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Volume: 05

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Drug Information Bulletin (Electronic)

th

Year

Number: 31

12th November 2011

New Drug: Fampridine

Content

Chinese Drug Exec Given Suspended Death Sentence Product patents and high prices in India US FDA approves new Contraceptive Etonogestrel FDA issues 'Safety Communication' on Fenofibrate Forthcoming Event

New Drug: Fampridine Fampyra 10 mg modified release tablets Approved indication: multiple sclerosis Australian Medicines Handbook section 16.6 Fampridine is a potassium channel blocker indicated for symptomatic improvement of walking in adults with multiple sclerosis, including relapsing remitting, secondary progressive, progressive relapsing and primary progressive. Currently there are no other drugs for this indication. Fampridine is thought to increase conduction in demyelinated nerves by inhibiting potassium channels. It can be used on its own or with other treatments for multiple sclerosis, including immunomodulatory drugs. The efficacy of fampridine has been studied in two phase III trials.1,2 In the first trial, 301 patients with walking

difficulties associated with multiple sclerosis were randomised to fampridine 10 mg twice daily or placebo, for 14 weeks. The primary outcome was based on changes in walking speed over 25 feet (7.6 m). A responder was defined as someone who consistently walked faster during treatment compared to baseline. In the fampridine group, 35% (78/224) of patients responded compared to only 8% (6/72) in the placebo group. The average increase in walking speed of people who responded to fampridine was 0.51 feet/second (approximately 15.5 cm/second) (25% faster).1 These results were confirmed in a second similarly designed trial in which 43% (51/119) of patients responded to fampridine compared to only 9% (11/118) of patients to the placebo. On average, patients who responded to fampridine walked 24.7% faster.2 Urinary tract infection was a very

2 common adverse event with ampridine. Neurological effects were common and included insomnia, balance disorder, dizziness, headache and asthenia. Falls and severe anxiety were also reported. In a trial of 206 patients, serious events were more common at higher doses (4% with placebo, 0% with 10 mg, 8% with 15 mg and 12% with 20 mg fampridine). One patient discontinued the 15 mg dose of fampridine because of nausea and dizziness and five patients discontinued the 20 mg dose two patients had seizures, one developed abnormal coordination, one had chest discomfort and headache and one patient had blurred vision, chest discomfort, balance disorder, headache and paraesthesia.3 Seizures have also occurred postmarketing and fampridine is contraindicated in patients with a history of seizures. Because of this potential toxicity, patients should not take a double or extra dose when a dose is missed. Tablets should be taken whole and not crushed or chewed. Following oral administration, peak concentrations of fampridine are reached after 34 hours. It is primarily excreted unchanged in the urine. The elimination half-life is normally 5.26.5 hours, but is prolonged in patients with renal impairment. Fampridine is therefore contraindicated in moderate to severe renal impairment. If renal function has not been assessed, creatinine clearance should be estimated before starting treatment. This is particularly important in the elderly. In patients with mild impairment, monitoring of renal function should be considered. This drug has not been tested in pregnant and lactating women. As fampridine is lipophilic, it may be excreted in human milk. Fampridine is the first drug to help improve walking in patients with multiple sclerosis. However in the trials, less than half of the patients (3543%) consistently walked faster (increase of 15.5 cm/second) after taking fampridine. Doctors and their patients have to consider whether this potential benefit is worth the risk of seizures and other serious neurological adverse effects. The safety and efficacy of fampridine during an exacerbation of multiple sclerosis is not known as these patients were excluded from the trials. Fampridine should only be continued if the patient responds within eight weeks of treatment. References: 1. Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet 2009;373:732-8. 2. Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, et al. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol 2010;68:494-502. 3. Goodman AD, Brown TR, Cohen JA, Krupp LB, Schapiro R, Schwid SR, et al. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology 2008;71:1134-41.
Source: Aust Prescr 2011;34:119-123

Chinese Drug Exec Given Suspended Death Sentence From Associated Press (November 9, 2011) BEIJING -- A Shanghai court handed the former chief executive of a large stateowned pharmaceutical company a suspended death sentence for corruption that enabled him to amass more than 50 million yuan ($8 million), an official said Wednesday. Wu Jianwen, the former head of Shanghai Pharmaceutical Group Ltd., was convicted of accepting bribes, embezzling public funds and other graft charges by the

3 Shanghai Intermediate People's Court, according to a court official surnamed Wang. Wang said the court handed down a suspended death sentence with a two-year reprieve. Such sentences usually are commuted to life in prison with good behavior. The punishment comes as China wrestles with food and product safety concerns and appears aimed at showing that authorities are cracking down on rampant corruption. Shanghai Pharma says it is China's third largest pharmaceutical maker and second largest distributor of pharmaceutical products. It was the parent company of Shanghai Hualian Pharmaceutical Co., which authorities shut down in 2007 for making tainted leukemia drugs blamed for causing leg pains and partial paralysis among dozens of patients. China's increasing importance as a pharmaceutical producer has ratcheted up concerns over a slew of scandals involving fake, adulterated and otherwise unsafe drugs _ especially given the thriving market in mail order medications. In 2007, China executed Zheng Xiaoyu, the former head of the country's food and drug regulatory authority, after he was convicted of taking bribes to approve flawed medicine blamed for several deaths. The punishment became a symbol of a product safety crisis which had been triggered by the discovery of potentially deadly substances in exports, from pet food ingredients to fish. Meanwhile, a city official convicted of graft was executed Wednesday after the highest court approved her death sentence, the state-run Xinhua News Agency reported. It said Luo Yaping, 50, embezzled 32 million yuan ($5 million) of public funds earmarked for compensation for land requisition from 2004 to 2007 when she worked in the Fushun city government in northeastern Liaoning province. The Supreme People's Court said in a statement that she also accepted 300,000 yuan ($47,000) in bribes from two real estate companies, Xinhua said. She was sentenced to death in December 2010 and unsuccessfully appealed the verdict in June. China is believed to carry out more courtordered executions each year than all other nations combined.
Source:pharmalive.com

Product patents and high prices in India One of the basic apprehensions of the reintroduction of product patent protection in pharmaceuticals in India has been that product monopolies will lead to very high prices. While high prices have been reported from time to time, no systematic studies were available. In a paper, which can be downloaded from http://facultylive.iimcal.ac.in/sites/facultyliv e.iimcal.ac.in/files/WPS%20685_0.pdf, we have tried to fill up this gap. The major conclusions of the paper are: 180 new drugs have been introduced in the Indian market between 1995 and 2010. Out of these 180 drugs, only 51 drugs are post-1995 molecules and hence patentable in India subject to Section 3(d) provisions. MNCs have monopolies for 33 drugs. Table 8 of the paper gives an idea about the pricing policies adopted by the MNCs. The prices charged are exorbitant particularly for life threatening diseases such as cancer. A single injection of Roches anti-cancer drug, Herception, for example costs INR 135200 (approx USD 2800). What has attracted widespread attention is Indias success as a pharmaceutical exporter. What is less noticed is that imports of finished

4 formulations have been rising sharply. For matured generics, the MNCs are entering into alliances with Indian companies for manufacturing. But for patented drugs, MNCs are importing these from their home countries Switzerland USA, France etc rather than manufacturing these in the country. With the taking over of some Indian companies, the aggregate market share of the MNCs in India has dramatically increased from less than 20% to 28% in 2010. The MNCs are on the way to dominating the industry again.
Source: E-DRUG

Forthcoming Events:

Golden Jubilee Celebration

50th National Pharmacy Week Celebration 20th 27th November 2011 by Indian Pharmaceutical Association Bengal Branch

US FDA approves new Contraceptive Etonogestrel ABC News Radio reports FDA has approved Merck's contraceptive, etonogestrel [Nexaplon], "for the prevention of pregnancy in women for up to three years." Etonogestrel "is a long-acting, progestin-only single-rod hormonal contraceptive," which "must be inserted under the skin of a woman's upper arm with a minor surgical in-office procedure." FDA issues 'Safety Communication' on Fenofibrate The US FDA has issued a safety communication and updated the prescribing information for the cholesterollowering agent fenofibric acid (Trilipix, Abbott), stating that the drug may not lower the risk of major cardiovascular events [1]. This is based on data from the ACCORD Lipid trial, in which the combination of fenofibrate plus simvastatin was compared with simvastatin alone in patients with type 2 diabetes mellitus. Details are available at: http://www.medscape.com/viewarticle/753 195?sssdmh=dm1.732627&src=nl_newsale rt

Inauguration
20th November, 2011 Venue Science City Mini Auditorium, Kolkata 21.11.2011: Calcutta Institute of Pharmaceutical Technology & Allied Health Sciences, Uluberia, Howrah. 22.11.2011: EIILM, Kolkata. 23.11.2011: Industrial Pharmacy Day. Venue: Rotary Sadan, Kolkata. Time: 5.30 pm. 25.11.2011: Hospital Pharmacy Day. Venue: R.G.Kar Medical College, Kolkata. 26.11.2011: Students Day. Venue: Jadavpur University. 27.11.2011: Seminar at Durgapur. Venue: Hotel Ispat. *** Tentative programme

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