On August 22, 2016 Pfizer Inc. (NYSE:PFE) and Medivation, Inc. (NASDAQ:MDVN) reported that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion (Press release, Pfizer, AUG 22, 2016, View Source [SID:1234514656]). The Boards of Directors of both companies have unanimously approved the merger, which is expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter. Pfizer does not expect the transaction to impact its current 2016 financial guidance. Schedule your 30 min Free 1stOncology Demo! "The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer," said Ian Read, chairman and chief executive officer, Pfizer. "The addition of Medivation will strengthen Pfizer’s Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value."
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Medivation’s portfolio includes XTANDI (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. XTANDI is the leading novel hormone therapy in the United States today and generated approximately $2.2 billion in worldwide net sales over the past four quarters, as recorded by Astellas Pharma Inc., with whom Medivation entered an agreement in 2009 to develop XTANDI globally and commercialize jointly in the U.S. Since its approval for advanced metastatic prostate cancer by the U.S. Food and Drug Administration in 2012, XTANDI has treated 64,000 men to date in the U.S. alone. Medivation and Astellas have built a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.
In addition, Medivation has a promising, wholly-owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib, currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors. Pidilizumab is an immuno-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies and has the potential to be combined with IO therapies in Pfizer’s portfolio.
"We believe the combination with Pfizer is the right next step in our growth trajectory and is a testament to the passion and dedication by which the Medivation team has delivered on our mission to profoundly transform patients’ lives through medically innovative therapies," said David Hung, M.D., founder, president and CEO of Medivation. "This compelling transaction will deliver significant and immediate value to our stockholders and provides new opportunities for our employees as part of a larger company. We believe that Pfizer is the ideal partner to extend the reach of our blockbuster XTANDI franchise and take our promising, late-stage assets – talazoparib and pidiluzimab – to their next stages of development so that they can be made available to patients as quickly as possible."
"The proposed acquisition of Medivation will build upon Pfizer’s success with our IBRANCE (palbociclib) launch in HR+/HER2- metastatic breast cancer and with our strong immuno-oncology portfolio, and will transform Pfizer into a leading oncology company," said Albert Bourla, group president, Pfizer Innovative Health. "IBRANCE and XTANDI are anchor brands in breast and prostate cancer respectively, giving Pfizer leadership in two hormone-driven cancers. Similar to IBRANCE in the breast cancer setting, XTANDI is being explored for its potential to move from metastatic prostate cancer to treat earlier stages of non-metastatic prostate cancer. In addition, Medivation’s portfolio within prostate cancer and across diverse tumors will complement Pfizer’s broad IO portfolio. Finally, Medivation adds commercial scale to better compete with other top tier oncology companies in advance of the potential emergence of Pfizer’s IO pipeline expected in the next few years. Together, we believe Pfizer and Medivation can bring the full force of our combined research and resources to combat two of the most common cancers, as well as speed cures and make accessible breakthrough medicines to patients, redefining life with cancer."
Cancer remains the second leading cause of death in the U.S. and a "Top 10" killer worldwide. According to the American Cancer Society, breast cancer and prostate cancer are among the top three cancers by annual incidence in the U.S. There are several parallels between breast and prostate cancer, including the incidence of prostate cancer in the U.S., which is similar to that of breast cancer with approximately 280,000 cases per year.
Pfizer expects to finance the transaction with existing cash.
Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all of the outstanding shares of Medivation common stock for $81.50 per share, net to the seller in cash, without interest, subject to any required withholding of taxes. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Medivation common stock. The merger agreement contemplates that Pfizer will acquire any shares of Medivation that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the Third- or Fourth-Quarter 2016.
Pfizer’s financial advisors for the transaction were Guggenheim Securities and Centerview Partners, with Ropes & Gray LLP acting as its legal advisor. J.P. Morgan Securities and Evercore served as Medivation’s financial advisors, while Cooley LLP and Wachtell, Lipton, Rosen & Katz served as its legal advisors.
Author: [email protected]
Interim Report for Kancera AB (publ) Q2 2016 January 1 – June 30, 2016
On August 19, 2016 Kancera reported results for Q2 2016 January 1 – June 30, 2016 (Press release, Kancera, AUG 19, 2016, View Source;releaseID=1182172 [SID:1234514645]).
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As a consequence of the acquisition of the subsidiary Kancera Förvaltning AB on 2016-06-16, the present Interim Report, Q2 2016, is prepared in accordance with IAS 34 and related parts of the Annual Accounts Act. The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU and the Swedish Annual Accounts Act. The accounting of the parent company has been prepared in accordance with the Annual Accounts Act and the Swedish Financial Reporting Board’s recommendation RFR 2, including a number of new or revised standards, interpretations and improvements adopted by the EU and apply from 1 January 2016. The transition to the new accounting standards was voluntary and did not affect the income statement or balance sheet for the period January 1 – March 31, 2016 accounted for using the previous principles, or the comparison figures used below in the comments from the previous year regarding the parent company Kancera AB (for comparison between the accounting policies, see Note 1).
The period January to March 2016 in brief
R&D expenses for the period amounted to SEK 8.7m (SEK 8.8m) of which the second quarter constituted SEK 4.4m (SEK 4.6m).
Operating income for the period amounted to SEK -10.5m (SEK -10.4m) of which the second quarter constituted SEK -5.5m (SEK -5.4m).
Income after financial items for the period amounted to SEK -10.5m (SEK -10.3m) of which the second quarter constituted SEK -5.5m (SEK -5.4m).
Earnings per share for the period were SEK -0.10 (SEK -0.10) of which the second quarter constituted SEK -0.05 (SEK -0.05).
Cash flow from operating activities for the period amounted to SEK -9.4m (SEK -10.9m) of which the second quarter constituted SEK -3.1m (SEK -5.8m).
Equity as of June 30, 2016 amounted to SEK 71.1m (SEK 31.2m) or SEK 0.68 (SEK 0.30) per share. The equity/assets ratio as of June 30, 2016 was 86 percent (76 percent).
Cash and cash equivalents as of June 30, 2016 amounted to SEK 68.7m (SEK 25.4m). Unpaid share issue expenses amount to approximately SEK 2.2m.
Significant events during the period
Kancera has from the 1st of January 2016 extended the lease of the company’s laboratories within the Karolinska Science Park for three years through an agreement with Humlegården Fastigheter.
Kancera has provided an update of the small molecule patent portfolio.
– A patent covering small molecule PFKFB3 inhibitors has been approved in the USA.
– A patent application covering new chemical series in the HDAC6 project has been filed.
– An international patent application covering ROR inhibitors has been strengthened by adding examples of additional highly potent ROR inhibitors.
Kancera reported that the company has developed a new series of ROR inhibitors that show improved pharmaceutical properties which will allow preclinical studies of their effect on e.g. solid tumors. These results have prompted Kancera to concentrate the investments in the ROR project to small molecule inhibitors and terminate the product development of a ROR-based vaccine. Furthermore, Kancera reported results from the Fractalkine project showing that KAN0440567 after oral administration to mice effectively blocks the function of the Fractalkine receptor.
Kancera announced that the company according to plan has received another payment of about SEK 2.8 million in January, 2016 from the EU for the A-PARADDISE project, which aims to develop drugs against parasitic diseases.
Kancera reported that ROR inhibitors have been tested against human triple negative breast cancer transferred to zebra fish. The experiments showed that Kancera’s small molecule ROR inhibitors are able to both reduce tumor size and metastases (spread) of this aggressive tumor form. Further, Kancera reported that the company´s PFKFB3 inhibitors are active in the same model of triple negative breast cancer and that a patent application has been filed covering the discovery that PFKFB3 inhibitors enhance the effect of radiation treatment.
Kancera reported that the Company due to positive efficacy data in disease models of cancer and pain has decided to exercise the exclusive option to acquire the Fractalkine project. The acquisition will be carried out in connection with the completion of the ongoing transfer of results and know-how from Acturum and AstraZeneca to Kancera. Payment for the project to Acturum Life Science AB will be made into three steps by a total of 6 million shares, of which the first payment is due at the submission of the application for authorization of a clinical trial after an approval by Kancera´s shareholders. In parallel, the company intends to validate a broader use of the drug candidate (KAN0440567) in order to demonstrate its full commercial potential.
With the authorization of the extraordinary general meeting on 22 April 2016, Kancera AB carried out an issue of units with preferential rights for the shareholders, as well as an issue of units in the form of over-allotment space through a separate directed share issue without preferential rights. The rights issue, which was fully subscribed in May 2016, concerned 20,785,072 units and an over-allotment space of 4,000,000 units consisting of one share and one warrant at a price of SEK 2.50 per unit. On top of this compensation to underwriters and financial advisors was added. After registration of the issuance of the over-allotment option and compensation to underwriters and financial advisors, the number of shares in Kancera AB amounts to 131,486,720 and the number of warrants to 27 561 356. The new issue has brought Kancera AB approximately SEK 61.9 million before issue costs. The issue assets will be used for Kancera’s drug development, clinical studies and the further development of the Company’s capacity to commercialize products. The majority of Kancera’s resources are now concentrated on taking at least one of Kancera’s drug candidates in the ROR and Fractalkine projects to clinical trial for chronic lymphocytic leukemia and pancreatic cancer, respectively. In parallel, the Company intends to validate a broader use of the drug candidates from these projects in order to demonstrate their full commercial potential.
Kancera provided the following operational update of the fractalkine and ROR projects:
– the Fractalkine antagonist KAN0440567 is able to eliminate pain resulting from inflammation of the pancreas. This type of pain is similar to the pain resulting from cancer in the pancreas and therefore these results support the continued development of KAN0440567 towards clinical trials against cancer.
– the ROR inhibitor KAN0439834 has been shown to effectively kill resistant cancer cells from the bone marrow of multiple myeloma (MM) patients. MM originates in the bone marrow and is an incurable chronic disease today. Further studies are now focused on translating these findings to effects in animal models of MM which will provide a basis for decisions on future clinical trials evaluating Kancera’s ROR inhibitors.
Kancera AB announced that VINNOVA has paid an additional SEK 358,451 to the HDAC6 project as part of the grant totaling SEK 2 million which has been designated by VINNOVA for the further development of Kancera’s HDAC6 inhibitors against cancer. This payment was made following the approval of Kancera’s third progress report for the project.
Kancera AB hereby announces that its subsidiary Kancera Förvaltning AB has been formed. The operations of the subsidiary include mainly financial management including Kancera’s stock option plan.
Significant events after the end of the reporting period
Kancera AB has not reported any significant events after the end of the period.
Xenetic Biosciences Announces FDA Acceptance of Investigational New Drug Application to Initiate Phase 2 Clinical Trial of Virexxa® in Endometrial Cancer
On August 19, 2016 Xenetic Biosciences, Inc. (OTCQB: XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that an Investigational New Drug (IND) application for the Company’s product candidate, Virexxa (sodium cridanimod), has been allowed to proceed by the U.S. Food and Drug Administration (FDA) (Press release, Xenetic Biosciences, AUG 19, 2016, View Source [SID:1234514655]). This enables Xenetic to initiate a Phase 2 clinical study of Virexxa in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy. The primary objective of the study is to assess the anti-tumor activity of Virexxa. Secondary objectives include assessment of additional efficacy, pharmacokinetic and safety/tolerability parameters. Further translational objectives are to observe the effect of Virexxa in combination with progestins, on the levels of progesterone receptor (PrR) and activated progesterone receptors (APrR) in tumor tissues. Schedule your 30 min Free 1stOncology Demo! "This IND clearance enables us to proceed with our Phase 2 study in endometrial cancer and represents a major step forward in our clinical development of Virexxa," stated Scott Maguire, CEO. "We believe Virexxa to be a next-generation therapeutic that has the potential to provide women with no additional treatment options a novel and effective therapy."
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Endometrial cancer is the most common malignancy of the female genital tract and represents a major health concern, as overall five-year survival rates have not improved over the past three decades. Annually in the United States, an estimated 60,050 patients are diagnosed with endometrial cancer and 10,470 deaths occur from this disease, representing 1.8% of all cancer deaths in the US. The incidence of endometrial cancer is on the rise with a lifetime risk of approximately 3% while the disease-specific mortality of endometrial carcinoma has been rising in the last 25 years. Endometrial cancer patients whose tumors no longer express progesterone receptors are not candidates for progestin-based therapy. Patients who fail monotherapy with progestins have no additional treatment options. Virexxa may improve sensitivity to progestin therapy in subjects with advanced or recurrent PrR-negative tumors.
About Virexxa
Virexxa is a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. Restoration of PrR expression may re-sensitize endometrial tumor tissue to progestin therapy in previously unresponsive tumors.
Virexxa is currently being studied in an ongoing Phase 2 multi-national study enrolling 58 subjects with documented evidence of progesterone receptor negative (PrR-negative) endometrial cancer as determined by tumor biopsy. This study is being conducted in conjunction with Pharmsynthez PJSC (St. Petersburg Russia) and its subsidiary AS Kevelt (Tallinn, Estonia). For more information on this Phase 2 study of Virexxa for the treatment of PrR-negative endometrial cancer, please visit www.clinicaltrials.gov and reference Identifier NCT02064725.
10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
Immunomedics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Immunomedics, AUG 18, 2016, View Source [SID1234514636]).
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Virogin Biotech Ltd. Joining Forces with Guangdong University of Technology, Establishing Joint Research Lab on Virotherapy
On August 18, 2016 Virogin Biotech Ltd. ("Virogin") reported its strategic collaboration with Guangdong University of Technology (GDUT) in China (Press release, Virogin Biotech, AUG 18, 2016, View Source [SID1234518864]).
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The first step of such collaboration is the Joint Research Lab on Virotherapy, which will be located in Institute of Biomedical and Pharmaceutical Sciences at GDUT. The Institute is a newly established faculty at GDUT equipped with brand new laboratories for translational research. The lab will focus primarily on oncolytic virology and cancer immunology, and is expected to be fully functional by October 2016.
Guangdong University of Technology is a key provincial university in Guangzhou, Guangdong, China. The university offers a wide range of courses in engineering, science, technology, management, liberal arts and law; and it has the privilege to confer Doctor’s, Master’s, and Bachelor’s degrees. It has played an active role in international scientific research and cultural cooperation and exchanges.
Guangdong University of Technology
The objectives of Virogin’s strategic collaboration with GDUT are 1) to facilitate and bridge the gap between academic research and industrial application; 2) to establish a platform for technical exchange and resource pooling; and 3) to further academic research and development by combining Virogin’s experience and expertise in the field with GDUT’s strong research capabilities and cutting-edge infrastructure.
Dr. Wen Tan, Dean of Institute of Biomedical and Pharmaceutical Sciences at GDUT, expressed his excitement and vision for the future of the joint lab, "Oncolytic virology and cancer immunology are the emerging trends in the biomedical world. As the Dean, it is my responsibilities to provide our students with the most up-to-date knowledge and exposure. As for our partner, Virogin Biotech is a very promising company in this field with a strong R&D team and an experienced management team. Its CSO Dr. William Jia is not only one of the pioneers in the field of oncolytic virology with over 20 years of research experience, but also the ideal person to facilitate such collaboration, because as a professor at UBC he would be able to better understand and bring together academia and industry. Ultimately through our collaboration with Virogin Biotech, we wish to establish a world-class research facility in virotherapy."
Virogin Biotech’s Co-founders – CSO Dr. William Jia and CEO Mr. Chris Huang also indicated their high expectation for the collaboration, "Guangdong University of Technology is a well-known and well-respected university in China that also actively involves in international scientific research collaboration. The Institute of Biomedical and Pharmaceutical Sciences, despite being new, has very strong research capabilities with state-of-the-art research facilities and infrastructure. With our company’s active involvement, we expect to pool resources together, while sharing our years of experience and expertise in oncology and virotherapy. We’ve already recruited several talented PhDs globally to carry out post-doctoral studies in the field at this lab. We believe by combining our strengths, we will be able to achieve mutually beneficial outcomes; and ultimately, reaching significant scientific breakthroughs that would benefit the world."
Virogin‘s Co-founders Dr. William Jia and Mr. Chris Huang, accompanying Dr. Wen Tan, Dean of GDUT’s Institute of Biomedical and Pharmaceutical Sciences, at Dr. Jia‘s research lab at UBC.