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H1 2016 Results

On July 28, 2016 AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience reported financial results for the first half of 2016 and second quarter ended June 30, 2016 (Press release, AstraZeneca, JUL 28, 2016, View Source [SID:1234514093]).

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Q2 2016
Total worldwide product sales for the second quarter of 2016 was $ 5,469 million USD in comparison to that of 5,836 million USD for the second quarter of 2015. Total oncology product sales increased from $ 707 million USD in the second quarter of 2015 to $848 million USD in the second quarter of 2016.
Regional sales for the second quarter of 2016 equated to; US – $ 1,963m USD, Europe -$ 1,249 m USD, Established ROW- $ 809 m USD and Emerging markets – $ 1,448m USD. Total regional sales of oncology products were; US- $ 227 m USD, Europe – $ 179 m USD, Established ROW – $ 202 m USD and $ 240 m USD in Emerging Markets.

For AstraZeneca’s detailed H1 and Q2 2016 report, visit: View Source

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H1 2016 Results

H1 2016
Total worldwide product sales for the first half of 2016 was $ 11,034 million USD in comparison to that of 11,584 million USD for the first half of 2015. Total oncology product sales increased from $ 1,381 million USD in the first half of 2015 to $ 1,586 million USD in the first half of 2016.
Regional sales for the first half of 2016 equated to; US – $ 4,209m USD, Europe -$ 2,467m USD, Established ROW- $ 1,445m USD and Emerging markets – $ 2,913m USD. Total regional sales of oncology products were; US- $ 417 m USD, Europe – $ 345 m USD, Established ROW – $ 363 m USD and $ 461 m USD in Emerging Markets.

Q2 2016
Total worldwide product sales for the second quarter of 2016 was $ 5,469 million USD in comparison to that of 5,836 million USD for the second quarter of 2015. Total oncology product sales increased from $ 707 million USD in the second quarter of 2015 to $848 million USD in the second quarter of 2016.
Regional sales for the second quarter of 2016 equated to; US – $ 1,963m USD, Europe -$ 1,249 m USD, Established ROW- $ 809 m USD and Emerging markets – $ 1,448m USD. Total regional sales of oncology products were; US- $ 227 m USD, Europe – $ 179 m USD, Established ROW – $ 202 m USD and $ 240 m USD in Emerging Markets.

For AstraZeneca’s detailed H1 and Q2 2016 report, visit: View Source

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Supplemental Application Filed for Somatuline® in Japan for Additional Indication of Neuroendocrine Tumors

On July 28, 2016 Ipsen (Euronext: IPN; ADR: IPSEY) and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, reported that Teijin Pharma has filed a supplemental application with Pharmaceuticals and Medical Devices Agency to use Ipsen’s subcutaneous drug Somatuline (lanreotide) for the treatment of neuroendocrine tumors (NETs) (Press release, Ipsen, JUL 28, 2016, View Source [SID:1234514143]). The drug is currently available in Japan as a treatment for acromegaly and pituitary gigantism.

Ipsen and Teijin Pharma are confident that Somatuline will provide a beneficial treatment option for patients in Japan with neuroendocrine tumors.

The application is supported by CLARINET, an investigational, Phase III randomized, double-blind, placebo-controlled study which assessed the antiproliferative effects of Somatuline 120mg in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) which was conducted across 14 countries in Europe and the USA. Treatment with Somatuline 120 mg achieved statistically significant prolongation of progression free survival over placebo in patients with GEP-NETs. The safety profile observed in the study is consistent with the known safety profile of Somatuline. CLARINET has been the basis of the approval of an indication for the treatment of gastroenteropancreatic NETs (GEP-NETs) in more than 40 countries, including the US and EU countries. The results complement the effects of Somatuline on existing indications relating to reduction of symptoms associated with NETs. The supplemental application submitted to the Pharmaceuticals and Medical Devices Agency is also based on results of the J-001 Phase II trial for NETs that Teijin Pharma has conducted in Japan.

About Neuroendocrine Tumors

Neuroendocrine cells, which release hormones, are widely distributed throughout the human body. Neuroendocrine tumors (NETs) are rare, slow growing cancers that can arise anywhere in the body, but most commonly occur in the gastrointestinal tract, lung or pancreas. NETs are often diagnosed at a late stage because the symptoms, if any, lack specificity. In some patients, hormones secreted from NETs can cause problems, such as abdominal pain, flushing, diarrhea or pulmonary symptoms, such as wheezing. NETs can spread to other organs of the body and can cause severe co-morbidities and also significantly decrease life expectancy.
The first choice of NET treatment is removal by surgery, but if this is not possible, or if a tumor returns following surgery, another option is treatment with drugs to inhibit tumor growth and/or reduce the associated symptoms. Currently there are limitations in the types of NET patients who can be treated, depending on the location and the grading of the primary tumor, so there is an unmet medical need for new medicines that can be prescribed for a wider variety of NET patients.

Jazz Pharmaceuticals and Pfenex Enter into a Worldwide License and Option Agreement Related to Product Candidates in Early Development for Hematological Malignancies

On July 28, 2016 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Pfenex Inc. (NYSE MKT: PFNX) reported an agreement under which Pfenex granted Jazz Pharmaceuticals worldwide rights to develop and commercialize multiple early stage hematology product candidates (Press release, Jazz Pharmaceuticals, JUL 28, 2016, View Source [SID:1234514100]). The agreement also includes an option for Jazz Pharmaceuticals to negotiate a license for a recombinant pegaspargase product candidate with Pfenex. This early development stage collaboration demonstrates Jazz Pharmaceuticals’ focus on identifying innovative technologies that may lead to the development of important therapeutic options for patients with hematological malignancies.

Under the agreement, Pfenex will receive upfront and option payments totaling $15 million and may be eligible to receive additional payments of up to $166 million based on the achievement of certain development-, regulatory-, and sales-related milestones, including up to $41 million for certain non-sales-related milestones. Pfenex may also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration. Both parties will be contributing to development efforts.

"The collaboration with Pfenex, including access to its unique protein expression technology, demonstrates our emphasis on diversifying and strengthening our portfolio to provide improved therapeutic options for patients." said Karen Smith M.D., Ph.D, global head of research and development and chief medical officer at Jazz Pharmaceuticals plc. "We look forward to working with Pfenex on the development of multiple product candidates that have the potential to broaden our hematology/oncology portfolio."

"Our collaboration with Jazz further validates Pfenex’s product development capability enabled by our protein expression platform technology. We look forward to working with Jazz on these assets in support of further advancement in clinical development," said Bertrand C. Liang, chief executive officer of Pfenex.

Pfizer and Western Oncolytics Announce Immuno-Oncology Research Collaboration to Investigate Novel Oncolytic Virus Technology

On July 28, 2016 Pfizer Inc. (NYSE:PFE) and Western Oncolytics reported that they have entered into a development collaboration, license and option agreement to advance Western Oncolytics’ novel oncolytic vaccinia virus, WO-12 (Press release, Pfizer, JUL 28, 2016, View Source [SID:1234514099]).

Oncolytic viruses are viruses engineered to kill cancer cells while sparing healthy cells, which subsequently elicits anti-cancer immune responses. This collaboration in oncolytic virus development adds another novel technology platform to Pfizer’s cancer vaccine efforts and provides an additional tool to bolster its immuno-oncology portfolio.

Under the terms of the agreement, Pfizer and Western Oncolytics will collaborate on preclinical and clinical development of WO-12 through Phase I trials. Following completion of Phase I trials, Pfizer has an exclusive option to acquire WO-12. Financial terms of the agreement were not disclosed.

"Our goal is to combine WO-12 with our portfolio of promising investigational immunotherapies to explore how these novel combinations could help further enhance the body’s immune response in fighting cancer cells," said James Merson, Ph.D., Chief Scientific Officer, Vaccine Immunotherapeutics at Pfizer. "We believe that the real advances in immuno-oncology will come from novel combinations, and cancer fighting viruses and vaccines could play a key role in helping transform cancer treatment and potentially enable us to treat more patients."

WO-12 is a preclinical investigational oncolytic virus. As an in vivo vaccine, it has the potential to be delivered directly to the tumor (intratumoral) or intravenously. More specifically, it is a virus engineered to replicate primarily in cancer cells while delivering several therapeutic genes that modulate the immune system to enhance efficacy against a range of cancers. By replicating inside cancer cells, it is designed to both kill the cancer cell and releases tumor antigens that direct the immune system to recognize the antigens and kill additional cancer cells. WO-12 has potential applications across multiple tumor types.

"We believe this collaboration will create a unique opportunity to accelerate and expand the clinical testing of WO-12 as well as to examine potential combinations with other immunotherapies in the Pfizer portfolio," said Steve Thorne, PhD, Chief Scientific Officer of Western Oncolytics and inventor of WO-12.

Kurt Rote, CEO of Western Oncolytics, added, "We have been very impressed with the expertise and commitment to success from everyone at Pfizer, and are excited to be partnering this promising therapy with a shared vision of improving the way patients are treated."