Biopeer

Discovery opens a new path in gene therapy for inherited blindness

Scientists at the University of Leeds discovered a new gene that is the root cause of one of the common forms of inherited blindness in infants. The research team found that mutation of the recessive gene, LCA5, causes Leber's congenital amaurosis (LCA). “LCA is usually a disease where protein function has been lost completely, but carriers of just one copy of the mutation, who will almost certainly have reduced protein levels, nevertheless function perfectly normally,” said Chris Inglehearn, professor at the Leeds Institute of Molecular Medicine, St. James's Hospital, Leeds. “This being the case, restoration of even a tenth of the missing protein may be enough to restore vision. So our findings, together with the recently announced clinical trials, hold great promise.” Mutations in LCA5 cause blindness only when a child carries two copies of the gene. The findings would be helpful in areas where marriage to first or second cousins is prevalent, as the disorder is more common among those populations.

Researchers at the University of Virginia Health System formulated a way to transfer genes that may restore hearing into diseased tissue of the human inner ear. The research team engineered a correct form of the gene KCNQ4, which when mutated causes hearing loss, and developed a gene therapy to transfer the gene into human hair cell harvested from the inner ear of the patients. “Our results show that gene therapy reagents are effective in human inner ear tissue. Taken together with the results from another group of scientists who showed that similar gene therapy compounds can produce new hair cells and restore hearing function in guinea pigs suggest that the future of gene therapy in the human inner ear is sound,” said Jeffrey Holt, associate professor of neuroscience and otolaryngology, University of Virginia.

Researchers at the University of Illinois-Chicago and Cornell University are developing a therapy to reactivate silenced genes in stroke and neurodegenerative patients. The study found that during a stroke, specific cellular events result in the death of brain cells. “For the first time, we show which one of the 11 histone deacetylase enzymes might be the best target to achieve cellular neuroprotection. This work gives us a good direction to follow in testing histone deacetylase inhibitors in animal models for diseases such as Parkinson's and Huntington's disease and even stroke,” said Alan Kozikowski, professor at the University of Illinois.

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More generic drugs on the way

Continuing its efforts to make low-cost drugs more widely accessible, the United States Food and Drug Administration (FDA) has granted approval to the generic versions of two drugs.

The FDA has given the nod to Indian pharmaceutical firm Ranbaxy Laboratories Ltd for producing the generic version of Cefprozil. Cefprozil is an antibiotic that fights infections in case of tonsillitis, sinusitis and other such illnesses. Bristol Myers Squibb manufactures Cefprozil under the brand name Cefzil. Ranbaxy Pharmaceuticals Inc, a subsidiary will be responsible for producing and marketing the drugs. The drug will be sold as tablets of 250mg and 500mg and is likely to hit the market in early 2007.

Meanwhile, the FDA also gave the go-ahead to the first generic version of Wellbutrin XL. Wellbutrin XL tablets are Bupropion Hydrochloride Extended-Release Tablets that are mainly prescribed to treat major depressive disorder. GlaxoSmithKline manufactures Wellbutrin XL but now Anchen Pharmaceuticals Inc, from California, USA, will be able to produce the generic version of the drug as 150mg and 300mg tablets.

In a blow to the FDA’s generic drugs program, a non-profit organization has released a report stating that the President’s Emergency Plan for AIDS Relief (PEPFAR) prefers brand-name drugs to treat HIV/AIDS patients instead of generic drugs. The Center for Public Integrity claims that as the brand-name drugs are more expensive, the program is not able to treat as many patients as it could have if it had obtained generic antiretroviral drugs.

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More generic drugs in pipeline

In a move widely hailed by AIDS activists, the Thai government has issued a compulsory license permitting drug manufacturers to bring out a less expensive version of Efavirenz. Efavirenz is an essential drug for AIDS victims and one of the brand names it is sold under is Stocrin. The Government Pharmaceutical Organization (GPO) will import the generic versions of the drug from Indian firms until it starts production of its own version in June 2007. The patent holders of the drug, Merck & Co Inc, are understandably upset with this decision and the government’s assurance that they will receive a 0.5 per cent royalty from the sales of the locally produced drug has not been adequate. Merck currently sells the drug for 1,400 baht per month while the imported generic drugs are expected to cost 800 baht and the GPO’s drug 700–800 baht per month.

Meanwhile, Teva Pharmaceutical Industries has received tentative approval from the United States Food and Drug Administration (US FDA) for its sumatriptan succinate tablets for acute migraine headaches. The company claims that its tablets are equivalent to Imitrex, sold by GlaxoSmithKline. The patent expires in February 2009 and Teva anticipates final clearance then.

The US FDA has granted approval to Abraxis Biosciences Inc for its generic version of Unasyn. The drug is a combination of Ampicillin and Sulbactam and is meant to be injected in cases of skin, intra-abdominal and other such bacterial infections. Pfizer owns the right to Unasyn.

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New generic drug approvals

In a boost to the generic drugs industry, the United States Food and Drug Administration (FDA) has approved two drugs while an Indian firm has launched the first generic version of Pemetrexed.

The FDA has granted final approval to Pliva, a subsidiary of Barr Pharmaceuticals to manufacture and market the generic version of Pravachol (Pravastatin Sodium). Pliva will market the Pravastatin tablets in strengths of 10mg, 20mg and 40mg as it has received the approval only for these strengths. However, it has received tentative approval for the 80mg strength and is hopeful about final approval. Pravastatin use is suggested for the prevention of coronary events in certain patients. Pravachol is owned by Bristol–Myers Squibb.

Meanwhile, regulatory approval to market a generic injectable version of ondansetron has been granted to Teva Pharmaceutical Industries. Ondansetron is the generic version of Zofran, a drug taken by chemotherapy patients to prevent nausea. Teva will sell the drug in varying strengths; in vials meant for single–doses (4mg) and multiple doses. The drug will also be packed in bags where it would already be mixed with dextrose. Since GlaxoSmithKline, the owner of Zofran, has agreed to waive the six months left of the exclusivity period, Teva will ship the drugs immediately.

In a separate development, Natco Pharma has announced the launch of its drug Pemnat. Pemnat is the generic version of Pemetrexed, a drug used in the treatment of pleural mesothelioma as well as non–small cell lung cancer. Pemnat will be marketed in vials of 20ml and will be available at less than one–third the cost of Pemetrexed.

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Generic drug industry in the news

The generic drugs market is seeing activity like never before. Consolidation is the buzzword at present in the generics industry—Novartis last year bought Germany's Hexal and its US affiliate Eon Labs, Teva bought Ivax Corporation in January, Mylan bought India's Matrix Laboratories in August. And now the hospital supplies firm Hospira will be buying Australian company Mayne Pharma for USD 2 bn. The combined entity will be the world’s biggest manufacturer of generic injectable drugs. “This combination will create the leading generic injectable pharmaceuticals company in the world, delivering unparalleled value to the global healthcare system as well as our respective shareholders and employees,” said Hospira CEO Christopher Begley.

Meanwhile, India's biggest drug maker Ranbaxy has entered into an agreement with Gilead Sciences Inc for manufacturing and marketing Active Pharmaceutical Ingredient (API) and formulations containing the anti-HIV drug Tenofovir Disoproxil Fumarate (TDF). Both would be manufactured at Ranbaxy's manufacturing facilities in India. The licence allows for technology transfer from Gilead to the company, it added.

In another development pertaining to the generic drugs industry, Wal-Mart has announced a price cut on nearly 300 generic drugs. The news has come as a major relief to those suffering from diabetes, cardiovascular disease, asthma, cold viruses and infections. By 2007, this initiative, which has commenced from the Tampa Bay area will, extend to the entire USA.

Bioxel leverages on generic taxanes

Canadian firm Bioxel has manufactured the first industrial-scale cGMP batch of its key intermediate for docetaxel, the active pharmaceutical ingredient (API) of Sanofi-Aventis’s chemotherapy drug Taxotere. Bioxel is preparing to supply docetaxel to generic drugmakers, once the first patents for Taxotere expire at the end of 2007.

Once Taxotere is off the patent, generic pharma can start producing it. Bioxel is gearing up its production plans to meet the demand that will emerge once the patents expire. As docetaxel can be manufactured only through a semi-synthetic route, it represents a challenge for generic drugmakers because the route of synthesis and the corresponding intermediates are well protected by the originator. Bioxel however, has been successful in developing semi-synthetic taxanes using a high-efficiency patent protected route. Bioxel will supply its clients with docetaxel API samples during the end of 2006.

Last month, Bioxel began commercial deliveries of paclitaxel to one of the largest European generics companies. Bioxel manufactures and sells cGMP compliant paclitaxel to specialty pharmaceutical companies and generic formulation manufacturers.

Bioxel has a two-pronged strategy for growth — expanding in the European market through paclitaxel and developing semi-synthetic taxanes for docetaxel API. This allows it to optimally use its taxane manufacturing platform and also access new markets.

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FDA approves two generic drugs and one clinical trial

The generic drugs industry got another boost when the US Food and Drug Administration (FDA) approved the generic versions of two more drugs.

KV Pharmaceutical Company has received approval from the FDA to market its Diltiazem HCl ER Capsules in six strengths. KV will market Diltiazem in the strengths of 120mg, 180mg, 240mg, 300mg, 360mg and 420mg through its subsidiary ETHEX Corporation as soon as possible. Also, since it is the first company to be allowed to market the 420mg strength dosage, KV hopes to get six months exclusivity on it. Diltiazem is the generic version of Tiazac, a product from the stable of Forest Pharmaceuticals, Inc. Tiazac is a calcium channel blocker used to treat hypertension and angina.

Another approval the FDA has granted is to Mylan Pharmaceuticals Inc, a subsidiary of Mylan Laboratories Inc, for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets. The strengths granted final approval are 25mg, 100mg and 200mg and Mylan is eligible for a 180-day market exclusivity for them. Topiramate 50mg has been granted tentative approval. Topiramate Tablets are the generic version of Topamax Tablets, manufactured by Ortho-McNeil.

Meanwhile, the FDA has cleared Iomai Corporation to begin a trial that will compare the immune response of the needle-free, patch-based influenza vaccine and the traditional vaccine. The trial volunteers will either be injected with a single dose of the traditional vaccine or will be given the Iomai patch to wear. Blood tests will then be conducted to analyze the two methods. Around 300 volunteers are expected to be enrolled in this trial, which will commence later this month.

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FDA nod for some generic drugs

The US Food and Drug Administration (FDA) has granted approval to Ohm Laboratories Inc for manufacturing and marketing Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC). The FDA has established that these tablets are bioequivalent to Imodium Advanced Caplets manufactured by McNeil Consumer and Specialty Pharmaceuticals. The tablets are meant to treat the symptoms of diarrhea, bloating, pressure and cramps. Ohm is a wholly owned subsidiary of India’s Ranbaxy Laboratories Limited and the approval for a 180 day marketing exclusivity has given a boost to the Indian generic drugs industry.

Meanwhile, the FDA also permitted Watson Pharmaceuticals to market a generic version of Seasonale, an oral contraceptive. Watson plans to unveil its product very soon and sell it under the name of Quasense. Though it lost its patent rights on Seasonale, Barr Laboratories has decided to combat Watson by launching its generic version of Seasonale, called Jolessa. Watson’s challenge did not deter Barr Pharmaceuticals Inc from upping its bid for Pliva to USD 2.5 billion. Icleand’s Actavis Group too is in the race to acquire the Croatian drug maker as it will give access to a growing sector of the European generic drugs market.

The FDA has also received an Abbreviated New Drug Application (ANDA) from Taro Pharmaceutical Industries Ltd for selling a generic version of Trileptal. The application is for permission to sell oxcarbazepine tablets in doses of 150, 300 and 600 mg. Novartis AG sells Trileptal as a treatment for partial seizures in adults and has filed a lawsuit against Taro to protect its patent rights.

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FDA approvals for devices and drugs

The US Food and Drug Administration (FDA) has approved the first artificial heart. The FDA granted Abiomed Inc, the developer of the heart, a humanitarian exemption that allows the firm to sell up to 4,000 artificial hearts in a year. The device is fully contained within the chest and does not have any outside wires. The power for the device comes from a battery belt. The company plans to train five hospitals around the country in implanting the hearts. However, its high cost of USD 25,000 and its large size are likely to put it outside the reach of many needy patients.

Meanwhile, the FDA has also cleared a new defibrillator. ZOLL Medical Corporation was granted the 510(k) marketing clearance for its new defibrillator designed for hospital use. The product is expected to be launched in 2007. Per Richard A Packer, President and Chief Executive Officer of ZOLL, like its other devices, the new device too will “help to address the worldwide problem of death from sudden cardiac arrest.”

The FDA has approved not only devices but drugs too. Taro Pharmaceutical Industries Ltd announced that it has received approval for its generic versions of an epilepsy treatment and injectable products. It is now allowed to manufacture 100 mg capsules of phenytoin sodium, the main ingredient in Pfizer Inc’s Dilantin Kapseals. Taro’s Irish unit too has received approvals for manufacturing products bioequivalent to comparable products of Hospira, Inc.

On the other hand, Cardinal Health Inc stated that the FDA has approved its manufacture of Panhematin, the first FDA-approved treatment for acute porphyria. The drug, owned by Ovation Pharmaceuticals Inc, will be the first to be produced at Cardinal’s new sterile plant.

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New FDA drug approvals

The United States Food and Drug Administration (FDA) has granted approval to one generic drug and two new drugs this week.

Several Abbreviated New Drug Applications (ANDAs) for generic versions of CIPRO IV have received approval from the FDA. CIPRO IV is manufactured by Bayer Corporation Pharmaceutical Division and is used to treat bacterial infections including lower respiratory tract infections, skin and skin structure infections and intraabdominal infections. Generic companies can now sell Ciprofloxacin Injection USP, at a concentration of 10mg/mL in vials of 20 mL and 40 mL and a bulk pack of 120 mL. The generic firms who have received the approval are Abraxis Pharm, Bedford Labs, Hospira and Sicor Pharms. The approval is part of the ongoing efforts of the agency to make safe and effective lower-cost generic medications available to the public.

Meanwhile, the Indian pharmaceutical firm Strides Arcolab received its second ANDA approval when the FDA granted tentative approval for Stavudine Capsules USP. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) program, as Stavudine is an important anti-retro viral in the treatment of AIDS. The approval is for the dosages of 30mg and 40 mg.

After much debate, the FDA has permitted the sale of the contraceptive pill Plan B as an over-the-counter option for women 18 years or older. However, women 17 years or younger in age will need a prescription for the drug. Duramed, a division of Barr Pharmaceuticals has committed to sell the drug with a rigorous labeling, packaging, education, distribution and monitoring program.

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