Article Listing - Roche forms new biotech unit, BASILEA, for infectious diseases and

Athera and Boehringer Ingelheim enter option agreement on a novel therapy for atherosclerosis

19 June 2013

Sweden-based Athera Biotechnologies, which is 65% owned by Karolinska Development, has entered into an option agreement with Boehringer Ingelheim on a novel preclinical antibody program, whereby Athera grants the family-owned German drug major an exclusive option to acquire the entire program. Athera's fully-human monoclonal antibody is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death.

Curie-Cancer and Sanofi cooperate in research on ovarian cancer

19 June 2013

Carnot label, have established a three-year research collaboration to identify new therapeutic targets for the development of treatments for ovarian cancer. Financial terms of the accord were not disclosed.

FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv

19 June 2013

The US Food and Drug Administration yesterday (June 18) revealed it is investigating two unexplained deaths in patients who received an intramuscular injection of US drug major Eli Lilly's (NYSE: LLY) antipsychotic drug Zyprexa Relprevv (olanzapine pamoate), a formulation that can last two to four weeks as opposed to daily versions of Zyprexa (olanzapine), which had peak sales of round $5 billion before losing patent protection in 2011, but just $1.7 billion in 2012, compared with less than $60 million last year for the "Relprevv" version.

Aspen Pharma offers to buy GlaxoSmithKline's thrombosis brands and manufacturing site

19 June 2013

UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday (June 18) that it has received an offer for its thrombosis brands and Notre-Dame de Bondeville (NDB) site from Aspen Global and Aspen Pharmacare (JSE: APN), South Africa's largest drugmaker. A period of exclusivity has been agreed with Aspen and GSK will respond to the offer subject to consultation with employees and the relevant works councils.

Negative US patent ruling for Novo Nordisk on Prandin

19 June 2013

Denmark-based insulin giant Novo Nordisk (NOV: N) says that the US Court of Appeals for the Federal Circuit partially affirmed a 2011 District Court decision, with a two to one ruling that a claim in a company patent related to the use of repaglinide (trade name Prandin) in combination with metformin for the treatment of type 2 diabetes was invalid. This decision favors approval and launch of a generic repaglinide product.

Daiichi Sankyo files for Japanese approval of Prasugrel

18 June 2013

Japanese drug major Daiichi Sankyo (TYO: 4568) says that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for the antiplatelet agent prasugrel for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI). Analysts at Credit Suisse have a net present value for prasugrel of 78.19 yen per share (4% of total) for Daiichi Sankyo.

Genmab and ADC Thera link for antibody drug conjugate combining HuMax-TAC and PBD warhead

18 June 2013

Denmark's Genmab (OMX: GEN) and Switzerland-based ADC Therapeutics have entered an agreement to develop a new antibody-drug conjugate (ADC) product combining Genmab's HuMax-TAC antibody and ADC's PBD-based warhead and linker technology. The companies have been conducting in vitro and in vivo studies since 2012 to investigate different warhead and linker combinations with HuMax-TAC, and now have the product ready for pre-IND preclinical development. The product will be developed for multiple cancer indications.

Ipsen reports mixed Ph III results with Somatuline Autogel in patients with acromegaly

18 June 2013

French drugmaker Ipsen (Euronext: IPN) announced the results of an international Phase IIIb study, PRIMARYS, assessing an investigational use of Somatuline Autogel (lanreotide) 120mg as first line therapy in newly diagnosed acromegaly patients with a macroadenoma, reporting mixed results. Somatuline is already approved and marketed for acromegaly, and generated sales of 225 million euros ($300 million) in 2012.

AOP Orphan spins off stake in Activartis as Elan shareholders vote down acquisition

18 June 2013

In the wake of yesterday's shareholders vote against Irish drugmaker Elan Corp's (NYSE: ELN) planned $340 million acquisition of Austrian firm AOP Orphan (The Pharma Letter June 18), the latter announced the spinoff of its 80 % stake in Activartis GmbH, a Vienna-based biotech company with a strong platform for immune-based cancer vaccines, to a group of private investors.

US FDA accepts Ruconest filing from Santarus and Pharming

18 June 2013

US drugmaker Santarus (Nasdaq: SNTS) and Netherlands-based Pharming Group (NYSE Euronext: PHARM) say that the US Food and Drug Administration has accepted for filing the Biologics License Application for the investigational drug Ruconest (recombinant human C1 esterase inhibitor) 50IU/kg. Ruconest is approved in Europe for the treatment of acute angioedema attacks in patients with HAE.

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