Affymetrix amended its acquisition agreement with eBiosciences

Affymetrix has amended its previous agreement signed in Nov 2011 to acquire eBioscience. With the new amended agreement, Affymetrix will pay $315M in cash subject to usual adjustments for the acquisition. The previously announced payment was $330M. The transaction is expected to close in the quarter ending June 30, 2012.  As with the previous agreement, the company will retain eBioscience's management team and operations in San Diego.

Affymetrix is headquartered in Santa Clara, CA. It has manufacturing facilities in Cleveland, Ohio and Singapore. The companies employ approximately 900 people worldwide.

Novartis acquired Fougera to become the biggest generic dermatology company worldwide

With Valeant has been trying its best to acquire as many companies as it can to make its presence in dermatology market, with one acquisition Sandoz, a generic dermatology division of Novartis, has positioned itself as the largest generic dermatology medicines worldwide and in the US. Sandoz announced that it has entered into a definitive agreement to acquire Fougera Pharmaceutical, a dermatology generics company with two primary sites located in New York, for $1.525B in an all-cash transaction.

The combined annual global sales of the two companies are estimated

Vosaroxin received orphan drug designation in the EU

Sunesis announced that the European Commission has granted orphan designation to the company's vosaroxin for the treatment of acute myeloid leukemia.  The designation will allow the company market vosaroxin exclusively for 110 years in all EU member countries once the product is approved for the proposed indication.

Vosaroxin has been given orphan drug status and fast

Valeant acquired University Medical Pharmaceuticals

Valeant Pharmaceuticals announced that it has entered into an agreement to acquire certain assets from University Medical Pharmaceuticals with approximately $64M plus potential milestones based on attainment of future revenue targets. University Medical is currently marketing AcneFree brand which is a the over-the-counter acne treatment.

The assets acquired through this transaction had approximately $32M in total revenues in 2011.

The FDA approved Elelyso of Pfizer and Protalix

Elelyso (taliglucerase) of Pfizer has received the US FDA approval for the long-term enzyme replacement therapy to treat a form of Gaucher disease.  This will mark the first approved plant cell-express medication that is derived from ProCellEx which is Protalix's proprietary manufacturing system using genetically engineered carrot cells.

Pfizer intends to prices taliglucerase injection at a 25% discount from the cost of imiglucerase.

Gaucher disease is an orphan disease. Type 1 Gaucher disease is often characterized by the lack of an enzyme called glucocerebrosidase that leads to a collection of lipids in the spleen, liver, kidney and other organs.  Patients with Gaucher disease often have disease-induced liver or spleen damage, low read blood cell counts, low blood platelets and bone problems. The disease is estimated to affect about 6,000 people in the US. 

Because of the rarity of the disease, the efficacy of the agent has only been studied in approximately 56 patients with type 1 Gaucher disease. In one of the clinical study, patients who had not received enzyme replacement therapy experienced improvement in spleen volumes at both study doses (30 units/kg and 60 units/kg) after nine months of treatment. This study enrolled approximately 31 patients. 

In another study that enrolled 25 patients who had previously received imiglucerase for at least two years, when Elelyso was given at the same dose as imiglucerase every other week, spleen and liver volumes, platelet counts and hemoglobin levels were maintained after 9 months of treatment. 

The most commonly observed adverse events were infusion reactions and allergic reactions. Symptoms of infusion reactions are headache, chest pain or discomfort, weakness, fatigue, hives, skin redness, increased blood pressure, back pain, joint pain, and flushing. Anaphylaxis reaction has also been observed in some patients receiving Elelyso infusions.

Pfizer will also introduced Gaucher Personal Support program in conjunction with the launch of the product. Through this program, Pfizer will provide assistance program that covering 100% of prescription co-pay expenses for eligible patients receiving Elelyso and having commercial health insurance. Pfizer will also set to provide financial assistance for eligible patients who are uninsured or under-insured where the law allows. 

For more information about GPS, please contact 8-55-ELELYSO (1-855-353-5976)

Pfizer and Protalix BioTherapeutics Collaboration

On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa. Under the terms of the agreement, Protalix has retained exclusive commercialization rights in Israel, while Pfizer received exclusive licensing rights for the commercialization of ELELYSO™ in all other markets. As part of this agreement, and at the conclusion of the FDA approval process, Protalix will transfer the ELELYSO™ NDA and IND to Pfizer.

Ista announced positive topline results of the phase II trial evaluating Beposone

Ista announced the positive topline results of the phase II trial evaluating Beposone nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis.

Beposone is a fixed dose combination of bepotastine and a steroid. The phase II trial was a randomized, multicenter, double-masked, placebo-controlled, parallel-group environmental

The FDA accepts the NDA submitted for lomitapide

Finding treatment of homozygous familial hypercholesterolemia, an orphan disease, is heating up with multiple companies are trying to get the drug to the market.

Aegerion of Cambridge, MA announced that the company's new drug application for lomitapide has been accepted for the review by the FDA. The company intends to seek approval to use lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies to reduce cholesterol in patients with homozygous familial hypercholesterolemia.

Lomitapide is an orally available, small

Mylan won patent infringement lawsuit and launched generic Doryx

Mylan announced that the company has launched doxycycline hyclate delayed release tablets 150 mg which is marketed by Warner Chilcott as Doryx.

The patent infringement lawsuit filed by Warner Chilcott to the US District Court for the District of New Jersey has been ruled in favor of Mylan.