On May 3, 2018 Allergan plc (NYSE: AGN) reported that its Board of Directors has declared a cash dividend of $0.72 per ordinary share for the second quarter of 2018 (Press release, Allergan, MAY 3, 2018, View Source [SID1234526043]). The dividend will be paid on June 15, 2018 to shareholders of record at the close of business on May 18, 2018.

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On May 3, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Thursday, May 10, 2018 at 5:00 p.m. ET to report its first quarter 2018 financial results and provide a corporate update (Press release, Fate Therapeutics, MAY 3, 2018, http://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-first-3 [SID1234526070]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 5592629. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On May 3, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended March 31, 2018(Press release, Spectrum Pharmaceuticals, MAY 3, 2018, View Source [SID1234526088]).

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"We had a productive first quarter as we continued to advance our lead pipeline drugs poziotinib and ROLONTIS," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We were honored to have poziotinib data appear in Nature Medicine, be presented at AACR (Free AACR Whitepaper), and announce our strengthened IP with MD Anderson in addition to releasing ROLONTIS topline data. In the next few months, we look forward to announcing important clinical data from both therapies at key scientific meetings."

Clinical Program Update:
Poziotinib, an irreversible tyrosine kinase inhibitor:
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The company has initiated a multi-center study which is currently enrolling non-small cell lung cancer (NSCLC) patients. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations at leading cancer centers throughout U.S. The study will evaluate objective response rate (ORR) as the primary endpoint, disease control rate (DCR), duration of response (DOR), progression free survival (PFS), quality of life (QOL) and safety as additional endpoints.

An investigator sponsored trial is ongoing at the University of Texas MD Anderson Cancer Center in NSCLC patients with exon 20 mutations in EGFR or HER2. The 50 patient EGFR cohort is fully enrolled.

In an April 2018 Nature Medicine publication, updated data from the first 11 NSCLC patients with EGFR exon 20 mutations receiving poziotinib in MD Anderson’s Phase 2 clinical trial showed a confirmed objective response rate of 64 percent. As noted in the publication, the median progression-free survival had not been reached, with a median follow up of 6.6 months. The safety profile was consistent

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with those previously described for poziotinib and other TKIs. The company expects additional data from this study at the World Conference on Lung Cancer, in Toronto (September 23-26, 2018).

Data presented at AACR (Free AACR Whitepaper) in April 2018, demonstrated pre-clinical and early clinical activity of poziotinib in HER2 exon 20 mutant NSCLC, suggesting poziotinib could be a promising agent for the numerous cancer types driven by HER2 exon 20 mutations.

The company is planning a basket trial to study poziotinib in exon 20 mutations across several solid tumors.

The company has entered into an exclusive licensing agreement with MD Anderson which strengthens and extends intellectual property on poziotinib. The filed patents, if granted, will extend until 2037.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:

A legistrational Phase 3 study, ADVANCE, was initiated under a special protocol assessment with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia.

The company announced the ADVANCE study met the primary efficacy endpoint of non-inferiority in duration of severe neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms. Phase 3 data abstract to be released by American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) followed by an oral presentation at Multinational Association of Supportive Care in Cancer (MASCC) in June 2018.

The company has completely enrolled RECOVER, an international Phase 3 study that has a design similar to ADVANCE.

Spectrum is working toward a pre-BLA meeting with the FDA to ensure alignment in preparation for a planned Q4 BLA submission.
Financial Guidance
The company has also raised guidance for 2018. Expected 2018 revenue will be between $95 million to $115 million, up from previously projected revenue of $90 million to $110 million. Additionally, the company expects its current cash and marketable securities to be sufficient to fund operations into 2020.

Three-Month Period Ended March 31, 2018 (All numbers are approximate)
GAAP Results
Total product sales were $28.1 million in the first quarter of 2018. Product sales in the first quarter included: FOLOTYN (pralatrexate injection) net sales of $12.7 million, EVOMELA (melphalan) for injection net sales of $8.1 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $3.0 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $0.9 million, and FUSILEV (levoleucovorin) net sales of $0.6 million.
Spectrum recorded net loss of $15.8 million, or $0.16 per basic and diluted share in the three-month period ended March 31, 2018, compared to net loss of $23.5 million, or $0.30 per basic and diluted share in the comparable period in 2017. Total research and development expenses were $17.9 million in the quarter, as compared to $14.8 million in the same period in 2017. Selling, general and administrative expenses were $24.1 million in the quarter, compared to $19.1 million in the same period in 2017.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $14.7 million, or $0.15 per basic and diluted share in the three-month period ended March 31, 2018, compared to non-GAAP net loss of $11.4 million, or $0.14 per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $17.1 million, as compared to $14.3 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $20.4 million, as compared to $15.7 million in the same period in 2017.

11500 S. Eastern Ave., Ste. 240 • Henderson, Nevada 89052 • Tel: 702-835-6300 • Fax: 702-260-7405 • www.sppirx.com • NASDAQ: SPPI

Conference Call
Thursday, May 3, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID# 8765418
International: (973) 796-5077, Conference ID# 8765418
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on May 3, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On May 3, 2018 Ferring Pharmaceuticals reported the signing of an agreement giving the company the option to secure global commercialisation rights to nadofaragene firadenovec/Syn3 (rAd-IFN/Syn3), a novel gene therapy being developed by FKD Therapies Oy (FKD) as a treatment for patients with high-grade non-muscle invasive bladder cancer (NMIBC), who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy (Press release, Ferring Pharmaceuticals, MAY 3, 2018, View Source [SID1234551851]). This option is exercisable on marketing approval from the US FDA. Ferring will create a new US oncology division with the specialist knowledge and presence to introduce novel advanced therapies to the market.

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rAd-IFN/Syn3 is currently undergoing Phase 3 development in the US under the sponsorship of Finnish gene therapy specialists FKD. The results of the earlier Phase 2 trial, published in the Journal of Clinical Oncology, reported 35% of BCG unresponsive NMIBC bladder cancer patients given one dose of rAd-IFN/Syn3 every three months, were free of high-grade disease at one year1. The ongoing Phase 3 study is designed to establish the efficacy and safety of the product. rAd-IFN/Syn3 has been awarded Fast Track and Breakthrough Therapy designations by the FDA.

"We are excited about the potential to commercialise rAd-IFN/Syn3, a novel gene therapy for bladder cancer patients," said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals. "The gene therapy sector is growing rapidly and building a presence in this specialised area is a very positive opportunity for Ferring."

Bladder cancer is one of the most frequently occurring cancers with an estimated 430,000 new cases being reported worldwide each year2. It is the fourth most common cancer in men in the US3 and is the most expensive cancer to treat on a life-time basis, with a high burden on patients, their relatives and healthcare systems4. In high-grade NMIBC patients, BCG is the gold standard treatment and although effective, over 60% of cases eventually re-occur5, 6. The outcome for such patients is poor, with total cystectomy (complete removal of the bladder) to prevent the cancer spreading to other organs generally being the next treatment option. As such, the BCG unresponsive population is one of high unmet clinical need.

"Today, bladder cancer patients have very limited medical options and new treatments that delay or prevent total removal of the bladder and improve clinical outcomes are urgently needed for patients," said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. "Phase 2 clinical results for rAd-IFN/Syn3 were very encouraging and we look forward to the Phase 3 data."

Gene therapy is one of a new class of therapeutic treatments known as advanced therapy medicinal products. rAd-IFN/Syn3 is built on adenoviral vector technology, a non-integrating vector, and results in enhanced expression of the therapeutic protein interferon alfa 2b. To date, it has completed three clinical trials in the US.

About rAd-IFN/Syn3

rAd-IFN/Syn3 (nadofaragene firadenovec/Syn3) is an investigational gene therapy consisting of an adenovirus containing the gene interferon alfa-2b. It is administered by catheter into the bladder, where the virus enters the cells of the bladder wall. Inside the cells, the virus breaks down leaving the active gene to do its work. The internal gene/DNA machinery of the cells picks up the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach turns the patient’s own bladder wall cells into multiple interferon microfactories, enhancing the body’s natural defences against the cancer. The Phase 3 trial for rAd-IFN/Syn3 opened in 2016 with up to 150 patients to be enrolled across 35 centers in the US.

On May 3, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported an exclusive licensing agreement with The University of Texas MD Anderson Cancer Center for intellectual property related to certain methods of use of poziotinib (Press release, Spectrum Pharmaceuticals, MAY 3, 2018, View Source [SID1234526013]).

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"We have been aggressively pursuing the potential of exon 20 mutations and treatment with poziotinib since the inception of our relationship with MD Anderson, but we’ve both only begun to scratch the surface of the science and poziotinib’s potential as a targeted treatment for various solid tumors," said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. "Late-stage poziotinib clinical data targeting the exon 20 mutations are promising, and we are thrilled to enter this new agreement that strengthens and potentially extends our patent protection until 2037 as we continue this journey of discovery together."

"Dr. John Heymach and his Lung Cancer Moon Shot team uncovered the potential of Spectrum’s drug poziotinib to help a neglected group of lung cancer patients and then worked closely with the company to bring this targeted therapy to clinical trial rapidly," said Ferran Prat, Ph.D., J.D., MD Anderson senior vice president, research administration and industry relations. "We are delighted to continue our collaboration with Spectrum under this agreement, which highlights how MD Anderson allies with private sector partners to provide new options for cancer patients."

Under the terms of the agreement, Spectrum has been granted a license that includes rights to filed patents related to exon 20 as well as any unidentified discoveries related to the use of poziotinib that may come from Dr. Heymach’s lab at MD Anderson in the future. The filed patents, if granted, are expected to extend the intellectual property protection to 2037. This agreement with MD Anderson further solidifies and extends Spectrum’s intellectual property protection for poziotinib.

About Poziotinib

Poziotinib is a novel, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.