DARA BioSciences Announces Stockholder Approval of Merger With Midatech
/EINPresswire.com/ -- RALEIGH, NC--(Marketwired - December 02, 2015) - DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment, today announced that its stockholders have approved the adoption of the previously announced merger agreement by and among DARA, Midatech Pharma PLC ("Midatech") and certain other parties thereto.
Pursuant to the merger agreement, upon completion of the contemplated merger, DARA will become a wholly owned subsidiary of Midatech.
The merger remains subject to customary closing conditions and is expected to close in the next week.
About DARA BioSciences, Inc.
DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments.
DARA holds exclusive U.S. marketing rights to Gelclair® oral rinse gel, Oravig® (miconazole) buccal tablets and Soltamox® (tamoxifen citrate oral liquid solution). DARA licensed the U.S. rights to Gelclair from the Helsinn Group in Switzerland, Oravig from Onxeo S.A. in France, and Soltamox from Rosemont Pharmaceuticals, Ltd, a U.K. based manufacturer and a subsidiary of Perrigo Company, plc.
DARA partners with Alamo Pharma Services, a subsidiary of Mission Pharmacal, to deploy a dedicated 20-person national sales team in the U.S. oncology market. In addition to promoting DARA's products Gelclair, Soltamox, and Oravig, this specialized oncology supportive care sales team also provides clinicians with access to two Mission Pharmacal prescription products: Ferralet
Gelclair is an alcohol-free bio-adherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatment. Gelclair should not be used by patients with a known or suspected hypersensitivity to the product or any of its ingredients. For further information on Gelclair and the Full Prescribing Information please visit www.Gelclair.com.
Oravig is the first and only muco-adhesive buccal tablet formulation of miconazole approved to treat oropharyngeal candidiasis (OPC), also known as oral thrush, in adult patients in the United States. Oravig should not be used in patients with a known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product.
Soltamox (tamoxifen citrate oral liquid solution), the only liquid form of tamoxifen, is indicated for the treatment of metastatic breast cancer, the adjuvant treatment of node-positive breast cancer in premenopausal women, the reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS), and for the reduction of the incidence of breast cancer in women at high risk for breast cancer. Currently, there are more than 1.8 million prescriptions of tamoxifen written on an annual basis in the United States. Between 30 and 70 percent of patients fail to complete their prescribed course of treatment, thereby diminishing its benefits in reducing the risk of breast cancer recurrence.
Tamoxifen Important Safety Information
Tamoxifen citrate is contraindicated in women who require concomitant coumadin-type anticoagulant therapy, in women with a history of deep vein thrombosis or pulmonary embolus, and in women with known hypersensitivity to the drug or any of its ingredients.
Serious and life-threatening events associated with tamoxifen in the risk reduction setting women at high risk for cancer and women with DCIS include uterine malignancies, stroke and pulmonary embolism.
The most common adverse reactions to tamoxifen treatment are (incidence > 20%) hot flashes, fluid retention, vaginal discharge, vaginal bleeding, vasodilatation, nausea, irregular menses, weight loss, and musculoskeletal events.
Tamoxifen carries the following Boxed Warning:
WARNING -- For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.
*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing Information.
**See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies in Prescribing Information.
The full Prescribing Information for Soltamox is available at www.soltamox.com/prescribing-information.
DARA is focused on expanding its portfolio of oncology supportive care products in the United States, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a Fast Track Drug, and has granted DARA two separate Orphan Drug Designations for the treatment of multiple myeloma and for the treatment of painful CCIPN that is refractory to conventional analgesics.
For more information please visit our web site at www.darabio.com.
Safe Harbor Statement
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties. These statements are based on the current expectations, estimates, forecasts and projections regarding management's beliefs and assumptions. In some cases, you can identify forward looking statements by terminology such as "may," "will," "should," "hope," "expects," "intends," "plans," "anticipates," "contemplates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negatives of those terms. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in DARA's most recent Annual Report on Form 10-K, filed with the SEC on March 3, 2015, and DARA's other filings with the SEC from time to time. Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Gelclair, Oravig, Soltamox, or other products, DARA's ability to achieve the desired results from the agreements with Mission and Alamo, compliance with FDA promotional regulations and other regulatory risks relating to DARA's ability to market Gelclair, Oravig, Soltamox, or other products in the United States or elsewhere, the potential delisting of DARA's common stock from the NASDAQ Capital Market, the ability to consummate the merger with Midatech PLC, DARA's ability to in-license and/or partner products, the current regulatory environment in which DARA sells its products, the market acceptance of those products, DARA's ability to develop KRN5500 into an FDA-approved commercial product or otherwise successfully partner the product candidate, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property and the intellectual property of others and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.
DARA BioSciences Contact
Steve Silver
Senior Vice President
Rx Communications Group
917-322-2569
ssilver@RxIR.com
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