On November 20, 2018 Danish dermatology specialists LEO Pharma and California rare disease pioneers PellePharm reported a strategic development and commercialization collaboration to address unmet medical needs across various skin diseases with no approved treatments, advancing innovation and access to potential therapies for patients with life-altering conditions, such as Gorlin Syndrome and High Frequency Basal Cell Carcinoma (BCC), two distinct and rare forms of skin cancer (Press release, Leo, NOV 20, 2018, View Source [SID1234576270]).

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"We are very excited about the partnership with PellePharm, who are pioneers in Gorlin Syndrome and experts in rare skin diseases. Supporting our ambitious 2025 strategy, it marks LEO Pharma’s entrance in rare skin diseases and it offers a unique opportunity to bring the first treatment forward to people suffering from a very severe skin disease for which there currently are no approved therapies," said Thorsten Thormann, vice president of research at LEO Pharma.

Under the terms of the agreement, LEO Pharma has initially committed $70 million comprised of equity financing and financial R&D support to fund the global Phase 3 trial for patidegib topical gel 2% for the prevention and treatment of Gorlin Syndrome, with LEO Pharma securing an option to acquire all shares in PellePharm. PellePharm and its stockholders could receive up to an additional $690 million including merger consideration, and regulatory and commercial milestone payments. In addition, PellePharm stockholders are eligible to receive a double-digit royalty after achieving certain commercial milestones.

"Our company is founded on the commitment to targeting rare dermatologic diseases at the source and bringing new groundbreaking treatments forward to patients as efficiently and effectively as possible. As a global leader in medical dermatology, LEO Pharma is a great fit as both a development and commercialization partner. This collaboration puts us on track to commence our pivotal Phase 3 Gorlin Syndrome trial in early 2019. Then after the potential merger, we look forward to working with LEO Pharma to address other rare skin diseases with unmet needs," said Sanuj Ravindran, president and chief executive officer of PellePharm.

The agreement establishes a joint development committee with PellePharm maintaining responsibility for global development and LEO Pharma supporting in an advising role. Both companies will jointly drive commercialization planning, and Anders Kronborg, chief financial officer of LEO Pharma, will join PellePharm’s board of directors.

"Gorlin Syndrome Group welcomes the news that PellePharm and LEO Pharma are collaborating in developing patidegib topical as a treatment for BCCs. Data from PellePharm’s Phase 2 study suggest patidegib is effective in treating BCCs, with minimal side effects. We hope that by working with LEO, these benefits can be confirmed in a Phase 3 study. An effective topical medication, which can prevent and/or treat BCCs, will avert the need for the painful, disruptive and disfiguring surgeries we currently undergo," said Sally Webster, chairperson and Matthew Helbert, trustee of Gorlin Syndrome Group U.K.

Currently, there are no FDA-approved therapies for Gorlin Syndrome, and the standard of care for this rare disease is surgery. Patients with this lifelong, severe disease can have as many as 30 surgeries per year beginning in their mid-teens.

PellePharm’s 2% topical formulation of patidegib aims to be the first approved therapy for the prevention of Gorlin Syndrome, also known as Basal Cell Carcinoma Nevus Syndrome (BCCNS), and has shown early promise in Phase 2 clinical trials treating patients with Gorlin Syndrome and Sporadic BCC in both the U.S. and the U.K.

"For more than 18 years, our organization has been dedicated to supporting, educating, and seeking much-needed treatments for people living with Gorlin Syndrome (BCCNS), and yet people with this devastating disease still have no FDA-approved therapies," said Jean Pickford, executive director of the BCCNS Alliance. "With the Phase 3 study of patidegib beginning recruitment in early 2019, we continue to be encouraged by PellePharm’s dedication to our community, now in partnership with LEO Pharma."

PellePharm was advised by Rothschild & Co. on this transaction.

About Patidegib

Patidegib topical gel has shown early promise in a Phase 2 clinical study for the mitigation of BCC tumors in Gorlin Syndrome by blocking the disease at its source within the hedgehog signaling pathway. The topical formulation of patidegib was developed to provide the efficacy previously demonstrated by oral patidegib in Phase 1 trials without the adverse systemic side effects. The gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for ongoing, at-home management of Gorlin Syndrome and High Frequency BCC. PellePharm has received both Orphan Drug Designation and Breakthrough Therapy Designation for patidegib topical gel in Gorlin Syndrome from the FDA.

About Gorlin Syndrome

Gorlin Syndrome is a rare, genetic disease characterized by constitutional, heritable mutations in one allele of the tumor suppressor gene encoding PATCHED1 (PTCH1), which acts as the primary inhibitor of the hedgehog signaling pathway. This leads to the formation of multiple basal cell carcinomas, often on the face.

With no FDA-approved drugs available for Gorlin Syndrome, the standard of care is surgery. People with severe Gorlin Syndrome may have as many as 30 surgeries per year, which can be repetitive, scarring and disfiguring. Approximately 10,000 people in the United States, or one in 31,000, are believed to be affected by Gorlin Syndrome. Gorlin Syndrome is known by several names, including Gorlin-Goltz Syndrome, Basal Cell Nevus Syndrome (BCNS), and Nevoid Basal Cell Carcinoma Syndrome (NBCCS).

About High Frequency Basal Cell Carcinoma (BCC)

High Frequency BCC, like Gorlin Syndrome, is a rare disease which is characterized by the development of an abnormally high number of BCCs. Unlike patients with Gorlin Syndrome, patients with High Frequency BCC are not born with a germline PTCH1 mutation and do not suffer from the other systemic manifestations of Gorlin Syndrome. The standard of care for patients with High Frequency BCC is surgery.

On November 20, 2018 GT Biopharma, Inc. (OTCQB: GTBP and Euronext Paris GTBP.PA) ("GT Biopharma" or the "Company"), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary NK-engager and Bispecific Antibody Drug Conjugate platforms, reported that its abstracts have been selected for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 1-4, 2018 in San Diego, CA (Press release, GT Biopharma , NOV 20, 2018, View Source [SID1234539519]).

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Summarized below are the abstract titles that have been selected for oral and poster presentations. The ASH (Free ASH Whitepaper) abstracts are now available online at the conference website, here.

Saturday, December 1, 2018

Session: 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Poster I
Time: 6:15 PM-8:15 PM PT
Presenter: Upasana Sunil Arvindam, MSc, BSc, Department of Microbiology and Immunology, University of Minnesota, Minneapolis, MN
Abstract #1454: CD16-IL15-CLEC12A Trispecific Killer Engager (TriKE) Drives NK Cell Expansion, Activation, and Antigen Specific Killing of Cancer Stem Cells in Acute Myeloid Leukemia

Monday, December 3, 2018

Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, Including HIV and Other Infections: Pre-Clinical T and NK Cell Immunotherapies
Time: 3:15 PM PT
Presenter: Emily Chiu, PhD, Medical School, University of Minnesota, Minneapolis, MN
Abstract #729: Induced Pluripotent Stem Cell-Derived NK Cells Genetically Modified to Express NKG2C/DAP12 Mediate Potent Function When Targeted through an NKG2C/IL-15/CD33 Tri-Specific Killer Engager (TriKE)

On November 20, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, reported that the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming centralized Marketing Authorization Application (MAA), which Stemline expects to complete in the first quarter of 2019, for ELZONRIS (tagraxofusp; SL-401) in blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, NOV 20, 2018, View Source [SID1234532630]).

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Under European Union legislation, a medicinal product of major public health interest may be reviewed under an accelerated assessment procedure. Accelerated assessment can significantly reduce the timeframe for the EMA Committee for Medicinal Products for Human Use (CHMP) to review an MAA.

In the U.S., ELZONRIS was granted breakthrough therapy designation for the treatment of patients with BPDCN. The Biologics License Application (BLA) for ELZONRIS in BPDCN has received Priority Review status from the U.S. Food and Drug Administration (FDA), with a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).

Ivan Bergstein, M.D., Stemline’s CEO, commented, "The granting of accelerated assessment to the ELZONRIS planned MAA underscores the robust clinical data, clear unmet medical need, and the heightened awareness of BPDCN worldwide. We look forward to working closely with the EMA to ensure that this important new treatment reaches patients in the European Union as quickly as possible. In the U.S., we are continuing our interactions with the FDA, and our commercial team is poised to rapidly execute a U.S. launch following possible approval of ELZONRIS for BPDCN."

On November 20, 2018 Medtronic plc (NYSE: MDT) reported financial results for its second quarter of fiscal year 2019, which ended October 26, 2018 (Press release, Medtronic, NOV 20, 2018, View Source;p=RssLanding&cat=news&id=2377762 [SID1234531598]).

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The company reported second quarter worldwide revenue of $7.481 billion, an increase of 6.1 percent as reported or 7.5 percent on an organic basis, which adjusts for a $95 million negative impact from foreign currency. As reported, second quarter GAAP net income and diluted earnings per share (EPS) were $1.115 billion and $0.82, respectively. As detailed in the financial schedules included through the link at the end of this release, second quarter non-GAAP net income and non-GAAP diluted EPS were $1.660 billion and $1.22, respectively, both increases of 14 percent. Adjusting for a positive 1 cent impact from foreign currency, second quarter non-GAAP diluted EPS increased 13 percent.

Second quarter U.S. revenue of $4.045 billion represented 54 percent of company revenue and increased 8.3 percent as reported. Non-U.S. developed market revenue of $2.282 billion represented 31 percent of company revenue and increased 1.8 percent as reported and 3.1 percent on a constant currency basis. Emerging market revenue of $1.154 billion represented 15 percent of company revenue and increased 7.3 percent as reported and 13.5 percent on a constant currency basis.

"This was an outstanding quarter for Medtronic. We are executing on multiple fronts, resulting in robust top-line growth, solid margin expansion, and increasing free cash flow," said Omar Ishrak, Medtronic chairman and chief executive officer. "Yet, even more exciting than our results this quarter is the progress we are making on our new product pipeline, which is stronger than at any time in our company’s history."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG worldwide second quarter revenue of $2.858 billion increased 3.1 percent, or 4.4 percent on a constant currency basis. CVG revenue performance was driven by high-single digit growth in CSH and APV, and low-single digit growth in CRHF, all on a constant currency basis.

CRHF second quarter revenue of $1.472 billion increased 0.3 percent, or 1.4 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by high-single digit constant currency growth in Pacing on strong sales of the Micra Transcatheter Pacing System and the Azure wireless pacemaker. Arrhythmia Management results were also driven by high-twenties growth of the TYRX Absorbable Antibacterial Envelope and mid-teens growth in AF Solutions, both on a constant currency basis.
CSH second quarter revenue of $906 million increased 6.1 percent, or 7.8 percent on a constant currency basis, led by mid-teens constant currency growth in transcatheter aortic valves resulting from the global strength of the CoreValve Evolut PRO. Coronary grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth of drug-eluting stents, low-double digit growth of coronary balloons, and high-teens growth of guide catheters, all on a constant currency basis.
APV second quarter revenue of $480 million increased 6.2 percent, or 7.3 percent on a constant currency basis. The strength in the division was broad based, with high-teens growth in endoVenous given strong demand for the VenaSeal(TM) closure system, low-double digit growth of the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) with continued strength in Japan, and mid-single digit growth in abdominal aortic aneurysm (AAA) stent graft systems.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG worldwide second quarter revenue of $2.047 billion increased 4.9 percent, or 6.8 percent on a constant currency basis. MITG revenue performance was balanced by high-single digit constant currency growth in both SI and RGR.

SI second quarter revenue of $1.393 billion increased 4.4 percent, or 6.6 percent on a constant currency basis, driven by low-double digit constant currency growth in Advanced Energy resulting from the strength of the LigaSure(TM) vessel sealing instruments with innovative nano-coating and Valleylab(TM) FT10 energy platform. Advanced Stapling grew in the high-single digits on a constant currency basis, driven by strong demand for Tri-Staple(TM) 2.0 endo stapling specialty reloads and the Signia(TM) powered stapler.
RGR second quarter revenue of $654 million increased 5.8 percent, or 7.3 percent on a constant currency basis. Growth was driven by Patient Monitoring, which grew in the high-single digits on a constant currency basis as a result of strength in Nellcor(TM) pulse oximetry. GI Solutions grew in the low-double digits on a constant currency basis, led by a strong performance in GI Diagnostics. Renal Care Solutions grew in the mid-single digits on a constant currency basis, driven by strength in renal access products.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide second quarter revenue of $1.993 billion increased 7.0 percent, or 7.8 percent on a constant currency basis. Group results were driven by high-teens growth in Pain Therapies, low-double digit growth in Specialty Therapies, high-single digit growth in Brain Therapies, and flat results in Spine, all on a constant currency basis.

Spine second quarter revenue of $656 million decreased 0.5 percent or increased 0.2 percent on a constant currency basis. When combined with the company’s sales of enabling technology used in spine surgeries, including robotics, navigation, imaging, and powered surgical instruments that are recognized in the Brain Therapies division, global Spine revenue grew in the low-single digits on a constant currency basis and U.S. Core Spine increased in the mid-single digits on a constant currency basis. Posterior Cervical grew in the low-double digits on a constant currency basis, driven by the recent launch of the Infinity(TM) OCT System.
Brain Therapies second quarter revenue of $618 million increased 7.5 percent, or 8.7 percent on a constant currency basis. Neurovascular grew in the mid-teens on a constant currency basis, with high-twenties constant currency growth of stents for acute ischemic stroke, including the Solitaire(TM) Platinum. Neurovascular also had strength in neuro access products, coils and intrasaccular therapies, and flow diversion products. Neurosurgery grew in the high-single digits, led by strong capital equipment sales of the StealthStation S8 surgical navigation system, Mazor X(TM) robotic guidance system, and Visualase MRI-guided laser ablation system.
Specialty Therapies second quarter revenue of $405 million increased 11.0 percent, or 11.5 percent on a constant currency basis. Results were led by mid-teens constant currency growth in Pelvic Health on strong sales of the InterStim(TM) II system.
Pain Therapies second quarter revenue of $314 million increased 18.9 percent, or 19.7 percent on a constant currency basis. The division had strong, mid-thirties constant currency growth in Pain Stimulation on the continued strength of the Intellis(TM) platform for spinal cord stimulation, as well as low-double digit constant currency growth in Targeted Drug Delivery.
Diabetes Group
The Diabetes Group includes the Advanced Insulin Management (AIM) and Emerging Technologies divisions. Diabetes Group worldwide second quarter revenue of $583 million increased 26.2 percent, or 27.5 percent on a constant currency basis. The group is experiencing strong, sustained global demand for its sensor-augmented insulin pump systems.

AIM second quarter revenue grew in the mid-twenties on a constant currency basis, driven by the sustained U.S. market demand for the MiniMed 670G hybrid closed loop insulin pump system with the Guardian sensor 3. AIM launched the MiniMed 670G in several European countries in the quarter, and initial user feedback has been very positive. The global adoption of its sensor-augmented insulin pump systems has resulted in strong sensor attachment rates, with integrated CGM sales growing in the mid-sixties on a constant currency basis.
Emerging Technologies second quarter revenue more than doubled on a constant currency basis, driven by the ongoing launch of the Guardian Connect CGM system with Sugar.IQ(TM) personal diabetes assistant.
Guidance
The company today updated its fiscal year 2019 guidance.

For fiscal year 2019, the company is increasing its organic revenue growth guidance from a range of 4.5 to 5.0 percent to a range of 5.0 to 5.5 percent. If recent exchange rates hold for the remainder of the fiscal year, the company’s fiscal year 2019 revenue would be negatively affected by approximately $420 million to $520 million.

Medtronic’s operational outperformance in the first half of fiscal year 2019 is allowing the company to absorb incremental expenses, including an increased impact of foreign exchange since the beginning of the fiscal year and expected impacts of China tariffs and the pending Mazor acquisition in the second half of the fiscal year, such that the company is maintaining its fiscal year 2019 diluted non-GAAP EPS guidance in the range of $5.10 to $5.15. If recent exchange rates hold for the remainder of the fiscal year, foreign exchange would have a neutral impact on the company’s fiscal year 2019 EPS, implying a constant currency EPS growth forecast of 9 to 10 percent.

"Our end markets are strong, and we are leading in most of the fastest growing markets in medical technology," said Ishrak. "Over the remainder of this fiscal year and into fiscal 2020, we expect to develop and bring to market a number of innovative new technologies, which will improve the lives of millions of people around the world, help healthcare systems become more efficient, and generate significant value for our shareholders."

Webcast Information
Medtronic will host a webcast today, November 20, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the second quarter financial schedules and non-GAAP reconciliations, click here. To view the second quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

On November 20, 2018 Adhera Therapeutics, Inc. (OTCQB: ATRX), an emerging specialty pharmaceutical company commercializing therapies that leverage its innovative distribution model and technology to improve the quality of care for patients suffering from chronic and acute diseases, reported financial and operating results for the third quarter of 2018 today (Press release, Marina Biotech, NOV 20, 2018, View Source [SID1234531579]).

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"The third quarter represented a strategic shift away from R&D and into commercialization," stated Robert Moscato, Jr., Chief Executive Officer of Adhera Therapeutics. "We have strategically positioned the company and changed the corporate identity while building a high-performance culture and streamlining communication. We hired a leadership team with a proven track record of building healthcare companies and commercializing life changing products, appointed new members to the Board of Directors to support the innovative business plan, recruited and trained an assiduous sales team and launched our first commercial product – PRESTALIA."

Recent Corporate Highlights

●The third quarter of 2018 marked the first full quarter of PRESTALIA sales in the United States. PRESTALIA, a fixed dose combination of perindopril arginine (an angiotensin-converting-enzyme inhibitor) and amlodipine besylate (a calcium channel blocker), was developed in coordination with Servier Laboratories, an international pharmaceutical company and global leader in the treatment of hypertension with turnover of €4.152 billion in 2017. The product is sold outside the United States under the brand name – Viacoram. Sales of Viacoram exceed $300 million annually. In the United States, PRESTALIA is distributed through our innovative distribution model and supported through PrestaliaDirect. Powered by Adhera’s DyrctAxess technology, PrestaliaDirect is a patient membership program that caps blood pressure medication costs, provides monitoring devices, offers online tracking tools and ships prescriptions directly to the patient. The sales performance of Viacoram in Europe does not necessarily indicate the potential sales performance of PRESTALIA by Adhera Therapeutics in the United States.

The Company moved its headquarters to Research Triangle Park, NC, began building its commercial team and broadening its Board of Directors to align with the innovative business plan.

The Company made key hires to strengthen the leadership team with the addition of Robert Moscato, Jr., former President and COO of Cerecor, Inc. named Chief Executive Officer, Eric Teague, former CFO and Board Member of ARCA, named Chief Financial Officer, and Jay Schwartz, former Vice President, Client Engagement Head for the Integrated Engagement Services division of IQVIA , named Sr. VP of Commercial Operations.

The Company appointed Uli Hacksell, Ph.D. and Nancy R. Phelan as members of its Board of Directors. Dr. Hackell serves as the Chairman of the Board of Directors and Ms. Phelan serves as a member of the audit committee. Both Dr. Hacksell and Ms. Phelan bring a bevy of pharmaceutical commercial and development experience to the company. Dr. Hacksell serves as Chairman of the Board of Directors of Cerecor Inc., he was previously President and Chief Executive Officer of Cerecor Inc., the Chief Executive Officer and a director of ACADIA Pharmaceuticals Inc. as well as Vice President of Drug Discovery and Technology, and President of Astra Draco AB, one of Astra’s largest research and development subsidiaries. Ms. Phelan is the Chief Business Officer of Innate Biologics as well as an Independent Board Member for FemmePharma Consumer Healthcare, Advisory Board Member for Eved, and a member of the Pharma Digital Health Roundtable Steering Committee. Ms. Phelan was Senior Vice President, Commercial Growth at Outcome Health, the Vice President, U.S. Customer Strategy and Operations and Head, Worldwide Commercial Operations for Bristol-Myers Squibb Company and held leadership roles in global and U.S. marketing at Wyeth, which was acquired by Pfizer Inc. in 2009.
The company hired a 20-person sales team and deployed transformational technology to connect across all commercial functions. This state-of-the-art approach will help maximize our ability to educate healthcare providers and improve patient outcomes.

Third Quarter Financial Results

We recorded $0.08 million in net sales for the three months ended September 30, 2018, as compared to no revenues for the three months ended September 30, 2017. In the first few months of launch, we sold over 500 bottles of PRESTALIA to our pharmacy partners. The strong initial demand for Prestalia was generated by more than 150 physicians writing over 600 prescriptions in the first few months of commercialization.

Total operating expenses increased by $6.81 million for the third quarter of 2018 as compared to the same period in 2017. The increase was primarily due to $4.79 million in Goodwill and intangible asset impairments, a $1.46 million increase in General and Administrative expenses, and a $0.87 million increase in sales, marketing, and commercial operations expenses. The increase in General and Administrative costs is primarily due to $1.31 million of compensation expense related to stock options granted to new members of the management team and the Board of Directors.

The net loss for the three months ended September 30, 2018 was $7.78 million compared to $0.97 million for the three months ended September 30, 2017. This change was due primarily to the $6.81 million increase in total operating expenses during the third quarter of 2018.

As of September 30, 2018, we had cash of $6.51 million, compared to cash of $0.11 million at December 31, 2017. The improvement in the cash balance was mainly due to the private placement of our newly created Series E and Series F Convertible Preferred Stock offerings during the second and third fiscal quarters of 2018. The Company also recorded $0.13 million and $0.36 million of accounts receivable and inventory, respectively, as of September 30, 2018. These amounts are related to the commercialization of Prestalia, and there were no accounts receivable or inventory as of December 31, 2017. Total current liabilities decreased by $3.55 million between December 31, 2017 and September 30, 2018, as the company paid off $1.91 million in notes payable and $1.18 million in amounts due to related parties. The company had no significant long-term liabilities as of September 30, 2018.