ViroPharma has signed a definitive agreement to acquire Swedish-based DuoCort Pharma AB for an initial $33.6 million – but only if Plenadren is approved by the European Commission (EC).

Under the terms of the agreement, the deal will be closed after the tablet’s approval, after the EC’s confirmation of Plenadren’s orphan drug designation, and an amended agreement with the product’s contract manufacturer.

Vincent Milano, ViroPharma's President and CEO, says the deal is in line with the company’s “objective of broadening our orphan drug portfolio”.

Further milestone patients of up to $131 million associated with manufacturing, sales thresholds and territory expansion have also been agreed as part of the acquisition.

Plenadren is a once daily dual-release oral glucocorticoid tablet with a release profile designed to closely mimic the body's natural secretion pattern of cortisol. ViroPharma now anticipates the commercial launch of the treatment – which it says will be the first “true innovation in over 50 years” – of adrenal insufficiency in the EU within a year. It estimates that peak annual sales for Plenadren could reach up to $50 million.

The Committee for Orphan Medicinal Products confirmed in September that Plenadren’s orphan designation would be maintained and protected for a decade of market exclusivity.

Bristol-Myers Squibb and Gilead Sciences have signed a licensing agreement to develop and commercialise a potential fixed-dose combination single pill for the treatment of HIV.

The combination would include BMS’ protease inhibitor Reyataz (atazanavir sulfate) and Gilead’s pharmacoenhancing agent cobicistat.

Elliott Sigal, Executive Vice President, Chief Scientific Officer and President, R&D, BMS, says the pill has the potential “simplify HIV therapy” and address unmet needs for innovative treatment options.

The combination is currently being studied in Phase II and Phase III studies in HIV-1 treatment-naive patients.

Reyataz is a prescription medicine used in combination with other medicines to treat people aged 6 years of age and older who are infected with HIV. Gilead’s cobicistat is a boosting agent that increases blood levels of certain strains of the virus.

Under the terms of the agreement, BMS will be responsible for the worldwide formulation, manufacturing, development, registration, distribution, and commercialisation. It will pay Gilead an undisclosed royalty based on the annual net sales of the product when released.

“This collaboration with Gilead builds on Bristol-Myers Squibb’s longstanding commitment to develop medicines that have the potential to provide meaningful benefit to HIV patients, specifically aiming to enhance treatment options,” said Mr Sigal.

Gilead will retain the sole rights for the manufacturing, development and commercialisation of cobicistat as a stand-alone product and for any future combinations with other agents.

Krka, d.d., Novo mesto has formally withdrawn its marketing application for Desloratadine Krka (desloratadine) with the EMA.

The generic of Aerius was intended to be used for the relief of symptoms associated with allergic rhinitis and urticaria.

In its official letter, Krka, d.d., Novo mesto said the withdrawal was down to a change in marketing strategy.

At the time of withdrawal, the tablets were awaiting marketing authorisation by the European Commission.

The application for a centralised marketing application was submitted to the EMA in February after Aerius was authorised for use in the EU in January. Prior to its application being pulled, the CHMP issued a positive opinion at its September meeting.

Pfizer is suing Merck to try to block its new Lipitor-plus-Zetia combination drug.

The new pill will be similar to Merck’s Vytorin, combining the company’s own statin drug Zocor (simvastatin) with cholesterol medication Zetia.

Analysts expect a Lipitor/Zetia version to generate $500 million by 2015.

Pfizer has faced generic competition from various angles on its blockbuster cholesterol therapy. The company recently reached a settlement agreement with a number of pharmaceutical companies to delay the launch of generic versions of Lipitor (atorvastatin) in the UK until May 2012.

It has also allowed Ranbaxy Laboratories to sell its generic version of the drug on November 30^th as well as agreeing to supply an authorised generic to Watson Laboratories on the same day.

However, Pfizer still has some patents on Lipitor that aren’t due to expire for a few years, and is citing one of these in its case against Merck.

The company has stated the patent covering Lipitor's crystalline structure, which is due to expire in 2017, but Merck claims that its Lipitor-plus-Zetia pill won't infringe on the patent.

The lawsuit triggers a 30-month regulatory delay, during which time efficacy questions about Vytorin will be asked. A previous study has found no significant difference in arterial narrowing with Vytorin than with Zocor use alone.

A new study is due in 2013, and if the clinical data works against Vytorin, then a Lipitor/Zetia combo may not be as successful in the market as expected.

The CHMP has adopted a positive opinion for Novartis’ Rasitrio, recommended as replacement therapy for patients with high blood pressure.

The single-pill treatment combines calcium channel blocker amlodipine with the diuretic hydrochlorothiazide (HCT) and Rasilez, the only approved direct renin inhibitor in the world.

Professor Roland E. Schmieder at the University Hospital of the University Erlangen-Nuremberg, Germany, commented that the drug will provide patients with a “comprehensive and convenient high blood pressure treatment in one pill”.

The CHMP positive opinion of Rasitrio is based on a Phase III clinical trial involving more than 1,181 patients with high blood pressure. Data showed that Rasitrio significantly reduced blood pressure compared to dual combinations of each of its individual components.

David Epstein, Division Head of Novartis Pharmaceuticals, said: “This positive CHMP opinion is an important step towards approval and making this new triple combination therapy available for patients whose blood pressure is not under control and who may require multiple medications.”

Approximately 1 billion people have high blood pressure worldwide, with many remaining uncontrolled despite treatment, with up to 85% of patients requiring multiple medications to help control their blood pressure.

High blood pressure can cause damage to the heart, brain and kidneys and is also linked with other conditions such as diabetes.

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

Merck has secured the worldwide exclusive rights to PI-2301, an experimental drug for multiple sclerosis (MS).

The acquisition from Peptimmune Inc covers the development and commercialisation rights for the product which has just completed Phase 1b clinical trials.

Susan Herbert, Head of Global Portfolio Development at the Merck Serono division says the drug “could play a valuable role in the treatment of this debilitating disease”.

The second-generation peptide copolymer is believed to enhance the regulatory response of the immune system. Merck will now investigate the application of the product in autoimmune diseases as it progresses to Phase II clinical trials.

“Over the years we have continuously worked on developing innovative treatment options that meet the individual needs of people living with multiple sclerosis,” said Susan Herbert.