On February 8, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported new findings from the Phase 3 SPARTAN clinical trial that showed treatment with ERLEADA, an investigational, next-generation1 androgen receptor inhibitor, decreased risk of metastasis or death by 72 percent and improved median metastasis-free survival (MFS) by more than two years (difference of 24.3 months) in patients with non-metastatic castration-resistant prostate cancer (CRPC) whose prostate specific antigen (PSA) is rapidly rising, compared to placebo (Press release, Johnson & Johnson, FEB 8, 2018, View Source [SID1234523893]). The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco (Abstract #161) and were simultaneously published in The New England Journal of Medicine.

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"While there have been advances in the treatment of prostate cancer over the years, metastatic castration-resistant prostate cancer is still a lethal disease. These compelling results are the first to show that metastases can be delayed in these patients," said Eric Small, M.D. FASCO, Professor of Medicine, and Chief of the Division of Hematology and Oncology at the University of California, San Francisco, and lead SPARTAN study investigator. "These data suggest that apalutamide could potentially be a new standard of care for patients with non-metastatic castration-resistant prostate cancer."

SPARTAN, a Phase 3, randomized, double-blind, placebo-controlled, multicenter study, enrolled 1,207 patients with non-metastatic castration-resistant prostate cancer and was conducted at 332 sites in 26 countries in North America, Europe, Asia-Pacific and Australia. Patients were randomized 2:1 to receive ERLEADA in combination with androgen deprivation therapy (ADT) (n=806), or placebo in combination with ADT (n=401).

ERLEADA in combination with ADT decreased the risk of metastasis or death by 72 percent compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P<0.0001).2 The median MFS was 40.5 months for ERLEADA in combination with ADT compared to 16.2 months for placebo in combination with ADT, prolonging MFS by more than two years. MFS benefit was consistently seen across all subgroups of patients.2

"Delaying the metastasis of prostate cancer is critical. Once the cancer starts to spread, the patient’s overall health, well-being and prognosis change drastically," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen Research & Development, LLC. "The ERLEADA data presented at ASCO (Free ASCO Whitepaper) GU demonstrate the important impact this medicine can have for patients with prostate cancer. Janssen is committed to addressing unmet needs for treatment across all stages of disease progression with novel combinations and novel therapeutics."

In addition to improving metastasis free survival, ERLEADA in combination with ADT, compared to placebo in combination with ADT, demonstrated clinical improvement across secondary endpoints, with statistically significant improvements in time to metastasis (TTM; median of 40.5 months in the ERLEADA arm compared to median of 16.6 months in the placebo arm) and progression-free survival (PFS; median of 40.5 months in the ERLEADA arm compared to median of 14.7 months in the placebo arm). Treatment with ERLEADA decreased the risk of symptomatic progression by 55 percent compared with placebo (HR=0.45; 95% CI, 0.32-0.63; P<0.0001). ERLEADA was associated with a 30 percent risk reduction of death compared to placebo at this early interim analysis for overall survival (OS).2 In exploratory endpoints, ERLEADA in combination with ADT, compared to placebo in combination with ADT, also achieved a 94 percent risk reduction in time to PSA progression (HR = 0.06; 95% CI, 0.05-0.08; P<0.0001), and a 51 percent risk reduction in second progression-free survival (PFS2). The combination of ERLEADA and ADT was tolerable, with maintenance of overall health-related quality of life.

The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for ERLEADA in combination with ADT versus placebo in combination with ADT were rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent). Treatment discontinuation due to adverse events were 11 percent in the ERLEADA arm compared to 7 percent in the placebo arm. Rates of serious adverse events (SAEs) were similar in the ERLEADA in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent, respectively).

About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (CRPC) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a total body bone scan or CT scan.3 Features include: lack of detectable metastatic disease;3 rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dL.4,5 Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.6 The relative 5-year survival rate for patients with distant stage prostate cancer is 30 percent.7 While it is critical to delay the onset of metastasis in patients with non-metastatic CRPC, there are currently no FDA approved treatments.

About ERLEADA
ERLEADA (apalutamide) is an investigational, next-generation1 oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. ERLEADA inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.

On February 8, 2018 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the fourth quarter and full year ended December 31, 2017 (Press release, Cambrex, FEB 8, 2018, View Source [SID1234523822]).

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Highlights

Net revenue increased 2.5% to $182.3 million compared to $177.9 million in the same quarter last year. Excluding the impact of foreign exchange, net revenue increased 1%. Full year net revenue increased 9% to $534.5 million, compared to $490.6 million in the full year 2016.
GAAP Diluted EPS from continuing operations increased 4% to $1.20 per share from $1.15 per share in the same quarter last year. Full year GAAP Diluted EPS from continuing operations increased 17% to $3.10 per share from $2.65 per share in the full year 2016.
EBITDA increased to $64.7 million compared to $63.6 million in the same quarter last year. Full year Adjusted EBITDA increased 13% to $174.6 million from $154.2 million in the full year 2016 (see table at the end of this release).
Net cash was $183.3 million at the end of the year, an increase of $64.9 million during the quarter and $109.1 million during the year.
The Company continued to execute on its strategic growth plan, investing in new manufacturing capacity and analytical laboratory space at its facilities in Charles City, Iowa, High Point, North Carolina, Karlskoga, Sweden and Milan, Italy.
The Company expects full year 2018 Adjusted net revenue, excluding the impact of foreign currency and change in accounting principle, to be between -2% and 2% compared to 2017 and Adjusted EBITDA to be between $150 and $160 million. (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).
"We are pleased with our strong financial performance in 2017, our seventh straight year of solid growth. The fourth quarter was a record revenue quarter with Net revenue up 2.5% compared to a record fourth quarter last year. Strong performance at our manufacturing facilities resulted in higher profit margins versus last year," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"With our recently completed large scale manufacturing capacity projects and the on-going investments in R&D and pilot plant capabilities, we are well positioned to ensure our facilities are able to keep up with the strong market demand."

Basis of Reporting
The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Fourth Quarter 2017 Operating Results – Continuing Operations
Net revenue was $182.3 million, an increase of $4.4 million, or 2.5%, compared to the fourth quarter of 2016. Excluding a 1.5% favorable impact of foreign exchange compared to the fourth quarter of 2016, net revenue increased 1%. The increase primarily reflects higher volumes in the generic and controlled substance product categories, partially offset by lower volumes and pricing of certain branded APIs.

Gross margin decreased to 43% from 45% compared to the same quarter last year. Excluding a 1% unfavorable impact of foreign exchange compared to the fourth quarter of 2016, margins were relatively flat year over year.

Selling, general and administrative expenses were $18.7 million, compared to $18.2 million in the same quarter last year. This increase was primarily due to higher expenses related to consulting for an operational excellence initiative.

Research and development expenses were $4.3 million, compared to $3.5 million in the same quarter last year. This increase was primarily driven by costs to develop new generic drug products and higher personnel related expenses.

Operating profit decreased to $55.9 million from $56.7 million in the same quarter last year. This decrease was primarily the result of higher operating expenses as described above.

Adjusted EBITDA was $64.7 million compared to $64.4 million in the same quarter last year (see table at the end of this press release).

Income tax expense was $15.6 million resulting in an effective tax rate of 28% compared to $18.4 million and an effective tax rate of 33% in the same quarter last year. The favorable impact of immediately recognizing certain effects of share-based compensation as required by a recently adopted accounting standard and the unfavorable impact of U.S. tax reform legislation enacted in December 2017, was negligible.

Income from continuing operations was $40.2 million or $1.20 per share compared to $37.9 million or $1.15 per share in the same quarter last year. Adjusted income from continuing operations was $42.4 million or $1.27 per share, compared to $40.8 million or $1.23 per share in the same quarter last year (see table at the end of this press release).

Capital expenditures and depreciation were $13.2 million and $8.3 million, respectively, compared to $11.9 million and $6.6 million, respectively, in the same quarter last year.

Net cash was $183.3 million at the end of the fourth quarter, an increase of $64.9 million during the quarter.

Financial Expectations – Continuing Operations
The following table shows the Company’s current expectations for its full year 2018 financial performance:

Expectations
Adjusted net revenue -2% – 2%
Adjusted EBITDA $150 – $160 million
Adjusted income from continuing operations per share $2.80 – $3.03
Free cash flow $35 – $45 million
Capital expenditures $70 – $80 million
Depreciation and amortization $33 – $37 million
Adjusted effective tax rate 23% – 25%
Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities, outcomes of tax disputes and the adoption of the new revenue recognition guidance effective January 1, 2018. Adjusted net revenue expectations exclude the impact of foreign exchange and change in accounting principle. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2018 will be computed on a basis consistent with the reconciliation of the 2017 financial results in the tables at the end of this press release. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes certain effects of share-based payments that were possibly deferred under the previous guidance. The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax laws or rates within the countries in which the Company operates and the effects of certain share-based payments.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s 2017 Form 10-K is filed with the SEC.

Conference Call and Webcast
A conference call to discuss the Company’s fourth quarter and full year 2017 results will begin at 8:30 a.m. Eastern Time on February 8, 2018 and can be accessed by calling 1-888-394-8218 for domestic and +1-323-701-0226 for international. Please use the passcode 9709552 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through February 15, 2018 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 9709552 to access the replay.

On February 8, 2018 Radius Health, Inc. (Nasdaq:RDUS), a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported that Jesper Høiland, President and CEO of the Company, will present a corporate update at the Leerink Partners 7th Annual Global Healthcare Conference on Thursday, February 15, 2018 (Press release, Radius, FEB 8, 2018, View Source [SID1234523864]).

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Information on the presentation is as follows:

Event: Leerink Partners 7th Annual Global Healthcare Conference
Date: Thursday, February 15, 2018
Time: 2:00 p.m. ET
Location: Holmes I/II (4th fl.), Lotte New York Palace Hotel, New York, NY
A live webcast of the presentation will be available by visiting the Investors section of Radius’ website at View Source A replay of the webcast will be archived on Radius’ website for 30 days following the presentation.

On February 8, 2018 AskAt Inc. (AskAt), headquartered in Nagoya, Japan, reported a license agreement with NewBay Medical Technology Co., Ltd. (NewBay), headquartered in Hangzhouwan New Zone, Ningbo, Zhejiang Province, People’s Republic of China (China), granting NewBay exclusive rights to develop, manufacture and commercialize AskAt’s EP4 Antagonist [AAT-008] in China in the area of Immuno-Oncology (Press release, AskAt, FEB 8, 2018, View Source [SID1234535052]). Under the terms of the signed agreement, AskAt will receive upfront payments from NewBay and is eligible to receive Development and Commercial Milestone payments and Royalties on sales of products in China.

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About AAT-008

AAT-008 is a novel prostaglandin EP4 antagonist that has exhibited potent anti-tumor activity in animal models of lung, breast, colon, stomach, prostate, and liver cancers, and synergistic activity in combination with anti-PD-1 anti-body.

On February 7, 2018 GSK reported improvements in sales, margins and cash flow in 2017 (Press release, GlaxoSmithKline, FEB 7, 2018, View Source [SID1234523795]).

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Latest on GlaxoSmithKline’s Cancer Pipeline, book your free 1stOncology demo here.

Total EPS 31.4p, +67% AER, +36% CER; Adjusted EPS 111.8p, +11% AER, +4% CER

2017 financial highlights

Turnover £30.2 billion, +8% AER, +3% CER

Sales growth across all 3 businesses: Pharmaceuticals £17.3 billion, +7% AER, +3%, CER; Vaccines £5.2 billion, +12% AER, +6% CER; Consumer Healthcare £7.8 billion, +8% AER, +2% CER

Improved Adjusted Group operating margin of 28.4% (2016: 27.5%). Pharmaceuticals 34.3%; Vaccines 31.9%; Consumer Healthcare 17.7%

Total EPS 31.4p, after accounting charges of £1.6 billion related to US tax reform

Adjusted EPS 111.8p, +11% AER, +4% CER, in line with 2017 guidance

2017 free cash flow of £3.4 billion (2016: £3.0 billion)

23p dividend declared for quarter; 80p for 2017

2018 financial guidance

2018 Adjusted EPS Guidance: Growth is subject to uncertainty of timing and impact of possible generic competition to Advair in the US:

In the event of no substitutable generic competitor to Advair in the US, expect 2018 Adjusted EPS growth to be 4 to 7% CER

In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, expect full year 2018 US Advair sales of around £750 million at CER (US$1.30/£1) with Adjusted EPS flat to down 3% CER

Both scenarios reflect the benefit of US tax reform with expected 2018 effective tax rate on Adjusted profits of 19-20%

Continue to expect 80p dividend for 2018

Product and pipeline highlights

New product sales of £6.7 billion, +51% AER, +44% CER, driven by strong performances from Tivicay and Triumeq in HIV, the inhaled Ellipta portfolio and Nucala in Respiratory and meningitis vaccines

Three key approvals: Shingrix vaccine for shingles; Trelegy Ellipta, once-daily single inhaler triple therapy for COPD; Juluca (dolutegravir and rilpivirine), first 2-drug regimen, once-daily, single pill for HIV

Preferential recommendation for Shingrix received from US CDC

Trelegy Ellipta approved in Europe for COPD

Nucala filed in US for eosinophilic COPD

Phase III HIV treatment study initiated investigating long-acting 2-drug regimen of cabotegravir plus rilpivirine administered every two months

In Oncology, Breakthrough Therapy Designation received from FDA for BCMA antibody-drug conjugate for relapsed and refractory multiple myeloma. Positive BCMA data presented at ASH (Free ASH Whitepaper) meeting.

Emma Walmsley, Chief Executive Officer, GSK said:

"In 2017 GSK delivered encouraging results from across the company with sales growth in each of our three global businesses, an improved Group operating margin, Adjusted EPS growth of 4% (CER) and stronger free cash flow.

"We are focused on competing effectively across our current portfolio and delivering three new launches which bring significant benefits to patients: Trelegy Ellipta which provides three medicines in a single inhaler to treat COPD; Juluca, the first 2-drug regimen, once-daily, single pill for HIV, helping to reduce the amount of medicines needed, and Shingrix, our new vaccine which represents a new standard for the prevention of shingles.

"Improving our Pharmaceuticals business remains our main priority and we are strengthening our pipeline with a focus on priority assets in two current therapy areas, Respiratory and HIV, and two potential areas, Oncology and Immuno-inflammation. We will provide a further update to investors at Q2 on our plans for R&D.

"We continue to make changes across GSK to drive improvements in performance and we have made several new appointments to key leadership positions.

"Looking ahead, in 2018 we could see a potential generic version of Advair in the US and our 2018 guidance reflects this. With the sales momentum we anticipate from new and recent launches and focused improvements in operating performance we are increasingly confident in our ability to deliver mid to high single digit growth in Adjusted EPS CAGR (2016-2020 at 2015 CER).

"Cash generation also continues to be a key focus with free cash flow for the year improving to £3.4 billion. We met our commitment to pay a total dividend of 80p for 2017 and continue to expect to pay 80p for 2018.

"Finally, I would like to thank all our customers, suppliers and employees for their support and hard work in 2017 and look forward to working with them in 2018 and beyond to deliver our strategic priorities and improved performance for GSK."

2018 guidance

The Group expects to make continued progress in 2018, although the expectation for Adjusted EPS growth is impacted by a number of factors including, in particular, uncertainties relating to the timing and extent of potential generic competition to Advair in the US.

In the event that no substitutable generic competitor to Advair is introduced to the US market in 2018, the Group expects 2018 Adjusted EPS growth of 4 to 7% at CER. This is based on an expected decline in 2018 US Advair sales of 20-25% at CER.

In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, the Group expects full year 2018 US Advair sales of around £750 million at CER (US$1.30/£1), with Adjusted EPS flat to down 3% at CER.

The effective tax rate for 2018 is expected to be approximately 19-20% of Adjusted profits after the impact of US tax reform which is expected to benefit the Group effective tax rate by two to three percentage points.

GSK is not able to give guidance for Total results as it cannot reliably forecast certain material elements of our Total results such as the future fair value movements on contingent consideration and put options. It should be noted that contingent consideration cash payments are made each quarter primarily to Shionogi by ViiV Healthcare which reduce the balance sheet liability and are hence not recorded in the income statement. An explanation of the acquisition-related arrangements with ViiV Healthcare, including details of cash payments to Shionogi, is set out on page 59.

If exchange rates were to hold at the average rates for January 2018 ($1.39/£1, €1.13/£1 and Yen 154/£1) for the rest of 2018, the estimated negative impact on full-year 2018 Sterling turnover growth would be around 4% and if exchange gains or losses were recognised at the same level as in 2017, the estimated negative impact on 2018 Sterling Adjusted EPS growth would be around 6%.

US tax reform

The enactment of the US Tax Cuts and Jobs Act in December 2017 is expected to have a positive impact on the future after tax earnings of GSK’s US businesses. This is primarily due to the reduction in Federal corporation tax rates from 1 January 2018, which is expected to benefit the Group effective tax rate on Adjusted profits in 2018 by two to three percentage points.

The implementation of the new law has resulted in a number of additional charges in 2017, which reduced Total earnings by £1,630 million.

Firstly, increased valuations of the HIV and Consumer Healthcare businesses due to lower US tax rates resulted in an increase in the related liabilities for contingent consideration and the put options of £666 million.

Secondly, an additional tax charge of £1,078 million comprised a reduction in the value of US deferred tax assets held against future liabilities, such as pensions, of £730 million, and a charge of £348 million arising on the reserves of subsidiaries of US entities in the Group. The cash impact of this latter charge will be spread over eight years from 2018, with approximately 60% expected to be payable in years six to eight.

These charges were partly offset by an allocation to non-controlling interests amounting to £114 million, as many of the adjustments related to ViiV Healthcare and the Consumer Healthcare Joint Venture.

These charges represent management’s estimates of the impact of US tax reform on the Group based on the information currently available. As more information on the detailed application of the Act becomes available, the assumptions underlying these estimates could change, with consequent adjustments to the charges taken that could have a material impact on the results of the Group.