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8-K – Current report

On January 29, 2016, in Tokyo, Japan (January 28, 2016, in San Francisco, CA), Medivation, Inc.’s collaboration partner Astellas Pharma Inc. (Astellas), reported its financial results for the quarter ended December 31, 2015 (Filing, 8-K, Medivation, JAN 29, 2016, View Source [SID:1234508921]).

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Astellas reported, among other things, that U.S. net sales of XTANDI (enzalutamide) capsules were $315.9 million for the quarter ended December 31, 2015 (Medivation’s fourth quarter), an increase of $85.7 million or 37% over the prior year quarter. The Astellas-reported net sales of $315.9 million increased by approximately one percent above the reported net sales of $313.0 million in the quarter ended September 30, 2015. Net sales for the quarter ended December 31 included an unfavorable adjustment of $2.6 million related to changes in Astellas’ estimate of prior period gross-to-net deductions against gross sales and an increase in channel partner inventory of just over one-half week of supply. As previously disclosed, the reported net sales of $313.0 million for the September quarter included a favorable adjustment of $17.9 million related to changes in Astellas’ estimate of prior period gross-to-net deductions against gross sales. Based on information provided by Astellas, the estimated growth in prescription demand from the quarter ended September 30, 2015 to the quarter ended December 31, 2015 was a low- to mid- single digit percentage. For the year ended December 31, 2015, U.S. net sales of XTANDI, as reported by Astellas, were $1.151 billion, an increase of $471.5 million or 69% over the prior year.

In its release, Astellas also reported net sales of XTANDI outside of the U.S. for the quarter ended December 31, 2015, expressed in various currencies. Medivation estimates such sales (expressed in U.S. dollars) were approximately $231 million for the quarter, which represents an increase of approximately 83% over the quarter ended December 31, 2014 and 13% over the quarter ended September 30, 2015. Medivation estimates net sales of XTANDI outside of the U.S. for the full year ended December 31, 2015 were approximately $757 million, an increase of approximately 99% over net sales for the year ended December 31, 2014. Fluctuating currency exchange rates reduced such estimated 2015 ex-U.S. net sales at the Astellas level, as expressed in U.S. dollars, by approximately 10% for the quarter and 14% for the year compared with the respective 2014 periods.

Based on the above, Medivation estimates worldwide net sales of XTANDI at the Astellas level were approximately $547 million for the quarter ended December 31, 2015 and $1.908 billion for the year ended December 31, 2015. Medivation earned the final sales milestone of $175 million under the collaboration with Astellas in the quarter ended December 31, 2015, based upon worldwide net sales exceeding $1.6 billion in the calendar year.

Medivation plans to report its own financial results for the quarter and year ended December 31, 2015, on February 25, 2016.

The information in this Item 7.01 is being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.

Spectrum Pharmaceuticals Begins Enrolling Patients in Registrational Trial of SPI-2012, a Novel, Long Acting G-CSF in Patients with Breast Cancer

On January 29, 2016 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, reported the Company has initiated the planned registrational trial for SPI-2012 (eflapegrastim), its novel, long-acting G-CSF (Press release, Spectrum Pharmaceuticals, JAN 29, 2016, View Source [SID:1234508908]). This trial will evaluate the safety and efficacy of SPI-2012 as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, and will serve as the basis for the Biologics License Application (BLA) filing.

"The initiation of the registration trial for SPI-2012 is a significant milestone in the history of our company," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "Revenues from our current marketed drugs have helped us invest in this exciting technology that opens the door for us to a blockbuster oncology market. In parallel, Spectrum has built a strong commercial infrastructure with specialized expertise in this indication that positions us well to aggressively compete in this market."

"I am excited to be the lead investigator for this important study, and about the potency and safety of SPI-2012 as demonstrated in Phase 2," said Lee S. Schwartzberg, M.D., FACP Professor of Medicine and Division Chief, Hematology Oncology, The University of Tennessee Health Science Center, and Executive Director, UT/West Cancer Center. "The LAPSCOVERY technology confers long-acting properties and increased bone marrow uptake through decreased renal and vascular clearance, as well as Fc-mediated transport of G-CSF. We look forward to a successfully conducted Phase 3 trial of SPI-2012. I believe this novel biologic drug, if approved, would be a very valuable addition to our supportive care armamentarium for cancer patients receiving myelosuppressive cytotoxic chemotherapy."

"SPI-2012 is a third generation agent for the treatment of neutropenia that has shown promising results in Phase 2 trials," said, Jeffrey L. Vacirca, M.D., FACP CEO, Managing Partner & Chief of Clinical Research at North Shore Hematology/Oncology Associates and Vice-President, Community Oncology Alliance. "In the Phase 2 trial, the duration of severe neutropenia was equivalent to pegfilgrastim at the medium dose and superior at the high dose. No new or significant dose-related toxicities have been observed in over 230 patients who have been treated with SPI-2012, and the incidence of adverse events has been similar to pegfilgrastim."

In accordance with the SPA, this registrational, Phase 3 or ADVANCE study (RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide) is a multicenter, randomized, active controlled trial that will enroll 580 newly diagnosed early-stage breast cancer patients, who will receive adjuvant or neoadjuvant chemotherapy every 21 days. Adjuvant chemotherapy is treatment given after primary surgical therapy to kill any remaining cancer cells and increase the chance of long-term disease-free survival; neoadjuvant chemotherapy is the administration of cytotoxic agents before surgical resection in early-stage breast cancer to shrink the tumor and potentially allow for breast-conserving surgery. SPI-2012 will be administered subcutaneously as a fixed dose equivalent to 3.6 mg of GCSF, which was selected based on the robust pharmacological and pharmacodynamic data from Phase 2. The primary study endpoint is the Duration of Severe Neutropenia (Absolute Neutrophil Counts [ANC] < 0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle. Secondary endpoints include the incidence of neutropenic complications, incidence of Febrile Neutropenia, Relative Dose Intensity, and safety.

About Special Protocol Assessments

A Special Protocol Assessment is a written agreement between a Sponsor and the U.S. Food and Drug Administration on the design, execution and analysis for a clinical trial that may form the basis of a new Biologics License Application or BLA. Final marketing approval depends upon the efficacy results, safety profile and an evaluation of the risk/benefit of treatment demonstrated in the Phase 3 clinical program.

About Breast Cancer

According to the American Cancer Society (ACS), breast cancer is the second most common form of cancer in women after skin cancer, and the second highest cause of female cancer deaths after lung cancer. Unfortunately, it is estimated that about 1 in 8 (12%) of women in the US will develop invasive breast cancer during their lifetime. In 2015 in the United States (US), an estimated 231,840 new cases of invasive breast cancer and 60,290 additional cases of in situ breast cancer will be diagnosed, and approximately 40,290 US women are expected to die from breast cancer. In addition, ~2,350 men are also expected to be diagnosed with breast cancer in 2015 with an estimated 440 deaths.

8-K – Current report

On January 29, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its proprietary ADC technology, reported financial results for the three-month period ended December 31, 2015 — the second quarter of the Company’s 2016 fiscal year (Filing, 8-K, ImmunoGen, JAN 29, 2016, View Source [SID:1234508907]). ImmunoGen also provided an update on product programs and reiterated its 2016 fiscal year guidance.

"ImmunoGen is off to a strong start for 2016, with multiple clinical trial initiations underway," commented Daniel Junius, President and CEO. "Of particular importance is the opening of our FORWARD I trial assessing mirvetuximab soravtansine as single-agent therapy for pretreated FRα-positive ovarian cancer, which we believe is the fastest path to registration for this promising ADC. We expect several presentations of mirvetuximab soravtansine data in 2016, including mature results from the 40-patient FRα-positive ovarian cancer Phase 1 cohort."

Mr. Junius continued, "Our partners also are making meaningful progress. Of particular note is Bayer’s initiation of a Phase 2 trial designed to support registration of its anetumab ravtansine product candidate. Roche expects data to be reported from its trial assessing Kadcyla in the neoadjuvant setting this year and — if positive — to bring these to regulatory authorities for potential filing in 2016. A third partner compound is on track to advance into registration testing later this year."

Update on Wholly Owned Product Programs

Mirvetuximab soravtansine — First FRα-targeting ADC is a potential new treatment for ovarian cancer and other FRα-positive solid tumors.

· Assessments as single-agent therapy for pretreated FRα-positive ovarian cancer:

· Updated Phase 1 findings were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November for the dataset reported at ASCO (Free ASCO Whitepaper) in May (abstracts #C47 and #5518, respectively). These included that 35% (7/20) of patients with FRα-positive platinum-resistant disease treated had a confirmed objective response, with most (6/7) responders on mirvetuximab soravtansine for 6 months or longer. This compares with ImmunoGen’s target response rate of 30% or more to advance the ADC as monotherapy. Most of the patients and all of the responders had high or medium FRα levels on their tumors.

· Patient enrollment is open for the Company’s FORWARD I Phase 2 trial, which is designed to support an Accelerated Approval pathway for mirvetuximab soravtansine. FORWARD I is being conducted in partnership with the GOG Foundation, Inc. To qualify for enrollment, patients must have ovarian cancer with high or medium FRα expression that was previously treated with 3 or 4 regimens.

· Patient enrollment was completed in 4Q2015 in the 20-patient Phase 1 expansion cohort requiring biopsies. The Company intends to present initial biomarker data from this assessment at a medical meeting in 2Q2016 in addition to reporting mature data from the 40-patient Phase 1 cohort in this disease at the meeting.

· Assessments as combination therapy for FRα-positive ovarian cancer:

· Encouraging preclinical data with a range of combination regimens were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting (abstract C170).

· In December, patient dosing began in the Phase 1b/2 trial, FORWARD II, assessing mirvetuximab soravtansine in combination with approved anticancer agents.

· Assessments for the treatment of other FRα-positive cancers:

· In 4Q2015, patient enrollment was completed in the 20-patient Phase 1 expansion cohort assessing the ADC for FRα-positive relapsed/refractory endometrial cancer. The Company expects to report findings from this assessment in 2H2016.

· Additional cancer types are being evaluated for FRα expression preclinically.

IMGN529 and coltuximab ravtansine — CD37- and CD19-targeting, respectively, ADCs for diffuse large B-cell lymphoma (DLBCL) and potentially other B-cell malignancies.

· Preclinical findings of strong synergy for IMGN529 used in combination with rituximab were reported at ASH (Free ASH Whitepaper) (abstract #1548) in December.

· Patient enrollment in a Phase 2 trial assessing IMGN529 in combination with rituximab is expected to begin early this year. Enrollment in a Phase 2 trial assessing coltuximab ravtansine in a different combination regimen is expected to begin in 2H2016.

IMGN779 — First CD33-targeting ADC utilizing an IGN cancer-killing agent. IGNs are a

new class of DNA-acting agents invented by ImmunoGen.

· Mechanism of action data were reported at ASH (Free ASH Whitepaper) (abstract #1366).

· ImmunoGen is preparing to initiate Phase 1 testing of IMGN779 for the treatment of acute myeloid leukemia in 1H2016.

Update on Partner Programs

Nine companies are advancing ADCs with ImmunoGen technology. Recent highlights include:

· Patient dosing has begun in Bayer’s global Phase 2 clinical trial designed to support registration of its mesothelin-targeting ADC, anetumab ravtansine. This event triggers a milestone payment to ImmunoGen that will be reflected in the Company’s 3QFY2016 financial results.

· Roche expects data from its KRISTINE trial assessing Kadcyla in the neoadjuvant setting for early HER2-positive breast cancer to be reported this year and, if positive, to bring these to regulatory authorities for potential filing in 2016.

· In December, Takeda took its first license for the exclusive right to develop ADCs to an undisclosed target using ImmunoGen technology.

· Also in December, CytomX announced it is advancing a novel anticancer agent targeting CD166 using its ProbodyTM technology and ImmunoGen’s ADC technology under a strategic collaboration established between the companies in early 2014.

Financial Results

For the Company’s quarter ended December 31, 2015 (2QFY2016), ImmunoGen reported a net loss of $(33.2) million, or $(0.38) per basic and diluted share, compared to net income of $13.6 million, or $0.16 per basic and diluted share, for the same quarter last year (2QFY2015).

Revenues for 2QFY2016 were $18.0 million, compared to $48.3 million for 2QFY2015. The current period includes $8.6 million of amortization of upfront fees previously received from Takeda and the prior year period includes $41.4 million of amortization of upfront fees previously received from Novartis and Lilly. The fees are recognized in their respective quarters due to the partner taking one or more licenses in the quarter. License and milestone fees for 2QFY2016 also include a $2 million milestone earned from Sanofi with the advancement of SAR428926 into clinical testing. Revenues in 2QFY2016 include $6.3 million of non-cash royalty revenues and $0.2 million of cash royalty revenues on Roche sales of Kadcyla for the three-months ended September 30, 2015, compared with $4.6 million in cash royalty revenues for the prior year period.

Operating expenses in 2QFY2016 were $46.3 million, compared to $34.5 million in 2QFY2015. Operating expenses in 2QFY2016 include research and development expenses of $38.2 million, compared to $27.6 million in 2QFY2015. This change is primarily due to increased third-party costs related to the advancement of our wholly owned product candidates, increased clinical trial costs, primarily related to our expansion of the mirvetuximab soravtansine development program, and increased

personnel expenses, principally due to recent hiring. Operating expenses include general and administrative expenses of $8.1 million in 2QFY2016, compared to $6.9 million in 2QFY2015. This increase is primarily due to increased personnel expenses and professional services.

ImmunoGen had approximately $212.3 million in cash and cash equivalents as of December 31, 2015, compared with $278.1 million as of June 30, 2015, and had no debt outstanding in either period. Cash used in operations was $63.0 million in the first six months of FY2016, compared with $34.4 million in the same period in FY2015. Capital expenditures were $7.6 million and $2.6 million for the first six months of FY2016 and FY2015, respectively.

Financial Guidance for Fiscal Year 2016

ImmunoGen’s financial guidance remains unchanged from that issued in July 2015. ImmunoGen expects: its revenues to be between $70 million and $80 million; its operating expenses to be between $175 million and $180 million; its net loss to be between $120 million and $125 million; its cash used in operations to be between $100 million and $105 million; and its capital expenditures to be between $13 million and $15 million. Cash and cash equivalents at June 30, 2016 are anticipated to be between $165 million and $170 million.

U.S. FDA APPROVES EISAI’S ANTICANCER AGENT HALAVEN(R) FOR THE TREATMENT OF ADVANCED LIPOSARCOMA

On January 29, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) of its in-house developed anticancer agent Halaven (eribulin mesylate) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen (Press release, Eisai, JAN 29, 2016, View Source [SID:1234508906]). Halaven is the first and only single agent to demonstrate an overall survival (OS) benefit in a Phase III trial in patients with advanced or recurrent and metastatic soft tissue sarcoma (leiomyosarcoma or liposarcoma). Following approval for use in the treatment of metastatic breast cancer in the United States, this marks the second indication for which Halaven has been approved by the FDA based on a statistically significant extension of OS.

This approval was based on the results from a multicenter, open-label, randomized Phase III study (Study 309) comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced or recurrent and metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen.

Halaven demonstrated a statistically significant extension in the study’s primary endpoint of OS over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.768 [95% CI=0.618-0.954], p=0.017).1
For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven, n=71, median OS: 15.6 months vs dacarbazine, n=72, median OS: 8.4 months; HR 0.51 [95% CI=0.35-0.75]).2 Additionally, in the study’s secondary endpoint of progression-free survival (PFS), patients treated with Halaven experienced an improvement in PFS over dacarbazine (Halaven median PFS: 2.9 months vs dacarbazine median PFS: 1.7 months; HR 0.52 [95% CI=0.35-0.78]).2

The most common adverse reactions (incidence greater than or equal to 25%) in study patients with liposarcoma and leiomyosarcoma treated with Halaven were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain and pyrexia, which was consistent with the known side-effect profile of Halaven.2 The most common (incidence greater than or equal to 5%) Grade 3-4 laboratory abnormalities reported in patients receiving Halaven were neutropenia, hypokalemia, and hypocalcemia. The most common serious adverse reactions reported in patients receiving Halaven were neutropenia (4.9%) and pyrexia (4.5%).2

Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissues (fat, muscle, nerves, fibrous tissues and blood vessels) in the body. Approximately 12,000 patients in the United States are diagnosed with soft tissue sarcoma each year, and liposarcoma is one of the most common forms of soft tissue sarcoma. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.

Applications seeking approval of Halaven for use in the treatment of soft tissue sarcoma have been submitted in Europe and Japan. Meanwhile, the agent has been designated as an orphan drug for the treatment of soft tissue sarcoma in the United States and Japan.

Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile.2 In addition, recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores.3 Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.4 It was first approved in the United States in November 2010 for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Halaven is currently approved for use in the treatment of breast cancer in approximately 60 countries including Japan and countries in Europe, the Americas and Asia.

Through this additional approval, Eisai remains committed to providing further clinical evidence for Halaven aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

< Notes to editors >

1. About Halaven (eribulin mesylate)
Halaven is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally Halaven is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Halaven is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores.3 Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.4
Halaven was first approved as a treatment in the United States in November 2010 for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Halaven is currently approved for use in the treatment of breast cancer in approximately 60 countries worldwide, including Japan and countries in the Europe, Americas and Asia. In Japan, Halaven has been approved to treat inoperable or recurrent breast cancer and was launched in the country in July 2011. Halaven has also been approved in countries in Europe and Asia indicated as a treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
Regarding soft tissue sarcoma, Halaven has been approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen, and applications seeking approval for this potential indication have been submitted in Japan and Europe. Meanwhile, Halaven has been designated as an orphan drug for soft-tissue sarcoma in the United States and Japan.

2. About Soft Tissue Sarcoma
Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue (fat, muscle, nerves, fibrous tissues and blood vessels) in the body. Approximately 12,000 patients in the United States and 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year. According to a patient survey conducted by Japan’s Ministry of Health, Labour and Welfare, there are approximately 4,000 patients with soft tissue sarcoma in Japan. As the structures where the tumors originate are diverse, there are various types of soft tissue sarcoma, and the most common types include leiomyosarcoma, liposarcoma and malignant fibrous histiocytoma. While treatment of soft tissue sarcoma is focused on curative surgery, if the degree of malignancy is high, treatment then becomes a combination of chemotherapy and radiation therapy. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.

3. About Study 309
Conducted primarily in Europe and the United States, Study 309 was a multicenter, open-label, randomized Phase III study comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced or recurrent and metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Patients received either Halaven (1.4 mg/m2 administered intravenously on Day 1 and Day 8) or dacarbazine (850–1200 mg/m2 administered intravenously on Day 1) every 21 days until disease progression.
From the results for the study, Halaven demonstrated a statistically significant extension in the study’s primary endpoint of overall survival (OS) over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.768 [95% CI=0.618-0.954], p=0.017).1 Furthermore, in the study’s secondary endpoints, there was no statistically significant difference found between Halaven and dacarbazine in either progression-free survival (PFS) (median PFS: 2.6 months in both arms) or progression-free rate at 12 weeks (PFR12wks) (Halaven PFR12wks: 33% vs dacarbazine PFR12wks: 29%).1
For patients with liposarcoma, Halaven demonstrated a statistically significant improvement in OS over dacarbazine (Halaven, n=71, median OS: 15.6 months vs dacarbazine, n=72, median OS: 8.4 months; HR 0.51 [95% CI=0.35-0.75]).2 Additionally, patients treated with Halaven experienced an improvement in PFS over dacarbazine (Halaven median PFS: 2.9 months vs dacarbazine median PFS: 1.7 months; HR 0.52 [95% CI=0.35-0.78]).2
The most common adverse reactions (incidence greater than or equal to 25%) in study patients with liposarcoma and leiomyosarcoma treated with Halaven were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%) and pyrexia (28%), which was consistent with the known side-effect profile of Halaven.2 The most common (incidence greater than or equal to 5%) Grade 3-4 laboratory abnormalities reported in patients receiving Halaven were neutropenia (32% vs. 8.9% in the dacarbazine arm), hypokalemia (5.4% vs. 2.8%) and hypocalcemia (5.0% vs. 1.4%). The most common serious adverse reactions reported in patients receiving Halaven were neutropenia (4.9%) and pyrexia (4.5%).2 The most common adverse reactions resulting in discontinuation of Halaven were fatigue and thrombocytopenia (0.9% each).

AbbVie Reports Full-Year 2015 and Fourth-Quarter Financial Results

On January 29, 2016 AbbVie (NYSE: ABBV) reported financial results for the fourth quarter and full year ended Dec. 31, 2015 (Press release, AbbVie, JAN 29, 2016, View Source;p=RssLanding&cat=news&id=2133541 [SID:1234508903]).

"AbbVie delivered strong performance in 2015, exceeding original sales, margin expansion, and earnings projections for the year," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We achieved significant growth in 2015, and expect to continue building on that momentum in 2016 with another year of strong performance."

Fourth-Quarter Results

Worldwide adjusted net revenues were $6.360 billion in the fourth-quarter, up 18.4 percent. On an operational basis, adjusted net revenues increased 24.4 percent, excluding a 6.0 percent unfavorable impact from foreign exchange rate fluctuations.

Global HUMIRA sales increased 16.0 percent on an operational basis, excluding the impact of foreign exchange. Exceptional U.S. HUMIRA growth of 20.7 percent was driven by continued momentum across all three major market categories – rheumatology, dermatology and gastroenterology. International HUMIRA sales growth was also strong in the fourth quarter, up 9.7 percent on an operational basis. Reported international HUMIRA sales growth in the quarter was reduced by 13.1 percent due to unfavorable foreign exchange.

Fourth-quarter global IMBRUVICA net revenue was $343 million, with U.S. sales of $295 million and international profit sharing of $48 million for the quarter.

Total company revenue growth was also driven by $554 million in global VIEKIRA sales in the quarter, as well as strong operational growth from Duodopa, Creon and Lupron.

Adjusted gross margin ratio in the fourth quarter was 80.5 percent, excluding intangible asset amortization and other specified items. On a GAAP basis, the gross margin ratio was 77.0 percent.

Adjusted selling, general and administrative (SG&A) expense was 23.9 percent of net revenues in the fourth quarter. On a GAAP basis, SG&A was 27.1 percent of net revenues.

Adjusted research and development (R&D) expense was 15.9 percent of net revenues in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline. On a GAAP basis, R&D was 16.8 percent of net revenues.

Adjusted operating margin in the fourth quarter was 40.1 percent, compared to 35.8 percent in fourth-quarter 2014. On a GAAP basis, the operating margin was 33.0 percent.

Net interest expense was $199 million. The adjusted tax rate in the quarter was 21.6 percent and 21.1 percent on a GAAP basis.

Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.13 in the fourth quarter, up 27 percent. Diluted earnings per share were $0.92 on a GAAP basis.

Key Events from the Fourth Quarter

AbbVie submitted a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA) to the U.S. Food and Drug Administration (FDA) for use in treatment-naïve chronic lymphocytic leukemia (CLL) patients, based on results from the Phase 3 RESONATE-2 study. These data, published in The New England Journal of Medicine (NEJM), found that IMBRUVICA significantly decreased the risk of progression or death (progression-free survival, PFS) and significantly decreased the risk of death (overall survival, OS) versus chlorambucil in treatment-naïve patients 65 years and older with CLL.

AbbVie submitted a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for venetoclax in patients with relapsed/refractory (R/R) CLL in patients with chromosome 17p deletion to the FDA and European Medicines Agency (EMA), respectively. Priority review status was granted by the FDA and validation provided by the EMA for these submissions based on results from a Phase 2, open-label trial that found treatment with venetoclax demonstrated a 79.4 percent overall response rate (ORR) as monotherapy treatment, including patients that achieved complete remission.

AbbVie has now received three FDA Breakthrough Therapy Designations for venetoclax. The first designation was received early last year for the treatment of patients with R/R CLL with chromosome 17p deletion. The second designation for venetoclax was received earlier this month for combination therapy with rituximab for patients with R/R CLL, including those with chromosome 17p deletion. A third designation was received this week for venetoclax in combination with hypomethylating agents (HMAs) in patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy).

AbbVie submitted a sNDA to the FDA for labeling considerations based on safety and efficacy results from the Phase 3 HELIOS trial of IMBRUVICA in patients with R/R CLL. The trial found that treatment with IMBRUVICA plus bendamustine and rituximab, versus placebo plus rituximab, significantly reduced the risk of disease progression or death by 80 percent and significantly improved ORR compared to placebo plus rituximab in previously-treated CLL/SLL patients.

The FDA accepted AbbVie’s sNDA and granted priority review for VIEKIRA PAK without ribavirin in patients with genotype 1b (GT1b) chronic hepatitis C virus infection (HCV) and compensated cirrhosis (Child-Pugh A). The application was supported by data from the TURQUOISE-III study, which showed 100 percent sustained virologic response at 12 weeks post-treatment (SVR12) in this patient population.

AbbVie announced that the FDA accepted its NDA for a once-daily, fixed-dosed formulation of VIEKIRA PAK to treat GT1 HCV. The proposed dosing for the fixed-dose formulation is three oral tablets, taken once daily with a meal, with or without ribavirin. AbbVie anticipates regulatory action on the new formulation in 2016.

At the American Society of Hematology (ASH) (Free ASH Whitepaper)’s Annual Meeting (ASH) (Free ASH Whitepaper) in December 2015, AbbVie presented new results from a Phase 2, open-label study of venetoclax in treatment-naïve patients 65 years and older with AML who were not eligible for intensive-induction chemotherapy. These data found that combination treatment with venetoclax and hypomethylating agents resulted in complete response rates of approximately 71 percent, which is roughly double the response rate that would be expected with current standard of care treatment. AbbVie plans to initiate registration studies of venetoclax for this indication in 2016.

AbbVie’s IMBRUVICA partner Janssen presented results from the Phase 3 RAY study which demonstrated treatment with IMBRUVICA significantly prolonged PFS and improved ORR in patients with R/R mantle-cell lymphoma (MCL), compared with temsirolimus. Specifically, IMBRUVICA was found to reduce the risk of disease progression or death by 57 percent with a median follow-up of 20 months. These data were also published online in The Lancet.

AbbVie announced that data from a Phase 2 study evaluating IMBRUVICA therapy in treatment-naïve patients with follicular lymphoma (FL) demonstrated that a combination of IMBRUVICA and rituximab was well-tolerated and associated with ORR of 82 percent.

AbbVie presented data from its next-generation HCV regimen (ABT-493 and ABT-530) being evaluated as a pan-genotypic, once-daily treatment option for patients with HCV at the 2015 Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Results demonstrated 12 weeks of treatment resulted in 97-100 percent SVR12 in GT1 non-cirrhotic HCV, 96-100 percent in genotype (GT2) and 83-94 percent in genotype 3 (GT3) patients. Additionally, data from the SURVEYOR-I study were also presented at the meeting and showed that non-cirrhotic GT1 HCV patients who received shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved SVR12 rates of 97 percent. The company initiated Phase 3 studies in the fourth quarter of 2015.

At the American College of Rheumatology (ACR) Annual Meeting, AbbVie presented the full 12-week, Phase 2b safety data for ABT-494, an investigational oral JAK-1 inhibitor, from the BALANCE-I study (efficacy data was previously top-lined). This study evaluated a broad dose range to understand the boundaries of JAK-1 selectivity and the efficacy of ABT-494 versus placebo in previously treated patients with rheumatoid arthritis (RA) with persistent and active disease. The study met its primary endpoint, achieving an ACR20 response after 12 weeks of treatment using an LOCF approach, and ACR20 for all dose levels. The BALANCE I and II results support the company’s decision to move ABT-494 into Phase 3 studies with a once-daily dose. The Phase 3 program was initiated in late 2015 and a Phase 2 trial of ABT-494 is ongoing for the treatment of Crohn’s disease.

The FDA approved Empliciti (elotuzumab) for the treatment of multiple myeloma (MM) as a combination therapy in patients who have received one to three prior therapies. Empliciti was co-developed by AbbVie and Bristol-Myers Squibb (BMS) and will be marketed by BMS. This approval was based on data from a Phase 3 study which demonstrated that patients treated with Empliciti plus standard of care therapy achieved a 30 percent reduction in the risk of disease progression or death compared to standard of care alone. This is the first FDA approval for an immune-stimulatory antibody for MM in this indication.

Confirming Full-Year 2016 Outlook

AbbVie is confirming its diluted earnings-per-share guidance of $4.90 to $5.10 on an adjusted basis for the full-year 2016, representing strong double-digit growth versus 2015 and positioning AbbVie to be among the industry leaders for growth again in 2016. The company’s 2016 adjusted diluted earnings-per-share guidance excludes $0.45 per share of intangible asset amortization expense and other specified items. Including these items, AbbVie’s diluted earnings-per-share guidance is $4.45 to $4.65 on a GAAP basis.