mlkrborn
13 years ago
Par Pharmaceutical (PRX) Acquires Three Generic Products From Teva Pharmaceuticals (TEVA) 39.29 : Co announced that it acquired rights to three products from Teva Pharmaceuticals in connection with Teva's acquisition of Cephalon. Under terms of the agreement, Par will own the ANDAs of fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix, as well as the U.S. rights to market modafinil tablets, the generic version of Provigil. According to IMS Health data, annual sales in the U.S. for Actiq and the equivalent generic products are $173 mln. Annual sales in the U.S. for Provigil and Amrix are ~$1.1 bln and $125 mln, respectively.
mlkrborn
13 years ago
WPI,PRX,KVA, SANDOZ, AZN: Complex world of generics!
Watson Pharma Continues To Benefit From Toprol Market Presence
Date : 01/20/2010 @ 2:11PM
Source : Dow Jones News
Watson Pharma Continues To Benefit From Toprol Market Presence
Watson (NYSE:WPI)
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Watson Pharmaceuticals Inc. (WPI) has grabbed a large share of the market for a generic version of AstraZeneca Plc's (AZN AZN.LN) blood pressure treatment Toprol XL, and is seeking regulatory approval to launch additional dosages.
The summer launch of the drug prompted the Morristown, N.J., drug maker to boost its 2009 financial expectations in July, as manufacturing issues at competitors made the opportunity more lucrative. Generic medicine prices are generally very competitive, but the reduced competition in the market has provided higher pricing and, thus, better margins for Watson.
The company's stock has performed well, it is up 74% in the last year and recently traded at $41.41. Adam Greene, an analyst with RBC Capital Markets believes that the upside from Toprol still isn't adequately reflected in the stock.
"Although that may depend on competitive landscape and how long the party lasts," he said.
Watson's version of the 50 milligram pill, known generically as metoprolol, had a 50% market share of total prescriptions in December, according to SDI, a drug-data research firm, and the less popular 25 milligram pill had a 46% share.
Watson is seeking Food and Drug Administration approval of the 100 milligram and 200 milligram strengths as well. A company spokeswoman said the launch has gone as expected, but declined to comment on the agency's approval timeline.
"We expect metoprolol ER will continue to be significant contributor for us in 2010," she said. Watson will host an investor day on Thursday, where it is expected to provide 2010 financial projections.
In 2008, Sandoz, the generic unit of Novartis AG (NVS NOVN.VX), recalled generic Toprol XL after the FDA sent a warning letter about a manufacturing facility. K-V Pharmaceutical Co. (KVA, KVB), another generic supplier, stopped manufacturing and shipping all of its products in early 2009 and recalled most products already on the market, including Toprol, as it deals with an FDA investigation.
Watson hasn't been the only beneficiary of the Toprol manufacturing problems. The drug was once a big U.S. seller for AstraZeneca, bringing in sales of $1.4 billion in 2006, the last year before it went generic. But the shortage reinvigorated sales for both the branded version and an authorized generic it makes for Par Pharmaceutical Cos. (PRX).
AstraZeneca cornered the market and U.S. sales of Toprol XL in the first half of 2009 rose to $474 million, compared with $295 million for all of 2008. AstraZeneca reports full-year results Jan. 28.
But that grip has been slipping since Watson launched, and the current market split won't last forever.
Greene notes that Par and Watson are "playing nice" and not waging a price battle in order to grab market share, as sometimes happens in generic drug markets.
That dynamic may shift if Sandoz or K-V Pharmaceutical are able to return to the market, although regulators have been very cautious when it comes to allowing generic Toprol on the market, as Watson knows from its previous and ongoing reviews.
Officials from Sandoz and K-V weren't immediately available to comment.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
ffco4sa
15 years ago
FDA Accepts Drug Application for Miconazole Lauriad(R) to Treat Oropharyngeal Candidiasis
Aug 19, 2009 8:00:00 AM
WOODCLIFF LAKE, N.J., Aug. 19 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad((R)) mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole MBT delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection.
The NDA submission was based primarily on data from a Phase III study demonstrating noninferiority to Mycelex((R)) Troche (clotrimazole)* in the complete resolution of signs and symptoms of OPC. The randomized, double-blind, double-dummy study was conducted in 577 HIV-positive patients in 40 sites in the United States, Canada, and South Africa.
"The NDA acceptance of miconazole MBT represents a significant milestone for Strativa Pharmaceuticals as this would be the first oral miconazole therapy available in the U.S. and would provide healthcare providers with a new option for treating OPC," said John A. MacPhee, president of Strativa Pharmaceuticals. "We believe miconazole MBT's delivery system and once-daily dosing schedule will offer an effective, convenient alternative to currently available local therapies, which require several doses per day to treat OPC." Strativa could launch miconazole MBT in the second half of 2010, if approved.
OPC, familiarly known as thrush, is an oral fungal infection most common in individuals with weakened immune systems -- particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.
Miconazole MBT was approved in 11 countries and is currently being marketed in several EU territories including France, Germany and the UK under the trade name Loramyc((R)). While miconazole MBT would be the first miconazole treatment available in oral form in the U.S., other dosage forms of miconazole have been marketed around the world. Under a licensing agreement with BioAlliance Pharma SA, Strativa is the exclusive U.S. distributor of BioAlliance's miconazole MBT. Upon FDA approval of the product, Strativa will pay BioAlliance $20 million, as well as a royalty on future net sales. BioAlliance may also be entitled to milestone payments if net sales achieve specified targets.
About Strativa Pharmaceuticals
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch. For additional information, please visit www.strativapharma.com.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products that address resistance issues. For press release and other company information, visit www.bioalliancepharma.com.
ffco4sa
15 years ago
Par Pharmaceutical & Aveva Drug Delivery Systems Receive Final Approval to Market Generic Catapres TTS(R)
Par to Begin Shipping Clonidine TDS in the Near Future
Aug 18, 2009 6:37:00 PM
WOODCLIFF LAKE, N.J., Aug. 18 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its licensing partner, Aveva Drug Delivery Systems, has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for a clonidine transdermal system. Clonidine TDS is a generic version of Boehringer Ingelheim's Catapres TTS((R)) and is the first generic seven-day patch indicated in the treatment of hypertension. Clonidine TDS is available in 0.1 mg/day, 0.2 mg/day and 0.3 mg/day strengths. Annual U.S. sales of Catapres TTS((R)) were approximately $297 million, according to IMS Health data. Par will begin shipping clonidine TDS to the trade in the near future.
Paul V. Campanelli, President of Par's generic division, said, "We are very pleased to have received this critical approval. Par and Aveva have been working together tirelessly to bring this important product to market."
"We appreciate Par's support and commitment throughout the development effort and the extended approval process of this important first generic product," stated Wallace Reams, President and Chief Operating Officer of Aveva Drug Delivery Systems.
Under the terms of its agreement with Aveva, Par has exclusive rights to market, sell and distribute Aveva's clonidine TDS in the U.S. The product will be manufactured by Aveva, and the companies will share profits from the sales of the product.
Important information about clonidine TDS
Clonidine Transdermal System is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
Clonidine Transdermal System should not be used in patients with known hypersensitivity to Clonidine or to any other component of the Transdermal system.
About Aveva Drug Delivery Systems
Aveva Drug Delivery Systems is a Nitto Denko company, which is one of the world's largest manufacturers of and a pioneer in transdermal drug delivery systems. Nitto Denko has a 40-year history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or are high-quality, low-cost brand equivalents. Leveraging this experience, Aveva offers a full range of research, development and manufacturing capabilities using a number of sophisticated technologies to produce proprietary and generic transdermal drug delivery systems that fortify R&D pipelines and maximize the life cycles of products. For press release and other company information visit www.avevadds.com.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
EZ2
22 years ago
Press Release Source: Par Pharmaceutical, Inc.
Par Pharmaceutical Announces Filing Of Tramadol Hydrochloride Tablets With Acetaminophen
Monday October 21, 6:00 am ET
ANDA Filing with Paragraph IV Certification Is Believed To Be First for Tramadol Hydrochloride Tablets with Acetaminophen
SPRING VALLEY, N.Y., Oct. 21 /PRNewswire-FirstCall/ -- Par Pharmaceutical, Inc., a subsidiary of Pharmaceutical Resources, Inc. (NYSE: PRX - News), today announced that through its alliance partner Kali Laboratories, Inc., an Abbreviated New Drug Application (ANDA) was filed with a paragraph IV certification for tramadol hydrochloride tablets with acetaminophen. Johnson and Johnson currently markets 37.5 mg tramadol HCl/325 mg acetaminophen tablets under the brand name Ultracet®. Introduced in September 2001, Ultracet® is indicated for the short-term (five days or less) management of acute pain. The product achieved U.S. sales of more than $40 million in the second quarter of 2002.
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Kali Laboratories, Inc. submitted the ANDA to the U.S. Food and Drug Administration (FDA) in which Par believes was the first ANDA to be filed with a paragraph IV certification. According to current FDA practice, Par believes it may be entitled to exclusively market a generic tramadol/acetaminophen product for up to 180 days.
"We are very pleased to add another promising drug candidate to our ever expanding new product pipeline," said Scott Tarriff, president and chief executive officer. "Par has over twenty-five drugs awaiting FDA approval and, now with tramadol, as many as six of these may represent first-to-file opportunities. With more than 40 additional drugs currently in development, our Company possesses a new product pipeline that is among the most robust in our industry."
Kali Laboratories, Inc., a research and development-based company located in New Jersey, will manufacture tramadol hydrochloride tablets with acetaminophen and Par will have the exclusive right to market the product. Under terms of its agreement with Kali, Par will retain the majority of the profit generated by the sale of the product following receipt of final marketing clearance.
PRX, a holding company, develops, manufactures, and distributes generic pharmaceuticals through its wholly owned subsidiary, Par Pharmaceutical. Through its FineTech unit, PRX also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. PRX currently manufactures and distributes over 139 products representing various dosage strengths of 58 drugs. For press release and other Company information, visit our website at http://www.parpharm.com .
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management's expectations with respect to future events or future financial performance. Any such statements that refer to PRX's anticipated future results, product performance, release date of future products, or other non-historical facts are forward-looking and reflect PRX's current perspective of existing trends and information. These statements involve risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the uncertainty associated with complex litigation, including the eventual outcome and litigation costs and expenses incurred along the way, the success of PRX's product development activities, and the timeliness with which regulatory authorizations and product introductions may be achieved, market acceptance of PRX's products, the availability of raw materials on commercially reasonable terms, successful compliance with extensive, costly, complex, and evolving governmental regulations and restrictions, exposure to product liability, and other risks and uncertainties detailed in PRX's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
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Source: Par Pharmaceutical, Inc.
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