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Seattle Genetics Reports First Quarter 2017 Financial Results

On April 27, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology company, reported financial results for the first quarter ended March 31, 2017 (Press release, Seattle Genetics, APR 27, 2017, View Source [SID1234518719]).

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The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments, vadastuximab talirine (SGN-CD33A) and enfortumab vedotin (ASG-22ME) activities, as well as progress with its pipeline of antibody-drug conjugates (ADCs) and other proprietary programs.

"We continue to successfully execute on our ADCETRIS commercial objectives, and are positioned to achieve several important clinical development milestones during 2017. Notably, we expect to report top-line data from the phase 3 ECHELON-1 trial this year. ECHELON-1 has the potential to redefine the way newly diagnosed classical Hodgkin lymphoma patients are treated for the first time in decades. In addition, we are on track to submit a supplemental BLA to the FDA in mid-2017 for ADCETRIS use in CTCL based on data from the ALCANZA trial," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Across our pipeline, enrollment in our phase 3 CASCADE trial of vadastuximab talirine (SGN-CD33A) is strong. And, based on positive feedback from the FDA, we plan to advance enfortumab vedotin (ASG-22ME) into a pivotal trial in metastatic urothelial cancer later this year. We are delivering on our goal of building Seattle Genetics into a multi-product oncology company addressing the substantial unmet medical needs of cancer patients."

ADCETRIS Program Highlights

ALCANZA Phase 3 Trial: A supplemental Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is planned for mid-2017. The supplemental BLA is based on positive data from the phase 3 ALCANZA trial as well as data from two investigator-sponsored trials in cutaneous T-cell lymphoma (CTCL). ADCETRIS previously received Breakthrough Therapy Designation for the most common subtypes of CTCL: mycosis fungoides and primary cutaneous anaplastic large cell lymphoma.
ECHELON-1 Phase 3 Trial: Top-line data are anticipated in 2017 from the phase 3 ECHELON-1 trial in frontline classical Hodgkin lymphoma. ECHELON-1 is evaluating ADCETRIS as part of a combination regimen in newly diagnosed patients with advanced Hodgkin lymphoma.
ECHELON-2 Phase 3 Trial: Top-line data are expected in 2018 from the phase 3 ECHELON-2 trial in frontline CD30-expressing mature T-cell lymphoma (MTCL), also known as peripheral T-cell lymphoma (PTCL).
ADCETRIS is not currently approved for use in CTCL, frontline Hodgkin lymphoma or frontline MTCL.

Vadastuximab Talirine (SGN-CD33A) Program Highlights

CASCADE Phase 3 Trial: Enrollment is proceeding well in the global, randomized phase 3 CASCADE clinical trial evaluating vadastuximab talirine in combination with hypomethylating agents (HMAs) in older patients with newly diagnosed acute myeloid leukemia (AML).
Planned Phase 2 Trial: A randomized phase 2 trial in younger patients with newly diagnosed AML is planned for the second half of 2017. The trial will assess the standard-of-care regimen known as 7+3 versus 7+3 in combination with vadastuximab talirine.
Enfortumab Vedotin (ASG-22ME) Program Highlights

Planned Registrational Trial: Based on positive feedback from the FDA, Seattle Genetics and its collaborator Astellas plan to initiate in the second half of 2017 a pivotal phase 2 trial of single-agent enfortumab vedotin for metastatic urothelial cancer patients who have been previously treated with a checkpoint inhibitor therapy.
ASCO: Updated data from a phase 1 trial in metastatic urothelial cancer will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place June 2 – 6, 2017 in Chicago, IL.
Phase 1 Trial in Japan: Astellas and Seattle Genetics initiated a phase 1 trial in Japan to evaluate the tolerability and pharmacokinetics of enfortumab vedotin in patients with metastatic urothelial cancer. The trial will enable future studies and regulatory submission in Japan.
Other Recent Activities

Presence at AACR (Free AACR Whitepaper): Seattle Genetics’ ADC and immuno-oncology programs and technology advances were highlighted in 14 presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. Data described novel ADC linker technologies, the ability of ADCETRIS to activate antitumor immune responses, which support continued clinical evaluation in combination with checkpoint inhibitors, and preclinical data on two immuno-oncology agents, SEA-CD40 and SGN-2FF.
ADC Collaborations: In April 2017, Seattle Genetics generated a milestone under its ongoing ADC collaboration with AbbVie triggered by AbbVie’s exercise of an exclusive option to Seattle Genetics’ ADC technology for a specific target antigen.
First Quarter 2017 Financial Results

Total revenues in the first quarter ended March 31, 2017 were $109.1 million, compared to first quarter of 2016 revenues of $111.2 million. Revenues in the first quarter of 2017 included:

ADCETRIS net sales of $70.3 million, a 20 percent increase from net sales of $58.6 million in the first quarter of 2016.
Royalty revenues of $17.0 million, compared to $32.3 million in the first quarter of 2016. Royalty revenues are primarily driven by international sales of ADCETRIS by Takeda. Royalty revenues in the first quarter of 2016 included a $20.0 million sales milestone payment from Takeda.
Amounts earned under the company’s ADCETRIS and ADC collaborations totaling $21.8 million, compared to $20.2 million in the first quarter of 2016.
Total costs and expenses for the first quarter of 2017 were $168.4 million, compared to $132.2 million for the first quarter of 2016. The increase in 2017 costs and expenses was primarily driven by investment in enfortumab vedotin, vadastuximab talirine, ADCETRIS product supply to Takeda and the company’s pipeline programs.

Non-cash, share-based compensation cost for the first quarter of 2017 was $14.5 million, compared to $12.2 million for the first quarter of 2016.

Net loss for the first quarter of 2017 was $60.0 million, or $0.42 per share, compared to a net loss of $20.5 million, or $0.15 per share, for the first quarter of 2016.

As of March 31, 2017, Seattle Genetics had $536.4 million in cash, cash equivalents and investments.

Ipsen reports strong first quarter 2017 sales growth of 19,1%

On April 27, 2017 Ipsen, a global specialty-driven pharmaceutical group, reported sales for the first quarter of 2017 (Press release, Ipsen, APR 27, 2017, View Source [SID1234518698]).

2017 first quarter sales

In the first quarter of 2017, Consolidated Group sales grew 19.1% to €438.0 million driven by Specialty Care growth of 25.4%1 including growth of 86.3%1 from North America.

Commenting on the first quarter 2017 performance, David Meek, Chief Executive Officer of Ipsen said: "In the first quarter, Specialty Care continued to drive remarkable organic top-line growth for Ipsen, led by the outstanding performance of Somatuline, both in the United States and Europe, as well as a strong acceleration for Dysport. We continue to face headwinds in certain emerging markets for our Consumer Healthcare business." David Meek continued, "After the successful closing of the Onivyde transaction, our largest acquisition to date, we are focused on the successful execution of the Onivyde and Cabometyx launches. These two important products strengthen our presence in Oncology and will contribute meaningfully to our top-line growth and profitability in the coming years."

Ipsen confirms its financial targets for 2017, with Specialty Care sales growth year-on-year greater than +18.0%1, Consumer Healthcare sales growth year-on-year greater than +4.0%1 and Core Operating margin greater than 24% of net sales.

In addition, Ipsen announces the change in name of its Primary Care division to Consumer Healthcare. This reflects the evolution over the last two years of the promotional model from classical prescription-based to a combination of prescription and over-the-counter (OTx) in select countries with gastrointestinal portfolios. The transaction announced in February to acquire a portfolio of select consumer healthcare assets from Sanofi will strengthen the evolution of the Consumer Healthcare portfolio in France and Central Europe with the strategic intent to further develop the OTx model in most geographies.

View Ipsen’s full Q1 report at View Source

FDA Approves XATMEP™, the First and Only Ready-To-Use Methotrexate Oral Solution

On April 26, 2017 Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for children, reported that the United States Food and Drug Administration (FDA) approved XATMEP (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution (Press release, Silvergate Pharmaceuticals, APR 26, 2017, View Source [SID1234625387]). XATMEP is indicated for the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients.

"XATMEP is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of methotrexate for children without the need for needles, crushing of tablets or compounding into a liquid formulation," said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

XATMEP (methotrexate) Oral Solution, 2.5 mg/mL, is a ready-to-use product that requires no preparation, facilitating accuracy and ease of dispensing at the pharmacy. XATMEP is manufactured under CGMPs in accordance with FDA regulations. It eliminates the need for needles, crushing or splitting tablets or for compounding tablets into a liquid formulation. It requires refrigeration but may be stored at room temperature for 60 days after dispensing. XATMEP is available through an extensive network of pharmacies and a qualified mail-order service. For additional information on how to obtain XATMEP, please call 1-855-379-0382.

INDICATIONS

XATMEP is a folate analog metabolic inhibitor indicated for the:

management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
About XATMEP

XATMEP (methotrexate) Oral Solution was developed, primarily, to meet the need for a ready-to-use, 2.5 mg/mL, methotrexate oral solution for the treatment of pediatric patients for the indications stated above. Currently, there is no FDA-approved, ready-to-use oral liquid formulation of methotrexate for use by pediatric patients requiring body surface area (BSA) dosing (mg/m2) or who have difficulty swallowing or cannot consume tablets, or those with needle-phobia. Silvergate Pharmaceuticals, Inc.’s XATMEP (methotrexate) Oral Solution resolves these unmet medical needs in pediatric patients.

IMPORTANT SAFETY INFORMATION

XATMEP includes a BOXED WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY

See full prescribing information for complete boxed warning.

Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression (5.1), infection (5.2), renal (5.3), gastrointestinal (5.4), hepatic (5.5), pulmonary (5.6), hypersensitivity and dermatologic (5.7).
Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy (4). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP (5.9, 8.1, 8.3).
ADDITIONAL IMPORTANT SAFETY INFORMATION

XATMEP is contraindicated in patients who are hypersensitive to methotrexate.
XATMEP is contraindicated in patients who are pregnant or nursing.
Warnings and Precautions:

Monitor closely and modify dose or discontinue XATMEP as appropriate.

Methotrexate can cause the following severe, life-threatening or fatal adverse reactions:

Bone marrow suppression: pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia.
Serious infections: bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia, invasive fungal, hepatitis B reactivation, tuberculosis, Herpes zoster and cytomegalovirus infections.
Renal toxicity and renal impairment, including acute renal failure.
Gastrointestinal toxicity: diarrhea, stomatitis, vomiting, hemorrhagic enteritis, fatal intestinal perforation. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant us of NSAIDs.
Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure.
Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases at all dose levels.
Hypersensitivity: anaphylaxis.
Dermatologic reactions: toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme. Radiation dermatitis and "sunburn" may be recalled.
Secondary malignancies: lymphoproliferative disease has been reported with low-dose oral methotrexate which regressed when methotrexate is withdrawn.
Embryo-fetal toxicity and fetal death: Consider the risks and benefits of XATMEP and risks to the fetus when prescribing to a pregnant patient with a neoplastic disease. XATMEP is contraindicated in non-neoplastic disease.
Immunizations may be ineffective when given during XATMEP therapy.
Immunization with live virus vaccines is not recommended during XATMEP therapy.
Effects on reproduction: Methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. Effective contraception should be practiced by patients of reproductive potential while receiving XATMEP therapy, and for 3 and 6 months afterwards for males and females, respectively.
Third-space accumulation: Evacuate significant third-space accumulation prior to methotrexate administrations.
Concomitant radiation therapy increases the risk of soft tissue necrosis and osteonecrosis associated with methotrexate.
Closely monitor laboratory parameters for hematology, renal function and liver function. Increase monitoring during initial dosing, dose changes and during periods of increased risk of elevated methotrexate blood levels (e.g., dehydration).
Improper dosing: Once weekly dosing is appropriate. Fatal toxicity has been reported with daily dosing. An accurate millimeter measuring device should be used.
Advise women not to breastfeed.
Adverse Reactions: See full prescribing information for additional adverse reactions.

Most common adverse reactions are ulcerative stomatitis, leukopenia, nausea, abdominal distress, and elevated liver function tests.

Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased risk to infection.

Drug Interactions:

Oral antibiotics: Hematologic and gastrointestinal toxicity may increase.
Hepatotoxins: May increase hepatoxicity.
Probenecid: Consider alternative drugs as may increase methotrexate exposure.
Theophylline: May reduce theophylline clearance.
To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

Please see accompanying full Prescribing Information, including the complete BOXED WARNING.

About Silvergate Pharmaceuticals, Inc.
Headquartered near Denver, Colorado, Silvergate Pharmaceuticals, Inc., is a privately held pharmaceutical company dedicated to leading the way in the development and commercialization of innovative pediatric medications that are safe, effective, and readily available.

Silvergate Pharmaceuticals is committed to filling the unmet needs of children, developing innovative medications that will help improve the quality of care and outcomes for pediatric patients. For more information, please visit View Source

Reference: XATMEP [prescribing information]. Greenwood Village, CO: Silvergate Pharmaceuticals, Inc.; 2017.

10-Q – Quarterly report [Sections 13 or 15(d)]

MediciNova has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

GSK delivers another quarter of continued progress

On April 26, 2017 GlaxoSmithKline reported another quarter of continued progress (Press release, GlaxoSmithKline, APR 26, 2017, View Source [SID1234518697]).

Q1 sales of £7.4 billion, +19% AER, + 5% CER
Total EPS of 21.4p >100% AER, >100% CER; Adjusted EPS of 25.0p, +31% AER, +9% CER

View full Q1 2017 results (PDF): View Source

Summary:

Financial highlights

Sales growth across all three businesses: Pharmaceuticals £4.2 billion, +17% AER, +4% CER; Vaccines £1.2 billion, +31% AER, +16% CER; Consumer Healthcare £2.0 billion, +16% AER, +2% CER
Improved Group operating margin reflecting leverage from sales growth, focus on costs and benefits of restructuring. Pharmaceuticals 34.4%; Vaccines 29.6%; Consumer Healthcare 17.2%
Net cash flow from operations of £1.1 billion (Q1 2016: £0.5 billion). Free cash flow of £0.7 billion
(Q1 2016: £0.2 billion outflow), primarily reflecting improved operating performance and the net benefit of exchange rate movements
19p dividend declared for Q1 2017. Continue to expect 80p for FY 2017
2017 Adjusted CER earnings per share guidance maintained
Product and pipeline highlights

New product sales of £1.4 billion +72% AER, +52% CER. On track to deliver £6 billion (CER) sales in 2018
Results from MUSCA study demonstrate Nucala significantly improves quality of life and lung function in patients with severe asthma
Positive SWORD study presented for two-drug regimen of dolutegravir and rilpivirine for treatment of HIV
Positive results reported in-house from ZOSTER-048 study of Shingrix in individuals previously vaccinated with Zostavax*
Flonase Sensimist launched in US; second Rx to OTC switch in 3 years
Outlook assumptions and cautionary statements

Assumptions related to 2017 guidance and 2016-2020 outlook

In outlining the expectations for 2017 and the five-year period 2016-2020, the Group has made certain assumptions about the healthcare sector, the different markets in which the Group operates and the delivery of revenues and financial benefits from its current portfolio, pipeline and restructuring programmes.

For the Group specifically, over the period to 2020 GSK expects further declines in sales of Seretide/Advair. The introduction of a generic alternative to Advair in the US has been factored into the Group’s assessment of its future performance. The Group assumes no premature loss of exclusivity for other key products over the period. The Group’s expectation of at least £6 billion of revenues per annum on a CER basis in 2018 from products launched since 2013 includes contributions from the current pipeline asset Shingrix. The Group also expects volume demand for its products
to increase, particularly in Emerging Markets.

The assumptions for the Group’s revenue and earnings expectations assume no material interruptions to supply of the Group’s products and no material mergers, acquisitions, disposals, litigation costs or share repurchases for the Company; and no change in the Group’s shareholdings in ViiV Healthcare or Consumer Healthcare. They also assume no material changes in the macro-economic and healthcare environment.

The Group’s expectations assume successful delivery of the Group’s integration and restructuring plans over the period 2016-2020. Material costs for investment in new product launches and R&D have been factored into the expectations given. The expectations are given on a constant currency basis and assume no material change to the Group’s effective tax rate.

Assumptions and cautionary statement regarding forward-looking statements

The Group’s management believes that the assumptions outlined above are reasonable, and that the aspirational targets described in this report are achievable based on those assumptions. However, given the longer term nature of these expectations and targets, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macroeconomic activity, changes in regulation, government actions or intellectual property protection, actions by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, “forward-looking statements”. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Other than in accordance with its legal or regulatory obligations (including under the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements.