Article Listing - Important decision for the biotech industry from UK Supreme Court
EU Commission fines Lundbeck and other Pharmas over "pay-for-delay" deals
19 June 2013
In a much awaited decision following its investigations of patent settlements (or pay-for-delay deals) between pharmaceutical companies and generic drugmakers started in 2008, the European Commission revealed today (June 19) that it has imposed a fine of 93.8 million euros ($125 million) on Danish pharmaceutical company Lundbeck (LUND: CO) and fines totalling 52.2 million euros on several producers of generic medicines.
Mixed results for AstraZeneca/B-MS' Onglyza; Newron's safinamide does well in PD
19 June 2013
Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb have announced mixed top-line results of the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of diabetes drug Onglyza (saxagliptin).
Actavis and Kissei file law suits against Sandoz and Hetero over Rapaflo patent
19 June 2013
USA-based Actavis (NYSE: ACT), itself predominantly a generic drug marketer, and Japan's Kissei Pharmaceutical confirmed that they have filed law suits against Swiss drug major Novartis' (NOVN: VX) Sandoz unit and India's Hetero in the US District Court for the District of Delaware for infringement of US Patent No 5,387,603 covering Rapaflo (silodosin), a treatment for the signs and symptoms of benign prostatic hyperplasia (BPH).
Protalix BioTherapeutics enters Gaucher drug Uplyso deal with Brazil's Ministry of Health
19 June 2013
Israel-based Protalix BioTherapeutics (TASE:PLX) has entered into a supply and technology transfer agreement with Fundacao Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health for Uplyso (alfataliglicerase), the company's proprietary enzyme replacement therapy for the treatment of Gaucher disease.
Royalty pulls plug on Elan buy (for now?); analysts' view on what comes next
19 June 2013
In the ongoing hostile takeover saga, US private equity firm Royalty Pharma has withdrawn its request for a judicial review of the Irish Takeover Panel's decision requiring it to lapse its offer for drugmaker Elan Corp (NYSE: ELN) oration, if, among other things, Elan shareholders approved the Share Repurchase Program (The Pharma Letter June 18).
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.
- FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv
- Negative US patent ruling for Novo Nordisk on Prandin
- Aspen Pharma offers to buy GlaxoSmithKline's thrombosis brands and manufacturing site
- US Supreme Court says patent settlement can "sometimes" be illegal
- Daiichi Sankyo files for Japanese approval of Prasugrel
