Accord

Intas Recent Acquisition

Intas recent acquisition Intas Pharmaceuticals Ltd., through its wholly owned subsidiary Accord Healthcare Ltd., announced today that it has entered into definitive agreements to acquire Actavis UK Ltd. & Actavis Ireland Ltd. from Teva Pharmaceutical Industries Ltd. The transaction is part of the European Commission’s anti-trust divestiture requirements arising from Teva’s acquisition of Actavis Generics.

This transaction represents a unique opportunity for Intas to build scale in the UK & Ireland - adding to the company’s market leading hospital franchise - and creates a strong platform for further European expansion. Additionally, this acquisition will make Accord a leading generics player in the UK market.

The transaction is only subject to regulatory approval, which is expected to be provided in the next three months, with completion following shortly thereafter.

The European Medicines Agency adopted a positive opinion for Accofil™ marketing authorization

The European Medicines Agency´s Committee for Medicinal Products for Human Use (EMA/CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Accofil™ (filgrastrim), a biosimilar medicine intended for the treatment of neutropenia from Accord Healthcare.

Accofil™ 30 and 48 MU, solution for injection/infusion in pre-filled syringe is intended for the treatment of neutropenia. Neutropenia is a granulocyte disorder characterized by an abnormally low number of neutrophils. Neutrophils usually make up 50-70% of circulating white blood cells and serve as the primary defense against infections by destroying bacteria in the blood. The active substance of Accofil™ is filgrastrim, an immunostimulating medicinal product (L03AA02) which regulates the production and release of functional neutrophils from the bone marrow.

Accofil™ is a biological medicinal product similar to the reference product Neupogen® authorised in the EU. Studies have shown Accofil™ to have a comparable quality, safety and efficacy profile to Neupogen® (filgrastrim).

Accord Healthcare prevails in Spain in the case against AstraZeneca relating to the invalidity of the patent covering quetiapine ER (Seroquel®).

On the 28th of October, the Barcelona Court of Appeal has revoked AstraZeneca’s patent on Quetiapine ER in Spain.

In July 2012 the Commercial Court N.2 of Barcelona upheld the validity of EP907364 patent on Quetiapine ER. The Barcelona Court of Appeal has now overturned the previous decision and has declared that the patent is invalid due to the lack of inventive step. The Court of Appeal has found that the claim for sustained released formulation on Quetiapine is obvious.

UK Appeals court Confirms invalidity of Quetiapine SR Patent

Judgment in the case was handed down by the Court of Appeal on the 30th of April and confirms the decision of the UK High Court in March 2012 that AstraZeneca’s patent is invalid, allowing Accord Healthcare UK to launch its generic version of Seroquel®.

The decision to fight this action is vindicated by the Court’s judgment and means that the over 5 million patients in the UK with serious mental illnesses such as schizophrenia and bipolar disorder now have better access to a more convenient and effective medicine. Accord will continue to actively extend the number of products that are brought to market and this decision is a reminder of the hurdles faced by generic companies in commercializing products in Europe.

The Seroquel®brand, AstraZeneca's second-best seller behind cholesterol drug Crestor®, accounted for 17 percent of the company's sales of $33.6 billion in 2011. Sales of Seroquel XR® were $1.49 billion or 4.4 percent of total revenue.

To access the decision, follow this link: http://www.bailii.org/ew/cases/EWCA/Civ/2013/454.html

German patent court decision on Quetiapine Tablets

Upon request of Accord Healthcare, Teva and Hexal the Federal Patent Court invalidated AstraZeneca’s patent EP (DE) 0 907 364, which was for a sustained release formulation of an anti-psychotic drug Quetiapine(marketed as Seroquel XR). After the decision Astra Zeneca renounced on the further enforcement of several interim injunctions that had been granted on the basis of the AstraZeneca patent against generic companies by the Düsseldorf court in May 2012.

The decision of the Federal Patent Court follows a series of other decisions in Europe dealing with the validity of the AstraZeneca patent. The results have been mixed: In Spain and the Netherlands the patent was upheld, in UK the patent was invalidated.

The Federal Patent Court invalidated the patent for lack of inventive step. The reasoning that was just issued by the Federal Patent Court is similar to the reasoning of the UK High Court.

The Federal Patent Court found that it was clear from the prior art (e.g. Gefvert) that a once daily administration of an immediate release formulation of Quetiapine was not sufficient to ensure an effective treatment. The person skilled in the art was motivated to consider an SR formulation since he could assume that such formulations would not only reduce the frequency of administration but also improve patience compliance and lead to a constant plasma level of the active agent which is a particular important clinical advantage. Formulating the Quetiapine using a gelling agent was obvious to try and just required routine tests. The Federal Patent Court rejected the argument of the patentee that certain specific properties of Quetiapine would have deterred the skilled person from considering an SR formulation of Quetiapine. According to the Court there are no hints in the patent specification that such problems indeed existed and had to be solved by inventive activity.

The above written reasoning follows the ruling already announced in November 2012.

The decision of the Federal Patent Court is not yet final and binding, but can still be appealed by AZ.

To read the written decision, please follow the link: http://www.eplawpatentblog.com<

Accord CSR – Cancer Patient Fundraising

Similar to previous years, and in line with its social corporate responsibility, Accord has actively taken part in community contribution by volunteering in a fund raising event, in this case against cancer.

Early May, Accord employees from the Spanish affiliate took part in a fund raising day for cancer patients. The aim of this action organized by the AECC – The Spanish Association Against Cancer – is to provide psychological and medical support to patients and their families, as well as promoting medical investigation in this field.

Accord expects participating in next year’s fund raising after this year’s great success and rewarding experience.