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.

On July 11, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS) (Press release, CytRx, JUL 11, 2016, View Source;p=RssLanding&cat=news&id=2184496 [SID:1234513826]).

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In accordance with the FDA-granted special protocol assessment, the current analysis occurred following 191 progression events. Because enrollment was interrupted by a partial clinical hold in November 2014, this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase 3 study after the hold was resolved and enrollment resumed. This resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation. CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints. The Company expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the Food and Drug Administration (FDA) in the fourth quarter of 2016. The partial clinical hold was related to a single patient enrolled in a compassionate use study, which was subsequently resolved successfully.

For the current evaluation, the study did not show a significant difference between aldoxorubicin and investigator’s choice therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study’s primary endpoint (hazard ratio: 0.91). However, the most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease ≥ 4 months), showed a near doubling in the aldoxorubicin arm compared to investigator’s choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator’s choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.

"While results from this current analysis are immature, a near doubling of response rates with aldoxorubicin suggests a highly active therapy which may benefit certain patients with soft tissue sarcoma," said Sant Chawla, M.D., F.R.A.C.P., Principal Investigator and the Director of the Sarcoma Oncology Center in Santa Monica, California. "Because enrollment was interrupted by a clinical hold, both PFS and response data need to be analyzed at a future date to account for patients enrolled later in the trial. I look forward to this subsequent analysis providing a more complete understanding of aldoxorubicin’s potential in this very challenging disease."

Treatment-related adverse events for aldoxorubicin were consistent with those observed in prior studies. Aldoxorubicin was not associated with clinically significant cardiac, kidney or liver toxicities. The Company plans to present updated results of the study at an upcoming medical meeting.

"The complexity, in terms of tumor diversity and primary location, makes soft tissue sarcoma extremely difficult to treat, especially in the relapsed and refractory setting, resulting in few treatment advances over the last four decades," said Daniel Levitt, M.D., Ph.D., Executive Vice President and Chief Medical Officer of CytRx. "This first-of-its-kind study in STS included a comparator arm with multiple regimens, allowing for treatments to be matched to specific sarcoma subtypes. Despite a requirement for this challenging study design, aldoxorubicin demonstrated markedly greater activity over investigator’s choice therapy. That said, the unforeseen clinical hold that interrupted this study impacted the outcome of the current evaluation, underscoring a need for a subsequent analysis."

"In over 550 patients treated to date, aldoxorubicin has demonstrated anti-tumor activity in multiple tumor types and has shown a manageable safety profile," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "With approximately $68.2 million in cash and equivalents as of our last 10-Q filing, CytRx is funded through the next Phase 3 STS trial analysis and through a readout of our global Phase 2b trial of aldoxorubicin in small cell lung cancer. We are deeply grateful for the continued support and commitment of the patients, their families, the investigators and clinical support professionals participating in the Phase 3 trial."