Merck loses bid to revive $200 million Gilead verdict at U.S. high court

The U.S. Supreme Court on Monday handed a defeat to Merck & Co by refusing to hear its appeal of a ruling that it had dishonestly obtained patent rights and could not collect a $200 million (£156.5 million) verdict against rival drugmaker Gilead Sciences Inc in a dispute involving blockbuster hepatitis C drugs.

WASHINGTON (Reuters) – The U.S. Supreme Court on Monday handed a defeat to Merck & Co by refusing to hear its appeal of a ruling that it had dishonestly obtained patent rights and could not collect a $200 million (£156.5 million) verdict against rival drugmaker Gilead Sciences Inc in a dispute involving blockbuster hepatitis C drugs.

A jury awarded Merck $200 million in 2016 after finding Gilead’s Hepatitis C drugs Sovaldi and Harvoni infringed two of its patents, but a judge later ruled the patents unenforceable because of a pattern of misconduct by Merck including lying under oath by one of its in-house lawyers.

Merck had urged the Supreme Court to place limits on the doctrine of “unclean hands” that can prevent plaintiffs from winning lawsuits if they acted in bad faith.

Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure. Injection drug use is among the causes of the infection.

Direct-acting anti-viral medications like Gilead’s Sovaldi and Harvoni have revolutionized treatment of hepatitis C, with cure rates of more than 90 percent. Merck holds patents that it has said cover a compound that is the foundation for all major antiviral treatments for chronic hepatitis C.

A federal court jury in San Jose, California awarded Merck $200 million in 2016 after finding Sovaldi and Harvoni infringed two of its patents.

A judge threw out the verdict later that year, ruling that in the process of applying for one of the patents, Merck used confidential information it obtained in 2004 while discussing a possible partnership with Pharmasset Inc, a company Gilead bought in 2011.

The judge also said a Merck in-house lawyer testified untruthfully in a deposition and at trial about his participation in a confidential call with Pharmasset personnel.

Merck’s litigation against Gilead has included several reversals of fortune.

In 2016, a jury in Delaware said Gilead infringed a related patent and ordered it to pay Merck $2.54 billion in royalties, the largest verdict ever in a patent case. But a judge threw out the verdict in February 2018, ruling that Merck’s patent was invalid because it was not sufficiently detailed in its wording.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Merck-and-loses-bid-to-revive-200-million-Gilead-verdict-at-U-S-high-court-27833256/

Durect Says Novartis Ends Non-Opioid Painkiller Deal, Disputes Termination Fee

Durect Monday said Novartis AG Sandoz unit had ended a deal to develop and commercialize Durect’s Posimir non-opioid postoperative painkiller and is disputing its obligation to pay a termination fee.

The Cupertino, Calif., biopharmaceutical company agreed in May 2017 to license Posimir to Sandoz for a $20 million upfront fee, up to $43 million in development and regulatory milestone payments, and up to $230 million in sales-based milestones.

The companies amended the deal a year later, reducing the potential development and regulatory milestone payments to $30 million, after a phase 3 study of Posimir missed its primary endpoint.

Durect on Monday said Sandoz is returning its U.S. development and commercialization rights to Posimir as part of a refocusing of its resources but is disputing its obligation to pay a termination fee. Durect said it has initiated a formal dispute resolution process related to the fee, the amount of which hasn’t been publicly disclosed.

The company said it will evaluate and consider potential next steps for Posimir.

https://www.marketscreener.com/DURECT-CORPORATION-9083/news/Durect-Says-Novartis-Ends-Non-Opioid-Painkiller-Deal-Disputes-Termination-Fee-27834404/

Medtronic early view for below trend reported EPS growth in FY20: JPMorgan

JPMorgan analyst Robbie Marcus noted that Medtronic CFO Karen Parkhill discussed expectations for the back half of FY19 and high level views on FY20 at the firm’s healthcare conference. For FY19, the company is now expecting organic growth closer to the middle of its 5.0-5.5% range, driven by softness in CVG, said Marcus. The CFO said headwinds from higher tax rates and foreign exchange could push reported EPS growth below the company’s long-range target of 8%, but expressed confidence in its ability to still hit its 4% guidance floor, adding that softer reported EPS growth in FY20 should set up FY21 for above trend reported EPS growth, according to Marcus. He maintains an Overweight rating on Medtronic shares, which are down nearly 5% to $83.92 in afternoon trading.
https://thefly.com/landingPageNews.php?id=2844911

Allergan CEO says not looking at ‘transformational’ deal

Allergan CEO Brent Saunders said the company is not looking to do a “transformational” deal and that the sale process for its Women’s Health and antibiotics assets is continuing, according to Bloomberg. Saunders also said during an interview that the company plans to submit migraine drug ubrogepant with the FDA “imminently,” according to Bloomberg.
https://thefly.com/landingPageNews.php?id=2844915

Acorda Provides 2018 Highlights and 2019 Guidance at J.P. Morgan

Acorda Therapeutics, Inc. (NASDAQ: ACOR) today provided 2018 highlights, 2019 guidance and commercialization plans for INBRIJA at the 37^th Annual J.P. Morgan Healthcare Conference in San Francisco.

“The approval of INBRIJA is a major milestone for Acorda. We are eager to bring this much-needed therapy to the Parkinson’s community,” said Ron Cohen, M.D., Acorda’s President and CEO. “Acorda has one of the pre-eminent specialty neurology sales forces in the industry. Our team will immediately begin visiting key movement disorder centers to begin demonstrations and training on the appropriate use of INBRIJA. We expect INBRIJA to be available in the first quarter of 2019.”

Burkhard Blank, M.D., Acorda’s Chief Medical Officer, added, “INBRIJA represents the first FDA approval of a treatment using the ARCUS® technology, a platform that allows delivery of relatively large doses of medication through inhalation. ARCUS has the potential to be used in the development of a variety of inhaled medicines. In 2019, we will continue our development of an ARCUS-based treatment for migraine.”

2018 Financials

• AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg unaudited net sales for 2018 are expected to be greater than $430 million, subject to change based on discounts and allowances recorded in the fourth quarter of 2018.
• The Company is reiterating its 2018 non-GAAP operating expense guidance of R&D $100-$110 million and SG&A $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under “Non-GAAP Financial Measures.”
• 2018 year-end cash and cash equivalents were approximately $445 million (unaudited).
• Final results are subject to completion of the Company’s year-end audit.

2019 Guidance

• During INBRIJA’s 2019 launch year, the Company expects to assess key metrics such as total and new prescriptions, unique prescribers, and managed care access, and does not expect to provide INBRIJA revenue projections.
• The Company will no longer provide revenue guidance for AMPYRA, due to the unpredictable trajectory of revenue decline given the entrance of generics.
• R&D expenses for the full year 2019 are expected to be $70-$80 million and SG&A expenses for the full year 2019 are expected to be $200-$210 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under “Non-GAAP Financial Measures.”

Presentation/Webcast Details

Dr. Cohen will provide a corporate overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9 at 8:00 a.m. Pacific/11:00 a.m. Eastern. The presentation is available via webcast at https://jpmorgan.metameetings.net/events/healthcare19/sessions/23912-acorda-therapeutics-inc/webcast or at www.acorda.com.

https://www.biospace.com/article/releases/acorda-provides-2018-highlights-and-2019-guidance-at-j-p-morgan-healthcare-conference/

Arena: Positive Long-Term Data on Phase 2 Ulcerative Colitis Trial

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive data from the open-label extension (OLE) of the Phase 2 OASIS trial of its investigational drug candidate etrasimod, a next-generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator in development for the treatment of moderate to severely active ulcerative colitis (UC). Overall, etrasimod demonstrated durable, long-term clinical remission and was generally safe and well tolerated in this trial.

Open-Label Extension of Phase 2 OASIS Trial Design
This was a 34-week open-label extension evaluating the long-term safety, tolerability and efficacy of etrasimod in 118 subjects (84% of OASIS study completers) who completed the 12-week Phase 2 OASIS randomized, placebo-controlled trial. Of the 118 subjects, 105 received only 2 mg etrasimod during the OLE study regardless of previous study treatment. Key efficacy measurements included clinical response, clinical remission, and endoscopic improvement at end of treatment (46 weeks).

Key Efficacy Measurements
Of the subjects who completed 2 mg etrasimod treatment during the OLE study (n=84), 79% achieved clinical response, 39% achieved clinical remission, and 51% had endoscopic improvement at the end of the OLE study.

For OLE study completers who received 2 mg etrasimod in the original Phase 2 OASIS trial (n=22), 82% experienced clinical response, 50% were in clinical remission, and 55% had endoscopic improvement at the end of the OLE study.

Among subjects achieving clinical response or clinical remission on 2 mg etrasimod at 12 weeks in OASIS, sustained treatment effect over 46 weeks was observed, with 93% experiencing sustained clinical response and 75% experiencing sustained clinical remission at both 12 and 46 weeks.

Key Safety Measurements
Etrasimod demonstrated a favorable long-term safety profile; adverse events in the OLE study were generally mild to moderate in severity and no new safety findings were noted. Impact on heart rate and atrioventricular (AV) conduction was minimal throughout the study with no discontinuations from study related to bradycardia or AV block.

The Company plans to present full study results at future medical congresses.

“We are pleased with the long-term safety and efficacy that etrasimod has demonstrated in the open-label extension of our Phase 2 OASIS trial,” said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. “These data further support our belief in etrasimod as an important future therapy in inflammatory bowel disease and our strong commitment to improve the lives of patients suffering from these grievous conditions.”

“There remains a significant unmet need for new oral therapies for ulcerative colitis. It is encouraging to see longer-term safety and tolerability data and durable treatment effects of etrasimod, which are important for patients suffering from this chronic condition,” said Bruce E. Sands, MD, Mount Sinai Hospital and the Icahn School of Medicine, Mt. Sinai, New York. “These results further support the initiation of the Phase 3 clinical development program to further evaluate etrasimod in ulcerative colitis.”

https://www.biospace.com/article/releases/arena-pharmaceuticals-reports-positive-long-term-data-from-the-open-label-extension-of-the-phase-2-oasis-trial-evaluating-etrasimod-for-treatment-of-ulcerative-colitis/

Meditation Studio Launches ‘Goodnight Kiddo’, ‘Deep Sleep’ Apps

 Meditation Studio, a 5-star rated meditation app that makes meditation simple and accessible, with more than 500 guided meditations and 6 courses, announces two new sleep collections – Goodnight Kiddo and Deep Sleep – along with a new Night Mode feature to help both kids and grown-ups fall asleep. The new collections and features will be available on January 15, 2019 via a Meditation Studio subscription for $7.99 (monthly) and $49.99 (annually).

Parents know how important sleep is for their children, but it is not always easy to get them off to dreamland. Goodnight Kiddo is the first-of-its-kind collection of sleep meditations paired with music designed to help kids ages four to eight fall asleep more peacefully. Original music, composed exclusively for Meditation Studio’s sleep collections, matches the voice and narrative of meditations with names like Fluffy Cloud, Snuggles and Butterfly Tickles.

“The original musical compositions create a truly unique experience with these meditations,” said Patricia Karpas, Co-Founder of Meditation Studio and Host of Untangle, Meditation Studio’s original podcast. “It gives kids and parents a calm and gentle experience designed to help them drift off to sleep with the sweetest of dreams.”

Goodnight Kiddo gives parents access to an on-demand Meditation Studio for their kids, with content from leading experts such as Chrissy Carter, Patricia O’Keefe andStefanie Goldstein. Goodnight Kiddo meditations can be accessed via the Meditation Studio iOS app or the Goodnight Kiddo Alexa skill.

For the adults who need a good night’s rest, Meditation Studio is releasing its Deep Sleep Collection which features guided meditations with original music and ambient sounds. The collection includes titles such as Bedtime Harmony, Deep Slumber andWind Down. It is designed to help meditators leave the day behind, experience a deep and restful sleep, and wake up feeling ready to take on a new day. Meditation Studio is releasing a new Night Mode feature that will allow meditators to toggle to dark mode, making it easier on the eyes at bedtime.

Featured by Apple as “10 Best Apps of the Year,” Meditation Studio solves the big and little everyday challenges with its original and inspiring guided meditations, motivating courses and more than 40 hand-selected leading teachers. The careful curation of content and experts, such as Dr. Elisha Goldstein, Emily Fletcher, Chrissy Carter andMelli O’Brien, with diverse backgrounds from PhD psychologists and sleep doctors to Monks and mindfulness experts, are what set Meditation Studio apart from the pack.

The Meditation Studio app is now available in the AppStore.

https://www.biospace.com/article/releases/meditation-studio-releases-and-quot-goodnight-kiddo-and-quot-and-and-quot-deep-sleep-and-quot-meditation-collections-giving-grown-ups-and-kiddos-new-options-for-sweet-dreams/