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.)

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Voter suppression and Florida’s butterfly effect

MiamiHerald.com/columnists

Edgar Oliva waited to vote at Shenandoah Elementary School and fretted.

The line was too long. The clock was ticking. He had to get to work across town.

Twice before, during in-person early voting, he tried to vote but he had to leave because lines were even longer. Tuesday was his third try at voting in between one of his two jobs, cleaning carpets in Doral and working at an airport hotel.

About 4 p.m. on Election Day, he gave up.

“I had the intention of voting but there were always a lot of people,” Oliva, a native of Guatemala, told a Miami Herald reporter as he left the scene.

Oliva had so much company on Tuesday.

Voter after voter who spoke to Herald reporters on Election Day said the longer early voting lines dissuaded them from casting early ballots in person. And then the unexpected long lines on Election Day just compounded the sense of frustration in some places. Many dropped out of line.

The experience played out across the state. Data show the 71.13 percent turnout percentage in 2012 fell well short of the rates in 2008 (75 percent) and 2004 (74 percent).

In 38 of 67 counties, fewer people cast a ballot for president this time than in 2008.

Only 80,351 more people voted now than in 2008 even though the voter rolls increased by 686,812, according to the latest numbers from the state’s elections division. The vote totals will change slightly as provisional ballots are counted.

Relatively speaking, Florida in 2012 moved backward when it came to voting.

If the statistics and the experience of voters like Oliva are not evidence of voter suppression, then we’ll need to change the definition of “suppressant” in Webster’s dictionary: “an agent (as a drug) that tends to suppress or reduce in intensity rather than eliminate something (as appetite).”

Tuesday showed the appetite was there.

But the government wasn’t.

The chief suppressant: HB1355, signed into law by Gov. Rick Scott in 2011.

The law shortened early voting periods. And it created a longer ballot by giving lawmakers the ability to print the entire text of proposed constitutional amendments because the courts kept rejecting the Legislature’s ballot summaries as misleading.

Early voting was shortened to prevent a repeat of 2008, when Barack Obama won Florida, largely on the strength of early voting. So Republicans cut early voting days from 14 to eight. And they loaded amendments on the ballot, which stretched for at least 10 pages in Miami-Dade.

The other voter suppressant was local: a lack of enough voting booths and ballot scanners in some precincts. That’s controlled by each county’s supervisor of elections.

Bottom line: there was less time to vote a longer ballot without adequate equipment this election.

There were a significant number of early votes — 2.4 million — and almost as many absentee ballots, 2.35 million. Together, the early and absentee ballots account for about 56 percent of those cast this election.

Republicans typically prefer absentee ballot voting. So it wasn’t touched by HB 1355. Democrats prefer in-person early voting. That’s what the Republican Legislature and Scott cut.

Some Republicans have said that those who complain about long lines have no excuse, that they should have voted by absentee ballot.

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Malaysian charged with Facebook insult of sultan

KUALA LUMPUR, Malaysia (AP) — The sister of a Malaysian man who has been charged with insulting a state sultan on Facebook said Friday that he is innocent and will lodge a complaint over his detention.

Anisa Abdul Jalil said her brother Ahmad Abdul Jalil was charged Thursday with making offensive postings on Facebook last month. But she said there is no evidence linking Ahmad to the posts in question, which were made by someone using the name “Zul Yahaya.”

“This is ridiculous as they have failed to build a case against him. We are very angry. It is a dirty game and an abuse of power, an abuse of the court process,” Anisa told the Associated Press.

Ahmad was freed on bail Thursday after six days of detention, during which he was denied access to lawyers and family members.

Anisa said Ahmad told the family that police tried to force a confession from him but he stood firm. She said Ahmad will file a complaint with police for unlawful detention and intimidation.

Defense lawyer Fadiah Nadwa Fitri said they would appeal to throw out the charges against Ahmad when the case is next heard Nov. 28.

The posts in question were directed at Sultan Ibrahim Iskandar of southern Johor state. Fadiah said that according to the charge sheet, the postings likened the sultan’s skin and behavior to that of a pig, which is viewed as a dirty animal in Islam.

“The charges are unfounded. Ahmad is vocal and is critical about political matter but he didn’t write the postings. It seems that Ahmad is being prosecuted for exercising his rights,” Fadiah said. Ahmad faces up to a year in jail if convicted, she added.

Nine Malaysian states have sultans and other royal figures. Though their roles are largely ceremonial, they command wide respect after centuries of hereditary rule.

Under Malaysian law, acts that provoke hatred against royal rulers are considered seditious. Only a few people have been charged with the crime in recent years.

Social Media News Headlines – Yahoo! News

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Exclusive New Mike and Molly Clip for Yard Sale Episode

It's never too late for a bit of spring cleaning.

Related: Melissa McCarthy Happy at Any Size

Molly (Melissa McCarthy) decides a yard sale is in order when she realizes her house is too crowded, but it isn't long before the move proves more trouble than it's worth.

Watch an exclusive sneak peek in the player above!

You can catch this new episode of Mike & Molly tonight on CBS.

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Obama honors sacrifice made by nation's veterans (VIDEO)

REUTERS

President Barack Obama pauses after placing a Veterans Day wreath at the Tomb of the Unknowns at Arlington National Cemetery in Arlington, Va., today.

WASHINGTON — President Barack Obama paid tribute at a Veterans Day ceremony at Arlington National Cemetery to "the heroes over the generations who have served this country of ours with distinction."

He said the wreath he laid earlier at Tomb of the Unknowns was intended to remember every service member who has worn a uniform and served the nation.

In a speech at the Memorial Amphitheater during the brisk, sunny morning, Obama said America will never forget the sacrifice made by its veterans and their families.

"No ceremony or parade, no hug or handshake is enough to truly honor that service," the president said, adding that the country must commit every day "to serving you as well as you've served us."

He spoke of the Sept. 11 generation, "who stepped forward when the Towers fell, and in the years since have stepped into history, writing one of the greatest chapters in military service our country has ever known. You've toppled a dictator and battled an insurgency in Iraq. You pushed back the Taliban and decimated al-Qaida in Afghanistan. You delivered justice to Osama bin Laden."

Obama also said this was the first Veterans Day in a decade with no American troops fighting and dying in Iraq, and that a decade of war in Afghanistan is coming to a close.

Over the next few years, he said, more than 1 million service members will make the transition to civilian life. As they come home, Obama urged their fellow citizens to always be there for them and their families.

Later, the president and his wife, first lady Michelle Obama, and Vice President Joe Biden and his wife, Jill, greeted families in the cemetery's Section 60, home to graves of service members killed in Afghanistan and Iraq.

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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.

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With each stitch, two South Florida soldiers are honored

By now, they should have been veterans.

Tech Sgt. Tim Weiner should be 41, retired from the Air Force, living near his brothers — also veterans — in Colorado.

Sgt. Adam Cann should be 30, out of the U.S. Marines, back home in Broward County, perhaps settled down with one of his many pretty girlfriends and working as a chef.

Instead, they are the lost sons of parents whose pain has hardly abated since their combat deaths in Iraq: Cann in 2006, Weiner in 2007, both after multiple deployments.

Over the years, Leigh and Carol Cann of Davie, Marcia Weiner Fenster and Pierre Fenster of Lauderhill, have sought emotional comfort in projects dedicated to their sons’ memories.

This Veterans Day, they can add the physical comfort of handmade quilts created in their sons’ honor by a national network called Home of the Brave Quilts.

So far, the group has created and presented 5,365 quilts, based on a Civil War-era pattern, to families of the fallen.

On Thursday, the Canns and Fensters met, for the first time, at Holman Honda in Fort Lauderdale, where Home of Brave presented their quilts. They embraced and cried, bonding over a loss unique to those who have seen somber military officers on their front porches and known, without being told, that their lives would never be the same.

Also on hand: Angela Adkins and Dana Rankin, the Holman Automotive Group employees who crafted the quilts, square by square, for heartbroken strangers.

Sgt. Adam Leigh Cann was the middle of three boys, born Jan. 25, 1982. He died 20 days shy of his 24th birthday, on Jan. 6, 2006, when a suicide bomber detonated outside a police recruiting center in Ramadi, Iraq.

He was assigned to Security Battalion, Marine Corps Base Camp Pendleton, in California. His unit was attached to the 2nd Marine Division, II Marine Expeditionary Force.

Adam and his bomb-detecting dog Bruno were patrolling a crowd when Bruno alerted to the bomber. Adam placed himself against the man, forcing the explosion sideways.

He’s credited with saving Bruno, fellow U.S. fighters and police headquarters. It’s believed that the bomber planned to detonate inside the building.

A U.S. Army officer died, along with 37 Iraqis. Bruno, a German shepherd, later retired to California, where he died at age 7.

Tech Sgt. Timothy R. Weiner was one of four brothers in the active-duty military in the mid-2000s. They have a civilian sister. He was born May 27, 1971, and left a wife and son.

He served in an elite EOD unit: Explosive Ordnance Disposal (bomb disposal). In addition to his work in war zones, Tim was part of top-secret security details.

He joked to his mother that the president of the United States couldn’t use a restroom until he’d declared it safe.

“That’s power!’’ he crowed.

He and two other EODS from the 775th Civil Engineer Squadron, based at Hill Air Force Base in Utah, died Jan. 7, 2007, near Camp Liberty, trying to disarm a car bomb.

“I think they would have been good buddies,’’ Marcia Fenster told Leigh Cann.

Adam Cann “was always active and spirited,’’ said his father, who raised his children alone, after a divorce, then remarried. “He was really funny. He had this laugh to make you smile. And he was leader among his friends. A lot of people were attracted to him.’’

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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!

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'Suspicious' East Harlem fire sends 2 to hospital — cops find one victim may have been stabbed first

Two people were hospitalized after a fire tore through a Park Avenue apartment building in East Harlem, sources said.

Investigators believe the fire may have been suspicious and it appeared as though one of the victims may have been stabbed, sources added. Both victims were rushed to Harlem Hospital, one in critical condition and the other in serious condition, authorities said.

It was not immediately clear what sparked the blaze on the tenth floor around 4:15 p.m.

kconley@nypost.com

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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.”

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