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Amgen Submits Applications In The US And Europe For Kyprolis® (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma

On January 27, 2015 Amgen and its subsidiary Onyx Pharmaceuticals reported on the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kyprolis (carfilzomib) for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy (Press release Amgen, JAN 27, 2015, View Source [SID:1234501397]). In the U.S., the sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. In the European Union (EU), Kyprolis received orphan drug designation and the MAA has been granted accelerated assessment.

The sNDA and MAA are based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of Patients with Relapsed Multiple MyEloma) trial and other relevant data.

“Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing,” said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals, Inc. “The U.S. and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma.”

Orphan designation is granted by the EMA for medicines intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of no more than five in 10,000. The intended medicine must aim to provide significant benefit to those affected by the condition.

Kyprolis is in a class of drugs called proteasome inhibitors and was granted accelerated approval by the FDA in 2012. Kyprolis is also approved for use in Argentina, Israel and Mexico.

Q4/Annual

Opdivo was first approved in July of 2014 in Japan for the treatment of unresectable melanoma and later in December the same year in the US or the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor (Press release Bristol-Myers Squibb, DEC 22, 2014, View Source [SID:1234501237]).

On January 27, 2015 Bristol-Myers Squibb reported accrued sales in US dollars for Opdivo during 2014 (Filing Q4/Annual , Bristol-Myers Squibb, JAN 27, 2015, View Source [SID:1234501395]):
USA: $1M
Non-US (Japan): $5M
Worldwide: $6M

Amatsigroup acquires Seps Pharma in Belgium

On January 26, 2015 AMATSIGROUP, the leading French supplier of services devoted to the development of both human and veterinary pharmaceutical products, reported the acquisition of Belgian company SEPS Pharma, which provides drug product development services, encompassing preformulation and formulation development, analytical drug product development, process development and clinical trial manufacturing (Press release, Amatsigroup, JAN 26, 2015, View Source [SID1234520755]). Founded in 2007 and located in Ghent, Belgium, SEPS Pharma counts a team of 30 highly-qualified people specialized in the development of innovative oral (liquid and solid dosage forms), inhalable and injectable formulations with acknowledged expertise in enhancing the bioavailability and controlling the drug release. With over 25 clients in Europe, US and Japan, the Belgian company recorded a 2014 revenue of €5 million.

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Provectus Biopharmaceuticals’ Novel Synthesis Patent Application Allowed by Chinese Patent Office

On January 26, 2015 Provectus Biopharmaceuticals reported that it has received notification of allowance from the Chinese Patent Office for its patent application protecting the synthetic process used to produce the small molecule Rose Bengal, the active pharmaceutical ingredient (API) in PV-10, the Company’s lead oncology drug candidate (Press release Provectus Pharmaceuticals, JAN 26, 2015, http://www.pvct.com/pressrelease.html?article=20150126.1 [SID:1234501388]).

The pending Chinese patent covers the same process as the one granted by the US Patent Office in September 2013, as U.S. Patent 8,530,675, "Process for the Synthesis of 4,5,6,7-tetrachloro-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenzofuran-1,9-xanthen]-3-one (Rose Bengal) and Related Xanthenes." The application details a new process for the manufacture of Rose Bengal and related iodinated xanthenes in high purity. The allowed claims cover the process under which pharmaceutical grade Rose Bengal and related xanthenes are produced, reducing the formation of certain previously unknown transhalogenated impurities that currently exist in commercial grade Rose Bengal in uncontrolled amounts. The requirement to identify and control related substances is in accordance with International Conference on Harmonisation (ICH) guidelines for manufacture of API suitable for phase 3 clinical trial material and commercial pharmaceutical use. Once issued later this year, the patent is expected to provide protection for Rose Bengal API to 2031 and covers any hypothetical process that controls the amount of transhalogenated impurities in Rose Bengal through the awarded Jepson style claims.

Eric Wachter, CTO of Provectus, stated, "The issuance of this patent will enhance the protection of our novel synthesis process for the manufacture of Rose Bengal covering the entire Chinese market. As we prepare to begin our phase 3 clinical trial for intralesional PV-10 as a treatment for melanoma and as we discuss with Chinese interests licensing PV-10 for other indications, it is important that we defend our intellectual property in this way. We are pleased that the Chinese authorities have been so helpful in this, and we will continue to protect our stockholders’ interests in this way as we seek out partners globally to further develop our product line."

Progenics Pharmaceuticals Relaunches Pivotal Trial of AZEDRA(TM) in Pheochromocytoma

On January 23, 2015 Progenics Pharmaceuticals reported that it has dosed the first subject in the resumed pivotal Phase 2 clinical study of Azedra in patients with malignant pheochromocytoma and paraganglioma (Press release Progenics Pharmaceuticals, JAN 23, 2015, View Source [SID:1234501379]). The trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). Progenics acquired Azedra, a novel targeted cancer radiotherapy, in conjunction with its 2013 acquisition of Molecular Insight Pharmaceuticals (MIP).

"Relaunching this study is a very important milestone for patients with metastatic and/or recurrent pheochromocytoma/paraganglioma," said Dr. Daniel Pryma, Associate Professor of Radiology and Clinical Director of Nuclear Medicine and Molecular Imaging at the University of Pennsylvania, a current investigator and lead investigator on the original trial. "This treatment has been generally well tolerated and the data emerging from the trial to date has been encouraging. I am pleased to be resuming this study and feel that Azedra could represent the best treatment in malignant pheochromocytoma/paraganglioma in the future."

The study is designed to evaluate the efficacy and safety of the administration of two therapeutic doses of Azedra in patients with malignant relapsed/refractory pheochromocytoma or paraganglioma, ultra-orphan cancers with limited treatment options. The primary objective of the study is to determine the clinical benefit of Azedra based on the proportion of study participants with a reduction of all antihypertensive medication by at least 50% for at least six months. The SPA requires that 25% of 58 evaluable patients achieve the primary endpoint.

In late 2010, MIP suspended enrollment in the trial to seek additional funding. The trial has now resumed to fulfill enrollment requirements under the SPA. The trial has treated 41 patients and 32% of those patients have achieved the primary endpoint. The most common adverse events observed have been gastroenterological and hematologic disorders.

"As a targeted cancer treatment, Azedra has the potential to improve outcomes in patients suffering from pheochromocytoma and paraganglioma," stated Mark Baker, CEO of Progenics. "We are focused on successfully completing this pivotal trial and look forward to completing patient enrollment by the end of 2015, building on the promising data seen to date, and advancing this promising candidate toward the marketplace."

Azedra has received Orphan Drug and Fast Track designations from the FDA.