On July 11, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a generic version of Merck’s Temodar (Press release, Mylan, JUL 11, 2016, View Source [SID:1234513811]). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

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Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, had U.S. sales of approximately $176.5 million for the 12 months ending May 31, 2016, according to IMS Health.

Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

On July 11, 2016 Celsion Corporation (NASDAQ:CLSN) reported that its ongoing Phase III OPTIMA trial evaluating ThermoDox in primary liver cancer, also known as hepatocellular carcinoma or HCC, was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting (Press release, Celsion, JUL 11, 2016, View Source [SID:1234513809]). ThermoDox is the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of HCC.

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Soo-Young Park, M.D., Associate Professor, Kyungpook National University, School of Medicine Division of Gastroenterology and Hepatology, delivered the presentation, titled, "Radiofrequency Ablation +/- Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) in Intermediate-Size Hepatocellular Carcinoma: The Ongoing Phase III OPTIMA Study." The OPTIMA Study is an ongoing global, pivotal, double-blind, placebo-controlled clinical trial evaluating ThermoDox in combination with Radio Frequency Ablation (RFA) standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The study was developed in consultation with leading primary liver cancer, statistical and regulatory experts, and is based on extensive analysis of prior clinical and preclinical studies of ThermoDox plus standardized RFA.

"The OPTIMA study represents an important study in the field of HCC, one of the most common and deadly cancers worldwide," said Dr. Park. "ThermoDox plus standardized RFA has the potential to significantly improve overall survival of newly diagnosed patients, and I look forward to working with my colleagues to further advance this trial."

"Data from the earlier HEAT Study suggest that not only does this approach potentially prolong survival, but may also serve as a curative treatment for HCC," stated Won Young Tak, M.D., Professor, Kyungpook National University, School of Medicine, Division of Gastroenterology and Hepatology. "If positive, this study could potentially establish ThermoDox plus standardized RFA as a first-line treatment for HCC."

In July 2015, Celsion reported the latest overall survival (OS) analysis of the HEAT Study post hoc subgroup. The OS analysis demonstrated that in a large, well bounded, subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox and standardized RFA (defined as RFA standardized to a minimum of 45 minutes or sRFA > 45 min) provided an average 58% improvement in OS compared to standardized RFA alone. The Hazard Ratio (HR) at this analysis was 0.63 (95% CI 0.43 – 0.93), with a p-value of 0.0198. In this large subgroup, median OS for the ThermoDox plus standardized RFA group translates into a 25.4 month (more than 2.1 year) survival benefit over the standardized RFA only group – totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox plus standardized RFA group versus 53.6 months for the standardized RFA only group.

"The strength of the preclinical and clinical data to date reinforces our confidence in the potential of ThermoDox in HCC and for a successful trial outcome," stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We are extremely encouraged with the investigators’ interest and enthusiasm for our approach. With the trial enrolling patients in 13 countries, and in 9 of up to 20 sites in the Peoples Republic of China, we remain focused on the efficient execution of the only active Phase III study in newly diagnosed HCC patients."

The OPTIMA Study

OPTIMA, a pivotal, double-blind, placebo-controlled Phase III clinical trial, is expected to enroll up to 550 patients at up to 75 sites in the North America, Europe, China and Asia Pacific. As of June 2016, the study has been successfully enrolling patients at more than 50 clinical sites in 13 different countries in North America, Europe and Asia Pacific. In December 2015, Celsion announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the OPTIMA Study at up to 20 additional clinical sites in China, the country where approximately 50% of the 850,000 new cases of primary liver cancer are diagnosed each year and where the Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.

The primary endpoint for the OPTIMA Study is overall survival (OS). The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC). The design of the OPTIMA Study is supported by the retrospective analysis of a large subgroup of 285 patients in the Company’s previous 701 patient HEAT Study in primary liver cancer. The study is also designed to establish a clear path to approval in major liver cancer markets worldwide, with results from the OPTIMA Study, if successful, providing the basis for a global registration filing and marketing approval.

About LTLD (ThermoDox)

Celsion’s most advanced program is a heat-mediated, tumor-targeting drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. In one of its most advanced applications, LTLD, when combined with radiofrequency thermal ablation (RFA), has the potential to address a range of cancers. For example, RFA in combination with ThermoDox has been shown to expand the "treatment zone" with a margin of highly concentrated chemotherapy when treating individual primary liver cancer lesions. The goal of this application is to significantly improve efficacy.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. The first: Rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, LTLD is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. The second: When an external heating device heats the tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that release the chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area related to tumor invasion, supporting precise drug targeting.

On July 11, 2016 AMRI (NASDAQ: AMRI) reported that it has completed the acquisition of Prime European Therapeuticals S.p.A., also known as "Euticals", a privately-held company headquartered in Lodi, Italy, specializing in custom synthesis and the manufacture of active pharmaceutical ingredients (APIs) (Press release, Albany Molecular Research, JUL 11, 2016, View Source [SID:1234513793]). This completes the transaction initially announced on May 5, 2016.

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The acquisition positions AMRI as one of the largest independent developers and suppliers of API to the pharmaceutical industry, and in particular, provides the company with an established custom synthesis presence in key European markets.

"We are delighted to have Euticals join the AMRI family as we create an industry leader in global contract research and manufacturing. Euticals’ API platform is a significant addition to AMRI’s capabilities, and we are excited about the future opportunities our company will have as a result of this pivotal acquisition," said William S. Marth, AMRI’s president and chief executive officer.

Mr. Marth added: "This significantly expands AMRI’s customer base, further diversifies our revenue streams, and moves us significantly closer to our goal of reaching $1 billion in annual revenues by 2018. The Euticals acquisition accelerates our company’s strategy to become a global, preeminent provider of contract research, development and manufacturing services to the pharmaceutical industry, while at the same time enhancing our ability to expertly serve our customers.

"As we prepare to celebrate AMRI’s 25th anniversary this year, the closing of this transaction is a timely achievement that I am confident will position AMRI for success over many years to come," concluded Mr. Marth.

AMRI financed the EUR 315 million transaction through the issuance of approximately 7.1 million shares of AMRI common stock (valued at signing), seller notes totaling EUR 55 million and the remainder in cash. In connection with the acquisition, AMRI secured $235 million in incremental borrowings under its existing Senior Secured Revolving Credit Facility, which bears interest at LIBOR with a floor of 1% plus 475 basis points, and repaid its $30 million revolving credit facility. AMRI intends to provide updated 2016 financial guidance, including the impact of the Euticals’ acquisition, in early August in conjunction with the company’s second quarter financial results.

The 7.1 million shares of AMRI common stock issued in connection with the transaction were offered and sold outside the United States to Lauro Cinquantesette S.p.A. (Lauro 57), the sole stockholder of Euticals and an eligible investor pursuant to Regulation S of the Securities Act of 1933, as amended. Such shares have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration under or an applicable exemption from such registration requirements. This press release does not constitute an offer to sell, or a solicitation of an offer to purchase, the shares in any jurisdiction in which such offer or solicitation would be unlawful.

Nomura acted as exclusive financial advisor to AMRI in connection with this transaction and Goodwin Procter LLP and LCA Studio Legale acted as AMRI’s legal advisors. Lincoln International acted as sole financial advisor to Lauro 57, and Chiomenti Studio Legale and Debevoise & Plimpton LLP acted as Lauro 57’s legal advisors.

On July 11, 2018, as part of its business strategy to build a meaningful and differentiating presence in Global Oncology Therapy market, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) reported the roll-out of Gemcitabine InfuSMART in Europe (Press release, Sun Pharma, JUL 11, 2016, View Source [SID1234525572]). InfuSMART is a technology in which oncology products are developed in a Ready-To-Administer (RTA) bag. Until now, compounding of oncology products was done at compounding centres or compounded in hospital pharmacies, an extra step before the medicine can be administered to patients. With the roll-out of Gemcitabine InfuSMART, Sun Pharma becomes world’s first pharmaceutical company to manufacture and launch a licensed RTA oncology product. This innovatively differentiated product will have a shelf life of two years. Over the next few months, Sun Pharma will launch Gemcitabine InfuSMART across Netherlands, UK, Spain, Germany, Italy & France.

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Sun Pharma received regulatory approval to produce Gemcitabine InfuSMART in eight key SKUs. The InfuSMART concept involves dose banding practice whereby, through agreement between prescribers and pharmacists, standardized doses of intravenous cytotoxic drugs are used for ranges (or ‘bands’) of doses calculated for individual patients. More InfuSMART oncology products are currently in Sun Pharma’s pipeline to be rolled out in the future.

Commenting on the roll-out of InfuSMART in Europe, Ms Hellen de Kloet, Business Head – Western Europe & ANZ, Sun Pharma said, "Sun Pharma’s Gemcitabine InfuSMART ready-to-administer infusion products provide the combined advantage of long stable compounded medicine along with safety. Its ready availability for treatment can make a difference to the healthcare worker and patients. Traditionally such medicines are compounded at hospitals (in-house) or outsourced to compounding pharmacies making it a time-consuming and potentially hazardous process. Launch of InfuSMART will help us remain a meaningful player in the global oncology therapy market by offering differentiating cancer treatment solutions. We believe there are opportunities for us to expand our portfolio of ready-to-administer products across multiple therapies where time and safety are an important element of treatment."

The NHS (UK) has been encouraging development of licensed RTA products. It has issued guidelines for hospitals for procuring such medicines. The launch of Gemcitabine InfuSMART offers Sun Pharma a definite first-mover advantage in Europe for cancer treatment. The Gemcitabine InfuSMART RTA infusion bag is developed at Sun Pharma’s R&D centre in India.

According to WHO, cancer figures amongst the leading causes of morbidity and mortality worldwide, with approximately 14 million new cases and 8.2 million cancer related deaths in 2012. The number of new cases is expected to rise by about 70% over the next two decades. Among men, the five most common cancers diagnosed in 2012 were lung, prostate, colorectum, stomach, and liver cancer. Among women the five most common cancers diagnosed were breast, colorectum, lung, cervix and stomach.