UPDATE 1-FDA OKs Merck OTC version of overactive bladder drug
Fri Jan 25, 2013 12:40pm EST
Jan 25 (Reuters) - U.S. health regulators approved Merck & Co's nonprescription version of Oxytrol to treat overactive bladder in women ages 18 and older, the agency said on Friday.
The U.S. Food and Drug Administration said the over-the-counter version of Oxytrol would be available for women only and that the drug remained available to men by prescription.
Overactive bladder, which affects an estimated 33 million Americans, is a condition in which the bladder squeezes too often or without warning. Symptoms include leaking urine, feeling a sudden and urgent need to urinate, and frequent urination.
Oxytrol for Women is a patch that contains oxybutynin, a medicine that helps relax the bladder muscle, and is designed to be applied to the skin every four days, the FDA said.
Oxybutynin belongs to a class of drugs known as anticholinergics. Pfizer Inc's Detrol is the market leader in the class with annual sales of about $700 million.
Oxytrol will be the first drug in the class to be sold over the counter. Merck licensed exclusive rights to sell OTC Oxytrol from Actavis Inc, the generic drugmaker formerly known as Watson Pharmaceuticals.
Merck said it expected the OTC patch to be available in the fall.
The FDA decided to approve the OTC version of the Merck drug, based on the results of nine studies of women that demonstrated that consumers can understand the information on the label, properly determine whether the product is right for them, and use the drug appropriately, the agency said.
Last week, the FDA approved the popular wrinkle treatment Botox from Allergan Inc to treat overactive bladder in people who cannot tolerate drugs from the class to which Oxytrol belongs or are not helped by these medications.
Allergan's BOTOX® (onabotulinumtoxinA) Receives U.S. Food and Drug Administration Approval for the Treatment of Overactive Bladder for Adults Who Have an Inadequate Response to or Are Intolerant of an Anticholinergic Medication.
I am pleased to see management has a new corporate logo but it looks like Allergan has been working on taking the market.
The CEO of Sientra, Hani Zeini, is giving a presentation this wednesday in Santa Barbara. Since all the breast implant manufacturers are in SB it should be interesting.
I sold out my shares at $42 figuring lawsuit would torpedo deal. I did okay but hate to see so much money left on table because of lawyers.
Medicis (MRX) is falling after the company disclosed in an SEC filing that it had been sued by dermatological product maker Q-Med. The lawsuit alleges that Q-Med has the right to block Medicis' pending merger with Valenant Pharmaceuticals (VRX). Q-Med, whose dermal filler products are sold by Medicis, is asking a court to affirm that it has the right to block the merger, as well as a preliminary injunction that would prohibit Medicis from transferring to Valeant its right to distribute Q-Med products.
This team is a chronic under performer. I sold ZMH and bought SYK and its been a #$%$ trade off ever since. They need to get the business into the hands of a competent management team.
David Pyott sold 616,300 shares on October 4-5. It appears he still owns 399,151 directly, through his trust, 401K and ESOP. This looks to be well over 60% of his holdings. Mr. Pyott joined Allergan in January 1998 as President and Chief Executive Officer and now serves as Chairman of the Board (since 2001), President and CEO.
• Total sales are up 13% about $20 million but UGG sales are down for quarter.
• From the press release “UGG® brand sales decreased 0.3% to $107.9 million compared to $108.3 million for the same period last year.
• Teva® brand sales decreased 15.4% to $34.1 million compared to $40.3 million for the same period last year.”
• All the growth came from acquisition of Sanuk brand ($28 million) and core business is down year on year.
• Operating losses ballooned uncontrolled to $28.5 million from 10.8 million loss last year.$174 million in sales and the company has a loss? Now that is spending.
• Sadly, management is very busy working on their new corporate headquarters while the business flounders.
To be accurate the insider did not buy shares. Someone in his family did. So do not take too much credit here. These guys are selling out like crazy.
stop selling the shares every time the window opens. Its hard for longs to make a case for ownership when the management won't.
Sorry I did not sell last year.
Allergan is a strong DTC marketer. They will expand the market via advertising and awareness. With Latisse (for lashes) they were able to bundle the product promotionally with Juvederm and Botox for cosmetic use. They basically gave the prodct away to drive adoption and use. I do not think those tools will be available to market to urologists given reimbursement constraints. (They were fined $600 million last year.) Just the same, expect the market to expand and they will take a large share. Hopefully UPI can hang on to some share but it best get serious about have a tough competitor.
Boy am I happy I found this stock. I had been shredding my cash using a 20 sheet shredder and this is so much faster! This management team is great! Copying patented technologies and trademarks is a sign of world class performance. Boy am I relieved the court validated NuVasive’s technology and gave Medtronic a $100 million to drive home the point. Its great to hear that the loss of $100 million has in “no way impact the daily operations of our business.” Not until tomorrow anyway. I think we need another round of bonuses. Comp committee, another round please.
I am not a shareholder of Netflix but sadly I am a customer. I would jump at a chance to change to any other service. This may be the worst run company on the planet. I have no idea what is going on with steaming and dvd service. The year over year profits were up some 56% per Yahoo finance. I suppose they thought that was too much so they decided to torture the customers into quitting the service. Good luck .. you will need it with this management team.
Mentor Worldwide corporate officials are being tight-lipped about their plan to cut their workforce but local employees will feel the impact. A company spokesman said the cosmetic-product and breast-implant maker in Goleta will downsize an unspecified number of employees at its 400-person corporate headquarters within the month.
The company, which became a unit of conglomerate Johnson & Johnson two years ago, said the jobs are being eliminated in the face of waning demand for its product line.
Chris Allman, a Mentor spokesman, told the News-Press that the reduction in force is occurring "in all departments across the organization here," but did not pinpoint what types of jobs will be affected by the cut or if they will be absorbed by employees at other J&J-affiliated companies.
Mr. Allman believes the layoff isn't large enough to trigger a Worker Adjustment and Retraining Notification to state and federal labor authorities, who provide unemployment and job training assistance. WARN offers protection to employees, their families and communities by requiring employers to give affected employees and other state and local representatives notice 60 days in advance of a plant closing or mass layoff.
"I have not received a WARN notice, but it could be delayed because of the Labor Day holiday," said Ray McDonald, executive director at Santa Barbara County Workforce Investment Board, an agency that assists dislocated workers. "The WARN notice is triggered by 50 employees laid off."
Affected employees can apply for positions with other J&J-owned companies, he said.
Mentor, which has an estimated 2,000 employees worldwide, used to have manufacturing operations in Goleta but chose to move them out of state. In 1991, Mentor relocated its manufacturing to Dallas to escape high production costs.
Johnson & Johnson acquired Mentor in 2009 for $1 billion. The company is a stand-alone business unit reporting through Ethicon Inc., a provider of suture, mesh, hemostats and other products for a wide range of surgical procedures.
J&J doesn't reveal the sales of breast augmentation products, but in the second quarter of fiscal year 2011, Ethicon contributed $1.3 billion to Johnson & Johnson's total revenue of $16.6 billion. While this segment doesn't form a large part of Johnson & Johnson's total operations, Ethicon has a range of other products whose sales are growing.
Mentor has several competitors in the breast-implant arena, such as Allergan, the Irvine-based maker of wrinkle-smoother Botox, other drugs and medical cosmetics.
Analysts say the breast-implant market is more sensitive to economic conditions than most. Most of it comprises cosmetic surgeries that can cost thousand of dollars and generally aren't covered by health insurance.
Before the economic downturn, easy credit made it possible for more people to splurge on cosmetic procedures, especially breast implants.
Mentor doesn't say how much credit its customers use, but an industry analyst following the company estimated in a Wall Street Journal article that, prior to the recession, roughly 50 percent of breast-implant revenue came on credit. The analyst now estimates that between 30 percent and 40 percent of patients use credit to pay for their breast implants.
Mr. Allman would not speculate on whether future layoffs are planned, but said the company, which was founded on the South Coast in 1984, did experience other layoffs when Mentor was a publicly traded company.
"Mentor routinely evaluates its business model and structure, examining all aspects of its internal resources, skill sets and capabilities to make sure it is aligned to meet changing dynamics in the marketplace," Mr. Allman stated.
I listened to the call and did not recognize the name of the new face of latisse, Christina Hendricks. I googled her up and still do not really recognize her but I have to say I am dis-appointed. She may be the picture of the American women for someone but she has massively oversized breast implants and may well be a candidate for a lapband. (check her BMI score). With the millions of pretty faces we see everyday, I think we could have done better. By the way I am long AGN and really not liking this week much.
I listen to the call and I was disappointed. I have heard more urgency at the department of motor vehicles. Who can be happy with talk of 5% growth and blaming the economy?
While I do own some of this stock, AGN, I do not think a P/E in the low to mid thirties is likely. Currently the Forward earning are 3.50 so forward p/E of 30 seems too high.
Have you ever listened to a conference call? this team is a disaster. No wonder the shorts are circling it like buzzards. Akdag seems unprepared and uncooperative, and severely out of touch with the competitive environment. Maybe some one should tell him gross margins are dropping like a rock and sales are down 23 of the last 4 quarters. I sadly own several thousand shares at much higher prices.