3. May 2012 12:53
Novartis has agreed a $1.525 billion cash deal to acquire New York-based dermatology generic specialist Fougera Pharmaceuticals.
The acquisition will create the world’s largest generic dermatology medicines company when combined with Novartis’ own generic arm Sandoz.
Jeff George, Global Head of Sandoz, said the deal will give patients access “to high quality, affordable dermatological medicines”.
Fougera, which employs around 700 staff primarily in two main sites in New York, earned net sales last year of $429m from its 45 products and 200 SKUs. It operates two main businesses: Fougera Pharmaceuticals and PharmaDerm – a branded specialty company with 17 brands and more than 40 SKUs.
According to 2011 IMS data, the Sandoz and Fougera’s combined businesses will generate global annual sales of around $620m, primarily in the US.
“Fougera and Sandoz serve many of the same customers in the US, creating significant sales and cost synergies with Sandoz’s sizeable US generics business,” said Don DeGolyer, President of Sandoz US. “We welcome the team from Fougera Pharmaceuticals into Sandoz and Novartis.”
The transaction, which still required regulatory approval, is expected to be completed towards the end of 2012.
3. May 2012 12:12
Pharmaceutical companies should collaborate more with patients during early-stage research in order to better meet the needs of its customers, according to a new report.
Research suggests that patient perspectives are increasingly been sought during drug development to help pharma identify and define valuable new medicines.
But further collaboration is needed, the report says, in order to consider the relevance to patients of new products so that clinical trials can be designed appropriately with these points in mind.
Patient Reported Outcomes (PROs) are not a new move by pharmaceutical companies conducting research during drug development.
Pharma has used PROs in cases where appropriate measurements in clinical trials must be developed and validated as part of the drug development process. But complex planning is initially required which often delays the start of research.
PROs are seen as valuable by health regulators with the FDA and EMA working on processes to support such schemes. Reimbursement authorities also use the outcomes to define value.
Organisations are also in place to assist pharmaceutical companies to gather information from patients, carers and clinicians who share interests in a particular disease area. The EU Patient Partnership Project promotes the roles of patient organisations during clinical trials to empower them to interact with key stakeholders during research stages.
But the project has identified barriers between pharma and patient bodies including a lack of expertise and awareness of clinical research by patients and an unwillingness to enter collaboration by pharma over concerns of negative publicity.
The report, Patient Perspectives – Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge, adds that these concerns need to be corrected and that further PRO tests are conducted to ensure that pharma meets the needs of patients, regulators and reimbursement authorities in the future.
3. May 2012 10:44
Both the US FDA and the EMA have approved a second suite for filling and finishing products at Genzyme’s manufacturing plant in Waterford, Ireland.
The approval means Genzyme will almost double its ability to fill and finish Pompe disease treatments Myozyme and Lumizyme (alglucosidase alfa).
Bill Aitchison, Genzyme’s Head of Global Manufacturing Operations, said the approval is an “important milestone” for Genzyme as it aims to build a “robust manufacturing network”.
The manufacturing site employs more than 500 people and has been in operation for more than a decade. It is considered to be Genzyme’s centre of excellence for aseptic manufacturing and recently underwent a $150 million expansion earlier this year.
Genzyme now hopes to begin the process of securing further approval from the American and European health regulators to fill and finish additional products in the suite. The Sanofi company has the long-term aim to use the Irish plant as a filling and finishing platform across its portfolio of products.