divendres, 30 d’octubre del 2015

Possible Pfizer-Allergan tie-up sparks fresh tax inversion angst on Capitol Hill

Pfizer, Allergan(Reuters) — Pfizer (NYSE:PFE) faces political risks in Washington if it proceeds with a bid for Allergan (NYSE: AGN), but with little chance of legislation to curb such tax inversion deals, the Obama administration may be able to throw up only limited obstacles.

Lawmakers are widely seen as unlikely to tackle major tax code changes before the 2016 presidential election, but they were already scolding Pfizer publicly yesterday, showing that companies considering inversion deals do face reputational risk.

“When corporations choose to invert and don’t pay their fair share of taxes, they leave the rest of us to pick up the tab. That isn’t right,” Sen. Richard Durbin (D-Ill.) said in a statement. Durbin has voiced similar views on prior inversions, including 1 that was abandoned by retailer Walgreen. The $50 billion inversion deal that united Medtronic (NYSE:MDT) and Covidien also drew criticism from lawmakers last year.

An inversion deal typically involves a U.S. company buying a foreign company and then relocating corporate headquarters, on paper at least, to the foreign company’s home country, with the goal of reducing the combined company’s overall taxes.

New York-based Pfizer and Dublin-based Allergan said they have not reached an agreement and declined to give details.

A tax inversion is being discussed in the current talks, which could create the world’s largest drugmaker, a person familiar with the matter told Reuters.

Ireland has been a frequent redomiciling destination for U.S. corporations fleeing the U.S. tax system, though most of them leave their actual core operations in the U.S.

The latest wave of inversions crested in late 2014, when the Obama administration cracked down, making it harder both to do the deals and to realize their benefits.

A U.S. Treasury Dept. spokesperson said further actions could be taken, but stressed that only Congress can slam the door completely.

Among the department’s options is tightening rules against a tax-dodging technique known as “earnings stripping” that is often a key component of inversions. This practice involves shifting profits earned in the U.S. to a lower-tax jurisdiction.

“We are continuing our review of a broad range of options for further action but there is a limit to what we can do administratively. Congress must take action to end this loophole,” the Treasury spokesperson said in a statement.

Steven Rosenthal, senior fellow at the Urban-Brookings Tax Policy Center, a think tank, agreed that earnings stripping was a good place for the Treasury to start.

“Otherwise you leave a loophole and incentive for these combinations to continue,” Rosenthal said.

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MassDevice.com +3 | The top 3 medtech stories for October 30, 2015

plus3-1x1

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. CasMed deals vital signs monitoring biz to Zoe Medical

MassDevice.com news

CAS Medical Systems said that it sold its 740 Select line of vital sign monitoring products to Zoe Medical for an unspecified amount.

Branford, Conn.-based CasMed said it made the move so that it can focus solely on its Fore-Sight cerebral oximetry business. The 740 Select operation put up $3.7 million in sales last year and $1.3 million during the 1st 6 months of 2015, the company said. Read more


2. Glaukos, Transcend Medical settle spat over eye stent patents

MassDevice.com news

Glaukos said that it agreed to settle a patent infringement lawsuit brought by eye stent rival Transcend Medical.

The agreement, in which both sides agree not to sue for patent infringement, calls for Transcend to pay a 1% royalty on sales of its Cy-Pass micro-stent until April 2022, with the total amount capped at $6 million, Glaukos said. Read more


1. Appeals court rules for Medtronic in remote monitoring patent spat

MassDevice.com news

A federal appeals court handed a win to Medtronic that could wind up helping Twin Cities rival St. Jude Medical, in a pair of decisions concerning patents covering remote patient monitoring technology.

In the Medtronic case, the U.S. Court of Appeals for the Federal Circuit ruled that a lower court judge wrongly interpreted the patent, overturning validity decision in favor of Atlas IP and remanding the case back to the U.S. District Court for Southern Florida. The Federal Circuit also upheld Judge Cecilia Altonaga’s judgment of non-infringement in favor of Medtronic. Read more

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Inside Valeant’s ambitious plan for its contact lens business

Valeant Pharmaceuticals(Reuters) — Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) has pursued a plan in recent months to dominate the market for specialty contact lenses, according to 2 people familiar with the company’s approach and some of the company’s communications with its customers.

The Canadian drugmaker’s goal, spelled out to key employees and demonstrated through its actions, has been to acquire other manufacturers, take on competitors and raise prices for unfinished lens components.

Valeant entered the contact lens business with its purchase of Bausch & Lomb in 2013 for $8.7 billion. At the time of the acquisition, Bausch & Lomb manufactured about 75% of the basic components of rigid gas permeable lenses, known as “buttons,” said Kurtis Brown, who worked for Bausch & Lomb prior to Valeant’s purchase. After manufacture, buttons are customized for individual patients, typically by laboratories specializing in that process.

With the acquisition of Paragon Vision Sciences in May for an undisclosed sum, Valeant and Bausch & Lomb further consolidated their grip on the market, gaining control of more than 80% percent of the gas permeable button market, according to 1 of the sources familiar with Valeant’s operations and the representative of an industry group.

Rigid lenses comprise only about 10% of the contact lens market, and are popular among people who cannot wear soft lenses.

The acquisition of Paragon also gave Valeant and Bausch & Lomb full control of the small market for Ortho-K buttons, which are used to create 1 type of gas permeable lens, said Brown, now a marketing manager for lens manufacturer Menicon America. Sales of Ortho-K buttons and finished Ortho-K lenses comprise only about $5 million in annual sales for Valeant companies.

The FTC is investigating the Paragon purchase as part of an anti-trust probe, a source interviewed by the FTC told Reuters. Valeant disclosed this week that it had received a letter from the FTC on or about Oct. 16 seeking more information about its acquisition of Paragon. Valeant declined to comment on specifics of its strategy in the specialty contact lens market but defended its purchase of Paragon.

“Our acquisition of Paragon Holdings supports our mission to improve consumers’ lives by bringing to market innovative, specialty eye care solutions, and we are cooperating with the FTC on its inquiry,” the company said in a statement emailed to Reuters.

Bausch & Lomb is now operated as a division of Valeant, and Paragon has been rolled into Bausch & Lomb.

In recent months, Bausch & Lomb also has moved to acquire laboratories that turn the raw components – buttons – into finished lenses.

The plan has encountered challenges, however, with at least 4 laboratories – including Alden Optics, Art Optical and Tru-Form Optics – holding out, at least for now, against Bausch & Lomb’s purchase overtures, according to 1 of the sources familiar with Valeant’s contact lens operations and some of the labs themselves.

In the months after it began trying to acquire laboratories, Bausch & Lomb increased button prices for its customers, which included more than 30 laboratories that customize lenses, according to Jan Svochak, president of the Contact Lens Manufacturers Assn., an industry trade group.

The price increases for buttons ranged from 15% to more than 120%, a source with direct knowledge of the price hikes said.

Keith Parker, owner & president of Advanced Vision Technology, said that his lab was hit with a first price increase from Bausch & Lomb in mid-September and a 2nd on October 1, all on overnight-wear lenses.

“They were substantial,” he said of the price increases. “Some of them 100%, some of them more than 100%.”

The company also did away with volume discounts, Parker said.

In response to the price increases, some labs have begun switching to other button suppliers, such as Contamac, according to at least 3 laboratories interviewed by Reuters. Contamac has not responded to a request for comment.

Last week, Bausch & Lomb sent a letter to the optometrist community promising to “adjust down” some of the increased prices after complaints from laboratories.

In the long run, Bausch & Lomb hopes to do more manufacturing and distribution of finished lenses directly to optometrists. This would enable Bausch & Lomb to bypass some of the laboratories now filling that role and thereby buttress its profits, according to 1 of the people familiar with Valeant’s operations and several laboratories.

According to the 2 sources familiar with Valeant’s contact lens operations, Bausch & Lomb hopes a newly created division, to be called Advanced Vision Products, will bring in more than $100 million in revenue by the end of 2016 from sales of specialty contact lens products, including customized gas permeable contact lenses.

Bausch & Lomb currently earns about $30 million annually from manufacturing gas permeable lenses and their basic components, the sources said.

Valeant was already the subject of a U.S. probe into price increases for its heart medications, and its stock price was battered last week after short-seller Andrew Left accused it of using mail-order pharmacies to fraudulently book revenues.

Valeant denied Left’s assertions and laid out a detailed defense on Monday of its relationship with specialty pharmacy Philidor, the firm at the center of Left’s accusations.

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Ex-Siemens Healthcare exec Sorensen gets in on Deerfield’s Imris buy

ImrisDr. Gregory Sorensen, the former chief of Siemens Healthcare (NYSE:SI) North America division, is taking out a minority stake in Deerfield Imaging, the former Imris business the investment company bought out of bankruptcy this year.

Imris and 2 subsidiaries, including its NeuroArm Surgical business, filed for Chapter 11 bankruptcy protection last May, under a bailout plan with Deerfield Management. Today Deerfield said Sorensen plans to take out a “significant” minority interest in the former Imris business and is set to become executive chairman.

“I’m very excited to be part of this partnership,” said Sorensen. “I’m passionate about improving patient care via scientific advances, and Imris has a strong record of deep technological innovation that has been shown to improve outcomes. I see great untapped potential in the Imris technology and am confident I can help this company unlock that value for the benefit of all stakeholders.”

“Dr. Sorensen’s focus on patient outcomes and satisfaction and product innovation will help take our product development and market leadership to the next level. We are excited to have him join our team,” added Deerfield Imaging president & CEO Jay Miller.

“Dr. Sorensen’s decision to take a leadership role and significant stake in Imris validates the potential for the Imris technology and we look forward to a strong growth trajectory and continued successful patient care under his leadership and vision,” noted Deerfield Management partner Ted Huber.

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Hospitals to pay $250m for ICD coverage violations

hospital(Reuters) — Hundreds of U.S. hospitals will pay a total of more than $250 million stemming from allegations that they implanted cardiac devices in Medicare patients in violation of coverage requirements, the U.S. Justice Dept. said today.

The 457 hospitals are from 43 states, the Justice Dept. said.

The settlement involves a type of device that detects and treats extremely fast, life-threatening heart rhythms, called fibrillations, by delivering a shock to the heart, the Justice Department said.

But only patients with certain medical characteristics and risk factors qualify for the device, known as an implantable cardioverter defibrillator, or ICD, the Justice Dept. said.

Medicare guidelines provide that doctors should not implant ICDs in patients who have recently suffered a heart attack or had other procedures, such as heart bypass surgery. Each of the hospitals that settled on Friday had implanted ICDs during 40 day waiting periods that Medicaid requires for heart attack patients and 90 day waiting periods for bypass patients.

The conduct occurred between 2003 and 2010.

Hospitals hit with the largest fines include Ascension Health in St. Louis, Missouri ($14.9 million), Catholic Health East in Newtown Square Pennsylvania, now part of Trinity Health Corp ($11 million), and Catholic Health Initiatives in Englewood Colorado ($7.8 million).

The hospitals and others were defendants in a federal whistleblower suit brought under the U.S. False Claims Act, a law that imposes liability on companies that defraud the U.S. government.

Spokespeople for Ascension and Trinity said the hospitals were pleased to have resolved the matter. The Trinity spokeswoman said the hospital fully cooperated with the Justice Dept. and that its doctors acted in patients’ bests interests. Trinity settled the case to avoid additional legal costs, the spokeswoman said.

A Catholic Health Initiatives spokesman could not be immediately reached for comment.

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Sunrise Labs’ Golf Tournament Raises $10,000 for Joslin Diabetes Center

Sunrise Labs, an ISO-13485 certified medical device product development firm in Auburn, NH, is pleased to announce its first charity golf tournament, Fore the Cure, raised $10,000 for Joslin Diabetes Center.

The Fore the Cure tournament took place on Monday, September 21 at Breakfast Hill Golf Club in Greenland, NH. The $10,000 donation was raised from the event’s registration fees as well as event sponsorships.

Sixty-eight golfers participated in the tournament and seventeen sponsors generously donated signage, prizes, food, and beverages.

“Joslin has consistently been there for diabetics for as long as I can remember; starting with my sister attending the Clara Barton Camp for girls with diabetes when she was just 8 years old. The research and support they provide improves the lives of hundreds of thousands of people living with diabetes and Sunrise is proud to help support their efforts,” said Eric Soederberg, President of Sunrise Labs.

“We are grateful to Sunrise Labs for their generous donation,” said Peter S. Amenta, M.D., Ph.D, CEO and President of Joslin Diabetes Center. “Donations like this one from Sunrise provide critical support for Joslin as we work towards our mission of preventing, treating and curing diabetes.”

Sunrise Labs
www.sunriselabs.com

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Steris to close $2B Synergy Health buyout next week

Steris, Synergy Health mergerSteris (NYSE:STE) said today that it expects to close the $2 billion merger with the U.K.’s Synergy Health next week, reporting fiscal 2nd-quarter numbers that beat expectations on Wall Street despite a -72% bottom-line plunge.

Last month a federal judge today shot down the U.S. Federal Trade Commission’s bid to block the pending, $1.9 billion merger. Today Steris said it expects to put a bow on the deal Nov. 2.

Mentor, Ohio-based Steris posted profits of $8.7 million, or 14¢ per share, on sales of $489.9 million for the 3 months ended Sept. 30, representing a -72.0% profit slide on sales growth of 5.9% compared with Q2 2014. Adjusted to exclude 1-time items, including a pension settlement and expenses from the acquisition, earnings per share were 83¢, 6¢ ahead of expectations on Wall Street, where analysts were looking for sales of $488.7 million.

“Steris is in a good position heading into our 2nd half, with solid top- and bottom-line growth,” president & CEO Walt Rosebrough said in prepared remarks. “We are very pleased to be days away from closing the Synergy Health acquisition. We are excited about the future, as the combined company will bring together the many strengths of both businesses, which will allow us to accomplish more than either one of us could separately.”

Steris affirmed its outlook for stand-alone adjusted EPS of $3.15 to $3.30 on stand-alone sales growth of 6% to 7% for fiscal 2016. The company said it plans to update its guidance “as soon as practical” after the Synergy merger’s close.

STE shares were up 5.5% to $73.87 apiece today in mid-day trading.

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No timeline on Sientra’s return to breast implant market

SientraThere’s no timeline yet for a return to the U.S. market with its breast implants, Sientra (NSDQ:SIEN) CEO Hani Zeini told analysts this week.

Earlier this month Sientra put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, after Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales after contamination was detected during an audit of the company’s manufacturing practices.

The problem for Sientra was compounded by an Oct. 22 fire at the Silimed plant, which damaged 1 of 2 buildings where the Sientra implants are made. Zeini remained noncommittal when asked about the timeline for getting things back on track.

“I can always count on you to keep asking the same questions but as I indicated on this call, we’re not going to give guidance, we’re not going to discuss long term guidance, future guidance, and 2016 guidance, as we have done in the past. When the appropriate time arrives, we’re fully transparent and we’ll do so accordingly,” Zeini said, according to the Pacific Coast Business Times.

Sientra has about a year’s worth of inventory on hand that it could sell after getting the go-ahead from the FDA, he said.

Leerink Partners analyst Richard Newitter said Sientra has 2 paths back to market: Reestablishing production in Brazil or using the existing inventory.

A Brazilian reboot “involves either 1) activating a production line at Silimed’s 2nd manufacturing plant (F1, unaffected by the fire), but this would require modifying the lines for SIEN’s breast implant production and receiving regulatory clearance. Regarding the plant that was affected by the fire (F2), it is unclear what the extent of the damage is and whether the equipment used to manufacture Sientra implants is operational as fire officials have not allowed anyone to access the building since the investigation is ongoing,” Newitter wrote.

The 2nd option “would involve using SIEN’s existing inventory following a period of extended testing,” he wrote.

“In this scenario, the company expects to deliver findings to the FDA by the end of calendar 2015 and resume sales following approval. Should this come to fruition, management would resume sales out of existing inventory, which should last for ~12 months – which assumes existing order patterns according to mgmt – before the company would need to replenish inventory,” Newitter wrote in a note to investors.

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PathMaker Neurosystems wins the fast track at FDA for MyoRegulator device

Pathmaker NeurosystemsPathMaker Neurosystems said it won expedited access pathway designation from the FDA for its MyoRegulator PM-2200 system, which is designed to treat muscle spasticity.

The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston-based company said.

In June PathMaker inked a deal with Proven Process to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation. The MyoRegulator device aims to treat muscle spasticity in patients with stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological conditions, the company said.

“The EAP designation for MyoRegulator is significant, as FDA reserves this priority review program only for devices with demonstrated potential to fill an unmet medical need and benefit patient health,” PathMaker regulatory & clinical affairs vice president Sheila Hemeon-Heyer said in prepared remarks. “We are excited to be working with FDA through the EAP program to rapidly bring to patients this important new technology for treating spasticity.”

“Through the FDA Expedited Access Pathway program, we will be able to more rapidly bring to market this breakthrough technology for treating muscle tone disorders,” added president & CEO Dr. Nader Yaghoubi. “As one of the first companies selected into this program, we look forward to working with FDA to rapidly make MyoRegulator available to patients and clinical institutions worldwide.”

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CasMed deals vital signs monitoring biz to Zoe Medical

740 SelectCAS Medical Systems (NSDQ:CASM) said yesterday that it sold its 740 Select line of vital sign monitoring products to Zoe Medical for an unspecified amount.

Branford, Conn.-based CasMed said it made the move so that it can focus solely on its Fore-Sight cerebral oximetry business. The 740 Select operation put up $3.7 million in sales last year and $1.3 million during the 1st 6 months of 2015, the company said.

“Divesting these non-strategic assets allows for added focus on our core business of Fore-Sight cerebral oximeters and sensors,” president & CEO Thomas Patton said in prepared remarks. “We have made substantial progress in our transition to a single-use disposables business model as Fore-Sight sensors sales have represented an increasingly large percentage of total sales. We have recorded 21 consecutive quarters of double-digit sensor sales growth in the U.S. and recently launched our Fore-Sight Elite products for use with pediatric and neonatal patients. Our Fore-Sight business continues to track well against our expectations that the second half of 2015 will be stronger than the 1st half.”

“The addition of the 740 Select product line to our organization represents a great opportunity to bring the technology to new markets,” added Zoe Medical CEO Bengt Hermanrud. “As both a developer and supplier of the Select, our familiarity with the product will allow us to quickly create exciting new clinical solutions for our customers.”

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Appeals court rules for Medtronic, St. Jude Medical in remote monitoring patent spats

Medtronic, St. Jude MedicalA federal appeals court yesterday handed a win to Medtronic (NYSE:MDT) that could wind up helping Twin Cities rival St. Jude Medical (NYSE:STJ), in a pair of decisions concerning patents covering remote patient monitoring technology.

In the Medtronic case, the U.S. Court of Appeals for the Federal Circuit ruled that a lower court judge wrongly interpreted the patent, overturning validity decision in favor of Atlas IP and remanding the case back to the U.S. District Court for Southern Florida. The Federal Circuit also upheld Judge Cecilia Altonaga’s judgment of non-infringement in favor of Medtronic.

That could help St. Jude in its fight with Atlas. The appeals court yesterday also vacated Altonaga’s non-infringement judgment against Atlas, likewise sending that case back to the Southern Florida court.

Atlas, a so-called ‘non-practicing entity” or patent troll, is also pursuing patent infringement claims againts Boston Scientific (NYSE:BSX) and Biotronik.

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Glaukos, Transcend Medical settle spat over eye stent patents

Transcend Medical, GlaukosGlaukos (NYSE:GKOS) said yesterday that it agreed to settle a patent infringement lawsuit brought by eye stent rival Transcend Medical.

The agreement, in which both sides agree not to sue for patent infringement, calls for Transcend to pay a 1% royalty on sales of its Cy-Pass micro-stent until April 2022, with the total amount capped at $6 million, Glaukos said.

The deal does not cover stents designed to relieve eye pressure by unconventional outlflow pathways, the company said, meaning its iStent Supra suprachoroidal micro-bypass stent is not bound by the covenant.

“We believe this settlement provides an efficient and reasonable solution to this patent dispute,” Glaukos president & CEO Thomas Burns said in prepared remarks. “It allows us to move forward and focus our full attention and resources on executing our growth strategy to transform glaucoma therapy with a family of micro-scale injectable therapies that can be used individually or in combination to address the full range of glaucoma disease states and progression.”

Glaukos allegedly left Dr. Richard Hill’s name off of its patent applications in a bid to avoid paying royalties to the university, according to court documents. Hill’s name was later added to the patents and Glaukos wound up paying UCI $2.7 million plus a 2.5% royalty on iStent sales, according to the documents. Goldberg ruled that there’s enough evidence to “support a finding that intent to deceive is the single most reasonable inference to be drawn at this stage of the proceedings.”

“Therefore, I find that the evidence could support a finding that intent to deceive is the single most reasonable inference to be drawn at this stage of the proceedings. As such, a trial is necessary to resolve disputed issues of material fact, assess the credibility of witnesses and more fully develop the record,” he wrote.

Glaukos said it might appeal and plans a vigorous defense at the inequitable conduct trial. The patents in the case relate only to its iStent Supra device, not the original iStent that won FDA approval in 2012 or the iStent Inject device that’s in U.S. investigational trials.

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dijous, 29 d’octubre del 2015

MassDevice.com +3 | The top 3 medtech stories for October 29, 2015

plus3-1x1

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. HeartWare looks to get MVAD program back on track

MassDevice.com news

HeartWare International said that it’s on track to restart a CE Mark trial for its MVAD implantable heart pump.

Investors initially pared 30.0% from HTWR shares after the company said Oct. 12 that it might not be able to resume the trial as soon as was expected. Framingham, Mass.-based HeartWare, which put a hold on enrollment in its CE Mark trial Sept. 9 due to controller manufacturing and software issues, added that it began investigating reports of adverse events in certain trial subjects “typical of those seen in other clinical trials for ventricular assist devices.” Read more


2. Smith & Nephew puts up $275m for Blue Belt, misses with Q3 top line

MassDevice.com news

Smith & Nephew said that it agreed to acquire robot-assisted surgery company Blue Belt Technologies for $275 million, but missed top-line expectations for the 3rd quarter.

Minneapolis-based Blue Belt makes the portable Navio system, which is designed to work with 8 different knee systems, including Smith & Nephew’s Zuk and Journey Uni devices. The London-based medical products giant, noting that Blue Belt is its “most successful” implant sales partner, plans to continue to support implants from other manufacturers with the Blue Belt system. Read more


1. Ex-Covidien CEO Almeida to take the reins at Baxter

MassDevice.com news

Baxter said that it tapped former Covidien chief José Almeida to replace Robert Parkinson Jr. as chairman & CEO after Parkinson’s retirement next year.

Almeida, who led Covidien to its $50 billion acquisition by Medtronic early this year, will start immediately at Deerfield, Ill.-based Baxter to get up to speed, the company said. Read more

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Conventus Orthopaedics raises $21m

Conventus Orthopaedics

Conventus Orthopaedics said it raised $21 million out of a hoped-for $23.1 million for its shoulder and wrist fracture repair technology.

Minneapolis-based Conventus is developing a nitinol device that’s designed to expand inside the bone as an internal scaffold to prevent collapse of a shoulder fracture. Another Conventus device also uses nitinol to treat distal fractures of the radius.

Conventus raised a $24 million Series AA round in December 2014 earmarked, in part, for commercializing the FDA-cleared Conventus DRS wrist fracture device and to propel R&D for the PH shoulder repair device, which later won 510(k) clearance from the FDA.

“For years, shoulder surgeons have expressed the need for more versatile surgical options to repair simple to complex proximal humeral fractures,” CEO Paul Buckman said at the time. “The Conventus PH cage will expand what is possible in patient care by enabling surgeons to repair a wider variety of proximal humeral fractures through less invasive means. We believe this is another important building block in our technology platform and has the potential to transform the repair of shoulder fractures.”

Seven unnamed investors participated in the most recent equity funding, according to an SEC filing. Conventus stands to clear about $17.5 million after deducting $3.5 million for payments to executive officers and directors, according to the filing.

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Abiomed’s fiscal Q2 beat-n-raise not enough for investors

AbiomedInvestors drove Abiomed (NSDQ:ABMD) shares down nearly 29% today despite fiscal 2nd-quarter results that beat expectations on the back of a 47.5% top-line gain.

The Danvers, Mass.-based heart pump maker posted profits of $7.7 million, or 17¢ per share, on sales of $76.4 million, for profit growth of 101.5% compared with the same period last year.

The consensus outlook on Wall Street was for earnings of 16¢ on sales of $74.6 million. Abiomed raised its outlook for the rest of fiscal 2016, saying it now expects operating margins of 15% to 17%, up from prior guidance for 14% to 16%. Full-year sales are expected to be between $305 million and $315 million, up from $300 million to $310 million.

Bafflingly, ABMD shares were down 28.3% to $70.72 apiece in mid-afternoon activity today. 

“We have had an exciting start to fiscal year 2016, with 1st-half revenue growth of 49% and establishment of Protected PCI as a new indication. As evidenced by our patient growth and awareness at TCT, Protected PCI has been validated by physicians that treat higher risk patients requiring percutaneous hemodynamic support in the cath lab,” chairman, president & CEO Michael Minogue said in prepared remarks. “We are confident that in the years ahead, Abiomed will deliver strong growth, support new indications and countries, and launch new best in class products. As always, Abiomed is committed to meaningfully impacting the lives of our patients and helping our physicians improve outcomes.”

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Pfizer, Allergan in talks on merger

Pfizer, Allergan(Reuters) — Allergan (NYSE: AGN) and Pfizer (NYSE:PFE) today confirmed that they’re in preliminary, friendly talks on a potential merger, a deal that would create the world’s largest drugmaker.

Both Pfizer and Allergan said no agreement has been reached and declined to discuss any terms that might lead to such a tie-up.

Allergan shares jumped 8.2% to $310.92 apiece today, while Pfizer was off almost 1% to $35.12.

Pfizer CEO Ian Read earlier today said he’s open to any moves that produce the best long-term value for the company.

Speaking at a Wall Street Journal event, Read said he was looking at various growth strategies, including a deal, “if that would add value to shareholders.”

“Or we could sit tight or we could do a split. Or we could do a business development deal and then do a split, whatever produces the best long-term value,” Read said.

Pfizer is expected to decide by late next year whether to sell or spin off its older off-patent products unit to pare the business down and focus on innovative, patent-protected medicines.

Allergan, the product of a recent merger with generic drugmaker Actavis, is itself in the process of selling a large portfolio of generic medicines to Teva Pharmaceutical Industries (NYSE:TEVA) for $40.5 billion. That deal is expected to close in the 1st quarter of 2016.

A purchase of Dublin-based Allergan, with a market value of more than $113 billion, would be the biggest in Pfizer’s long history of huge deals and restore it as the world’s largest drugmaker, worth about $330 billion.

Pfizer recently closed a $15 billion purchase of hospital products company Hospira, which is also developing biosimilar versions of leading biotech drugs.

A deal with Allergan could allow Pfizer to take advantage of the far lower corporate tax rate in Ireland, a strategy it pursued with a failed bid for British rival AstraZeneca last year.

“Our tax rate highly disadvantages American multinational high-tech businesses,” Read said. “I am fighting with one hand tied behind my back.”

He said a tax inversion deal would boost Pfizer’s ability to invest in research.

A tax inversion is being discussed, a person familiar with the matter told Reuters. The discussions so far have been led by the CEOs and senior executives, the source said.

In the last 15 years, Pfizer has acquired Warner-Lambert, Pharmacia and Wyeth, leading to many thousands of job cuts, typically referred to as cost-saving synergies.

Apart from tax considerations, the deal would give Pfizer access to Allergan’s dominance in the aesthetics field with Botox, and ophthalmology markets, which Morningstar analyst Michael Waterhouse described as “particularly attractive assets.”

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Greatbatch closes $1.7B Lake Region Medical buy

Greatbatch MedicalGreatbatch (NYSE:GB) said it closed the $1.73 billion, cash-and-stock acquisition of OEM medical device maker Lake Region Medical Oct. 27.

Frisco, Texas-based Greatbatch laid out $478 million in cash and some 5.1 million shares of stock (which closed Oct. 27 at $49.27 per share, making that portion of the offer worth another $251 million). Greatbatch said it also agreed to assume $1 billion worth of Wilmington, Mass.-based Lake Region Medical’s debt.

The deal creates an OEM juggernaut in the medical device space, about a year after Lake Region merged with Accellent. The buyout leaves Greatbatch stockholders with about 83.4% of the combined company and Lake Region Medical shareholders with the remaining 16.6%.

“The combination of Greatbatch and Lake Region Medical brings together 2 highly complementary organizations that can provide a new level of industry leading capabilities and services to OEM customers while building value for shareholders,” Greatbatch president & CEO Thomas Hook said when the deal was announced in August. “Through this transformative deal, we are going to be at the forefront of innovating technologies and products that help change the face of healthcare, providing our customers with a distinct advantage as they bring complete systems and solutions to market. In turn, our customers will be able to accelerate patient access to life enhancing therapies.”

“I am very proud of the Lake Region Medical team and what they have accomplished over many years,” added Lake Region chairman & CEO Donald Spence. “Today marks the start of an important new chapter for the company and I am confident the combination of Lake Region Medical and Greatbatch will form an even stronger entity with unmatched technology and manufacturing capabilities to better serve our customers into the future.”

The companies posted combined revenues of about $1.5 billion last year. Greatbatch said it expects the deal to add to its earnings per share at a double-digit clip next year, with net synergies worth $25 million of operating profits. That figure is expected to rise to $60 million in 2018, the company said.

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HeartWare looks to get MVAD program back on track next month

HeartWareHeartWare International (NSDQ:HTWR) said today that it expects to get a CE Mark trial back on track next month for its MVAD implantable heart pump, just weeks after saying it doubted it would have the study on line in November.

Investors initially pared 30.0% from HTWR shares after the company said Oct. 12 that it might not be able to resume the trial as soon as was expected. Framingham, Mass.-based HeartWare, which put a hold on enrollment in its CE Mark trial Sept. 9 due to controller manufacturing and software issues, added that it began investigating reports of adverse events in certain trial subjects “typical of those seen in other clinical trials for ventricular assist devices.”

Today the company said it once again expects to restart the trial next month, having made “substantial progress” in resolving the issues.

“We are also reviewing reported adverse events, which are typical of those seen in other clinical trials for ventricular assist devices, and we are confident that we will resolve the issues in order to resume the MVAD CE Mark clinical trial,” president & CEO Doug Godshall said in prepared remarks.

HeartWare also reported vastly wider 3rd-quarter losses of -$29.9 million, or -$1.73 per share, on a -5.0% sales decline to $65.2 million for the 3 months ended Sept. 30. Adjusted earnings per share were -$1.36, 79¢ off of the expectation on Wall Street, where analysts were looking for sales of $67.5 million.

“Our financial performance during the 3rd quarter demonstrated the underlying strength of our business but was impacted by anticipated headwinds, including clinical trial activity and foreign currency fluctuation,” Godshall said. “The HVAD system drove strong, double-digit international unit sales growth for the 2nd quarter in a row, signifying continued physician confidence in HVAD as the leading ventricular assist therapy for end-stage heart failure.

“In early August, we successfully completed enrollment in the 465-patient Endurance2 destination therapy study of our HVAD system. As a result, we sold 15 units for the destination therapy study in the 3rd quarter of 2015, compared to 62 units sold for this study in the 3rd quarter of 2014. Exclusive of Endurance2 trial units, U.S. unit sales increased by approximately 4% over the 3rd quarter of 2014,” he said.

HeartWare plans to submit 1-year follow-up data from Endurance2 next summer, ahead of a bid for pre-market approval from the FDA late in 2015, Godshall said.

HTWR shares were up 1.0% to $43.72 apiece today in late-morning trading.

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Boston Scientific settles Salazar pelvic mesh lawsuit

Boston ScientificBoston Scientific (NYSE:BSX) asked a Texas state court this week to dismiss a product liability lawsuit brought over its Obtryx pelvic mesh, saying it reached a settlement with the plaintiffs.

Martha Salazar claimed that the Obtryx device, implanted in 2010 to treat her urinary incontinence, caused nerve damage, persistent pain and infection that her lawyer said prevents her from sitting comfortably and from normal walking or exercise. A Dallas jury ruled in September 2014 that the device caused Salazar’s injuries, awarding her $73.5 million in damages in the company’s 1st courtroom loss over the vaginal slings.

A month later Judge Ken Molberg of the Dallas County District Court invoked a Texas cap on damages in halving that judgment. Boston Scientific appealed that decision in June, but asked the Texas appeals court to dismiss the appeal in an Oct. 27 motion.

“The parties have resolved by settlement the case upon which the present appeal is based. Appellant Boston Scientific Corporation respectfully requests that the court dismiss the appeal,” according to the motion. “Appellant asks that costs be assessed against the party incurring them.”

The Dallas County jury had found that the Obtryx sling was defectively designed and that Boston Scientific also failed to adequately warn patients and doctors of the risks of the device. A finding of gross negligence prompted the $50 million punitive damages award on top of a $23.5 million award for compensatory damages.

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Zimmer Biomet’s Q3 tops forecasts

Zimmer BiometZimmer Biomet (NYSE:ZBH) shares gained today after the orthopedics giant reported 3rd-quarter results that topped expectations and raised its earnings outlook for the rest of the year.

Warsaw, Ind.-based Zimmer Biomet posted profits of $22.2 million, or 11¢ per share, on sales of $1.76 billion for the 3 months ended Sept. 30, for a bottom-line slide of -87.2% on sales growth of 59.3% compared with Q3 2014.

Adjusted to exclude 1-time items, earnings per share were $1.64, 8¢ ahead of expectations on Wall Street, where analysts were looking for sales of $1.76 billion.

“We are pleased with the achievements of our global teams during Zimmer Biomet’s 1st quarter as a combined company,” president & CEO David Dvorak said in prepared remarks. “In an operating period marked by significant progress in the execution of our sales channel integration, we generated sequential top-line improvement and strong earnings growth. As we exit this year and progress through 2016, we are well positioned to continue improving revenue growth and delivering on our synergy commitments.”

Zimmer Biomet raised its earnings forecast for the rest of the year, saying adjusted EPS are now expected to be $6.83 to $6.87, up from prior guidance of $6.65 to $6.80. Zimmer attributed the raised guidance to better-than-expected synergies from the merger of Zimmer and Biomet.

The company cut its sales outlook, however, saying it expects constant-currency revenue growth of 1.0% to 1.5%, compared with 1.5% to 2.0% previously.

Zimmer Biomet also said it’s putting a share repurchasing program back in place, with $599.5 million left in the kitty for stock buybacks.

ZBH shares were up 6.9% to $104.57 in mid-morning trading today.

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Smith & Nephew puts up $275m for Blue Belt, misses with Q3 top line

Smith & Nephew, Blue Belt TechnologiesSmith & Nephew (NYSE:SNN) said today that it agreed to acquire robot-assisted surgery company Blue Belt Technologies for $275 million, but missed top-line expectations for the 3rd quarter.

Minneapolis-based Blue Belt makes the portable Navio system, which is designed to work with 8 different knee systems, including Smith & Nephew’s Zuk and Journey Uni devices. The London-based medical products giant, noting that Blue Belt is its “most successful” implant sales partner, plans to continue to support implants from other manufacturers with the Blue Belt system.

“Our experience working with Blue Belt Technologies and our customer insight has convinced us that robotics will become increasingly mainstream across orthopedic reconstruction in the foreseeable future,” Smith & Nephew CEO Olivier Bohuon said in prepared remarks. “This acquisition is a compelling strategic move, with the combination of complementary products and R&D programs creating a platform from which we can shape this exciting new area of surgery. It reinforces our distinctive orthopedic reconstruction strategy, which combines cutting edge innovation, disruptive business models and a strong emerging markets platform to drive outperformance.”

“Blue Belt Technologies has redefined robotics in orthopaedic surgery, establishing strong traction with customers who are attracted by the high degrees of implant placement accuracy made possible by Navio, as well as its ease of use, portability and attractive economics. We are delighted to be joining with Smith & Nephew, with whom we share a passion for innovation and a mission to support healthcare professionals. Together, we will realise the many opportunities to bring the benefits of robotics-assisted surgery to more patients and new indications,” added Blue Belt president & CEO Eric Timko.

A total knee system is slated to launch in 2017 for its Journey II implant, Smith & Nephew said, and a revision knee system is in the pipeline. Blue Belt’s development program for a bi-cruciate-retaining implant will be incorporated into the British company’s own bi-cruciate-retaining knee arthroplasty program, the Journey II XR implant. Total hip arthroplasty and adjacencies including sports medicine are also on the horizon, the company said.

Blue Belt’s medium-term revenues are expected to grow at a 50% clip from their $19 million level now, but R&D expenses are forecast to dilute trading profit margin by roughly 60 basis points next year, Smith & Nephew said. Blue Belt employs about 120 workers in Minneapolis, Pittsburgh and Manchester, U.K.

Third-quarter sales miss expectations

SNN shares were off -6.3% to $33.12 apiece in pre-market trading today after Smith & Nephew reported lower-than-expected sales for the 3 months ended Sept. 26. Smith & Nephew posted sales of $1.11 billion, down -3.7% compared with Q3 2014 and $21 million, or -1.9%, below the consensus expectation on Wall Street.

“We are pleased with our progress in 2015, with the 3rd quarter again demonstrating that our actions are delivering a strong performance, such as our above-market revenue growth in knee implants and the sustained improvement in advanced wound care. We had a good quarter in the U.S., our largest market, and are successfully stabilizing our European business which delivered a 2nd consecutive quarter of revenue growth against a market backdrop that remains challenging,” Bohuon said.

U.S. sales of $532 million were up 5.3%, but revenues from established overseas markets were down -14.9% to $400 million. Emerging market sales were flat at $173 million. Knee implant sales grew 3.5% to $205 million for the quarter; advanced wound care sales were off -4.8% to $316 million.

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Ex-Covidien CEO Almeida to take the reins at Baxter

Jose AlmeidaBaxter (NYSE:BAX) said yesterday that it tapped former Covidien chief José Almeida to replace Robert Parkinson Jr. as chairman & CEO after Parkinson’s retirement next year.

Almeida, who led Covidien to its $50 billion acquisition by Medtronic early this year, will start immediately at Deerfield, Ill.-based Baxter to get up to speed, the company said.

When Baxter announced Parkinson’s pending retirement in July, Parkinson said the time is right for retirement, given his impending 65th birthday and 11 years at the helm of Baxter. Parkinson will stay on to ease the transition and is due to be named chairman emeritus after he retires, Baxter said.

”Joe brings to Baxter tremendous experience in the global medical products marketplace and has a demonstrated record of improving profitability and creating value for all stakeholders,” Parkinson said in prepared remarks. ”His deep understanding of the complex global supply chain will be a great strength for the company as he oversees a broad portfolio of medically necessary products across a geographically expansive marketplace. What Joe brings to Baxter in skill and experience is imperative to the company’s stated goal of accelerating profitable growth over the near and long term.”

”Baxter is a trusted and admired brand in healthcare. The foundational mission of Baxter to save and sustain lives is at the center of the company’s ability to endure, serving the needs of healthcare providers and patients for more than 80 years,” Almeida added. ”Leading the company as it emerges from the spinoff of Baxalta presents an outstanding opportunity to create value and further the company’s mission.”

”We are extremely pleased for Joe to assume the leadership role at Baxter and carry forward important growth initiatives underway, while creating new opportunities to unleash value,” noted lead independent director Thomas Stallkamp. ”Joe has more than 24 years of global healthcare experience and an outstanding record of results and clear alignment to our strategy and culture, which led the board to unanimously endorse him as the right leader for the company. We also owe our gratitude to Bob Parkinson, whose leadership, integrity and vision have transformed and prepared Baxter for sustained success.”

Last week Baxter added Boston Scientific CEO Mike Mahoney to its board, appointing him to its governance and compensation committees.

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Five reasons your global sales aren’t growing

ZS Associatesby Bret Caldwell

With growth rates slowing for U.S. medical device sales, many American companies are exploring investment opportunities outside the country. Abroad, we find approximately 95% of the world’s population, 75% of the GDP, 65% of medtech spend, and 60% of healthcare spend. So with numerous U.S.-based medtech firms achieving more than half their sales domestically, it’s easy to understand why many are exploring and investing in global opportunities. However, their non-U.S. sales performance hasn’t always met expectations. Many find that products don’t perform as well as planned, penetration takes much longer than expected and commercial productivity is underwhelming.

But some companies are finding success, by trying different strategies and learning from their initial mistakes. Over time, they’ve developed commercial strategies that are better suited beyond U.S. borders and that succeed in supporting growth. The most important secret to their success doesn’t lie in knowing exactly what to do in each country, as that often varies by region, but in avoiding their most significant mistakes. As a shortcut to your own global sales success, I’ve compiled the five most common reasons that global commercial initiatives fail.

  1. Not customizing appropriately. At the highest level, the biggest mistake that companies make is assuming that the commercial strategy that worked well in the United States will work across the globe. Using a global message, value proposition, segmentation and targeting scheme, product configuration and pricing is unlikely an optimal strategy. Some customization is almost always needed. To succeed, you need to balance the inefficiency cost of customization with the increased adoption it can generate, and find the point where you optimize profitability.
  2. Failing to leverage local market knowledge. Most companies will do a simple assessment of market size and ask for feedback from local management regarding their interest in a product, but fail to dive into many more details, which can be critical for success. For example, clinical surgical practices can differ dramatically between the United States, Europe, Asia and elsewhere in terms of adoption of new procedures, use of minimally invasive techniques, acceptance of implantable devices and many other factors. At a minimum, you need to look at per capita metrics and growth rates, and the closer you can get to relevant procedure measures (or good proxies), the better. To further improve your chances of success, you need to understand the current standards of care, how the product will be reimbursed, who are the key decision makers and influencers, what regulatory issues might arise, and which hospitals might be early adopters and reference centers.
  3. Underinvesting in global marketing. Expecting your U.S. product manager to design and implement a global strategy is doomed from the start. At a minimum, centralized global marketing resources are needed, but chances of success improve exponentially as you build regional and local marketing expertise. Localizing your marketing strategy, which may require some local clinical studies, clinical training, or providing customized marketing and sales tools, is worth considering as well.
  4. Launching the wrong products. Many companies pressure their local affiliates to launch every new product developed. Similarly, some countries are excited to get the latest technology without really understanding how appropriate it might be. Many times, simpler products at a lower price will be more successful and can later be used as a door opener for launching more innovative technologies as the market evolves and opportunities grow.
  5. Picking the wrong countries. Most likely there are limits to the investments you can make each year, and some hard decisions need to be made to prioritize countries. There also will be some countries that won’t be worth your investment. But simply selecting the largest or fastest-growing may be ill advised. Some will be more appropriate than others for different types of products. Try to determine in advance how quickly and broadly your new product might be adopted. How well could you leverage existing customers and relationships to support a launch? Will you have to create the market or can you take market share from other similar, but inferior or more expensive, products?

Once you’ve corrected for these mistakes, you also need to make sure you establish performance metrics and follow through with measurement over time. If you don’t define success, you’ll never know if you achieved it. Early on, you’ll want to have leading indicators, like the number of trained physicians, number of new and repeat customers, and number of speaker events. Later, you will also need to track more common metrics like sales, share and growth. On a global scale, you should also begin to look at relative performance across the globe, so you can reallocate investments as you learn more about each market.

Although some of these ideas may seem basic, surprisingly once commercial strategies go beyond U.S. borders, common sense can get lost in translation. Several of these ideas also require investment of resources and money, which can be more difficult to secure in some corporations. Implementing a few global product expansions while avoiding the mistakes mentioned, and creating more and more short-term success stories may be the key to getting more consistent funding and turning around your business performance outside the United States.


 

zs-associates-bret-caldwell-1x1Bret Caldwell is a principal at global sales and marketing firm ZS in the Medical Products and Services practice. He has experience in an extensive range of sales and marketing issues, such as sales force design, product launch support and global market development. To read the latest medtech insights from ZS, visit the company’s blog, “The Pacemaker: Making Medtech Tick.”

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