Watson Confirms Pataday™ Patent Challenge
Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%. Watson’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is a generic version of Alcon, Inc.’s Pataday™ (olopatadine hydrochloride ophthalmic solution) 0.2%, which is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Alcon Research, Ltd., Alcon Pharmaceuticals, Ltd., and Kyowa Hakko Kirin Co., Ltd. filed suit against Watson on June 9, 2011 in the United States District Court for the Southern District of Indiana seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 5,641,805, 6,995,186, and 7,402,609. Alcon’s lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s ANDA until October 29, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending April 30, 2011, Pataday had total U.S. sales of approximately $224 million according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women’s Health. Watson has operations in many of the world’s established and growing international markets.
Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing information as of the date of this release. It is important to note that Watson’s goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson’s current expectations depending upon a number of factors, risks and uncertainties affecting Watson’s business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the difficulty of predicting the timing and outcome of the pending patent litigation; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers’ facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s quarterly report on form 10-Q for the quarter ended March 31, 2011 and Watson’s annual report on Form 10-K for the year ended December 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Pfizer goes to court to protect exclusive rights to sell Viagra
Patent protection and product pipelines are top priorities for every pharmaceutical manufacturer, which is why Pfizer Inc. and Teva Pharmaceuticals International Ltd. will be in federal court in Norfolk, Va., starting Wednesday as Pfizer fights to keep exclusive rights to Viagra through 2019.
Pfizer sells about $1 billion worth of the little blue pills per year in the United States to help men with erectile dysfunction, amounting to about 2 1/2 percent of the company’s sales.
Along with other pharmaceutical companies, Pfizer has been fretting because some top-selling drugs are nearing the dates at which generic-pharmaceutical firms can produce and sell similar products for less money. The pipelines are connected because pharmaceutical leaders worry that few blockbusters are coming along to replace the older moneymakers.
Pfizer, based in New York, has operations in the Philadelphia suburbs. Israel-based Teva, the world’s leader in generic-pharmaceutical sales, has its North American headquarters in North Wales.
In this case, Pfizer hopes U.S. District Judge Rebecca Beach Smith will enforce the second of two patents it holds on sildenafil, which became the trade-named product Viagra. The first patent for sildenafil is not in dispute.
“We believe our patent is valid and infringed, and are enforcing our rights under the patent,” Pfizer said in a statement. “Furthermore, many of Teva’s arguments had been previously considered and rejected by the U.S. Patent and Trademark Office, both during a six-year examination by the USPTO of Pfizer’s patent and again during a seven-year reexamination by the USPTO.”
A Teva USA spokeswoman said via e-mail that the company had no comment.
Pfizer sued in the Eastern District of Virginia because the district has a reputation for speedy decisions and patent cases can take months to resolve. This one might not be settled until next year, and Teva hopes that Pfizer’s exclusive rights will expire March 27, 2012.
In the 1990s, Pfizer won its original patent for sildenafil as a compound to treat high blood pressure and other heart problems. But during clinical trials, a high percentage of men taking the medication immediately had erections.
Rarely is such serendipity so lucrative. Pfizer has fought in court for years to protect the market born of that research. A suit against Eli Lilly was eventually settled; Lilly sells Cialis for treatment of the same condition. In March 2010, Pfizer settled an eight-year suit with GlaxoSmithKline and Bayer, which had combined to sell Levitra.
Erectile dysfunction, also known as ED, was not invented with the now-ubiquitous TV ads – there was just no easy way to treat the problem. But Viagra’s launch changed that, and Pfizer was eventually granted a second patent in 2002 that is due to expire in 2019.
Teva is arguing that the second patent is invalid, and that anyone schooled in drug research would have figured out that the compound would help with erectile dysfunction. Pfizer argues that if any such people were so smart, why didn’t they invent it, file for a patent, and make billions before Pfizer did?
“Viagra has received more media attention and entered the pop culture to an extent greater than any other drug,” Pfizer attorney Daniel P. DiNapoli said during a recent court hearing, the transcript shows. “Part of the reason for that, no doubt, is the subject matter to which Viagra relates – sex. But there were ED treatments before Viagra, and none of those received anywhere near the attention that Viagra has received.
“And what distances Viagra from these other ED treatments was that Viagra was an effective oral treatment for erectile dysfunction, an ED pill. Pfizer’s success with Viagra was the end result of a long research and development project.”
Pacira Pharmaceuticals, Inc. Announces FDA Extension of EXPAREL™ PDUFA Target Date by Three Months
Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) by three months. The new PDUFA goal date is October 28, 2011.
The FDA requested additional information from Pacira, which the company has submitted. The FDA determined that this information constituted a major amendment. The agency has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide the FDA time to complete the review.
About Pacira
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, manufacture and commercialization of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL, the company’s most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive Phase 3 clinical development for postoperative analgesia by infiltration. EXPAREL consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile.
About EXPAREL™
EXPAREL is Pacira’s proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam®, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Market data indicate that there is an unmet medical need for a longer-acting anesthetic/analgesic for postsurgical pain management. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and suggest statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggest that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.
Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL’s potential, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the timing of, and our ability to obtain regulatory approval of EXPAREL; the timing of our anticipated commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercialization and marketing capabilities; and other factors discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2010, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
On 13 Local Patent Applications In Pharmaceuticals Last Year
Only 13 local patent applications in pharmaceuticals was received last year as compared to 403 from foreign countries.
Domestic Trade, Cooperatives and Consumerism Minister, Datuk Seri Ismail Sabri Yaakob said the number reflected that the level of awareness on copyright among the people was still low.
He said the intellectual property protection system in Malaysia was in line with international practises and fulfilled the requirements of the TRIPs (trade-related aspects of intellectual property rights) Agreement.
A total of 6,380 patent applications were received last year, an increase of 11 per cent from 5,676 applications in 2009, he said in his speech at the opening of a seminar on “1 Malaysia Medicines: The Way Forward In Intellectual Property” here.
The text of the speech was read by his deputy, Datuk Rohani Abdul Karim.
Ismail Sabri said those involved in pharmaceuticals played an important role in research.
“The outcome of the research should be registered as intellectual property,” he added.
He said there were had more than 1,300 health-based products from natural resources registered with the Health Ministry.
The seminar, organised by the Malaysian Pharmaceutical Association, with the cooperation of the Intellectual Property Corporation of Malaysia (MyIPO), is attended by 120 participants.