Watson Pharmaceuticals To Pay $1,700,000 In Drug Pricing Settlement
Watson Announces Initiation of Esmya(R) U.S. Phase 3 Clinical Trial
"Initiation of the U.S. pivotal trial is underway on schedule and we are hopeful that this Phase 3 study will demonstrate improvement on pre-surgical hemoglobin concentrations, an endpoint indicating that heavy bleeding and anemia have been alleviated," said Fred Wilkinson, Executive Vice President, Watson Global Brands. "Esmya®, if approved, may be an important medicine for women whose fibroid-symptom severity often leads to excessive bleeding and related pain."
In December 2010, Watson announced that it had entered into an exclusive license agreement with Gedeon Richter Plc to develop and market Esmya® in the United States and Canada. Under terms of the agreement, Watson paid a $17 million license fee, and will pay royalties based on sales in the U.S. and Canada. The Company will also make additional payments based on the achievement of certain regulatory milestones.
During an end of phase 2 meeting, the FDA required that a new phase 3 trial be conducted evaluating anemic patients with an improvement in hemoglobin as the primary endpoint. Watson expects the U.S. Phase 3 trial to be completed by 4Q 2013, at which time the company will prepare a New Drug Application for submission to the U.S. Food and Drug Administration.
Esmya® 5mg tablet was approved last month by the European Commission (EC) for pre-operative treatment of moderate-to-severe symptoms of uterine fibroids. This approval is applicable for all Member States in the European Union. The results of the European studies were recently published in the New England Journal of Medicine.(1)(2)(3) Esmya® is expected to be launched in certain European countries in a month.
Watson has met with Health Canada and it was agreed that a New Drug Submission (NDS) could be filed based on the European clinical program. Watson intends to submit the NDS in mid 2012.
Watson Confirms Court Stays Preliminary Injunction
Weekly Investment Analysts’ Ratings Changes for Watson Pharmaceuticals Incorporated (WPI
Watson Pharmaceuticals Incorporated (WPI) Upgraded by RBC Capital (RY
Watson Pharmaceuticals Incorporated (WPI) Share Price Target Lowered to $60.00 by Collins Stewart Analysts
Watson Pharmaceuticals Incorporated (WPI) Shares Downgraded to “Neutral” by Citigroup (C) Analysts
Watson Pharmaceuticals Incorporated (WPI) PT Lowered to $73.00 by Piper Jaffray (PJC
Watson Pharmaceuticals Launches Generic Lipitor
Watson to expand Salt Lake City R&D, manufacturing facility PBR Staff Writer
Court denies request to prevent Watson drug launch
Watson Temporarily Barred From Selling Generic Seasonique
Teva Pharmaceutical Industries Ltd. (TEVA), the world’s biggest generic-drug company, won an appeals court order that temporarily prevents Watson Pharmaceuticals Inc. (WPI) from selling a generic version of the contraceptive Seasonique.
The temporary ban lets the U.S. Court of Appeals for the Federal Circuit in Washington consider whether sales should be halted further until it rules on a separate appeal by Teva’s Duramed unit to block Watson’s generic copy. Watson has until July 1 to respond, according to the order issued today.
Watson, which planned to begin selling copies as soon as June 20, “will oppose this motion to appeal and seek to be able to launch the product,” said Charlie Mayr, a spokesman for the Corona, California-based company. Teva had filed an emergency attempt to prevent sales until a trial could be held with U.S. District Judge Larry Hicks in Reno, Nevada, who denied the request yesterday. The Federal Circuit ruling today temporarily puts sales on hold until it can sort out Teva’s appeal.
Teva, based in Petah Tikva, Israel, contends the copy would infringe a patent that expires in 2024, and wants to ensure Watson can’t bring the drug to market before then. In Hicks’s decision denying Teva, he cited Watson’s defense that the patent may be invalid.
“Duramed has not raised serious questions that Watson’s patent invalidity defense lacks merit,” Hicks said.
Watson Confirms Court Decision Rejecting Teva's Motion to Prevent Launch of Generic SEASONIQUE®
WATSON PHARMACEUTICALS RECEIVES FAVORABLE RULING IN PATENT CASE (WPI,TEVA)
A judged erred last year in upholding Teva's patent without holding a trial, the U.S. Court of Appeals for the Federal Circuit said on Friday. The case was sent back to the lower court for further consideration.
Watson has already conceded it infringed upon the patent, leaving the validity of the patent as the only remaining issue to be resolved in the case.
Shares of Watson Pharmaceuticals are trading up 0.5% at $55.91.
Watson Pharmaceuticals has a potential upside of 9.8% based on a current price of $55.91 and an average consensus analyst price target of $61.40.
Watson Pharmaceuticals is currently above its 50-day moving average (MA) of $55.26 and above its 200-day of $48.18.
In the last five trading sessions, the 50-day MA has climbed 0.47% while the 200-day MA has risen 0.65%.
Watson Pharmaceuticals, Inc. develops, manufactures, and sells generic and brand name pharmaceutical products. The Company's core focus is specialty products, nephrology, urology, and generic products.
Watson Pharmaceutical (WPI) Could Break Through $55.76 Resistance Level
Watson Pharmaceuticals Had a Bearish Engulfing Candle
Watson Pharmaceuticals, Inc. (NYSE:WPI) develops, manufactures, and sells generic and brand name pharmaceutical products. The Company's core focus is specialty products, nephrology, urology, and generic products.
Watson's current stock range is defined by calculated support defined at $53.73 and by the resistance level at $57.45, which should be used by traders planning their trades.
Watson To Present At The 2011 Citi Global Healthcare Conference
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on urology and women’s health. Watson has operations in many of the world’s established and growing international markets.
Watson Pharmaceuticals Q4 Profit Drops; Backs 2011 Outlook - Update
Watson Pharmaceuticals Inc. (WPI: News ) reported Tuesday a 68 percent year-over-year drop in profit for the fourth quarter, despite strong double-digit revenue growth, hurt by significant charges.
However, adjusted earnings per share increased 9.4 percent and came in line with analysts' expectations, while quarterly revenues topped their estimates. The company also reaffirmed its earnings and revenue forecast for the full-year 2011.
Watson is engaged in the development, manufacturing and sale of branded as well as off-patent or generic drugs.
The Corona, California-based specialty pharmaceutical company reported net income of $18.3 million or $0.15 per share for the fourth quarter, lower than $56.9 million or $0.51 per share in the prior-year quarter.
Excluding special items, adjusted net income for the quarter increased to $116.5 million or $0.93 per share from $94.4 million or $0.85 per share in the year-ago quarter.
On average, 20 analysts polled by Thomson Reuters expected the company to report earnings of $0.93 per share for the fourth quarter. Analysts' estimates typically exclude special items.
Net revenues for the quarter increased 21 percent to $952.7 million from $785.70 million in the same quarter last year, and topped sixteen Wall Street analysts' consensus estimate of $927.64 million.
Watson Pharmaceuticals Bulls in Charge
Watson Pharmaceuticals, Inc. (NYSE:WPI) develops, manufactures, and sells generic and brand name pharmaceutical products. The Company's core focus is specialty products, nephrology, urology, and generic products.
Watson Pharmaceuticals is currently trading 1.1% versus its previous trading session close, and it has calculated support and resistance at $48.20 and $53.75 respectively. Clearly with this action this range has been penetrated, and traders will be reviewing price action to establish a new tradable range
The overall market index S&P 500 is trading higher by 0.36% from its previous trading close, which means that Watson Pharmaceuticals stock is outperforming the overall market.
Watson Pharma Provides FY11 Guidance, Long-term Targets - Update
Specialty pharmaceutical firm Watson Pharmaceuticals, Inc. (WPI: News ) Friday provided earnings and revenue outlook for fiscal 2011 during an investor meeting held in New York. The company also announced its earnings growth forecast for the long term and detailed on the pipeline developments within its Global Generics and Global Brands businesses.
According to the company's president and chief executive officer Paul Bisaro, 2010 was a successful year with a 25 percent rise in total net revenues and a 12 percent growth in adjusted cash earnings per share.
"In addition to delivering continued strong results, we fully integrated our commercial generic operations in key global markets and further expanded into high growth emerging markets. We successfully expanded our Global Generics and Global Brands product pipelines and initiated our first biologic development project," Bisaro noted.
For fiscal 2010, the company's Global Generics revenue is expected to be $2.35 billion while Global Brands revenue is estimated to be $400 million. The company also forecasts Anda Distribution revenue of approximately $830 million for the full-year 2010.
Watson is set to announce its fourth-quarter and fiscal 2010 results on February 15.
Superhit News
-
US health regulator USFDA has issued a warning letter to German drug firm Fresenius Kabi AG for lapses at its drug manufacturing fac...
-
Goods and Service Tax (GST) is high on the agenda for the new government and its rollout is a priority. GST will benefit the Indian pharma...
-
Rib-X Pharmaceuticals, Inc. announced today the signature of an exclusive worldwide research collaboration agreement and option for license ...
-
Physiomics: Reports difficult trading but highlights growing interest from big pharmaceutical groupsPhysiomics ( LON:PYC ) said that trading conditions were difficult in the six months ended 31 December 2010, but it believes it is in a be...
-
Hindusthan National Glass and Industries Ltd is expected to finalize a strategic overseas acquisition in the pharmaceuticals space in the n...
-
The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey through a written reply in the Lok Sabha informed about th...
-
India's Central Drugs Standard Control Organization (CDSCO) has suspended the manufacturing of eye drops at the Chennai-based firm after...
-
The government is hoping to see the implementation of the track and trace system for domestic and export supply chain in another one y...
-
Amylin Pharmaceuticals, Inc. AMLN +16.15% and Alkermes plc ALKS +4.61% today announced that the U.S. Food and Drug Administration (FDA) has ...
-
Diclofenac injection is a painkiller which is manufactured by Themis Medicare Ltd and marketed by Novartis India under the brand name ...