February’s top stories: Actavis and Forest $25bn deal, Janssen Biotech’s FDA approval

5 March 2014 (Last Updated March 5th, 2014 01:00)

Actavis has entered into a definitive agreement to acquire specialty pharmaceutical company Forest Laboratories for $25bn, while Janssen Biotech has received US FDA approval to use its Imbruvica (ibrutinib) capsules for treatment of patients with chronic lymphocytic leukaemia. Pharmaceutical-technology.com wraps-up the key headlines from February 2014.

February’s top stories: Actavis and Forest $25bn deal, Janssen Biotech’s FDA approval

Actavis

Actavis to buy Forest Laboratories for $25bn

Actavis

Actavis entered into a definitive agreement to acquire fully integrated, specialty pharmaceutical company Forest Laboratories for $25bn, or $89.48 per Forest share in a cash and stock combination.

The acquisition of Forest is expected to be completed in 2015. It will increase specialty drugs to represent about 50% of combined company revenue of more than $15bn.

The deal is expected to yield double-digit accretion to non-GAAP earnings in 2015 and 2016, with significant annual free cash-flow generation of more than $4bn in 2015.

Janssen Biotech's leukaemia drug Imbruvica gets FDA approval

Janssen

Janssen Biotech received approval from the US Food and Drug Administration (FDA) to use its Imbruvica (ibrutinib) capsules for treatment of patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Imbruvica is being jointly developed and commercialised by Janssen and Pharmacyclics. It is the first once-daily, single-agent, oral Bruton's tyrosine kinase (BTK) inhibitor for patients with CLL, a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells.

The drug was previously approved by FDA in November 2013 to treat mantle cell lymphoma (MCL) patients who have received at least one prior therapy.

Alvogen launches first biosimilar monoclonal antibody Inflectra in Europe

Alvogen

US-based specialty pharmaceutical firm Alvogen launched a biosimilar monoclonal antibody (mAb) therapy 'Inflectra (Infliximab)' in Central and Eastern Europe.

Inflectra is a biosimilar medicine to the reference medicinal product 'Remicade (Infliximab)'. It is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway.

The drug has been approved to treat inflammatory conditions, including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.

Gilead submits NDA to US FDA for hepatitis C combination therapy

Gilead

Gilead Sciences filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400mg for treatment of patients with chronic hepatitis C genotype 1 infection.

The NDA includes data supporting the use of LDV/SOF in patients with genotype 1 HCV infection, with treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis.

The NDA is supported by three Phase III studies, ION-1, ION-2 and ION-3, where 2,000 genotype 1 HCV patients were given the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks.

Mallinckrodt to buy Cadence Pharmaceuticals for $1.3bn

Irish pharmaceutical firm Mallinckrodt entered into a definitive agreement to acquire US-based biopharmaceutical company Cadence for $1.3bn to strengthen its specialty drugs portfolio.

Subject to customary terms and conditions, the deal is expected to be complete by mid or late-March.

Under the deal, Mallinckrodt's subsidiary will start a tender offer to acquire all the outstanding shares of Cadence for $14 per share in cash.

FDA rejects expanded use of Bayer and Janssen's anti-clot drug Xarelto

Xarelto

The Food and Drug Administration rejected the supplemental new drug applications seeking the use of Bayer and Janssen's anti-clotting drug Xarelto (rivaroxaban) for prevention of heart attacks or strokes in patients with acute coronary syndrome (ACS).

FDA has issued complete response letters (CRLs) regarding supplemental new drug applications (sNDAs) for the use of Xarelto 2.5mg twice-daily (BID) in combination with standard antiplatelet therapy to reduce the risk of stent thrombosis in ACS patients.

Both sNDAs are based on results from the 15,526-patient Phase III ATLAS ACS 2 TIMI 51 (Anti-Xa therapy to lower cardiovascular events in addition to aspirin with/without thienopyridine therapy in subjects with acute coronary syndrome) clinical trial of Xarelto.

EMA panel issues positive opinion for lung drugs Anoro and Incruse

EMA

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation for GlaxoSmithKline (GSK) and Theravance's umeclidinium/vilanterol (UMEC/VI), under the brand name 'Anoro', for treatment of chronic obstructive pulmonary disease (COPD).

The drug is a combination of umeclidinium, a long-acting muscarinic antagonist (LAMA) that helps lung function, and vilanterol, a beta agonist that opens the airways, in a single inhaler, the Ellipta.

The European Commission's final decision on UMEC/VI is expected during the second quarter of 2014 and its proposed strength is 55mcg / 22mcg.

Health Canada approves Celgene's myeloma drug POMALYST

Health Canada

Health Canada approved Celgene's POMALYST oral therapy (pomalidomide capsules) in combination with dexamethasone for treatment of patients with multiple myeloma.

POMALYST is approved for patients for whom both lenalidomide and bortezomib have failed and who have received at least two prior treatments and shown disease progression on their last regimen.

It has been observed that treatment with POMALYST has improved rates of overall survival and extended progression-free survival in patients who no longer respond to lenalidomide or bortezomib.

Chelsea receives FDA accelerated approval for Northera for treatment of patients with symptomatic NOH

Chelsea Therapeutics received approval from the US Food and Drug Administration (FDA) to use Northera capsules (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).

Northera is the first and only therapy approved by the FDA, which shows symptomatic benefit in patients with NOH, a rare, chronic and often debilitating drop in blood pressure upon standing that is related with Parkinson's disease, multiple-system atrophy and pure autonomic failure.

Approval was granted under the FDA's accelerated approval programme, which allows for conditional approval of a drug to treat serious unmet medical need based on clinical data showing that the drug has an effect on an intermediate clinical measure.

European Universities and companies partner in €85m antibiotics development project

European

More than 30 European universities and companies, led by GlaxoSmithKline (GSK) and Uppsala University in Sweden, have joined forces in a €85m six-year programme funded by the Innovative Medicines Initiative (IMI) for developming new antibiotics to combat Gram-negative pathogens.

Despite the growing epidemic of antibiotics resistance, only two new classes of antibiotics have been brought to the market in the last 30 years, necessitating the discovery of new antibiotics.

However, the discovery and development of new antibiotics poses significant scientific, clinical, and financial challenges especially against Gram-negative bacteria, which have effective barriers against drugs.