utilization of characters that are either indicative of curative effect, intended use, target audience or may imply efficacy.
Regardless of the market you’re in, developing a strong pharmaceutical name is tough, but in China it can be particularly challenging. You must keep in mind translations, the use of characters and regulatory conditions. Biological and pharmaceutical products rely heavily on the protection of intellectual property rights, so it’s essential for foreign companies to gain thorough understanding of China’s IPR protection system before entering the market.
Multinational companies have greatly expanded their businesses in China over the years and have aligned with local pharmaceutical companies, which has proven to be a winning strategy for both parties. And as these companies and other foreign players continue to expand their footprint in China, competition will become fierce as each seeks to penetrate the market. Pricing, intricate knowledge of regional markets and developing strong brands will determine who gets ahead and who doesn’t.
Why INN's are so Important to a Drug's Life
Every pharmaceutical asset begins with a nonproprietary, generic name, or an International Nonproprietary Name (INN). This name could potentially be the first strategic decision you make for the commercial life of your brand.
But what exactly is an INN name and why do they exist?
Since the inception of the INN naming system in 1950 it has been providing health professionals with a way to uniquely and universally identify each pharmaceutical substance. INN's are not only important in identifying a drug's pharmaceutical ingredients but in providing safe prescription and dispensing of medicines to patients, and communication between health professionals worldwide. The World Health Organization (who manages & issues INN's) issues INN's in English, Latin, French, Russian, and Spanish, and more recently Arabic and Chinese versions are also being issued.
Here Vince Budd, Senior Vice President at Addison Whitney, speaks of the importance INN's have on the success and lifecycle of a drug:
"Although INN’s aren’t actually considered intellectual property, developing an INN is without a doubt a strategic endeavor that many commercial, medical and regulatory officers take very seriously. First, the commercial team of an organization sees this as the first opportunity to put some sort of face or image to the asset. Although WHO would like manufactures to use trivial or fantasy letter strings when building generic names around INN stems, many approved INN’s are actually quite suggestive about the product. This helps some of the branding activities that soon follow. Also, many manufacturers must think about the life cycle of the asset and potential generic competition, which also impacts the type of INN name that is sought. The bottom line is INN development is serious business and the wrong or right name can certainly have an impact on the future success of a drug. "
According to WHO there are roughly 8,000 INN's listed today, and that number grows by approximately 120-150 each year. Every INN must be submitted to and approved by WHO, and must follow their general principles for developing INN's.
Source: World Health Organization
Tobacco Gets Graphic
If you plan to purchase cigarette packs after September 2012 you may be surprised, or even disturbed by what you see. The Food and Drug Administration is requiring graphic warning labels with images ranging from a man exhaling smoke through a tracheotomy hole in his neck to a diseased lung to be placed prominently on cigarette packs. Cigarette marketers also will be required to place 1-800-QUIT-NOW numbers on new packaging.
The vivid images are the biggest change to cigarette warning labels since the mid 1980s, when the government began requiring tobacco companies to put health warnings on cigarette packs and tobacco ads. Targeting the cigarette packages themselves shows that the FDA understands the importance of compelling package design. Consumers are influenced by the entire experience of a product. The design of the outside of a package is just as important as what’s inside. A package is more than just a container; it is an asset that can motivate a purchase. Having an effective package design in a crowded marketplace is essential to making a product stand out.
So where does a tobacco company go from here? How does one market a product with packaging designed to shock consumers and discourage them from using the product? “The cigarette companies are in an environment where their product is seen as dangerous,” Brannon Cashion, president of Addison Whitney, told USA TODAY. He points out that tobacco marketers have done a good job dealing with growing anti-smoking efforts. What they need to do is stress innovation, such as developing low nicotine and electronic cigarettes.
“In order to continue to manufacture the product, they have to continue to put innovations in place that can do everything possible to make as safe an environment as possible for those who smoke and the people most affected with their smoking.”
For more information on the new FDA cigarette health warnings, click here.
FDA Approval: Edarbi
FDA approves Edarbi to treat high blood pressure (source: FDA Press Announcement)
On Friday, February 25, 2011, The U.S. Food and Drug Administration approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.
Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).
“High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research. “High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”
Edarbi will be available in 80 milligram and 40 mg doses, with the recommended dose set at 80 mg once daily. The 40 mg dose will be available for patients who are treated with high-dose diuretics taken to reduce salt in the body.
Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps. If blood pressure rises and stays high over time, it can damage the body in many ways. Nearly 1 in 3 adults in the United States has high blood pressure, which increases the risks of stroke, heart failure, heart attack, kidney failure, and death.
Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.
Adverse reactions reported by patients taking Edarbi in clinical trials were similar to those reported by those taking an inactive drug (placebo).
Edarbi has a boxed warning that says the use of the drug should be avoided in pregnant women because use of the drug during the second or third trimester can cause injury and even death in the developing fetus. If a woman becomes pregnant while using the drug, it should be discontinued as soon as possible.
Edarbi is made by Takeda Pharmaceutical North America of Deerfield, Ill.
For more information on pharmaceutical naming, branding, research or submission documents, please contact Vince Budd at Addison Whitney via email or phone 704.697.4021.
FDA Approval: Viibryd
Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. Clinical Data plans to make Viibryd available in U.S. pharmacies in the second quarter of this year.
“It is also the first drug that the Company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data.”
"When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient," said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego. "Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile."
The mechanism of the antidepressant effect of Viibryd is not fully understood but is thought to be related to its enhancement of serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist at serotonergic 5HT1A receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd's antidepressant effect are unknown.
For more information about recent drug approvals or pharmaceutical branding, please contact Vince Budd at [email protected]
FDA Approval: Brilique
LONDON, Dec 6 (Reuters) - AstraZeneca's new heart medicine Brilique -- or Brilinta -- won final clearance from EU regulators on Monday, putting it on track to compete with Plavix, the world's second biggest-selling drug, next year.
AstraZeneca is relying on revenues from the new product to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.
The approval by the European Commission had been expected following a positive recommendation from experts at the European Medicines Agency in September.
AstraZeneca said that of the European markets that would start selling Brilique in 2011, the majority of launches would occur in the second half of the year due to pricing and reimbursement negotiations.
The drug is recommended for preventing dangerous blood clots in patients with serious chest pain or previous heart attacks.
It is a competitor for Sanofi-Aventis and Bristol-Myers Squibb's top-seller Plavix, which had sales last year of more than $9.5 billion, and AstraZeneca will face a tough competitive marketplace, since Plavix is off patent in parts of Europe and loses U.S. patent protection in 2012.
In the United States, where the medicine will be sold as Brilinta, the Food and Drug Administration is due to decide on whether to approve it by Dec. 16. It was endorsed by a U.S. advisory panel in July, despite a perplexing lack of benefit seen among a North American sub-group of patients in a clinical trial that found it was superior to Plavix overall. (Reporting by Ben Hirschler, editing by Kate Kelland)
FDA Approval: Halaven
FDA Approves Eisai Inc. (ESALF.PK)'s Halaven For Late-Stage Breast Cancer
11/15/2010
SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.
Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.
Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.
Halaven's safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.
The study was designed to measure the length of time from when this treatment started until a patient's death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.
"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Halaven shows a clear survival benefit and is an important new option for women."
The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.
Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late- stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.
Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.
For more information:
FDA: Office of Oncology Drug Products
NCI: Breast Cancer
Media Inquiries: Erica Jefferson, 301-796-4988, [email protected]
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
FDA Approval: Ofirmev
PRNewswire via COMTEX News Network/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced last week that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV(TM) (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
"The approval of OFIRMEV is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children," said Ted Schroeder, President and CEO of Cadence. "IV acetaminophen is the unit market share leader among all injectable pain medications in Europe. With our planned launch early in the first quarter of 2011, we believe that OFIRMEV will fill a significant gap in the United States for the treatment of pain and fever in the hospital setting."
Acute pain, particularly postoperative pain, often requires a multi-modal approach in which two or more analgesics are used with the goal of providing better analgesic efficacy. U.S. physicians already prescribe acetaminophen frequently in combination with opioids for oral management of pain, where it is the most widely used non-opioid in fixed combination therapies. In clinical studies, OFIRMEV improved pain relief, reduced opioid consumption, and improved patient satisfaction when used as part of a multi-modal regimen.
"OFIRMEV is a long-awaited and much needed addition to postoperative pain management," said Eugene R. Viscusi, M.D., Director of Acute Pain Management at Thomas Jefferson University in Philadelphia. "With the approval of OFIRMEV, clinicians will now be better able to use a multi-modal approach to pain management in the hospital setting, when oral medication can't be used."
FDA Pharmaceutical Approval: Kapvay
FLORHAM PARK, N.J., Oct. 4 /PRNewswire/ -- Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. Food and Drug Administration approval of the non-stimulant medication KAPVAY™ (clonidine hydrochloride) extended-release tablets, an extended-release oral formulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6-17 years. KAPVAY™ is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication. KAPVAY™ can also be used as monotherapy when treating ADHD.
An oral, non-stimulant, twice-daily therapy, KAPVAY™ is a centrally acting alpha2-adrenergic receptor agonist. While the mechanism of action of alpha2 agonists in ADHD is not known, it is believed to involve the pre-frontal cortex (PFC) of the brain. Studies suggest that the PFC regulates attention and plays a critical role in impulse control, working memory and executive function.
"The FDA approval of KAPVAY™ represents an exciting milestone in the field of ADHD," said Donald C. Manning, MD, PhD, Chief Medical Officer of Shionogi Inc. "The extended-release formulation of KAPVAY™ minimizes the peaks and troughs in blood levels, thereby decreasing overactivation of the alpha receptors in the brain and periphery. We look forward to providing this important, beneficial treatment for ADHD to patients, both as monotherapy and add-on therapy to stimulants."
"ADHD is a complex disorder that requires individualized treatment. While there are prescription treatment options available, many ADHD patients on stimulants do not achieve adequate control of symptoms," explained Rakesh Jain, MD, MPH, Director of Psychiatric Drug Research for R/D Clinical Research at Lake Jackson, Texas, and an investigator in the clinical trials. "KAPVAY™, when added to a stimulant, addresses an unmet need, and improves ADHD symptoms beyond what is achieved by stimulants alone. This is a significant step forward for the treatment of ADHD to have an approved product for add-on therapy in our treatment armamentarium."
ADHD is a neurobehavioral disorder that occurs in childhood and may continue into adolescence and adulthood, which affects more than 4.5 million children ages 3-17 in the U.S. alone. Approximately 3-7 percent of U.S. school-aged children are believed to suffer from this disorder. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity/over-activity.
For more information on Kapvay or Shionogi, please visit the corporate website or Kapvay product website.
FDA Pharmaceutical Approval: Suboxone
According to ClinicaSpace, MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, today announced that its partner, Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (LSE: RB), has received approval from the U.S. Food and Drug Administration (FDA) to market Suboxone® (buprenorphine HCl/naloxone HCl dihydrate) sublingual film for the treatment of opioid dependence.
This is the second U.S. marketing authorization for a prescription product based on MonoSol Rx's PharmFilm® technology, closely following the July 2010 FDA approval of the anti-emetic Zuplenz® (ondansetron) oral soluble film.
Suboxone® sublingual film delivers a convenient, quick-dissolving therapeutic dose of buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. The drugs rapidly absorb under the tongue to ensure compliance.
A. Mark Schobel, President and CEO of MonoSol Rx, stated, "We are very pleased to announce the approval of Suboxone® sublingual film and disclose our important relationship with Reckitt Benckiser. Following the FDA approvals of Suboxone® sublingual film and Zuplenz® oral soluble film, both within the past two months, the agency has clearly accepted our proprietary PharmFilm® technology as a viable prescription drug dosage form.