Wednesday, March 19, 2008
Hi-Tech Pharmacal Receives Final Approval for Ofloxacin Otic Solution
Mar 18, 2008 - Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Ofloxacin otic solution, 0.3%. Hi-Tech's Ofloxacin otic solution is the generic equivalent of Daiichi's Floxin(R) otic solution, 0.3% indicated for the treatment of bacterial infections of the ear which in 2007, had sales of $105 million according to IMS.
Tuesday, March 18, 2008
Are generics safe and effective as Brand name Drugs?
The Los Angeles Times is serving up a package of stories this morning questioning whether generic drugs are as good as the brand-name medications they copy.
The Times cites complaints about a variety of generics, including drugs for epilepsy, depression and the heart. It tells the story of patients like Jillian Bealer, of Buffalo, N.Y., who’d been taking antidepressant Wellbutrin XL for attention deficit disorder and an anxiety disorder. But after switching to a generic, her mental health deteriorated. While the FDA defends its generic-drug approval practice and says it’s confident generics are equivalent to brands, the Times quotes a number of doctors who say they’re not convinced.
Like Times, we found that both doctors and patients felt passionately that generics weren’t always up to mark. But despite lots of searching, we couldn’t find a solid, randomized and well-controlled study proving there was a problem. The Epilepsy Foundation and allied doctors acknowledged they didn’t have one either.
My own thinking says generics are good enough as branded products.
Today's Question: Do you think that Generics are good enough as Branded products w.r.t safety or efficacy? Please comment.
The Times cites complaints about a variety of generics, including drugs for epilepsy, depression and the heart. It tells the story of patients like Jillian Bealer, of Buffalo, N.Y., who’d been taking antidepressant Wellbutrin XL for attention deficit disorder and an anxiety disorder. But after switching to a generic, her mental health deteriorated. While the FDA defends its generic-drug approval practice and says it’s confident generics are equivalent to brands, the Times quotes a number of doctors who say they’re not convinced.
Like Times, we found that both doctors and patients felt passionately that generics weren’t always up to mark. But despite lots of searching, we couldn’t find a solid, randomized and well-controlled study proving there was a problem. The Epilepsy Foundation and allied doctors acknowledged they didn’t have one either.
My own thinking says generics are good enough as branded products.
Today's Question: Do you think that Generics are good enough as Branded products w.r.t safety or efficacy? Please comment.
Monday, March 17, 2008
Neurochem Withdraws Its Marketing Authorisation Application for Kiacta (eprodisate disodium)
March 17, 2008-The European Medicines Agency (EMEA) has been formally notified by Neurochem Luxco II SARL of its decision to withdraw the application for a centralised marketing authorisation for the medicine Kiacta (eprodisate disodium) capsules.
Kiacta was expected to be used for the treatment of amyloid A amyloidosis, a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
The application for marketing authorisation for Kiacta was submitted to the EMEA on 4 September 2006. The Agency’s Committee for Medicinal Products for Human Use (CHMP) had given a negative opinion recommending the refusal of the marketing authorisation on 13 December 2007. The company had requested a re-examination of the negative opinion. The re-examination had not yet finished when the company withdrew.
In its official letter, the company stated that the withdrawal of Kiacta was based on the request by the CHMP for an additional placebo-controlled study, which the company is not able to provide within the timeframe allowed by the centralised procedure.
More information about Kiacta and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.
Kiacta was expected to be used for the treatment of amyloid A amyloidosis, a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
The application for marketing authorisation for Kiacta was submitted to the EMEA on 4 September 2006. The Agency’s Committee for Medicinal Products for Human Use (CHMP) had given a negative opinion recommending the refusal of the marketing authorisation on 13 December 2007. The company had requested a re-examination of the negative opinion. The re-examination had not yet finished when the company withdrew.
In its official letter, the company stated that the withdrawal of Kiacta was based on the request by the CHMP for an additional placebo-controlled study, which the company is not able to provide within the timeframe allowed by the centralised procedure.
More information about Kiacta and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.
Abraxis Bioscience Announces Filing of Marketing Application in Japan for Abraxane in the Treatment of Breast Cancer
Mar 17, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that its partner, Taiho Pharmaceutical Co., Ltd., has filed a Japanese New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare in Japan to market ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer. ABRAXANE is the first and only approved protein-bound nanometer-sized solvent-free taxane and is the first commercial product to validate Abraxis' proprietary nab(TM) technology platform.
"The J-NDA application is an important milestone as we broaden the use of ABRAXANE on a global basis," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "This submission in Japan was the result of close collaboration between the Taiho and Abraxis development teams, and followed the completion of phase I bridging studies in Japan."
ABRAXANE is now approved in Europe, the U.S., India and Canada, encompassing a total of 33 countries. ABRAXANE also is under active review in Australia, Russia, Korea and China by their respective regulatory agencies.
The submission in Japan includes four clinical studies that were part of the original New Drug Application in the United States, including the randomized, pivotal Phase 3 multicenter, comparative study of 460 women with metastatic breast cancer conducted by Abraxis and published in the Journal of Clinical Oncology. This randomized trial compared ABRAXANE at a dose of 260 mg/m2 given as a 30-minute infusion without pre-medication versus solvent-based paclitaxel injection (Taxol(R)) at 175 mg/m2 given as a 3-hour infusion with standard steroid and antihistamine pre-medication. The Phase 3 study demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival in the approved indication, and showed comparable tolerability versus Taxol. Additionally, the submission in Japan included several subsequent Phase I and Phase 2 studies, including two conducted by Taiho.
Abraxis BioScience has entered into a license agreement with Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Pharmaceutical Co. Ltd., under which it granted to Taiho the exclusive rights to develop, market and sell ABRAXANE in Japan. A joint committee also was established to oversee the development of ABRAXANE in Japan for the treatment of breast, lung and gastric cancer and other solid tumors. The market for chemotherapy agents in Japan is estimated at approximately $2.6 billion in 2007.
"The J-NDA application is an important milestone as we broaden the use of ABRAXANE on a global basis," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "This submission in Japan was the result of close collaboration between the Taiho and Abraxis development teams, and followed the completion of phase I bridging studies in Japan."
ABRAXANE is now approved in Europe, the U.S., India and Canada, encompassing a total of 33 countries. ABRAXANE also is under active review in Australia, Russia, Korea and China by their respective regulatory agencies.
The submission in Japan includes four clinical studies that were part of the original New Drug Application in the United States, including the randomized, pivotal Phase 3 multicenter, comparative study of 460 women with metastatic breast cancer conducted by Abraxis and published in the Journal of Clinical Oncology. This randomized trial compared ABRAXANE at a dose of 260 mg/m2 given as a 30-minute infusion without pre-medication versus solvent-based paclitaxel injection (Taxol(R)) at 175 mg/m2 given as a 3-hour infusion with standard steroid and antihistamine pre-medication. The Phase 3 study demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival in the approved indication, and showed comparable tolerability versus Taxol. Additionally, the submission in Japan included several subsequent Phase I and Phase 2 studies, including two conducted by Taiho.
Abraxis BioScience has entered into a license agreement with Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Pharmaceutical Co. Ltd., under which it granted to Taiho the exclusive rights to develop, market and sell ABRAXANE in Japan. A joint committee also was established to oversee the development of ABRAXANE in Japan for the treatment of breast, lung and gastric cancer and other solid tumors. The market for chemotherapy agents in Japan is estimated at approximately $2.6 billion in 2007.
Takeda Submitted a New Drug Application for a Fixed Dose Combination Tablet of Blopress with Diuretic in Japan for Treatment of Hypertension
March 17, 2008 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it submitted a New Drug Application of a fixed dose combination tablet of Blopress® (generic name: candesartan cilexetil) and diuretic (generic name: hydrochlorothiazide) for treatment of hypertension to the Ministry of Health, Labour and Welfare in Japan.
Discovered by Takeda, Blopress is an angiotensin II[*] receptor blocker (“ARB”), which was launched in 1999 and became the first ARB with an indication of Chronic Heart Failure in Japan. Hydrochlorothiazide is classified as a thiazide diuretic and lowers the blood pressure by increasing the flow of urine, which results in volume depletion. It is considered that there is a synergistic anti-hypertensive effect by concominant therapy of ARB and diuretic.
[*] Angiotensin II is known as one of the potent vasopressor hormones.
“We believe that the fixed dose combination tablet of Blopress with diuretic will be able to offer the better control of blood pressure,” said Masaomi Miyamoto, Ph.D., general manager of Pharmaceutical Development Division of Takeda. “We expect that this New Drug Application lead to maximization of added value of Blopress.”
Takeda is persuing every possiblity of fixed dose combination for its product line, which will contribute to the patient’s improved compliance. Currently, the fixed dose combinations of; Actos® (generic name: pioglitazone HCl) which is a member of the thiazolidinedione class of "insulin-sensitizing" agents with sulfonylurea ?generic name: glimepiride HCl?, and Actos with biganide (generic name: metformin HCl) are being marketed in overseas.
Discovered by Takeda, Blopress is an angiotensin II[*] receptor blocker (“ARB”), which was launched in 1999 and became the first ARB with an indication of Chronic Heart Failure in Japan. Hydrochlorothiazide is classified as a thiazide diuretic and lowers the blood pressure by increasing the flow of urine, which results in volume depletion. It is considered that there is a synergistic anti-hypertensive effect by concominant therapy of ARB and diuretic.
[*] Angiotensin II is known as one of the potent vasopressor hormones.
“We believe that the fixed dose combination tablet of Blopress with diuretic will be able to offer the better control of blood pressure,” said Masaomi Miyamoto, Ph.D., general manager of Pharmaceutical Development Division of Takeda. “We expect that this New Drug Application lead to maximization of added value of Blopress.”
Takeda is persuing every possiblity of fixed dose combination for its product line, which will contribute to the patient’s improved compliance. Currently, the fixed dose combinations of; Actos® (generic name: pioglitazone HCl) which is a member of the thiazolidinedione class of "insulin-sensitizing" agents with sulfonylurea ?generic name: glimepiride HCl?, and Actos with biganide (generic name: metformin HCl) are being marketed in overseas.
Tianyin Pharmaceutical Announces SFDA Approval to Market Azithromycin Dispersible Tablets
Tianyin Pharmaceutical, Co., Inc., , a manufacturer and supplier of modernized traditional Chinese medicine (''TCM'') based in Chengdu, China, today announced that the Company has been granted SFDA approval and is scheduled to launch Azithromycin Dispersible Tablets in the domestic market on April 15, 2008.
The manufacturing license for Azithromycin Dispersible Tablets is not only the first one Tianyin has received but also the first drug approval SFDA has granted to Sichuan Province in 2008. This is the third generic western medicine to be included in Tianyin's product portfolio. The Company will continue to diversify its TCM products, with additional western medicines as they receive approvals for the 10 drugs that are currently in the SFDA pipeline.
Azithromycin is highly effective in treating upper and lower respiratory tract infections and other bacterial infections in skins and reproductive system. Ever since the drug's first introduction, its sales have been growing steadily. Worldwide sales have grown from US$ 619 million in 1996 to $2.01 billion in 2003, representing a 32.6% growth over the previous year. Azithromycin has become a blockbuster product and is now among the TOP 50 prescription drugs in terms of global sales. It is estimated that approximately $350 million in total Azithromycin sales were generated in China during 2007.
''We are pleased to have the first of our pipeline products approved by the SFDA and believe that the launch of Azithromycin provides the opportunity for significant growth in both sales revenue and net profit in the coming years,'' stated Dr. Guoqing Jiang, Chairman and CEO.
The largest domestic distributor of Azithromycin, Anhui Huayuan Pharmaceutical Co., Ltd. is currently one of Tianyin's top strategic partners and has awarded the Company a $3.66 million distribution contract for 2008 covering most of the PRC for Azithromycin and other products. Margins associated with this product are in line with the Company's blended average during the past year. This collaboration will help speed the market entry of Tianyin's Azithromycin Dispersible Tablets and enable the Company to leverage its National SFDA manufacturing approval to gain market share throughout China.
The manufacturing license for Azithromycin Dispersible Tablets is not only the first one Tianyin has received but also the first drug approval SFDA has granted to Sichuan Province in 2008. This is the third generic western medicine to be included in Tianyin's product portfolio. The Company will continue to diversify its TCM products, with additional western medicines as they receive approvals for the 10 drugs that are currently in the SFDA pipeline.
Azithromycin is highly effective in treating upper and lower respiratory tract infections and other bacterial infections in skins and reproductive system. Ever since the drug's first introduction, its sales have been growing steadily. Worldwide sales have grown from US$ 619 million in 1996 to $2.01 billion in 2003, representing a 32.6% growth over the previous year. Azithromycin has become a blockbuster product and is now among the TOP 50 prescription drugs in terms of global sales. It is estimated that approximately $350 million in total Azithromycin sales were generated in China during 2007.
''We are pleased to have the first of our pipeline products approved by the SFDA and believe that the launch of Azithromycin provides the opportunity for significant growth in both sales revenue and net profit in the coming years,'' stated Dr. Guoqing Jiang, Chairman and CEO.
The largest domestic distributor of Azithromycin, Anhui Huayuan Pharmaceutical Co., Ltd. is currently one of Tianyin's top strategic partners and has awarded the Company a $3.66 million distribution contract for 2008 covering most of the PRC for Azithromycin and other products. Margins associated with this product are in line with the Company's blended average during the past year. This collaboration will help speed the market entry of Tianyin's Azithromycin Dispersible Tablets and enable the Company to leverage its National SFDA manufacturing approval to gain market share throughout China.
Anesiva submits sNDA to US FDA to expand indication for Zingo
Anesiva, Inc. has submitted a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) to expand the indication for Zingo to treat the pain associated with peripheral IV insertions and blood draws in adults. Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system is already approved by the FDA to provide local analgesia prior to peripheral IV insertions and blood draws in children three to 18 years of age.
The sNDA submission is based on results of a multi-centre, randomised, double-blind study in 699 adult patients, which demonstrated less procedural pain associated with blood draws or IV cannulations in those treated with Zingo compared to placebo. Of the study participants, 348 patients received placebo and 345 received Zingo one to three minutes before undergoing medical procedures requiring venipuncture or IV line placement at the back of hand or antecubital fossa (crux of the elbow). The primary endpoint was pain upon needle insertion, utilizing the VAS pain scale. The mean pain score in the Zingo-treated patients was significantly lower than in the placebo group (p = 0.003).
Demographic characteristics and sites of administration were evenly distributed across treatment groups. Zingo was found to be well tolerated in this patient population. The most common skin assessment findings were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration. The incidence of adverse events with Zingo was no higher than with placebo.
"The initial commercial thrust for Zingo is in the paediatric setting, where we have focused our marketing efforts and have an experienced sales force already in place in advance of the planned commercial availability of Zingo in the second quarter of 2008," said John P. McLaughlin, chief executive officer, Anesiva. "Filing the sNDA for Zingo in adults represents another key milestone in Anesiva's efforts to expand and accelerate the growth of Zingo, and potentially offers a solution for adults concerned about pain associated with venous access procedures."
Peripheral venous access procedures are among the most common procedures performed at a hospital, with more than 400 million performed each year in US hospitals on adults. More than 60 million of these procedures take place in the emergency department, and another 27 million IV line placements are associated with pre-surgery procedures.
Zingo is an easy-to-administer, single-use, needle-free system that delivers sterile lidocaine powder to provide topical, local analgesia to reduce the pain associated with peripheral IV insertions or blood draws. Zingo's rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after administration. In clinical trials, the most common adverse events with Zingo were redness, red dots and swelling.
The sNDA submission is based on results of a multi-centre, randomised, double-blind study in 699 adult patients, which demonstrated less procedural pain associated with blood draws or IV cannulations in those treated with Zingo compared to placebo. Of the study participants, 348 patients received placebo and 345 received Zingo one to three minutes before undergoing medical procedures requiring venipuncture or IV line placement at the back of hand or antecubital fossa (crux of the elbow). The primary endpoint was pain upon needle insertion, utilizing the VAS pain scale. The mean pain score in the Zingo-treated patients was significantly lower than in the placebo group (p = 0.003).
Demographic characteristics and sites of administration were evenly distributed across treatment groups. Zingo was found to be well tolerated in this patient population. The most common skin assessment findings were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration. The incidence of adverse events with Zingo was no higher than with placebo.
"The initial commercial thrust for Zingo is in the paediatric setting, where we have focused our marketing efforts and have an experienced sales force already in place in advance of the planned commercial availability of Zingo in the second quarter of 2008," said John P. McLaughlin, chief executive officer, Anesiva. "Filing the sNDA for Zingo in adults represents another key milestone in Anesiva's efforts to expand and accelerate the growth of Zingo, and potentially offers a solution for adults concerned about pain associated with venous access procedures."
Peripheral venous access procedures are among the most common procedures performed at a hospital, with more than 400 million performed each year in US hospitals on adults. More than 60 million of these procedures take place in the emergency department, and another 27 million IV line placements are associated with pre-surgery procedures.
Zingo is an easy-to-administer, single-use, needle-free system that delivers sterile lidocaine powder to provide topical, local analgesia to reduce the pain associated with peripheral IV insertions or blood draws. Zingo's rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after administration. In clinical trials, the most common adverse events with Zingo were redness, red dots and swelling.
Glenmark launches Clobetasol products in US
Glenmark Pharmaceuticals Inc (GPI), the US subsidiary of Glenmark Pharmaceuticals Limited, one of the world's leading, integrated specialty pharmaceutical and high-quality generic companies, has commenced marketing and distribution of five Clobetasol Propionate dermatology products in the US market.
The company has acquired the US marketing rights for a line of Clobetasol Propionate products which include - cream, E cream, ointment, gel and topical solution through an US-based pharmaceutical development company, a company press release said.
Clobetasol Propionate is used to treat diseases such as eczema and psoriasis, where it is used on the scalp and body. It is also dispensed to counter auto-immune presentations, such as Alopecia areata (hair loss due to auto-immune diseases) and Lichen planus (auto immune skin nodules). The total sales for the five above mentioned Clobetasol Propionate products in the 12 month period ending December 2007 were in excess of USD 28 million, as per the IMS Health report.
This dermatology portfolio marks Glenmark's entry into the US semisolid product market. The company plans to launch an additional 11 dermatological products in the next 12 months.
Based on these recent launches, GPI now has a portfolio of 28 generic products for the US market. The company currently has over 35 ANDAs undergoing US FDA approval process/launch.
The company has acquired the US marketing rights for a line of Clobetasol Propionate products which include - cream, E cream, ointment, gel and topical solution through an US-based pharmaceutical development company, a company press release said.
Clobetasol Propionate is used to treat diseases such as eczema and psoriasis, where it is used on the scalp and body. It is also dispensed to counter auto-immune presentations, such as Alopecia areata (hair loss due to auto-immune diseases) and Lichen planus (auto immune skin nodules). The total sales for the five above mentioned Clobetasol Propionate products in the 12 month period ending December 2007 were in excess of USD 28 million, as per the IMS Health report.
This dermatology portfolio marks Glenmark's entry into the US semisolid product market. The company plans to launch an additional 11 dermatological products in the next 12 months.
Based on these recent launches, GPI now has a portfolio of 28 generic products for the US market. The company currently has over 35 ANDAs undergoing US FDA approval process/launch.
Sun Pharma gets US FDA nod for generic Ethyol
Sun Pharmaceutical Industries Ltd. said the US FDA has granted approval for its Abbreviated New Drug Application (ANDA) to market a generic version of MedImmune's Ethyol, amifostine for injection 500mg.
This generic amifostine for injection, used as an adjuvant in cancer treatment, is therapeutically equivalent to MedImmune's Ethyol amifostine for injection 500mg. Ethyol has annual sales of approximately USD 80 million in the US.
Sun Pharma, being the first-to-file an ANDA for generic Ethyol with a para IV certification, has a 180-day marketing exclusivity.
Ethyol is covered under 3 patents - '471 (July 31, 2012), '731 (July 31, 2012) and '409 (Dec 8, 2017). This ANDA was filed with para IV certification against all the patents. Medimmune filed a suit in the District Court of Maryland and the case is under litigation.
Sun Pharma's amifostine for injection will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin.
This generic amifostine for injection, used as an adjuvant in cancer treatment, is therapeutically equivalent to MedImmune's Ethyol amifostine for injection 500mg. Ethyol has annual sales of approximately USD 80 million in the US.
Sun Pharma, being the first-to-file an ANDA for generic Ethyol with a para IV certification, has a 180-day marketing exclusivity.
Ethyol is covered under 3 patents - '471 (July 31, 2012), '731 (July 31, 2012) and '409 (Dec 8, 2017). This ANDA was filed with para IV certification against all the patents. Medimmune filed a suit in the District Court of Maryland and the case is under litigation.
Sun Pharma's amifostine for injection will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin.
Sunday, March 16, 2008
Eisai Submits Application for Aricept Oral Jelly Formulation in Japan
TOKYO, March 14, 2008-Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that the company submitted an application for a new oral jelly formulation of Aricept® (donepezil hydrochloride) in Japan. If approved, it will become the first Alzheimer's disease treatment available in an oral jelly formulation in the world.
Generally, Alzheimer's disease affects eldery population, and there are some patients who have difficulty swallowing a tablet or granule formulation with water due to the decline in their ability to swallow or the water enters into their trachea while taking the medication. For the patients with such problems, the new jelly formulation will make it easier to administer with the soft and jelly-like texture which can be taken without water. In addition, it can be devided with a spoon into an appropriate volume depending on the patient's ability to swallow, which reduces the burden of caregivers who help their patients take the medication.
Aricept®, an acetylcholinesterase inhibitor developed by Eisai Co., Ltd., is the only approved prescription medicine for the treatment of Alzheimer's disease in Japan. It is believed to work by inhibiting the hydrolysis of acetylcholine, thereby increasing available levels of this neurotransmitter in the brain. It is estimated that there are approximately 1.25 million people with Alzheimer's disease in Japan, and the number is set to increase every year as the aging of the society is progressed.
In Japan, Aricept® is available in tablets, fine granule, and orally rapid disintegrating tablets. Through the addition of the new oral jelly formulation of Aricept® that helps patients adhere to taking medications appropriately, Eisai will continue to make contributions to improving the quality of life of Alzheimer's disease patients, their families and caregivers.
Generally, Alzheimer's disease affects eldery population, and there are some patients who have difficulty swallowing a tablet or granule formulation with water due to the decline in their ability to swallow or the water enters into their trachea while taking the medication. For the patients with such problems, the new jelly formulation will make it easier to administer with the soft and jelly-like texture which can be taken without water. In addition, it can be devided with a spoon into an appropriate volume depending on the patient's ability to swallow, which reduces the burden of caregivers who help their patients take the medication.
Aricept®, an acetylcholinesterase inhibitor developed by Eisai Co., Ltd., is the only approved prescription medicine for the treatment of Alzheimer's disease in Japan. It is believed to work by inhibiting the hydrolysis of acetylcholine, thereby increasing available levels of this neurotransmitter in the brain. It is estimated that there are approximately 1.25 million people with Alzheimer's disease in Japan, and the number is set to increase every year as the aging of the society is progressed.
In Japan, Aricept® is available in tablets, fine granule, and orally rapid disintegrating tablets. Through the addition of the new oral jelly formulation of Aricept® that helps patients adhere to taking medications appropriately, Eisai will continue to make contributions to improving the quality of life of Alzheimer's disease patients, their families and caregivers.
Cellectis Sues Precision BioSciences for Infringement of its Patents Concerning Meganuclease Technology
March 13, 2008 /PRNewswire-FirstCall/ -- Cellectis SA , a world leader in rational genome engineering, has announced today that it filed a patent infringement lawsuit against Precision BioSciences, Inc. in the United States District Court for the Eastern District of North Carolina. The lawsuit seeks a declaration that, by making and selling certain meganucleases, Precision BioSciences infringes two Cellectis patents relating to its proprietary meganuclease recombination systems. The Precision Biosciences' meganucleases at issue are intended to target site-specific DNA breaks and effect a desired genome modification in a given transgenic organism, such as a plant. The lawsuit seeks both monetary damages for infringement, as well as a permanent injunction preventing Precision BioSciences from any further making, using or selling of such meganucleases. "We take our intellectual property rights very seriously and intend to vigorously pursue this patent infringement case," said Dr. Andre Choulika, CEO and co-founder of Cellectis SA., and the man who participated in coining the term "meganuclease."
Since its creation in January 2000 and throughout its development, Cellectis has made special efforts to protect new discoveries made by its research team as well as those of its partner, the world-renowned Institut Pasteur. Cellectis currently owns the exclusive rights to over 35 issued patents and 113 pending patent applications. Most of these patents are based on Cellectis' fully integrated genome engineering system referred to as its Meganuclease Recombination Systems (MRSs). These systems offer natural, efficient, precise and flexible genome surgery with several applications, among others, in the therapeutic area and in the plant science field.
Since its creation in January 2000 and throughout its development, Cellectis has made special efforts to protect new discoveries made by its research team as well as those of its partner, the world-renowned Institut Pasteur. Cellectis currently owns the exclusive rights to over 35 issued patents and 113 pending patent applications. Most of these patents are based on Cellectis' fully integrated genome engineering system referred to as its Meganuclease Recombination Systems (MRSs). These systems offer natural, efficient, precise and flexible genome surgery with several applications, among others, in the therapeutic area and in the plant science field.
Panacea Biotec revokes Cyclosporin patent of Novartis AG in Europe
European Patent Office in Munich has given the decision in the favor of Panacea Biotec Ltd. by revoking Novartis European Patent number EP1059913 in its entirety.
Panacea Biotec had filed an ‘Opposition’ in 2005 against European patent bearing patent number EP1059913 assigned to Novartis AG, entitled “Emulsion preconcentrates containing cyclosporine or a macrolide”. ‘Opposition’ proceedings’ by Panacea Biotec were filed on the grounds of ‘Lack of Novelty’ and ‘Inventive-step’ against EP1059913 over the prior arts cited by the opponent. ‘Novartis’ filed its response for the Opposition. Later on; Novartis filed two auxiliary requests in order to protect their granted patent. In August 2007, summons for ‘Oral hearing’ were issued to both the parties, ‘Opponent herein referred to as Panacea Biotec’ and ‘Patentee herein referred to as Novartis AG’. Subsequently on Oral hearing the European Patent - EP patent 1059913 was revoked on account of being taken of the amendments made by the patent proprietor (Novartis) during opposition proceedings such that the patent and the invention to which it relates were found not to meet the requirements of the EPC (Art. 101(3) (b) EPC).
This victory stands as the testimony for Panacea Biotec to be an Innovation focused company. Further; this case serves as one of the major victories by an Indian pharmaceutical company in the lucrative European market.
Panacea Biotec had filed an ‘Opposition’ in 2005 against European patent bearing patent number EP1059913 assigned to Novartis AG, entitled “Emulsion preconcentrates containing cyclosporine or a macrolide”. ‘Opposition’ proceedings’ by Panacea Biotec were filed on the grounds of ‘Lack of Novelty’ and ‘Inventive-step’ against EP1059913 over the prior arts cited by the opponent. ‘Novartis’ filed its response for the Opposition. Later on; Novartis filed two auxiliary requests in order to protect their granted patent. In August 2007, summons for ‘Oral hearing’ were issued to both the parties, ‘Opponent herein referred to as Panacea Biotec’ and ‘Patentee herein referred to as Novartis AG’. Subsequently on Oral hearing the European Patent - EP patent 1059913 was revoked on account of being taken of the amendments made by the patent proprietor (Novartis) during opposition proceedings such that the patent and the invention to which it relates were found not to meet the requirements of the EPC (Art. 101(3) (b) EPC).
This victory stands as the testimony for Panacea Biotec to be an Innovation focused company. Further; this case serves as one of the major victories by an Indian pharmaceutical company in the lucrative European market.
Thursday, March 13, 2008
Glenmark launches nabumetone & hydroxyzine tabs in US
Glenmark Pharmaceuticals Inc (GPI), the US subsidiary of Glenmark Pharmaceuticals Limited (Glenmark), has initiated the marketing and distribution of nabumetone tablets and hydroxyzine hydrochloride tablets in the US market.
Glenmark commenced shipping immediately upon final approval from the US Food and Drug Administration for an Abbreviated New Drug Application (ANDA) for nabumetone tablets in 500mg and 750mg strengths and hydroxyzine hydrochloride tablets in 10mg, 25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals Inc (InvaGen).
The company will exclusively market and distribute nabumetone and hydroxyzine hydrochloride tablets while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on nabumetone and hydroxyzine hydrochloride tablets' sale in the US will be shared equally between Glenmark and Invagen.
Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or inflammation caused by arthritis. According to IMS Health data, for the 12 month period ending December 2007, the market size of nabumetone was USD 97 million.
Hydroxyzine belongs to a group of medicines called sedating antihistamines. Its main use is to help in the treatment of anxiety. According to IMS Health data, for the 12 month period ending December 2007, the market size of hydroxyzine hydrochloride was USD 60 million.
Glenmark commenced shipping immediately upon final approval from the US Food and Drug Administration for an Abbreviated New Drug Application (ANDA) for nabumetone tablets in 500mg and 750mg strengths and hydroxyzine hydrochloride tablets in 10mg, 25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals Inc (InvaGen).
The company will exclusively market and distribute nabumetone and hydroxyzine hydrochloride tablets while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on nabumetone and hydroxyzine hydrochloride tablets' sale in the US will be shared equally between Glenmark and Invagen.
Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or inflammation caused by arthritis. According to IMS Health data, for the 12 month period ending December 2007, the market size of nabumetone was USD 97 million.
Hydroxyzine belongs to a group of medicines called sedating antihistamines. Its main use is to help in the treatment of anxiety. According to IMS Health data, for the 12 month period ending December 2007, the market size of hydroxyzine hydrochloride was USD 60 million.
District Court Upholds Validity of P&G's Actonel Patent, Rejecting Teva's Obviousness Arguments
(As per the article published on Orange book blog)
Proctor & Gamble v. Teva Pharms. USA, No. 04-940 (D. Del. 2008)
Late last month, the U.S. District Court for the District of Delaware (J. Farnan) upheld the validity of Proctor & Gamble's U.S. Patent No. 5,583,122, which claims risedronate sodium, the active ingredient in Actonel. Teva had challenged the '122 patent in a paragraph IV certification in its ANDA. P&G's U.S. sales of Actonel, which is indicated for the prevention and treatment of osteoporosis, were approximately $1 billion last year.
Teva alleged that the '122 patent is invalid as obvious in light of U.S. Patent No. 4,761,406, entitled "Regimen for Treating Osteoporosis." Alternatively, Teva alleged that the '122 patent is invalid for obviousness-type double patenting in view of the '406 patent. Specifically, Teva argued that the structural similarities between risedronate, claimed in the '122 patent, and 2-pyr EHDP, disclosed and claimed in the '406 patent, render claims 4, 16 and 23 of the '122 patent obvious.
The district court's opinion relies heavily on the Federal Circuit's decision last year in Takeda v. Alphapharm:
The Federal Circuit has held that "structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness." Takeda. In addition to structural similarities, the Federal Circuit has also required a showing of "adequate support in the prior art" for the change in structure. Id. Clarifying these principals further, the Federal Circuit has held that a prima facie case of unpatentability requires a "showing that the prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention."
Reviewing the evidence adduced at trial in light of these legal principles, the Court concludes that Teva has not established by clear and convincing evidence that "the prior art would have suggested making the specific molecular modifications necessary" to achieve risedronate. To begin, the Court is unpersuaded that a person of ordinary skill in the art would have selected 2-pyr EHDP as the "lead compound" out of the numerous compounds disclosed in the '406 patent.
The court further concluded, "even if Teva can establish a prima facie case of obviousness, Proctor & Gamble has demonstrated sufficient evidence of unexpected results regarding resedronate's potency and toxicity to rebut such a prima facie showing." Finally, the court determined that Teva had not proven double patenting, as "the same type of analysis is used for an obviousness-type double patenting inquiry as for a Section 103 obviousness inquiry."
The '122 patent won't expire until December 2013. Teva immediately announced its intention to appeal the district court's decision to the Federal Circuit.
Proctor & Gamble v. Teva Pharms. USA, No. 04-940 (D. Del. 2008)
Late last month, the U.S. District Court for the District of Delaware (J. Farnan) upheld the validity of Proctor & Gamble's U.S. Patent No. 5,583,122, which claims risedronate sodium, the active ingredient in Actonel. Teva had challenged the '122 patent in a paragraph IV certification in its ANDA. P&G's U.S. sales of Actonel, which is indicated for the prevention and treatment of osteoporosis, were approximately $1 billion last year.
Teva alleged that the '122 patent is invalid as obvious in light of U.S. Patent No. 4,761,406, entitled "Regimen for Treating Osteoporosis." Alternatively, Teva alleged that the '122 patent is invalid for obviousness-type double patenting in view of the '406 patent. Specifically, Teva argued that the structural similarities between risedronate, claimed in the '122 patent, and 2-pyr EHDP, disclosed and claimed in the '406 patent, render claims 4, 16 and 23 of the '122 patent obvious.
The district court's opinion relies heavily on the Federal Circuit's decision last year in Takeda v. Alphapharm:
The Federal Circuit has held that "structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness." Takeda. In addition to structural similarities, the Federal Circuit has also required a showing of "adequate support in the prior art" for the change in structure. Id. Clarifying these principals further, the Federal Circuit has held that a prima facie case of unpatentability requires a "showing that the prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention."
Reviewing the evidence adduced at trial in light of these legal principles, the Court concludes that Teva has not established by clear and convincing evidence that "the prior art would have suggested making the specific molecular modifications necessary" to achieve risedronate. To begin, the Court is unpersuaded that a person of ordinary skill in the art would have selected 2-pyr EHDP as the "lead compound" out of the numerous compounds disclosed in the '406 patent.
The court further concluded, "even if Teva can establish a prima facie case of obviousness, Proctor & Gamble has demonstrated sufficient evidence of unexpected results regarding resedronate's potency and toxicity to rebut such a prima facie showing." Finally, the court determined that Teva had not proven double patenting, as "the same type of analysis is used for an obviousness-type double patenting inquiry as for a Section 103 obviousness inquiry."
The '122 patent won't expire until December 2013. Teva immediately announced its intention to appeal the district court's decision to the Federal Circuit.
ProEthic Pharmaceuticals Announces Launch of Ibudone for Acute Pain
Mar 13, 2008 - ProEthic Pharmaceuticals, Inc. today announced the launch of Ibudone(TM) (hydrocodone bitartrate and ibuprofen tablets), a new prescription fixed combination of hydrocodone and ibuprofen for the short-term (generally less than 10 days) management of acute pain.
Ibudone provides the highest hydrocodone/ibuprofen dosage available - 10 mg of hydrocodone/ 200 mg of ibuprofen - in each tablet. Peak plasma levels are achieved in less than two hours. Ibudone is also available with 5 mg hydrocodone/ 200 mg of ibuprofen.
Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, "By combining 10 mg of hydrocodone with the gold standard NSAID, ibuprofen, Ibudone offers a powerful new option for relieving acute pain. It is important to note that Ibudone does not have the risk of acetaminophen liver toxicity, a leading cause of acute liver failure in the United States. In addition, Ibudone also offers physicians Schedule III prescribing convenience, a key issue with today's busy practices."
ProEthic acquired the exclusive marketing, sales and distribution rights to Ibudone from Vintage Pharmaceuticals (Huntsville, Alabama). To learn more about Ibudone, visit www.ibudone.com.
Ibudone provides the highest hydrocodone/ibuprofen dosage available - 10 mg of hydrocodone/ 200 mg of ibuprofen - in each tablet. Peak plasma levels are achieved in less than two hours. Ibudone is also available with 5 mg hydrocodone/ 200 mg of ibuprofen.
Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, "By combining 10 mg of hydrocodone with the gold standard NSAID, ibuprofen, Ibudone offers a powerful new option for relieving acute pain. It is important to note that Ibudone does not have the risk of acetaminophen liver toxicity, a leading cause of acute liver failure in the United States. In addition, Ibudone also offers physicians Schedule III prescribing convenience, a key issue with today's busy practices."
ProEthic acquired the exclusive marketing, sales and distribution rights to Ibudone from Vintage Pharmaceuticals (Huntsville, Alabama). To learn more about Ibudone, visit www.ibudone.com.
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