11/01/07 Lannett to Commence Marketing Meloxicam for Arthritis
PHILADELPHIA--(BUSINESS WIRE)--Jan 11, 2007 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, announced today that it will shortly commence distributing Meloxicam, the generic equivalent of Boehringer Ingelheim's Mobic(R). Sales of Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis, were approximately $1.4 billion for the twelve months ended November 2006, according to Wolters Kluwer.
Meloxicam will be supplied to Lannett by Unichem Laboratories, Inc., an India-based company with which Lannett formed a strategic alliance in 2004. The U.S. Food and Drug Administration (FDA) recently approved Unichem's Abbreviated New Drug Application (ANDA) for Meloxicam.
"Over the last several years, we have entered into a number of strategic alliances to augment our internal drug development program and expand the company's product offering," said Arthur Bedrosian, president and chief executive officer of Lannett Company. "While other generic manufacturers received their approvals for Meloxicam before Unichem, thus limiting its potential financial contribution to Lannett, we are pleased that our alliance with Unichem has produced its first tangible result and are hopeful of more to come."
10/01/07 MedImmune Announces District Court's Rejection of Sun Pharmaceutical's Motion to End Litigation Regarding Generic Amifostine
GAITHERSBURG, Md., January 10, 2007 /PRNewswire-FirstCall/ -- MedImmune, Inc. today announced that the U.S. District Court for the District of Maryland has rejected Sun Pharmaceutical Industries, Ltd.'s (Sun) motion to end the patent infringement action regarding Sun's proposed generic amifostine product. MedImmune Oncology, Inc. initially filed suit against Sun in August 2004.
MedImmune Oncology is a subsidiary of MedImmune, through which the company manufactures Ethyol(R) (amifostine). To date, Ethyol accounts for all oncology-based revenues for the company. Over the last several years, MedImmune has substantially increased the reinvestment of its revenue dollars back into research and development, in large part focused on expanding and advancing its oncology portfolio. As such, the company now has 20 oncology product candidates in various stages of development.
In yesterday's decision, the court specifically denied Sun's motion for summary judgment of non-infringement of MedImmune's U.S. Patent No. 5,591,731 (the '731 patent). At the same time, the court granted Sun's motion for summary judgment in part, ruling that Sun's proposed amifostine product does not infringe a different patent, U.S. Patent No. 5,424,471 (the '471 patent). The '731 and '471 patents cover Ethyol.
"This decision means that MedImmune may continue its efforts of vigorously enforcing the '731 patent against Sun,'" said William C. Bertrand, Jr., J.D., MedImmune's senior vice president and general counsel. "We are confident that we will prevail in this enforcement action. Additionally, we are considering our options with respect to appealing the decision on the '471 patent.'"
09/01/07 GPhA Praises Supreme Court Decision Allowing Swifter Resolution of Patent Disputes
Court Upholds Declaratory Judgments
ARLINGTON, Va., January 09, 2007 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today said the U.S. Supreme Court's decision in MedImmune v. Genentech is a win for consumers, enabling affordable medicines to reach the market in a timely manner. GPhA had filed a "friend of the court" brief in support of MedImmune, arguing that without declaratory judgments, the launch of affordable generic drugs would be unduly delayed, to the detriment of consumers.
"Today's decision is a victory for consumers and the entire healthcare system in the fight to reduce healthcare costs while improving care," said GPhA President and CEO Kathleen Jaeger. "By striking down the Federal Circuit's 'reasonable apprehension' test, the Supreme Court has ruled in favor of American consumers by making it harder for brand companies to delay generics from coming to market."
Jaeger pointed out that generics provide the same medicine and the same results as brands, yet at a significantly lower cost-as much as 80% less. In fact, generics save consumers and taxpayers billions of dollars each year in prescription drug costs.
The 1984 Hatch-Waxman Act sought to permit the resolution of patent disputes before the expiration of patents to accelerate consumer access to affordable medicines. In 2003, Congress recognized that some brand drug companies had sought to delay this infringement litigation, forcing generic companies to decide between launching a product with the risk of being sued and foregoing launching the product at all. In response, Congress expressly provided generic companies with the ability to bring declaratory judgment actions to promptly resolve patent disputes. Today's Supreme Court decision means that generic companies will now be able to use those provisions to benefit consumers with expedited market entry.
GPhA's friend of the court brief is available online at http://www.gphaonline.org/AM/TemplateRedirect.cfm?Template=/CM/ContentDisplay. cfm&ContentID=3121.
09/01/07 Akorn, Inc. Signs Exclusive Definitive Agreement For the Development and Supply of Three Ophthalmic ANDA Drug Products
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jan 9, 2007 - Akorn, Inc. (AMEX: AKN) today announced that it has signed a Definitive Agreement with Azad Pharma, a privately-held pharmaceutical company located in Toffen, Switzerland, to develop and supply Latanoprost, Bimatoprost and Travoprost, three ophthalmic ANDA drug products for the treatment of glaucoma. The total United States market size for these three products is $870M, according to 2006 IMS data.
The drug products are expected to be manufactured by Taejoon Pharmaceutical Co. Ltd., located in Seoul, South Korea. Azad is the Agent for Taejoon Pharmaceuticals in this Agreement. Taejoon and Azad are responsible for completion of the Regulatory dossiers and upon ANDA approval, will manufacture and supply the products to Akorn in a blow-fill seal container closure system.
Akorn is responsible for the Regulatory filings of the ANDA's and will own the ANDA's. As part of this Agreement, Akorn will have exclusive Marketing and Distribution rights for the three drug products in the U.S. and Canada. Akorn expects to launch and market the drug products based on their respective patent expiry dates.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "This Agreement continues to broaden our product development efforts in ophthalmology. Currently, we have eight ophthalmic ANDA submissions on file with the Office of Generic Drugs, have announced a tentative approval for Diclofenac, and are preparing to file an NDA for Akten, indicated for ocular anesthesia soon after announcing the results of our 200 patient clinical trial in January 2007.
"This Agreement with Azad and Taejoon represents Akorn's first Business Development partnership in the Pacific Rim."
Mike Baronian, Azad Pharma's Chairman and Chief Executive Officer stated, "Azad Pharma's focus is in Oncology and Ophthalmology and Akorn's core competence in Ophthalmology in the North American market makes it an ideal partner to penetrate this very exciting market , using Taejoon's excellent product portfolio."
04/01/07 Abraxis BioScience Launches Ondansetron Injection, USP
LOS ANGELES--(BUSINESS WIRE)--Jan 4, 2007 - Abraxis BioScience, Inc. (NASDAQ: ABBI), an integrated, global biopharmaceutical company, today announced that it has launched Ondansetron Injection, USP, the generic equivalent of GlaxoSmithKline's Zofran(R) Injection. According to IMS, sales in 2005 of ondansetron in the United States exceeded $587 million. The company markets ondansetron in AP-rated single-dose and multiple-dose bar coded, latex-free vials.
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin, and prevention of postoperative nausea and/or vomiting.
03/01/07 Mylan's Levothyroxine Sodium Tablets USP Approved as Generic Equivalent to Levothroid
PITTSBURGH, Jan. 3 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted the company approval to market its currently approved Levothyroxine Sodium Tablets, USP as a bioequivalent and, therefore, therapeutically equivalent (i.e. AB-rated) product to Levothroid(R) Tablets (manufactured by Lloyd Pharmaceuticals for Forest Laboratories Inc.).
The Mylan product is currently available in 0.025 mg, 0.050 mg, 0.075 mg, 0.088 mg, 0.100 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.150 mg, 0.175 mg, 0.200 mg and 0.300 mg strengths.
Total U.S. sales for all strengths of Levothroid(R) Tablets, USP were approximately $32.9 million for the 12-month period ended Sept. 30, 2006, according to data from IMS Health. Levothyroxine Sodium Tablets are approved for the treatment of hypothyroidism and pituitary TSH suppression.
Robert J. Coury, Mylan's Vice Chairman and CEO commented, "Once again, Mylan continues to lead the industry through our achievement of being the first and only company to offer an AB-rated generic alternative for all four Levothyroxine brands: Synthroid(R), Levoxyl(R), Unithroid(R) and Levothroid(R)."
Total U.S. sales for all Levothyroxine brands and generic equivalents were approximately $1 billion for the 12-month period ended Sept. 30, 2006, according to data from IMS Health.
02/01/07 Lupin Pharmaceuticals Announces Tentative Approval of Generic Zoloft
BALTIMORE, January 02, 2007 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg. Final approval is expected upon the expiration of the first ANDA filer's 180-day marketing exclusivity in February 2007.
Upon final approval, Lupin's Sertraline Tablets will be the AB-rated generic equivalent of Pfizer's ZOLOFT(R) Tablets, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $3.1 billion for the twelve months ended July 2006, based on IMS sales data.
02/01/07 Ranbaxy Granted Final U.S. FDA Approval to Manufacture and Market Atenolol Tablets
PRINCETON, N.J., January 02, 2007 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Tenormin(R) of AstraZeneca LP. Total annual market sales for Atenolol were $133.6 million (IMS - MAT: September 2006).
Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. Atenolol is also indicated for the long-term management of patients with angina pectoris due to coronary atherosclerosis and is also indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.
"We are pleased to receive this final FDA approval to market Atenolol tablets. This will further expand our product portfolio of affordable generic alternatives to the brand in the treatment of cardiovascular disorders. This approval is the result of a strategic alliance with Ipca Laboratories Ltd. of Mumbai, India, who will develop a number of generic prescription pharmaceutical products which will be marketed by RPI in the U.S. in the future following U.S. FDA approval. RPI labeled Atenolol tablets will be made available to our customers in the U.S. healthcare system during first quarter 2007," according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.
29/12/06 Bradley Pharmaceuticals Announces Launch of Authorized Generic of Pamine (methscopolamine bromide)
FAIRFIELD, N.J., December 29, 2006 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. reported today that A. Aarons, Inc., a subsidiary of Bradley Pharmaceuticals, has announced the launch of methscopolamine bromide tablets, an authorized generic of the Company's Pamine(R) tablets. The Company is currently accepting orders. The generic product is available in both 2.5 mg and 5 mg forms, and will meet the same level of quality and be manufactured with the same level of active and inactive pharmaceutical ingredients as Pamine(R) branded products. Pamine(R), currently marketed by Bradley through its Kenwood Therapeutics Division, is indicated as adjunctive therapy for peptic ulcer.
Bradley Pharmaceuticals Chairman, President and CEO, Daniel Glassman stated, "While Pamine (R) represented approximately 7% of Bradley Net Sales, during the nine months ended September 30, 2006, we proactively planned for this introduction and are pleased to be in a position to successfully execute our strategy of extending the life cycles of our established brands. The introduction of the Pamine(R) generic expands the A. Aarons line of generic products offered to the wholesale and chain pharmacy distribution channels. The A. Aarons subsidiary was launched in January of 2006 and its presence in the generic market is beginning to grow both in volume and acceptance. Consistent with other products that have experienced generic competition in our portfolio, we will continue to manufacture and distribute branded Pamine(R)."
Pamine(R) Tablets, like other anticholinergics, may produce drowsiness or blurred vision. Patients should be cautioned regarding activities requiring mental alertness, such as driving a motor vehicle or operating machinery. Diarrhea may be an early symptom of incomplete intestinal obstruction; in such cases, Pamine(R) is not appropriate treatment and may be harmful. Use of Pamine(R) is contraindicated in patients with glaucoma, blockage in the urinary tract, blockage in the gastrointestinal tract, decreased gastrointestinal motility, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, paralytic ileus, toxic megacolon complicating ulcerative colitis, and myasthenia gravis.
29/12/06 Savient Pharmaceuticals Announces Launch of Authorized Generic of Oxandrin with Watson Pharmaceuticals
EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Dec 29, 2006 - Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) ("Savient" or "the Company") announced today that Watson Pharmaceuticals (NYSE:WPI), under the terms of its previous supply and distribution agreement with Savient, has launched an A-B rated authorized generic of oxandrolone tablets, USP (C-III), an Oxandrin(R) brand equivalent product manufactured and supplied through Savient. The authorized generic product will be launched immediately and distributed by Watson in both the 2.5 mg and 10 mg dosages. The A-B rated authorized generic of oxandrolone tablets will continue to meet all quality control standards of the Oxandrin(R) brand and will contain the same active and inactive pharmaceutical ingredients. Oxandrin(R) is Savient's oral anabolic agent for the treatment of involuntary weight loss, a frequent and sometimes life-threatening condition associated with numerous disease states. Savient will continue to market and distribute the Oxandrin(R) brand product.
This action by Savient follows the denial by the Court of Appeals for the Federal Circuit on December 28, 2006, of the Company's motion for a preliminary injunction pending its appeal of the action of U.S. District Court for the District of New Jersey on December 12, 2006 lifting of the Temporary Restraining Order ("TRO") it had previously granted on December 4, 2006. Savient has been seeking these restraints under its pending lawsuit against Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company (NYSE:NVS), and Upsher-Smith Laboratories for infringement of Savient's methods of use patents for Oxandrin(R), in particular U.S. Patent Nos. 5,872,147 ("the '147' patent"); 6,090,799 ("the '799 patent"); 6,576,659 ("the '659 patent"); 6,670,351 ("the '351 patent"); and 6,828,313 ("the '313 patent").
"We are pleased to be launching our authorized generic of Oxandrin(R) with Watson, a leading marketer of prescription brand equivalent products," said Christopher Clement, President and Chief Executive Officer, of Savient. "Over the last three years we have been anticipating potential generic competition, and, as previously announced, made sure that we, in collaboration with Watson, would be prepared to make certain that both the brand and its A-B rated authorized generic formulation would be available to the patients who depend on Oxandrin(R) to manage involuntary weight loss, a debilitating and sometimes life-threatening condition associated with diseases such as AIDS, cancer, and chronic obstructive pulmonary disease. We remain resolute in that regard today and for the future.
"We have a strong balance sheet with nearly $200 million in cash and continue to make progress with our Phase 3 clinical trial of Puricase(R) for treatment failure gout, and do not expect these unrelated activities to affect those programs," concluded Mr. Clement.
28/12/06 Boca Pharmacal Receives FDA Approval for Generic Pamine and Pamine Forte Tablets
CORAL SPRINGS, Fla., December 28, 2006 /PRNewswire/ -- Boca Pharmacal, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Kenwood Therapeutics Pamine(R) (Methscopolamine Bromide) Tablets, 2.5 mg and Pamine(R) Forte (Methscopolamine Bromide) Tablets 5 mg. The Company plans to launch its product immediately.
Methscopolamine Bromide 2.5 mg and Methscopolamine Bromide 5 mg are indicated for the treatment of adjunctive therapy for the treatment of peptic ulcer.
Robert J Edwards Jr., Chairman and CEO commented that, "This is an exciting time for Boca Pharmacal. Methscopolamine Bromide is the first of many approvals we expect over the next twelve months. Our mission is to offer lower volume items that may have been overlooked by some of the larger generic companies. We do not plan to market the next blockbuster item coming off patent; but instead focus on delivering niche type products."
28/12/06 Canadian Federal Court of Appeals Rules in Sanofi-Aventis' Favor in the Canadian Plavix Notice of Compliance Proceedings
PARIS and NEW YORK, December 28, 2006 /PRNewswire-FirstCall/ -- Sanofi-aventis and Bristol-Myers Squibb announced today that the Canadian Federal Court of Appeals dismissed Apotex Inc.'s ("Apotex") appeal of the judgment of the Federal Court of Canada prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in connection with its 75mg clopidogrel bisulfate tablets. Absent a Notice of Compliance, Apotex cannot market its 75mg clopidogrel bisulfate tablets in Canada.
27/12/06 FDA Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution
ROCKVILLE, Md., Dec. 27, 2006-The Food and Drug Administration today approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy. The approval is an important step in the agency's effort to increase the availability of lower-cost generic medications. In 2005, Ondansetron was the 20th highest-selling brand-name drug in the United States in 2005, with sales totaling $839,256,543 as reported in the online magazine Drug Topics.
"This approval will result in significant savings for the American public," said Gary J. Buehler, director, Office of Generic Drugs. "Generic drugs are safe and effective alternatives to brand name drugs and undergo a thorough scientific and regulatory review."
The economic benefits of FDA's generic drug approval program are significant because generic drug products, which are used to fill over 50 percent of all prescriptions, frequently cost a fraction of the price of the brand-name drugs. Such savings are likely to increase as more competitors enter the market. (See http://www.fda.gov/cder/ogd/generic_competition.htm).
The Office of Generic Drugs reviews and takes action on generic drug applications as expeditiously as possible. The same thorough and rigorously scientific review standards of safety, efficacy and quality are applied to generic drug applications as are applied to new drug applications. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use.
For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm
26/12/06 Bedford Laboratories to Begin Shipping Injection USP
BEDFORD, OH – December 26, 2006 – Bedford Laboratories™, a division of Ben Venue Laboratories Inc., announced that it will begin marketing Ondansetron Injection USP as of December 26, 2006. This product is AP rated and is equivalent to Zofran® by GlaxoSmithKline. Ondansetron Injection USP is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. It is also indicated for prevention of postoperative nausea and/or vomiting.
“As part of our objective to offer an extensive selection of specialty products to meet the changing needs of healthcare professionals, we are pleased to announce the addition of Ondansetron Injection USP to our portfolio,” said David Gaugh, General Manager of Bedford Laboratories.
26/12/06 Dr. Reddy's Announces Final Approval of Ondansetron Tablets with 180-Days of Marketing Exclusivity
HYDERABAD, India--(BUSINESS WIRE)--Dec 27, 2006 - Dr. Reddy's Laboratories Limited (NYSE:RDY) announced today, that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application ("ANDA") for Ondansetron Hydrochloride Tablets, 4 mg, 8mg, 16 mg and 24 mg. As the first company to file an ANDA containing a paragraph IV certification for this product, Dr. Reddy's has been awarded a 180-day period of marketing exclusivity. The Company will commence the shipment of this product shortly.
GV Prasad, Vice-Chairman and CEO of Dr. Reddy's commented, "We are obviously pleased with the final approval of our generic version of Zofran(R) with 180-days of marketing exclusivity. With six product introductions to date in the current year, we are making good progress in building a sustainable base generics business with potential upsides in the US in the medium term. This reaffirms our commitment to developing one of the largest pipelines in the U.S. generic industry."
Dr. Reddy's Ondansetron Hydrochloride Tablets are the AB-rated generic equivalent of GSK's Zofran(R) Tablets, a product indicated for the prevention of nausea and vomiting associated with cancer treatment. The brand product has annual IMS sales (June 2006 MAT) of approximately $639 million.
Today's approval follows an order by the United States Court Of Appeals for the DC Circuit denying Apotex's request that the FDA not approve Dr. Reddy's generic Zofran(R) products pending a determination of its motion for a preliminary injunction.
26/12/06 Hospira Launches Ondansetron Injection
-- Medication To Be Offered in Multiple Delivery Formats --
LAKE FOREST, Ill., Dec. 26, 2006 -- Hospira, Inc. (NYSE:HSP), a leading global hospital products company, today announced the launch of ondansetron injection. The medication is the generic version of GlaxoSmithKline's Zofran®, which posted 2005 U.S. sales of more than $600 million. Ondansetron is an antiemetic used for the prevention of nausea and vomiting caused by cancer chemotherapy and anesthesia/surgery. It is available from Hospira in a 4 mg single-dose vial and a 40 mg multiple-dose vial.
"Ondansetron represents the most widely used antiemetic in its class, and we will offer the generic version in a broad number of injectable delivery systems," said Thomas G. Moore, vice president and general manager, Specialty Injectable Pharmaceuticals, Hospira. "This generic medication will provide customers with a less costly alternative to help improve the quality, safety and affordability of care."
Hospira will offer the only generic injectable ondansetron product portfolio that includes vials as well as a premix and a proprietary syringe (still pending review by the U.S. Food and Drug Administration). The iSecure™ syringe is a prefilled, disposable and ready-to-use syringe that will provide convenience and efficiency for the administration of injectable medications. To help hospitals reduce medication errors, Hospira also labels all of its injectable products with unit-of-use bar codes.
Hospira is the leading U.S. supplier of generic injectable pharmaceuticals, offering more than 130 generic injectable products in more than 600 dosages and formulations. The company's broad portfolio includes products for cardiovascular, anesthesia, anti-infectives, analgesics, emergency and other therapeutic areas.
Generic specialty injectables, including biosimilars, will continue to be a large growth opportunity for Hospira. More than $5 billion worth of proprietary, small-molecule pharmaceuticals will face patent expiration in the United States by the end of the decade. Additionally, biosimilars represent a large, emerging market with a growing number of patents for proprietary biopharmaceuticals expiring. Overall, the company today has more than 40 generic products in development.
26/12/06 U.S. Appeals Court Upholds Lilly's 2011 Zyprexa Patent
INDIANAPOLIS, December 26, 2006 /PRNewswire-FirstCall/ -- The Court of Appeals for the Federal Circuit in Washington, D.C., today affirmed the U.S. District Court's decision that upheld Eli Lilly and Company's Zyprexa(R) patent expiring in 2011. Oral arguments were heard on April 6, 2006, by the appeals court. On April 14, 2005, in the case of Eli Lilly and Company v. Zenith Goldline Pharmaceuticals et al., the U.S. District Court for the Southern District of Indiana ruled in favor of Lilly on all of the generic companies' patent challenges, including obviousness, double patenting, inequitable conduct, anticipation, and public use.
"Today's appeals court ruling not only affirms the validity of our patent, but upholds patent law that helps enable the significant investments required to develop the next generation of revolutionary medicines for the patients who need them," said Sidney Taurel, Lilly chairman and chief executive officer.
26/12/06 Celgene Notified of ANDA Filing for Thalidomide
SUMMIT, N.J., December 26, 2006 /PRNewswire-FirstCall/ -- Celgene Corporation announced that the Company has been notified of an Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA), with a Paragraph IV certification, by Barr Pharmaceuticals, Inc. This applicant is seeking authorization to market a generic version of thalidomide 100 mg and 50 mg tablets in the United States for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Celgene Corporation markets thalidomide under the brand name THALOMID(R) and has approval to market as a treatment in combination with dexamethasone for newly diagnosed multiple myeloma, as well as for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
Celgene intends to file a complaint alleging infringement of Celgene patents, within the required forty-five day response period. By bringing suit, Celgene is entitled to up to a 30-month injunction against the applicant's marketing of generic thalidomide. Celgene has seven issued patents in the Orange Book with expiration dates of 2018 and 2020, which cover methods of more safely administering pharmaceutical products, including thalidomide through S.T.E.P.S.(R), an integral part of the FDA approved THALOMID labeling. Furthermore, Celgene holds additional broad patents protecting methods of using thalidomide in the treatment of hematological and solid tumor cancers.
Celgene intends to vigorously protect and defend its intellectual property rights against infringement. Marketing of an FDA-approved generic thalidomide may not commence until FDA approval of the generic and either a decision favorable to the ANDA applicant
26/12/06 Barr Confirms Generic Thalomid Capsule, 50 mg and 100 mg Application
WOODCLIFF LAKE, N.J., December 26, 2006 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today confirmed that it is seeking approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Celgene Corporation's Thalomid(R) (thalidomide) Capsules, 50 mg and 100 mg.
Barr filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Thalomid Capsules with the FDA in September 2006. As originally filed, that ANDA sought approval to manufacture and market the 200 mg strength. The Company received notification of the application's acceptance for filing from the FDA on December 5, 2006. Following receipt of the notice from the FDA, Barr notified Celgene, the patent owner and New Drug Applications (NDA) holder. Also in December 2006, the Company amended its application to include the 50 mg and 100 mg capsule strengths.
On December 13, 2006, Celgene confirmed it had received notification of Barr's ANDA on file with the FDA containing a Paragraph IV certification for Thalomid Capsules, 200 mg. Celgene indicated that it intends to file a complaint alleging infringement of the patents protecting Thalomid Capsules, 200 mg within the required forty-five day response period.
On November 28, 2006, the U.S. Patent and Trade Office (PTO) issued a new patent for Celgene's Thalomid Capsule product. Barr amended its ANDA on file with the FDA to certify against the patent in December 2006. Barr's amendment included a certification that the patent listed in the Orange Book for Thalomid Capsules was invalid or would not be infringed by Barr's product. Barr notified Celgene of its challenge to the new patent.
Thalomid Capsules, 50 mg, 100 mg and 200 mg had annual sales of approximately $424 million for the twelve months ended October 2006, based on IMS sales data.
26/12/06 Bedford Laboratories to Begin Shipping Ondansetron Injection USP
BEDFORD, Ohio, Dec. 26 /PRNewswire/ -- Bedford Laboratories(TM), a division of Ben Venue Laboratories Inc., announced that it will begin marketing Ondansetron Injection USP as of December 26, 2006, 2006. This product is AP rated and is equivalent to Zofran(R) by GlaxoSmithKline. Ondansetron Injection USP is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. It is also indicated for prevention of postoperative nausea and/or vomiting.
"As part of our objective to offer an extensive selection of specialty products to meet the changing needs of healthcare professionals, we are pleased to announce the addition of Ondansetron Injection USP to our portfolio," said David Gaugh, General Manager of Bedford Laboratories.
Bedford Laboratories will supply Ondansetron Injection USP, 2mg/mL packaged in 4mg/2mL single-dose vials and 40mg/20mL multi-dose vials. Prescribing information is available upon request from the Bedford Laboratories' professional services department, (800) 521-5169, or from the company's web site, http://www.bedfordlabs.com.
26/12/06 Par Pharmaceutical Receives Approval for Ondansetron Orally Disintegrating Tablets
Par to Manufacture, Barr Pharmaceuticals Inc.'s PLIVA Subsidiary to Market Product;
WOODCLIFF LAKE, N.J., December 26, 2006 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ondansetron orally disintegrating tablets (ODT) in 4 mg and 8 mg strengths. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the product, which will be marketed by PLIVA, Inc., the U.S. subsidiary of PLIVA d.d., which is a subsidiary of Barr Pharmaceuticals, Inc. of Woodcliff Lake, New Jersey.
Ondansetron ODT is the generic version of GlaxoSmithKline's Zofran ODT(R). The product is used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy and with initial and repeat courses of moderately emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual U.S. sales of Zofran ODT(R) are approximately $300 million, according to IMS Health.
Under the terms of an agreement between the two companies, Barr will have exclusive rights to market, sell and distribute ondansetron ODT in the U.S. The product will be manufactured by Par, and the companies will split profits from the sales of the product.
21/12/06 Bentley Pharmaceuticals' Generic Simvastatin Approved for U.S. Market
EXETER, N.H.--(BUSINESS WIRE)--Dec 21, 2006 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, announced today that its U.S. marketing partner, Perrigo Company, has received approval from the U.S. Food and Drug Administration (FDA) to market generic simvastatin 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets in the U.S. The FDA has determined that these formulations, which will be manufactured at Bentley's facilities in Spain, are bioequivalent and have the same therapeutic effect as that of the reference drug, Zocor(R) (Merck & Co.), whose patent expired on June 23, 2006 and 180-day exclusivity period expired on December 19, 2006.
The FDA also completed its evaluation and approval of the Bentley manufacturing facility for the production and supply of simvastatin for the U.S. market. In anticipation of this approval, Bentley has already commenced the manufacturing of simvastatin tablets to allow for immediate distribution in the U.S. There can be no assurance of what the sales levels or pricing will be upon formation of the market for generic simvastatin.
"We are pleased with the FDA's approval of our facility to manufacture our first generic drug for distribution in the U.S. market," said John A. Sedor, president of Bentley Pharmaceuticals. "This approval marks an important strategic milestone for Bentley."
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley's proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley manufactures and markets a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.
21/12/06 FDA Announces Tentative Approval of Efavirenz
ROCKVILLEE, Md., Dec. 21, 2006--The Food and Drug Administration, on December 19, 2006, granted tentative approval for efavirenz Capsules, 50 mg, 100 mg, and 200 mg., manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.
This is a generic version of the already-approved Sustiva Capsules, 50 mg, 100 mg, and 200 mg, manufactured by Bristol Myers Squibb Co.
Efavirenz is a member of the class of drugs known as nonnucleoside reverse transcriptase inhibitors (NNRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. This tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.
21/12/06 Ranbaxy Granted Final Approval For Simvastatin Tablets
Cholesterol-Lowering Simvastatin Currently Marketed in the U.S. as Zocor ®
Gurgaon, India, December 21, 2006
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg in the U.S. The FDA’s Office of Generic Drugs has determined Ranbaxy’s Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg to be bioequivalent, therefore, therapeutically equivalent to the listed drug Zocor® Tablets, 5 mg, 10 mg, 20 mg and 40 mg of Merck Research Laboratories. Total annualized market sales for Simvastatin were $4.8 billion, of which $4.2 billion were for the 5 mg, 10 mg, 20 mg and 40 mg tablets (IMS – MAT: September 2006).
Simvastatin tablets are indicated in the treatment of patients with coronary heart disease (CHD) or at high risk of CHD, reductions in risk of CHD mortality and cardiovascular events, patients with hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH). A Simvastatin regimen can be started simultaneously with diet.
“Ranbaxy has marketed the 80 mg tablets of Simvastatin on an exclusive basis since the patent expired in June of this year. We are now in a position to expand our product offerings to include the four additional strengths of Simvastatin and can now offer the complete line of marketed strengths for this product to our customers. Simvastatin has assumed a prominent position in the management of patients with hypercholesterolemia, and is now available as an alternative to the brand at an affordable price. This undoubtedly will have a positive economic benefit to patients, as well as to the U.S. healthcare system,” according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.
21/12/06 Perrigo Announces FDA Approval For Simvastatin Tablets
ALLEGAN, Mich., December 21, 2006 /PRNewswire-FirstCall/ -- The Perrigo Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Simvastatin Tablets, USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. Perrigo's partner, Bentley Pharmaceuticals, Inc. is manufacturing the product at their Belmac Laboratories facility located in Zaragoza, Spain. Shipments will begin immediately.
The product is the AB-rated equivalent to Merck & Co., Inc.'s Zocor(R) Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, a lipid lowering agent with multiple cardiovascular indications (Refer to product labeling for detailed information). According to Wolters Klewer data, annual sales for the last 12 months ending 09/2006 were approximately $5 billion.
21/12/06 Teva Introduces Simvastatin Tablets USP 80 mg
NORTH WALES, Penn., Dec. 20, 2006 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Simvastatin Tablets USP, 80 mg. This product is AB rated and bioequivalent to Zocor®* Tablets. With the addition of this new strength, Teva now offers simvastatin Tablets in 5 mg, 10 mg, 20 mg, 40 mg and 80 mg strengths. This new strength is available in bottle sizes of 30, 90, and 1000.
“Our customers count on Teva for a continuous supply of new generic products,” states John Denman, V.P. Sales and Marketing. “We are excited to offer a new strength of Simvastatin Tablets to our customers and their patients.”
21/12/06 Spectrum Announces Settlement of Sumatriptan Litigation
* Litigation dismissed after the 30-day review period passed with no
comment from the Federal Trade Commission (FTC)
* Spectrum expects Sumatriptan Injection to launch in 2H 2008
* Spectrum received $5 million as a milestone payment from PAR earlier
* Spectrum to receive majority of profit from sales
IRVINE, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced today that patent litigation relating to sumatriptan injection, the generic version of GlaxoSmithKline's(R) Imitrex(R) Injection, has been dismissed by the United States District Court for the District of Delaware pursuant to the previously-announced settlement agreement between Spectrum and GSK.
In November, Spectrum and GSK reached an agreement to settle patent litigation relating to sumatriptan injection. The terms of the confidential agreement provide that Spectrum may exclusively distribute authorized generic versions of certain sumatriptan injection products in the United States with an expected launch during GSK's sumatriptan pediatric exclusivity period which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008. Spectrum will launch sumatriptan injection through its partner for the sale and distribution of the drug, Par Pharmaceutical Companies, Inc.
"As we expected, at our request the court has dismissed this patent litigation with GSK which will allow us to move forward under the previously announced settlement agreement for sumatriptan injection," stated Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum. "This will enable our partner PAR Pharmaceutical to continue with the launch of sumatriptan injection ahead of GSK's patent expiration and allow us to begin receiving profits upon sales as early as 2008."
In February 2006, Spectrum entered into an agreement with Par Pharmaceutical to develop and market generic drugs for the company, including sumatriptan injection. In 2004, Spectrum filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration seeking marketing clearance for sumatriptan injection, which was tentatively approved by the FDA in October 2006.
21/12/06 Mylan Closing of Public Offer to Acquire 20% of Matrix
PITTSBURGH, Dec. 21 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that it has completed its acquisition of 20% of the fully diluted voting equity capital of Matrix Laboratories Limited, at a price of Rs. 306 per share (approximately $6.84 per share at the December 20, 2006 exchange rate), pursuant to a Public Offer in India. The Public Offer, a requirement under Indian law in connection with Mylan's previously-announced plans to acquire a controlling stake in Matrix, was commenced by MP Laboratories (Mauritius) Ltd., an indirect wholly owned subsidiary of Mylan, along with Mylan on November 22, 2006 and expired on December 11, 2006, in accordance with applicable Indian regulations.
A total of 54,585,189 shares were validly tendered, of which Mylan has accepted 30,836,662 shares. Payment for the shares properly tendered and accepted has been dispatched to the shareholders.
As announced on August 28, 2006, Mylan will acquire an additional 51.5% of Matrix's shares outstanding for Rs. 306 per share in cash pursuant to an agreement with certain selling shareholders. The transaction, which is subject to customary closing conditions, is expected to close in the first quarter of calendar 2007.
20/12/06 Court Grants Favorable Decision to Ranbaxy on Atorvastatin
Pfizer's Representation to the Australian Patent Office Held to be False & Misleading. Overall Ruling Mixed as Court Also Upholds Another Pfizer Patent
PRINCETON, N.J., December 20, 2006 /PRNewswire/ -- Ranbaxy Laboratories Limited announced that the Federal Court of Australia today handed down a favorable decision in the company's case against Pfizer regarding Pfizer's Australian atorvastatin patent 628198. Atorvastatin is a cholesterol-lowering drug which is marketed by Pfizer as Lipitor(R).
Justice Neil Young ruled that one of Pfizer's patents is invalid for false suggestion and misrepresentation in obtaining the grant of Australian patent 628198, but said that Ranbaxy's atorvastatin product infringes another Pfizer patent. The Court's ruling followed a trial in Melbourne which took place from October 9th to 23rd, 2006. The invalidity of Pfizer's Australian patent 628198 was principally based on Pfizer's representation to the Australian Patent Office that the potency of the R-enantiomer (atorvastatin) in relation to its ability to inhibit production of cholesterol was unexpectedly 10-fold more than that of the corresponding racemic material. This representation was held to be "false and misleading."
Jay Deshmukh, Ranbaxy's Senior Vice President -- Global Intellectual Property, noted, "We are pleased with this decision as it stands, as it advances the entry of Ranbaxy's generic atorvastatin in Australia to May 18, 2012."
19/12/06 EPO Announces European Nexium® Substance Patent Decision
AstraZeneca today announced that the European Patent Office (EPO) has ruled that one of the European substance patents for Nexium® (EP 0652872) will be rejected, following an appeal from the German generic manufacturer Ratiopharm. The original patent expiry for this patent was 2014.
While disappointed with the EPO decision, AstraZeneca has confidence in the intellectual property portfolio protecting Nexium®. This portfolio includes process, method of use and additional substance patents with expiration dates ranging from 2009 through to 2019. In addition to these patents Nexium has data exclusivity valid to 2010 in major European markets.
Process patent (EP 0773940) is under opposition with the EPO and an Opposition Division oral hearing is scheduled for 7th March 2007.
AstraZeneca will defend and enforce its intellectual property rights protecting Nexium.
Worldwide sales reached $4.6 billion in 2005. Europe accounted for $1.1 billion.
19/12/06 Reliant Files Patent Infringement Lawsuit Against Par
LIBERTY CORNER, N.J., December 19, 2006 /PRNewswire/ -- Reliant Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Par Pharmaceutical, Inc. ("Par") for infringement of U.S. Patent No. 5,681,588 (the "'588 Patent"), which expires in 2014 and relates to Reliant's Rythmol(R) SR product. The '588 Patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for Rythmol(R) SR.
The lawsuit is in response to Par's notification that it has filed a Paragraph IV Certification in connection with its Abbreviated New Drug Application (an "ANDA") to the FDA for a generic version of 325mg Rythmol(R) SR capsules (the "Notice"). According to the Notice, Par is seeking approval to engage in the commercial manufacture, use or sale of its generic version prior to the expiration of the '588 Patent.
Reliant intends to vigorously protect and defend its intellectual property rights against infringement.
19/12/06 Abbott Fails to Block Copy of Antibiotic
Abbott Laboratories has lost a bid to stop Novartis AG's Sandoz unit from selling a generic copy of the extended release version of the antibiotic Biaxin.
U.S. District Judge David H. Coar in Chicago on Friday denied Abbott's request for a temporary restraining order to halt sales of Biaxin XL.
"We believe the impact on Abbott is small, but nonetheless worth noting," Weinstein said Monday in a note to clients.
North Chicago-based Abbott reported total sales of $22.3 billion last year.
Biaxin generated $580 million in global sales in the first nine months of this year, including $95 million in the U.S. Biaxin XL, taken once a day, accounts for more than half of all Biaxin sales. The twice-a-day version has had generic competition since May 2005.
Sandoz began selling generic Biaxin XL on Dec. 4, Weinstein said. Abbott claims that the Sandoz version infringes three patents, including one for an extended release version of the compound clarithromycin.
19/12/06 Lupin Announces Tentative Approval of Trandolapril Tablets
BALTIMORE, December 19, 2006 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1mg, 2mg and 4mg. Final approval is expected upon expiry of patent protection for the brand product on June 12, 2007.
Upon final approval, Lupin's Trandolapril Tablets will be the AB-rated generic equivalent of Abbott's Mavik(R) Tablets, indicated for the treatment of hypertension. The brand product had annual sales of approximately $53 million for the twelve months ended July 2006, based on IMS sales data.
19/12/06 Endo Submits Citizen Petition to FDA Regarding Lidoderm
CHADDS FORD, PA, Dec 19, 2006 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Holdings Inc. announced today the submission of a Citizen Petition with the U.S. Food and Drug Administration requesting that the FDA apply existing bioequivalence regulations to any Abbreviated New Drug Application (ANDA) seeking regulatory approval of a generic drug product that references Endo's Lidoderm(R) (lidocaine topical patch 5%).
As disclosed on October 17, 2006, Endo became aware that, in response to an independent inquiry, the FDA's Office of Generic Drugs (OGD) had proposed that a study of blood levels of lidocaine should be used as the key measure in proving bioequivalence of a generic version of Lidoderm(R). This petition contends that this proposed standard deviates from applicable regulations and OGD's past practices, both of which contemplate demonstration of bioequivalence for a topically acting product like Lidoderm(R) through a comparative clinical efficacy study.
Lidoderm(R), as a topical patch and not a systemic patch, acts at the site of application. As such, blood levels of the active ingredient, lidocaine, cannot be used as the key measure in proving bioequivalence. To appropriately assess the efficacy and safety of any generic version of Lidoderm(R), Endo believes that it is critical that the FDA require any ANDA satisfy the regulations by following these additional criteria to those that FDA has proposed:
An applicant attempting to demonstrate bioequivalence of its generic product to Lidoderm(R) must conduct comparative clinical studies demonstrating identical safety and efficacy between the generic version and Lidoderm(R).
An applicant relying on Lidoderm(R) as its Reference Listed Drug must show that its product produces the same local analgesic effect as Lidoderm(R) without producing a complete sensory block, in order to assure that the generic product has the same labeling, efficacy and safety profile as Lidoderm(R).
Peter A. Lankau, President and Chief Executive Officer, said, "There are five Orange Book-listed patents for Lidoderm(R), the last of which expires in 2015. We firmly believe that this patent estate protects our intellectual property in Lidoderm(R). We have filed a Citizen Petition to address a separate concern: that any generic that would potentially come to market would ensure that a patient receiving a generic version of Lidoderm(R) would feel confident that its safety and efficacy would be the same as Lidoderm(R). Only by conducting comparative clinical studies can it be appropriately demonstrated that a generic version and Lidoderm(R) are truly bioequivalent."
19/12/06 Mylan Announces Final FDA Approval for Finasteride Tablets
PITTSBURGH, Dec. 19 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Finasteride Tablets USP, 5mg.
The Mylan brand of Finasteride Tablets, a generic version of Merck's Proscar® Tablets, is approved for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms and reduce the risk of the need for surgery including transurethral resection of the prostate and prostatectomy. Total U.S. sales for the 5mg strength of Finasteride Tablets was approximately $553 million for the 12-month period ended Sept. 30, 2006, according to data from IMS Health.
This product will be shipped immediately.
18/12/06 IMPAX Announces Approval of Generic Wellbutrin XL 300 mg
Product Launched Under Exclusivity Transfer Agreement with Anchen and Teva
HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 18, 2006--IMPAX Laboratories, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin XL, 300 mg. The product has been launched, pursuant to an Exclusivity Transfer Agreement with Anchen Pharmaceuticals, Inc. and a subsidiary of Teva Pharmaceutical Industries Ltd.
Anchen obtained approval of its generic Wellbutrin XL product, and in accordance with this agreement, selectively waived its 180-day period of marketing exclusivity in favor of IMPAX Laboratories. Pursuant to the Company's existing strategic alliance agreement with Teva, Teva has U.S. marketing rights to IMPAX's version of this product. Wellbutrin XL 300 mg, marketed by GlaxoSmithKline, had U.S. sales in excess of $1.0 billion for the 12 months ended October 31, 2006, according to Wolters Kluwer Health.
Under the Exclusivity Transfer Agreement, Teva will make certain payments to Anchen in return for a waiver of its exclusivity to IMPAX. In addition, Teva is indemnifying IMPAX against certain losses that might arise from certain legal risks.
"We are very pleased to have received our ninth FDA approval this year, and look forward to offering patients this widely sold anti-depressant as a generic drug beginning immediately," commented Larry Hsu, Ph.D., President and Chief Executive Officer of IMPAX Laboratories.
"In addition, generic Wellbutrin XL is the first of our Tier 3 products to be marketed under the 12-product Strategic Alliance Agreement signed with Teva in July 2001. Under that agreement, upon the first launch date of any Tier 2 or Tier 3 product in the U.S., IMPAX plans to repurchase for $1.00, 16.67% of the IMPAX common stock, or approximately 244,000 shares, sold to Teva during the development phase of the agreement," Dr. Hsu added.
Both the IMPAX and Anchen ANDAs for generic Wellbutrin 300 mg were filed with Paragraph IV certifications with respect to certain patents held by Biovail Laboratories International SRL and listed in the Orange Book. Biovail initiated patent infringement lawsuits against both companies. The IMPAX litigation is ongoing, and IMPAX has filed a motion for summary judgment of noninfringement. Anchen has been granted summary judgment of noninfringement with regard to the Anchen product.
15/12/06 Serbian Court Upholds Krka's Appeal on Zyllt Sales Ban
Pharma company Krka has scored a victory in its ongoing legal battle with French company Sanofi Aventis in Serbia, as a higher court overturned a ban on sales of its anticoagulant Zyllt imposed in November by a court of first instance.
The Commercial Court in Belgrade upheld last Friday, 15 December, 15 december an appeal by Krka against the ruling of the Novi Sad Commercial Court that bans the sale of Zyllt because it supposedly violates a patent held by Sanofi Aventis, Krka reported on Tuesday, 12 December in a posting on the website of the Ljubljana Stock Exchange.
Sanofi Aventis has resorted to legal action because it claims that Krka's product violates the patent protecting the active ingredient clopidogrel in the hydrogen sulphate salt form.
Krka rejects this, saying that Zyllt was arrived at in an independent procedure and that it has characteristics that do not violate any valid patents in Serbia and Montenegro.
A similar case in Poland earlier this year also resulted in the court rejecting Sanofi Aventis' request for a ban on the sales of Zyllt.
15/12/06 Anchen Announces Approval of Generic Wellbutrin XL(R)
IRVINE, Calif.-(Business Wire)-December 15, 2006 - Anchen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application to market its generic version of Biovail Corporation's anti-depressant Wellbutrin XL(R) (Bupropion hydrochloride) Extended-Release Tablets, 150 mg and 300 mg.
Commenting on today's approval, Dr. Chih-Ming Chen, Chief Executive Officer and Chairman of Anchen said, "We are extremely pleased to receive FDA approval of our generic version of Wellbutrin XL(R). Today's approval represents an important milestone in Anchen's development and commitment to offer high quality products for consumers at affordable cost."
Anchen is still involved in ongoing litigation concerning this product. In August 2006, the District Court granted Anchen's motion for summary judgment of non-infringement. Biovail has appealed the District Court decision.
15/12/06 Medichem Passes 3rd Consecutive FDA Inspection
Barcelona, December 15 2006.- Spanish company Medichem S.A., one of the world’s leading manufacturers of Active Ingredients for the pharmaceutical industry, has recently passed an US Food and Drug Administration (FDA) inspection without any observation for the third consecutive time (“No form 483”)
With this outcome Medichem became part of an exclusive group of pharmaceutical companies that completed three consecutive inspections without any observation.
The inspection of Medichem’s plant in Celrŕ (Girona, Spain) was carried out by two FDA officers between November 20th and 23rd, 2006.
Eight different Active Pharmaceutical Ingredients (APIs) were covered during the inspection of the Spanish manufacturing site. The management of materials, laboratory and quality systems were audited as well.
Medichem has been selling to the US market since the 80’s. Since then more than 25 products have been sold and the company has been regularly audited by the FDA. At the end of the last three FDA inspections (1999, 2002 and 2006), no “form 483” was issued (a form 483 is the written FDA report that reflects/identifies/lists observations and deficiencies found during the inspection. “No form 483 issued” means that neither deficiencies nor observations have been detected).
Ervin Veszprémi, Medichem’s CEO commented: “we are very pleased with the outcome of this difficult inspection, because it tells us that our commitment to achieve the highest quality levels is in the right direction. We will now double our efforts to maintain and further improve our service levels to our customers."
15/12/06 Caraco to Market Extended Phenytoin Sodium Capsules 100mg
DETROIT, Dec 15, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today that it will market Extended Phenytoin Sodium Capsules, USP 100mg (Phenytoin ER) on behalf of Sun Pharmaceutical Industries, Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin ER.
Phenytoin ER is an anticonvulsant drug. It is useful in the treatment of seizures related to epilepsy and neurosurgery. This new product is the bioequivalent to Dilantin Kapseals(R), a registered trademark of Parke Davis,(Pfizer). According to IMS Data, Phenytoin ER generic and brand products combined have annual sales of approximately $170 million.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to have the opportunity to market this product as it adds value to our overall portfolio of products. We continue to focus on working towards expanding our product offering as quickly and effectively as possible. We plan to launch this product as the third entrant in the generic pharmaceutical market immediately. This will bring our total product selection to 27 different products represented by 56 various strengths."
15/12/06 Bioequivalence to Become Compulsory for Generics in Vietnam
From 2009, generic drugs produced cheaply in Vietnam must prove they are equivalent to the patented medicines on which they are modeled, authorities have said.
The Vietnam health ministry’s Pharmaceutical Department told a conference held in Hanoi Friday that generic drugs – or drugs modeled after patented, brand-name drugs but usually cheaper – would be obliged to test for bioequivalence prior to entering the market.
If two products are bioequivalent, they would be, for all intents and purposes, the same.
The department also said the ministry was planning to build two bioequivalence testing centers in Hanoi in the north, Ho Chi Minh City in the south, and Da Nang city in the central region.
Vietnam is set to formally join the WTO next year, meaning patented drugs will become much more expensive. Generic drugs are expected to be produced to replace the brand name drugs.
Bioequivalence testing would also be a prerequisite for export of generic drugs, the department said.
15/12/06 AstraZeneca's Nexium Faces EU Patent Ruling
AstraZeneca monopoly on top-selling drug Nexium will be in the spotlight next week when the European Patent Office hears an appeal over the product's patent on December 19.
The substance-of-matter patent that protects the heartburn and antiulcerant pill was already upheld once in November 2003 following a challenge by German generic drug manufacturer Ratiopharm.
House broker Deutsche Bank expects this second and final ruling to go in AstraZeneca's favour, saying that there appear to be no new material facts in the case.
But others are less certain.
Citigroup sees a risk that AstraZeneca could lose, which would allow cheap generic versions of Nexium on to the European market four years early, reducing the brokerage's discounted cash flow valuation of the stock by 5 percent.
Nexium's European patent is not due to expire until 2014. But even if it loses next week, data exclusivity will protect the medicine from generic competition until at least 2010.
A negative patent ruling in Europe could prompt fears about exclusivity in the more important U.S. market, where the company made two-thirds of 2005 Nexium sales of $4.6 billion.
But industry analysts believe differences between patents and legal systems mean the European verdict will have little direct relevance for the United States, where Nexium is being challenged by Teva Pharmaceutical Industries Ltd (TEVA.O: Quote, Profile , Research).
At issue in next week's European hearing is whether the patent on Nexium is valid, since the drug is merely a refined version -- or isomer -- of previous AstraZeneca blockbuster Prilosec.
AstraZeneca, which has always expressed strong confidence in its patent position, contends it was not obvious that isolating the isomer would have produced an improved drug.
Nexium is a key driver of profit and sales for AstraZeneca, which is really heavily on existing products to maintain growth in the coming years following a series of late-stage product setbacks.
14/12/06 Ranbaxy Final Approval for Cefprozil Anti-infective Tablets
Gurgaon, India, December 14, 2006 - Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Cefprozil Tablets USP, 250 mg and 500 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil® Tablets, 250 mg and 500 mg, respectively, of Bristol Myers Squibb Company Pharmaceutical Research Institute. Total annual market sales for Cefprozil Tablets were $76.6 million (IMS - MAT: September 2006).
Cefprozil Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in certain conditions, including: Pharyngitis/tonsillitis, Otitis Media, Acute Sinusitis, secondary bacterial infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis and uncomplicated skin and skin-structure infections.
“Ranbaxy is pleased to be granted approval for Cefprozil tablets which represents yet another addition to our ever-growing product portfolio of anti-infectives that will be available as an affordable generic alternative to the brand equivalent. This formulation will be produced in our cGMP compliant, cephalosporin dedicated facility located in Dewas, India. Our plans are to bring this product to the market in early 2007 during the height of the respiratory season," according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.
13/12/06 HollisterStier Contract Agreement With GeneraMedix
SPOKANE, Wash., December 13, 2006 /PRNewswire/ -- HollisterStier Contract Manufacturing signed a manufacturing contract with GeneraMedix Inc. to develop a process for compounding and lyophilizing multiple generic drug products. GeneraMedix plans to utilize HollisterStier's Project Management System to meet targeted timelines and project specifications. Specific terms of the agreement were not disclosed.
Anthony Bonanzino Ph.D., President and CEO of HollisterStier said, "Establishing this new arrangement with GeneraMedix is further evidence of HollisterStier's substantial technical competency. Merging the core competencies of each organization assures a rapid market introduction to meet this important patient need."
Ronald F. Quadrel, President and CEO of GeneraMedix Inc. said, "This new Agreement with HollisterStier Contract Manufacturing is another step in the development and buildup of our generic injectable product portfolio. We are very pleased to be working together with HollisterStier on these new products. We believe that HollisterStier has the team, the experience and the infrastructure to ensure the successful development and commercial supply of these products."
13/12/06 Barr Confirms Generic Thalomid(R) Capsule Application
WOODCLIFF LAKE, N.J., Dec. 13 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Celgene Corporation's Thalomid(R) (thalidomide) Capsules, 200 mg.
Thalomid Capsules, 200 mg had annual sales of approximately $59 million for the twelve months ended October 2006, based on IMS sales data.
Barr filed its ANDA containing a paragraph IV certification for a generic version of Thalomid Capsules, 200 mg with the FDA in September 2006, and received notification of the application's acceptance for filing in December 2006. Following receipt of the notice from the FDA, Barr notified Celgene, the patent owner and New Drug Applications (NDA) holder. On December 13, 2006, Celgene confirmed it had received notification of Barr's ANDA on file with the FDA containing a Paragraph IV certification. Celgene indicated that it intends to file a complaint alleging infringement of the patents protecting Thalomid Capsules, 200 mg within the required forty-five day response period.
11/12/06 Savient Announces Modification of Temp Restraining Order
EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Dec 11, 2006 - Savient Pharmaceuticals, Inc. announced today that the U.S. District Court for the District of New Jersey, after considering legal briefs and supporting affidavits from all parties, ordered late on Friday that the temporary restraints contained in the Temporary Restraining Order ("TRO") previously issued by the Court enjoining all sales of generic oxandrolone tablets by Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company, and Upsher-Smith Laboratories be lifted at 5:00pm on Tuesday, December 12, 2006. However, the Court has certified a legal issue for appeal by Savient, although the opinion underlying the Court's Order has not yet been made available and thus the basis of such appeal is not yet known at this time. The TRO was granted in the lawsuit filed by Savient against Sandoz and Upsher-Smith for infringement of Savient's U.S. Patent Nos. 5,872,147 ("the '147' patent"); 6,090,799 ("the '799 patent"); 6,576,659 ("the '659 patent"); 6,670,351 ("the '351 patent"); and 6,828,313 ("the '313 patent"). These patents relate to various methods of using Savient's product Oxandrin(R) (oxandrolone tablets, USP) CIII.
"The basis of the Court's Order on Friday is unclear to all parties at this time." said Christopher Clement, President and Chief Executive Officer of Savient. "We look forward to receiving and studying the Court's opinion in order to understand better what the Court has directed and to determine the next actions and steps that may be available to us in defending our patent rights related to the use of Oxandrin(R). We continue to be committed to pursuing all actions necessary to enforce our patent positions, which we believe are strong, and anticipate ultimately a favorable outcome."
Savient will provide a further update on this matter once the Court's opinion has been received and analyzed.
08/12/06 DUSA Clarifies USPTO Action and River's Edge Motion
WILMINGTON, MASSACHUSETTS--(CCNMatthews - Dec. 8, 2006) - DUSA Pharmaceuticals, Inc.(R) reported today that River's Edge Pharmaceuticals, LLC filed a motion late yesterday to lift the preliminary injunction entered in May by the United States District Court in New Jersey, prohibiting sales of River's Edge generic version of DUSA's Nicomide(R) product.
River's Edge bases its motion on the fact that the U.S Patent and Trademark Office ("PTO") has accepted River's Edge's request for Inter Partes reexamination of the patent pertaining to Nicomide, and has issued an office action as the first step in the process. As previously stated, DUSA(R) did not oppose the request for reexamination as it has confidence in the patent claims.
Bob Doman, DUSA's President and COO stated, "We fully expected the PTO to grant the request for reexamination since the vast majority of these requests are granted. DUSA will be responding to the office action with its arguments in due course, as the next step in the process and we remain confident in the validity of the patent. We have reviewed the brief submitted by River's Edge to the court in New Jersey, and do not believe it contains any substantial new argument for lifting the injunction."
08/12/06 Preliminary Injunction Against Apotex Upheld on Appeal
PARIS and NEW YORK, December 08, 2006 /PRNewswire-FirstCall/ -- Sanofi-aventis and Bristol-Myers Squibb Company (the "companies") announced today that the United States Court of Appeals for the Federal Circuit has upheld the August 31, 2006 preliminary injunction issued by the United States District Court for the Southern District of New York. The injunction ordered Apotex to halt its sales of a generic version of clopidogrel bisulfate that competes with PLAVIX(R) pending the District Court's decision in the trial on the merits. As a result of the decision of the Court of Appeals, the preliminary injunction remains in place.
The companies believe that the Apotex generic product infringes their intellectual property rights, which they continue to vigorously defend in the pending patent litigation. Trial on the merits is currently scheduled to begin on January 22, 2007.
08/12/06 Canadian Federal Court Upholds Lipitor Patent
NEW YORK, December 08, 2006 /PRNewswire-FirstCall/ -- Pfizer Inc announced today that the Canadian Federal Court in Toronto has granted its application for an order preventing Novopharm Ltd. from launching a generic version of Lipitor until expiration of the product's patent (Canadian Patent 2,021,546) in July, 2010. The decision is subject to appeal.
"This is yet another decision recognizing the protection of the intellectual property supporting Lipitor," said Pfizer General Counsel Allen Waxman. "Patents like this one provide the incentive to develop new, life- saving medicines that benefit millions of patients globally and Pfizer will continue to vigorously defend its intellectual property rights wherever they are challenged."
06/12/06 Insmed Patent Litigation Verdict Announced
RICHMOND, Va.--(BUSINESS WIRE)--Dec 6, 2006 - Insmed, Inc. (NASDAQ:INSM) announced today that the company was found by a jury in the U.S. District Court for the Northern District of California to have infringed on patents held by Genentech, Inc. and Tercica, Inc.
After an 11-day jury trial and 7 days of deliberations, the Oakland, California jury today rendered the following verdict in the patent infringement lawsuit filed by Genentech, Inc. and Tercica, Inc. against Insmed and two of its subsidiaries, Insmed Therapeutic Proteins, Inc. and Celtrix Pharmaceuticals, Inc.
The jury found Insmed infringed U.S. Patent No. 5,258,287. The jury did not find the infringement to be willful.
The jury found Insmed infringed U.S. Patent 5,187,151. The jury found the infringement to be willful.
The jury upheld the validity of U.S. Patent 6,331,414. Previously, the Court found that Insmed infringed this patent. The jury did not find the infringement to be willful.
The jury awarded damages of $7.5 million as an upfront payment and a royalty of 15% for sales below $100 million and 20% for sales above $100 million.
The lawsuit centers around Iplex (rhIGF-I/rhIGFBP-3), Insmed's IGF-1 therapy, approved by the FDA to treat children with severe short stature.
Geoffrey Allan, Ph.D., President and CEO of Insmed, Inc. said, "The company is reviewing the decision and assessing our options, including post-trial motions and an appeal."
06/12/06 Akorn and Strides Arcolab Agree to Increase to 29 ANDA's
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Dec 6, 2006 - Akorn, Inc. and Strides Arcolab Limited (NSE: STAR, BSE: 532531) today announced that both Companies have agreed to fund, develop, and commercialize an additional 10 ANDA injectable drug products for the Akorn-Strides, LLC Joint Venture. Akorn and Strides created and funded the Joint Venture in 2005 and since that time have developed and submitted 15 ANDA's. Prior to year end, the Joint Venture expects to submit an additional 2 ANDA's for a total of 17 ANDA's filed in 2006. The Joint Venture is developing liquid, lyophilized and dry powder fill generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.
The additional funding provided to the Joint Venture will expand the Akorn-Strides, LLC to 29 ANDA's for a total of 53 SKU's, or product line offerings. The Joint Venture expects to generate revenues in 2007 based on initial product approvals and subsequent product launches.
Arthur S. Przybyl, President and CEO of Akorn and Member Manager of Akorn-Strides, LLC stated, "We are pleased with the progress of the Joint Venture since its inception. Strides Arcolab has demonstrated on-time execution in developing ANDA injectable drug products for the Joint Venture. Akorn has been filing regulatory submissions for the Joint Venture at a rate of approximately two per month. It stands to reason that expanding the Joint Venture product portfolio will only help to generate greater revenues and market presence."
Arun Kumar, Executive Vice Chairman and Managing Director of Strides and Member Manager of Akorn-Strides, LLC stated, "We are delighted to expand the pipeline of products to 29 in our Joint Venture with Akorn and we are confident that the Joint Venture will emerge as a significant provider of quality sterile products in the North American region."
04/12/06 Savient Files Lawsuit Against Sandoz & Upsher-Smith
EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Dec 4, 2006 - Savient Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company (NYSE: NVS), and Upsher-Smith Laboratories for infringement of Savient's U.S. Patent Nos. 5,872,147 ("the '147' patent"); 6,090,799 ("the '799 patent"); 6,576,659 ("the '659 patent"); 6,670,351 ("the '351 patent"); and 6,828,313 ("the '313 patent"). These patents relate to various methods of using Savient's product Oxandrin(R) (oxandrolone tablets, USP) CIII. Oxandrin(R) is Savient's oral anabolic agent indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infection, or severe trauma. Oxandrin(R) is also indicated for patients who, without definite pathophysiologic reason, fail to gain or maintain normal weight. Oxandrin(R) can also be used to offset the protein catabolism associated with prolonged corticosteroid use.
The suit was brought following the U.S. Food and Drug Administration's (FDA) decision late on Friday, December 1, 2006, to deny both Citizens Petitions filed by Savient, which had been pending since February 2004 and September 2005, and reliable information received by Savient indicating that Abbreviated New Drug Applications (ANDA) filed by both Sandoz and Upsher-Smith had also been approved by the FDA. Savient has also filed a Motion seeking a Temporary Restraining Order and Preliminary Injunction to restrain Sandoz and Upsher-Smith from marketing and selling their generic formulations of Oxandrin(R).
Savient also announced that it is examining the impact of the FDA decisions and its agreement with Watson on its pending patent infringement lawsuit against Barr Laboratories, a wholly owned subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL).
In addition, Savient acknowledged that in anticipation of these developments it had previously entered into a supply and distribution agreement with Watson Pharmaceuticals, Inc. (NYSE: WPI) granting Watson exclusive U.S. distribution rights to Savient's A-B rated authorized generic of oxandrolone tablets, USP (C-III), an Oxandrin(R) brand equivalent product, which will be manufactured and supplied to Watson through Savient. The authorized generic product, when launched into the market, will be distributed by Watson in both the 2.5 mg and 10 mg dosage strengths. The A-B rated authorized generic of oxandrolone tablets will continue to meet all quality control standards of the Oxandrin(R) brand, will contain the same active and inactive pharmaceutical ingredients and will contain in its labeling the geriatric dosing regime for which Savient has been granted exclusivity by the FDA. Savient will also continue to market and distribute the Oxandrin(R) brand product.
01/12/06 Ranbaxy Acquires Be-Tabs Pharmaceuticals For USD 70 MN
Gurgaon (Haryana) India, December 01, 2006: Ranbaxy Laboratories Limited (Ranbaxy), India’s largest pharmaceutical company, today announced the acquisition of Be-Tabs Pharmaceuticals (Pty) Limited (“Be-Tabs”), in South Africa, for a total consideration of USD 70 Million (500 Million ZAR). The transactions, subject to requisite approvals from South Africa’s Competition Council authority, are expected to be completed in the first quarter of the year 2007.
The acquisition will be EPS accretive in year one.
Be Tabs, the 5th largest generics player, is amongst the most established companies in South Africa with an excellent brand equity and a good profitable track record.
Be Tabs is a significant acquisition in a market that is large and growing with high entry barriers.
The acquisition further strengthens Ranbaxy’s South Africa operations and places the Company amongst the top 5 generic players in the market.
Be Tabs has a strong OTC portfolio with significant brand recognition that can be leveraged with wholesalers, pharmacists & consumers.
The Company is the largest Penicillin manufacturer in South Africa.
The transactions will be funded from Ranbaxy’s FCCB proceeds.
The transaction is valued at 2.2 times of sales and 7.7 times of EBITDA multiples.
Commenting on the acquisition, Malvinder Mohan Singh, CEO & Managing Director, Ranbaxy, said, “The acquisition of Be-Tabs’ results in considerable synergies and further strengthens Ranbaxy’s foothold in South Africa. It reinforces our position by expanding our portfolio in a key market that is exhibiting strong growth potential. The move will help us to provide effective disease management solutions in support of the government’s objective to make healthcare affordable to a wider cross-section of the population.”
On the occasion, Desmond Brothers, CEO of Ranbaxy South Africa, said, “We are pleased with the acquisition of Be-Tabs. It is our clear intent to accelerate our growth in the local market. Ranbaxy with its India centric advantage is well positioned to leverage these competencies and capture the synergies unleashed in the process, for the benefit of the South African market.”