Noven’s niche: The Miami company is key producer of transdermal patches

At the Noven Pharmaceuticals plant in southwest Miami, scientists and technicians use highly specialized machinery to blend prescription medications and adhesives to make layered transdermal patches that release precise quantities of drugs over time after being applied to a patient’s skin.

Noven, a subsidiary of Japan’s Hisamitsu Pharmaceutical, has about 700 employees nationwide and ranks as a relatively small player among pharma giants. Nonetheless, the company, a leading research and development center for medicinal patches, produces a line of specialty pharmaceuticals and is the U.S. market leader in sales of estrogen patches for women.

“By industry standards, Noven is a small company,” said Jeffrey F. Eisenberg, Noven’s Miami-based president and CEO. “But we have a line of specialized products that competes successfully in the U.S. and overseas. We are experts in developing transdermal patches and produce other pharmaceutical products.”

In one key market — estrogen patches for women — Noven holds about a 68 percent share, he added. And the company has a robust research and development department in Miami at work on a variety of new drugs.

Medications may be delivered to patients orally, via injection or through transdermal patches, which can administer drugs slowly over an extended period of time. While Noven makes products other than medicinal patches, it devotes an important share of resources to transdermal patch technology.

“We have a talented group of scientists who are at the forefront of this specialty,” Eisenberg said. “We have M.D.s, PhDs in biology and chemistry and chemical engineers who specialize in pressure-sensitive adhesives and polymer chemistry.”

Noven has won more than 30 U.S. and 100 international patents and is developing several new drugs. The company recently announced it is making progress on studies to evaluate a new, amphetamine-based transdermal patch for treating Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Currently, there is no such patch approved for use with ADHD, the company said.

Noven also has applied to the U.S. Food & Drug Administration for approval of a new oral, non-hormonal medication to treat menopausal hot flashes.

Making patches is a complex process that requires the design and development of an ideal combination of drug, adhesive and backing, Eisenberg said. Patches must be formulated so that they will deliver a safe and effective dose of medication over a period of time and adhere to the skin as required.

At the Noven patch facility, which has the capacity for making 500 million patches per year, active drug compounds are mixed with custom adhesives in large, specialized kettles. The mix of drug and adhesive is then applied to sheets of release liner material under very precise tolerances. Noven removes a blending solvent from the compound and applies the backing material, making a three-layer patch. Laminate rolls subsequently are sent to punching, pouching and packing machines (Patches are punched into different sizes.). All of this occurs under strict quality control procedures and is not open to the public.

Noven was founded in 1987 by Steven Sablotsky, a chemical engineer, who had worked for another pharmaceutical firm and was an expert in transdermal patches. Noven went public in 1988 and operated as a publicly-traded company until it was taken over in 2009 by Hisamitsu, a Japanese pharmaceutical company that also manufactures and markets transdermal patches. (Salonpas, an over-the-counter analgesic patch widely advertised in South Florida, is made by Hisamitsu.)

Read More..

STREAMING: Soundgarden Live on Letterman

Soundgarden is the latest band to headline the Live on Letterman concert series, streaming now!

RELATED: New Music Tuesday!

The Grammy Award-winning rockers are performing at the Ed Sullivan Theater in New York City preceding the release of King Animal, their first album in 16 years. Former acts to appear on the live concert series include Adele, Coldplay, Taylor Swift, Katy Perry, Carrie Underwood and more.

Late Show with David Letterman airs weeknights at 11:35/10:35c on CBS. King Animal drops tomorrow, November 13.

Read More..

Judge orders hearing to determine if cop killer competent enough for death penalty

They say he’s too dumb to die for his heinous crimes.

A federal judge has scheduled a series of special hearings later this month to hear testimony about whether a man convicted of the execution-style murder of two undercover NYPD officers is mentally competent to face the death penalty — again.

Ronell Wilson has already been convicted of the point-blank shooting death of detectives Rodney Andrews and James Nemorin during a 2003 undercover gun buy-and-bust operation on Staten Island.

And Wilson was condemned to death after his conviction, but in 2010 a federal appeals court overturned that sentence because of a procedural misstep.

But Wilson’s defense attorneys insist that he should not be eligible for the death penalty again because they say he has a low-functioning intellect.

They’re hoping that the convicted cop-killer may be spared under the terms of a landmark US Supreme Court ruling that bars execution of the mentally incompetent.

Brooklyn federal Judge Nicholas Garaufis will preside over the special hearings and listen as medical experts, specialists in mental retardation, and others weigh in on the issue.

The hearings - expected to span two weeks - are scheduled to begin later this month and stretch into December.

Brooklyn federal prosecutors do not believe that Wilson is mentally impaired and are expected to call witnesses that buttress their position.

If the court deems Wilson to be mentally fit, the judge will then schedule a new penalty-phase trial, where jurors will determine whether Willson should be executed by lethal injection or sentenced to life in prison.

mmaddux@nypost.com

Read More..

Gov. Rick Scott may shift stance on health reform law

With the reelection of President Barack Obama, Florida’s Republican leaders are reconsidering their fervent opposition to federal healthcare reform, triggering a discussion that could have huge repercussions for South Florida.

At stake is more than $6 billion in federal funding for Miami-Dade and Broward over the next decade and the possibility of health insurance for a large percentage of the 1.4 million people in the two counties who now lack coverage.

After the defeat of Mitt Romney, who vowed to halt Obama’s healthcare overhaul, the Republican leaders of the Florida House and Senate quickly said the Legislature needed to reexamine the federal act. On Friday evening, Gov. Rick Scott said he agreed there needed to be a discussion.

“Just saying ‘no’ is not an answer,” Scott said in a statement that repeated exactly what Sen. Don Gaetz, R-Destin, the incoming Senate president, told The Miami Herald on Thursday.

“I don’t like this law,” Gaetz also said, “but this is the law, and I believe I have a constitutional obligation to carry it out.” He added that he thinks “there needs to be some adult debate between Republicans and Democrats” on finding ways to make the law work.

Still, Gaetz, Scott and others in the Republican leadership, which controls both the Florida House and Senate, have many criticisms of what both parties now call “Obamacare.” Some are searching for compromises on how it is carried out in the state. What this means for patients and the healthcare industry in Florida — particularly South Florida — remains an enormous question mark.

Time is running short for decisions as the once-distant consequences of the Affordable Care Act are scheduled to kick in during the next 14 months.

The first deadline is Friday. That’s when states must tell Washington whether they plan to set up exchanges — marketplaces where individuals can purchase insurance at discounted group rates and cannot be denied because of pre-existing conditions.

Florida’s political leaders acknowledge they won’t make the deadline. The exchanges are scheduled to start Jan. 1, 2014, and if a state doesn’t set up an exchange, its residents can participate in a federal exchange.

The next provision starts Jan. 1 with an increase in Medicaid fees for primary care physicians. Primary care physicians, who have long complained about low rates for Medicaid, which provides coverage for the poor, are scheduled to be paid at considerably higher Medicare rates — with the feds picking up all of the added cost. But such a pay hike can only happen with the approval of the governor and Legislature, and it’s unclear whether that will happen.

The following year, on Jan. 1, 2014, the biggest changes are slated to start, including a major expansion of people covered by Medicaid. An analysis from the Safety Net Hospital Alliance of Florida shows that if the state doesn’t expand coverage, Florida will lose $27.9 billion in federal funds over 10 years.

That breaks down to a $4.5 billion loss for Miami-Dade during that time, and a $2.3 billion loss for Broward, according to the alliance’s analysis.

Under the law, Washington will pay all Medicaid expansion costs for the first three years, but then the states would have to pay up to 10 percent of the costs in following years — an expense that the Safety Net Alliance calculates will come to $1.7 billion over 10 years in Florida. The expansion could provide coverage to an additional million-plus Floridians. Reform supporters say the expansion would provide cheaper basic care that would help prevent serious illnesses that lead to expensive hospital stays.

Read More..

2-year-old boy drowns in pond on Long Island

HUNTINGTON — A 2-year-old boy has drowned in a pond on Long Island.

Suffolk County police say the child fell into the pond in Hecksher Park at around 11:30 a.m. Sunday.

When police arrived at the scene, a good Samaritan was administering CPR. But the boy was later pronounced dead at Huntington Hospital.

The boy was at the park with his father. Their names were not immediately released.

Police said the death appeared to be accidental.

Read More..

Florida group pushes for more alimony reform

Debbie Leff Israel, the Weston woman who helped start the Florida Second Wives Club, won’t marry her fiancée because her salary can be used to recalculate what he pays to support his ex-wife.

Alan Frisher, a Brevard County financial advisor, was ordered to pay his former wife permanent alimony in 2003 when the couple divorced, a ruling he considers “abusive and unjust.”

The two are unlikely allies in a fight for alimony reform in Florida, a movement that began quietly about a decade ago but is now gaining ground around the country and earning the attention of legislators and family law attorneys.

“Our premise is to educate legislators so they get a complete view of what’s going on, not just one side,” says Frisher, co-director and spokesman for Tavares-based Florida Alimony Reform. “The laws on the books were constructed from the early ‘50s and a lot has changed since then. Women are working, they have equal rights and the economics [of marriage] are quite different.”

While the grassroots movement is comprised mostly of men, more and more women, primarily second wives, are joining in for the same reasons Israel did. Under current law, Israel’s salary as a math professor at Broward Community College can qualify as a factor in the alimony wars if she marries fiancée John Kelapire and his former wife requests more money. That’s because when the paying ex-spouse has fewer expenses — the result of sharing expenses in a re-marriage — a judge can order an increase in alimony.

“That’s just not fair,” Israel says of the law. “It doesn’t encourage people to be self-sufficient and it ties you to the ex for life.”

Israel says she could’ve been awarded permanent alimony when she divorced but chose to receive it only for a set time. “It was in my own best interest,” she says, adding that skipping permanent alimony prompted her to become self-sufficient more quickly.

In the overwhelming majority of divorces, some form of alimony is awarded to the lesser-earning spouse, usually the wife. But as women earn more and become the breadwinners, they, too, are on the paying end, and those numbers are likely to grow. Though no figures are kept, experts say most alimony orders are for a limited period of time to give the ex-spouse time to become self-supporting. Permanent alimony cases are in the minority; the concept was created to protect women who had stayed home for decades to raise a family and had few, if any, marketable skills.

Before changes in 2010 and 2011, there were several types of alimony, either through statute or court rulings. These included temporary alimony (from date of filing through final judgment), permanent alimony (indefinite), rehabilitative alimony (designed to help the ex become self-supporting) and lump sum alimony. Case law had also established “bridge the gap” alimony (short term payments for a specific purpose) and nominal alimony (a minimal amount that can be increased if circumstances change).

Florida Alimony Reform wants to do away with permanent alimony entirely, replacing it with a concept the organization calls “long-term durational” alimony, which would end when the payer reaches retirement age.

Frisher cites various FAR members who have been forced to continue paying ex-spouses even in retirement, when their take-home pay drops and alimony eats up a larger percentage of their income. “Modifications are allowed, but it’s expensive to go to court,” he adds. “And you get very different results depending on the judge. Given the same set of circumstances, you may get a totally different ruling in Brevard than in Broward. We want to make sure the law is consistent and predictable.”

Read More..

Terra Group plans single-family development in Doral with modern architecture

Terra Group expects to break ground soon on a major mixed-use development in Doral, including 300 single-family homes and a grocery-anchored shopping center.

Separately, the Miami developer said it recently acquired four parcels on the edge of Miami’s Midtown/Design District near 36th Street and Biscayne Boulevard through Terra Skylar Investments, a new venture formed with partners Avra Jain and Joseph Del Vecchio, giving it a foothold in a rapidly emerging hotspot.

The Doral Commons project — which will span more than 90 acres between Northwest 97th Avenue and Northwest 107th Avenue on the north side of 74th Street — will be the first project to break with the Mediterranean-style architecture for which the city is known.

“We’re going to be doing modern architecture for the first time in the city of Doral. We plan to have clean lines with a lot of glass. It will be very interesting architecture,” said David Martin, Terra’s president and chief operating officer.

The 3,000- to 4,000-square-foot homes planned for two gated communities will start in the $600,000s, with larger homes in the $1 million range.

Pascual, Perez, Kiliddjian & Associates will be the architect for the Doral project, Martin said.

Terra closed on the purchase of the Doral land from Flagler Development about two weeks ago.

Terra currently has three residential projects under way in Doral: Doral Cay, Vintage and Las Ramblas.

“The problem with Doral is the scarcity of land,” Martin said. “This is our last opportunity to develop something in Doral, and we want to do something design driven.”

He said the homes will feature more garage, storage and closet space than the standard fare.

On the retail side, the Doral project will include a 150,000-square-foot neighborhood shopping center featuring a supermarket and other retail, such as food and beverage, fashion along with some space for banks, Terra said. Courtelis Co. will handle leasing.

Meanwhile near the Midtown/Design District neighborhood, which is in the midst of major development plans, Terra Skylar acquired a 50,000-square-foot office building at 3550 Biscayne Boulevard and several nearby parcels.

For now, Martin said the plan is to maintain the office building with its current tenants. Metro One is handling the leasing. Plans for the undeveloped lots are still in the making but will probably include residential, retail or hospitality, Martin said.

“It’s really a key piece of that neighborhood,” said Martin, who described the area as “where Miami’s creative class of tomorrow wants to live, work and play.”

Read More..

Buzzmakers: Brooke's Cancer Fight & World War Z

What had ET readers buzzing this week?

1. It's Brad vs. Zombies in World War Z

Zombie attack!!! Brad Pitt plays a family man and United Nations employee who faces a deadly zombie pandemic in World War Z -- we gave you an exclusive first look and now we've got the intense trailer!

Just when you thought that the zombie genre may be starting to generate less screams and more Zzzz's, World War Z arrives with an adrenaline shot in the arm for the genre -- complete with insane special effects and a claustrophobic urgency and realism not seen since the introduction of those "speed zombies" in 28 Days Later.

Directed by Marc Forster (Quantum of Solace), World War Z invades theaters June 21, 2013.

2. Oprah Reveals Her 2012 'Favorite Things'

It's officially the holiday season!

Oprah just revealed her "Favorite Things" for 2012, which includes such items as a $1,800 Jetson E-Bike, a $192 hand-picked Tom Ford lipstick palette and a $238 Lafco soap set.

"This luxuriously oversize, deliciously scented soap is my new go-to gift. I even brought a set to Mr. and Mrs. Colbert when I interviewed Stephen for Next Chapter," she says about the pricey soap set.

But of course if you don't have the income of Oprah, you can pick up O's December issue to learn how you can win all 49 of Oprah's favorite things, which hits newsstands November 6.

"Oprah's Favorite Things" is also getting its own two-hour, prime time special airing Nov. 18 on OWN. The special will surprise unsuspecting military spouses with items from the media mogul's exclusive must-have gift selections for the holiday season, and for the first time, viewers of Oprah's Favorite Things: 2012 will have the opportunity to watch and win select items featured in each segment of the show.

3. Brooke Burke-Charvet Reveals Cancer Diagnosis

Brooke Burke-Charvet released a video online Thursday to announce that she was recently diagnosed with a cancerous growth on her thyroid gland. In the video posted on her Modern Mom blog, the 41-year-old actress and TV host explained that a nodule was discovered on her thyroid and after a series of tests over the last few months, it was eventually determined to be cancerous and her thyroid will have to be removed.

"Which means that I'm going to have a nice big scar right her across my neck," Brooke said. "And I don't get to just walk around and pretend like nothing happened or not follow up or not share it, because it's going to be pretty much dead center."

Brooke said the discovery -- which originated from a regular physical -- came as a complete shock because she's otherwise healthy. "As crazy as it is, my head is in the right place, and it's going to be good," she said, adding that the doctors consider this a form of "good cancer" compared to many others and the prognosis is good. "I'm just going to make a positive out of this negative thing."

She said the surgery has been scheduled and she promised to keep her fans updated through her blog. "Now I'm ready to deal with it and I'm going to be fine. And I feel really, really strong."

Speaking on Thursday's episode of The Talk, Brooke's co-host on Dancing with the Stars, Tom Bergeron, commented on her cancer diagnosis. "My love and support are with you -- we are all there with her," he said. Bergeron added that he personally has a very positive outlook. "I've known about this for a few months. I have had experience with this in my family. You never want to hear the word cancer. But thyroid cancer is one of the most treatable cancers. It has an incredibly high success rate."

4. Kirstie on Secret Relationship with Swayze

Kirstie Alley reveals to ET's Chris Jacobs intimate details about what she says was a powerful attraction and hidden relationship with her North and South co-star, Patrick Swayze. Although both stars were married during filming of the mini-series, Alley tells Jacobs when she first saw Swayze, they had an intense attraction and she tried to avoid "going down that road," but they ultimately fell in love.

"Both of us were married. We did not have an affair. But again, I think what I did was worse. Because I think when you fall in love with someone when you're married, you jeopardize your own marriage and their marriage. It's doubly bad," said Alley.

Alley goes on to say that although she's friends with Patrick's wife, Lisa Niemi, who asked Alley to speak at Swayze's funeral, she is uncertain if Lisa is aware of their relationship.

5. One Direction & Drew Brees Play Catch - Exclusive

One Direction and Drew Brees teamed up last month to film an adorable Pepsi spot and during Thursday night's episode of The X Factor, the band will not only perform their newest singles, Live While We're Young and Little Things, but also reveal an alternate ending to the ad!

For those who missed the spot, the original ended with Drew Brees sacrificing his last can of Pepsi in order to become an unofficial member of One Direction. But, according to Angelique Krembs, VP Marketing for Pepsi, they also wanted to show fans what would happen if Drew won the last can of Pepsi. "Our latest Live For Now spot has received an enormous amount of buzz and online excitement," Krembs said. "And of course everyone wants to see the boys from 1D suit up in football gear and have some fun."

While you have to wait until Thursday to see the entire surprise ending to Pepsi's Live For Now television commercial, ETonline scored an exclusive sneak peek of One Direction tossing the pigskin around with Brees!

Tune in to The X Factor on November 8 at 8 p.m. to see the alternate ending!

Read More..

Driver leaves moving car on Long Island highway

DIX HILLS — Police say a driver fell or jumped out of his moving SUV on Long Island highway, seriously hurting himself while the car kept going on its own and crashed.

Suffolk County police say it's unclear why Christopher Wilson abruptly left or tumbled out of his Chevrolet Blazer around 1 p.m. Saturday on the eastbound side of the Long Island Expressway. He landed on the roadway just west of Exit 51 in Dix Hills but managed to escape being hit by any cars.

Police say the driverless SUV kept going for about another quarter-mile before slamming into a light post, veering onto the grass by the highway and hitting a couple of trees.

The 40-year-old Wilson was flown to Stony Brook University Hospital in serious condition. He's from Huntington Station.

Read More..

American Airlines growing in Miami

American Airlines says November is bringing a record schedule at Miami International Airport.

The airline along with regional carrier American Eagle will serve 114 destinations with 328 flights a day starting later this month. The newest routes are between Miami and Asuncion, Paraguay, which starts Thursday, and Miami and Roatán, Honduras, starting Nov. 17.

American is also increasing the frequency of flights to 38 cities.

American Eagle will transition to a fleet of 50-seat regional jets, doing away with turbo prop planes.

Although American is restructuring under bankruptcy protection, the airline has said long-term plans call for 20 percent growth at its five major hubs, including Miami.

Read More..