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8-K – Current report

On January 28, 2016 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, reported the biopsy data at 6 months for the first seven patients to complete the Phase 2a proof-of-concept study in localized prostate cancer (Filing, 8-K, Sophiris Bio, JAN 28, 2016, View Source [SID:1234508931]).

A review of the biopsy data from the first seven men to complete the study showed that four patients experienced a response to treatment: One patient experienced complete ablation of the tumor where no evidence of the treated tumor remained on a targeted biopsy at 6 months; three patients experienced either a reduction in the maximum cancer core length or a reduction in Gleason pattern; three patients had no response to treatment.

"This new trial is very exciting — we have promising data showing that topsalysin can ablate cancer cells and we look forward to reviewing the results from the remaining 11 patients as they complete the study. We could be on the cusp of a new class of therapeutics for the focal treatment of localized prostate cancer," stated Professor Mark Emberton, Dean, Faculty of Medical Sciences, University College London and Honorary Consultant Urologist University College London Hospital NHS Foundation Trust.

Dr. Hashim Ahmed, Principal Investigator for the study, Division of Surgery and Interventional Sciences, University College London, said, "Topsalysin could offer a tissue-sparing cancer treatment that carries little in the way of side effects. This treatment has the potential to help men avoid radical treatments such as radiation therapy or complete removal of the prostate."

This one-time administration of topsalysin directly into a pre-identified clinically significant tumor appears to be well tolerated with no serious adverse events and no new safety signals being reported. This is consistent with safety observed in the 365 patients that have been treated with topsalysin in the Company’s BPH program to date.

"The biological activity that we have observed further validates the mechanism of action of topsalysin. We are gaining valuable experience on how we might best optimize both the delivery and dose of topsalysin based on lesion size, and the remaining patients to complete the study will help in that assessment," said Dr. Ahmed.

The ongoing Phase 2a proof of concept study is a single-center, open-label study at University College London, which is well known for the focal treatment of prostate cancer in the UK. In this study, previously obtained multiparametric magnetic resonance images (mpMRIs) of each patient’s prostate tumor lesions are mapped to real-time three-dimensional transrectal ultrasound. These images are used to guide the injection of topsalysin to treat a single, histologically-proven, clinically significant prostate cancer lesion. The primary objective of the study is safety and tolerability, and the key efficacy variable is the change in the treated lesion on targeted biopsy after 6 months. The study is designed to assess whether topsalysin has the potential to provide patients with clinically significant, localized, low to intermediate risk prostate cancer a tissue-sparing cancer treatment that carries little in the way of side effects. A total of 18 patients were enrolled and treated in this study. Sophiris expects to have final data on all patients by the end of the second quarter of 2016.

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[PDF]Change in the Company Name of Western Pharmaceutical Subsidiaries of Kyowa Hakko Kirin

On January 29, 2016 Kyowa Hakko Kirin Co., Ltd. (Tokyo 4151; President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") reported that it will change the name of all its western pharmaceutical subsidiaries, using "Kyowa Kirin" as a common company brand name (Press release, Kyowa Hakko Kirin, JAN 28, 2016, View Source [SID:1234508911]). Every subsidiary will begin officially operating under this new company trade name at various points during 2016.

Kyowa Hakko Kirin is expanding its business globally and, as shown in its business vision, "Kyowa Hakko Kirin will be a Japan-based Global Specialty Pharmaceutical Company contributing to human health and well-being worldwide through innovative drug discovery and global commercialization, driven by state-of-the art antibody technologies mainly in the core therapeutic areas of oncology, nephrology and immunology". The company plans to launch late stage development products in the US and Europe in this mid-term business plan. Kyowa Hakko Kirin’s decision to unify all of its western pharmaceutical subsidiaries under one name, "Kyowa Kirin", is in pursuit of its aim to become a Global Specialty Pharmaceutical Company.

"I am convinced that a unified brand name will strengthen interaction and integration in our group." said Nobuo Hanai, Ph.D., President and CEO of Kyowa Hakko Kirin. "This will assist us in leaping forward as a Global Specialty Pharmaceutical Company, creating innovations across the group’s various business bases."

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

01/28/2016 Corcept Therapeutics Announces Preliminary Fourth Quarter and Full Year 2015 Summary Financial Results, Provides 2016 Revenue Guidance and Corporate Update

On January 28, 2016 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported its preliminary financial results for the quarter and year ended December 31, 2015 (Press release, Corcept Therapeutics, JAN 28, 2016, http://www.corcept.com/news_events/view/pr_1454017543 [SID:1234508902]). The company also provided an update

Preliminary 2015 Financial Results; 2016 Revenue Guidance

Corcept reported preliminary revenue of $15.0 million for the fourth quarter of 2015 and $50.3 million for the full year. Preliminary GAAP net income for the fourth quarter of 2015 was $0.01 per share, compared to a net loss of $0.04 per share in the fourth quarter of 2014. For the full year, the company reported a preliminary GAAP net loss of $0.06 per share for 2015, compared to a net loss of $0.31 per share in 2014. The company’s cash and cash equivalents were $40.4 million at year-end, an increase of $4.0 million from September 30, 2015.

The company estimates 2016 revenue will be $76-81 million.

"Our Korlym revenue grew 89 percent last year. We expect significant growth in 2016 and beyond, as there are still many patients who could benefit from the medication and have not received it," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "The continued growth in our Cushing’s syndrome business, in conjunction with our lean business model, allowed us to generate our first GAAP profit last quarter and will be sufficient to fund our planned development activities."

2016 Clinical and Pre-Clinical Development

"Our clinical and pre-clinical pipeline will expand significantly in 2016," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer. "Our Phase 1/2 trial of mifepristone with eribulin to treat triple-negative breast cancer will generate efficacy and safety results around mid-year."

"We also plan to begin two Phase 2 studies of our next-generation, selective cortisol modulator, CORT125134, by the end of the first quarter," Dr. Fishman said. "And we are advancing additional selective cortisol modulators towards Phase 1, including CORT118335, a compound that has shown promise in animal models of non-alcoholic fatty liver disease."

Dr. Fishman also noted the importance to Corcept’s development program of its collaborations with independent researchers. "We have more than thirty pre-clinical and clinical studies underway with academic investigators around the world. Their work has deepened our understanding of cortisol modulation’s therapeutic potential and is invaluable as we select new development targets. Our oncology program, for example, is based on pioneering work by University of Chicago researchers in the study of cortisol modulators, both mifepristone and our next-generation compounds, as potential treatments for TNBC, ovarian and prostate cancer."

Mifepristone for the Treatment of Triple-Negative Breast Cancer

Corcept is investigating whether mifepristone, the active ingredient in Korlym, will enhance the effect of eribulin in patients with TNBC. At the San Antonio Breast Cancer Symposium in December 2015, Corcept presented preliminary data from its Phase 1/2 trial’s efficacy phase. Enrollment is ongoing.

Two Phase 2 Trials of CORT125134

CORT125134 is a next-generation, selective cortisol modulator. It was well-tolerated in its Phase 1 trial, which showed that the compound shares Korlym’s ability to modulate activity at the glucocorticoid receptor (the essential quality in treating Cushing’s syndrome). Unlike Korlym, CORT125134 is not active at the progesterone receptor and so does not terminate pregnancy or cause other side effects associated with progesterone receptor antagonism. When administered with a chemotherapeutic agent, CORT125134 slows tumor growth significantly in mouse models of TNBC and castration-resistant prostate cancer. In vitro, it similarly slows the growth of ovarian cancer tumor cells. Corcept has submitted INDs to the FDA covering CORT125134’s use in two Phase 2 trials – one to treat patients with Cushing’s syndrome and another for the treatment of patients with a range of solid tumors.

Conference Call

Corcept will hold a conference call on January 28, 2016, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss this announcement. To participate, dial 1-888-771-4371 from the United States or 1-847-585-4405 internationally approximately 10 minutes before the start of the call. The passcode will be 4156 8920.

A replay will be available through February 12, 2016 at 1-888-843-7419 from the United States and 1-630-652-3042 internationally. The passcode will be 4156 8920.

About Korlym

Korlym modulates the effect of cortisol at the glucocorticoid receptor (GR), one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness and the FDA has designated it as an Orphan Drug for that indication.

About Cushing’s Syndrome

Endogenous Cushing’s syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20-50. An estimated 10-15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing’s syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About Triple-Negative Breast Cancer

Triple-negative breast cancer is a form of the disease in which the three receptors that fuel most breast cancer growth – estrogen, progesterone and the HER-2/neu gene – are not present. Because the tumor cells lack the necessary receptors, treatments that target estrogen, progesterone and HER-2 receptors are ineffective. In 2013, approximately 40,000 women were diagnosed with TNBC. It is estimated that more than 75 percent of these women’s tumor cells expressed the GR receptor to which cortisol binds. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients exists.

Amgen’s 2015 Revenues Increased 8 Percent To $21.7 Billion And Adjusted Earnings Per Share (EPS) Increased 19 Percent To $10.38

On January 28, 2016 Amgen (NASDAQ:AMGN) reported financial results for the fourth quarter and full year of 2015 (Press release, Amgen, JAN 28, 2016, View Source;p=RssLanding&cat=news&id=2133283 [SID:1234508901]). Key results include:

For the fourth quarter, total revenues increased 4 percent to $5,536 million, with 3 percent product sales growth driven by Enbrel (etanercept), Sensipar (cinacalcet), Prolia (denosumab), Kyprolis (carfilzomib) and XGEVA (denosumab). Adjusted operating income grew 16 percent to $2,366 million and adjusted EPS grew 21 percent to $2.61.

For the full year, total revenues increased 8 percent to $21,662 million, with 8 percent product sales growth. Adjusted operating income grew 19 percent to $10,052 million and adjusted EPS grew 19 percent to $10.38.

2015 adjusted operating margin improved by 4 percentage points to 48 percent.

GAAP EPS were $2.37 in the fourth quarter compared to $1.68 a year ago and $9.06 for the full year compared to $6.70 in 2014. GAAP operating income was $2,033 million in the fourth quarter compared to $1,459 million a year ago and $8,470 million for the full year compared to $6,191 million in 2014. 2014 was negatively impacted by charges for the restructuring plan announced in the third quarter of 2014.

Free cash flow for the full year was $8.5 billion compared to $7.8 billion in 2014 driven by higher revenues and higher operating income.

"2015 was an exceptional year for Amgen with six innovative new launches, strong financial performance, continued pipeline advances and improved operating margins driven by our transformation efforts," said Robert A. Bradway, chairman and chief executive officer. "We remain on track to meet or exceed our 2018 commitments and deliver value for patients and shareholders."

References in this release to "adjusted" measures, measures presented "on an adjusted basis" or to free cash flow refer to non-GAAP financial measures. These adjustments and other items are presented on the attached reconciliations.

Product Sales Performance

Total product sales increased 3 percent for the fourth quarter of 2015 versus the fourth quarter of 2014. The increase was driven primarily by ENBREL, Sensipar, Prolia, Kyprolis and XGEVA. Product sales increased 8 percent for the full year.

ENBREL sales increased 8 percent year-over-year for the fourth quarter driven by net selling price, offset partially by the impact from inventory changes and competition. Sales increased 14 percent for the full year driven by net selling price, offset partially by the impact from competition.

Neulasta (pegfilgrastim) sales decreased 2 percent year-over-year for the fourth quarter driven by lower unit demand and unfavorable changes in foreign exchange rates, offset partially by net selling price. Sales increased 3 percent for the full year driven by net selling price, offset partially by unfavorable changes in foreign exchange rates.

Aranesp (darbepoetin alfa) sales increased 4 percent year-over-year for the fourth quarter and 1 percent for the full year. Unit demand grew in the United States (U.S.) as dialysis customers shifted some purchases from EPOGEN (epoetin alfa) to Aranesp.

Unit demand growth was offset partially by unfavorable changes in foreign exchange rates and net selling price.

Sensipar/Mimpara sales increased 21 percent year-over-year for the fourth quarter and 22 percent for the full year driven by net selling price and higher unit demand.

Prolia sales increased 21 percent year-over-year for the fourth quarter and 27 percent for the full year driven by higher unit demand.

XGEVA sales increased 10 percent year-over-year for the fourth quarter and 15 percent for the full year driven primarily by higher unit demand.

EPOGEN sales decreased 37 percent year-over-year for the fourth quarter and 9 percent for the full year driven by the impact of competition and, to a lesser extent, the shift in U.S. dialysis customer purchases to Aranesp.

NEUPOGEN (filgrastim) sales decreased 4 percent year-over-year for the fourth quarter driven by the impact of competition in the U.S. and unfavorable changes in foreign exchange rates, offset partially by favorable changes in accounting estimates. Sales decreased 9 percent for the full year driven by the impact of competition in the U.S.

Kyprolis sales increased 63 percent year-over-year for the fourth quarter and 55 percent for the full year driven by higher unit demand.

Nplate (romiplostim) sales increased 15 percent year-over-year for the fourth quarter and 12 percent for the full year driven by higher unit demand.

Vectibix (panitumumab) sales increased 2 percent year-over-year for the fourth quarter and 9 percent for the full year driven by higher unit demand, offset partially by unfavorable changes in foreign exchange rates.
Product Sales Detail by Product and Geographic Region

Operating Expense, Operating Margin and Tax Rate Analysis, on an Adjusted Basis

Operating Expenses decreased 4 percent year-over-year in the fourth quarter of 2015 and remained flat for the full year. Changes in foreign exchange rates reduced operating expenses by 2 percent in the fourth quarter and 3 percent for the full year.

Cost of Sales margin improved by 1.6 percentage points year-over-year in the fourth quarter of 2015 and 1.3 percentage points for the full year driven primarily by manufacturing efficiencies, higher net selling price and lower royalties.

Research & Development (R&D) expenses decreased 10 percent year-over-year in the fourth quarter of 2015 driven by savings from transformation and process improvement efforts, as well as a $60 million upfront payment in the fourth quarter of 2014 related to the Company’s cancer immunotherapy collaboration with Kite Pharma. For the full year, R&D expenses decreased 5 percent driven primarily by savings from transformation and process improvement efforts, offset partially by increased support for launch products.

Selling, General & Administrative (SG&A) expenses increased 3 percent year-over-year in the fourth quarter of 2015 and 6 percent for the full year driven primarily by investments in new product launches, offset partially by savings from transformation and process improvement efforts.

Operating Margin improved by 5 percentage points year-over-year in the fourth quarter of 2015 and 4 percentage points for the full year.

Adjusted Tax Rate for the fourth quarter of 2015 increased 1.4 percentage points year-over-year driven primarily by a lower benefit from the federal R&D tax credit. The full year adjusted tax rate increased 1.9 percentage points driven primarily by changes in the geographic mix of earnings.

The Company generated $1.9 billion of free cash flow in the fourth quarter of 2015 versus $2.2 billion in the fourth quarter of 2014. For the full year, free cash flow was $8.5 billion compared to $7.8 billion in 2014 driven by higher revenues and higher operating income.

The Company’s first quarter 2016 dividend of $1.00 per share declared on Dec. 15, 2015, will be paid on March 8, 2016, to all stockholders of record as of Feb. 16, 2016.

During the fourth quarter, the Company repurchased 1.2 million shares of common stock at a total cost of $184 million. For the full year, the Company repurchased 12 million shares of common stock at a total cost of $1.85 billion. At the end of 2015, the Company had $4.9 billion remaining under its stock repurchase authorization.

2016 Guidance

For the full year 2016, the Company now expects:

Total revenues in the range of $22.0 billion to $22.5 billion and adjusted EPS in the range of $10.60 to $11.00. Previously, the Company expected total revenues in the range of $21.7 billion to $22.3 billion and adjusted EPS in the range of $10.35 to $10.75.
Adjusted tax rate to be in the range of 19.5 percent to 20.5 percent, which includes the benefit of the federal R&D tax credit.
Capital expenditures to be approximately $700 million.

The Company provided the following updates on selected product and pipeline programs:

Repatha

In January 2016, Repatha was approved in Japan for the treatment of patients with familial hypercholesterolemia (FH) or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins).

Kyprolis

In November, the European Medicines Agency (EMA) approved the Marketing Authorization Application (MAA) for Kyprolis in combination for the treatment of relapsed multiple myeloma based on data from the Phase 3 ASPIRE study.

In December, a Variation to the MAA was submitted to the EMA to expand the indication for Kyprolis in relapsed multiple myeloma based on data from the Phase 3 ENDEAVOR study.

In January 2016, the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for Kyprolis in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

BLINCYTO (blinatumomab)

In November, the EMA approved the MAA for BLINCYTO for the treatment of Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia.
IMLYGIC

In December, the EMA approved the MAA for IMLYGIC for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.
XGEVA

Data from the event driven Phase 3 study for the prevention of skeletal-related events in patients with multiple myeloma is expected in Q4 2016.

Romosozumab

Data from the Phase 3 registrational study in women with postmenopausal osteoporosis is expected in Q1 2016.
AMG 334

Data from the Phase 2b study in patients with chronic migraine is expected in H2 2016.
Biosimilars

In January 2016, the FDA accepted for review Amgen’s Biologics License Application for ABP 501, a biosimilar candidate to Humira (adalimumab), and set a Biosimilar User Fee Act target action date of Sept. 25, 2016.

In December, a MAA was submitted to the EMA for ABP 501.

Non-GAAP Financial Measures
In this news release, management has presented its operating results for the fourth quarters and full years of 2015 and 2014 in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on an adjusted (or non-GAAP) basis. In addition, management has presented its full year 2016 EPS and tax rate guidance in accordance with GAAP and on an adjusted (or non-GAAP) basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the fourth quarters and full years of 2015 and 2014. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s core business activities by facilitating comparisons of results of core business operations among current, past and future periods. In addition, the Company believes that excluding the non-cash amortization of intangible assets, including developed product technology rights, acquired in business combinations treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. The Company believes that FCF provides a further measure of the Company’s liquidity.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

8-K – Current report

On January 28, 2016 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) reported that Teva Pharmaceuticals has commenced shipment of BENDEKA, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine (Filing, 8-K, Eagle Pharmaceuticals, JAN 28, 2016, View Source [SID:1234508898]). BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

According to Paul Rittman, Senior Vice President and General Manager, Teva Oncology, "With the launch of BENDEKA, Teva furthers our commitment to providing treatment options for patients with these rare forms of cancer. We believe BENDEKA represents an important benefit to both patients and healthcare providers, and are pleased it is now available. Based on the product profile, we expect BENDEKA to replace TREANDA liquid."

Under a February 2015 exclusive license agreement for BENDEKA, Teva is responsible for all U.S. commercial activities for the product including promotion and distribution.

The information furnished pursuant to Item 7.01 of this current report shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended. As such, this information shall not be incorporated by reference into any of the Company’s reports or other filings made with the Securities and Exchange Commission. The furnishing of the information in this current report is not intended to, and does not, constitute a determination or admission by the Company that the information in this current report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.