Tuesday, December 18, 2018
Sanofi to transfer listing to Nasdaq from NYSE
Sanofi announced that it will be transferring the listing of its American depositary shares, or ADS, from the New York Stock Exchange, or NYSE, to The Nasdaq Global Select Market, or Nasdaq, effective December 31, after market close. Sanofi’s ADSs are expected to begin trading as a Nasdaq-listed security at market open on January 2, 2019, and will continue to be listed under the ticker symbol (SNY). This transition will not impact the company’s primary listing on Euronext.
https://thefly.com/landingPageNews.php?id=2838907
Goldman downgrades Alkermes to Sell ahead of potential schizophrenia launch
Goldman Sachs analyst Terence Flynn downgraded Alkermes to Sell from Neutral and lowered his price target for the shares to $26 from $49. The drugmaker closed the trading day down 3%, or $1.13, to $31.82. The analyst downgraded the shares after removing sales of ALKS 5461 for depression from his model as well as the “M&A component” from his price target. He now sees 21% downside to his price target. Recent channel checks suggest the current profile of ALKS 3831 for schizophrenia, based on weight gain alone, is unlikely to be “practice changing,” Flynn tells investors in a research note. Further, the checks suggest that the metabolic data is viewed as equally if not more important than the weight data. He also believes Alkermes’ level of investment ahead of a potential ALKS 3831 launch is underappreciated. On depression drug ALKS 5461, Flynn expects the FDA to issue a complete response letter on or before the January 31 action date. The analyst does not expect Study 217 to be sufficient to address potential FDA issues following the negative panel outcome.
FTC Approves Teva Petition to Give Pfizer More Time to Sell Drug
The Federal Trade Commission said Tuesday that it approved a petition from Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) to reopen a 2012 decision that limited the amount of time Pfizer Inc. (PFE) can sell the drug Embeda.
In 2012, Watson Pharmaceuticals Inc. and Actavis Inc. merged in a $5.92 billion deal that made Watson the world’s third-largest maker of generic drugs. The FTC alleged at the time that the merger might lessen future competition for some generic drugs, including the abuse-resistant opioid painkiller Embeda.
The commission ordered Watson and Actavis to supply Embeda to Pfizer Inc. for no longer than four years after Pfizer’s relaunch of Embeda in 2015. The FTC also required Watson and Actavis to transfer technology for manufacturing Embeda to Pfizer or a third party. In 2016, Teva acquired Actavis’s rights and obligations under the Embeda supply agreement and continued Watson’s plans to develop a generic version of Embeda.
In its petition, Teva says Pfizer has not completed the tech transfer of Embeda manufacturing to a third party so Teva can produce its own version of the generic drug. Due to the four-year supply limitation, Pfizer can’t sell the drug after December, preventing patients from filling Embeda prescriptions. At Pfizer’s request, Teva said it wants to extend the Embeda supply agreement for an additional period, allowing patients access to the drug.
Smith & Nephew expands opportunity in meniscal repair through acquisition
Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces that it has agreed to acquire Ceterix® Orthopaedics, Inc, the developer of the NovoStitch® Pro Meniscal Repair System.
This unique device addresses complex meniscal tear patterns not adequately served by other repair systems. It is highly complementary to Smith & Nephew’s leading FAST-FIX◊ 360 Meniscal Repair System, which addresses vertical tears, the most commonly repairable meniscal injury today.
Currently more than 1.2 million1 meniscal tears are treated surgically in the US each year. In only 15-20%1 of the cases is the meniscus repaired, rather than removed. With products like NovoStitch Pro and FAST-FIX 360 we see the opportunity to double this proportion in the medium term.
Smith & Nephew will pay an initial cash consideration of $50 million and up to a further $55 million over the next five years, contingent on financial performance.
‘NovoStitch Pro is an outstanding technology that addresses an unmet clinical need,’ said Brad Cannon, President Sports Medicine and ENT, Smith & Nephew. ‘We are excited by the opportunities to take this new option to our customers. No other company is better positioned to support changing clinical practice as the standard for meniscal treatment pivots from resection to repair.’
The NovoStitch Pro allows surgeons to repair arthroscopically a broader range of meniscal tear types, including horizontal, radial, complex, bucket handle and root tears, as well as vertical tears.
‘The new NovoStitch Pro Meniscal Repair System is one of the most innovative technologies developed for arthroscopic knee repair,’ said Dr. Peter Kurzweil, president of Memorial Orthopaedic Surgical Group in Long Beach, California. ‘NovoStitch offers the potential to repair tear types that were previously considered difficult or impossible to sew, with good control and access for the surgeon.’
The NovoStitch Pro will be sold through Smith & Nephew’s extensive sports medicine sales force as well as Ceterix’s existing dedicated sales force. NovoStitch Pro has 510(k) clearance for sale in the US.
‘We are proud of the impact our technology has made in developing the meniscal repair market and are excited by the opportunity to reach many more customers and their patients as an integrated part of Smith & Nephew’s extensive Sports Medicine portfolio,’ said John McCutcheon, Chief Executive Officer of Ceterix.
The transaction is expected to close in early 2019, subject to the satisfaction of customary conditions. The acquisition will be financed from existing cash and debt facilities.
Almirall Phase 3 antifungal trial hit primary endpoint
Almirall, S.A (ALM) has announced today that the pivotal study for P-3058 (10% terbinafine nail solution) has met the primary endpoint of complete cure rate and key secondary endpoints in the treatment of mild to moderate onychomycosis. P-3058 was statistically significantly superior to P-3058 nail solution vehicle at Week 60, following a treatment for 48 weeks.
The study included an open label arm of amorolfine 5% nail lacquer. Complete cure rate was numerically in favour of P-3058 nail solution.
Study description
This phase III study was a multicentre, randomized, double-blind, vehicle controlled, parallel-group study to evaluate the efficacy and safety of P-3058 10% terbinafine nail solution versus its Vehicle (double blind) and versus an active comparator (open label).
A total of 953 patients with mild-to-moderate distal lateral subungual onychomycosis (DLSO) caused by dermatophytes involving ≥ 20% to ≤ 50% of the target big toenail area without lunula/matrix involvement were randomised to P-3058, its vehicle, or amorolfine 5% nail lacquer. Patients applied P-3058 nail solution or its vehicle once daily for 4 weeks then once weekly for the remaining 44 weeks of treatment. Amorolfine 5% nail lacquer was applied once weekly for 48 weeks.
Primary Endpoint:
Rate of complete cure at the end of follow up (12 weeks after the 48-week treatment course) defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement (nail totally clear) of the target nail.
Key Secondary Endpoints:
· Responder rate defined as negative KOH microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail at the end of follow up.
· Mycological cure rate defined as negative KOH microscopy and negative culture for dermatophytes of the target toenail at the end of follow up.
Disease
Onychomycosis is a fungal infection of the nail. It is difficult to treat, requiring long-term treatment and good compliance to achieve eradication of the fungus and acceptable clinical out-come.
‘NH physician assistant guilty of Insys opioid kickback scheme’: Reuters
A former physician assistant in New Hampshire was convicted on Tuesday of charges that he accepted nearly $50,000 in kickbacks from Insys Therapeutics Inc in exchange for prescribing its addictive fentanyl spray.
A federal jury in Concord, New Hampshire, found Christopher Clough, 45, guilty of all charges he faced in a case that stemmed from a years-long investigation into the Arizona company’s efforts to promote its opioid medication Subsys.
Clough is scheduled to be sentenced on March 29. Patrick Richard, Clough’s lawyer, said he is evaluating his options, including an appeal.
The verdict came a month before six former Insys executives and managers including John Kapoor, a onetime billionaire who was its founder and chairman, face trial on charges that they conspired to bribe medical practitioners to prescribe Subsys.
The under-the-tongue spray is meant only for treating pain in cancer patients and contains fentanyl, an opioid 100 times stronger than morphine.
Prosecutors in that case allege Kapoor and his co-defendants conspired to bribe doctors and others like Clough by paying them fees to participate in speaker programs ostensibly meant to educate medical professionals about Subsys that were actually shams.
Federal prosecutors in Boston have said they plan to introduce evidence about Clough at the trial of Kapoor, former Chief Executive Michael Babich and their co-defendants. They have pleaded not guilty.
Prosecutors said Clough, who worked at a clinic called PainCare in Somersworth, New Hampshire, accepted nearly $50,000 from Insys to act as a speaker while prescribing Subsys to mostly non-cancer patients.
Witnesses at Clough’s trial included two ex-members of Insys’ sales staff, Jeffrey Pearlman and Natalie Babich, who previously pleaded guilty to conspiring to pay kickbacks and agreed to cooperate with prosecutors.
Babich, a former sales representative who is now married to Michael Babich, testified Clough frequently got paid for being a speaker at dinners with her with no other attendees.
Pearlman, a former district sales manager, testified that Insys used speaker fees to get doctors “more and more hooked on the company.”
Clough’s lawyers contended that he had no idea Insys was trying to bribe medical practitioners like himself and that he prescribed Subsys because he thought it would help his patients.
In August, Insys said it had agreed to settle a related U.S. Justice Department probe for at least $150 million. It resolved a probe by New Hampshire’s attorney general focused on payments to Clough for $3.4 million in 2017.
Judge Orders Redstone Guardian
A California judge on Monday ordered that Sumner Redstone, the controlling shareholder of CBS Corp. and Viacom Inc., be placed under court-appointed guardianship, as part of a yearslong legal battle involving the 95-year-old media mogul’s ex-girlfriend.
At a hearing in Los Angeles Superior Court, Judge David Cowan said he would grant the motion by Mr. Redstone’s grandson, Tyler Korff, for the appointment of a guardian “ad litem,” an independent representative most often used when children or the incapacitated are involved in a legal dispute.
However, the judge said that he was appointing the guardian, not because of Mr. Redstone’s mental capacity, but because of his extreme difficulty speaking, according to lawyers who attended the hearing.
Robert Klieger, Mr. Redstone’s attorney, said the decision had no bearing on the status of Mr. Redstone’s trust, which holds 80% of the shares of National Amusements Inc., a holding company that in turn owns nearly 80% voting stakes in CBS and Viacom.
The trust remains under Mr. Redstone’s sole control until he dies or is deemed incapacitated, at which point it will be overseen by seven trustees, including his daughter, Shari Redstone, and grandson, Mr. Korff.
“The judge appointed, with Sumner’s not opposing, a guardian ad litem solely based on Sumner’s physical disability in the form of Sumner’s speech impairment,” Mr. Klieger said in an interview. “He made no finding, and specifically did not find, that there’s any mental incapacity.”
He added: “This does not trigger the trust. It has no implications whatsoever for National Amusements, CBS or Viacom.”
In the past few years, Mr. Redstone’s deteriorating health has become a significant factor in corporate-governance struggles at the media companies he controls, as well as in litigation with his former companions. Shari Redstone, his daughter, now effectively controls his empire. The Redstone family has maintained that he has ailments but isn’t mentally incapacitated.
In ordering the appointment of the guardian, Judge Cowan denied a request by Mr. Redstone’s ex-girlfriend, Manuela Herzer, to have his mental capacity examined.
For more than three years, Ms. Herzer has been fighting in court against Mr. Redstone’s decision in the fall of 2015 to kick her out of his Beverly Hills, Calif., mansion, remove her as his health-care agent and write her out of his estate plans, alleging that he lacked the mental capacity to make these decisions at the time.
She alleges that a subsequent suit, filed by Mr. Redstone to claw back the $75 million in gifts he gave her, is actually driven by Ms. Redstone, his daughter. Ms. Redstone, through her lawyers, has denied the allegation.
In that litigation, Mr. Redstone’s lawyers have declined to have him deposed, citing his frail health. Ms. Herzer’s lawyer, Ronald Richards, has pointed to this fact, arguing that Mr. Redstone isn’t aware of the litigation being pursued in his name.
“Tyler Korff’s motion for a guardian ad litem got the intended consequences — avoiding an exam by an independent geriatric psychiatrist,” Mr. Richards said in an email. “They knew if a [guardian ad litem] was appointed, then whether Mr. Redstone has capacity would be less important in the judge’s mind.”
He added: “The public and Ms. Herzer have been once again deprived of getting to the truth.”
A trial is set in the probate case — one of several legal battles between Ms. Herzer and the Redstones — for Jan. 14.
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